1. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), today announced that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra, will participate in a fireside conversation with Justin Kim, Executive Director, Biotech Equity Research for Oppenheimer & Co. at the virtual Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on Wednesday, September 22, 2021 at 9:55 a.m. ET.

    A live webcast of the conversation will be available on the Investors & Media page of the company's website. The event will remain archived on the website for 90 days.

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a biotechnology company developing novel immune-modulating therapies to treat ocular and systemic diseases. Two of the company's…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), today announced that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra, will participate in a fireside conversation with Justin Kim, Executive Director, Biotech Equity Research for Oppenheimer & Co. at the virtual Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on Wednesday, September 22, 2021 at 9:55 a.m. ET.

    A live webcast of the conversation will be available on the Investors & Media page of the company's website. The event will remain archived on the website for 90 days.

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a biotechnology company developing novel immune-modulating therapies to treat ocular and systemic diseases. Two of the company's lead product candidates, reproxalap and ADX-629, target RASP, which are pre-cytokine, systems-based mediators of inflammation. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191 (methotrexate for intravitreal injection), a drug candidate in Phase 3 testing for the prevention of proliferative vitreoretinopathy. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

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  2. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a biotechnology company developing novel immune-modulating therapies to treat ocular and systemic diseases, today announced that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra, will participate in the following investor conferences:

    • Citi's 16th Annual BioPharma Virtual Conference
      Date: Thursday, September 9, 2021
      Time: 8:50 a.m. ET

      Panel: Eyes on the Prize - Next Generation Retinal Therapeutics

    • H.C. Wainwright 23rd Annual Global Investment Conference
      Date: Monday, September 13, 2021
      Time: Available On-Demand Beginning at 7:00 a.m. ET
      Format: Analyst-Hosted Fireside Conversation

    To view these events, please visit the Investors & Media page of the company's…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a biotechnology company developing novel immune-modulating therapies to treat ocular and systemic diseases, today announced that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra, will participate in the following investor conferences:

    • Citi's 16th Annual BioPharma Virtual Conference

      Date: Thursday, September 9, 2021

      Time: 8:50 a.m. ET

      Panel: Eyes on the Prize - Next Generation Retinal Therapeutics

    • H.C. Wainwright 23rd Annual Global Investment Conference

      Date: Monday, September 13, 2021

      Time: Available On-Demand Beginning at 7:00 a.m. ET

      Format: Analyst-Hosted Fireside Conversation

    To view these events, please visit the Investors & Media page of the company's website. After the presentations, the events will remain archived on the website for 90 days.

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a biotechnology company developing novel immune-modulating therapies to treat ocular and systemic diseases. Two of the company's lead product candidates, reproxalap and ADX-629, target RASP, which are pre-cytokine, systems-based mediators of inflammation. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191 (methotrexate for intravitreal injection), a drug candidate in Phase 3 testing for the prevention of proliferative vitreoretinopathy. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

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    • Top-Line Results from Phase 3 TRANQUILITY and TRANQUILITY-2 Clinical Trials of Reproxalap in Dry Eye Disease Expected in Fourth Quarter of 2021
    • U.S. FDA Grants Orphan Drug Designation to ADX-2191 for the Treatment of Primary Vitreoretinal Lymphoma and Retinitis Pigmentosa
    • Initial Results from Phase 2 Clinical Trials of Oral RASP Inhibitor ADX-629 in Multiple Systemic Indications Anticipated in Fourth Quarter of 2021 or First Quarter of 2022
    • Cash and Cash Equivalents of $249.7 Million as of June 30, 2021; Projected Cash Runway Through 2023, Including Potential New Drug Applications; Initial Commercialization of Reproxalap, if Approved; and Continued Development of Compounds for Retinal and Systemic Diseases
    • Management to Host Conference
    • Top-Line Results from Phase 3 TRANQUILITY and TRANQUILITY-2 Clinical Trials of Reproxalap in Dry Eye Disease Expected in Fourth Quarter of 2021
    • U.S. FDA Grants Orphan Drug Designation to ADX-2191 for the Treatment of Primary Vitreoretinal Lymphoma and Retinitis Pigmentosa
    • Initial Results from Phase 2 Clinical Trials of Oral RASP Inhibitor ADX-629 in Multiple Systemic Indications Anticipated in Fourth Quarter of 2021 or First Quarter of 2022
    • Cash and Cash Equivalents of $249.7 Million as of June 30, 2021; Projected Cash Runway Through 2023, Including Potential New Drug Applications; Initial Commercialization of Reproxalap, if Approved; and Continued Development of Compounds for Retinal and Systemic Diseases
    • Management to Host Conference Call at 8:00 a.m. ET Today

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a biotechnology company developing novel immune-modulating therapies to treat ocular and systemic diseases, today reported financial results for the quarter ended June 30, 2021 and recent corporate highlights.

    "We continue to make meaningful strides toward our goal of developing effective and highly differentiated new therapies to treat ocular and systemic diseases with significant unmet medical need," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. "We remain on schedule to report top-line results from the Phase 3 TRANQUILITY and TRANQUILITY-2 dry eye disease clinical trials in the fourth quarter of this year, and we look forward to releasing results of our Phase 2 clinical trials of ADX-629 in systemic immunological diseases by the end of the year or early 2022."

    Recent Corporate Highlights and Program Updates

    • Phase 3 TRANQUILITY and TRANQUILITY-2 Dry Eye Disease Clinical Trial Results Expected in the Fourth Quarter of 2021: Enrollment is ongoing in the dry eye chamber Phase 3 TRANQUILITY Trial of reproxalap. An identical trial, TRANQUILITY-2, is expected to begin enrollment this quarter. Ocular redness is the primary endpoint of the TRANQUILITY trials, which include tear RASP levels, Schirmer's test, and dry-eye symptoms as secondary endpoints. Top-line results are expected in the fourth quarter of this year. In addition, the company has initiated a multi-center, double-masked, randomized, vehicle-controlled, parallel-group Phase 2 clinical trial of reproxalap in dry eye disease. The Phase 2 trial is designed to optimize the measurement of tear RASP levels, with approximately 75 patients expected to be enrolled per arm. Similar to TRANQUILITY, ocular redness is the primary endpoint in the trial.
    • Orphan Drug Designation Granted for ADX-2191 in Two Additional Retinal Disease Indications: The U.S. Food and Drug Administration (FDA) granted orphan drug designation to ADX-2191 (methotrexate for intravitreal injection) for the treatment of two rare retinal diseases: primary vitreoretinal lymphoma, an aggressive, high-grade cancer; and retinitis pigmentosa (RP), a clinical group of rare genetic eye diseases characterized by retinal cell death and loss of vision. Aldeyra plans to initiate a Phase 2 clinical trial of ADX-2191 in patients with RP this year. The FDA's orphan drug designation program is designed to provide financial incentives to sponsors for developing drugs and biologics for rare diseases and conditions, in part defined as affecting fewer than 200,000 people in the United States. Sponsors of designated orphan drugs are eligible for partial tax credits for clinical trial costs, waiver of the user fee for marketing applications and, upon approval, consideration for seven years of marketing exclusivity.
    • Phase 2 Clinical Trial Results from ADX-629, an Orally Available, Systems-Based RASP Inhibitor, Expected in the Fourth Quarter of 2021 or First Quarter of 2022: Initial Phase 2 clinical trial results from ADX-629, a novel orally available RASP inhibitor currently undergoing testing in asthma, psoriasis, and COVID-19, are expected in the fourth quarter of 2021 or first quarter of 2022. ADX-629 represents a first-in-class systems-based therapeutic approach for the potential treatment of a myriad of immune-mediated diseases that today are treated with single-target drugs that can lead to serious toxicity.

    Second-Quarter 2021 Financial Results

    Cash and cash equivalents as of June 30, 2021 were $249.7 million. Based on Aldeyra's current operating plan, the company believes that existing cash and cash equivalents will be sufficient to fund currently projected operating expenses through the end of 2023, including potential New Drug Application submissions for reproxalap; initial commercialization of reproxalap, if approved; and continued development of the company's product candidates in ocular and systemic immune-mediated diseases.

    For the quarter ended June 30, 2021, Aldeyra reported a net loss of $14.9 million, compared with a net loss of $7.5 million for the quarter ended June 30, 2020. Net loss per share was $0.28 for the quarter ended June 30, 2021, compared with $0.25 for the same period in 2020. Losses have resulted from the costs of clinical trials and research and development programs, as well as from general and administrative expenses.

    Research and development expenses were $11.5 million for the quarter ended June 30, 2021, compared with $4.9 million for the same period in 2020. The increase of $6.6 million is primarily related to the increase in clinical research and development expenditures.

    General and administrative expenses were $3.1 million for the quarter ended June 30, 2021, compared with $2.2 million for the quarter ended June 30, 2020. The increase of $0.9 million is primarily due to an increase in personnel-related costs and other miscellaneous administrative expenses.

    For the quarter ended June 30, 2021, total operating expenses were $14.5 million, compared with total operating expenses of $7.1 million for the same period in 2020.

    Conference Call & Webcast Information

    Aldeyra will host a conference call at 8:00 a.m. ET today to discuss second-quarter 2021 financial results and recent corporate highlights. The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 4968588. Due to expected high demand, please dial in at least 15 minutes prior to the start time.

    A live webcast of the conference call will also be available on the Investor Relations page of the company's website at https://ir.aldeyra.com. After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a biotechnology company developing novel immune-modulating therapies to treat ocular and systemic diseases. Two of the company's lead product candidates, reproxalap and ADX-629, target RASP, which are pre-cytokine, systems-based mediators of inflammation. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191 (methotrexate for intravitreal injection), a drug candidate in Phase 3 testing for the prevention of proliferative vitreoretinopathy. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

    Safe Harbor Statement

    This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding submission of potential New Drug Applications; the anticipated timing of results from Aldeyra's clinical trials; and Aldeyra's projected cash runway. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "on track," "scheduled," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra's clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; updated or refined data based on Aldeyra's continuing review and quality control analysis of clinical data, Aldeyra's ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities; delay in or failure to obtain regulatory approval of Aldeyra's product candidates; the ability to maintain regulatory approval of Aldeyra's product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Aldeyra's product candidates in clinical trials focused on the same or on different indications; the risk that the results from smaller clinical trials or portions of clinical trials may not accurately predict results of larger scale trials or the remainder of a clinical trial; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; uncertainty as to Aldeyra's ability to commercialize (alone or with others) Aldeyra's product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency or use of Aldeyra's cash resources and needs for additional financing; political, economic, legal, social and health risks, including the recent COVID-19 outbreak and subsequent public health measures, that may affect Aldeyra's business or the global economy; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding competition; Aldeyra's anticipated growth strategies; Aldeyra's ability to attract or retain key personnel; Aldeyra's limited sales and marketing infrastructure; Aldeyra's ability to establish and maintain development partnerships; Aldeyra's ability to successfully integrate acquisitions into its business; Aldeyra's expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra's ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra's business and the market in which it operates; and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2020, which is on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at https://www.sec.gov/. Additional factors may be described in those sections of Aldeyra's Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, expected to be filed with the SEC in the third quarter of 2021.

    In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

    ALDEYRA THERAPEUTICS, INC.
    CONSOLIDATED BALANCE SHEETS
     
     
     
    June 30, December 31,

    2021

     

    2020

    ASSETS (Unaudited)
    Current assets:
    Cash and cash equivalents

    $ 124,739,010

    $ 52,858,311

    Cash equivalent - reverse repurchase agreements

    125,000,000

    25,000,000

    Prepaid expenses and other current assets

    6,521,718

    5,200,957

    Total current assets

    256,260,728

    83,059,268

    Right-of-use assets

    118,401

    233,310

    Fixed assets, net

    48,083

    59,925

    Total assets

    $ 256,427,212

    $ 83,352,503

     
     
    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current liabilities:
    Accounts payable

    $ 1,094,461

    $ 381,638

    Accrued expenses

    6,196,300

    8,134,765

    Current portion of credit facility

    3,659,776

    Current portion of operating lease liabilities

    118,401

    233,310

    Total current liabilities

    7,409,162

    12,409,489

    Long-term debt

    15,338,105

    11,434,456

    Total liabilities

    22,747,267

    23,843,945

     
    Commitments and contingencies
    Stockholders' equity:
    Common stock, voting, $0.001 par value; 150,000,000 authorized

    and 57,997,345 and 38,667,491 shares issued and outstanding, respectively

    57,997

    38,667

    Additional paid-in capital

    496,764,448

    296,385,619

    Accumulated deficit

    (263,142,500)

    (236,915,728)

    Total stockholders' equity

    233,679,945

    59,508,558

    Total liabilities and stockholders' equity

    $ 256,427,212

    $ 83,352,503

    ALDEYRA THERAPEUTICS, INC.
    CONSOLIDATED STATEMENTS OF OPERATIONS
    (UNAUDITED)
     
     
    Three Months Ended June 30, Six Months Ended June 30,

    2021

     

    2020

     

     

    2021

     

    2020

     
    Operating expenses:
    Research and development

    $ 11,474,446

    $ 4,885,875

    $ 19,200,788

    $ 11,519,478

    General and administrative

    3,068,652

    2,220,003

    6,173,355

    5,224,844

    Loss from operations

    (14,543,098)

    (7,105,878)

    (25,374,143)

    (16,744,322)

     
    Other income (expense):
    Interest income

    39,665

    71,710

    63,427

    281,809

    Interest expense

    (433,477)

    (486,048)

    (916,056)

    (925,863)

    Total other income (expense), net

    (393,812)

    (414,338)

    (852,629)

    (644,054)

    Net loss

    $ (14,936,910)

    $ (7,520,216)

    $ (26,226,772)

    $ (17,388,376)

     
    Net loss per share - basic and diluted

    $ (0.28)

    $ (0.25)

    $ (0.52)

    $ (0.59)

     
    Weighted average common shares outstanding - basic and diluted

    54,280,393

    30,118,456

    49,979,545

    29,586,148

     

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  3. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for ADX-2191 (methotrexate for intravitreal injection) for the treatment of retinitis pigmentosa (RP). There are no approved drug treatments for patients with RP, a clinical group of rare genetic eye diseases characterized by retinal cell death and loss of vision. The disease affects an estimated 82,000-110,000 individuals in the United States, and approximately 1 in 4,000 people worldwide.

    "Retinitis pigmentosa is a serious and incurable sight-threatening disease that represents a major unmet need in the field of ophthalmology," stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for ADX-2191 (methotrexate for intravitreal injection) for the treatment of retinitis pigmentosa (RP). There are no approved drug treatments for patients with RP, a clinical group of rare genetic eye diseases characterized by retinal cell death and loss of vision. The disease affects an estimated 82,000-110,000 individuals in the United States, and approximately 1 in 4,000 people worldwide.

    "Retinitis pigmentosa is a serious and incurable sight-threatening disease that represents a major unmet need in the field of ophthalmology," stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "ADX-2191 has now received orphan designations for three distinct clinical indications, highlighting the broad platform potential of ADX-2191 to treat an array of rare retinal disorders."

    Methotrexate inhibits dihydrofolic reductase, an enzyme involved in cellular replication and activation. In addition to RP, the FDA has granted orphan drug designation to ADX-2191 for the treatment of primary vitreoretinal lymphoma, a rare, aggressive, high-grade cancer; and both orphan drug and fast track designation to ADX-2191 for the prevention of proliferative vitreoretinopathy, a rare inflammatory disorder of the retina that leads to severe retinal scarring and blindness and is the leading cause of failure of retinal reattachment surgery.

    The FDA's orphan drug designation program is designed to provide financial incentives to sponsors for developing drugs and biologics for rare diseases and conditions, in part defined as affecting fewer than 200,000 people in the United States. Sponsors of designated orphan drugs are eligible for partial tax credits for clinical trial costs, waiver of the user fee for marketing applications and, upon approval, consideration for seven years of marketing exclusivity.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a biotechnology company developing novel immune-modulating therapies to treat ocular and systemic diseases. Two of the company's lead product candidates, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are pre-cytokine, systems-based mediators of inflammation. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191 (methotrexate for intravitreal injection), a drug candidate in Phase 3 testing for the prevention of proliferative vitreoretinopathy. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

    Safe Harbor Statement

    This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Aldeyra's plans and expectations for its product candidates, including ADX-2191. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "on track," "scheduled," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra's clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; updated or refined data based on Aldeyra's continuing review and quality control analysis of clinical data, Aldeyra's ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities; delay in or failure to obtain regulatory approval of Aldeyra's product candidates; the ability to maintain regulatory approval of Aldeyra's product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Aldeyra's product candidates in clinical trials focused on the same or on different indications; the risk that the results from smaller clinical trials or portions of clinical trials may not accurately predict results of larger scale trials or the remainder of a clinical trial; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; uncertainty as to Aldeyra's ability to commercialize (alone or with others) Aldeyra's product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency or use of Aldeyra's cash resources and needs for additional financing; political, economic, legal, social and health risks, including the recent COVID-19 outbreak and subsequent public health measures, that may affect Aldeyra's business or the global economy; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding competition; Aldeyra's anticipated growth strategies; Aldeyra's ability to attract or retain key personnel; Aldeyra's limited sales and marketing infrastructure; Aldeyra's ability to establish and maintain development partnerships; Aldeyra's ability to successfully integrate acquisitions into its business; Aldeyra's expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra's ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra's business and the market in which it operates; and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2020 and Form 10-Q for the quarter ended March 31, 2021, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at https://www.sec.gov/. Additional factors may be set forth in those sections of Aldeyra's Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, expected to be filed with the SEC in the third quarter of 2021.

    In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

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  4. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that President and Chief Executive Officer Todd C. Brady, M.D., Ph.D. will participate in analyst-led fireside conversations at the BTIG Virtual Biotechnology Conference and the H.C. Wainwright Ophthalmology Virtual Conference.

    • BTIG Virtual Biotechnology Conference
      Date: Monday, August 9, 2021
      Time: 9:30 a.m. ET
    • H.C. Wainwright Ophthalmology Virtual Conference
      Date: Tuesday, August 17, 2021
      Time: Available On-Demand Beginning at 7:00 a.m. ET

    To view these events, please visit the Investor & Media page of the company's website. After the presentations, the events will remain archived on the website for 90 days.

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that President and Chief Executive Officer Todd C. Brady, M.D., Ph.D. will participate in analyst-led fireside conversations at the BTIG Virtual Biotechnology Conference and the H.C. Wainwright Ophthalmology Virtual Conference.

    • BTIG Virtual Biotechnology Conference

      Date: Monday, August 9, 2021

      Time: 9:30 a.m. ET
    • H.C. Wainwright Ophthalmology Virtual Conference

      Date: Tuesday, August 17, 2021

      Time: Available On-Demand Beginning at 7:00 a.m. ET

    To view these events, please visit the Investor & Media page of the company's website. After the presentations, the events will remain archived on the website for 90 days.

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a biotechnology company developing novel immune-modulating therapies to treat ocular and systemic diseases. Two of the company's lead product candidates, reproxalap and ADX-629, target RASP, which are pre-cytokine, systems-based mediators of inflammation. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191 (methotrexate for intravitreal injection), a drug candidate in Phase 3 testing for the prevention of proliferative vitreoretinopathy. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

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  5. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) will host a conference call at 8:00 a.m. ET Thursday, August 5, 2021 to report financial results for the quarter ended June 30, 2021 and discuss recent business highlights.

    The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 4968588. A live webcast of the conference call will also be available on the Investors & Media page of the company's corporate website at https://ir.aldeyra.com.

    After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a biotechnology company developing novel immune-modulating therapies…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) will host a conference call at 8:00 a.m. ET Thursday, August 5, 2021 to report financial results for the quarter ended June 30, 2021 and discuss recent business highlights.

    The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 4968588. A live webcast of the conference call will also be available on the Investors & Media page of the company's corporate website at https://ir.aldeyra.com.

    After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a biotechnology company developing novel immune-modulating therapies to treat ocular and systemic diseases. Two of the company's lead product candidates, reproxalap and ADX-629, target RASP, which are pre-cytokine, systems-based mediators of inflammation. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191 (methotrexate for intravitreal injection), a drug candidate in Phase 3 testing for the prevention of proliferative vitreoretinopathy. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

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  6. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company for ADX-2191 (methotrexate for intravitreal injection) for the treatment of primary vitreoretinal lymphoma (PVRL). There are no approved treatments for PVRL, a rare, aggressive, high-grade cancer that affects approximately 2,800 people in the United States, with approximately 600 new cases diagnosed annually.

    "PVRL is an often fatal cancer that creates unique challenges for diagnosis and treatment," stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "The FDA's orphan drug designation fosters an important clinical development and commercialization pathway for ADX-2191…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company for ADX-2191 (methotrexate for intravitreal injection) for the treatment of primary vitreoretinal lymphoma (PVRL). There are no approved treatments for PVRL, a rare, aggressive, high-grade cancer that affects approximately 2,800 people in the United States, with approximately 600 new cases diagnosed annually.

    "PVRL is an often fatal cancer that creates unique challenges for diagnosis and treatment," stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "The FDA's orphan drug designation fosters an important clinical development and commercialization pathway for ADX-2191, which represents the first methotrexate preparation specifically formulated for intraocular injection. The designation is another important step forward for our retinal disease program, complementing our ongoing clinical development of ADX-2191 for the prevention of proliferative vitreoretinopathy, the leading cause of failure of retinal reattachment surgery."

    The FDA's orphan drug designation program is designed to provide financial incentives to sponsors for developing drugs and biologics for rare diseases and conditions, in part defined as affecting fewer than 200,000 people in the United States. Sponsors of designated orphan drugs are eligible for tax credits for clinical trial costs, waiver of the user fee for marketing applications and, upon approval, consideration for seven years of marketing exclusivity.

    About ADX-2191

    ADX-2191 (methotrexate for intravitreal injection) inhibits dihydrofolate reductase, an enzyme involved in cellular replication and activation. Methotrexate is the most commonly used intravitreal medication for the treatment of PVRL. ADX-2191 was previously granted orphan drug status and fast track designation by the FDA for the prevention of proliferative vitreoretinopathy, a rare but serious sight-threatening retinal disease with no approved treatment.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a biotechnology company developing novel immune-modulating therapies to treat ocular and systemic diseases. Two of the company's lead product candidates, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are pre-cytokine, systems-based mediators of inflammation. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191 (methotrexate for intravitreal injection), a drug candidate in Phase 3 testing for proliferative vitreoretinopathy. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

    Safe Harbor Statement

    This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Aldeyra's plans and expectations for its product candidates, including ADX-2191. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "on track," "scheduled," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra's clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; updated or refined data based on Aldeyra's continuing review and quality control analysis of clinical data, Aldeyra's ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities; delay in or failure to obtain regulatory approval of Aldeyra's product candidates; the ability to maintain regulatory approval of Aldeyra's product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Aldeyra's product candidates in clinical trials focused on the same or on different indications; the risk that the results from smaller clinical trials or portions of clinical trials may not accurately predict results of larger scale trials or the remainder of a clinical trial; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; uncertainty as to Aldeyra's ability to commercialize (alone or with others) Aldeyra's product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency or use of Aldeyra's cash resources and needs for additional financing; political, economic, legal, social and health risks, including the recent COVID-19 outbreak and subsequent public health measures, that may affect Aldeyra's business or the global economy; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding competition; Aldeyra's anticipated growth strategies; Aldeyra's ability to attract or retain key personnel; Aldeyra's limited sales and marketing infrastructure; Aldeyra's ability to establish and maintain development partnerships; Aldeyra's ability to successfully integrate acquisitions into its business; Aldeyra's expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra's ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra's business and the market in which it operates; and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2020 and Form 10-Q for the quarter ended March 31, 2021, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at https://www.sec.gov/. Additional factors may be set forth in those sections of Aldeyra's Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, expected to be filed with the SEC in the third quarter of 2021.

    In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

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  7. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a biotechnology company developing novel immune-modulating therapies to treat ocular and systemic diseases, today announced that the company was added to the broad-market Russell 3000® Index and the small-cap Russell 2000® Index, effective after the U.S. market opened on June 28, 2021, as part of the 2021 Russell reconstitution.

    The annual reconstitution of the Russell indexes captures the 4,000 largest US stocks as of May 7, 2021 by total market capitalization. The Russell 3000® Index is comprised of the large-cap Russell 1000® Index and the small-cap Russell 2000® Index. FTSE Russell, a leading global index provider, determines membership for the Russell indexes primarily by objective…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a biotechnology company developing novel immune-modulating therapies to treat ocular and systemic diseases, today announced that the company was added to the broad-market Russell 3000® Index and the small-cap Russell 2000® Index, effective after the U.S. market opened on June 28, 2021, as part of the 2021 Russell reconstitution.

    The annual reconstitution of the Russell indexes captures the 4,000 largest US stocks as of May 7, 2021 by total market capitalization. The Russell 3000® Index is comprised of the large-cap Russell 1000® Index and the small-cap Russell 2000® Index. FTSE Russell, a leading global index provider, determines membership for the Russell indexes primarily by objective, market-capitalization rankings and style attributes.

    "Our addition to the Russell indexes reflects the growing interest in Aldeyra over the past 12 months, as we have advanced reproxalap toward commercialization in dry eye disease and allergic conjunctivitis, initiated Phase 2 clinical trials of ADX-629 in systemic disease, and enhanced our liquidity," stated Todd C. Brady, M.D., Ph.D., the company's President and Chief Executive Officer. "As a result of our strong pipeline, highly differentiated therapeutic approach, and anticipated development milestones, Aldeyra is well positioned to attract new investors in the coming quarters."

    Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell's US indexes.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a biotechnology company developing novel immune-modulating therapies to treat ocular and systemic diseases. Two of the company's lead product candidates, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are pre-cytokine, systems-based mediators of inflammation. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

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  8. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021, at 4:30 p.m. ET.

    A live webcast of the fireside chat will be available on the investor relations page of the company's corporate website at https://ir.aldeyra.com. After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics
    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021, at 4:30 p.m. ET.

    A live webcast of the fireside chat will be available on the investor relations page of the company's corporate website at https://ir.aldeyra.com. After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead product candidates, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

    View Full Article Hide Full Article
    • Recently Announced Phase 3 INVIGORATE Clinical Trial Results Indicated Statistically Significant Activity of Reproxalap in Ocular Itching and Redness Associated with Allergic Conjunctivitis
    • Top-Line Results from Phase 3 TRANQUILITY and TRANQUILITY-2 Trials of Reproxalap in Dry Eye Disease Expected in the Second Half of 2021
    • Initial Phase 2 Clinical Trial Results for ADX-629, a Novel Orally Available Systems-Based RASP Inhibitor with Potential Broad Applicability Across Immune-Mediated Diseases, Expected in the Second Half of 2021
    • Raised Gross Proceeds of $125 Million Before Deduction of Underwriting Discounts and Commissions, in Underwritten Public Offering
    • Projected Cash Runway Through 2023, Including Potential New Drug Applications;
    • Recently Announced Phase 3 INVIGORATE Clinical Trial Results Indicated Statistically Significant Activity of Reproxalap in Ocular Itching and Redness Associated with Allergic Conjunctivitis
    • Top-Line Results from Phase 3 TRANQUILITY and TRANQUILITY-2 Trials of Reproxalap in Dry Eye Disease Expected in the Second Half of 2021
    • Initial Phase 2 Clinical Trial Results for ADX-629, a Novel Orally Available Systems-Based RASP Inhibitor with Potential Broad Applicability Across Immune-Mediated Diseases, Expected in the Second Half of 2021
    • Raised Gross Proceeds of $125 Million Before Deduction of Underwriting Discounts and Commissions, in Underwritten Public Offering
    • Projected Cash Runway Through 2023, Including Potential New Drug Applications; Initial Commercialization of Reproxalap, if Approved; and Continued Pipeline Development
    • Management to Host Conference Call at 8:00 a.m. ET Today

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today reported financial results for the quarter ended March 31, 2021 and provided recent business highlights.

    "We expect 2021 to be a catalyst-rich year for Aldeyra as we continue to advance reproxalap, our lead program, toward potential commercialization in anterior ocular inflammatory disease," stated President and CEO Todd C. Brady, M.D., Ph.D. "We recently completed the Phase 3 INVIGORATE Trial of reproxalap, achieving statistically significant superiority over vehicle across all assessed signs and symptoms of allergic conjunctivitis, including ocular itching and redness. We look forward to meeting with the U.S. Food and Drug Administration in the second half of this year to discuss the INVIGORATE results and the potential submission of a New Drug Application (NDA). In addition, we remain on track to report top-line results in the second half of this year from the Phase 3 TRANQUILITY and TRANQUILITY-2 clinical trials of reproxalap in dry eye disease.

    "We believe we continue to operate from a position of financial strength," Dr. Brady stated. "With the recent follow-on public offering, we expect to have sufficient capital to prepare reproxalap for NDA submission and a potential commercial launch, if approved, while investing in the clinical development of ADX-629, ADX-2191, and other product candidates in retinal and systemic immunological diseases with unmet medical need."

    Recent Highlights and Program Updates

    • Primary, Key Secondary, and All Secondary Endpoints Met in Phase 3 INVIGORATE Allergic Conjunctivitis Clinical Trial: In the first-ever Phase 3 clinical trial of a novel investigational product in an allergen chamber, 0.25% reproxalap ophthalmic solution (reproxalap) demonstrated statistically significant improvement over vehicle for the primary endpoint of ocular itching (p<0.0001), the key secondary endpoint of ocular redness (p<0.0001), and the secondary endpoints of ocular tearing and total ocular severity score (each p<0.0001). The results of INVIGORATE, the second positive Phase 3 trial for reproxalap in allergic conjunctivitis, indicate potential clinical utility before and during exposure to moderate to high levels of pollen.
    • Phase 3 TRANQUILITY and TRANQUILITY-2 Dry Eye Disease Trial Results Expected in Second Half of 2021: Patient enrollment has begun in the dry eye chamber Phase 3 TRANQUILITY Trial of reproxalap. The primary endpoint of the trial is ocular redness, which was statistically lower (p=0.03) for reproxalap relative to vehicle in the TRANQUILITY run-in cohort results announced in January 2021. Tear RASP (reactive aldehyde species) levels will also be assessed. Approximately 150 dry eye disease patients are expected to be enrolled per arm. Reproxalap will be administered four times the day prior to entry into the dry eye chamber, just before entry into the chamber, and 45 minutes after chamber entry. Enrollment in TRANQUILITY is ongoing, and enrollment in the confirmatory TRANQUILITY-2 Trial is expected to begin in the second quarter of 2021. Aldeyra plans to report top-line results from both trials in the second half of this year.
    • Phase 2 Clinical Trial Results from ADX-629, an Orally Available RASP Inhibitor, Expected Second Half of 2021: Initial Phase 2 clinical results from ADX-629, a novel orally available RASP inhibitor currently undergoing testing in asthma, psoriasis, and COVID-19, are expected in the second half of 2021. ADX-629 represents a first-in-class systems-based therapeutic approach for an orally administered RASP inhibitor, the potential applicability of which could extend to a myriad of immune-mediated diseases that today are treated with single-target drugs that can lead to serious toxicity.
    • Public Offering Completed: Aldeyra sold 10,000,000 shares of its common stock at a public offering price of $12.50 per share in an underwritten public offering. The offering generated gross proceeds of $125.0 million and net proceeds of $117.3 million after deducting underwriting discounts, commissions, and estimated offering expenses.

    First-Quarter 2021 Financial Summary

    Cash and cash equivalents as of March 31, 2021 were $138.4 million. Based on Aldeyra's current operating plan, the company believes that existing cash and cash equivalents, as of March 31, 2021, together with the net proceeds from the sale of common stock in the underwritten public offering in May 2021, will be sufficient to fund currently projected operating expenses through the end of 2023, including potential NDA submission for reproxalap; initial commercialization of reproxalap, if approved; and continued early and late-stage development of the company's product candidates in ocular and systemic immune-mediated diseases.

    For the quarter ended March 31, 2021, Aldeyra reported a net loss of $11.3 million, compared with a net loss of $9.9 million for the quarter ended March 31, 2020. Net loss per share was $0.25 for the quarter ended March 31, 2021, compared with $0.34 for the same period in 2020. Losses have resulted from the costs of Aldeyra's clinical trials and research and development programs, as well as from general and administrative expenses.

    Research and development (R&D) expenses were $7.7 million for the quarter ended March 31, 2021, compared with $6.6 million for the same period in 2020. The increase of $1.1 million is primarily related to clinical development and manufacturing costs, partially offset by lower personnel related costs and a decrease in preclinical costs.

    General and administrative expenses were $3.1 million for the quarter ended March 31, 2021, compared with $3.0 million for the quarter ended March 31, 2020.

    For the quarter ended March 31, 2021, total operating expenses were $10.8 million, compared with total operating expenses of $9.6 million for the same period in 2020.

    Conference Call & Webcast Information

    Aldeyra will host a conference call at 8:00 a.m. ET today to discuss its first-quarter 2021 financial results and recent highlights. The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 6779202. Due to the expected high demand on our conference call provider, please plan to dial in to the call at least 15 minutes prior to the start time.

    A live webcast of the conference call will also be available on the Investor Relations page of the company's website at https://ir.aldeyra.com. After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead product candidates, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

    Safe Harbor Statement

    This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding submission of potential New Drug Applications; the anticipated timing of results from Aldeyra's clinical trials; and Aldeyra's projected cash runway. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "on track," "scheduled," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra's clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; updated or refined data based on Aldeyra's continuing review and quality control analysis of clinical data, Aldeyra's ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities; delay in or failure to obtain regulatory approval of Aldeyra's product candidates; the ability to maintain regulatory approval of Aldeyra's product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Aldeyra's product candidates in clinical trials focused on the same or on different indications; the risk that the results from smaller clinical trials or portions of clinical trials may not accurately predict results of larger scale trials or the remainder of a clinical trial; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; uncertainty as to Aldeyra's ability to commercialize (alone or with others) Aldeyra's product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency or use of Aldeyra's cash resources and needs for additional financing; political, economic, legal, social and health risks, including the recent COVID-19 outbreak and subsequent public health measures, that may affect Aldeyra's business or the global economy; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding competition; Aldeyra's anticipated growth strategies; Aldeyra's ability to attract or retain key personnel; Aldeyra's limited sales and marketing infrastructure; Aldeyra's ability to establish and maintain development partnerships; Aldeyra's ability to successfully integrate acquisitions into its business; Aldeyra's expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra's ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra's business and the market in which it operates; and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2020, which is on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at https://www.sec.gov/. Additional factors may be described in those sections of Aldeyra's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, expected to be filed with the SEC in the second quarter of 2021.

    In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

    ALDEYRA THERAPEUTICS, INC.
    CONSOLIDATED BALANCE SHEETS
     
     
     

    March 31,

     

    December 31,

    2021

     

    2020

    ASSETS

    (Unaudited)

     

     

    Current assets:
    Cash and cash equivalents

    $

    88,442,379

     

    $

    52,858,311

     

    Cash equivalent - reverse repurchase agreements

     

    50,000,000

     

     

    25,000,000

     

    Prepaid expenses and other current assets

     

    8,630,543

     

     

    5,200,957

     

    Total current assets

     

    147,072,922

     

     

    83,059,268

     

    Right-of-use assets

     

    175,619

     

     

    233,310

     

    Fixed assets, net

     

    57,559

     

     

    59,925

     

    Total assets

    $

    147,306,100

     

    $

    83,352,503

     

     
     
    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current liabilities:
    Accounts payable

    $

    448,591

     

    $

    381,638

     

    Accrued expenses

     

    5,371,681

     

     

    8,134,765

     

    Current portion of credit facility

     

    5,094,938

     

     

    3,659,776

     

    Current portion of operating lease liabilities

     

    175,619

     

     

    233,310

     

    Total current liabilities

     

    11,090,829

     

     

    12,409,489

     

    Long-term debt, net of current portion

     

    10,140,799

     

     

    11,434,456

     

    Total liabilities

     

    21,231,628

     

     

    23,843,945

     

     
    Commitments and contingencies
    Stockholders' equity:
    Common stock, voting, $0.001 par value; 150,000,000 authorized and 47,651,035 and 38,667,491 shares issued and outstanding, respectively

     

    47,651

     

     

    38,667

     

    Additional paid-in capital

     

    374,232,411

     

     

    296,385,619

     

    Accumulated deficit

     

    (248,205,590

    )

     

    (236,915,728

    )

    Total stockholders' equity

     

    126,074,472

     

     

    59,508,558

     

    Total liabilities and stockholders' equity

    $

    147,306,100

     

    $

    83,352,503

     

    ALDEYRA THERAPEUTICS, INC.
    CONSOLIDATED STATEMENTS OF OPERATIONS
    (UNAUDITED)
     

    Three Months Ended March 31,

    2021

     

    2020

     
    Operating expenses:
    Research and development

    $

    7,726,342

     

    $

    6,633,603

     

    General and administrative

     

    3,104,702

     

     

    3,004,841

     

    Loss from operations

     

    (10,831,044

    )

     

    (9,638,444

    )

     
    Other income (expense):
    Interest income

     

    23,762

     

     

    210,100

     

    Interest expense

     

    (482,580

    )

     

    (439,816

    )

    Total other income (expense), net

     

    (458,818

    )

     

    (229,716

    )

    Net loss

    $

    (11,289,862

    )

    $

    (9,868,160

    )

     
    Net loss per share - basic and diluted

    $

    (0.25

    )

    $

    (0.34

    )

     
    Weighted average common shares outstanding - basic and diluted

     

    45,630,910

     

     

    29,210,889

     

     

     

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  9. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) will host a conference call at 8:00 a.m. ET Thursday, May 6, 2021 to report financial results for the quarter ended March 31, 2021 and discuss recent business highlights.

    The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 6779202. A live webcast of the conference call will also be available on the Investors & Media page of the company's corporate website at https://ir.aldeyra.com.

    After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) will host a conference call at 8:00 a.m. ET Thursday, May 6, 2021 to report financial results for the quarter ended March 31, 2021 and discuss recent business highlights.

    The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 6779202. A live webcast of the conference call will also be available on the Investors & Media page of the company's corporate website at https://ir.aldeyra.com.

    After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead investigational compounds, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

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  10. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced the pricing of an underwritten public offering of 10,000,000 shares of its common stock at a public offering price of $12.50 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses payable by Aldeyra, are expected to be $125 million. In addition, Aldeyra has granted the underwriters a 30-day option to purchase up to 1,500,000 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. All…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced the pricing of an underwritten public offering of 10,000,000 shares of its common stock at a public offering price of $12.50 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses payable by Aldeyra, are expected to be $125 million. In addition, Aldeyra has granted the underwriters a 30-day option to purchase up to 1,500,000 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. All of the shares in the offering are being sold by Aldeyra. Aldeyra anticipates using the net proceeds from the offering for the preparation of a potential New Drug Application submission for Aldeyra's lead compound, reproxalap; the preparations for the commercial launch of reproxalap and the subsequent commercialization of reproxalap, if approved; early stage pipeline development programs, as well as for working capital and other general corporate purposes. The offering is expected to close on or about May 3, 2021, subject to satisfaction of customary closing conditions.

    Jefferies and SVB Leerink are acting as joint book-running managers for the offering. BTIG, H.C. Wainwright & Co., JonesTrading Institutional Services LLC and Laidlaw & Company (UK) Ltd. are acting as co-lead managers for the offering.

    The shares of common stock described above are being offered by Aldeyra pursuant to a shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC) and declared effective by the SEC on April 15, 2021. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC's web site at www.sec.gov. Copies of the final prospectus supplement (when available) and accompanying prospectus relating to these shares of common stock may also be obtained by sending a request to: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at 877-821-7388 or by email at Prospectus_Department@Jefferies.com, or from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, by telephone at 1-800-808-7525, ext. 6105, or by email at syndicate@svbleerink.com.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdictions.

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead investigational compounds, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy.

    Safe Harbor Statement

    This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including but not limited to statements regarding the closing of the public offering and the anticipated use of the proceeds thereof. These forward-looking statements are subject to a number of risks, including the satisfaction of customary closing conditions related to the public offering and the risk factors set forth from time to time in Aldeyra's SEC filings, including but not limited to the risks that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2020 which is on file with the SEC and available on the SEC's website at www.sec.gov. In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

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  11. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced that it intends to offer and sell, subject to market and other conditions, $125 million of shares of its common stock in an underwritten public offering. Aldeyra also expects to grant the underwriters a 30-day option to purchase up to an additional $18.75 million of shares of common stock sold in the offering, at the public offering price, less the underwriting discounts and commissions. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced that it intends to offer and sell, subject to market and other conditions, $125 million of shares of its common stock in an underwritten public offering. Aldeyra also expects to grant the underwriters a 30-day option to purchase up to an additional $18.75 million of shares of common stock sold in the offering, at the public offering price, less the underwriting discounts and commissions. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares in the offering are to be sold by Aldeyra, with net proceeds to be used for the preparation of a potential New Drug Application submission for Aldeyra's lead compound, reproxalap; the preparations for the commercial launch of reproxalap and the subsequent commercialization of reproxalap, if approved; early stage pipeline development programs, as well as for working capital and other general corporate purposes.

    Jefferies and SVB Leerink are acting as joint book-running managers for the offering.

    The shares of common stock described above are being offered by Aldeyra pursuant to a shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC) and declared effective by the SEC on April 15, 2021. A preliminary prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC's web site at www.sec.gov. When available, copies of the preliminary prospectus supplement relating to these securities may also be obtained by sending a request to: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at 877-821-7388 or by email at Prospectus_Department@Jefferies.com, or from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, by telephone at 1-800-808-7525, ext. 6105, or by email at syndicate@svbleerink.com.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead investigational compounds, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy.

    Safe Harbor Statement

    This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including but not limited to statements regarding the public offering and the anticipated use of the proceeds thereof. These forward-looking statements are subject to a number of risks, including the satisfaction of customary closing conditions related to the proposed public offering and the risk factors set forth from time to time in Aldeyra's SEC filings, including but not limited to the risks that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2020 which is on file with the SEC and available on the SEC's website at www.sec.gov. In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

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    • Results Consistent with Phase 3 ALLEVIATE Allergic Conjunctivitis Clinical Trial and Previous Chamber Results in Phase 2 Allergic Conjunctivitis Trial and Run-In Cohort of Phase 3 TRANQUILITY Dry Eye Disease Trial
    • Reproxalap Potentially Represents the First New Allergic Conjunctivitis Therapeutic Mechanism in Decades
    • Company to Discuss Results in Conference Call and Webcast at 8:00 a.m. ET Today

    Aldeyra

    • Statistical Significance Achieved for Primary Endpoint of Ocular Itching at All Prespecified Timepoints (p<0.0001)
    • Statistical Significance Achieved for Key Secondary Endpoint of Ocular Redness (p<0.0001)
    • Statistical Significance Achieved for Secondary Endpoints of Ocular Tearing (p<0.0001) and Total Ocular Severity Score (p<0.0001)
    • Results Consistent with Phase 3 ALLEVIATE Allergic Conjunctivitis Clinical Trial and Previous Chamber Results in Phase 2 Allergic Conjunctivitis Trial and Run-In Cohort of Phase 3 TRANQUILITY Dry Eye Disease Trial
    • Reproxalap Potentially Represents the First New Allergic Conjunctivitis Therapeutic Mechanism in Decades
    • Company to Discuss Results in Conference Call and Webcast at 8:00 a.m. ET Today

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced positive top-line results from the Phase 3 INVIGORATE Clinical Trial of 0.25% reproxalap ophthalmic solution (reproxalap), an investigational new drug, in patients with allergic conjunctivitis. The clinical trial successfully achieved statistical significance for the primary endpoint and all secondary endpoints.

    "The statistically significant superiority of reproxalap over vehicle across all allergic conjunctivitis symptoms and signs assessed in INVIGORATE is remarkable, and suggests utility in one of the world's most common ocular surface diseases," stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "We believe the consistent activity observed across chamber models in allergic conjunctivitis and dry eye disease bodes well for the commercial positioning of reproxalap as potentially the only broadly applicable topical anterior segment immune-modulating drug that may be used for chronic treatment, if approved for marketing."

    The randomized, double-masked, vehicle-controlled, two-way crossover design allergen chamber Phase 3 INVIGORATE Trial enrolled 95 allergic conjunctivitis patients. The primary efficacy endpoint was change from baseline in subject-reported ocular itching score on a 0‑4 point scale over a majority of 11 timepoints from 110 to 210 minutes after allergen chamber entry. The key secondary endpoint was change from baseline in ocular redness on a 0‑4 point scale over the duration of the allergen chamber (approximately 3.5 hours).

    Relative to patients treated with vehicle, patients treated with reproxalap reported statistically significant ocular itching score reduction over all 11 prespecified primary endpoint comparisons (p<0.0001 for each comparison) from 110 to 210 minutes in the allergen chamber. The reproxalap-treated patients demonstrated statistically significant reduction from baseline compared to vehicle (p<0.0001) for the key secondary endpoint of investigator-assessed ocular redness over the duration of the allergen chamber. Statistical significance was also achieved for the two secondary endpoints of change from baseline in patient-reported ocular tearing score on a 0‑3 point scale over the duration of the allergen chamber (p<0.0001) and change from baseline in total ocular severity score (11-point composite of the itching, redness, and tearing scores) over the duration of the allergen chamber (p<0.0001).

    "Ocular allergy is a market that is ripe for innovation, and allergic conjunctivitis sufferers know it," said Milton Hom, OD, of Canyon City Eyecare in Azusa, CA. "Exacerbated by the rise in global temperatures, seasonal pollen counts are exploding, leading to escalations in the prevalence of allergic conjunctivitis and dry eye disease that are growing unchecked. Even with the availability of treatments over the counter, many patients are using more than one prescription to manage ocular symptoms and redness. Based on my review of the INVIGORATE data, reproxalap, as one of the first new therapeutic mechanisms of action in years, would be a meaningful complement to the current treatment paradigm for moderate-to-severe allergic conjunctivitis patients."

    In the Phase 3 ALLEVIATE Trial, 0.25% reproxalap demonstrated statistically significant reductions from vehicle in patient-reported ocular itching over one hour following direct topical conjunctival allergen challenge. In Aldeyra's Phase 2 allergen chamber trial, 0.25% reproxalap demonstrated statistically significant reductions from vehicle in patient-reported ocular itching and investigator-assessed ocular redness. In the run-in cohort of the Phase 3 TRANQUILITY Trial in dry eye disease patients, 0.25% reproxalap demonstrated statistically significant reductions from vehicle in patient-reported ocular dryness scores and investigator-assessed ocular redness in the dry eye chamber. The primary endpoint of the Phase 3 TRANQUILITY and TRANQUILITY-2 trials is ocular redness over the duration of the chamber. Results from the TRANQUILITY trials in dry eye disease are expected in the second half of 2021.

    Reproxalap ophthalmic solution has now been administered to more than 1,200 patients across 14 clinical trials. Consistent with prior clinical experience with reproxalap, there were no observed safety or tolerability concerns in the INVIGORATE Trial and no observed adverse events other than mild and transient instillation site discomfort typical of many prescribed topical ophthalmic medications for anterior segment inflammation.

    Aldeyra plans to meet with the U.S. Food and Drug Administration (FDA) in the second half of 2021 to discuss the INVIGORATE results and the potential submission of a New Drug Application.

    Conference Call & Webcast Information

    Aldeyra will host a conference call at 8:00 a.m. ET today to discuss results of the INVIGORATE Trial. The dial-in numbers are (844) 940-4939 for domestic callers and (639) 380-0129 for international callers. The Conference ID is 7578367. Due to the expected high demand on our conference provider, please plan to dial in to the call at least 15 minutes prior to the start time.

    A live webcast of the conference call will be available on the Investor Relations page of the company's website at https://ir.aldeyra.com. After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Reproxalap

    Reproxalap, an investigational new drug, is a novel small-molecule immune-modulating covalent inhibitor of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease. Reproxalap's mechanism of action has been validated with the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications. Reproxalap is currently in Phase 3 clinical development as a 0.25% ophthalmic solution for the treatment of dry eye disease and allergic conjunctivitis, two ocular inflammatory diseases that often occur together.

    About Allergic Conjunctivitis

    Allergic conjunctivitis affects more than 1 billion people worldwide,1 including more than 66 million in the U.S.2 The disease is thought to be mediated in part by reactive aldehyde species (RASP), leading to activation of intracellular inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. The symptoms of allergic conjunctivitis – ocular itching and tearing – are chronic, painful, and persistent, affecting quality of life and leading to loss of work that can create a substantial economic burden for patients and their families.3 Although allergic conjunctivitis is one of the most common diseases treated by ophthalmologists and optometrists, in many cases physicians and patients report that currently available therapy is inadequate. Today, nearly one in five allergic conjunctivitis patients utilizes corticosteroids or other adjunctive therapy in addition to antihistamines.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead investigational compounds, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy. For more information, visit https://www.aldeyra.com and follow us on LinkedIn, Facebook, and Twitter.

    Safe Harbor Statement

    This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the planned NDA submission of reproxalap in allergic conjunctivitis and the commercial potential thereof. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "on track," "scheduled," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra's clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; updated or refined data based on Aldeyra's continuing review and quality control analysis of clinical data, Aldeyra's ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities; delay in or failure to obtain regulatory approval of Aldeyra's product candidates; the ability to maintain regulatory approval of Aldeyra's product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Aldeyra's product candidates in clinical trials focused on the same or on different indications; the risk that the results from smaller clinical trials or portions of clinical trials may not accurately predict results of larger scale trials or the remainder of a clinical trial; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; uncertainty as to Aldeyra's ability to commercialize (alone or with others) Aldeyra's product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency or use of Aldeyra's cash resources and needs for additional financing; political, economic, legal, social and health risks, including the recent COVID-19 outbreak and subsequent public health measures, that may affect Aldeyra's business or the global economy; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding competition; Aldeyra's anticipated growth strategies; Aldeyra's ability to attract or retain key personnel; Aldeyra's limited sales and marketing infrastructure; Aldeyra's ability to establish and maintain development partnerships; Aldeyra's ability to successfully integrate acquisitions into its business; Aldeyra's expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra's ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra's business and the market in which it operates; and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2020, which is on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at https://www.sec.gov/. Additional factors may be described in those sections of Aldeyra's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, expected to be filed with the SEC in the second quarter of 2021.

    In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

    1 White Book on Allergy (2013 Update)

    2 Singh K, Axelrod S, Bielory L. The epidemiology of ocular and nasal allergy in the United States, 1988-1994. J Allergy ClinImmunol. 2010;126(4):778-783.e6

    3 Andrew D. Pitt, Andrew F. Smith, Lynda Lindsell, Li Wern Voon, Peter W. Rose & Anthony J. Bron (2004) Economic and quality-of-life impact of seasonal allergic conjunctivitis in Oxfordshire, Ophthalmic Epidemiology, 11:1, 17-33, DOI: 10.1076/opep.11.1.17.26437

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  12. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced it will hold a webcast and conference call on Tuesday, April 27, 2021, at 8:00 a.m. (ET) to provide top-line results from the Phase 3 INVIGORATE Clinical Trial of reproxalap in allergic conjunctivitis.

    The dial-in numbers are (844) 940-4939 for domestic callers and (639) 380-0129 for international callers. The Conference ID is 7578367. A live, listen-only audio webcast of the conference call can be accessed on the investor relations page of Aldeyra's corporate website at ir.aldeyra.com.

    After the live webcast…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced it will hold a webcast and conference call on Tuesday, April 27, 2021, at 8:00 a.m. (ET) to provide top-line results from the Phase 3 INVIGORATE Clinical Trial of reproxalap in allergic conjunctivitis.

    The dial-in numbers are (844) 940-4939 for domestic callers and (639) 380-0129 for international callers. The Conference ID is 7578367. A live, listen-only audio webcast of the conference call can be accessed on the investor relations page of Aldeyra's corporate website at ir.aldeyra.com.

    After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead investigational compounds, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy. For more information, visit https://www.aldeyra.com and follow us on LinkedIn, Facebook, and Twitter.

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  13. Enrollment Completed in Phase 3 INVIGORATE Trial, with Top-Line Results Expected in the First Half of 2021

    − Top-Line Results from Phase 3 TRANQUILITY and TRANQUILITY-2 Trials Expected in the Second Half of 2021

    − Projected Cash Runway Through 2023, Including Potential New Drug Application Submissions for Dry Eye Disease and Allergic Conjunctivitis

    Management to Host Conference Call at 8:00 a.m. ET Today

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today reported business highlights and financial results for the year ended December 31, 2020.

    "During the past year…

    Enrollment Completed in Phase 3 INVIGORATE Trial, with Top-Line Results Expected in the First Half of 2021

    − Top-Line Results from Phase 3 TRANQUILITY and TRANQUILITY-2 Trials Expected in the Second Half of 2021

    − Projected Cash Runway Through 2023, Including Potential New Drug Application Submissions for Dry Eye Disease and Allergic Conjunctivitis

    Management to Host Conference Call at 8:00 a.m. ET Today

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today reported business highlights and financial results for the year ended December 31, 2020.

    "During the past year, we have worked diligently to advance our lead investigational compound reproxalap into pivotal Phase 3 clinical trials in dry eye disease and allergic conjunctivitis, two of the largest markets in ophthalmology," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. "Based on clinical results to date, we believe reproxalap has the potential to be first-line therapy for the treatment of dry eye disease and an important alternative to corticosteroids for the treatment of allergic conjunctivitis. We look forward to the potential to further validate the opportunities for reproxalap with the results of the TRANQUILITY, TRANQUILITY-2, and INVIGORATE trials, as we begin 2021 in a strong financial position, with liquidity expected to fund our current clinical development plans and operations through 2023."

    Recent Highlights and Program Updates

    • Phase 3 INVIGORATE Allergic Conjunctivitis Trial Enrollment Completed: Aldeyra has completed patient enrollment of its randomized, double-masked, crossover design, vehicle-controlled, allergen chamber Phase 3 INVIGORATE Trial of 0.25% reproxalap ophthalmic solution in patients with allergic conjunctivitis. The primary efficacy endpoint is patient-reported ocular itching score assessed on a 9-point scale. Investigator-assessed ocular redness is a key secondary endpoint. Top-line results are expected in the first half of 2021.
    • Phase 3 TRANQUILITY Dry Eye Disease Trial Design Finalized: In February 2021, Aldeyra announced the finalization of the design of the multi-center, randomized, double-masked, parallel-group, vehicle-controlled Phase 3 TRANQUILITY Trial of 0.25% reproxalap ophthalmic solution for the treatment of dry eye disease. Approximately 150 dry eye disease patients are expected to be enrolled per arm. The primary endpoint is ocular redness over 90 minutes in a dry eye chamber. Tear RASP levels, Schirmer's Test, and dry eye disease symptoms will be secondary endpoints. The protocol will utilize the two-day dosing paradigm, dry eye challenge design, and enrollment criteria of the run-in cohort. Results from the run-in cohort, announced in January 2021, demonstrated statistically significant improvement of reproxalap over vehicle in eye dryness score and other dry eye disease symptoms after a single day of dosing, and, during exposure to a dry eye chamber, statistically significant improvement of reproxalap over vehicle in eye dryness symptom score, ocular discomfort score, and ocular redness. TRANQUILITY and the confirmatory Phase 3 TRANQUILITY-2 Trial are on schedule to initiate enrollment in the first half of 2021. Top-line results from both trials are expected in the second half of 2021.
    • Phase 2 Clinical Testing of Novel Orally Administered RASP Inhibitor ADX-629 Initiated: In the fourth quarter of 2020, Aldeyra announced the initiation of Phase 2 proof-of-concept clinical trials of ADX-629, a first-in-class orally administered RASP inhibitor for the treatment of psoriasis, atopic asthma, and COVID-19. The trials are part of a systematic strategy to assess the activity of ADX-629 across different types of systemic inflammatory disease. Top-line results from the trials are expected by the end of 2021.
    • Enrollment of Phase 3 GUARD Proliferative Vitreoretinopathy Trial of ADX-2191 Continues: Completion of enrollment is expected in 2021 for Part 1 of the Phase 3 GUARD Trial of ADX-2191 (0.8% methotrexate intravitreal injection) for the prevention of proliferative vitreoretinopathy, a rare but serious sight-threatening retinal disease with no approved treatment.
    • Public Offering Completed: Aldeyra announced the closing of an underwritten public offering of 7,868,421 shares of its common stock at a price of $9.50 per share, including 1,026,315 additional shares of common stock sold pursuant to the full exercise of the underwriters' option to purchase additional shares. The underwritten offering generated gross proceeds of $74.7 million and net proceeds of $70.0 million after deducting underwriting discounts, commissions, and offering expenses.

    Full-Year 2020 Financial Summary

    Cash and cash equivalents as of December 31, 2020 were $77.9 million. Based on its current operating plan and including the net proceeds from the underwritten public offering completed in January 2021, Aldeyra believes that existing cash and cash equivalents will be sufficient to fund currently anticipated operating expenses through the end of 2023, including the completion of the Phase 3 TRANQUILITY and TRANQUILITY-2 trials in dry eye disease; the completion of the Phase 3 INVIGORATE trial in allergic conjunctivitis; the Phase 2 clinical trials of ADX-629 in psoriasis, atopic asthma, and COVID-19; and the completion of Part 1 of the adaptive Phase 3 GUARD clinical trial in proliferative vitreoretinopathy.

    The net loss for full-year 2020 was $37.6 million, or $1.11 per share, compared with a net loss of $60.8 million, or $2.24 per share, for full-year 2019.

    Research and Development (R&D) expenses were $24.7 million for full-year 2020 compared with $44.4 million for full-year 2019. The decrease of $19.7 million in R&D expenses primarily reflected a reduction in clinical research and development expenditures, partially offset by an increase in non-cash compensation costs related to a portion of a contingent acquisition milestone.

    Acquired in-process research and development expenses were $1.8 million for full-year 2020 compared with $6.6 million for full-year 2019. The $4.8 million decrease is related to lower in-process research and development expenses associated with the 2019 acquisition of Helio Vision.

    General and administrative (G&A) expenses were $10.0 million for full-year 2020 compared with $12.2 million for full-year 2019. The decrease of $2.2 million in G&A expenses primarily reflected lower personnel costs, legal costs, public company costs related to continuing compliance with the Sarbanes Oxley Act of 2002, and miscellaneous administrative costs.

    Conference Call & Webcast Information

    Aldeyra will host a conference call at 8:00 a.m. ET today to discuss its full-year 2020 financial results. The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 6253616. Due to the expected high demand on our conference provider, please plan to dial in to the call at least 15 minutes prior to the start time.

    A live webcast of the conference call will also be available on the Investor Relations page of the company's website at https://ir.aldeyra.com. After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead investigational compounds, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com and follow us on LinkedIn, Facebook, and Twitter.

    Safe Harbor Statement

    This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: the timing of results from the company's Phase 3 INVIGORATE Trial for the treatment of allergic conjunctivitis; the timing of results from the company's Phase 3 TRANQUILITY and TRANQUILITY-2 Trials for the treatment of dry eye disease; the timing of results from the company's Phase 2 proof-of-concept clinical trials of ADX-629; the company's anticipated cash runway; the timing of potential New Drug Application submissions for dry eye disease and allergic conjunctivitis; and the completion of enrollment of Part 1 of the Phase 3 GUARD Trial of ADX-2191 for the treatment of proliferative vitreoretinopathy. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "on track," "scheduled," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra's clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; updated or refined data based on Aldeyra's continuing review and quality control analysis of clinical data, Aldeyra's ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities; delay in or failure to obtain regulatory approval of Aldeyra's product candidates; the ability to maintain regulatory approval of Aldeyra's product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Aldeyra's product candidates; the risk that the results from smaller clinical trials or portions of clinical trials may not accurately predict results of larger scale trials or the remainder of a clinical trial; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; uncertainty as to Aldeyra's ability to commercialize (alone or with others) Aldeyra's product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency or use of Aldeyra's cash resources and needs for additional financing; political, economic, legal, social and health risks, including the recent COVID-19 outbreak and subsequent public health measures, that may affect Aldeyra's business or the global economy; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding competition; Aldeyra's anticipated growth strategies; Aldeyra's ability to attract or retain key personnel; Aldeyra's limited sales and marketing infrastructure; Aldeyra's ability to establish and maintain development partnerships; Aldeyra's ability to successfully integrate acquisitions into its business; Aldeyra's expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra's ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra's business and the market in which it operates; and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2019 and Aldeyra's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at https://www.sec.gov/. Additional factors may be described in those sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2020, expected to be filed with the SEC in the first quarter of 2021.

    In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

    ALDEYRA THERAPEUTICS, INC.
    CONSOLIDATED BALANCE SHEETS
     
     
     

    December 31,

     

    December 31,

    2020

     

    2019

    ASSETS
    Current assets:
    Cash and cash equivalents

    $

    52,858,311

     

    $

    16,425,830

     

    Cash equivalent - reverse repurchase agreements

     

    25,000,000

     

     

    28,000,000

     

    Marketable securities

     

     

     

    28,938,545

     

    Prepaid expenses and other current assets

     

    5,200,957

     

     

    1,804,450

     

    Total current assets

     

    83,059,268

     

     

    75,168,825

     

    Fixed assets, net

     

    59,925

     

     

    148,449

     

    Right-of-use assets

     

    233,310

     

     

    201,007

     

    Total assets

    $

    83,352,503

     

    $

    75,518,281

     

     
     
    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current liabilities:
    Accounts payable

    $

    381,638

     

    $

    808,302

     

    Accrued expenses

     

    8,134,765

     

     

    11,873,122

     

    Current portion of credit facility

     

    3,659,776

     

     

     

    Current portion of operating lease liabilities

     

    233,310

     

     

    226,328

     

    Total current liabilities

     

    12,409,489

     

     

    12,907,752

     

    Long-term debt, net of current portion

     

    11,434,456

     

     

    14,528,212

     

    Total liabilities

     

    23,843,945

     

     

    27,435,964

     

     
    Commitments and contingencies
    Stockholders' equity:
    Preferred stock, $0.001 par value, 15,000,000 shares authorized, none issued and outstanding

     

     

     

     

    Common stock, voting, $0.001 par value; 150,000,000 authorized and 38,667,491 and 28,656,832 shares issued and outstanding, respectively

     

    38,667

     

     

    28,657

     

    Additional paid-in capital

     

    296,385,619

     

     

    247,409,793

     

    Accumulated other comprehensive income

     

     

     

    5,866

     

    Accumulated deficit

     

    (236,915,728

    )

     

    (199,361,999

    )

    Total stockholders' equity

     

    59,508,558

     

     

    48,082,317

     

    Total liabilities and stockholders' equity

    $

    83,352,503

     

    $

    75,518,281

     

     
    ALDEYRA THERAPEUTICS, INC.
    CONSOLIDATED STATEMENTS OF OPERATIONS
     
     

    Years ended December 31,

    2020

     

    2019

     
    Operating expenses:
    Research and development

    $

    24,681,301

     

    $

    44,351,851

     

    Acquired in-process research and development

     

    1,754,265

     

     

    6,567,754

     

    General and administrative

     

    9,985,454

     

     

    12,154,702

     

    Loss from operations

     

    (36,421,020

    )

     

    (63,074,307

    )

     
    Other income (expense):
    Interest income

     

    292,224

     

     

    1,541,349

     

    Interest expense

     

    (1,904,198

    )

     

    (603,846

    )

    Total other income (expense), net

     

    (1,611,974

    )

     

    937,503

     

    Loss before income taxes

     

    (38,032,994

    )

     

    (62,136,804

    )

    Income tax benefit

     

    479,265

     

     

    1,309,973

     

    Net loss

    $

    (37,553,729

    )

    $

    (60,826,831

    )

     
    Net loss per share - basic and diluted

    $

    (1.11

    )

    $

    (2.24

    )

     
    Weighted average common shares outstanding - basic and diluted

     

    33,965,955

     

     

    27,111,840

     

     

     

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  14. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that President and Chief Executive Officer Todd C. Brady, M.D., Ph.D. will discuss the potential of reproxalap as a novel, rapid-onset first-line treatment for dry eye disease as part of the Ophthalmology Innovation Summit's Dry Eye Disease Innovation Showcase, which will take place virtually on Thursday, March 11, 2021 from 1:00 p.m. to 4:00 p.m. ET.

    The event will include a market overview and company presentations as well as panel discussions featuring experts who will provide industry and clinical perspectives on the dry eye disease market.

    Registration is complimentary. To register, click here: https://bit.ly/3chgZJh

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that President and Chief Executive Officer Todd C. Brady, M.D., Ph.D. will discuss the potential of reproxalap as a novel, rapid-onset first-line treatment for dry eye disease as part of the Ophthalmology Innovation Summit's Dry Eye Disease Innovation Showcase, which will take place virtually on Thursday, March 11, 2021 from 1:00 p.m. to 4:00 p.m. ET.

    The event will include a market overview and company presentations as well as panel discussions featuring experts who will provide industry and clinical perspectives on the dry eye disease market.

    Registration is complimentary. To register, click here: https://bit.ly/3chgZJh

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead investigational compounds, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

    View Full Article Hide Full Article
  15. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) will host a conference call at 8:00 a.m. ET Thursday, March 11, 2021 to report financial results for the year ended December 31, 2020 and discuss recent business highlights.

    The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 6253616. A live webcast of the conference call will also be available on the Investors & Media page of the company's corporate website at https://ir.aldeyra.com.

    After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) will host a conference call at 8:00 a.m. ET Thursday, March 11, 2021 to report financial results for the year ended December 31, 2020 and discuss recent business highlights.

    The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 6253616. A live webcast of the conference call will also be available on the Investors & Media page of the company's corporate website at https://ir.aldeyra.com.

    After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead investigational compounds, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

    View Full Article Hide Full Article
  16. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that President and Chief Executive Officer Todd C. Brady, M.D., Ph.D. will participate in analyst-led fireside conversations at the H.C. Wainwright Global Life Sciences Conference and the Oppenheimer 31st Annual Healthcare Conference.

    • H.C. Wainwright Global Life Sciences Conference
      Date: Tuesday, March 9, 2021
      Time: 7:00 a.m. ET
    • Oppenheimer 31st Annual Healthcare Conference
      Date: Tuesday, March 16, 2021
      Time: 9:20 a.m. ET

    To view these events, please visit the Investor & Media page of the company's website. After the presentations, the events will remain archived on the website for 90 days.

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a clinical-stage biotechnology…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that President and Chief Executive Officer Todd C. Brady, M.D., Ph.D. will participate in analyst-led fireside conversations at the H.C. Wainwright Global Life Sciences Conference and the Oppenheimer 31st Annual Healthcare Conference.

    • H.C. Wainwright Global Life Sciences Conference

      Date: Tuesday, March 9, 2021

      Time: 7:00 a.m. ET
    • Oppenheimer 31st Annual Healthcare Conference

      Date: Tuesday, March 16, 2021

      Time: 9:20 a.m. ET

    To view these events, please visit the Investor & Media page of the company's website. After the presentations, the events will remain archived on the website for 90 days.

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead investigational compounds, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

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  17. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer, will present at the 10th Annual SVB Leerink Global Healthcare Conference at 3:40 p.m. ET Friday, February 26, 2021.

    A live webcast of the presentation will be available on the investor relations page of the company's corporate website at https://ir.aldeyra.com/. After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics, Inc.
    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer, will present at the 10th Annual SVB Leerink Global Healthcare Conference at 3:40 p.m. ET Friday, February 26, 2021.

    A live webcast of the presentation will be available on the investor relations page of the company's corporate website at https://ir.aldeyra.com/. After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead investigational compounds, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

    View Full Article Hide Full Article
    • TRANQUILITY to Utilize Two-Day Treatment and Challenge Design
    • Consistent with Previously Announced Top-Line TRANQUILITY Run-In Cohort Results, Ocular Redness Selected as Primary Endpoint
    • Tear RASP Levels Reduced After Single Doses of Reproxalap in Run-In Cohort of TRANQUILITY and Selected as Secondary Endpoint for Confirmation of Mechanism of Action

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced the finalization of the design of the Phase 3 TRANQUILITY Trial of 0.25% reproxalap ophthalmic solution for the treatment of dry eye disease. Consistent with…

    • TRANQUILITY to Utilize Two-Day Treatment and Challenge Design
    • Consistent with Previously Announced Top-Line TRANQUILITY Run-In Cohort Results, Ocular Redness Selected as Primary Endpoint
    • Tear RASP Levels Reduced After Single Doses of Reproxalap in Run-In Cohort of TRANQUILITY and Selected as Secondary Endpoint for Confirmation of Mechanism of Action

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced the finalization of the design of the Phase 3 TRANQUILITY Trial of 0.25% reproxalap ophthalmic solution for the treatment of dry eye disease. Consistent with previously announced results from the run-in cohort of TRANQUILITY, ocular redness over 90 minutes in a dry eye chamber will be the primary endpoint. Approximately 150 dry eye disease patients are expected to be enrolled per arm. The TRANQUILITY protocol will utilize the two-day dosing paradigm, dry eye challenge design, and enrollment criteria of the run-in cohort.

    Tear RASP levels from the TRANQUILITY run-in cohort were reduced after single doses of the novel RASP inhibitor reproxalap, as assessed by enzyme-linked immunosorbent assay (ELISA) of 4-hydroxynonenal protein adducts (HNE), a RASP selected based on results from a natural history study of dry eye patients conducted by Aldeyra. For subjects with sufficient tear volumes for analysis, across the two doses where tear RASP levels were assessed before and after drug administration, HNE levels declined by an average of 1018 picograms/milliliter (pg/mL) in reproxalap-treated patients (n=9) versus an increase of 32 pg/mL in vehicle-treated patients (n=7). Accordingly, tear RASP levels have been selected as a secondary endpoint for confirmation of mechanism of action. HNE is well-characterized in the scientific literature as a critical pro-inflammatory RASP,1 and ocular levels of HNE correlate with the signs and symptoms of dry eye disease.2

    "The rapid activity of reproxalap demonstrated in the run-in cohort of TRANQUILITY in improving ocular redness, potentially the only dry eye disease sign of interest to patients, allows for the use of a two-day challenge design — a time and cost-efficient model for Phase 3 clinical testing," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. "Consistent with the observed rapid improvement in dry eye disease signs and symptoms, the reduction of tear RASP levels was evident after single doses of reproxalap, representing, to our knowledge, the first confirmation of drug mechanism in clinical trials of a topical ocular dry eye disease drug."

    TRANQUILITY and the confirmatory Phase 3 TRANQUILITY-2 Trial are expected to initiate in the first half of 2021. Results from both trials are expected in the second half of 2021.

    About Reproxalap

    Reproxalap is a novel small-molecule immune-modulating covalent inhibitor of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease. Reproxalap's mechanism of action has been validated with the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications. Reproxalap is currently in Phase 3 clinical development as a 0.25% ophthalmic solution for the treatment of dry eye disease and allergic conjunctivitis, two ocular inflammatory diseases that often occur together.

    About Dry Eye Disease

    Dry eye disease is a common inflammatory disease estimated to affect 34 million or more adults in the United States.3 The disease is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment. Among many physicians and patients, existing therapy for dry eye disease is generally regarded as inadequate and often requires weeks or months to demonstrate activity. In patients with dry eye disease, pro-inflammatory RASP may contribute to ocular inflammation and changes in tear lipid composition. By diminishing RASP levels, Aldeyra's lead RASP inhibitor reproxalap represents a novel and differentiated approach for the treatment of the symptoms and signs of dry eye disease.

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead investigational compounds, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

    Safe Harbor Statement

    This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding expectations regarding the main cohort of TRANQUILITY and the Phase 3 TRANQUILITY-2 Trial. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "on track," "scheduled," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra's clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; updated or refined data based on Aldeyra's continuing review and quality control analysis of clinical data, Aldeyra's ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities; delay in or failure to obtain regulatory approval of Aldeyra's product candidates; the ability to maintain regulatory approval of Aldeyra's product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Aldeyra's product candidates; the risk that the results from smaller clinical trials or portions of clinical trials may not accurately predict results of larger scale trials or the remainder of a clinical trial; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; uncertainty as to Aldeyra's ability to commercialize (alone or with others) Aldeyra's product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency or use of Aldeyra's cash resources and needs for additional financing; political, economic, legal, social and health risks, including the recent COVID-19 outbreak and subsequent public health measures, that may affect Aldeyra's business or the global economy; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding competition; Aldeyra's anticipated growth strategies; Aldeyra's ability to attract or retain key personnel; Aldeyra's limited sales and marketing infrastructure; Aldeyra's ability to establish and maintain development partnerships; Aldeyra's ability to successfully integrate acquisitions into its business; Aldeyra's expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra's ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra's business and the market in which it operates; and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2019 and Aldeyra's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at https://www.sec.gov/. Additional factors may be described in those sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2020, expected to be filed with the SEC in the first quarter of 2021.

    In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

    1Ayala A, Muñoz MF, Argüelles S. Lipid peroxidation: production, metabolism, and signaling mechanisms of malondialdehyde and 4-hydroxy-2-nonenal. Oxid Med Cell Longev. 2014;2014:360438. doi: 10.1155/2014/360438. Epub 2014 May 8. PMID: 24999379; PMCID: PMC4066722.

    2Choi W, Lian C, Ying L, Kim GE, You IC, Park SH, Yoon KC. Expression of Lipid Peroxidation Markers in the Tear Film and Ocular Surface of Patients with Non-Sjogren Syndrome: Potential Biomarkers for Dry Eye Disease. Curr Eye Res. 2016 Sep;41(9):1143-9. doi: 10.3109/02713683.2015.1098707. Epub 2016 Jan 5. PMID: 26731289.

    3Paulsen AJ, Cruickshanks KJ, Fischer ME, Huang GH, Klein BE, Klein R, Dalton DS. Dry eye in the beaver dam offspring study: prevalence, risk factors, and health-related quality of life. Am J Ophthalmol. 2014 Apr;157(4):799-806. doi: 10.1016/j.ajo.2013.12.023. Epub 2014 Jan 2. PMID: 24388838; PMCID: PMC3995164.

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  18. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced the closing of its underwritten public offering of 7,868,421 shares of its common stock at a public offering price of $9.50 per share, including 1,026,315 additional shares of common stock sold pursuant to the full exercise of the underwriters' option to purchase additional shares. All of the shares in the offering were sold by Aldeyra. The gross proceeds to Aldeyra following the underwriters' exercise of their option to purchase additional shares, before deducting underwriting discounts and commissions and offering…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced the closing of its underwritten public offering of 7,868,421 shares of its common stock at a public offering price of $9.50 per share, including 1,026,315 additional shares of common stock sold pursuant to the full exercise of the underwriters' option to purchase additional shares. All of the shares in the offering were sold by Aldeyra. The gross proceeds to Aldeyra following the underwriters' exercise of their option to purchase additional shares, before deducting underwriting discounts and commissions and offering expenses, were approximately $74.7 million.

    Aldeyra anticipates using the net proceeds from the underwritten offering for the continued development of its lead compound, reproxalap, and its other product candidates, as well as for working capital, and other general corporate purposes.

    Jefferies LLC and SVB Leerink LLC acted as joint book-running managers for the offering. BTIG LLC and Oppenheimer & Co. Inc. acted as co-lead managers for the offering.

    The shares of common stock described above were offered by Aldeyra pursuant to a shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC) and declared effective by the SEC on July 27, 2018. A final prospectus supplement relating to and describing the terms of the offering was filed with the SEC on January 14, 2021, and is available on the SEC's web site at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus relating to these securities may also be obtained by sending a request to: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at 877-821-7388 or by email at Prospectus_Department@Jefferies.com, or from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, by telephone at 1-800-808-7525, ext. 6132, or by email at syndicate@svbleerink.com.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdictions.

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead investigational compounds, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer.

    Safe Harbor Statement

    This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including but not limited to statements regarding the anticipated use of the proceeds from Aldeyra's public offering of common stock. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Aldeyra's SEC filings, including but not limited to the risks that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2019 and Aldeyra's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 which are on file with the SEC and available on the SEC's website at www.sec.gov. In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

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  19. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced the pricing of an underwritten public offering of 6,842,106 shares of its common stock at a public offering price of $9.50 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by Aldeyra, are expected to be approximately $65.0 million. In addition, Aldeyra granted the underwriters a 30-day option to purchase up to 1,026,315 additional shares of common stock at the public offering price, less the underwriting discounts…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced the pricing of an underwritten public offering of 6,842,106 shares of its common stock at a public offering price of $9.50 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by Aldeyra, are expected to be approximately $65.0 million. In addition, Aldeyra granted the underwriters a 30-day option to purchase up to 1,026,315 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. All of the shares in the offering are being sold by Aldeyra. Aldeyra anticipates using the net proceeds from the offering for the continued development of Aldeyra's lead compound, reproxalap, and its other product candidates, as well as for working capital, and other general corporate purposes. The offering is expected to close on or about January 19, 2021, subject to customary closing conditions.

    Jefferies LLC and SVB Leerink LLC are acting as joint book-running managers for the offering. BTIG LLC and Oppenheimer & Co. Inc. are acting as co-lead managers for the offering.

    The shares of common stock described above are being offered by Aldeyra pursuant to a shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC) and declared effective by the SEC on July 27, 2018. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC's web site at www.sec.gov. Copies of the final prospectus supplement (when available) and accompanying prospectus relating to these securities may also be obtained by sending a request to: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at 877-821-7388 or by email at Prospectus_Department@Jefferies.com, or from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, by telephone at 1-800-808-7525, ext. 6132, or by email at syndicate@svbleerink.com.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdictions.

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead investigational compounds, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer.

    Safe Harbor Statement

    This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including but not limited to statements regarding the closing of the public offering and the anticipated use of the proceeds thereof. These forward-looking statements are subject to a number of risks, including the satisfaction of customary closing conditions related to the proposed public offering and the risk factors set forth from time to time in Aldeyra's SEC filings, including but not limited to the risks that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2019 and Aldeyra's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 which are on file with the SEC and available on the SEC's website at www.sec.gov. In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

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  20. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering. Aldeyra also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the amount of shares of common stock sold in the offering, at the public offering price, less the underwriting discounts and commissions. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering. Aldeyra also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the amount of shares of common stock sold in the offering, at the public offering price, less the underwriting discounts and commissions. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares in the offering are to be sold by Aldeyra, with net proceeds to be used for the continued development of Aldeyra's lead compound, reproxalap, and its other product candidates, as well as for working capital and other general corporate purposes.

    Jefferies LLC and SVB Leerink LLC are acting as joint book-running managers for the offering.

    The shares of common stock described above are being offered by Aldeyra pursuant to a shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC) and declared effective by the SEC on July 27, 2018. A preliminary prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC's web site at www.sec.gov. When available, copies of the preliminary prospectus supplement relating to these securities may also be obtained by sending a request to: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at 877-821-7388 or by email at Prospectus_Department@Jefferies.com, or from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, by telephone at 1-800-808-7525, ext. 6132, or by email at syndicate@svbleerink.com.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead investigational compounds, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer.

    Safe Harbor Statement

    This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including but not limited to statements regarding the public offering and the anticipated use of the proceeds thereof. These forward-looking statements are subject to a number of risks, including the satisfaction of customary closing conditions related to the proposed public offering and the risk factors set forth from time to time in Aldeyra's SEC filings, including but not limited to the risks that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2019 and Aldeyra's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 which are on file with the SEC and available on the SEC's website at www.sec.gov. In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

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  21. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright BioConnect 2021 Virtual Conference.

    The fireside chat will be available beginning at 6:00 a.m. ET Monday, January 11, 2021 on the Investors & Media section of the Aldeyra Therapeutics website at https://ir.aldeyra.com. The event will remain archived on the website for 90 days.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead investigational compounds…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright BioConnect 2021 Virtual Conference.

    The fireside chat will be available beginning at 6:00 a.m. ET Monday, January 11, 2021 on the Investors & Media section of the Aldeyra Therapeutics website at https://ir.aldeyra.com. The event will remain archived on the website for 90 days.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead investigational compounds, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

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    • Statistical Significance of Reproxalap Over Vehicle Achieved for Ocular Redness, an FDA-Approvable Sign, and Clinical Symptoms of Ocular Dryness and Discomfort
    • Acute Improvement in Ocular Redness and Symptom Scores Demonstrated Within Minutes of Reproxalap Administration in Dry Eye Chamber
    • Main Cohort of TRANQUILITY Expected to Begin Enrollment in February 2021, Following Completion of Tear RASP Analysis and Finalization of Trial Design
    • Management to Host Conference Call at 8:00 a.m. ET Today

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced positive top-line symptom, redness, and Schirmer's test results from the run-in cohort of the Phase 3 TRANQUILITY clinical trial in patients with dry eye disease.

    The double-masked…

    • Statistical Significance of Reproxalap Over Vehicle Achieved for Ocular Redness, an FDA-Approvable Sign, and Clinical Symptoms of Ocular Dryness and Discomfort
    • Acute Improvement in Ocular Redness and Symptom Scores Demonstrated Within Minutes of Reproxalap Administration in Dry Eye Chamber
    • Main Cohort of TRANQUILITY Expected to Begin Enrollment in February 2021, Following Completion of Tear RASP Analysis and Finalization of Trial Design
    • Management to Host Conference Call at 8:00 a.m. ET Today

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced positive top-line symptom, redness, and Schirmer's test results from the run-in cohort of the Phase 3 TRANQUILITY clinical trial in patients with dry eye disease.

    The double-masked, single-center, parallel-group run-in cohort enrolled 23 patients: 12 patients were randomized to receive 0.25% reproxalap ophthalmic solution and 11 patients were randomized to receive vehicle ophthalmic solution. Patients received four doses one day prior to and two doses on the day of exposure to a 90-minute dry eye chamber with minimal humidity, high airflow, and forced visual tasking.

    Over all time points in aggregate in the dry eye chamber, reproxalap was observed to be statistically superior to vehicle for the two assessed symptoms, visual analog scale (VAS) ocular dryness score (p = 0.001) and ocular discomfort score (p < 0.0001) in the run-in cohort of TRANQUILITY. Consistent with previously announced allergen chamber Phase 2 clinical trial results, reproxalap demonstrated statistically significant improvement over vehicle (p = 0.03) in ocular redness, an objective sign of dry eye disease. Improvement in ocular symptoms and redness occurred within minutes after reproxalap dosing. Following acute dosing on the day prior to the dry eye chamber, Schirmer test scores were directionally in favor of reproxalap over vehicle, and reproxalap was statistically superior to vehicle in improvement in VAS dryness score (p = 0.003), ocular discomfort 4-symptom questionnaire (OD4SQ) dryness score (p = 0.006), OD4SQ grittiness score (p = 0.006), and OD4SQ discomfort score (p = 0.003). Consistent with clinical experience in over 1,100 patients, no adverse findings on safety assessments were observed, and reproxalap was well-tolerated.

    "The symptom improvement observed in the run-in cohort of TRANQUILITY announced today support the first-line potential use of reproxalap in dry eye disease, and represent the first results from an ophthalmic solution for chronic use that demonstrate activity acutely following drug administration," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. "The activity of reproxalap in reducing ocular redness, initially demonstrated in the allergen chamber Phase 2 clinical trial, was also observed in the dry eye chamber run-in results of TRANQUILITY, and we look forward to initiating enrollment of the main cohort."

    Among many patients and physicians, current dry eye disease therapies are considered inadequate. Discontinuation rates for lifitegrast and cyclosporine, which currently comprise standard of care, exceed 60% within 12 months of initiation of therapy, in part due to delayed onset of effect.1

    "The potential for patients to experience acute symptomatic relief and observe rapid improvement in ocular redness after the initiation of therapy represents a new possible paradigm in dry eye disease treatment and could offer significant clinical advantage over existing therapies, which often require weeks of drug administration before patients experience even moderate improvement," stated Victor Perez, M.D., Professor of Ophthalmology at Duke University School of Medicine and a member of Aldeyra's Anterior Segment Scientific Advisory Board.

    The main cohort of TRANQUILITY is expected to begin enrollment in February 2021, following completion of tear RASP analysis from the run-in cohort and confirmation of endpoints and number of subjects. Results from TRANQUILITY are expected in the second half of 2021. A second Phase 3 clinical trial, TRANQUILITY-2, is expected to initiate in the first quarter of 2021.

    Conference Call Information

    Aldeyra will host a conference call to discuss this announcement today, Thursday, January 7, 2021, at 8:00 a.m. ET. The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID is 7076648. A live webcast of the conference call will also be available on the Investor Relations section of the Aldeyra Therapeutics website at https://ir.aldeyra.com. Presentation slides will be available on the investor relations page approximately 30 minutes prior to the start of the conference call and webcast.

    After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Reproxalap

    Reproxalap is a novel small-molecule immune-modulating covalent inhibitor of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease. Reproxalap's mechanism of action has been validated with the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications. Reproxalap is currently in Phase 3 clinical development as a 0.25% ophthalmic solution for the treatment of dry eye disease and allergic conjunctivitis, two ocular inflammatory diseases that often occur together in the same patient.

    About Dry Eye Disease

    Dry eye disease is a common inflammatory disease estimated to affect 34 million or more adults in the United States.2 The disease is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment. Among many physicians and patients, existing therapy for dry eye disease is generally regarded as inadequate and often requires weeks or months to demonstrate activity. In patients with dry eye disease, pro-inflammatory RASP may contribute to ocular inflammation and changes in tear lipid composition. By diminishing RASP levels, Aldeyra's lead RASP inhibitor reproxalap represents a novel and differentiated approach for the treatment of the symptoms and signs of dry eye disease.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead investigational compounds, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

    Safe Harbor Statement

    This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the initial clinical results from the run-in cohort of the Phase 3 TRANQUILITY Trial and expectations regarding the main cohort of TRANQUILITY and the TRANQUILITY-2 Trial. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "on track," "scheduled," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra's clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; updated or refined data based on Aldeyra's continuing review and quality control analysis of clinical data, Aldeyra's ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities; delay in or failure to obtain regulatory approval of Aldeyra's product candidates; the ability to maintain regulatory approval of Aldeyra's product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Aldeyra's product candidates; the risk that the results from smaller clinical trials or portions of clinical trials may not accurately predict results of larger scale trials or the remainder of a clinical trial; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; uncertainty as to Aldeyra's ability to commercialize (alone or with others) Aldeyra's product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency or use of Aldeyra's cash resources and needs for additional financing; political, economic, legal, social and health risks, including the recent COVID-19 outbreak and subsequent public health measures, that may affect Aldeyra's business or the global economy; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding competition; Aldeyra's anticipated growth strategies; Aldeyra's ability to attract or retain key personnel; Aldeyra's limited sales and marketing infrastructure; Aldeyra's ability to establish and maintain development partnerships; Aldeyra's ability to successfully integrate acquisitions into its business; Aldeyra's expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra's ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra's business and the market in which it operates; and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2019 and Aldeyra's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at https://www.sec.gov/. Additional factors may be described in those sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2020, expected to be filed with the SEC in the first quarter of 2021.

    In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

    1 White DE, Zhao Y, Ogundele A, et al. Real-World Treatment Patterns of Cyclosporine Ophthalmic Emulsion and Lifitegrast Ophthalmic Solution Among Patients with Dry Eye. Clin Ophthalmol. 2019;13:2285-2292.

    2 Paulsen AJ, Cruickshanks KJ, Fischer ME, et al. Dry eye in the beaver dam offspring study: prevalence, risk factors, and health-related quality of life. Am J Ophthalmol. 2014;157(4):799-806. doi:10.1016/j.ajo.2013.12.023.

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  22. Event Scheduled for 8:00 a.m. ET Thursday, January 7, 2021

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) will host a conference call and webcast at 8:00 a.m. ET Thursday, January 7, 2021, to discuss top-line symptom, redness, and Schirmer's test results from the run-in cohort of the Phase 3 TRANQUILITY clinical trial in patients with dry eye disease. The main cohort of TRANQUILITY is expected to begin enrollment in February 2021, following completion of tear RASP analysis from the run-in cohort and confirmation of endpoints and number of subjects.

    The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID is 7076648. A live webcast of the conference call will also be available…

    Event Scheduled for 8:00 a.m. ET Thursday, January 7, 2021

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) will host a conference call and webcast at 8:00 a.m. ET Thursday, January 7, 2021, to discuss top-line symptom, redness, and Schirmer's test results from the run-in cohort of the Phase 3 TRANQUILITY clinical trial in patients with dry eye disease. The main cohort of TRANQUILITY is expected to begin enrollment in February 2021, following completion of tear RASP analysis from the run-in cohort and confirmation of endpoints and number of subjects.

    The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID is 7076648. A live webcast of the conference call will also be available on the Investor Relations section of the Aldeyra Therapeutics website at https://ir.aldeyra.com.

    After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead investigational compounds, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

    Safe Harbor Statement

    This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the top-line symptom, redness and Schirmer's test results from the run-in cohort of the Phase 3 TRANQUILITY Trial and expectations regarding the main cohort of TRANQUILITY Trial. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "on track," "scheduled," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra's clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; updated or refined data based on Aldeyra's continuing review and quality control analysis of clinical data, Aldeyra's ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities; delay in or failure to obtain regulatory approval of Aldeyra's product candidates; the ability to maintain regulatory approval of Aldeyra's product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Aldeyra's product candidates; the risk that the results from smaller clinical trials or portions of clinical trials may not accurately predict results of larger scale trials or the remainder of a clinical trial; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; uncertainty as to Aldeyra's ability to commercialize (alone or with others) Aldeyra's product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency or use of Aldeyra's cash resources and needs for additional financing; political, economic, legal, social and health risks, including the recent COVID-19 outbreak and subsequent public health measures, that may affect Aldeyra's business or the global economy; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding competition; Aldeyra's anticipated growth strategies; Aldeyra's ability to attract or retain key personnel; Aldeyra's limited sales and marketing infrastructure; Aldeyra's ability to establish and maintain development partnerships; Aldeyra's ability to successfully integrate acquisitions into its business; Aldeyra's expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra's ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra's business and the market in which it operates; and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2019 and Aldeyra's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at https://www.sec.gov/. Additional factors may be described in those sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2020, expected to be filed with the SEC in the first quarter of 2021.

    In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

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    • Nanomolar Antiviral Potency of ADX-1612 Against SARS-CoV-2 Confirmed in Preclinical Studies
    • Novel Anti-Inflammatory Activity of ADX-1612 Demonstrated in SARS-CoV-2-Infected Human Cells
    • International Collaboration Established with the Laboratory of Dr. Markus Landthaler at the Max Delbrück Center for Molecular Medicine in Berlin, Germany for Assessment of ADX-1612 in Cell and Animal COVID-19 Models
    • Additional Third-Party Publications of ADX-1612 Activity in COVID-19-Related Experiments Released

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced confirmation of SARS-CoV-2 antiviral activity of ADX-1612, in addition to novel anti-inflammatory activity in SARS-CoV-2-infected primary human cells in preclinical studies. The…

    • Nanomolar Antiviral Potency of ADX-1612 Against SARS-CoV-2 Confirmed in Preclinical Studies
    • Novel Anti-Inflammatory Activity of ADX-1612 Demonstrated in SARS-CoV-2-Infected Human Cells
    • International Collaboration Established with the Laboratory of Dr. Markus Landthaler at the Max Delbrück Center for Molecular Medicine in Berlin, Germany for Assessment of ADX-1612 in Cell and Animal COVID-19 Models
    • Additional Third-Party Publications of ADX-1612 Activity in COVID-19-Related Experiments Released

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced confirmation of SARS-CoV-2 antiviral activity of ADX-1612, in addition to novel anti-inflammatory activity in SARS-CoV-2-infected primary human cells in preclinical studies. The results are derived from an international collaboration with the Max Delbrück Center for Molecular Medicine in the Helmholtz Association (MDC) in Berlin, Germany, which plans additional studies with colleagues at the Charité – Universitätsmedizin Berlin University Hospital in cell and animal COVID-19 models.

    "The antiviral and anti-inflammatory activity of ADX-1612 demonstrated in COVID-19 models may be applicable to viral diseases generally," stated Emanuel Wyler, Ph.D., Research Scientist at MDC.

    "We look forward to continuing our collaboration with Aldeyra as we advance ADX-1612 to additional cell and animal models to further characterize the activity of ADX-1612 in COVID-19 and other viral infections," added Markus Landthaler, Ph.D., Group Leader of the Coronavirus Task Force and the Laboratory for RNA Biology and Post-transcriptional Regulation at MDC.

    In May 2020, Dr. Wyler and colleagues identified HSP90 as a key antiviral target against SARS-CoV-21 and have confirmed the antiviral activity of ADX-1612, a potent HSP90 inhibitor, reported by Aldeyra earlier this year. Additional reports of the activity of ADX-1612, also known as ganetespib, and other HSP90 inhibitors have been subsequently published by independent laboratories.2

    The anti-inflammatory activity of ADX-1612, as assessed by cytokine transcription in SARS-CoV-2-infected primary human cells, included down-regulation of TNF-α, IFN-1β, IL-6, and a variety of other cytokines and pro-inflammatory mediators.

    "We are thrilled to work with the MDC as we continue to characterize the activity of ADX-1612 as a potential antiviral and immune-modulating approach for the treatment of serious viral infections," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra.

    About ADX-1612

    ADX-1612, which has been clinically tested in more than 1,600 subjects for the potential treatment of cancer, is an inhibitor of chaperone protein HSP90, a target widely implicated in viral disease.3 Complementary to the nucleic acid inhibition mechanism of action of remdesivir and related antiviral compounds, ADX-1612 potentially leads to the inhibition of proteins associated with viral replication and infection, and thereby may enhance the activity of other antiviral drugs for the treatment of COVID-19 and other viral infections. Importantly, via comprehensive expression profiling of human cell lines infected with SARS-CoV-2, HSP90 was identified as a key pharmaceutical target for viral inhibition.1 More recently, the anti-inflammatory activity of ADX-1612 has been demonstrated in SARS-CoV-2-infected human cells.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead compounds, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

    Safe Harbor Statement

    This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the antiviral and anti-inflammatory activity of ADX-1612 and plans for additional preclinical testing. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "on track," "scheduled," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra's clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; updated or refined data based on Aldeyra's continuing review and quality control analysis of clinical data, Aldeyra's ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities; delay in or failure to obtain regulatory approval of Aldeyra's product candidates; the ability to maintain regulatory approval of Aldeyra's product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Aldeyra's product candidates; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; uncertainty as to Aldeyra's ability to commercialize (alone or with others) Aldeyra's product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency or use of Aldeyra's cash resources and needs for additional financing; political, economic, legal, social and health risks, including the recent COVID-19 outbreak and subsequent public health measures, that may affect Aldeyra's business or the global economy; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding competition; Aldeyra's anticipated growth strategies; Aldeyra's ability to attract or retain key personnel; Aldeyra's limited sales and marketing infrastructure; Aldeyra's ability to establish and maintain development partnerships; Aldeyra's ability to successfully integrate acquisitions into its business; Aldeyra's expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra's ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra's business and the market in which it operates; and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2019 and Aldeyra's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at https://www.sec.gov/.

    In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

    1 Bulk and single-cell gene expression profiling of SARS-CoV-2 infected human cell lines identifies molecular targets for therapeutic intervention. BioRxiv, 2020, https://doi.org/10.1101/2020.05.05.079194.

    2 Global analysis of protein-RNA interactions in SARS-CoV-2 infected cells reveals key regulators of infection, https://doi.org/10.1101/2020.11.25.398008; SARS-CoV-2 infection remodels the host protein thermal stability landscape, https://doi.org/10.21203/rs.3.rs-105193/v1.

    3 HSP90: a promising broad-spectrum antiviral drug target. Arch Virol. 2017; 162(11): 3269‐3282, https://doi.org/10.1007/s00705-017-3511-1; Could targeting the heat shock protein 90 revolutionize antiviral therapy? Future Virology 2018; 13(2): 119-127, https://doi.org/10.2217/fvl-2017-0111.

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  23. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced the initiation of Phase 2 clinical trials of ADX-629, a first-in-class orally administered reactive aldehyde species (RASP) inhibitor, for the treatment of COVID-19, atopic asthma, and psoriasis as part of a systematic strategy to assess activity across different types of immunological diseases. The Phase 2 clinical trials follow a successful Phase 1 clinical trial of ADX-629, which demonstrated no treatment-related adverse events at any dose tested, as well as target engagement evidenced by statistically lower RASP levels in drug-treated subjects relative to controls.

    "The initiation of Phase 2 clinical testing of ADX-629, a first-in-class orally administered RASP inhibitor…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced the initiation of Phase 2 clinical trials of ADX-629, a first-in-class orally administered reactive aldehyde species (RASP) inhibitor, for the treatment of COVID-19, atopic asthma, and psoriasis as part of a systematic strategy to assess activity across different types of immunological diseases. The Phase 2 clinical trials follow a successful Phase 1 clinical trial of ADX-629, which demonstrated no treatment-related adverse events at any dose tested, as well as target engagement evidenced by statistically lower RASP levels in drug-treated subjects relative to controls.

    "The initiation of Phase 2 clinical testing of ADX-629, a first-in-class orally administered RASP inhibitor, is an exciting milestone for Aldeyra as we broaden the focus of our RASP platform from ocular indications to systemic disease," stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "The Phase 2 clinical trials announced today underscore our mission to develop new therapies that improve patient outcomes by fine-tuning the body's immune response. Unlike traditional immunologic drugs, ADX-629 is designed to modulate the immune system rather than shut down singular molecular targets, an approach that may lead to toxicity."

    COVID-19 – A Clinical Model of Cytokine Release Syndrome

    The multi-center, double-blind, placebo-controlled, parallel-group Phase 2 clinical trial in COVID-19 will evaluate the safety, tolerability, efficacy, and pharmacodynamics of ADX-629 in adult patients. Approximately 30 patients will be randomized to receive either 300 mg of ADX-629 or placebo twice daily for up to 28 days. Key endpoints will include the National Institute of Allergy and Infectious Diseases COVID-19 scale and plasma levels of cytokines and RASP. Enrollment is expected to begin by year-end.

    Atopic Asthma – A Clinical Model of Allergic Inflammation

    The single-center, double-masked, placebo-controlled, crossover Phase 2 clinical trial will assess the safety and efficacy of ADX-629 in adult patients with mild asthma induced by bronchial asthma challenge. Twelve patients with cat or house dust mite allergen-induced asthma will be randomized to receive either 600 mg of ADX-629 or placebo twice daily for approximately one week. Outcomes will include pulmonary function testing following allergen and methacholine challenge, sputum eosinophil counts, and plasma levels of cytokines and RASP. Enrollment is expected to begin in the first quarter of 2021.

    Psoriasis – A Clinical Model of Autoimmune Disease

    The multi-center, open-label, single-group Phase 2 clinical trial will assess the safety and efficacy of ADX-629 in adult patients with mild to moderate plaque psoriasis. Ten adult patients will receive 250 mg of ADX-629 twice daily for up to 90 days. Outcomes will include psoriasis area and severity index, skin cytokine transcription profiles, plasma leukocyte cytokine release following endotoxin-challenge, and plasma levels of cytokines and RASP. Enrollment is expected to begin in the first half of next year.

    "We believe that ADX-629 has broad applicability to systemic immune-mediated diseases," Dr. Brady said. "We look forward to characterizing more fully the immune modulating activity of ADX-629 in multiple types of severe inflammation."

    About ADX-629

    ADX-629 is a novel orally administered RASP inhibitor in Phase 2 clinical development for the treatment of immune-mediated diseases. RASP inhibitors potentially represent upstream immunological switches that modulate immune systems from pro-inflammatory states to anti-inflammatory states. ADX-629 is a member of the same chemical class as reproxalap, a RASP inhibitor in Phase 3 clinical trials for dry eye disease and allergic conjunctivitis, two common ocular inflammatory diseases.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead compounds, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

    Safe Harbor Statement

    This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the initiation and enrollment of Phase 2 clinical trials of ADX-629 in COVID-19, atopic asthma, and psoriasis. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "on track," "scheduled," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra's clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; updated or refined data based on Aldeyra's continuing review and quality control analysis of clinical data, Aldeyra's ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities; delay in or failure to obtain regulatory approval of Aldeyra's product candidates; the ability to maintain regulatory approval of Aldeyra's product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Aldeyra's product candidates; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; uncertainty as to Aldeyra's ability to commercialize (alone or with others) Aldeyra's product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency or use of Aldeyra's cash resources and needs for additional financing; political, economic, legal, social and health risks, including the recent COVID-19 outbreak and subsequent public health measures, that may affect Aldeyra's business or the global economy; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding competition; Aldeyra's anticipated growth strategies; Aldeyra's ability to attract or retain key personnel; Aldeyra's limited sales and marketing infrastructure; Aldeyra's ability to establish and maintain development partnerships; Aldeyra's ability to successfully integrate acquisitions into its business; Aldeyra's expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra's ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra's business and the market in which it operates; and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2019 and Aldeyra's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at https://www.sec.gov/.

    In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

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  24. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced enrollment of the first patient in the Phase 3 TRANQUILITY Trial of 0.25% reproxalap ophthalmic solution for the treatment of dry eye disease.

    The multi-center randomized, double-masked, parallel design, vehicle-controlled clinical trial will assess the efficacy and safety of reproxalap compared to vehicle in objective sign endpoints of dry eye disease, including tear RASP (reactive aldehyde species) levels after single and multiple doses, and after exposure to a dry eye chamber; Schirmer test (tear volume…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced enrollment of the first patient in the Phase 3 TRANQUILITY Trial of 0.25% reproxalap ophthalmic solution for the treatment of dry eye disease.

    The multi-center randomized, double-masked, parallel design, vehicle-controlled clinical trial will assess the efficacy and safety of reproxalap compared to vehicle in objective sign endpoints of dry eye disease, including tear RASP (reactive aldehyde species) levels after single and multiple doses, and after exposure to a dry eye chamber; Schirmer test (tear volume) following a single dose; and conjunctival redness in the dry eye chamber over 90 minutes. A run-in cohort of 20 patients is expected to be completed this year. Results from the run-in will be used to power the main cohort of the trial, and will confirm primary and secondary endpoints.

    "Initiation of the Phase 3 TRANQUILITY Trial, the first trial designed to characterize the acute effects of reproxalap on RASP and other objective signs of dry eye disease, marks another important step toward a planned NDA submission in dry eye disease by the end of 2021," said Todd C. Brady, M.D., Ph.D. "For the more than 30 million U.S. patients with dry eye disease, we believe that reproxalap has the potential to fulfill significant unmet need as a treatment with rapid onset of action and durable symptom control."

    About Reproxalap

    Reproxalap is a novel small-molecule immune-modulating covalent inhibitor of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease. Reproxalap's mechanism of action has been validated with the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications. Reproxalap is currently in Phase 3 clinical development as a 0.25% ophthalmic solution for the treatment of dry eye disease and allergic conjunctivitis, two ocular inflammatory diseases that often occur together in the same patient.

    About Dry Eye Disease

    Dry eye disease is a common inflammatory disease estimated to affect 34 million or more adults in the United States.1 The disease is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment. Among physicians and patients, existing therapy for dry eye disease is generally regarded as inadequate and often requires weeks or months to demonstrate activity. In patients with dry eye disease, pro-inflammatory RASP may contribute to ocular inflammation and changes in tear lipid composition. By diminishing RASP levels, Aldeyra's lead RASP inhibitor reproxalap represents a novel and differentiated approach for the treatment of the symptoms and signs of dry eye disease.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead compounds, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

    Safe Harbor Statement

    This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the timing and projected enrollment of the Phase 3 TRANQUILITY Trial of reproxalap, the submission of a new drug application (NDA) in dry eye disease and the potential utility of reproxalap as a treatment of dry eye disease. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "on track," "scheduled," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra's clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; updated or refined data based on Aldeyra's continuing review and quality control analysis of clinical data, Aldeyra's ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities; delay in or failure to obtain regulatory approval of Aldeyra's product candidates; the ability to maintain regulatory approval of Aldeyra's product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Aldeyra's product candidates; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; uncertainty as to Aldeyra's ability to commercialize (alone or with others) Aldeyra's product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency or use of Aldeyra's cash resources and needs for additional financing; political, economic, legal, social and health risks, including the recent COVID-19 outbreak and subsequent public health measures, that may affect Aldeyra's business or the global economy; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding competition; Aldeyra's anticipated growth strategies; Aldeyra's ability to attract or retain key personnel; Aldeyra's limited sales and marketing infrastructure; Aldeyra's ability to establish and maintain development partnerships; Aldeyra's ability to successfully integrate acquisitions into its business; Aldeyra's expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra's ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra's business and the market in which it operates; and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2019 and Aldeyra's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov.

    In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.


    1 Paulsen AJ, Cruickshanks KJ, Fischer ME, et al. Dry eye in the beaver dam offspring study: prevalence, risk factors, and health-related quality of life. Am J Ophthalmol. 2014;157(4):799-806. doi:10.1016/j.ajo.2013.12.023.

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  25. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that the company's senior management will participate in the following virtual investor conferences:

    • Jefferies Virtual London Healthcare Conference: Aldeyra President and CEO Todd C. Brady, M.D., Ph.D., is scheduled to participate in a fireside chat at 1:10 p.m. ET on Wednesday, November 18, 2020. The fireside chat will be broadcast live and archived for 90 days on the company's website at https://ir.aldeyra.com/on the "Events & Presentations" page. In addition, company executives are scheduled to host virtual one-on-one meetings with institutional investors.
    • A.G.P./Alliance Global Partners Virtual Healthcare Symposium: Aldeyra executives are scheduled to host virtual one-on-one…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that the company's senior management will participate in the following virtual investor conferences:

    • Jefferies Virtual London Healthcare Conference: Aldeyra President and CEO Todd C. Brady, M.D., Ph.D., is scheduled to participate in a fireside chat at 1:10 p.m. ET on Wednesday, November 18, 2020. The fireside chat will be broadcast live and archived for 90 days on the company's website at https://ir.aldeyra.com/on the "Events & Presentations" page. In addition, company executives are scheduled to host virtual one-on-one meetings with institutional investors.
    • A.G.P./Alliance Global Partners Virtual Healthcare Symposium: Aldeyra executives are scheduled to host virtual one-on-one meetings with institutional investors on November 19, 2020.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead compounds, reproxalap and ADX-629, target reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory disease, leading to elevated levels of cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

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  26. Initiation of Phase 3 Objective Sign Trial in Dry Eye Disease Planned for the Fourth Quarter 2020

    Phase 2 Clinical Trials of ADX-629 in COVID-19, Atopic Asthma, and Psoriasis Expected to Initiate in the Fourth Quarter of 2020

    Top-line Results from the Phase 3 INVIGORATE Clinical Trial in Allergic Conjunctivitis Expected in the First Half of 2021

    Cash, Cash Equivalents, and Marketable Securities of $86.2 Million as of September 30, 2020, Expected to Support Operations Through 2022

    Management to Host Conference Call at 8:00 a.m. ET Today

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients…

    Initiation of Phase 3 Objective Sign Trial in Dry Eye Disease Planned for the Fourth Quarter 2020

    Phase 2 Clinical Trials of ADX-629 in COVID-19, Atopic Asthma, and Psoriasis Expected to Initiate in the Fourth Quarter of 2020

    Top-line Results from the Phase 3 INVIGORATE Clinical Trial in Allergic Conjunctivitis Expected in the First Half of 2021

    Cash, Cash Equivalents, and Marketable Securities of $86.2 Million as of September 30, 2020, Expected to Support Operations Through 2022

    Management to Host Conference Call at 8:00 a.m. ET Today

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced financial results for the third quarter of 2020 and provided a corporate update.

    "Our novel RASP inhibitor reproxalap continues to progress toward New Drug Application (NDA) submissions for dry eye disease and allergic conjunctivitis, two of the largest markets in ophthalmology," stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "Among a number of key clinical milestones planned for the fourth quarter of 2020, we expect to initiate a pivotal Phase 3 objective sign clinical trial of reproxalap for the treatment of dry eye disease, and Phase 2 clinical trials of ADX-629 in COVID-19, atopic asthma, and psoriasis."

    "We concluded the third quarter in a strong financial position, with cash, cash equivalents, and marketable securities of $86.2 million as of September 30," Dr. Brady continued. "Based on our current operating plans, we expect to have sufficient capital to fund operations through 2022, including NDA submissions for reproxalap in dry eye disease and allergic conjunctivitis, assuming positive clinical trial results and regulatory review."

    Recent Highlights

    • American Academy of Ophthalmology 2020: Aldeyra announced the presentation of new clinical utility data from the Phase 2 allergen chamber clinical trial of reproxalap in allergic conjunctivitis. The data will be presented in a poster at the American Academy of Ophthalmology 2020 Virtual Annual Meeting from November 11 through November 15, 2020.



    • Phase 2 Clinical Trial Data Published in Journal of Ocular Pharmacology and Therapeutics: The peer-reviewed Journal of Ocular Pharmacology and Therapeutics published the positive results of a randomized, corticosteroid-controlled Phase 2 clinical trial of reproxalap in patients with noninfectious anterior uveitis, a sight-threatening ocular inflammatory condition typically treated with topical corticosteroids.



    • Regulatory Clearance for Phase 2 Clinical Trial in COVID-19: In September 2020, Aldeyra announced receipt of a Study May Proceed letter from the U.S. Food and Drug Administration to begin a Phase 2 clinical trial evaluating ADX-629, a novel orally available RASP inhibitor, for the treatment of adult patients hospitalized for COVID-19.

    Clinical-Stage Pipeline Updates

    • Reproxalap – A Novel Topical Ocular RASP Inhibitor for the Treatment of Dry Eye Disease and Allergic Conjunctivitis: Aldeyra plans to initiate a Phase 3 clinical trial in the fourth quarter of 2020 to assess the activity of reproxalap in objective signs of dry eye disease, including tear RASP levels, after single and multiple doses of drug. The trial initiation timing is subject to the finalization of trial design, assay development, and potential disruptions due to the COVID-19 pandemic. Enrollment is ongoing in the Phase 3 INVIGORATE Trial of reproxalap for the treatment of patients with allergic conjunctivitis. INVIGORATE is a randomized, double-masked, crossover, vehicle-controlled clinical trial to assess the efficacy and safety of reproxalap compared to vehicle using an allergen chamber. Consistent with prior allergic conjunctivitis trials, the primary endpoint will be subject-reported ocular itching score, as agreed with FDA. Aldeyra expects top-line results in the first half of 2021. NDA submission in dry eye disease and allergic conjunctivitis is expected by the end of 2021, assuming positive clinical trial results and regulatory review.
    • ADX-629 A Novel Orally Available RASP Inhibitor for the Treatment of Systemic Inflammatory Diseases: Phase 2 clinical testing of ADX-629 for the treatment of COVID-19, atopic asthma, and psoriasis is expected to begin by the end of this year.



    • ADX-2191 – 0.8% Methotrexate Intravitreal Injection for Rare Proliferative Ocular Diseases: Completion of enrollment in Part 1 of the Phase 3 GUARD Trial of ADX-2191 for the prevention of proliferative vitreoretinopathy (PVR), a rare but serious sight-threatening retinal disease with no approved treatment, is expected in 2021.

    Financial Results for the Quarter Ended September 30, 2020

    For the quarter ended September 30, 2020, Aldeyra reported a net loss of $8.9 million, compared with a net loss of $18.7 million for the quarter ended September 30, 2019. Net loss per share was $0.23 for the quarter ended September 30, 2020, compared with $0.69 for the same period in 2019. Losses have resulted from the costs of Aldeyra's clinical trials and research and development programs, as well as from general and administrative expenses.

    Research and development expenses were $6.1 million for the quarter ended September 30, 2020, compared with $16.2 million for the same period in 2019. The decrease of $10.1 million is primarily related to decreases in clinical research and development expenditures and lower personnel related costs, partially offset by increases in manufacturing and preclinical development costs.

    General and administrative expenses were $2.3 million for the quarter ended September 30, 2020, compared with $2.8 million for the same period in 2019. The decrease of $0.5 million is due to decreases in personnel related costs and other miscellaneous administrative costs.

    For the quarter ended September 30, 2020, total operating expenses were $8.4 million, compared with total operating expenses of $19.0 million for the same period in 2019.

    As of September 30, 2020, cash, cash equivalents, and marketable securities were $86.2 million. Based on current operating plans, Aldeyra's cash, cash equivalents, and marketable securities as of September 30, 2020 are expected to be sufficient to fund operations through the end of 2022, including potential NDA submissions for reproxalap in dry eye disease and allergic conjunctivitis, assuming positive clinical trial results and regulatory review. Use of Aldeyra's cash, cash equivalents, and marketable securities is also expected to include the continuation of Part 1 of the Phase 3 GUARD Trial in PVR and Phase 2 clinical testing of ADX-629.

    Conference Call & Webcast Information

    Aldeyra will host a conference call today at 8:00 a.m. ET to discuss its third-quarter 2020 financial results. The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 5472726. Due to the expected high demand on our conference provider, please plan to dial in to the call at least 15 minutes prior to the start time.

    A live webcast of the conference call will also be available on the investor relations page of the company's corporate website at https://ir.aldeyra.com. After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead compounds, reproxalap and ADX-629, target reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

    Safe Harbor Statement

    This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Aldeyra's strategy, future operations, expected cash runway, prospects, plans, and objectives and Aldeyra's plans and expectations for its product candidates, including reproxalap, ADX-629, ADX-2191, and ADX-1612. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "on track," "scheduled," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials.

    As a result of the COVID-19 pandemic, clinical site availability, staffing, and patient recruitment have been negatively affected and the timelines to complete Aldeyra's clinical trials may be delayed. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra's clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; updated or refined data based on Aldeyra's continuing review and quality control analysis of clinical data, Aldeyra's ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities; delay in or failure to obtain regulatory approval of Aldeyra's product candidates; the ability to maintain regulatory approval of Aldeyra's product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or trials involving Aldeyra's product candidates; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; the current and potential future impact of the COVID-19 pandemic on Aldeyra's business, results of operations and financial position; uncertainty as to Aldeyra's ability to commercialize (alone or with others) Aldeyra's product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency or use of Aldeyra's cash resources and needs for additional financing; political, economic, legal, social and health risks, including the recent COVID-19 outbreak and subsequent public health measures, that may affect Aldeyra's business or the global economy; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding competition; Aldeyra's anticipated growth strategies; Aldeyra's ability to attract or retain key personnel; Aldeyra's limited sales and marketing infrastructure; Aldeyra's ability to establish and maintain development partnerships; Aldeyra's ability to successfully integrate acquisitions into its business; Aldeyra's expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra's ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra's business and the market in which it operates; and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2019 and Aldeyra's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov. Additional factors may be set forth in those sections of Aldeyra's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, expected to be filed with the SEC in the fourth quarter of 2020.

    In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

     
    ALDEYRA THERAPEUTICS, INC.
    CONSOLIDATED BALANCE SHEETS
     
     
     

    September 30,

     

    December 31,

    2020

     

    2019

    ASSETS

    (Unaudited)

     

     

    Current assets:
    Cash and cash equivalents

    $

    71,175,507

     

    $

    16,425,830

     

    Cash equivalent - reverse repurchase agreements

     

    15,000,000

     

    28,000,000

     

    Marketable securities

     

     

     

    28,938,545

     

    Prepaid expenses and other current assets

     

    2,017,273

     

     

    1,804,450

     

    Total current assets

     

    88,192,780

     

     

    75,168,825

     

    Right-of-use assets

     

    52,195

     

     

    201,007

     

    Fixed assets, net

     

    79,455

     

     

    148,449

     

    Total assets

    $

    88,324,430

     

    $

    75,518,281

     

     
     
    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current liabilities:
    Accounts payable

    $

    123,900

     

    $

    808,302

     

    Accrued expenses

     

    4,018,635

     

     

    11,873,122

     

    Current portion of credit facility

     

    2,259,417

     

     

     

    Current portion of operating lease liabilities

     

    58,720

     

     

    226,328

     

    Total current liabilities

     

    6,460,672

     

     

    12,907,752

     

    Long-term debt

     

    12,693,311

     

     

    14,528,212

     

    Total liabilities

     

    19,153,983

     

     

    27,435,964

     

     
    Commitments and contingencies
    Stockholders' equity:
    Common stock, voting, $0.001 par value; 150,000,000 authorized

    and 38,631,709 and 28,656,832 shares issued and outstanding, respectively

     

    38,632

     

     

    28,657

     

    Additional paid-in capital

     

    294,755,363

     

     

    247,409,793

     

    Accumulated other comprehensive income

     

     

     

    5,866

     

    Accumulated deficit

     

    (225,623,548

    )

     

    (199,361,999

    )

    Total stockholders' equity

     

    69,170,447

     

     

    48,082,317

     

    Total liabilities and stockholders' equity

    $

    88,324,430

     

    $

    75,518,281

     

     
    ALDEYRA THERAPEUTICS, INC.
    CONSOLIDATED STATEMENTS OF OPERATIONS
    (UNAUDITED)
     
     

    Three Months Ended September 30,

     

     

    Nine Months Ended September 30,

    2020

     

    2019

     

     

    2020

     

    2019

     
    Operating expenses:
    Research and development

    $

    6,133,580

     

    $

    16,223,972

     

    $

    17,653,058

     

    $

    34,737,420

     

    Acquired in-process research and development

     

     

     

    (47,102

    )

     

     

     

    6,500,602

     

    General and administrative

     

    2,255,617

     

     

    2,839,319

     

     

    7,480,461

     

     

    8,940,771

     

    Loss from operations

     

    (8,389,197

    )

     

    (19,016,189

    )

     

    (25,133,519

    )

     

    (50,178,793

    )

     
    Other income (expense):
    Interest income

     

    5,215

     

     

    330,329

     

     

    287,025

     

     

    1,262,378

     

    Interest expense

     

    (489,191

    )

     

    (29,154

    )

     

    (1,415,055

    )

     

    (59,766

    )

    Total other income (expense), net

     

    (483,976

    )

     

    301,175

     

     

    (1,128,030

    )

     

    1,202,612

     

    Loss before income taxes

     

    (8,873,173

    )

     

    (18,715,014

    )

     

    (26,261,549

    )

     

    (48,976,181

    )

    Income tax benefit

     

     

     

     

     

     

     

    1,309,973

     

    Net loss

    $

    (8,873,173

    )

    $

    (18,715,014

    )

    $

    (26,261,549

    )

    $

    (47,666,208

    )

     
    Net loss per share - basic and diluted

    $

    (0.23

    )

    $

    (0.69

    )

    $

    (0.81

    )

    $

    (1.77

    )

     
    Weighted average common shares outstanding - basic and diluted

     

    37,796,946

     

     

    27,111,600

     

     

    32,395,217

     

     

    26,928,725

     

     

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  27. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that President and CEO Todd C. Brady, M.D., Ph.D., will discuss Aldeyra's novel therapeutic approaches to treating anterior and posterior segment ocular disease at the Eyecelerator 2020 Virtual Conference on Friday, November 6, 2020. Dr. Brady's presentation is scheduled begin at 1:19 p.m. PT / 4:19 p.m. ET as part of Company Showcase III, "Advancing Trials in the Public Eye."

    The presentation will highlight data from clinical trials of Aldeyra's lead drug candidates, 0.25% reproxalap ophthalmic solution and ADX-2191 (0.8% methotrexate intravitreal injection). Reproxalap is in Phase 3 clinical trials for the treatment of dry eye disease and allergic conjunctivitis, two of the…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that President and CEO Todd C. Brady, M.D., Ph.D., will discuss Aldeyra's novel therapeutic approaches to treating anterior and posterior segment ocular disease at the Eyecelerator 2020 Virtual Conference on Friday, November 6, 2020. Dr. Brady's presentation is scheduled begin at 1:19 p.m. PT / 4:19 p.m. ET as part of Company Showcase III, "Advancing Trials in the Public Eye."

    The presentation will highlight data from clinical trials of Aldeyra's lead drug candidates, 0.25% reproxalap ophthalmic solution and ADX-2191 (0.8% methotrexate intravitreal injection). Reproxalap is in Phase 3 clinical trials for the treatment of dry eye disease and allergic conjunctivitis, two of the largest markets in ophthalmology. ADX-2191 is in Phase 3 testing for the prevention of proliferative vitreoretinopathy (PVR), a rare but serious sight-threatening retinal disease with no approved treatment.

    Eyecelerator, a partnership between the American Academy of Ophthalmology (AAO) and the American Society of Cataract and Refractive Surgery (ASCRS), is designed to connect entrepreneurs, investors, businesses and ophthalmologists to advance ophthalmic innovation. To register for the Eyecelerator 2020 Virtual Conference, visit https://www.eyecelerator.com/november-2020.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead compounds, reproxalap and ADX-629, target reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

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  28. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, will host a conference call at 8:00 a.m. ET on Thursday, November 5, 2020, to discuss financial results for the quarter ended September 30, 2020, and provide a corporate update.

    The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 5472726. Due to the expected high demand on our conference provider, please plan to dial in to the call at least 15 minutes prior to the start time.

    A live webcast of the conference call will also be available on the…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, will host a conference call at 8:00 a.m. ET on Thursday, November 5, 2020, to discuss financial results for the quarter ended September 30, 2020, and provide a corporate update.

    The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 5472726. Due to the expected high demand on our conference provider, please plan to dial in to the call at least 15 minutes prior to the start time.

    A live webcast of the conference call will also be available on the investor relations page of the company's corporate website at https://ir.aldeyra.com. After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead compounds, reproxalap and ADX-629, target reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

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  29. Rapid and Durable Clinical Response Demonstrated in Symptoms and Signs of Allergic Conjunctivitis

    Clinical Relevance Demonstrated with Responder Analyses

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that it will present new data from the Phase 2 allergen chamber clinical trial of reproxalap ophthalmic solution (0.25% and 0.5%) in allergic conjunctivitis. The data will be presented in a poster at the American Academy of Ophthalmology 2020 Virtual Annual Meeting (AAO 2020) from November 11 through November 15, 2020.

    In the randomized, double-masked, crossover, vehicle-controlled Phase 2 clinical trial, 70 subjects with allergic conjunctivitis were assessed over 3.5 hours in an allergen chamber of aerosolized ragweed pollen…

    Rapid and Durable Clinical Response Demonstrated in Symptoms and Signs of Allergic Conjunctivitis

    Clinical Relevance Demonstrated with Responder Analyses

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that it will present new data from the Phase 2 allergen chamber clinical trial of reproxalap ophthalmic solution (0.25% and 0.5%) in allergic conjunctivitis. The data will be presented in a poster at the American Academy of Ophthalmology 2020 Virtual Annual Meeting (AAO 2020) from November 11 through November 15, 2020.

    In the randomized, double-masked, crossover, vehicle-controlled Phase 2 clinical trial, 70 subjects with allergic conjunctivitis were assessed over 3.5 hours in an allergen chamber of aerosolized ragweed pollen (3,500 grains/m³). Reproxalap or vehicle ophthalmic solution was administered bilaterally one minute before chamber entry and at 90 minutes after chamber entry, when peak symptoms typically occur. Compared to vehicle, both concentrations of reproxalap demonstrated statistically significant and clinically relevant improvements in subject-reported ocular itching and tearing and investigator-assessed ocular redness over the duration of exposure in the allergen chamber and for more than one hour after exiting the chamber (P < 0.0001 for all assessments), indicating both prophylactic and treatment effect of drug. In addition, time-to-event responder analyses demonstrated the clinical relevance of the superiority of reproxalap over vehicle for ocular itching and ocular redness. No safety or tolerability concerns were observed.

    "The new data presented at AAO this year further support the clinical utility of reproxalap, the first novel mechanistic approach in late-stage allergic conjunctivitis clinical trials in decades, as uniquely effective," said Todd C. Brady, M.D., Ph.D. President and CEO of Aldeyra. "The results of the allergen chamber trial suggest that reproxalap could offer durable activity with an onset of action that is essentially immediate."

    The 0.25% concentration of reproxalap was advanced to the Phase 3 INVIGORATE Trial, a randomized, double-masked, crossover, vehicle-controlled clinical trial to assess the efficacy and safety of reproxalap compared to vehicle using an allergen chamber. Consistent with prior allergic conjunctivitis trials, the primary endpoint will be subject-reported ocular itching score. Patient enrollment is ongoing, and top-line results are expected in the first half of 2021.

    Details of the poster presentation:

    Title:

     

    A Phase 2 Clinical Trial of Topical Ocular Reproxalap, a Novel RASP Inhibitor, in an Allergen Chamber Model of Allergic Conjunctivitis

    Session:

     

    PO103 - Cornea, External Disease

    Date/Time:

     

    On Demand

    Abstract Link:

      https://bit.ly/2IU5egX

    About Reproxalap

    Reproxalap is a novel small-molecule immune-modulating covalent inhibitor of reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory disease. Reproxalap's mechanism of action has been validated with the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications.

    About Allergic Conjunctivitis

    Allergic conjunctivitis affects more than 1 billion people worldwide,1 including more than 66 million in the U.S.2 The disease is thought to be mediated in part by reactive aldehyde species (RASP), leading to activation of intracellular inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. The symptoms of allergic conjunctivitis – ocular itching and tearing – are chronic, painful, and persistent, affecting quality of life and leading to loss of work that can create a substantial economic burden for patients and their families.3 Although allergic conjunctivitis is one of the most common diseases treated by ophthalmologists and optometrists, in many cases physicians and patients report that currently available therapy is inadequate. Today, nearly one in five allergic conjunctivitis patients utilize corticosteroids or other adjunctive therapy in addition to antihistamines.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead compounds, reproxalap and ADX-629, target reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

    Safe Harbor Statement

    This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Aldeyra's plans and expectations for reproxalap ophthalmic solution as a potential treatment for allergic conjunctivitis. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "on track," "scheduled," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra's clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; updated or refined data based on Aldeyra's continuing review and quality control analysis of clinical data, Aldeyra's ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities; delay in or failure to obtain regulatory approval of Aldeyra's product candidates; the ability to maintain regulatory approval of Aldeyra's product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Aldeyra's product candidates; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; uncertainty as to Aldeyra's ability to commercialize (alone or with others) Aldeyra's product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency or use of Aldeyra's cash resources and needs for additional financing; political, economic, legal, social and health risks, including the recent COVID-19 outbreak and subsequent public health measures, that may affect Aldeyra's business or the global economy; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding competition; Aldeyra's anticipated growth strategies; Aldeyra's ability to attract or retain key personnel; Aldeyra's limited sales and marketing infrastructure; Aldeyra's ability to establish and maintain development partnerships; Aldeyra's ability to successfully integrate acquisitions into its business; Aldeyra's expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra's ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra's business and the market in which it operates; and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2019 and Aldeyra's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov. Additional factors may be described in those sections of Aldeyra's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, expected to be filed with the SEC in the fourth quarter of 2020.

    In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

    _____________________________

    1 White Book on Allergy (2013 Update)

    2 Singh K, Axelrod S, Bielory L. The epidemiology of ocular and nasal allergy in the United States, 1988-1994. J Allergy ClinImmunol. 2010;126(4):778-783.e6

    3 Andrew D. Pitt, Andrew F. Smith, Lynda Lindsell, Li Wern Voon, Peter W. Rose & Anthony J. Bron (2004) Economic and quality-of-life impact of seasonal allergic conjunctivitis in Oxfordshire, Ophthalmic Epidemiology, 11:1, 17-33, DOI: 10.1076/opep.11.1.17.26437

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  30. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that President and CEO Todd C. Brady, M.D., Ph.D., Chief Financial Officer Joshua Reed, and Chief Commercial Officer David McMullin will be participating in a fireside chat and hosting one-on-one meetings at Oppenheimer's Fall Healthcare Life Sciences & MedTech Summit, which is being held in a virtual format.

    The fireside chat is scheduled to begin at 2:30 p.m. ET Wednesday, September 23, 2020. A live webcast of the event will be available on the investor relations page of the company's corporate website at https://ir.aldeyra.com. After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that President and CEO Todd C. Brady, M.D., Ph.D., Chief Financial Officer Joshua Reed, and Chief Commercial Officer David McMullin will be participating in a fireside chat and hosting one-on-one meetings at Oppenheimer's Fall Healthcare Life Sciences & MedTech Summit, which is being held in a virtual format.

    The fireside chat is scheduled to begin at 2:30 p.m. ET Wednesday, September 23, 2020. A live webcast of the event will be available on the investor relations page of the company's corporate website at https://ir.aldeyra.com. After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead compounds, reproxalap and ADX-629, target reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

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  31. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that senior management will be presenting and hosting one-on-one meetings at the following investor conferences:

    • H.C. Wainwright 22nd Annual Global Investment Conference
      Presentation Date: Monday, September 14, 2020
      Time: 3:30 p.m. ET
    • 2020 Cantor Global Virtual Healthcare Conference
      Presentation Date: Wednesday, September 16, 2020 (Fireside Chat)
      Time: 2:40 p.m. ET

    A live webcast of the presentations will be available on the investor relations page of the company's corporate website at https://ir.aldeyra.com. After the live webcast, the events will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that senior management will be presenting and hosting one-on-one meetings at the following investor conferences:

    • H.C. Wainwright 22nd Annual Global Investment Conference

      Presentation Date: Monday, September 14, 2020

      Time: 3:30 p.m. ET
    • 2020 Cantor Global Virtual Healthcare Conference

      Presentation Date: Wednesday, September 16, 2020 (Fireside Chat)

      Time: 2:40 p.m. ET

    A live webcast of the presentations will be available on the investor relations page of the company's corporate website at https://ir.aldeyra.com. After the live webcast, the events will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead compounds, reproxalap and ADX-629, target reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

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  32. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that it has received a Study May Proceed letter from the U.S. Food and Drug Administration (FDA) to begin a Phase 2 clinical trial evaluating ADX-629, a novel orally available reactive aldehyde species (RASP) inhibitor, for the treatment of adult patients hospitalized for COVID-19.

    "The FDA's clearance of our Investigational New Drug application for Phase 2 testing in patients with COVID-19 is an important milestone for ADX-629, which represents a new paradigm in the treatment of immune-mediated diseases," stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "The COVID-19 clinical trial is part of a broad systemic disease strategy designed to demonstrate ADX-629…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that it has received a Study May Proceed letter from the U.S. Food and Drug Administration (FDA) to begin a Phase 2 clinical trial evaluating ADX-629, a novel orally available reactive aldehyde species (RASP) inhibitor, for the treatment of adult patients hospitalized for COVID-19.

    "The FDA's clearance of our Investigational New Drug application for Phase 2 testing in patients with COVID-19 is an important milestone for ADX-629, which represents a new paradigm in the treatment of immune-mediated diseases," stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "The COVID-19 clinical trial is part of a broad systemic disease strategy designed to demonstrate ADX-629 proof of concept in serious inflammatory diseases with critical medical need."

    The planned Phase 2 clinical trial is expected to enroll approximately 30 patients with COVID-19. Patients will be enrolled upon hospitalization for COVID-19 and treated with orally administered ADX-629 or placebo twice-daily for up to 28 days. Key endpoints will include the National Institute of Allergy and Infectious Diseases COVID-19 scale and levels of cytokines and RASP.

    Additional proof of concept Phase 2a clinical trials of ADX-629 in psoriasis and atopic asthma are expected to initiate in the fourth quarter of 2020. The timing of trial initiations depends, in part, on restrictions related to COVID-19, the availability of clinical research facilities and staffing, the ability to recruit patients, and regulatory feedback.

    About ADX-629

    ADX-629 is a novel orally administered RASP inhibitor in Phase 2 clinical development for the treatment of immune-mediated diseases. RASP inhibitors have the potential to represent upstream immunological switches that modulate immune systems from pro-inflammatory states to anti-inflammatory states. ADX-629 is a member of the same chemical class as reproxalap, a RASP inhibitor in Phase 3 clinical trials for dry eye disease and allergic conjunctivitis, two common ocular inflammatory diseases.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead compounds, reproxalap and ADX-629, target reactive aldehyde species (RASP) which are elevated in ocular and systemic inflammatory disease, and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis, and ADX-629 is in Phase 2 clinical development for the treatment of systemic inflammatory diseases. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

    Safe Harbor Statement

    This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Aldeyra's strategy, future operations, prospects, plans, and objectives and Aldeyra's plans and expectations for ADX-629 and its other product candidates. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "on track," "scheduled," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials. As a result of the COVID-19 pandemic, clinical site availability, staffing, and patient recruitment have been negatively affected and the timelines to complete our clinical trials may be delayed. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra's clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; updated or refined data based on Aldeyra's continuing review and quality control analysis of clinical data, Aldeyra's ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities; delay in or failure to obtain regulatory approval of Aldeyra's product candidates; the ability to maintain regulatory approval of Aldeyra's product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or trials involving Aldeyra's product candidates; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; the current and potential future impact of the COVID-19 pandemic on our business, results of operations and financial position; uncertainty as to Aldeyra's ability to commercialize (alone or with others) Aldeyra's product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency or use of Aldeyra's cash resources and needs for additional financing; political, economic, legal, social and health risks, including the recent COVID-19 outbreak and subsequent public health measures, that may affect Aldeyra's business or the global economy; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding competition; Aldeyra's anticipated growth strategies; Aldeyra's ability to attract or retain key personnel; Aldeyra's limited sales and marketing infrastructure; Aldeyra's ability to establish and maintain development partnerships; Aldeyra's ability to successfully integrate acquisitions into its business; Aldeyra's expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra's ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra's business and the market in which it operates; and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2019 and Aldeyra's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov.

    In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

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  33. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that President and Chief Executive Officer Todd C. Brady, M.D., Ph.D., will participate in an ophthalmology panel discussion during Citi's 15th Annual BioPharma Virtual Conference, taking place September 8-11, 2020. In addition, Aldeyra's senior management will host one-on-one meetings at the conference.

    Panel Details

    Title: Seeing 20/20 in 2020
    Date: Thursday, September 10, 2020
    Time: 9:50 a.m. ET

    A live webcast of the panel discussion will be available on the investor relations page of the company's corporate website at https://ir.aldeyra.com. After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that President and Chief Executive Officer Todd C. Brady, M.D., Ph.D., will participate in an ophthalmology panel discussion during Citi's 15th Annual BioPharma Virtual Conference, taking place September 8-11, 2020. In addition, Aldeyra's senior management will host one-on-one meetings at the conference.

    Panel Details

    Title: Seeing 20/20 in 2020

    Date: Thursday, September 10, 2020

    Time: 9:50 a.m. ET

    A live webcast of the panel discussion will be available on the investor relations page of the company's corporate website at https://ir.aldeyra.com. After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead compounds, reproxalap and ADX-629, target reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in Phase 2 testing for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

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  34. Based on FDA Agreement that RASP is an Objective Sign of Dry Eye Disease, Assessment of Tear RASP Levels in Dry Eye Disease Patients Expected to Begin in the Fourth Quarter of 2020

    New Drug Application (NDA) Submission for Reproxalap in Dry Eye Disease Expected by the End of 2021

    Current Cash Expected to Support Operations Through 2022, Including Potential Approvals for Dry Eye Disease and Allergic Conjunctivitis

    Management to Host Conference Call at 8:00 a.m. ET Today

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced financial results for…

    Based on FDA Agreement that RASP is an Objective Sign of Dry Eye Disease, Assessment of Tear RASP Levels in Dry Eye Disease Patients Expected to Begin in the Fourth Quarter of 2020

    New Drug Application (NDA) Submission for Reproxalap in Dry Eye Disease Expected by the End of 2021

    Current Cash Expected to Support Operations Through 2022, Including Potential Approvals for Dry Eye Disease and Allergic Conjunctivitis

    Management to Host Conference Call at 8:00 a.m. ET Today

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced financial results for the second quarter of 2020 and provided a corporate update.

    "We continue to make important progress in advancing a number of clinical-stage programs focused on the development of reproxalap and ADX-629, our first-in-class reactive aldehyde species (RASP) inhibitors," stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "Following a successful meeting with the US Food and Drug Administration (FDA) in June, we are on track to initiate clinical trials assessing levels of RASP, a pro-inflammatory mediator, in the tears of patients with dry eye disease. Clinical development of ADX-629, an orally available RASP inhibitor, in COVID-19, psoriasis, and atopic asthma is expected to begin during the second half of this year."

    "We also have enhanced our financial flexibility with recent common stock sales to Perceptive Advisors and Avidity Partners, transactions that generated gross proceeds of approximately $19.5 million and completed our previously announced at-the-market offering program," Dr. Brady continued. "We now expect to be able to fund operations through 2022, including potential approvals for reproxalap in dry eye disease and allergic conjunctivitis."

    Recent Highlights

    • Use of RASP as an Objective Sign for Treatment of Dry Eye Disease: In June 2020, Aldeyra announced agreement with the FDA for the use of RASP as an objective sign for the treatment of dry eye disease, marking the first new objective sign for the disease in more than a decade.
    • IND Submission for ADX-629: Aldeyra completed an Investigational New Drug (IND) submission under the FDA's Coronavirus Accelerated Treatment Program to initiate a Phase 2 clinical trial of ADX-629 in patients with COVID-19.
    • Orphan Medicinal Product Designation for ADX-2191: The European Commission designated ADX-2191 as an orphan medicinal product for the treatment of retinal detachment. ADX-2191, a novel and proprietary intravitreal formulation of methotrexate, is being evaluated in the Phase 3 GUARD Trial for prevention of recurrent retinal detachment due to proliferative vitreoretinopathy (PVR), the leading cause of failure of retinal detachment surgery. Drugs that receive the orphan medicinal product designation in the European Union (EU) are entitled to protocol assistance, research funding, and, upon approval, 10 years of EU market exclusivity.

    Clinical-Stage Pipeline Updates

    • Reproxalap – A Novel Topical Ocular RASP Inhibitor for the Treatment of Dry Eye Disease and Allergic Conjunctivitis: In the fourth quarter of this year, Aldeyra intends to initiate clinical testing to assess the activity of topical ocular reproxalap in reducing tear levels of RASP and other objective signs of dry eye disease, subject to finalization of trial design, RASP assay development, and potential disruptions due to the COVID-19 pandemic. In addition, a safety trial in dry eye disease patients is expected to be initiated in the fourth quarter of 2020. NDA submission is expected by the end of 2021, assuming positive clinical trial results and regulatory review. Top-line results from the Phase 3 INVIGORATE allergen chamber trial, the second Phase 3 trial of reproxalap in allergic conjunctivitis, are expected in the first half of 2021.
    • ADX-629 A Novel Orally Available RASP Inhibitor for the Treatment of Systemic Inflammatory Diseases: An IND for Phase 2 clinical testing of ADX-629 in patients with COVID-19 has been filed with the FDA. Additionally, in the fourth quarter of this year, the company expects to initiate Phase 2a clinical trials of ADX-629 in patients with psoriasis and atopic asthma.
    • ADX-2191 An Intravitreal Methotrexate Injectable for Rare Proliferative Ocular Diseases: Aldeyra has filed for Orphan Drug Designation (ODD) with the FDA for ADX-2191 for the treatment of primary vitreoretinal lymphoma, a rare, aggressive, high-grade cancer that arises in the vitreous and retina. Additionally, an update on enrollment in the Phase 3 GUARD trial of ADX-2191 for the prevention of PVR, a rare but serious sight-threatening retinal disease with no approved treatment, is expected by the end of this year.
    • ADX-1612 A Protein Chaperome Inhibitor for Systemic Disease: Enrollment has been completed in the investigator-sponsored Phase 2 EUDARIO Trial of ADX-1612 in ovarian cancer. Regarding the ADX-1612 COVID-19 program, consistent with FDA feedback, additional preclinical antiviral testing of ADX-1612 against SARS-CoV-2, the virus that causes COVID-19, will be performed by the National Institute of Allergy and Infectious Diseases, which has accepted the company's request to evaluate ADX-1612 in in vivo models. Aldeyra expects to provide an update on the ADX-1612 COVID-19 program by the end of 2020.

    Financial Results for the Quarter Ended June 30, 2020

    For the quarter ended June 30, 2020, Aldeyra reported a net loss of $7.5 million, compared with a net loss of $13.3 million for the quarter ended June 30, 2019. Net loss per share was $0.25 for the quarter ended June 30, 2020, compared with $0.49 for the same period in 2019. Losses have resulted from the costs of Aldeyra's clinical trials and research and development programs, as well as from general and administrative expenses.

    Research and development expenses were $4.9 million for the quarter ended June 30, 2020, compared with $10.7 million for the same period in 2019. The decrease of $5.8 million is primarily related to the decreases in clinical and preclinical development, manufacturing, and personnel costs.

    General and administrative expenses were $2.2 million for the quarter ended June 30, 2020, compared with $3.1 million for the same period in 2019. The decrease of $0.9 million is due to decreases in personnel related costs, including stock-based compensation, and other miscellaneous administrative costs.

    For the quarter ended June 30, 2020, total operating expenses were $7.1 million, compared with total operating expenses of $13.7 million for the same period in 2019.

    As of June 30, 2020, cash, cash equivalents, and marketable securities were $66.2 million. Subsequent to June 30, 2020, $25.2 million in cash was received from at-the-market offering program sales to Perceptive Advisors, Avidity Partners, and other investors. Based on current operating plans, cash, cash equivalents, and marketable securities as of June 30, 2020, plus the additional at-the-market offering program proceeds, are expected to be sufficient to fund operations through the end of 2022, including potential NDA approvals for reproxalap in dry eye disease and allergic conjunctivitis, assuming positive clinical trial results, and planned NDA submissions, acceptances, and approvals. Use of Aldeyra's cash, cash equivalents, and marketable securities are also expected to include the continuation of Part 1 of the Phase 3 GUARD Trial in PVR, and Phase 2 clinical testing of ADX-629, an orally administered RASP inhibitor, in inflammatory diseases.

    Conference Call & Webcast Information

    Aldeyra will host a conference call today at 8:00 a.m. ET to discuss its second-quarter 2020 financial results. The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 9297174. Due to the expected high demand on our conference provider, please plan to dial in to the call at least 15 minutes prior to the start time.

    A live webcast of the conference call will also be available on the investor relations page of the company's corporate website at https://ir.aldeyra.com. After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

    About Aldeyra Therapeutics

    Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company's lead compounds, reproxalap and ADX-629, target reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company's clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in Phase 2 testing for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

    Safe Harbor Statement

    This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Aldeyra's strategy, future operations, expected cash runway, prospects, plans, and objectives and Aldeyra's plans and expectations for its product candidates, including reproxalap, ADX-629, ADX-2191, and ADX-1612. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "on track," "scheduled," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials.

    As a result of the COVID-19 pandemic, clinical site availability, staffing, and patient recruitment have been negatively affected and the timelines to complete our clinical trials may be delayed. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra's clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; updated or refined data based on Aldeyra's continuing review and quality control analysis of clinical data, Aldeyra's ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities; delay in or failure to obtain regulatory approval of Aldeyra's product candidates; the ability to maintain regulatory approval of Aldeyra's product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or trials involving Aldeyra's product candidates; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; the current and potential future impact of the COVID-19 pandemic on our business, results of operations and financial position; uncertainty as to Aldeyra's ability to commercialize (alone or with others) Aldeyra's product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency or use of Aldeyra's cash resources and needs for additional financing; political, economic, legal, social and health risks, including the recent COVID-19 outbreak and subsequent public health measures, that may affect Aldeyra's business or the global economy; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding competition; Aldeyra's anticipated growth strategies; Aldeyra's ability to attract or retain key personnel; Aldeyra's limited sales and marketing infrastructure; Aldeyra's ability to establish and maintain development partnerships; Aldeyra's ability to successfully integrate acquisitions into its business; Aldeyra's expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra's ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra's business and the market in which it operates; and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2019 and Aldeyra's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov. Additional factors may be set forth in those sections of Aldeyra's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, expected to be filed with the SEC in the third quarter of 2020.

    In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

     
    ALDEYRA THERAPEUTICS, INC.
    CONSOLIDATED BALANCE SHEETS
     
     
     
    June 30, December 31,

     

    2020

     

     

    2019

     

    ASSETS (Unaudited)
    Current assets:
    Cash and cash equivalents

    $

    50,688,834

     

    $

    16,425,830

     

    Cash equivalent - reverse repurchase agreements

     

    10,000,000

     

    $

    28,000,000

     

    Marketable securities

     

    5,500,975

     

     

    28,938,545

     

    Prepaid expenses and other current assets

     

    5,232,717

     

     

    1,804,450

     

    Total current assets

     

    71,422,526

     

     

    75,168,825

     

    Right-of-use assets

     

    103,074

     

     

    201,007

     

    Fixed assets, net

     

    101,695

     

     

    148,449

     

    Total assets

    $

    71,627,295

     

    $

    75,518,281

     

     
     
    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current liabilities:
    Accounts payable

    $

    216,689

     

    $

    808,302

     

    Accrued expenses

     

    3,693,594

     

     

    11,873,122

     

    Current portion of credit facility

     

    894,042

     

     

     

    Current portion of operating lease liabilities

     

    116,124

     

     

    226,328

     

    Total current liabilities

     

    4,920,449

     

     

    12,907,752

     

    Long-term debt

     

    13,917,180

     

     

    14,528,212

     

    Total liabilities

     

    18,837,629

     

     

    27,435,964

     

     
    Commitments and contingencies
    Stockholders' equity:
    Common stock, voting, $0.001 par value; 150,000,000 authorized

    and 32,997,346 and 28,656,832 shares issued and outstanding, respectively

     

    32,997

     

     

    28,657

     

    Additional paid-in capital

     

    269,502,290

     

     

    247,409,793

     

    Accumulated other comprehensive income

     

    4,754

     

     

    5,866

     

    Accumulated deficit

     

    (216,750,375

    )

     

    (199,361,999

    )

    Total stockholders' equity

     

    52,789,666

     

     

    48,082,317

     

    Total liabilities and stockholders' equity

    $

    71,627,295

     

    $

    75,518,281

     

     
    ALDEYRA THERAPEUTICS, INC.
    CONSOLIDATED STATEMENTS OF OPERATIONS
    (UNAUDITED)
     
     
    Three Months Ended June 30, Six Months Ended June 30,

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

     
    Operating expenses:
    Research and development

    $

    4,885,875

     

    $

    10,664,858

     

    $

    11,519,478

     

    $

    18,513,448

     

    Acquired in-process research and development

     

     

     

    (49,848

    )