Executive Summary

Aldeyra reported Q1 2023 net loss of $15.6M and EPS of $0.27 loss; operating expenses were $16.8M, with R&D down $1.0M YoY and G&A up $1.4M YoY .
Cash and cash equivalents were $165.0M; management guided cash runway into H2 2024, supporting potential initial commercialization plans if NDAs are approved .
Multiple near-term catalysts: INVIGORATE-2 Phase 3 results in allergic conjunctivitis (Q2 2023), Phase 2 readouts for ADX‑2191 in retinitis pigmentosa and ADX‑629 in chronic cough (Q2 2023), and NDA PDUFA dates for ADX‑2191 (June 21, 2023) and reproxalap (Nov 23, 2023) .
Company discontinued quarterly earnings calls starting Q1 2023, emphasizing future calls for clinical/regulatory events—shifting investor focus to catalysts vs. quarterly financials .

What Went Well and What Went Wrong

Cash runway extended into H2 2024, supporting commercialization and continued development; cash balance increased to $165.0M vs. $144.4M at Dec 31, 2022 .
Clear regulatory milestones: ADX‑2191 NDA Priority Review (PDUFA Jun 21, 2023) and reproxalap NDA PDUFA (Nov 23, 2023); FDA noted no potential filing review issues for both NDAs .
CEO tone confident on pipeline breadth and upcoming catalysts: “Multiple regulatory and clinical catalysts are planned for the coming quarters...” (Todd C. Brady) .

No revenue and continued operating losses; Q1 net loss of $15.6M with total OpEx of $16.8M reflects ongoing R&D/G&A investment without product revenue .
R&D decreased YoY due to lower external clinical costs, but G&A rose notably on personnel and legal, indicating higher overhead as programs advance .
Discontinuation of quarterly earnings calls may reduce regular financial visibility; investors must rely on clinical/regulatory updates rather than quarterly financial discussions .

Metric	Q2 2022	Q3 2022	Q1 2023
Revenue ($USD Millions)	$0.0	$0.0	$0.0
Net Loss ($USD Millions)	$17.8	$14.6	$15.6
EPS (Basic & Diluted, $)	$(0.30)	$(0.25)	$(0.27)
R&D Expense ($USD Millions)	$14.6	$11.5	$11.2
G&A Expense ($USD Millions)	$3.1	$3.2	$5.6
Total Operating Expenses ($USD Millions)	$17.7	$14.8	$16.8

Notes: Aldeyra is an early-stage company with no product revenues; statements of operations present only expenses and losses .

Metric	Jun 30, 2022	Sep 30, 2022	Dec 31, 2022	Mar 31, 2023
Cash & Cash Equivalents ($USD Millions)	$42.0	$107.2	$144.4	$165.0
Marketable Securities ($USD Millions)	$75.7	$56.7	$29.9	$0.0
Total Liabilities ($USD Millions)	$27.0	$27.5	$30.3	$31.0
Stockholders’ Equity ($USD Millions)	$174.0	$162.2	$151.0	$137.2

Metric	Q2 2022	Q3 2022	Q1 2023
Net Income Margin %	NM (no revenue)	NM (no revenue)	NM (no revenue)
EBIT Margin %	NM (no revenue)	NM (no revenue)	NM (no revenue)

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Corporate	Through end of 2023	Into H2 2024	Raised duration
ADX‑2191 NDA (PVRL)	Regulatory	Pre-NDA meeting Q4 2022; submit as soon as end-2022	Priority Review; PDUFA Jun 21, 2023	Advanced to PDUFA date
Reproxalap NDA (Dry Eye)	Regulatory	Submit Q4 2022	FDA accepted; PDUFA Nov 23, 2023	Advanced to PDUFA date
INVIGORATE‑2 (Allergic Conjunctivitis)	Clinical	Results 2023	Top-line expected Q2 2023	Narrowed to Q2 timing
Quarterly Calls	IR Policy	Held through Q3 2022	Discontinued starting Q1 2023	Discontinued

Note: No Q1 2023 earnings call; themes drawn from Q2/Q3 2022 calls and Q1 2023 press release.

Topic	Previous Mentions (Q2 2022)	Previous Mentions (Q3 2022)	Current Period (Q1 2023)	Trend
Regulatory/NDAs	Plan reproxalap NDA in H2 2022; ADX‑2191 pre‑NDA in H2 2022	Reproxalap NDA on track Q4 2022; ADX‑2191 pre‑NDA Q4 2022	Both NDAs accepted; PDUFA dates set	Advancing to decision points
R&D Execution	TRANQUILITY‑2 and chamber crossover positive; GUARD results expected H2 2022	GUARD positive summary; INVIGORATE‑2 expected 2023	INVIGORATE‑2 top-line Q2 2023; multiple Phase 2 readouts Q2 2023	Catalysts imminent
Commercial Strategy	Optionality: partner vs. internal launch for reproxalap	Positioning on rapid onset; dry eye market dynamics	Focus on regulatory outcomes; no new commercialization specifics	Awaiting approvals
Systemic RASP (ADX‑629)	Phase 2 starts in multiple indications; ethanol challenge concept	Acute alcoholic hepatitis proof-of-concept endpoints and rationale	Chronic cough Phase 2 top-line expected Q2 2023	Broadening indications
IR/Communications	Active conference participation	Earnings calls ongoing	Quarterly calls discontinued; event-driven calls planned	Less frequent financial calls

“Aldeyra continues to build a robust pipeline of novel drug candidates for the treatment of immune-mediated diseases… Multiple regulatory and clinical catalysts are planned for the coming quarters...” — Todd C. Brady, President & CEO .
Cash runway and commercialization readiness: existing cash supports initial commercialization and continued development if approvals occur .
Priority Review context: FDA identified no filing review issues in ADX‑2191 and reproxalap NDAs .

No quarterly earnings call was held for Q1 2023; Aldeyra discontinued quarterly financial calls beginning with this announcement and will host calls for major clinical/regulatory events .

Wall Street consensus (S&P Global) for Q1 2023 EPS and revenue was unavailable due to data access limits at the time of this analysis; as such, estimate vs. actual comparisons cannot be provided. Results should be interpreted without an estimates benchmark this quarter.
S&P Global consensus unavailable.

Near-term binary catalysts: ADX‑2191 PDUFA (Jun 21, 2023) and reproxalap PDUFA (Nov 23, 2023) are the principal stock drivers; FDA noted no potential filing review issues for both NDAs .
Additional Q2 2023 readouts (INVIGORATE‑2, ADX‑2191 RP Phase 2, ADX‑629 chronic cough) add event density and potential upside or downside volatility .
Balance sheet strength: $165.0M cash and runway into H2 2024 supports pre-launch and multiple trials, reducing financing risk near term .
Operating profile: continued losses with no revenue; monitor G&A growth and R&D allocation as programs approach commercialization .
Communications shift: fewer scheduled financial updates; track company IR page and 8-Ks for event-driven disclosures .
Trading implications: position sizing should reflect regulatory timing; consider hedging around PDUFA dates and Phase 2 readouts given asymmetric outcomes .
Medium-term thesis: platform breadth in ocular/systemic RASP may support multi-asset value if first approvals occur; commercialization plans and payer access will be critical—watch subsequent guidance post-approvals .