Aldeyra Therapeutics, Inc. (ALDX): Business Model Canvas [Dec-2025 Updated]

You're staring down the barrel of a major biotech inflection point with Aldeyra Therapeutics, and honestly, understanding their business model right now is key to knowing where your capital stands. We're talking about a company whose entire near-term fate rests on a single FDA decision for reproxalap, yet their structure-built around the proprietary Reactive Aldehyde Species (RASP) platform-is already deeply tied to a commercial giant like AbbVie, promising a potential $100 million milestone and a 40% profit split post-approval. This is biotech binary risk at its finest. Still, with an estimated net loss of 24 cents per share for Q3 2025, you need to see exactly how their Key Resources, like cash extending into the second half of 2027, align with their heavy R&D Cost Structure; dive into the full nine-block canvas below to map out the opportunity and the very real risks.

Aldeyra Therapeutics, Inc. (ALDX) - Canvas Business Model: Key Partnerships

You're looking at the core external relationships Aldeyra Therapeutics, Inc. relies on to move its pipeline, especially reproxalap, toward commercialization as of late 2025. These alliances are critical for funding, manufacturing scale, and market access.

AbbVie Inc. for U.S. co-development and commercialization of reproxalap

This is the most significant financial partnership. The option agreement, expanded in late 2024, sets up the path for AbbVie Inc. to take the lead on reproxalap in the United States. The Prescription Drug User Fee Act (PDUFA) target action date for the New Drug Application (NDA) was set for April 2, 2025. If AbbVie exercises its option following potential FDA approval, the financial structure is quite clear:

• Aldeyra Therapeutics receives a $100 million upfront cash payment, which is net of a previously paid $1 million non-refundable option fee.
• Aldeyra Therapeutics is eligible for up to $300 million in total regulatory and commercial milestone payments.
• A specific milestone of $100 million is payable upon FDA approval for dry eye disease.
• For U.S. commercialization, profits and losses are split with AbbVie taking 60% and Aldeyra Therapeutics receiving 40%.
• For markets outside the U.S., Aldeyra Therapeutics is eligible to receive tiered royalties on net sales.

The expanded agreement also dictates cost-sharing for pre-commercial activities, with AbbVie paying 60% and Aldeyra Therapeutics paying 40% if the option is exercised. The option expiration is tied to the FDA approval date, expiring 10 business days after approval, if granted.

Financial Element	Amount/Split	Context
Initial Option Fee	$1 million	Non-refundable payment to Aldeyra Therapeutics
Upfront Payment (Upon Option Exercise)	$100 million	Less prior option fees
Total Potential Milestones	Up to $300 million	Regulatory and commercial
FDA Approval Milestone	$100 million	Upon U.S. Food and Drug Administration approval
U.S. Profit/Loss Split	AbbVie 60% / Aldeyra Therapeutics 40%	For U.S. commercialization

Contract Research Organizations (CROs) for clinical trial execution

Aldeyra Therapeutics relies on external expertise to manage its clinical development programs. The financial records for the period ending March 31, 2025, list clinical trial prepayments to contract research organizations as a financial instrument on the Consolidated Balance Sheets. No specific contract values or the number of active CROs are detailed in the latest filings.

Contract Manufacturing Organizations (CMOs) for drug supply and scale-up

Ensuring drug supply is a key operational partnership. In 2025, the U.S. Food and Drug Administration (FDA) completed routine site inspections of the reproxalap drug substance and drug product manufacturing facilities. These inspections resulted in Voluntary Action Indicated (VAI) designations, and the FDA notified the manufacturers that the inspections were closed, indicating successful navigation of a critical manufacturing hurdle in 2025.

Academic and research institutions for early-stage RASP platform discovery

The expansion of the Reactive Aldehyde Species (RASP) platform is driven by ongoing research. In November 2025, Aldeyra Therapeutics announced the expansion of the RASP platform to include programs in Central Nervous System diseases, based on new preclinical results. The company's overall approach involves developing pharmaceuticals that modulate protein systems, aiming to optimize multiple pathways at once while minimizing toxicity.

• The RASP platform includes modulators such as ADX-248, ADX-743, ADX-631, ADX-246, and ADX-629.
• Preclinical results supporting the CNS expansion included improved grip strength and balance in models of Parkinson's disease and amyotrophic lateral sclerosis.
• The company announced the advancement of ADX-743 for obesity/hypertriglyceridemia, expecting an Investigational New Drug (IND) application submission in 2025.

Finance: draft 13-week cash view by Friday.

Aldeyra Therapeutics, Inc. (ALDX) - Canvas Business Model: Key Activities

You're looking at the core engine of Aldeyra Therapeutics, Inc. (ALDX) right now, which is heavily weighted toward regulatory milestones and pipeline advancement as of late 2025. The key activities revolve around pushing reproxalap across the finish line and setting up the next wave of RASP modulators.

Late-stage clinical development and regulatory submission for reproxalap

The primary focus here is securing approval for topical ocular reproxalap for dry eye disease. Aldeyra Therapeutics resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on June 17, 2025. This resubmission was based on a Phase 3 randomized, double-masked, vehicle-controlled dry eye chamber trial that achieved its primary endpoint of reducing ocular discomfort with a P=0.002 in May 2025. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2025. The drug has been studied in over 2,900 patients across its development program. The company reported a net loss of $27.4 million for the nine months ending September 30, 2025, an improvement from the $40.0 million loss in the same period in 2024. For Q3 2025, the reported Earnings Per Share (EPS) was -$0.13, beating expectations by 23.53%. The full-year 2025 costs for the ongoing dry eye clinical trials were expected to be approximately $6 million.

Here's a quick look at the regulatory timeline and financial context:

Activity Detail	Date/Value
NDA Resubmission Date	June 17, 2025
Chamber Trial Primary Endpoint P-value	0.002
PDUFA Target Action Date	December 16, 2025
Nine Months Ended 9/30/2025 Net Loss	$27.4 million
Q3 2025 Actual EPS	-$0.13

Research and development (R&D) of next-generation RASP modulators (ADX-248, ADX-246)

Aldeyra Therapeutics is actively focusing its pipeline on next-generation Reactive Aldehyde Species (RASP) modulators. This activity involves prioritizing candidates for later-stage IND filings. The company announced positive Phase 2 trial results for ADX-629 in alcohol-associated hepatitis on October 28, 2025.

The R&D focus for the next-gen molecules is detailed below:

• ADX-248 targets metabolic inflammation; IND filing anticipated in 2026.
• ADX-246 targets dry age-related macular degeneration; IND filing expected in 2026.
• The company's projected operational cash runway extends into the second half of 2027, supporting these R&D efforts.

Pre-commercialization planning and market access strategy with AbbVie

This activity centers on the commercial framework for reproxalap, should it gain approval. Aldeyra Therapeutics executed an Expansion Side Letter with AbbVie in November 2024 to outline collaborative launch activities and cost-sharing. The potential deal structure is significant, offering substantial financial upside contingent on regulatory success.

The financial terms tied to the AbbVie option agreement include:

• Total potential milestone payments up to $400 million if fully exercised.
• A $100 million milestone payment upon U.S. approval of reproxalap.
• U.S. commercialization profit and loss sharing is set at 60% for AbbVie and 40% for Aldeyra Therapeutics.
• For ex-U.S. markets, Aldeyra Therapeutics is eligible for tiered royalties on net sales.
• AbbVie previously paid a $1 million non-refundable option fee and an additional $5 million option extension fee on December 21, 2023.

Intellectual property protection and patent portfolio maintenance

Maintaining the intellectual property around the RASP modulator platform is a constant key activity, underpinning the value of the pipeline, including reproxalap and the next-generation candidates like ADX-248 and ADX-246. The company's market capitalization was reported at $314.04 million with 60.05 million shares outstanding as of late 2025. The balance sheet as of September 30, 2025, showed total assets of $77.8 million and cash, cash equivalents, and marketable securities totaling $75.3 million. The Current Ratio was reported at 2.86, which suggests a strong liquidity position to support ongoing IP and legal maintenance.

Aldeyra Therapeutics, Inc. (ALDX) - Canvas Business Model: Key Resources

You're looking at the core assets Aldeyra Therapeutics, Inc. (ALDX) relies on to drive its business forward. These aren't just line items; they are the foundation for their next steps in the clinic and toward commercialization. Honestly, for a clinical-stage biotech, the quality of the science and the cash on hand are what really matter right now.

The most critical resource is definitely their scientific foundation.

• Proprietary Reactive Aldehyde Species (RASP) modulator platform technology. This platform is designed to develop pharmaceuticals that modulate protein systems, aiming to optimize multiple pathways at once while minimizing toxicity.

Next up is their lead asset, which is what most investors are watching closely.

• Reproxalap, a first-in-class investigational drug candidate. This RASP modulator is in late-stage development for dry eye disease and allergic conjunctivitis.

The company has also been strategic about its pipeline beyond Reproxalap, replacing older candidates with newer ones based on recent data. Here's a quick look at the updated RASP modulator pipeline candidates:

• ADX-248: Targeted for metabolic inflammation, including obesity and hypertriglyceridemia, with an Investigational New Drug (IND) application filing anticipated in 2026.
• ADX-246: Targeted for a dry form of age-related macular degeneration (dry AMD), with an IND application filing also anticipated in 2026.
• ADX-2191: A novel formulation of intravitreal methotrexate for the potential treatment of primary vitreoretinal lymphoma and retinitis pigmentosa.

Financially speaking, the runway extension is a huge resource, giving them time to execute without immediate dilution pressure. Based on their October 2025 updates, the projected operational runway, supported by their balance sheet, extends into the second half of 2027.

To give you a concrete view of their financial standing as of the end of the third quarter of 2025, look at this snapshot:

Financial Metric	Amount as of September 30, 2025	Source Date
Cash, Cash Equivalents, and Marketable Securities	$75.3 million	Q3 2025 Report (Nov 2025)
Total Assets	$77.8 million	Q3 2025 Report (Nov 2025)
Total Stockholders' Equity	$49.2 million	Q3 2025 Report (Nov 2025)
Cash, Cash Equivalents, and Marketable Securities	$90.1 million	Q1 2025 Report (Mar 31, 2025)
Total Debt	$15.2 million	Q4 2024 Report (Mar 31, 2025 data)

The team itself is a key intangible resource. You need people who know the landscape when you're dealing with complex regulatory pathways and specialized diseases.

• Experienced executive and R&D team in ophthalmology and immune-mediated diseases.

For context on operating costs, their Research and Development expenses for the three months ended March 31, 2025, were $7.4 million, a 20.1% increase from the same period in 2024. That R&D spend is directly tied to developing these key resources. Finance: draft 13-week cash view by Friday.

Aldeyra Therapeutics, Inc. (ALDX) - Canvas Business Model: Value Propositions

You're looking at the core value Aldeyra Therapeutics, Inc. (ALDX) is trying to deliver across its product candidates. It's all about hitting specific, high-unmet-need areas with a novel mechanism.

Reproxalap: Rapid reduction of ocular discomfort and redness for dry eye disease

The value here centers on clinical proof points. In a Phase 3 dry eye chamber trial, reproxalap was statistically superior ($\text{P}=0.002$) to vehicle for the primary endpoint of ocular discomfort. Specifically, the $\text{LS mean difference}$ on the $\text{0-100}$ ocular discomfort symptom score from $\text{80}$ to $\text{100}$ minutes after chamber entry was $\text{-6.5}$ [$\text{-10.5, -2.5}$].

The market context is massive, with the Dry Eye Disease ($\text{DED}$) market projected to hit $\text{\$7.6}$ billion globally by $\text{2030}$. Aldeyra, Inc. estimates that only $\text{15\%}$ of $\text{DED}$ patients currently use prescription treatments. If approved, analysts estimate peak sales for reproxalap could reach $\text{\$500}$ million annually.

Here's a quick look at the numbers supporting the DED proposition as of late $\text{2025}$:

Metric	Value
Phase 3 Chamber Trial P-value (Ocular Discomfort)	0.002
Ocular Discomfort LS Mean Difference (Reproxalap vs. Vehicle)	-6.5
Total Patients Studied in Clinical Trials (to date)	>2,900
Projected Global DED Market by 2030	$7.6 billion
Estimated Peak Annual Sales (if approved)	$500 million
PDUFA Target Action Date (NDA Resubmission)	December 16, 2025

Also, the manufacturing facilities completed routine site inspections in $\text{2025}$ resulting in Voluntary Action Indicated ($\text{VAI}$) designations, with the $\text{FDA}$ notifying manufacturers that inspections are closed with no further action necessary.

First-in-class mechanism targeting RASP, a novel anti-inflammatory approach

The core value is the mechanism itself: targeting reactive aldehyde species ($\text{RASP}$). This approach aims to address both signs and symptoms of chronic inflammation. Across all clinical trials to date, reproxalap was studied in over $\text{2,900}$ patients, and the most commonly reported adverse event was mild and transient instillation site irritation; no serious safety signals were observed.

Potential treatment for rare retinal diseases with ADX-2191 (e.g., primary vitreoretinal lymphoma)

For Primary Vitreoretinal Lymphoma ($\text{PVRL}$), $\text{ADX-2191}$ offers a novel, sterile, non-compounded intravitreal formulation of methotrexate where currently no $\text{FDA}$-approved therapy exists. $\text{PVRL}$ affects approximately $\text{100}$ to $\text{200}$ people per year in the $\text{EU}$ and $\text{200}$ to $\text{600}$ in the $\text{US}$. The clinical trial proposed under the Special Protocol Assessment Agreement Letter is expected to begin in the second half of $\text{2025}$ and conclude in $\text{2026}$. For Retinitis Pigmentosa ($\text{RP}$), the $\text{FDA}$ granted Fast Track designation, and a planned Phase $\text{2/3}$ trial is expected to initiate in $\text{2025}$.

Pipeline of RASP modulators for systemic immune-mediated and metabolic diseases

Aldeyra, Inc. is focusing its $\text{RASP}$ platform on next-generation molecules following pipeline adjustments announced on $\text{October 28, 2025}$. This strategic shift extended the projected operational cash runway into the second half of $\text{2027}$. The company's market capitalization was approximately $\text{\$319}$ million with a share price of $\text{\$5.30}$ as of mid-November $\text{2025}$.

The reprioritization involved specific asset swaps:

• Stopping clinical development of $\text{ADX-629}$.
• Prioritizing $\text{ADX-248}$ over $\text{ADX-743}$ for metabolic inflammation, including obesity.
• Switching focus from $\text{ADX-631}$ to $\text{ADX-246}$ for dry Age-related Macular Degeneration ($\text{AMD}$).

The value proposition for these systemic candidates is supported by preclinical or Phase $\text{1}$ data suggesting broad applicability. For instance, $\text{ADX-248}$ showed high levels of exposure following once-daily oral dosing in Phase $\text{1}$ studies, and new preclinical data showed positive effects in Parkinson's disease and $\text{ALS}$ models, including improvements in grip strength and balance. Investigational New Drug ($\text{IND}$) application filings for both $\text{ADX-248}$ and $\text{ADX-246}$ are anticipated in $\text{2026}$.

Here's how the pipeline focus shifted:

Indication Area	Prioritized Asset	Replaced Asset	Next Step Timeline
Metabolic Inflammation (e.g., Obesity)	ADX-248	ADX-743	IND filing in 2026
Dry AMD	ADX-246	ADX-631	IND filing in 2026
Neuroinflammatory Diseases (Expansion)	ADX-248	N/A (Expansion)	Preclinical data supportive

Finance: review the $\text{Q3 2025}$ cash position of $\text{\$75.3}$ million against the extended runway forecast of $\text{H2 2027}$ runway by next week.

Aldeyra Therapeutics, Inc. (ALDX) - Canvas Business Model: Customer Relationships

You're looking at how Aldeyra Therapeutics, Inc. manages its relationships with the key groups that drive its success-from the doctors who will prescribe its drugs to the investors funding the pipeline. For a clinical-stage company, these relationships are everything, especially when you're navigating a major regulatory decision like the one for reproxalap.

High-touch engagement with key opinion leaders (KOLs) and specialists

Engagement with Key Opinion Leaders (KOLs) and specialists centers on the late-stage clinical data for reproxalap, a reactive aldehyde species (RASP) modulator for dry eye disease and allergic conjunctivitis. The relationship is built on presenting the clinical profile of this first-in-class therapy to the ophthalmology community, which has existing treatments like Xiidra and Restasis.

The focus here is on establishing credibility with prescribers ahead of potential commercialization. While specific counts of engaged specialists aren't public, the nature of the relationship is high-touch, driven by the need to educate on a novel mechanism of action-modulating protein systems to optimize multiple pathways while minimizing toxicity.

Investor relations and communication on clinical milestones

Investor relations for Aldeyra Therapeutics, Inc. is intensely focused on clinical and regulatory milestones, which directly impact valuation and partnership dynamics. The company maintains active communication channels, including a dedicated Investor Relations website at https://ir.aldeyra.com, managed by staff like Laura Nichols, Associate Director of Investor Relations & Business Operations.

Key communications in 2025 revolved around the reproxalap New Drug Application (NDA) resubmission, which received an FDA Prescription Drug User Fee Act (PDUFA) target action date of April 2, 2025. The company provided updates through webcasts and conference participation, such as the Research & Development Update Webcast on November 13, 2025, and the CEO's participation in the Jefferies Global Healthcare Conference on November 20, 2025 in London.

Financially, investor communication must address the burn rate and cash runway. For instance, the Q1 2025 financial results showed a net loss of approximately $9.93 million, with Research and development expenses at $7.4 million and General and administrative expenses at $3.0 million for that quarter. As of March 31, 2025, the company reported total cash, cash equivalents, and marketable securities of $90.1 million against total liabilities of $29.6 million.

Here are some key investor touchpoints from the period:

• PDUFA date set for reproxalap: April 2, 2025.
• R&D Update Webcast hosted: November 13, 2025.
• Jefferies Global Healthcare Conference participation: November 20, 2025.
• Q1 2025 Net Loss reported: $9.93 million.
• Cash position as of March 31, 2025: $90.1 million.

Indirect patient support and education via advocacy groups

Aldeyra Therapeutics, Inc. engages patients indirectly, primarily through collaboration with patient advocacy groups. While specific financial or engagement metrics for Aldeyra's direct support programs aren't detailed, the industry context for 2025 emphasizes a shift toward deeper partnership. Experts suggest that pharmaceutical companies must move beyond simple consultation to co-create products with patient advocacy groups and ensure transparency on how patient input shapes decisions.

This relationship is critical for building trust, which industry data suggests has been a challenge, with patient perceptions of the biopharmaceutical industry declining over the preceding two years. For Aldeyra, this means ensuring that advocacy groups are informed about the potential benefits of reproxalap and ADX-2191, especially given the focus on unmet needs in immune-mediated diseases.

Collaborative management with commercial partner AbbVie

The relationship with commercial partner AbbVie, Inc. is structured around the development, manufacture, and commercialization of reproxalap in the U.S. This partnership is defined by clear financial triggers and profit-sharing terms following the NDA acceptance and option agreement expansion.

The financial structure governing this collaboration is laid out below:

Financial Component	Aldeyra Therapeutics, Inc. Entitlement	AbbVie, Inc. Entitlement
Upfront Payment (Upon Option Exercise)	$100 million cash payment (less $6 million in prior option fees)	Option to co-exclusive license in the US
Regulatory/Commercial Milestones	Up to $300 million total, including $100 million upon FDA approval	Triggers for milestone payments
US Commercialization Profit/Loss Split	40% share	60% share
International Commercialization	Tiered royalties on net sales	Exclusive license for activities outside the US
Pre-commercial Activities Cost Split (If Option Exercised)	40% of costs	60% of costs

The option agreement was expanded in parallel with the NDA acceptance, allowing both Aldeyra Therapeutics, Inc. and AbbVie to initiate pre-commercial activities. AbbVie's option to exercise the license expires 10 business days following FDA approval, if granted.

Aldeyra Therapeutics, Inc. (ALDX) - Canvas Business Model: Channels

You're looking at how Aldeyra Therapeutics, Inc. plans to get reproxalap-if approved-into the hands of U.S. ophthalmologists and patients. This involves regulatory navigation, a major commercial partner, and scientific communication.

AbbVie's established U.S. ophthalmology and commercial sales force (post-approval)

The primary commercial channel hinges on the option agreement with AbbVie Inc. Should AbbVie exercise its option following FDA approval, the established U.S. ophthalmology and commercial sales force of AbbVie will drive market access.

The financial structure for this channel, post-option exercise, is clearly defined:

Commercial Aspect	AbbVie Share	Aldeyra Therapeutics Share
U.S. Commercialization Profits/Losses Split	60%	40%
U.S. Pre-commercial Activity Cost Split	60% (Implied by expanded agreement)	40% (Implied by expanded agreement)

This partnership also involves significant financial triggers that activate the channel. Aldeyra Therapeutics is eligible for up to $300 million in regulatory and commercial milestone payments, which includes a $100 million payment specifically upon FDA approval. AbbVie has also independently started certain pre-commercial planning activities.

Direct communication with the U.S. Food and Drug Administration (FDA) for NDA review

Direct engagement with the FDA is a critical channel for gaining market access. Aldeyra Therapeutics resubmitted the New Drug Application (NDA) for topical ocular reproxalap on June 17, 2025. The FDA officially accepted this resubmitted NDA for review on July 17, 2025. This acceptance established a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2025. This review period is the direct regulatory channel determining market entry.

Medical conferences and peer-reviewed publications for physician awareness

Building awareness among prescribing physicians relies on scientific dissemination. Aldeyra Therapeutics actively uses industry events to communicate data. For instance, the company was scheduled to participate in the 2025 Jefferies Global Healthcare Conference. Furthermore, the company presented data from its Phase 3 dry eye chamber trial, which met its primary endpoint of reducing ocular discomfort with a P-value of P=0.002 in May 2025.

Key communication milestones include:

• Data from Phase 3 dry eye chamber trial reported in August 2024.
• Fireside chat scheduled for June 5, 2025, at 4:20 p.m. ET.
• Research & Development Webcast event scheduled for November 13.

Specialty pharmacies and distributors for drug delivery (future)

The physical delivery channel for a specialty drug like reproxalap will likely involve a managed network. While Aldeyra Therapeutics has not disclosed its specific network structure as of late 2025, the broader U.S. specialty drug landscape provides context for this channel choice.

Industry data from early 2025 shows the following for manufacturer-defined specialty pharmacy networks:

Metric	Value
Total unique specialty drugs tracked with limited/exclusive networks (as of Jan 2025)	382
Percentage of tracked drugs with exclusive networks (only one pharmacy)	34%

The decision will likely fall into one of three models: Open distribution, Limited dispensing network, or Exclusive dispensing network. Given the partnership with AbbVie, a limited or exclusive network managed by AbbVie's existing infrastructure is the probable path.

Aldeyra Therapeutics, Inc. (ALDX) - Canvas Business Model: Customer Segments

You're looking at the core groups Aldeyra Therapeutics, Inc. targets with its development pipeline, especially around its late-stage assets. The focus is clearly on the ocular space, but the financial backing is just as critical for a clinical-stage firm.

Ophthalmologists and optometrists treating chronic dry eye disease (DED).

These are the prescribers you need to convince of the product's efficacy and tolerability. The market they operate in is substantial and growing, which signals a large potential pool for adoption if regulatory hurdles are cleared.

• The Dry Eye Disease treatment market was valued at $6.36 billion in 2025.
• This market is projected to reach $7.77 billion by 2030.
• Prescription drug growth in this sector is expanding at a 9.1% CAGR through 2030.
• In 2023, the United States represented the largest proportion of the 7MM DED market at 41% revenue share.
• Reproxalap has been studied in over 2,900 patients in clinical trials.

Patients with moderate-to-severe DED and allergic conjunctivitis (AC).

This segment represents the end-users who will ultimately use the product, assuming regulatory approval for reproxalap in DED and potential future indications like AC. The sheer scale of the diagnosed population is the opportunity here.

• The estimated total diagnosed prevalent cases of Dry Eye Disease in the 7MM reached nearly 54.7 million cases in 2023.
• The United States alone had an estimated 22.5 million diagnosed DED cases in 2023.
• In a Phase 3 chamber trial for DED, the ocular discomfort symptom score (0-100) showed an LS mean difference of -6.5 (P = 0.002) for reproxalap versus vehicle.
• The chamber trial involved 58 patients receiving reproxalap and 58 patients receiving vehicle.

Retinal specialists treating rare ocular inflammatory diseases.

While less data is immediately available on the specific patient numbers for rare inflammatory diseases like Primary Vitreoretinal Lymphoma (PVRL), this segment is targeted by the pipeline candidate ADX-2191. The focus here is on specialized, high-need areas.

Aldeyra Therapeutics had an NDA for ADX-2191 for PVRL under Priority Review with a PDUFA date of June 21, 2023, as reported in March 2023.

Institutional investors funding clinical-stage biotechnology companies.

This group provides the necessary capital to fund the late-stage trials and potential commercial launch activities. Their confidence, reflected in ownership stakes, is a key resource.

As of late 2025, the stock price was $4.96 per share on November 21, 2025. The company reported cash, cash equivalents, and marketable securities of $101 million as of December 31, 2024.

Institutional Shareholder (as of Q3 2025)	Shares Held	Total Value of Holdings (millions)
Knoll Capital Management, Llc.	5,475,516	Not explicitly stated for this holder
Perceptive Advisors Llc.	5,222,311	Not explicitly stated for this holder
Blackrock, Inc.	3,804,920	Not explicitly stated for this holder
Vanguard Group Inc.	3,591,869	Not explicitly stated for this holder
Total Institutional Owners/Shareholders Filing	42,499,995 (Total Shares Held)	$207 (Total Value of Holdings)

There are 255 institutional owners and shareholders filing 13D/G or 13F forms. The expected full-year 2025 costs for the ongoing DED clinical trials were approximately $6 million.

Aldeyra Therapeutics, Inc. (ALDX) - Canvas Business Model: Cost Structure

You're looking at where Aldeyra Therapeutics, Inc. is putting its capital to work, and it's heavily weighted toward getting reproxalap across the finish line. The cost structure is defined by significant, ongoing investment in clinical development, which is typical for a clinical-stage biopharma company like Aldeyra Therapeutics, Inc. The burn rate reflects the pursuit of regulatory approval for its lead candidate.

Here's a quick look at the core operating expenses for the third quarter and the nine months ending September 30, 2025, showing where the money is going:

Expense Category	Q3 2025 Amount (USD)	Nine Months Ended Sep 30, 2025 Amount (USD)
Research and Development (R&D) Expenses	$5.4 million	$21.4 million
General and Administrative (G&A) Expenses	$2.6 million	$7.2 million
Net Loss (Total)	$7.69 million	$27.4 million

The heavy investment in clinical trials is clearly visible in the R&D spend. Specifically, the full-year 2025 costs for the ongoing dry eye clinical trials are expected to be approximately $6 million. This figure represents a focused spend following the majority of costs incurred in 2024, as Aldeyra Therapeutics, Inc. works toward a potential New Drug Application (NDA) resubmission mid-year 2025.

General and administrative (G&A) costs, which cover things like legal fees and maintaining the company's intellectual property portfolio, also show a reduction compared to the prior year. For the third quarter of 2025, G&A expenses were $2.6 million, down from $3.7 million in Q3 2024. The nine-month total for G&A was $7.2 million, an improvement from $9.9 million in the same period of 2024. This reduction is primarily due to lower personnel and legal costs.

The bottom line reflects the development stage. For Q3 2025, Aldeyra Therapeutics, Inc. reported a basic loss per share from continuing operations of $0.13. This compares to an analyst estimate of $0.245 loss per share for the period, based on available data. The reported net loss for the quarter was $7.69 million.

To give you a sense of the financial runway supporting these costs, here are a few balance sheet highlights as of September 30, 2025:

• Cash, cash equivalents, and marketable securities totaled $75.3 million.
• Total assets were reported at $77.8 million.
• Total stockholders' equity amounted to approximately $49.2 million.

Finance: draft 13-week cash view by Friday.

Aldeyra Therapeutics, Inc. (ALDX) - Canvas Business Model: Revenue Streams

Aldeyra Therapeutics, Inc.'s revenue streams are heavily weighted toward potential future payments stemming from the exclusive option agreement with AbbVie Inc. concerning reproxalap, as of late 2025.

The core of the expected revenue generation is tied to the successful commercialization of reproxalap, contingent upon regulatory milestones. The agreement structure dictates specific financial triggers:

• Potential $100 million milestone payment from AbbVie upon U.S. Food and Drug Administration approval of reproxalap for dry eye disease.
• Potential future milestone payments totaling up to $300 million in regulatory and commercial achievements, which includes the $100 million approval payment. One analysis suggests this could total up to $400 million in milestone payments contingent on regulatory and commercial success.

Once commercialization begins in the United States, Aldeyra Therapeutics, Inc. is set to receive a significant share of the net profits from reproxalap sales. This profit-sharing arrangement is detailed as follows:

Geographic Market	Aldeyra Therapeutics, Inc. Share	Partner Share
United States	40% of profits and losses	60% for AbbVie Inc.
Outside the U.S.	Tiered royalties on net sales	N/A

For markets outside the U.S., the revenue stream shifts entirely to royalties. Aldeyra Therapeutics, Inc. would be eligible to receive tiered royalties on net sales of reproxalap. The specific royalty percentages are tiered and dependent on sales volume, which is a future-looking revenue component.

To put the company's current financial standing in context, Aldeyra Therapeutics, Inc. reported a net loss to common of -$7.68 million for the third quarter of 2025. For the nine months ending September 30, 2025, the company reflected a comprehensive loss of $27.4 million. The company's ability to realize these contingent revenues is paramount to its financial health.

The key financial components of the AbbVie collaboration are:

• Upfront Payment: $100 million, less prior option fees, upon option exercise.
• FDA Approval Milestone: $100 million payment.
• Total Potential Milestones: Up to $300 million.
• U.S. Profit Split: Aldeyra receives 40%.

Finance: draft 13-week cash view by Friday.