SLNOHIGH SIGNALOPPORTUNITY10-K

Soleno Therapeutics has successfully transitioned from a clinical-stage company to a commercial entity with FDA approval and initial sales of VYKAT XR for Prader-Willi syndrome.

This represents a fundamental business transformation as the company moved from drug development to revenue generation, with first prescriptions delivered in April 2025. The approval of their lead product candidate marks a critical milestone that validates years of R&D investment and opens significant market opportunities in the rare disease space.

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

The balance sheet reflects a substantial strengthening with stockholders' equity growing 83.6% to $450.1M and total assets expanding 70.4% to $563.8M, likely driven by equity financing to support commercialization. R&D expenses declined meaningfully to $40.6M as the company shifted focus from clinical development to commercial operations, while SG&A expenses increased 24.8% to $132.1M reflecting the build-out of commercial infrastructure. Cash position decreased modestly to $70.1M, suggesting active deployment of capital for launch activities.

FINANCIAL STATEMENT CHANGES
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.

Total Liabilities
Balance Sheet
+32.4%
$85.9M$113.7M

Liabilities grew 32.4% — significant increase in debt or obligations, assess impact on financial flexibility.

SG&A Expense
P&L
+24.8%
$105.9M$132.1M

SG&A increased modestly — likely reflects growth-related hiring or sales expansion investment.

Current Assets
Balance Sheet
+21.1%
$293.9M$355.8M

Current assets grew 21.1% — improving short-term liquidity or inventory/receivables build.

Cash & Equivalents
Balance Sheet
-20.3%
$87.9M$70.1M

Cash decreased 20.3% — monitor burn rate and upcoming capital needs.

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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