UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 26, 2018
ALDEYRA THERAPEUTICS, INC.
(Exact name of Registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
| 001-36332 | 20-1968197 | |
| (Commission File No.) |
(IRS Employer Identification No.) |
131 Hartwell Avenue, Suite 320
Lexington, MA 02421
(Address of principal executive offices and zip code)
Registrant’s telephone number, including area code: (781) 761-4904
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 7.01. Regulation FD.
On June 26, 2018, Aldeyra Therapeutics, Inc. (“Aldeyra”) intends to make a slide presentation at its 2018 Research Day in person in New York City and by webcast on Aldeyra’s website. A copy of Aldeyra’s slide presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
The furnishing of the attached slide presentation is not an admission as to the materiality of any information therein. The information contained in the slide presentation is summary information that is intended to be considered in the context of more complete information included in Aldeyra’s filings with the Securities and Exchange Commission and other public announcements that Aldeyra has made and may make from time to time by press release or otherwise. Aldeyra undertakes no duty or obligation to update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate.
The information in Item 7.01 of this Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing, regardless of any general incorporation language in any such filing, unless Aldeyra expressly sets forth in such filing that such information is to be considered “filed” or incorporated by reference therein.
Item 8.01 Other Events.
On June 26, 2018, Aldeyra issued a press release that provided an update on Aldeyra’s clinical development plans and pipeline. A copy of the press release is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
| (d) | Exhibits |
| Exhibit No. |
Description | |
| 99.1 | Slide presentation of Aldeyra Therapeutics, Inc. dated June 26, 2018. | |
| 99.2 | Press Release of Aldeyra Therapeutics, Inc. dated June 26, 2018. | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ALDEYRA THERAPEUTICS, INC. | ||||
| By: | /s/ Todd C. Brady, M.D., Ph.D. | |||
| Name: Todd C. Brady, M.D., Ph.D. | ||||
| Title: President and Chief Executive Officer | ||||
Dated: June 26, 2018
Research Day 2018 Update on Research Programs June 26, 2018 New York NASDAQ: ALDX ©Aldeyra Therapeutics, Inc. 2018 Exhibit 99.1
Disclaimers and Forward-Looking Statements This presentation and various remarks which may be made during this presentation contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding Aldeyra’s possible or assumed future results of operations, expenses and financing needs, business strategies and plans, research and development plans or expectations, trends, the structure, timing and success of Aldeyra’s planned or pending clinical trials, expected milestones, market sizing, pricing and reimbursement, competitive position, regulatory matters, industry environment and potential growth opportunities, among other things. Forward-looking statements include all statements that are not historical facts and, in some cases, can be identified by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan” or similar expressions and the negatives of those terms. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Aldeyra’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements reflect Aldeyra’s current views with respect to future events and are based on assumptions and subject to risks and uncertainties, including the development, clinical and regulatory plans or expectations for Aldeyra’s product candidates and Aldeyra’s continuing review and quality control analysis of clinical data. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements are described in Aldeyra’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as well as Aldeyra’s subsequent filings with the Securities and Exchange Commission. 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, completion, or reporting of clinical trials. 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 presentation is provided only as of June 26, 2018, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law.
Our Mission Developing Next-Generation Medicines to Improve the Lives of Patients with Immune-Mediated Diseases ~7% Of Western Society Suffer from some form of immune-mediated disease Disease control elusive despite existing therapies, and thus novel approaches are needed Unmet Needs Source: Shurin and Smolkin, Advances in Experimental Medicines and Biology 601:3-12, 2007; Kuek et al, Postgraduate Medical Journal 83(978): 251-260, 2007.
Developing Next-Generation Medicines to Improve the Lives of Patients with Immune-Mediated Diseases Deep and Innovative Pipeline focused on immune-mediated diseases Near-Term Development Catalysts support path to commercialization Solid Track Record of development success Solid Cash Position $ Large Market Potential of late-stage pipeline Cash, cash equivalents and marketable securities were $38.9 million as of March 31, 2018
Reproxalap: Lead Candidate With Significant Commercial Potential Ocular Inflammation Inborn Errors of Metabolism Dry Eye Disease Allergic Conjunctivitis Noninfectious Anterior Uveitis Sjögren-Larsson Syndrome Potential Competitive Advantages2 Rapid onset, broader activity Non-drying, durable activity, responder superiority vs. vehicle No expected risk of glaucoma or other corticosteroid toxicities Clinically demonstrated efficacy No FDA therapy currently approved Estimated U.S. Population1 150,000 flares per yr. 30 million 1,0003 20 million Reproxalap Development Stage Phase 2b Phase 3 Phase 3 Phase 3 1 Aldeyra estimates based on internal market research and publicly available information. 2 Pending clinical data, regulatory discussions, payor negotiations, competition, potential legislative changes, and other factors, which may not be in Aldeyra’s control. Preliminary assumptions are subject to change. 3 Extrapolated from a Swedish estimate and a U.S. genetic mutation analysis, it is generally assumed that there are approximately 1,000 Sjögren-Larsson Syndrome (SLS) patients in the United States and a greater number of SLS patients in Europe.
Deep and Innovative Pipeline Not Disclosed Reproxalap Ocular Reproxalap Dermal ADX-629 Systemic ADX-103 ADX-1612 Dry Eye Disease Allergic Conjunctivitis Noninfectious Anterior Uveitis Sjögren-Larsson Syndrome Autoimmune Disease Retinal Disease Lymphoproliferative Immune Disease Phase 2b results H2-2018 Phase 3 results H2-2018 / 2019 Phase 3 results 2019 Phase 3, Part 1 results 2019 Systemic Inflammatory Disease RASP Inhibitors Hsp90 Inhibitors Anti-Inflammatory Ovarian Cancer Mesothelioma Investigator Sponsored Trial ADX-1615 Autoimmune Disease Cancer Not Disclosed Ocular Inflammation Research Collaboration Investigator Sponsored Trial Indication Compound Approach = Positive Phase 2 clinical data reported in 2016 – 2017 ü ü ü ü ü ü RASP = Reactive Aldehydes Species that are Pro-inflammatory Preclinical Phase 1 Phase 2 Phase 3 Next Expected Milestone Research Program Update Phase 2 results H2-2018
2018 Progress and Near-Term Development Catalysts Support Path to Commercialization Initiated reproxalap Phase 2b clinical trial in dry eye disease First patient enrolled in reproxalap Phase 3, Part 1 clinical trial in Sjögren-Larsson Syndrome Q3 2018 Reproxalap dry eye disease Phase 2b clinical trial results H2-2018 Reproxalap allergic conjunctivitis Phase 3 results H2-2018/early 2019 Reproxalap noninfectious anterior uveitis Phase 3 clinical trial results 2019 Reproxalap Sjögren-Larsson Syndrome Phase 3, Part 1 clinical trial results 2019 H1 2018 H2 2018 2019 Initiated reproxalap Phase 3 clinical trial in allergic conjunctivitis Entered into research collaboration with Johnson & Johnson Innovation in systemic inflammatory diseases Disclosed in-license of a Hsp90 inhibitor *Contingent on funding, regulatory review, and other factors. Anticipated Milestones* Clinical sites initiated for reproxalap Phase 3, Part 1 clinical trial in Sjögren-Larsson Syndrome
Research Day 2018 Update on Research Programs June 26, 2018 New York NASDAQ: ALDX
Developing Next-Generation Medicines to Improve the Lives of Patients with Immune-Mediated Diseases Targeting RASP Targeting Hsp90 Partnership Update ADX-629 for Systemic Immune-Mediated Diseases ADX-103 for Inflammatory Retinal Disease ADX-1612 for Lymphoproliferative Immune Disease and Cancer ADX-1615 for Autoimmune Disease and Cancer J&J Innovation
Immune System Balance is Complex Stimulation Regulation Immune Balance Healthy Stimulation Imbalance Autoimmune Disease Regulation Imbalance Cancer
Novel Approaches to Address Immune-Mediated Disease RASP = Reactive Aldehydes Species that are Pro-inflammatory RASP Activated Cell Cell Proliferation Immune Cell Stimulus Hsp90 Inhibitors RASP Inhibitors
Targeting RASP for Systemic Immune-Mediated Diseases ADX-629
Targeting RASP: Mediators of Inflammation and Activators of the Immune System Thiol / Amine Adduct Formation Receptor / kinase, lipid modification Inflammasome, NFkB activation; cytokine release Scavenger Receptor A binding Auto-antibody formation RASP Activated Immune Cell Inflammation Scientific Literature Cardiovasc Res. 2010 Nov 1;88(2):352-9. HNE-induced 5-LO expression is regulated by NF-kB/ERK and Sp1/p38 MAPK pathways via EGF receptor in murine macrophages. Biofactors. 2005;24(1-4):229-36. Role of 4-hydroxy-2,3-nonenal in the pathogenesis of fibrosis. Cell Mol Biol Lett. 2015 Dec;20(4):647-62. The advanced lipoxidation end product precursor malondialdehyde induces IL-17E expression and skews lymphocytes to the th17 subset. J Leukoc Biol. 2012 Nov;92(5):1055-67. Proinflammatory effects of malondialdehyde in lymphocytes. Diabetes. 2008 Apr;57(4):879-88. Proinflammatory effects of advanced lipoxidation end products in monocytes. RASP = Reactive Aldehydes Species that are Pro-inflammatory
ADX-629: A Novel Pre-Clinical RASP Inhibitor for Treatment of Systemic Immune-Mediated Disorders Highly prevalent disease characterized by liver inflammation, fibrosis, cirrhosis, and hepatocellular carcinoma No FDA-approved therapy RASP end-products observed in NASH Over one million patients in the U.S. suffer from Ulcerative Colitis and Crohn’s Disease Chronic autoimmune disease with variable response to therapy RASP observed in preclinical models; decreased RASP metabolism observed in diseased human intestinal tissue Source: Prevalence data from U.S. Centers for Disease Control and Prevention NASH (non-alcoholic steatohepatitis) IBD (inflammatory bowel disease)
Normal hepatocyte Fatty hepatocyte Fatty & injured hepatocyte Apoptotic hepatocyte NASH Pathogenesis: Chronic Progression of Inflammation and Fibrosis Adapted from Diehl and Day NEMJ 377:2062-2072, 2017; RASP activity as shown based on published literature and Aldeyra data on file. RASP-Mediated RASP-Mediated Inflammation Fibrosis
Environmental factors Microorganisms Diet Infections Stress NSAIDs Appendectomy Smoking Antibiotics Genetic factors Antimicrobial peptides Autophagy Handling of bacteria Chemokines Cytokines Initiating triggers Phase I: Pre-disease stage Phase II: Acute intestinal inflammation Phase III: Recurrent inflammation Phase IV: Tissue destruction and complications IBD Pathogenesis: Chronic Relapsing Intestinal Inflammation Adapted from Neurath, Nature Reviews Immunology 14:329 – 342, 2014; RASP activity as shown based on published literature and Aldeyra data on file. RASP- Mediated RASP- Mediated RASP- Mediated Intestinal wall
ADX-629: A Pre-Clinical Novel RASP Inhibitor ADX-629 is an analog of reproxalap Reproxalap has demonstrated activity in immune-mediated diseases Pre-Clinical Models Sepsis Inflammatory pain Oral mucositis Allergic dermatitis Contact dermatitis Acute lung injury Corneal fibrosis Clinical Trials Dry eye disease Allergic conjunctivitis Noninfectious anterior uveitis Supporting scientific posters and presentations available on Aldeyra’s investors page at ir.aldeyra.com.
ADX-629 Decreased LPS-Induced Pro-inflammatory Cytokine Levels and Increased Levels of an Anti-inflammatory Cytokine in Animal Models Cytokine Decrease RANTES 93.8% MIP-1α 93.1% IL-12(p40) 92.4% G-CSF 91.1% LIF 85.8% MIG 83.3% IL-5 82.3% IL-17 77.4% M-CSF 75.1% GM-CSF 73.7% IL-13 73.6% IL-15 72.1% Cytokine Decrease IL-15 72.1% IL-9 72.0% IL-1b 71.5% IFNg 71.3% IL-12(p70) 68.8% IL-1α 67.5% IL-7 65.2% LIX 62.0% TNFα 60.3% IL-3 56.0% VEGF 55.2% Eotaxin 26.1 % Cytokine Increase IL-10 2103% ADX-629 (100 mg/kg) was administered intraperitoneally to mice LPS was administered intraperitoneally (1 mg/kg) 15 minutes later Blood was collected 2 hours after ADX-629 administration and plasma cytokines measured by ELISA p values range from < 0.05 to < 0.0001 Pro-Inflammatory Anti-Inflammatory
Planning to initiate clinical testing in 2019 Potential ADX-629 Development Overview 2018 2020 Today 144 days Jul 17 - Feb 1 106 days Feb 1 - Jun 30 155 days Jul 1 - Jan 31 155 days Jul 1 - Jan 31 Contingent on pre-clinical studies, clinical trials, funding, regulatory review, and other factors. Phase 2a IBD Clinical Trial Phase 2a NASH Clinical Trial IND-Enabling Toxicology Phase 1 Clinical Trial
Targeting RASP for Inflammatory Retinal Disease ADX-103
ADX-103: A Structurally Distinct Pre-Clinical RASP Inhibitor Potential product candidate for treatment of retinal disease RASP observed in retinal disease Efficacy in several preclinical models of ocular inflammation Diabetic macular edema (DME) Dry age-related macular degeneration (AMD) / Stargardt’s Disease Posterior uveitis DME: Glyoxal, methylglyoxal, allysine AMD/Stargardt’s Disease: Retinaldehyde Posterior uveitis: Malondialdehyde, 4-hydroxynonenal
Diabetic Macular Edema: ADX-103 Blocked Diabetes-Induced Retinal Changes in Animal Models Male Norway rats were administered streptozotocin (STZ), 55 mg/kg IP, on Day 0 to induce diabetes Two single doses of ADX-103 (17.5 µg each) were administered intravitreally, after induction of diabetes (Days 42 and 57) Histopathology of the retina was conducted at Day 71 Scale: 1 = minimal microscopically visible changes 2 = mild microscopically visible changes 3 = moderate microscopically visible changes Retinal Thickness Changes at Day 71 Presented at the 2018 ARVO annual meeting.
Endotoxin-Induced Uveitis: ADX-103 Decreased Ocular Inflammation in Animal Models Ocular inflammation in rats induced by footpad injection of a bacterial endotoxin (LPS) Severe model Peaks at 24 hours A single intravitreal dose of ADX-103 (25 µg/eye) was administered at hour 1 post-LPS administration Retina-choroid complex was scored for inflammatory changes at six and 24 hours Presented at the 2018 ARVO annual meeting. *p < 0.05; **p < 0.01 Retinal Inflammation at 6 Hrs. Post Insult Retinal Inflammation at 24 Hrs. Post Insult
Planning to initiate clinical testing in 2019 Potential ADX-103 Retina Program Overview 2018 2020 Today 144 days Jul 17 - Feb 1 106 days Feb 1 - Jun 30 155 days Jul 1 - Jan 31 155 days Jul 1 - Jan 31 Phase 2 Clinical Trial IND-Enabling Toxicology Phase 1/2 Clinical Trial Contingent on pre-clinical studies, clinical trials, funding, regulatory review, and other factors.
Targeting Hsp90 for Lymphoproliferative Immune Disease and Cancer ADX-1612
ADX-1612: Clinically Advanced Asset With Extensive Preclinical, Nonclinical, and Clinical Data In-licensed for its potential in immune-mediated disease ADX-1612 clinically-tested in oncology as ganetespib Preclinical efficacy in immune disorders Unregulated proliferation of immune cells Lymphoproliferative/immunoproliferative disorders Hyperactive immune system IV formulation Ongoing Investigator-Sponsored Trials (ISTs) using ADX-1612 in combination with platins
ADX-1612: Expanding The Potential Repertoire for Treatment of Immune-Mediated Diseases Adapted from Tukaj and Wegrzyn Cell Stress and Chaperones 21:213 – 218, 2016. Cytoplasm Nucleus ADX-1612 ADX-1612 Hsp90 Hsp90 Hsp70 NFkB Inflammation HSF1 HSE mRNA hsp70 ADX-1612 Hsp90 inhibitor Hsp90 Upregulated in stressful conditions Role in antigen presentation in dendritic cells Client proteins involved in signal transduction and cell cycle (e.g., cell proliferation, survival, apoptosis) Inhibition of Hsp90 Prevents proper folding of client proteins, leading to degradation and disruption of cell cycle Prevents DNA repair
ADX-1612: Observed Effects on Vasculitis in a Patient With Leukemia in Phase 1 Clinical Trial Pre-Treatment Post-Treatment Vasculitis: Inflammation of blood vessel walls Fever, headache, fatigue, weight loss, aches and pains, night sweats, rash, ulcers, numbness or weakness Clearing of limb rash after first ADX-1612 treatment Source: Data on file
ADX-1612: Inhibition of Immune Cell Proliferation Observed in an Animal Model of Lupus vehicle 2X/wk 1X/wk Every other wk ADX-1612 Treatment was initiated at 7 weeks of age and continued through 22 weeks of age Dosing: 50 mg/kg, IV twice weekly once weekly every other week Systemic autoimmunity (MRL/lpr mouse) Source: Data on file; Also see Liu et al., The Hsp90 inhibitor ganetespib alleviates disease progression and augments intermittent cyclophosphamide therapy in the MRL/lpr mouse model of systemic lupus erythematosus. PLoS ONE 10(5):e0127361 2015.
ADX-1612: Skin Lesions and Lymphoadenopathy Decreased in an Animal Model of Lupus Skin Lesion Score at 22 Weeks Lymphoadenopathy Score at 22 Weeks ADX-1612 vehicle 2X/wk 1X/wk every other wk vehicle 2X/wk 1X/wk every other wk ADX-1612 Source: Data on file
Proposed Indication: Post-Transplant Lymphoproliferative Disorder (PTLD) Lymphomas occurring after stem cell transplant or organ transplant Most serious complication of transplantation, resulting from immunosuppression Uncontrolled proliferation of lymphocytes Medication-induced reduction in immune surveillance Imbalance between immunosuppression and immune surveillance May progress to lymphoma No optimal therapy Hsp90 overexpressed in lymphomas Initiation of Phase 2a clinical trial currently anticipated in 2019 Polymorphic post-transplant lymphoproliferative disorder (PTLD) involving the rectum. Source: Yin and Lin; Basicmedical Key
DNA repair complex Rationale for Synergism of Hsp90 Inhibitor and Platins for The Treatment of Cancer Inhibition of Hsp90 prevents repair and inhibits proteins involved in tumor cell survival Platins induce DNA damage… Adapted from Noll et al., Front. Biosci. 9:421-437, 2004 Hsp90 …But damaged DNA can be repaired ADX-1612 Cultured Ovarian Cancer Cells Adapted from Kramer et al., Cell Death and Differ. 2:300 – 316, 2017 Wee1 Chk1 Src Raf MEK PDK1 AKT HIF-1α IKK Apaf-1 STAT3 STAT5 Key Cancer Proteins
ADX-1612: A Promising Asset for Oncology Investigator-sponsored trials (IST) in cancer ongoing Mesothelioma: ADX-1612 + pemextred (antimetabolite) / platinum (DNA damage inducer) therapy Expected data readout 2H 2018 Ovarian cancer (EUDARIO): ADX-1612 + carboplatin + niraparib (PARP inhibitor) Initiation currently anticipated 2H 2018 Timing subject to numerous factors that may be outside the control of Aldeyra.
ADX-1615: Oral Pro-Drug of ADX-1612 Orally administered Oral administration may be better suited to treatment of chronic immune-mediated disorders May also be useful in oncology setting Has shown activity in mast cell tumors in dogs (monotherapy) Manuscript submitted Next Steps Manufacturing IND-enabling toxicology studies Clinical testing could begin as early as 2020 Contingent on pre-clinical studies, funding, regulatory review, and other factors.
Partnership Update
Partnership Update Johnson & Johnson Innovation: Collaborative research agreement Focus: RASP inhibitors (not including reproxalap) Indications: immune-mediated diseases characterized by systemic inflammation Governed by Joint Scientific Review Committee Limited option to negotiate exclusive license to compounds developed during the collaboration
Research Day 2018 Update on Research Programs June 26, 2018 New York NASDAQ: ALDX
2018 Progress and Near-Term Development Catalysts Support Path to Commercialization Initiated reproxalap Phase 2b clinical trial in dry eye disease First patient enrolled in reproxalap Phase 3, Part 1 clinical trial in Sjögren-Larsson Syndrome Q3 2018 Reproxalap dry eye disease Phase 2b clinical trial results H2-2018 Reproxalap allergic conjunctivitis Phase 3 results H2-2018/early 2019 Reproxalap noninfectious anterior uveitis Phase 3 clinical trial results 2019 Reproxalap Sjögren-Larsson Syndrome Phase 3, Part 1 clinical trial results 2019 H1 2018 H2 2018 2019 Initiated reproxalap Phase 3 clinical trial in allergic conjunctivitis Entered into research collaboration with Johnson & Johnson Innovation in systemic inflammatory diseases Disclosed in-license of a Hsp90 inhibitor *Contingent on funding, regulatory review, and other factors. Anticipated Milestones* Clinical sites initiated for reproxalap Phase 3, Part 1 clinical trial in Sjögren-Larsson Syndrome
Early-Stage Development Expected Milestones: Novel Approaches to Address Immune-Mediated Disease ADX-1612 mesothelioma clinical trial results (investigator sponsored trial) H2-2018 ADX-1612 ovarian cancer clinical trial initiation (investigator sponsored trial) H2-2018 ADX-629 Phase 1 clinical trial initiation 2019 ADX-1612 lymphoproliferative immune disease Phase 2 clinical trial initiation 2019 ADX-103 retinal disease Phase 1/2 clinical trial initiation 2019 H2 2018 2019 ADX-629 NASH and/or IBD Phase 2a clinical trials initiation following Phase 1 *Contingent on pre-clinical studies, funding, regulatory review, and other factors. Anticipated Milestones*
Deep and Innovative Pipeline Not Disclosed Reproxalap Ocular Reproxalap Dermal ADX-629 Systemic ADX-103 ADX-1612 Dry Eye Disease Allergic Conjunctivitis Noninfectious Anterior Uveitis Sjögren-Larsson Syndrome Autoimmune Disease Retinal Disease Lymphoproliferative Immune Disease Phase 2b results H2-2018 Phase 3 results H2-2018 / 2019 Phase 3 results 2019 Phase 3, Part 1 results 2019 Systemic Inflammatory Disease RASP Inhibitors Hsp90 Inhibitors Anti-Inflammatory Ovarian Cancer Mesothelioma Investigator Sponsored Trial ADX-1615 Autoimmune Disease Cancer Not Disclosed Ocular Inflammation Research Collaboration Investigator Sponsored Trial Indication Compound Approach = Positive Phase 2 clinical data reported in 2016 – 2017 ü ü ü ü ü ü RASP = Reactive Aldehydes Species that are Pro-inflammatory Preclinical Phase 1 Phase 2 Phase 3 Next Expected Milestone Phase 2 results H2-2018
Exhibit 99.2
Aldeyra Therapeutics Announces Development Programs
at 2018 Research Day
Expanded Pipeline Features Distinct Mechanisms of Action Across Five Product Candidates
Three Additional Clinical Programs Planned for 2019
LEXINGTON, Mass., June 26, 2018 /(PRNewswire) — Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a biotechnology company devoted to the development of next-generation medicines to improve the lives of patients with immune-mediated diseases, announced product development programs in systemic inflammatory disease, retinal disease, and cancer at the company’s 2018 Research Day.
“Complementing our late-stage product candidate reproxalap, we have continued to execute on our mission of expanding our pipeline across multiple mechanisms of action and multiple molecular compositions,” commented Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “We are pleased to announce programs in immune-mediated disease, including inflammatory bowel disease, non-alcoholic steatohepatitis, retinal inflammation, lymphoproliferative immune disease, and cancer.”
Research Programs and Expected Milestones
| • | ADX-629 for the Treatment of Systemic Immune-Mediated Disease |
ADX-629 is an analog of reproxalap that diminished inflammatory cytokine release in animal models, which has been linked to multiple immune diseases such as non-alcoholic steatohepatitis (NASH) and inflammatory bowel disease (IBD). Phase 1 clinical testing of ADX-629 is expected to start in 2019.
| • | ADX-103 for the Treatment of Inflammatory Retinal Disease |
ADX-103 is a novel RASP (Reactive Aldehydes Species that are Pro-inflammatory) inhibitor in development for the treatment of inflammatory retinal disease such as potentially diabetic macular edema, dry age-related macular degeneration, or posterior uveitis. Phase 1/2 clinical testing of ADX-103 is expected to start in 2019.
| • | ADX-1612 for Lymphoproliferative Immune Disease and Cancer |
ADX-1612 is a novel HSP90 inhibitor in development for the treatment of post-transplant lymphoproliferative disorder and cancer. Hsp90 is a protein that facilitates cell replication, which is excessive and uncontrolled in certain inflammatory diseases and cancer. ADX-1612 is currently being studied in investigator-sponsored trials for mesothelioma, with clinical results expected in the second half of 2018, and ovarian cancer, with Phase 2 clinical trial initiation
expected in the second half of 2018. Aldeyra is further developing ADX-1612 for the treatment of lymphoproliferative immune disease, with Phase 2 clinical testing expected to start in 2019. The company is also developing an oral pro-drug of ADX-1612, ADX-1615, for the treatment of chronic immune-mediated disorders and cancer.
Presentation and Webcast
Management presentations will begin at 9:00 a.m. Eastern Time on Tuesday, June 26, 2018, at the offices of Dechert, LLP in New York City. A live webcast of the presentation and slide deck will be available on the investor relations page of Aldeyra’s corporate website at ir.aldeyra.com. After the live webcast, the event will remain archived on Aldeyra’s website for one year.
About Aldeyra Therapeutics
Aldeyra Therapeutics is developing next-generation medicines to improve the lives of patients with immune-mediated diseases. Aldeyra’s lead product candidate, reproxalap, is a first-in-class treatment in late-stage development for dry eye disease and other forms of ocular inflammation. The company is also developing other product candidates for autoimmune and metabolic diseases. None of Aldeyra’s product candidates have been approved for sale in the U.S. or elsewhere.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Aldeyra’s plans and expectations for the development of reproxalap and its other product candidates. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “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. 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, completion and reporting 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, the ability to obtain and maintain regulatory approval to conduct clinical trials and to commercialize Aldeyra’s product candidates, and the
labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Aldeyra’s product candidates; the size and growth of the potential markets for Aldeyra’s product candidates and the ability to serve those markets; Aldeyra’s expectations regarding Aldeyra’s expenses and revenue, the sufficiency of Aldeyra’s cash resources and needs for additional financing; 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 ability to establish and maintain development partnerships; 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, 2017 and Aldeyra’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, both of which are on file with the Securities and Exchange Commission(SEC) and available on the SEC’s website at www.sec.gov. 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, completion or reporting of clinical trials.
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.
Corporate Contact:
David McMullin
Aldeyra Therapeutics, Inc.
Tel: 781-761-4904 ext. 218
dmcmullin@aldeyra.com
Investor Contact:
Chris Brinzey
Westwicke Partners
Tel: 339-970-2843
Chris.brinzey@westwicke.com
Media Contact:
Cammy Duong
MacDougall Biomedical Communications
Tel: 781-591-3443
cduong@macbiocom.com