Aldeyra Therapeutics FY Conference Summary Company Overview - **Company**: Aldeyra Therapeutics (NasdaqCM: ALDX) - **Focus**: Development of pharmaceuticals targeting immune-mediated diseases through RASP modulators - **Key Products**: - Reproxalap: Treatment for dry eye disease and allergic conjunctivitis - ADX-2191: Novel formulation for primary vitreoretinal lymphoma and retinitis pigmentosa - ADX-248 and ADX-246: Oral treatments for atopic dermatitis and other conditions Key Points and Arguments Regulatory Updates - **PDUFA Date**: Extended to March 16, 2026, for reproxalap's approval for dry eye disease [2][4] - **Regulatory History**: - Received a Complete Response Letter (CRL) in 2023 due to a missed co-primary endpoint [4] - A second CRL was issued for a baseline imbalance, which is considered unique [5] - Resubmitted NDA with additional trial data, leading to the current PDUFA extension [6][7] Market Positioning - **Reproxalap's Differentiation**: - Potential to be the only drug with a rapid onset of action (minutes) for dry eye treatment [10][11] - Unique ability to control redness, which is significant for patient satisfaction [12] - **Allergic Conjunctivitis**: - Completed two positive Phase 3 trials, with plans for a supplemental NDA following dry eye approval [13][14] Partnership with AbbVie - **Terms of Agreement**: - AbbVie has an option to market reproxalap, with a $200 million potential payout upon approval [19][20] - Revenue split post-approval: 60% to AbbVie, 40% to Aldeyra [20] - **Collaboration**: Ongoing partnership for both dry eye and allergic conjunctivitis indications [18] Pipeline and Future Developments - **Upcoming Milestones**: - Focus on allergic conjunctivitis following dry eye approval [21] - Plans for NDA submission for ocular lymphoma (primary vitreoretinal lymphoma) [22] - **ADX-248 for Atopic Dermatitis**: - Positioned as a more potent oral treatment, currently in Phase 1 trials [26][27] Financial Outlook - **Cash Position**: - Reported $75 million in cash as of Q3, providing approximately two years of runway [28] - Budget allocation includes reserves for potential dry eye trials and support for ongoing programs [28][29] Additional Insights - **Market Landscape**: The dry eye treatment market is expanding, with various new agents being introduced, but none offering the rapid relief that reproxalap promises [9][10] - **Patient Considerations**: Emphasis on the importance of both efficacy and cosmetic outcomes for patients suffering from dry eye and allergic conjunctivitis [11][12] This summary encapsulates the critical aspects of Aldeyra Therapeutics' recent conference, highlighting the company's strategic positioning, regulatory challenges, and future opportunities in the biotechnology sector.

Core Viewpoint - Aldeyra Therapeutics, Inc. (ALDX) shows potential for significant upside, with a mean price target of $9 indicating a 79.3% increase from the current price of $5.02 [1] Price Targets and Analyst Estimates - The mean estimate consists of five short-term price targets with a standard deviation of $1.22, suggesting variability in analyst predictions [2] - The lowest price target of $7.00 indicates a 39.4% increase, while the highest target of $10.00 suggests a 99.2% increase [2] - A low standard deviation indicates strong agreement among analysts regarding the stock's price movement [9] Earnings Estimates and Analyst Agreement - Analysts have shown increasing optimism about ALDX's earnings prospects, as evidenced by a positive trend in earnings estimate revisions [11] - Over the last 30 days, the Zacks Consensus Estimate for the current year has increased by 19.4%, with one estimate moving higher and no negative revisions [12] - ALDX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13] Caution on Price Targets - Solely relying on consensus price targets for investment decisions may not be wise, as analysts' ability to set accurate targets has been questioned [3][7] - Price targets should be treated with skepticism, as they can often mislead investors [10]

Core Viewpoint - Aldeyra Therapeutics, Inc. is focused on developing innovative therapies for immune-mediated diseases and will participate in the Oppenheimer 36th Annual Healthcare Life Sciences Conference [1] Company Participation - Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra, will engage in a virtual fireside chat at the conference [1] - The discussion will be moderated by Andreas Argyrides, Managing Director, Senior Biotech [1]

Core Viewpoint - Aldeyra Therapeutics, Inc. (ALDX) shows significant potential for upside, with a mean price target of $9 indicating a 65.8% increase from the current trading price of $5.43, which has already gained 28.1% over the past four weeks [1]. Price Targets and Analyst Estimates - The mean estimate consists of five short-term price targets with a standard deviation of $1.22, where the lowest estimate is $7.00 (28.9% increase) and the highest is $10.00 (84.2% increase) [2]. - A low standard deviation suggests strong agreement among analysts regarding the stock's price movement, indicating a potential starting point for further research [9]. Earnings Estimates and Analyst Agreement - There is increasing optimism among analysts about ALDX's earnings prospects, as indicated by a positive trend in earnings estimate revisions, which correlates with near-term stock price movements [11]. - Over the last 30 days, the Zacks Consensus Estimate for the current year has increased by 19.4%, with one estimate moving higher and no negative revisions [12]. Zacks Rank and Investment Potential - ALDX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, suggesting a strong potential for upside in the near term [13]. - While the consensus price target may not be entirely reliable, the implied direction of price movement appears to be a good guide for potential investment [14].

Group 1: Company Performance - Aldeyra Therapeutics, Inc. (ALDX) has gained approximately 4.8% year-to-date, outperforming the Medical sector, which has seen an average gain of about 0.5% [4] - The Zacks Consensus Estimate for ALDX's full-year earnings has increased by 4.5% over the past quarter, indicating improved analyst sentiment and a stronger earnings outlook [4] - Aldeyra Therapeutics, Inc. is currently rated with a Zacks Rank of 2 (Buy), suggesting a positive outlook for the stock [3] Group 2: Industry Context - Aldeyra Therapeutics, Inc. is part of the Medical - Drugs industry, which consists of 141 companies and is currently ranked 159 in the Zacks Industry Rank [6] - Stocks in the Medical - Drugs industry have gained about 1.6% year-to-date, indicating that ALDX is performing better than its industry peers [6] - In contrast, ANI Pharmaceuticals, another stock in the Medical sector, has a year-to-date return of 1.3% and is part of the Medical - Biomedical and Genetics industry, which has declined by 4.4% this year [5][7]

Core Viewpoint - The article does not provide any specific insights or analysis related to a company or industry, focusing instead on the author's credentials and disclosures [1][2][3]. Group 1 - The author holds multiple degrees in Electronics and Telecommunication Engineering, Computer Science, Business Management, and Computer Applications from various institutions [1]. - The author collaborates professionally with another individual, ensuring that analyses are conducted independently [1]. - There is a clear statement of no current stock or derivative positions in any mentioned companies, indicating a lack of potential bias in the analysis [2]. Group 2 - The article emphasizes that past performance does not guarantee future results, highlighting the inherent uncertainties in investment [3]. - It clarifies that no recommendations or advice are being provided regarding investment suitability for particular investors [3]. - The authors are identified as third-party contributors, which may include both professional and individual investors without formal licensing [3].

Corporate Overview - Aldeyra Therapeutics focuses on developing innovative therapies for immune-mediated diseases by modulating protein systems rather than directly inhibiting single protein targets[7,8] - As of September 30, 2025, Aldeyra had $753 million in cash, cash equivalents, and marketable securities, expected to fund the company into the second half of 2027[10] RASP Modulation Platform - Aldeyra's approach involves modulating Reactive Aldehyde Species (RASP), which are formed by oxidation and bind to proteins, leading to pro-inflammatory signaling cascades[14] - RASP modulation allows for control of protein systems without completely turning single proteins on or off, potentially leading to broader activity with less toxicity[20,22] - ADX-629, an orally administered RASP modulator, has shown statistically significant changes in lipid profiles in multiple clinical trials, including a Phase 1 trial (P=0.005 for HDL), a Phase 2 psoriasis trial (P=0.036 for LDL/HDL ratio and P=0.0004 for FFA)[33] - ADX-248 binds to pro-inflammatory RASP HNE, leading to cytokine reduction in LPS-challenged mice and improved epidermal erosion scores in an oxazolone mouse model of atopic dermatitis (P=0.0093)[38] - ADX-248 increased brain dopamine and improved motor function in a preclinical Parkinson's disease model, with significant P values at different doses (P=0.05, P=0.001, P=0.004)[42] - ADX-246 binds to RASP retinaldehyde, reducing the toxic retinaldehyde metabolite A2E (P=0.04) in an Abcr knockout mouse model of dry AMD[44] Reproxalap - Reproxalap, a RASP modulator for dry eye disease, showed rapid activity in clinical trials and achieved the primary endpoint of ocular discomfort in a Phase 3 dry eye chamber trial (P=0.002)[48,53] - Aldeyra has an exclusive option agreement with AbbVie Inc for reproxalap, including a potential $100 million upfront payment, a $100 million milestone payment upon FDA approval in dry eye disease, and $200 million in additional regulatory and commercial milestones[61] - Phase 3 INVIGORATE allergen chamber trials for allergic conjunctivitis showed that reproxalap achieved the primary endpoint of patient-reported ocular itching with all P values < 0.0001[63] ADX-2191 - ADX-2191 has the potential to be the first approved drug for primary vitreoretinal lymphoma (PVRL), with approximately 200-600 new cases diagnosed in the United States per year[71]

Core Viewpoint - Aldeyra Therapeutics announced an extension of the PDUFA target action date for the new drug application of reproxalap, which is intended for the treatment of dry eye disease [2]. Group 1: Regulatory Update - The press release regarding the PDUFA extension is available on Aldeyra's website, emphasizing the importance of reviewing it alongside the prepared remarks from the conference call [2]. - Dr. Todd Brady, President and CEO of Aldeyra, is present to discuss the implications of the PDUFA extension for reproxalap [3].

Summary of Aldeyra Therapeutics Regulatory Update Conference Call Company Overview - **Company**: Aldeyra Therapeutics (NasdaqCM:ALDX) - **Focus**: Development of reproxalap for the treatment of dry eye disease Key Points Regulatory Update - **PDUFA Extension**: The FDA has extended the PDUFA target action date for the new drug application (NDA) of reproxalap, originally set for December 16, 2025, due to the request for additional clinical study reports (CSR) [2][8][10] - **NDA Resubmission**: The NDA for reproxalap was resubmitted on June 16, 2025, and accepted by the FDA as a complete Class II response on July 16, 2025 [6] - **Field Trial Results**: A field trial supportive of reproxalap did not meet its primary endpoint of reducing symptoms compared to the vehicle, which led to the FDA's request for the CSR to be included in the NDA [7][9] FDA Interactions - **Communication with FDA**: Aldeyra has had limited direct communication with the FDA's Office of Specialty Medicine, focusing primarily on the Division of Ophthalmology [5] - **Labeling Discussions**: A draft label was sent by the FDA to Aldeyra in early December, and Aldeyra has provided comments on it [9][32] - **Next Steps**: If no major deficiencies are identified during the extended review, labeling requests and potential post-marketing requirements will be communicated by February 16, 2026 [10] Commercialization and Agreements - **AbbVie Option Agreement**: AbbVie has 10 business days to exercise its option following the approval of the NDA, with no changes to the terms due to the extension [18][27] - **Commercialization Timeline**: The launch date for reproxalap will depend on FDA approval, with expectations that it could occur within one to two quarters post-approval [21] Additional Insights - **FDA Guidance**: There was a discussion regarding the standard practice of submitting all CSRs with an NDA, which was initially agreed upon to be limited to the chamber trial only [14][15] - **Safety Data Requests**: The request for safety data from the field trial is considered standard during NDA reviews [25] - **Director Changes**: The director of the Office of Specialty Medicine retired, which may have influenced the recent request for the CSR submission [13] Conclusion The call provided detailed insights into the regulatory status of reproxalap, the implications of the FDA's extension of the PDUFA date, and the company's ongoing interactions with the FDA. The potential for commercialization remains contingent on the outcome of the extended review process.

Group 1: B Riley Financial Inc - B Riley Financial reported earnings of $4.50 per share for the second quarter, a significant improvement from a loss of $14.35 per share in the same period last year [1] - The company's sales surged to $225.302 million, up from $94.885 million year-over-year [1] - Following the earnings report, B Riley Financial shares jumped 25% to $4.65 in pre-market trading [1] Group 2: Other Stocks in Pre-Market Trading - Biodexa Pharmaceuticals PLC-ADR gained 51.4% to $7.24 in pre-market trading [4] - Venus Concept Inc surged 31.1% to $2.19 after a decline of over 10% on Monday [4] - Uniqure NV rose 14.1% to $23.30 after gaining 5% on Monday [4] - Adagio Medical Holdings Inc gained 11.7% to $0.93 after a 15% decline on Monday [4] - Sunrise New Energy Co Ltd rose 10.5% to $0.94 after dipping 11% on Monday [4] - Socket Mobile Inc surged 10.3% to $1.29 in pre-market trading [4] - Rain Enhancement Technologies Holdco Inc shares jumped 10.1% to $6.65 in pre-market trading [4] - Organogenesis Holdings Inc gained 9.3% to $5.29 after announcing a planned Type-B meeting with the FDA [4] - Nektar Therapeutics rose 7.8% to $57.50 in pre-market trading [4] Group 3: Stocks Declining in Pre-Market Trading - Radiopharm Theranostics ADR fell 39.8% to $6.40 after a significant jump of 150% on Monday [4] - Saverone 2014 Ltd – ADR tumbled 37.8% to $2.20 after gaining 18% on Monday [4] - Zynex Inc fell 36.6% to $0.42 after a decline of around 10% on Monday [4] - Immuron Ltd – ADR fell 23.8% to $0.74 after a 5% decline on Monday [4] - iRobot Corp fell 23.2% to $0.90 after dipping 73% on Monday due to filing for Chapter 11 bankruptcy [4] - Envirotech Vehicles Inc dipped 17% to $0.93 in pre-market trading [4] - Aldeyra Therapeutics Inc declined 15.7% to $3.36 following a PDUFA extension for Reproxalap NDA [4] - Ascent Solar Technologies, Inc. dipped 15.1% to $3.54 after a 34% jump on Monday [4] - Lightwave Logic Inc dipped 14.5% to $3.22 after announcing a $35 million public offering [4] - Fractyl Health Inc fell 10.4% to $2.00 in pre-market trading [4]