ALDX Aldeyra Therapeutics Inc.

12.1
-0.04  -0%
Previous Close 12.14
Open 12.14
52 Week Low 3.78
52 Week High 15.95
Market Cap $697,337,556
Shares 57,631,203
Float 48,102,854
Enterprise Value $576,611,781
Volume 540,927
Av. Daily Volume 2,758,380
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Upcoming Catalysts

Drug Stage Catalyst Date
Reproxalap (ADX-102) - (TRANQUILITY)
Dry eye syndrome
Phase 3
Phase 3
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ADX-629
Psoriasis / atopic asthma / COVID-19
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Ganetespib (ADX-1612)
Ovarian cancer
Phase 2
Phase 2
Phase 2 trial ongoing.
Ganetespib (ADX-1612)
Post-transplant lymphoproliferative disorder
Phase 2
Phase 2
Development placed on hold - noted March 12, 2020.
Reproxalap (ADX-102) - (INVIGORATE)
Allergic conjunctivitis
Phase 3
Phase 3
Phase 3 trial met primary endpoint - April 27, 2021.
Reproxalap (ADX-102)
Noninfectious anterior uveitis
Phase 3
Phase 3
Phase 3 data did not meet endpoints - June 25, 2019.
ADX-2191
Proliferative vitreoretinopathy (PVR)
Phase 3
Phase 3
Phase 3 (Part 1) completion of enrollment due 2021.
Reproxalap (ADX-102)
Sjögren-Larsson Syndrome (SLS)
Phase 3
Phase 3
Development placed on hold - noted March 12, 2020.

Latest News

    • 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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  1. 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.

    View Full Article Hide Full Article
  2. 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 , 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 .

    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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  3. 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 , 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 .

    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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