Aldeyra Therapeutics (ALDX) 2025 Conference June 05, 2025 04:20 PM ET Speaker0 Good afternoon, everyone. Welcome to Jefferies Global Healthcare Conference. My name is Clara Dunn, one of the biotech analysts here at Jefferies. So it's my pleasure here to help Aldara's CEO, Doctor. Todd Brady, here with us today for this fireside chat. Welcome. Speaker1 Thank you, Clara. Speaker0 So before we dig into details of your pipeline, maybe it will be helpful for you to give us a quick overview of the company and wha ...

Collaboration with AbbVie - The company has entered into an exclusive option agreement with AbbVie Inc., granting AbbVie the option to obtain a co-exclusive license for the development and commercialization of reproxalap in the U.S. and an exclusive license outside the U.S.[95] - AbbVie has made a non-refundable payment of $1.0 million for the option and extended the exercise period by paying an additional $5.0 million[96] - Upon execution of the collaboration agreement, AbbVie will pay a $100.0 million upfront cash payment, with potential for up to $300.0 million in regulatory and commercial milestone payments[98] - The collaboration with AbbVie includes a profit-sharing model of 60% for AbbVie and 40% for the company from the commercialization of reproxalap in the U.S.[98] - The profit-sharing arrangement with AbbVie for the commercialization of reproxalap is set at 60% for AbbVie and 40% for the company in the U.S.[127] Financial Position and Funding - The company has no products approved for sale and has primarily funded operations through the sale of common stock and debt, indicating a need for additional capital to fund product development[101] - The Hercules Credit Facility allows for a term loan of up to $60.0 million, with $15.0 million funded as of March 31, 2025, and various amendments extending payment terms and conditions[103] - As of March 31, 2025, total stockholders' equity was approximately $63.6 million, with cash, cash equivalents, and marketable securities totaling $90.1 million[119] - As of March 31, 2025, the company expects its cash, cash equivalents, and marketable securities to fund operations into 2027, excluding potential licensing and product revenue[128] - The company anticipates needing additional funding for ongoing research and development activities, regulatory activities, and commercialization efforts[128] - The company may seek additional capital through debt, equity, or partnerships, amid economic uncertainties and market disruptions[129] Research and Development - The company is developing multiple product candidates, including reproxalap for dry eye disease and ADX-2191 for retinitis pigmentosa, with ongoing clinical trials and regulatory submissions[93] - Research and development expenses increased to $7.4 million for the three months ended March 31, 2025, up 20.1% from $6.2 million in the same period of 2024[115] - Approximately 40% of total research and development expenses for the three months ended March 31, 2025, were related to late-stage product candidates, primarily reproxalap[116] - The company expects research and development expenses to increase as it advances ADX-246, ADX-248, and other compounds through preclinical and clinical development[104] - The company does not expect reproxalap or any other product candidates to be commercially available before at least the second half of 2025[107] Operational Results - Net loss for the three months ended March 31, 2025, was approximately $9.9 million, representing a 22.9% increase from a net loss of $8.1 million in the same period of 2024[115] - Total other income (expense), net, decreased to $0.5 million for the three months ended March 31, 2025, down 62.0% from $1.3 million in the same period of 2024[118] - General and administrative expenses decreased to $3.0 million for the three months ended March 31, 2025, down 6.4% from $3.2 million in the same period of 2024[117] - Net cash used in operating activities for Q1 2025 was $12.5 million, an increase from $10.0 million in Q1 2024, primarily due to higher research and development expenses[131] - Net cash provided by investing activities was $7.3 million for Q1 2025, compared to a net cash outflow of $30.4 million in Q1 2024[132] - Net cash provided by financing activities was $1.0 million for Q1 2025, significantly higher than $18.2 thousand in Q1 2024[133] Regulatory and Compliance Risks - The company is subject to various risks and uncertainties that could impact its financial position and operational results, including regulatory approvals and market acceptance of its product candidates[94] - The company will incur ongoing costs related to compliance with the Sarbanes-Oxley Act and other regulatory requirements as a public entity[130]

Core Viewpoint - Aldeyra Therapeutics, Inc. is under investigation for potential violations of federal securities laws following the failure of its Phase III clinical trial for reproxalap, which was intended to treat dry eye disease [1][4]. Group 1: Company Overview - Aldeyra Therapeutics is a biotechnology company focused on developing therapies for immune-mediated and metabolic diseases, with reproxalap as its lead drug candidate for dry eye disease [2]. Group 2: Clinical Trial Results - The company announced the success of its Phase III dry eye chamber clinical trial, claiming the results were "uniquely supportive" and met FDA requirements for New Drug Application resubmission [3]. - However, the trial ultimately failed to demonstrate the efficacy of reproxalap in treating ocular symptoms associated with dry eyes, with methodological issues identified in the data [4]. Group 3: Stock Market Reaction - Following the FDA's Complete Response Letter on April 3, 2025, which stated that the NDA for reproxalap did not demonstrate efficacy, Aldeyra's stock price plummeted nearly 75%, dropping from $5.33 per share on April 2, 2025 [5].

R E P R O X A L A P F O R T H E P O T E N T I A L T R E A T M E N T O F D R Y E Y E D I S E A S E Topline Data Release and NDA Resubmission Plan May 6, 2025 Nasdaq: ALDX © Aldeyra Therapeutics, Inc. 2025 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 ...

Summary of Aldeyra Therapeutics Phase III Data Call Company Overview - **Company**: Aldeyra Therapeutics - **Focus**: Development of reproxalap, an investigational drug for the treatment of dry eye disease Key Industry Insights - **Industry**: Ophthalmology, specifically focusing on dry eye disease - **Market Need**: There is a growing prevalence of dry eye disease, necessitating treatments that provide rapid relief and sustained activity [13][14] Core Findings and Arguments 1. **Phase III Trial Results**: Aldeyra announced positive results from a Phase III dry eye chamber trial, achieving the primary endpoint of significantly reducing ocular discomfort associated with dry eye disease [2][5] 2. **Regulatory Pathway**: The FDA previously issued a complete response letter (CRL) requiring additional studies to demonstrate the drug's efficacy. The recent trial was designed to address these concerns [5][6][14] 3. **Statistical Significance**: The trial showed a highly statistically significant reduction in ocular discomfort with a p-value of 0.002, indicating strong efficacy of reproxalap compared to vehicle treatment [10][11] 4. **Safety Profile**: Reproxalap was well tolerated, with no patients discontinuing due to adverse events. The most common side effect was mild installation site irritation, lasting less than one minute for most patients [11][35] 5. **Unique Mechanism of Action**: Reproxalap is positioned as a potential paradigm shift in dry eye treatment, offering rapid symptom relief compared to existing therapies that require weeks for effect [13][46] 6. **NDA Resubmission Timeline**: The company plans to resubmit the New Drug Application (NDA) for reproxalap midyear, following a Type A meeting with the FDA to discuss the recent trial data [8][14][44] Additional Important Points 1. **Comparison with Previous Trials**: The recent trial improved upon previous studies by eliminating baseline imbalances in ocular discomfort scores across treatment arms, which had been a concern in earlier trials [12][25][68] 2. **Field Trials**: While a recent field trial did not reach statistical significance, it numerically favored reproxalap, supporting its efficacy when combined with the chamber trial results [12][21] 3. **Market Opportunity**: There is a significant opportunity for reproxalap in the dry eye market, as current treatments do not provide quick relief, and patients are seeking immediate solutions [46][47] 4. **Pipeline Development**: Aldeyra has plans for additional clinical trials in various conditions characterized by inflammation and metabolic dysfunction, indicating a robust pipeline beyond dry eye disease [15][16] Conclusion Aldeyra Therapeutics is advancing reproxalap as a promising treatment for dry eye disease, with recent Phase III trial results supporting its efficacy and safety. The company is preparing for NDA resubmission and aims to address FDA feedback to secure approval, positioning reproxalap as a potential leader in the ophthalmology market for rapid relief of dry eye symptoms.

Core Viewpoint - Aldeyra Therapeutics, Inc. is under investigation for potential violations of federal securities laws following the failure of its lead drug candidate, reproxalap, to demonstrate efficacy in treating dry eye disease, leading to a significant stock price decline [1][4][5]. Company Overview - Aldeyra Therapeutics is a biotechnology company focused on developing therapies for immune-mediated and metabolic diseases, with reproxalap as its lead drug candidate for dry eye disease [2]. Clinical Trial Results - The company announced success in its Phase III clinical trial for reproxalap, claiming the results were "uniquely supportive" and met FDA requirements for New Drug Application (NDA) resubmission [3]. - However, the trial ultimately failed to demonstrate the drug's efficacy, with methodological issues identified, including differences in baseline scores across treatment arms [4]. Regulatory Response - On April 3, 2025, the FDA issued a Complete Response Letter for the NDA for reproxalap, stating that the application "failed to demonstrate efficacy in adequate and well-controlled studies" [5]. - The FDA's concerns regarding the trial data contributed to the stock price plummeting nearly 75% from $5.33 per share on April 2, 2025 [5].

Core Viewpoint - Aldeyra Therapeutics, Inc. is under investigation for potential violations of federal securities laws following the failure of its Phase III clinical trial for reproxalap, which was intended to treat dry eye disease [1][4]. Company Overview - Aldeyra Therapeutics is a biotechnology company focused on developing therapies for immune-mediated and metabolic diseases, with reproxalap as its lead drug candidate for dry eye disease [2]. Clinical Trial Results - The company announced positive results from its Phase III dry eye chamber clinical trial, claiming the results were "uniquely supportive" and met FDA requirements for New Drug Application (NDA) resubmission [3]. - However, the trial ultimately failed to demonstrate the efficacy of reproxalap in treating ocular symptoms associated with dry eyes, with methodological issues identified in the trial data [4]. Regulatory Response - On April 3, 2025, the FDA issued a Complete Response Letter for the NDA for reproxalap, stating that the application "failed to demonstrate efficacy in adequate and well-controlled studies" [5]. - The FDA highlighted concerns regarding the trial data, particularly methodological issues such as differences in baseline scores across treatment arms [5]. Market Reaction - Following the FDA's announcement, Aldeyra Therapeutics' stock price plummeted nearly 75% in a single trading day, dropping from a closing price of $5.33 per share on April 2, 2025 [5].

Core Viewpoint - Aldeyra Therapeutics, Inc. is under investigation for potential violations of federal securities laws following the failure of its Phase III clinical trial for reproxalap, which was intended to treat dry eye disease [1][4]. Company Overview - Aldeyra Therapeutics is a biotechnology company focused on developing therapies for immune-mediated and metabolic diseases, with reproxalap as its lead drug candidate for dry eye disease [2]. Clinical Trial Results - The company announced success in its Phase III dry eye chamber clinical trial, claiming the results were "uniquely supportive" and met FDA requirements for New Drug Application (NDA) resubmission [3]. - However, the trial ultimately failed to demonstrate the efficacy of reproxalap in treating ocular symptoms associated with dry eyes, with methodological issues identified in the data [4]. Stock Market Reaction - Following the FDA's Complete Response Letter on April 3, 2025, which stated that the NDA did not demonstrate efficacy, Aldeyra's stock price plummeted nearly 75%, dropping from $5.33 per share on April 2, 2025 [5].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices by Aldeyra Therapeutics and its officers/directors following a significant stock price drop after the FDA's response regarding the company's drug application [1][3]. Company Summary - Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) received a Complete Response Letter from the FDA regarding its New Drug Application (NDA) for reproxalap, indicating that the application failed to demonstrate efficacy in treating dry eye disease [3]. - The FDA's letter highlighted that no manufacturing or safety issues were identified, but concerns were raised about the data from the trial, which may have been affected by methodological issues [3]. - Following the FDA's announcement, Aldeyra's stock price plummeted by $3.90, or 73.31%, closing at $1.42 per share on April 3, 2025 [3]. Legal Investigation - Pomerantz LLP is actively seeking claims from investors of Aldeyra, suggesting that there may be grounds for a class action lawsuit due to the alleged securities fraud [1]. - The firm has a long history in corporate and securities class litigation, having recovered multimillion-dollar damages for victims of securities fraud and corporate misconduct [4].

Core Viewpoint - Aldeyra Therapeutics, Inc. is under investigation for potential violations of federal securities laws following the failure of its lead drug candidate reproxalap in clinical trials, leading to a significant decline in stock price [1][5]. Company Overview - Aldeyra Therapeutics is a biotechnology company focused on developing therapies for immune-mediated and metabolic diseases, with reproxalap as its lead drug candidate aimed at treating dry eye disease [2]. Clinical Trial Results - The company announced success in its Phase III clinical trial for reproxalap, claiming the results were "uniquely supportive" and met FDA requirements for New Drug Application resubmission [3]. - However, the trial ultimately failed to demonstrate the drug's efficacy in treating ocular symptoms associated with dry eyes, with methodological issues identified in the trial data [4]. Stock Market Reaction - Following the FDA's Complete Response Letter on April 3, 2025, which stated that the NDA for reproxalap did not demonstrate adequate efficacy, Aldeyra's stock price plummeted nearly 75% from $5.33 per share on April 2, 2025 [5].