ALDX Aldeyra Therapeutics Inc.

7.68
-0.24  -3%
Previous Close 7.92
Open 8.25
52 Week Low 6.47
52 Week High 15.95
Market Cap $446,147,366
Shares 58,092,105
Float 48,563,756
Enterprise Value $234,548,444
Volume 693,281
Av. Daily Volume 597,258
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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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ADX-2191 - GUARD
Proliferative vitreoretinopathy (PVR)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
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.
Ganetespib (ADX-1612)
Ovarian cancer
Phase 2
Phase 2
Phase 2 trial ongoing.
Reproxalap (ADX-102)
Sjögren-Larsson Syndrome (SLS)
Phase 3
Phase 3
Development placed on hold - noted March 12, 2020.
Reproxalap (ADX-102)
Noninfectious anterior uveitis
Phase 3
Phase 3
Phase 3 data did not meet endpoints - June 25, 2019.
ADX-2191
Retinitis Pigmentosa
Phase 2
Phase 2
Phase 2 trial to initiate 4Q 2021.

Latest News

  1. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra or the Company), 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:

    • Berenberg US CEO Conference
      Format: Analyst-Hosted Fireside Chat
      Date: Wednesday, November 10, 2021
      Time: 10:00 a.m. ET
      Note: A live and recorded webcast of this event will be available on the Investors & Media page of the Company's website at https://ir.aldeyra.com/. The recorded webcast will be archived and available for 90 days.
    • 2021
      Format: Retina Showcase Presentation
      Date: Thursday, November…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra or the Company), 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:

    • Berenberg US CEO Conference

      Format: Analyst-Hosted Fireside Chat

      Date: Wednesday, November 10, 2021

      Time: 10:00 a.m. ET

      Note: A live and recorded webcast of this event will be available on the Investors & Media page of the Company's website at https://ir.aldeyra.com/. The recorded webcast will be archived and available for 90 days.
    • 2021

      Format: Retina Showcase Presentation

      Date: Thursday, November 11, 2021

      Time: 1:05 p.m. CT (2:05 p.m. ET)
    • Jefferies London Healthcare Conference

      Format: Analyst-Hosted Fireside Chat

      Time: Available On Demand Beginning at 8:00 a.m. GMT (3:00 a.m. ET) Thursday, November 18, 2021

      Note: A webcast of this event will be available on the Investors & Media page of the Company's website at https://ir.aldeyra.com/. The recorded webcast will be archived and available for 90 days.
    • Ophthalmology Day at BTIG

      Format: Analyst-Hosted Fireside Chat

      Date: Tuesday, November 30, 2021

      Time: 1:00 p.m. ET

    About Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics, Inc. 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 TRANQUILITY Expected This Quarter
    • Together with Recently Completed Phase 2 Clinical Trial, Positive Ocular Redness Results from TRANQUILITY Could Satisfy NDA Submission Requirements as Pivotal Trials for Improvement in an Objective Sign of Dry Eye Disease
    • Completed Phase 3 RENEW-Part 1 and Formulation Phase 2 Clinical Trials to be Submitted as Pivotal Trials in Satisfaction of NDA Symptom Requirements
    • Anticipated NDA Submission Expected in Early 2022

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra or the Company), a biotechnology company developing novel immune-modulating therapies to treat ocular and systemic diseases, today announced completion of enrollment in the Phase 3 TRANQUILITY Trial of 0.25% reproxalap…

    • Top-Line Results from TRANQUILITY Expected This Quarter
    • Together with Recently Completed Phase 2 Clinical Trial, Positive Ocular Redness Results from TRANQUILITY Could Satisfy NDA Submission Requirements as Pivotal Trials for Improvement in an Objective Sign of Dry Eye Disease
    • Completed Phase 3 RENEW-Part 1 and Formulation Phase 2 Clinical Trials to be Submitted as Pivotal Trials in Satisfaction of NDA Symptom Requirements
    • Anticipated NDA Submission Expected in Early 2022

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra or the Company), a biotechnology company developing novel immune-modulating therapies to treat ocular and systemic diseases, today announced completion of enrollment in the Phase 3 TRANQUILITY Trial of 0.25% reproxalap ophthalmic solution (reproxalap) for the treatment of patients with dry eye disease.

    "Following the recent announcement of top-line results from our Phase 2 clinical trial, which achieved the primary endpoint of ocular redness and which we intend to submit as a pivotal trial, completion of enrollment in TRANQUILITY is a significant milestone as we advance reproxalap toward an anticipated NDA submission early next year for the treatment of dry eye disease," stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "If the primary endpoint of ocular redness in TRANQUILITY is achieved, and in conjunction with two previously announced clinical trials demonstrating improvement in ocular dryness symptoms, we believe that the efficacy requirements for NDA submission will have been met."

    The multi-center, double-masked, parallel-group TRANQUILITY Trial enrolled 300 patients randomized equally to receive either reproxalap or vehicle. 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. The primary endpoint of the TRANQUILITY Trial is ocular redness. Top-line results from the trial are expected this quarter.

    Based on the results of the recently completed Phase 2 clinical trial, which enrolled 158 patients and achieved statistical significance in the primary endpoint of ocular redness, TRANQUILITY is at least 90% powered to detect a statistically significant difference in ocular redness. TRANQUILITY is one of two identically designed Phase 3 clinical trials Aldeyra is conducting in patients with dry eye disease. Enrollment in the second trial, TRANQUILITY-2, is ongoing. If successful, either TRANQUILITY or TRANQUILITY-2 could complete NDA submission requirements for demonstration of improvement in an objective sign of dry eye disease.

    Per draft U.S. Food and Drug Administration (FDA) guidance, to be considered for regulatory approval in the United States, a product candidate for the treatment of dry eye disease must demonstrate efficacy in an objective sign in at least two clinical trials and efficacy in a subjective symptom in at least two clinical trials. For satisfaction of symptom efficacy requirements, Aldeyra intends to submit two previously completed adequate and well-controlled symptom trials that pre-specified patient-reported ocular dryness score as a primary endpoint, the RENEW-Part 1 Trial and the Formulation Phase 2 clinical trial. For satisfaction of the sign efficacy requirements, Aldeyra intends to submit the recently completed Phase 2 clinical trial and, if positive, either TRANQUILITY or TRANQUILITY-2, all of which pre-specify ocular redness as a primary endpoint.

    "With its safety and efficacy profile—demonstrated in clinical trials encompassing more than 1,300 patients in aggregate—reproxalap has the potential to provide relief to the estimated 34 million adults in the U.S. who suffer from persistently disturbing symptoms and ocular redness caused by dry eye disease," Dr. Brady stated.

    More information on TRANQUILITY can be found on www.clinicaltrials.gov, (NCT04674358).

    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 Aldeyra Therapeutics, Inc.

    Aldeyra Therapeutics, Inc. 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 Aldeyra's development plans and expectations for its product candidates, including plans and expectations relating to current or future clinical development and regulatory progress of reproxalap in 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. In addition, FDA draft guidance and discussions with the Company are not binding on the agency. 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, including the timing of the 12-month safety trial of reproxalap in dry eye disease; 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 FDA may not accept Aldeyra's NDA submission for review; 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 COVID-19 pandemic and related 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, 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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  2. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced achievement of the primary endpoint of ocular redness in a randomized, double-masked, vehicle-controlled Phase 2 clinical trial in patients with dry eye disease.

    The clinical trial enrolled 158 patients: 80 patients were randomized to receive 0.25% reproxalap ophthalmic solution, and 78 patients were randomized to receive vehicle ophthalmic solution. Patients received four doses one day prior to and two doses during exposure to a 90-minute dry eye chamber with minimal humidity, high airflow, and forced visual tasking.

    Based on final enrollment and data from the run-in cohort of TRANQUILITY, Aldeyra's ongoing Phase 3 trial in dry eye disease, the Phase 2 trial exceeded 90…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced achievement of the primary endpoint of ocular redness in a randomized, double-masked, vehicle-controlled Phase 2 clinical trial in patients with dry eye disease.

    The clinical trial enrolled 158 patients: 80 patients were randomized to receive 0.25% reproxalap ophthalmic solution, and 78 patients were randomized to receive vehicle ophthalmic solution. Patients received four doses one day prior to and two doses during exposure to a 90-minute dry eye chamber with minimal humidity, high airflow, and forced visual tasking.

    Based on final enrollment and data from the run-in cohort of TRANQUILITY, Aldeyra's ongoing Phase 3 trial in dry eye disease, the Phase 2 trial exceeded 90% power to detect statistical significance in the primary endpoint of ocular redness over all time points in aggregate in the dry eye chamber. Ocular redness scores in the reproxalap group were observed to be statistically lower than those of vehicle (p = 0.016). Additionally, Schirmer's test scores assessed after the first dose were directionally in favor of reproxalap over vehicle and approached statistical significance (p = 0.068). Mean visual analog scale ocular dryness and ocular discomfort scores were lower in reproxalap-treated subjects than in vehicle-treated subjects at all of the 18 time points when symptoms were assessed in the dry eye chamber, including the first time point in the chamber, although differences did not reach statistical significance. Tear RASP level results from the trial are expected to be available later this quarter. Consistent with the clinical experience of reproxalap in more than 1,300 patients, there were no observed safety or tolerability concerns in the trial; the most common adverse event was mild and transient instillation site discomfort lasting less than one minute and similar to many prescribed topical ophthalmic medications for anterior segment inflammation.

    "Complementing our rapid and durable symptom control evidenced in three 12-week clinical trials, we are excited to announce achievement of statistical significance of an objective sign of dry eye disease in a well-controlled clinical trial," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. "Ocular redness may be the only dry eye disease sign that is of importance to patients, and the reduction in redness observed in this trial following reproxalap treatment potentially represents a major advance for the chronic treatment of dry eye disease."

    Two Phase 3 clinical trials of reproxalap in patients with dry eye disease, TRANQUILITY and TRANQUILITY-2, are ongoing. For each trial, the planned enrollment is 300 patients, and the primary endpoint is ocular redness. Pending confirmation of statistical powering and other analyses of the Phase 2 clinical trial results announced today, results from the TRANQUILITY trials are expected to be released by the end of the year.

    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 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 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 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 Aldeyra's development plans and expectations for its product candidates, including plans and expectations relating to current or future clinical development of reproxalap in 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 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 COVID-19 pandemic and related 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, 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 Paulsen 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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    • Company Expects to Report Top-Line Results from Phase 3 TRANQUILITY and TRANQUILITY-2 Clinical Trials of Reproxalap in Dry Eye Disease in the Fourth Quarter of 2021
    • Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa On Track to Initiate in the Fourth Quarter of 2021
    • Phase 2 Clinical Trial Results of ADX-629 in Multiple Systemic Indications Expected in the Fourth Quarter of 2021 or the First Quarter of 2022
    • Cash and Cash Equivalents of $241.4 Million as of September 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.
    • Company Expects to Report Top-Line Results from Phase 3 TRANQUILITY and TRANQUILITY-2 Clinical Trials of Reproxalap in Dry Eye Disease in the Fourth Quarter of 2021
    • Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa On Track to Initiate in the Fourth Quarter of 2021
    • Phase 2 Clinical Trial Results of ADX-629 in Multiple Systemic Indications Expected in the Fourth Quarter of 2021 or the First Quarter of 2022
    • Cash and Cash Equivalents of $241.4 Million as of September 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 recent corporate highlights and financial results for the quarter ended September 30, 2021.

    "We continue to make important progress in developing safe and effective treatments for ocular and systemic diseases to improve the lives of patients who have significant unmet medical needs," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. "Among key clinical milestones, we expect to release top-line results from the Phase 3 TRANQUILITY and TRANQUILITY-2 dry eye disease clinical trials in the fourth quarter of this year and are on track to report top-line results from Phase 2 clinical trials of ADX-629 in psoriasis, atopic asthma, and COVID-19 by the end of the year or early 2022. We also look forward to the planned initiation of our Phase 2 clinical trial of ADX-2191 in retinitis pigmentosa this quarter."

    Recent Corporate Highlights and Program Updates

    • Top-Line Results from the Phase 3 TRANQUILITY and TRANQUILITY-2 Trials in Dry Eye Disease Expected in the Fourth Quarter of 2021. Ocular redness is the primary endpoint of the TRANQUILITY trials, which include tear RASP levels, Schirmer's test, and dry eye disease symptoms as secondary endpoints. In addition, enrollment has completed in a multi-center, double-masked, randomized, vehicle-controlled, parallel-group Phase 2 clinical trial of reproxalap in dry eye disease. The Phase 2 trial was designed to optimize the measurement of tear RASP levels.
    • Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa Scheduled to Initiate in the Fourth Quarter of 2021. The primary endpoint of the trial is the safety and tolerability of ADX-2191 in patients with retinitis pigmentosa. Secondary endpoints are visual acuity, central retinal sensitivity, dark-adapted retinal sensitivity, and retinal morphometry.
    • Phase 2 Clinical Trial Results from ADX-629, an Orally Administered RASP Inhibitor, Expected in the Fourth Quarter of 2021 or First Quarter of 2022. ADX-629 is in proof-of-concept Phase 2 clinical trials for the treatment of psoriasis, atopic asthma, and COVID-19. ADX-629 represents a first-in-class systems-based therapeutic approach for the potential treatment of many immune-mediated diseases that today are treated with single-target drugs that can lead to toxicity.
    • Post-Acute Ocular Tolerability Comparison of Topical Reproxalap 0.25% and Lifitegrast 5% in Patients with Dry Eye Disease Paper Published in Peer-Reviewed Journal. Clinical Ophthalmology published the results of a clinical trial comparing the subjective eye drop experience of patients with dry eye disease over one hour after a single dose of two formulations of reproxalap versus lifitegrast.

    Third-Quarter 2021 Financial Results

    Cash and cash equivalents as of September 30, 2021 were $241.4 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; 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 September 30, 2021, Aldeyra reported a net loss of $15.8 million, compared with a net loss of $8.9 million for the quarter ended September 30, 2020. Net loss per share was $0.27 for the quarter ended September 30, 2021, compared with $0.23 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 $12.9 million for the quarter ended September 30, 2021, compared with $6.1 million for the same period in 2020. The increase of $6.8 million is primarily related to increases in our clinical research and development expenditures and consulting costs, partially offset by decreases in personnel related costs, including stock-based compensation, and manufacturing activities.

    General and administrative expenses were $2.5 million for the quarter ended September 30, 2021, compared with $2.3 million for the quarter ended September 30, 2020. The increase of $0.2 million is primarily due to an increase in miscellaneous administrative costs.

    For the quarter ended September 30, 2021, total operating expenses were $15.4 million, compared with total operating expenses of $8.4 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 third-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 8891298. 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 COVID-19 pandemic and related 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 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 described in those sections of Aldeyra's Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, expected to be filed with the SEC in the fourth 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

     
     
     

    September 30,

    December 31,

    2021

    2020

    ASSETS

    (Unaudited)

    Current assets:
    Cash and cash equivalents

    $

    116,368,688

     

    $

    52,858,311

     

    Cash equivalent - reverse repurchase agreements

     

    125,000,000

     

     

    25,000,000

     

    Prepaid expenses and other current assets

     

    5,403,261

     

     

    5,200,957

     

    Total current assets

     

    246,771,949

     

     

    83,059,268

     

    Right-of-use assets

     

    406,014

     

     

    233,310

     

    Fixed assets, net

     

    39,607

     

     

    59,925

     

    Total assets

    $

    247,217,570

     

    $

    83,352,503

     

     
     
    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current liabilities:
    Accounts payable

    $

    467,932

     

    $

    381,638

     

    Accrued expenses

     

    11,252,075

     

     

    8,134,765

     

    Current portion of credit facility

     

     

     

    3,659,776

     

    Current portion of operating lease liabilities

     

    222,158

     

     

    233,310

     

    Total current liabilities

     

    11,942,165

     

     

    12,409,489

     

    Operating lease liabilities, long-term

     

    184,599

     

     

     

    Long-term debt

     

    15,420,904

     

     

    11,434,456

     

    Total liabilities

     

    27,547,668

     

     

    23,843,945

     

     
    Stockholders' equity:
    Common stock, voting, $0.001 par value; 150,000,000 authorized and 58,045,432 and 38,667,491 shares issued and outstanding, respectively

     

    58,045

     

     

    38,667

     

    Additional paid-in capital

     

    498,549,312

     

     

    296,385,619

     

    Accumulated deficit

     

    (278,937,455

    )

     

    (236,915,728

    )

    Total stockholders' equity

     

    219,669,902

     

     

    59,508,558

     

    Total liabilities and stockholders' equity

    $

    247,217,570

     

    $

    83,352,503

     

    ALDEYRA THERAPEUTICS, INC.

    CONSOLIDATED STATEMENTS OF OPERATIONS

    (UNAUDITED)

     
     

    Three Months Ended

    September 30,

    Nine Months Ended

    September 30,

    2021

    2020

    2021

    2020

     
    Operating expenses:
    Research and development

    $

    12,894,344

     

    $

    6,133,580

     

    $

    32,095,132

     

    $

    17,653,058

     

    General and administrative

     

    2,546,807

     

     

    2,255,617

     

     

    8,720,161

     

     

    7,480,461

     

    Loss from operations

     

    (15,441,151

    )

     

    (8,389,197

    )

     

    (40,815,293

    )

     

    (25,133,519

    )

     
    Other income (expense):
    Interest income

     

    59,306

     

     

    5,215

     

     

    122,732

     

     

    287,025

     

    Interest expense

     

    (413,110

    )

     

    (489,191

    )

     

    (1,329,166

    )

     

    (1,415,055

    )

    Total other income (expense), net

     

    (353,804

    )

     

    (483,976

    )

     

    (1,206,434

    )

     

    (1,128,030

    )

    Net loss

    $

    (15,794,955

    )

    $

    (8,873,173

    )

    $

    (42,021,727

    )

    $

    (26,261,549

    )

     
    Net loss per share - basic and diluted

    $

    (0.27

    )

    $

    (0.23

    )

    $

    (0.80

    )

    $

    (0.81

    )

     
    Weighted average common shares outstanding - basic and diluted

     

    58,019,099

     

     

    37,796,946

     

     

    52,688,846

     

     

    32,395,217

     

     

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  3. Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) will host a conference call at 8:00 a.m. ET Thursday, October 28, 2021 to report financial results for the quarter ended September 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 8891298. 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…

    Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) will host a conference call at 8:00 a.m. ET Thursday, October 28, 2021 to report financial results for the quarter ended September 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 8891298. 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.

    View Full Article Hide Full Article
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