Core Thesis - Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) is viewed as a high-risk/high-reward investment opportunity, trading at a discount with a market cap of approximately $230 million and holding $133 million in cash and equivalents as of March 31st [1] Company Overview - Aldeyra is a clinical-stage biotechnology company focused on developing treatments for immune-mediated and metabolic diseases, particularly through reactive aldehyde species (RASP) modulators [2] - The lead product candidate, Reproxalap, targets chronic and acute symptoms of dry eye disease and allergic conjunctivitis, showing promising results in preclinical and clinical trials [2] Recent Developments - Following a significant drop in share price from $5.4 to $1.4 due to concerns over Reproxalap's new drug application (NDA), the stock has recovered to $3.86, attributed to proactive measures by Aldeyra and AbbVie [2] - Aldeyra plans to resubmit Reproxalap's NDA by Q4 2024, with a potential PDUFA date by Q2 2025, following the initiation of three parallel Phase 3 trials to address FDA concerns [2][5] Market Context - The global prevalence of dry eye disease was estimated at 29.5% in 2021, with a market size of approximately $5.2 billion in 2023 and a projected CAGR of 4.2% over the next six years [3] - Existing treatments like AbbVie's Restasis and Novartis' Xiidra have faced declining sales due to the emergence of biosimilars and slower mechanisms of action, creating an opportunity for faster-acting products like Reproxalap [3][4] Reproxalap Program Details - The ongoing Phase 3 trials include dry eye chamber trials and a field trial, designed to demonstrate Reproxalap's efficacy in a controlled environment [5][6] - If successful, Reproxalap could receive a label for treating acute symptoms of dry eye disease, with results expected by Q3 2024 [7] Financial Overview - Aldeyra's Q1 2024 financials indicate a healthy balance sheet, with a 44% reduction in operating expenses year-over-year and a net loss decrease of approximately 48% [15] - The company has a cash runway of about three years, allowing it to sustain operations until at least the potential PDUFA date for Reproxalap [15] Pipeline Beyond Reproxalap - Aldeyra's pipeline includes ADX-629, targeting alcoholic hepatitis and Sjögren-Larsson Syndrome, and ADX-2191, aimed at retinitis pigmentosa, both showing potential for significant revenue generation [9][10][13] - ADX-629 has demonstrated promising results in weight loss and lipid improvement, with potential applications in a market projected to reach $100 billion by 2030 [11] Valuation and Market Sentiment - ALDX shares are currently trading at $3.86, reflecting a year-to-date increase of 9.97%, with expectations of a strong price reaction if Reproxalap's trial results are positive [16][17] - The potential for Reproxalap to generate revenues similar to Restasis, along with milestone payments from AbbVie, could significantly impact Aldeyra's financial outlook [17]

The Medical group has plenty of great stocks, but investors should always be looking for companies that are outperforming their peers. Has Aldeyra Therapeutics, Inc. (ALDX) been one of those stocks this year? By taking a look at the stock's year-to-date performance in comparison to its Medical peers, we might be able to answer that question.Aldeyra Therapeutics, Inc. is one of 1048 individual stocks in the Medical sector. Collectively, these companies sit at #5 in the Zacks Sector Rank. The Zacks Sector Ran ...

Product Development - Aldeyra Therapeutics is developing a novel pharmaceutical platform targeting reactive aldehyde species (RASP) associated with various diseases, with a product pipeline including ADX-629 and reproxalap[92]. - Reproxalap is in late-stage development for dry eye disease, demonstrating broad-based, rapid-onset activity and consistent safety in Phase 2 and Phase 3 clinical trials[92]. - The company does not expect any of its product candidates, including reproxalap, to be commercially available before at least the first half of 2025[104]. Collaboration and Licensing - An exclusive option agreement with AbbVie was established, 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 million[93]. - AbbVie extended the option exercise period by paying an additional $5 million, allowing them to exercise the option until 18 months after the agreement date or 10 business days post-FDA approval[94]. - Upon execution of the collaboration agreement, AbbVie would pay a $100 million upfront cash payment, with potential milestone payments of up to $300 million[95]. - The profit-sharing arrangement for reproxalap in the U.S. is set at 60% for AbbVie and 40% for Aldeyra, while tiered royalties on net sales will apply outside the U.S.[95]. - An exclusive option agreement with AbbVie was established on October 31, 2023, with a non-refundable payment of $1 million received for the option[116]. - AbbVie extended the option exercise period by paying a non-refundable fee of $5 million, allowing them to exercise the option until 18 months after the agreement effective date or 10 business days post-FDA decision on reproxalap[117]. - Upon execution of the collaboration agreement, AbbVie will pay a $100 million upfront cash payment, with potential additional milestone payments of up to $300 million[119]. - The profit-sharing arrangement for reproxalap in the U.S. is set at 60% for AbbVie and 40% for the company, with tiered royalties applicable for sales outside the U.S.[119]. Financial Performance - The company reported a comprehensive loss of $8.1 million for the three months ended March 31, 2024, compared to a loss of $15.6 million for the same period in 2023[107]. - Research and development expenses decreased to $6.2 million for the three months ended March 31, 2024, from $11.2 million for the same period in 2023, a reduction of 44.64%[110]. - General and administrative expenses were $3.2 million for the three months ended March 31, 2024, down from $5.6 million in the same period in 2023, a decrease of 42.86%[110]. - Total other income (expense) was $1.3 million for the three months ended March 31, 2024, compared to $1.2 million for the same period in 2023, reflecting an increase of 8.33%[111]. - As of March 31, 2024, the company had total stockholders' equity of approximately $113.4 million and cash, cash equivalents, and marketable securities of $133.0 million[112]. - For the three months ended March 31, 2024, net cash used in operating activities was $10.0 million, an increase from $9.4 million in the same period in 2023[125]. - Net cash used in investing activities was $30.4 million for the three months ended March 31, 2024, compared to $30.0 million provided by investing activities in the same period in 2023[126]. - Net cash provided by financing activities was $18.2 thousand for the three months ended March 31, 2024, down from $52.6 thousand in the same period in 2023[127]. Capital Needs and Risks - Aldeyra has no products approved for sale and has primarily funded operations through equity sales and debt, indicating a need for additional capital to support product development[97]. - The company may pursue licensing or acquiring new immune-modulating approaches to expand its product pipeline[96]. - The company expects to generate operating losses for the foreseeable future, with significant investments in research and development ongoing[112]. - As of March 31, 2024, the company expects its cash, cash equivalents, and marketable securities to fund operations beyond 2026, but acknowledges the need for additional funding for ongoing R&D and commercialization activities[120]. - The company may need to secure additional capital through debt, equity, or partnerships due to economic uncertainties and potential disruptions in capital markets[122]. - The company faces risks related to the costs and timing of regulatory reviews and potential additional trials required for reproxalap[121]. - The company continues to incur costs associated with being a public entity, including compliance and insurance expenses[123]. Debt and Credit Facilities - The Hercules Credit Facility, as of March 31, 2024, had $15.0 million outstanding, with a total available term loan of up to $60.0 million[115].

Group 1 - Aldeyra Therapeutics, Inc. (ALDX) is currently outperforming its Medical sector peers with a year-to-date return of 10%, while the Medical sector has returned an average of -0.3% [2] - The Zacks Consensus Estimate for ALDX's full-year earnings has increased by 87% over the past 90 days, indicating improved analyst sentiment and a stronger earnings outlook [2] - Aldeyra Therapeutics, Inc. holds a Zacks Rank of 2 (Buy), suggesting it has favorable characteristics to outperform the market in the near term [1] Group 2 - Aldeyra Therapeutics, Inc. is part of the Medical - Drugs industry, which includes 187 stocks and currently ranks 147 in the Zacks Industry Rank, with an average loss of 12.7% year-to-date [3] - Another outperforming stock in the Medical sector is Inspire Medical Systems (INSP), which has a year-to-date return of 12.7% and a Zacks Rank of 1 (Strong Buy) [2][3] - The Medical Info Systems industry, to which Inspire Medical Systems belongs, has a current rank of 148 and has declined by 10.3% year-to-date [3]

Core Insights - Insider purchases have decreased in number and size as the second quarter begins, but notable purchases were still made by influential investors like Mario Gabelli and TotalEnergies [1] - Insider buying is often viewed as a positive signal for potential investors, especially during uncertain market conditions [1] Company Summaries - **GAMCO Natural Resources, Gold & Income Trust** - Total shares purchased: 870,000 - Price per share: $10.00 - Total cost: $8.7 million - Shares have increased over 8% since the purchase, with a yield of about 7.4% and monthly distributions [3] - **Boundless Bio Inc.** - Total shares purchased: 512,500 - Price per share: $16.00 - Total cost: $8.2 million - Shares have declined since the IPO, currently trading around $13, with five of seven analysts recommending a buy [4] - **Five Star Bancorp** - Total shares purchased: less than 252,900 - Price per share: $21.75 - Total cost: approximately $5.5 million - The stock is down about 16% year-to-date, but analysts suggest a 30% upside based on a $28.67 consensus price target [5] - **Clearway Energy Inc.** - Total shares purchased: almost 197,000 - Price per share: $22.54 to $23.08 - Total cost: around $4.5 million - Despite a recent 3% increase, shares are down over 13% year-to-date, but 27% higher than the 52-week low [7] - **Aldeyra Therapeutics Inc.** - Total shares purchased: almost 504,300 - Price per share: $3.24 to $4.21 - Total cost: over $1.9 million - The stock surged about 43% following FDA approval plans, with a consensus price target of $9.25 suggesting potential for nearly double the current price [8]

Aldeyra Therapeutics’(ALDX) clinical-stage immunology pipeline comprises two candidates, reproxalap and ADX-629, which are undergoing late-stage and mid-stage development, respectively.The company’s lead product candidate, Reproxalap, is currently being evaluated in two separate phase III studies for dry eye disease and allergic conjunctivitis.Shares of Aldeyra rallied 43.3% in the past week, driven by the company’s clinical development plan announced on Mar 28, which is intended to enable the resubmission ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For transition period from __________to__________ Commission file number 001-36332 ALDEYRA THERAPEUTICS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 20-1968197 (State or ...

Burlington, MA-based Aldeyra Therapeutics (ALDX) is a leader in the development of RASP (reactive aldehyde species) modulators for the treatment of immune-mediated diseases. Lately, it has seen success in its studies on its investigational RASP modulator, ADX-629, which has demonstrated potential activity in clinical studies of patients with psoriasis, asthma, COVID, ethanol toxicity, chronic cough and atopic dermatitis.Aldeyra Therapeutics is conducting a phase II study on ADX-629 in Sjögren-Larsson Syndro ...

The drug/biotech sector is seeing a recovery in 2024 after a rather lukewarm 2023. Biotech M&A activity is expected to be strong in 2024, which could be the prime reason for the optimistic outlook for the industry. In addition,innovation is likely to drive growth in the industry, with key spaces like weight loss/obesity and Alzheimer’s disease drugs attracting attention.High interest rates, global supply chain constraints, pressure in the U.S. regional banking space and rising geopolitical concerns (Russia/ ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-36332 ALDEYRA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 20-1968197 (State or Oth ...