Financial Performance - The net loss for the three months ended September 30, 2024, was $15.11 million, compared to a net loss of $8.19 million for the same period in 2023, indicating an increase in losses of approximately 84%[6] - Net loss for the nine months ended September 30, 2024, was $40,042,677, compared to a net loss of $32,789,548 for the same period in 2023, representing a 22% increase in losses year-over-year[11] - The company reported a comprehensive loss of $15.0 million for the three months ended September 30, 2024[7] Assets and Liabilities - Total current assets decreased from $147.81 million as of December 31, 2023, to $116.72 million as of September 30, 2024, representing a decline of approximately 21%[5] - Cash and cash equivalents decreased significantly from $142.82 million as of December 31, 2023, to $28.12 million as of September 30, 2024, a reduction of about 80%[5] - Total liabilities increased from $28.53 million as of December 31, 2023, to $32.22 million as of September 30, 2024, reflecting an increase of approximately 13%[5] - The accumulated deficit grew from $394.26 million as of December 31, 2023, to $434.30 million as of September 30, 2024, an increase of about 10%[5] - The total stockholders' equity decreased from $119.80 million as of December 31, 2023, to $85.10 million as of September 30, 2024, a decline of approximately 29%[5] Research and Development - Research and development expenses for the three months ended September 30, 2024, were $12.44 million, up 79% from $6.96 million in the same period of 2023[6] - The company anticipates needing additional funding in the future to support ongoing research and development activities, as well as commercialization efforts[16] - The company’s principal activities include research and development of therapies for immune-mediated and metabolic diseases[12] Stock and Compensation - The weighted average common shares outstanding for the three months ended September 30, 2024, were 59.53 million, compared to 58.99 million for the same period in 2023[6] - Stock-based compensation for the nine months ended September 30, 2024, was $6,710,160, slightly up from $6,553,112 in the same period of 2023, reflecting a 2.4% increase[11] - Total stock-based compensation expense for the three months ended September 30, 2024, was $3,225,794, an increase from $789,217 for the same period in 2023[57] Marketable Securities and Cash Flow - The company incurred $75,351,884 in purchases of marketable securities during the nine months ended September 30, 2024, with no such purchases reported in the same period of 2023[11] - The company reported a net cash decrease of $74,702,987 for the nine months ended September 30, 2024, compared to a decrease of $1,084,476 in the same period of 2023[11] - Cash and cash equivalents at the end of the period were $68,120,029, down from $143,334,888 at the end of September 2023, indicating a decrease of approximately 52%[11] Debt and Financing - The Company has a current long-term debt obligation of $15 million under the Hercules Credit Facility as of September 30, 2024[43] - The effective interest rate on the loan was 13.3% as of September 30, 2024[42] - The Maturity Date for the Hercules Credit Facility has been extended to April 1, 2026[40] Collaboration Agreements - The Company entered into an exclusive option agreement with AbbVie, receiving a non-refundable payment of $1 million for the option to collaborate on reproxalap development[72] - AbbVie will pay the Company a $100 million upfront cash payment and up to $300 million in milestone payments related to the Collaboration Agreement[75] - The profit-sharing arrangement for the commercialization of reproxalap in the U.S. is set at 60% for AbbVie and 40% for the Company[75] Changes in Operations - As of September 30, 2024, the Company ceased development of the Helio Product Candidate, which may result in the reversion of related intellectual property rights[23] - The Company has not reported any changes to significant accounting policies during the nine months ended September 30, 2024[20] Tax and Valuation - The Company has a 100% valuation allowance against net deferred tax assets due to ongoing losses since inception[49] - The Company is subject to tax in the U.S. and is open to examination for tax years ended December 31, 2023, 2022, 2021, and 2020[50]

Financial Performance - The net loss for the three months ended June 30, 2024, was $16.85 million, compared to a net loss of $8.99 million for the same period in 2023, indicating an increase in losses of approximately 87%[9] - The net loss for the six months ended June 30, 2024, was $24,929,694, compared to a net loss of $24,602,677 for the same period in 2023, indicating a slight increase in losses[20] - The company reported a net loss per share of $0.28 for the three months ended June 30, 2024, compared to a loss of $0.15 per share for the same period in 2023[9] Assets and Liabilities - Total current assets decreased from $147.81 million on December 31, 2023, to $125.65 million on June 30, 2024, representing a decline of approximately 15%[8] - Cash and cash equivalents decreased significantly from $142.82 million on December 31, 2023, to $31.03 million on June 30, 2024, a reduction of about 78%[8] - Total liabilities decreased slightly from $28.53 million on December 31, 2023, to $27.73 million on June 30, 2024, a decrease of approximately 3%[8] - Total stockholders' equity decreased from $119.80 million on December 31, 2023, to $98.31 million on June 30, 2024, a decline of approximately 18%[8] - The accumulated deficit increased from $394.26 million on December 31, 2023, to $419.19 million on June 30, 2024, an increase of approximately 6%[8] Research and Development - Research and development expenses for the three months ended June 30, 2024, were $14.97 million, compared to $6.96 million for the same period in 2023, reflecting a year-over-year increase of approximately 115%[9] - Research and development expenses for the six months ended June 30, 2024, were $1,898,358, down 38% from $3,053,738 for the same period in 2023[65] Cash Flow and Investments - The company used $23,196,985 in operating activities during the first half of 2024, compared to $22,801,654 in the same period of 2023[20] - The company reported a net cash used in investing activities of $48,614,499 for the first half of 2024, compared to a net cash provided of $30,000,000 in the same period of 2023[20] - The company recorded a net cash decrease of $71,793,293 for the first half of 2024, contrasting with an increase of $7,256,197 in the same period of 2023[20] Stock and Equity - The company had 59,414,489 shares outstanding as of June 30, 2024, an increase from 59,195,951 shares as of December 31, 2023[8] - The company reported a total of 8,765,797 common stock equivalents as of June 30, 2024, compared to 7,775,253 as of June 30, 2023, indicating an increase of approximately 12.7%[34] - The Company has 3,542,805 shares of common stock available for grant under the 2023 Equity Plan as of June 30, 2024[60] Debt and Financing - The effective interest rate on the Company's debt was 12.6% as of June 30, 2024[50] - The company has a credit facility with Hercules Capital, Inc., providing for a term loan of up to $60 million, with the maturity date extended to October 1, 2024[48] - Future principal payments, including the Supplemental End of Term Charge, total $15,292,500 for the year ending December 31, 2024[52] Legal and Regulatory Matters - The Company is currently involved in a securities class action lawsuit alleging violations of the Securities Exchange Act, with no reasonable prediction of the outcome at this time[84] - The Company has not experienced any losses related to indemnification obligations for its officers and directors, concluding that the fair value of these obligations is negligible[79] Other Financial Metrics - Interest income for the three months ended June 30, 2024, was $1.64 million, compared to $1.88 million for the same period in 2023, a decrease of about 13%[9] - The company reported a decrease in cash paid for interest during the period, totaling $884,500 compared to $823,521 in the prior year[20] - The total grant date fair value of RSUs vested was $1.1 million for the six months ended June 30, 2024[72]

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]

Group 1 - Aldeyra Therapeutics, Inc. (ALDX) has shown a year-to-date return of 5.4%, outperforming the average return of 3.8% for the Medical sector [2][3] - The Zacks Consensus Estimate for ALDX's full-year earnings has increased by 66.3% over the past three months, indicating improved analyst sentiment and earnings outlook [2] - Aldeyra Therapeutics, Inc. is ranked 92 in the Zacks Industry Rank within the Medical - Drugs industry, which has seen an average loss of 7.5% this year, further highlighting ALDX's relative performance [3] Group 2 - Teva Pharmaceutical Industries Ltd. (TEVA) has achieved a year-to-date return of 61.7%, significantly outperforming both the Medical sector and its own industry [2][3] - The consensus EPS estimate for Teva has increased by 0.3% over the past three months, and it also holds a Zacks Rank of 2 (Buy) [3] - The Medical - Generic Drugs industry, to which Teva belongs, is currently ranked 56 and has experienced a positive movement of +10.5% this year [3]

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]

Core Viewpoint - Aldeyra Therapeutics is advancing its clinical-stage immunology pipeline, focusing on reproxalap for dry eye disease and allergic conjunctivitis, with significant recent developments impacting its stock performance and future prospects [1][4]. Company Developments - Aldeyra's lead candidate, reproxalap, is in two phase III studies for dry eye disease and allergic conjunctivitis [1]. - The company announced a clinical development plan on March 28, aimed at resubmitting a new drug application (NDA) for reproxalap to the FDA [1]. - Following a complete response letter (CRL) from the FDA in November 2023, Aldeyra plans to initiate a dry eye chamber clinical study in the first half of 2024 to address efficacy concerns raised by the FDA [4][5]. Financial Position - As of December 31, 2023, Aldeyra reported cash and cash equivalents of $142.8 million, projected to fund operations beyond 2026 [6]. Licensing Agreement - Aldeyra has an exclusive option agreement with AbbVie Inc. for reproxalap, which could yield up to $300 million in milestone payments, including a $100 million payment upon FDA approval [7][8]. Clinical Trials - The upcoming dry eye chamber study will enroll approximately 100 patients to assess ocular discomfort, with the goal of demonstrating statistically significant improvement with reproxalap compared to a vehicle [5]. - Aldeyra plans to conduct an additional dry eye chamber clinical study to account for disease heterogeneity and site differences [6]. Stock Performance - Year-to-date, Aldeyra's shares have increased by 33.5%, contrasting with a 5.7% decline in the industry [2]. - Recently, shares rallied 43.3% following the announcement of the clinical development plan [1].

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 ...