ALDX Aldeyra Therapeutics Inc.

6.89
-0.24  -3%
Previous Close 7.13
Open 7.29
52 Week Low 1.48
52 Week High 8.05
Market Cap $236,957,169
Shares 34,371,507
Float 28,806,460
Enterprise Value $198,534,248
Volume 567,441
Av. Daily Volume 1,432,842
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Upcoming Catalysts

Drug Stage Catalyst Date
ADX-102 - Reproxalap
Dry eye syndrome
Phase 3
Phase 3
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Reproxalap (ADX-102) - INVIGORATE
Allergic conjunctivitis
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
ADX-629
COVID-19
Phase 1
Phase 1
Update due by the end of 2020.
ADX-629
Psoriasis and atopic asthma
Phase 2
Phase 2
Phase 2 trial planned for 4Q 2020.
ADX-1612
Ovarian cancer
Phase 2
Phase 2
Phase 2 enrolment to be completed in June 2020.
ADX-2191
Proliferative vitreoretinopathy (PVR)
Phase 3
Phase 3
Phase 3 enrolment delayed due to COVID-19.
Reproxalap (ADX-102)
Sjögren-Larsson Syndrome (SLS)
Phase 3
Phase 3
Development placed on hold - noted March 12, 2020.
ADX-1612 (ganetespib)
Post-transplant lymphoproliferative disorder
Phase 2
Phase 2
Development placed on hold - noted March 12, 2020.
ADX-102 reproxalap
Noninfectious anterior uveitis
Phase 3
Phase 3
Phase 3 data did not meet endpoints - June 25, 2019.

Latest News

  1. 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

    )

     

     

     

    6,547,703

     

    General and administrative

     

    2,220,003

     

     

    3,116,414

     

     

    5,224,844

     

     

    6,101,452

     

    Loss from operations

     

    (7,105,878

    )

     

    (13,731,424

    )

     

    (16,744,322

    )

     

    (31,162,603

    )

     
    Other income (expense):
    Interest income

     

    71,710

     

     

    432,908

     

     

    281,809

     

     

    932,049

     

    Interest expense

     

    (486,048

    )

     

    (28,649

    )

     

    (925,863

    )

     

    (30,612

    )

    Total other income (expense), net

     

    (414,338

    )

     

    404,259

     

     

    (644,054

    )

     

    901,437

     

    Loss before income taxes

     

    (7,520,216

    )

     

    (13,327,165

    )

     

    (17,388,376

    )

     

    (30,261,166

    )

    Income tax benefit

     

     

     

     

     

     

     

    1,309,973

     

    Net loss

    $

    (7,520,216

    )

    $

    (13,327,165

    )

    $

    (17,388,376

    )

    $

    (28,951,193

    )

     
    Net loss per share - basic and diluted

    $

    (0.25

    )

    $

    (0.49

    )

    $

    (0.59

    )

    $

    (1.08

    )

     
    Weighted average common shares outstanding - basic and diluted

     

    30,118,456

     

     

    26,985,454

     

     

    29,586,148

     

     

    26,836,292

     

     
     

     

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  2. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that senior management will be presenting and hosting 1x1 meetings at the following virtual investor conferences in August:

    • BTIG Virtual Biotechnology Conference 2020
      Presentation Date: Tuesday, August 11, 2020
      Time: 11:30 a.m. ET
    • 2020 Wedbush PacGrow Healthcare Virtual Conference
      Presentation Date: Wednesday, August 12, 2020
      Time: 12:35 p.m. ET

    A live webcast of these 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…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that senior management will be presenting and hosting 1x1 meetings at the following virtual investor conferences in August:

    • BTIG Virtual Biotechnology Conference 2020

      Presentation Date: Tuesday, August 11, 2020

      Time: 11:30 a.m. ET
    • 2020 Wedbush PacGrow Healthcare Virtual Conference

      Presentation Date: Wednesday, August 12, 2020

      Time: 12:35 p.m. ET

    A live webcast of these 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, 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 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.

    View Full Article Hide Full Article
  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, will host a conference call at 8:00 a.m. ET on Thursday, August 6, 2020, to discuss financial results for the quarter ended June 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 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…

    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, August 6, 2020, to discuss financial results for the quarter ended June 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 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, 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 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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  4. Gross Proceeds of Approximately $19.5 Million from At-the-Market Offering Program Sufficient to Extend Operations Through the End of 2022, Including Potential New Drug Application (NDA) Approvals for Reproxalap in Dry Eye Disease and Allergic Conjunctivitis, Based on Current Operating Plans

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a biotechnology company devoted to development of next-generation medicines to improve the lives of patients with immune-mediated diseases, today announced block sales of an aggregate of 4,580,361 shares of common stock to Perceptive Advisors, LLC and Avidity Partners Management LP, two leading healthcare-focused investment funds, under Aldeyra's previously announced at-the-market offering program. The…

    Gross Proceeds of Approximately $19.5 Million from At-the-Market Offering Program Sufficient to Extend Operations Through the End of 2022, Including Potential New Drug Application (NDA) Approvals for Reproxalap in Dry Eye Disease and Allergic Conjunctivitis, Based on Current Operating Plans

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a biotechnology company devoted to development of next-generation medicines to improve the lives of patients with immune-mediated diseases, today announced block sales of an aggregate of 4,580,361 shares of common stock to Perceptive Advisors, LLC and Avidity Partners Management LP, two leading healthcare-focused investment funds, under Aldeyra's previously announced at-the-market offering program. The shares were sold for a price of $4.25 per share. Aggregate gross proceeds, before deducting commissions, were approximately $19.5 million. The sales completed Aldeyra's previously disclosed at-the-market offering program and no further sales will be made under this program. Jefferies, LLC served as sales agent under the at-the-market offering program.

    Aldeyra anticipates using the net proceeds from the sales for the continued development of the company's lead compound reproxalap and other product candidates, as well as for debt maintenance, working capital, and other general corporate purposes. Based on current operating plans, cash, cash equivalents, and marketable securities are sufficient to fund operations through the end of 2022, including potential NDA approvals for reproxalap, a first-in-class topical ocular reactive aldehyde species (RASP) inhibitor, in dry eye disease and allergic conjunctivitis, assuming positive clinical trial results, and planned NDA submissions, acceptances, and approvals. Use of proceeds are also expected to include the continuation of Part 1 of the Phase 3 GUARD Trial for proliferative vitreoretinopathy, a rare retinal disease with no approved therapy, and Phase 2 clinical testing of ADX-629, an orally administered RASP inhibitor, in inflammatory diseases.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy the company's common stock nor shall there be any sale of such common stock in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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 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 the anticipated use of proceeds from the financing that is the subject of this release; the sufficiency of the company's cash, cash equivalents and marketable securities; and potential clinical outcomes from the company's trials in dry eye disease and 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. 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.

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  5. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer, will discuss the company's clinical programs in anterior and posterior ocular disease as part of the Ophthalmology Innovation Summit's Virtual Public Company Showcase on Thursday, July 16, 2020. Dr. Brady's presentation is scheduled for 1:40 to 1:50 p.m. ET.

    As part of the Showcase, Dr. Brady also will participate in the Ophthalmology Outlook Panel moderated by Emmett T. Cunningham Jr., M.D., Ph.D., MPH, Senior Managing Director for Blackstone Life Sciences. The panel discussion is scheduled for 2:20 to 3:00 p.m. ET.

    A webcast of Dr. Brady's presentation and the Ophthalmology Outlook Panel will be available…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer, will discuss the company's clinical programs in anterior and posterior ocular disease as part of the Ophthalmology Innovation Summit's Virtual Public Company Showcase on Thursday, July 16, 2020. Dr. Brady's presentation is scheduled for 1:40 to 1:50 p.m. ET.

    As part of the Showcase, Dr. Brady also will participate in the Ophthalmology Outlook Panel moderated by Emmett T. Cunningham Jr., M.D., Ph.D., MPH, Senior Managing Director for Blackstone Life Sciences. The panel discussion is scheduled for 2:20 to 3:00 p.m. ET.

    A webcast of Dr. Brady's presentation and the Ophthalmology Outlook Panel will be available on the investor relations page of the company's corporate website at https://ir.aldeyra.com or https://hopin.to/events/ois-virtual-public-company-showcase. Registration is required; suggested log-in is at least 10 minutes prior to the scheduled event. After the 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, 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 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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