Aldeyra Therapeutics (NasdaqCM:ALDX) 2025 Conference November 20, 2025 06:30 AM ET Company ParticipantsTodd Brady - CEOTodd Brady - President and CEOConference Call ParticipantsClara Dunn - Biotech AnalystClara DunnTo Jefferies Healthcare Conference in London. My name is Clara Dunn. I am one of the biotech analysts here at Jefferies. Thank you for joining this session with Aldeyra Therapeutics. I am joined by Dr. Todd Brady, President and Chief Executive Officer of Aldeyra. Welcome, Todd.Todd BradyThanks, C ...

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Core Viewpoint - Aldeyra Therapeutics is expanding its RASP platform to include central nervous system diseases and providing updates on its NDA stage product candidate, Reproxalap, for dry eye disease treatment [2][3]. Group 1: Company Updates - The company announced the expansion of its RASP platform into central nervous system diseases [2]. - Reproxalap is currently in the NDA stage and is aimed at treating dry eye disease [2]. Group 2: Presentation Details - The presentation includes remarks from key executives, including Dr. Todd Brady, President and CEO, and Dr. Adam Lazorchak, Director of Translational Sciences and Non-Clinical Development [3]. - A press release with important information is available on the company's website [3].

Aldeyra Therapeutics (NasdaqCM:ALDX) 2025 R&D Day November 13, 2025 08:00 AM ET Company ParticipantsTodd Brady - President and CEOClara Dong - VP of Biotechnology Equity ResearchAdam Lazorchak - Director of Translational Sciences in Non-clinical DevelopmentCatherine Novack - Director of Healthcare Equity ResearchLaura Nichols - Associate Director of Investor RelationsConference Call ParticipantsTom Shrader - Equity Research AnalystNone - AnalystOperatorThank you for your patience on today's call. We are loo ...

2025 Research & Development Webcast November 13, 2025 Nasdaq: ALDX © Aldeyra Therapeutics, Inc. 2025 CORPORATE OVERVIEW Disclaimers and Forward-Looking Statements This presentation contains 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, ...

Core Insights - Aldeyra Therapeutics, Inc. is focused on developing innovative therapies for immune-mediated diseases [1] Company Participation - Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra, will participate in a fireside chat at the 2025 Jefferies Global Healthcare Conference in London [1] - The discussion will be moderated by Clara Dong, Ph.D., Vice President of Biotechnology Equity Research [1]

Collaboration and Licensing Agreements - The company has entered into an exclusive option agreement with AbbVie Inc., granting AbbVie the option to obtain a co-exclusive license for reproxalap in the U.S. and an exclusive license outside the U.S., with an initial non-refundable payment of $1.0 million[97]. - AbbVie extended the option period by paying an additional non-refundable fee of $5.0 million, which will be credited against the upfront cash payment if the collaboration agreement is executed[98]. - Upon execution of the collaboration agreement, AbbVie will pay a $100.0 million upfront cash payment, with potential additional milestone payments of up to approximately $300.0 million[100]. - The company entered into an exclusive option agreement with AbbVie, granting them an option to obtain a co-exclusive license for reproxalap, with an initial non-refundable payment of $1.0 million[130]. - If the collaboration agreement is executed, AbbVie will pay a $100.0 million upfront cash payment, with potential additional milestone payments of up to $300.0 million[134]. Financial Performance and Expenses - Comprehensive loss for the nine months ended September 30, 2025, was $27.4 million, compared to $40.0 million for the same period in 2024, reflecting a decrease of 31.6%[113][116]. - Research and development expenses for the three months ended September 30, 2025, were $5.4 million, down 56.3% from $12.4 million in 2024, primarily due to a $4.4 million decrease in external clinical development costs[118][119]. - General and administrative expenses for the nine months ended September 30, 2025, were $7.2 million, a decrease of 27.2% from $9.9 million in 2024, attributed to lower personnel and legal costs[122][124]. - Net loss for the three months ended September 30, 2025, was $7.7 million, a reduction of 49.1% compared to $15.1 million in 2024[118]. - Total other income, net, for the nine months ended September 30, 2025, was $1.2 million, down 65.3% from $3.5 million in 2024, mainly due to lower investment balances[125]. Cash and Funding - As of September 30, 2025, the company had total stockholders' equity of approximately $49.2 million and cash, cash equivalents, and marketable securities of $75.3 million[126]. - The Hercules Credit Facility provides for a term loan of up to $60.0 million, with $15.0 million funded as of September 30, 2025, and interest-only payments until April 1, 2026[105]. - The Hercules Credit Facility has $15.0 million outstanding as of September 30, 2025, with interest-only payments until April 1, 2026[128][129]. - As of September 30, 2025, the company believes its cash, cash equivalents, and marketable securities will be sufficient to fund projected operating expenses and debt obligations into the second half of 2027[135]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $28.0 million, a decrease from $31.2 million in the same period in 2024, primarily due to a decrease in net loss from research and development activities[138]. - Net cash provided by investing activities was $31.7 million for the nine months ended September 30, 2025, compared to net cash used of $43.4 million in the same period in 2024, indicating a significant improvement[139]. - Net cash provided by financing activities was $1.1 million for the nine months ended September 30, 2025, compared to a net cash outflow of $0.2 million in the same period in 2024, primarily from exercises of options[140]. - The company may need to secure additional funding in the future through equity or debt financings, collaborations, or other sources to support ongoing research and development activities[136]. - The company anticipates needing substantial additional capital for continued clinical development and potential commercialization activities[135]. Research and Development Outlook - The company expects research and development expenses to increase as it advances product candidates ADX-248, ADX-246, and others through preclinical and clinical development[106]. - The company does not expect reproxalap or any other product candidates to be commercially available before at least the second half of 2025[110]. - Approximately 40% of the total research and development expenses for the nine months ended September 30, 2025, were related to late-stage product candidates, primarily reproxalap[123]. - The company may license or acquire new immune-modulating approaches to expand its product candidate pipeline[102]. Regulatory and Compliance Considerations - The company will continue to incur costs related to compliance with the Sarbanes-Oxley Act and other regulatory requirements as a public company[137]. - Future funding requirements will depend on various factors, including the costs and outcomes of regulatory reviews and clinical trials for product candidates[135]. - The company faces economic uncertainties, including inflation and geopolitical instability, which could impact its ability to obtain financing on commercially reasonable terms[136].

Core Insights - Aldeyra Therapeutics announced positive results from a Phase 2 clinical trial for ADX-629, showing statistically significant improvement in liver function in patients with alcohol-associated hepatitis [1][2][3] - The company is shifting its focus towards next-generation RASP modulators, specifically ADX-248 and ADX-246, for treating immune-mediated diseases [1][3][4] - The cash runway has been extended into the second half of 2027, allowing for continued development of its therapeutic pipeline [4][6] Clinical Trial Results - ADX-629 was administered orally for one month in a single-arm, multicenter Phase 2 clinical trial involving four patients with mild to moderate alcohol-associated hepatitis [2] - Statistically significant improvements were observed in the Model for End-Stage Liver Disease (MELD) score (P=0.001), triglyceride levels (P<0.0001), and C-Reactive Protein levels (P<0.0001) [2] - No serious adverse events were reported, indicating a favorable safety profile for ADX-629 [2] Pipeline Updates - ADX-248 has replaced ADX-743 for treating metabolic inflammation, with an Investigational New Drug (IND) application anticipated in 2026 [5] - ADX-246 has replaced ADX-631 for the treatment of dry age-related macular degeneration (AMD), with the IND application also expected in 2026 [5] - Clinical development of ADX-629 has been discontinued pending further testing in Sjögren-Larsson Syndrome [5] Financial Outlook - The operational runway based on cash, cash equivalents, and marketable securities has been extended into the second half of 2027, supporting ongoing and future projects [4][6] - The company is committed to developing a robust pipeline of novel therapeutics while maintaining fiscal prudence [6]

Core Insights - The biotechnology sector has seen notable momentum, with four stocks entering the top 10th percentile based on significant week-on-week gains [1][2] Group 1: Key Biotech Stocks - Aldeyra Therapeutics Inc. (ALDX) experienced a momentum percentile surge from 32.07 to 91.32, marking a 59.25-point increase, with an 8.62% year-to-date rise and a 6.58% increase over the year [6] - Alector Inc. (ALEC) improved its momentum percentile from 87.61 to 92.19, a 4.58-point rise, showing a 66.14% year-to-date increase but a decline of 30.99% over the year [6] - Black Diamond Therapeutics Inc. (BDTX) advanced its percentile from 88.36 to 92.61, a 4.25-point gain, with a remarkable 101.87% year-to-date increase and a 25.58% rise over the year [7] - Coherus Oncology Inc. (CHRS) edged up from 89.10 to 92.71, a climb of 3.61 percentile points, with a 30.00% year-to-date increase and an impressive 87.63% rise over the year [7] Group 2: Market Context - The S&P 500 index closed 0.28% lower, while the Nasdaq 100 and Dow Jones indices also saw declines of 0.15% and 0.52% respectively [5] - Futures for the S&P 500, Dow Jones, and Nasdaq 100 indices were trading higher on the following Friday, indicating potential market recovery [5]

Core Insights - The biotechnology sector has seen notable momentum, with four stocks entering the top 10th percentile based on significant week-on-week gains [1][2] Group 1: Key Biotech Stocks - Aldeyra Therapeutics Inc. (ALDX) experienced a momentum percentile surge from 32.07 to 91.32, marking a 59.25-point increase, with an 8.62% year-to-date rise and a 6.58% increase over the year [6] - Alector Inc. (ALEC) improved its momentum percentile from 87.61 to 92.19, a 4.58-point rise, showing a 66.14% year-to-date increase but a decline of 30.99% over the year [6] - Black Diamond Therapeutics Inc. (BDTX) advanced its percentile from 88.36 to 92.61, a 4.25-point gain, with a year-to-date increase of 101.87% and a 25.58% rise over the year [7] - Coherus Oncology Inc. (CHRS) edged up from 89.10 to 92.71, a climb of 3.61 percentile points, with a 30.00% year-to-date increase and an 87.63% rise over the year [7] Group 2: Market Context - The S&P 500 index closed 0.28% lower, while the Nasdaq 100 and Dow Jones indices also saw declines of 0.15% and 0.52% respectively, indicating a mixed market environment [5]