SLNOHIGH SIGNALOPPORTUNITY10-K

SLNO successfully launched their FDA-approved drug VYKAT XR in 2025, transforming from a pre-revenue biotech into a profitable commercial-stage company.

This represents a fundamental business transformation as the company moved from clinical trials to commercial operations with their first approved product. The FDA approval and successful product launch validates years of R&D investment and establishes SLNO as a commercial player in the rare disease space, specifically treating Prader-Willi syndrome.

Comparing 2026-02-25 vs 2025-02-28View on EDGAR →
FINANCIAL ANALYSIS

The financial metrics reflect a dramatic transformation from a cash-burning development company to a profitable commercial entity, with operating cash flow swinging from negative $69M to positive $47M and net income improving from a $176M loss to $21M profit. Revenue increased 139% to $1.5M from initial product sales, while R&D expenses appropriately declined 48% as the company shifted from development to commercialization. The significant increases in assets (+70%) and stockholders' equity (+84%) suggest successful capital raising to fund the commercial launch, though current liabilities also increased substantially, likely due to commercialization-related obligations.

FINANCIAL STATEMENT CHANGES
Current Liabilities
Balance Sheet
+227.3%
$18.7M$61.4M

Current liabilities surged 227.3% — significant near-term obligations; verify ability to meet short-term debt.

Operating Cash Flow
Cash Flow
+167.7%
-$69.1M$46.8M

Operating cash flow surged 167.7% — exceptional cash generation, highest quality earnings signal.

Revenue
P&L
+138.8%
$607K$1.5M

Strong top-line growth of 138.8% — accelerating demand or successful expansion into new markets.

Gross Profit
P&L
-123%
$255K-$59K

Gross margin compression — rising input costs, pricing pressure, or unfavorable product mix shift.

Net Income
P&L
+111.9%
-$175.8M$20.9M

Net income grew 111.9% — bottom-line growth signals improving overall business health.

Operating Income
P&L
+105%
-$187.7M$9.4M

Operating leverage kicking in — revenue growth outpacing cost growth, a hallmark of scaling businesses.

Stockholders Equity
Balance Sheet
+83.6%
$245.1M$450.1M

Equity base grew 83.6% — retained earnings accumulation or equity issuance strengthening the balance sheet.

Total Assets
Balance Sheet
+70.4%
$331.0M$563.8M

Asset base grew 70.4% — expansion through organic growth, acquisitions, or capital deployment.

Capital Expenditure
Cash Flow
-66.5%
$218K$73K

Capex reduced 66.5% — investment cycle winding down or capital discipline; may improve near-term free cash flow.

R&D Expense
P&L
-48.3%
$78.6M$40.6M

R&D spending cut 48.3% — could signal cost discipline or concerning reduction in innovation investment.

LANGUAGE CHANGES
NEW — 2026-02-25
PRIOR — 2025-02-28
ADDED
As of February 19, 2026, there were 51,624,384 shares of the registrant s Common Stock, par value $0.001 per share, outstanding.
Auditor Location: San Francisco, CA Auditor Firm ID: 199 Soleno Therapeutics, Inc.
On March 26, 2025, we announced that our lead product candidate, VYKAT TM XR (diazoxide choline) extended-release tablets, formerly known as DCCR, had been approved by the U.S.
VYKAT XR is indicated to treat hyperphagia in adults and pediatric patients four years of age and older with Prader-Willi syndrome (PWS).
On April 14, 2025, we announced that prescriptions of VYKAT XR had been delivered to the first individuals living with PWS who had been prescribed the medication and began recognizing revenue from the sales of VYKAT XR during the three months ended June 30, 2025.
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REMOVED
As of February 26, 2025, there wer e 45,857,291 shares of the registrant s Common Stock, par value $0.001 per share, outstanding.
Auditor Name: Marcum LLP Auditor Location: San Francisco, CA Auditor Firm ID: 688 Soleno Therapeutics, Inc.
Food and Drug Administration (FDA) for our lead product candidate, diazoxide choline extended-release tablets (DCCR) for the treatment of Prader-Willi syndrome (PWS) in individuals four years and older who have hyperphagia.
On August 27, 2024, we announced that the FDA had accepted the NDA for filing, designated the application for priority review and set a Prescription Drug User Fee Act (PDUFA) target action date of December 27, 2024.
On November 26, 2024, we announced that the FDA had extended the review period for our NDA and set a new PDUFA target action date of March 27, 2025.
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