SolenO Therapeutics Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>SolenO Therapeutics Inc. has filed its annual report detailing its 2023 financial performance and business operations.</b>

AI Summary

SOLENO THERAPEUTICS INC (SLNO) filed a Annual Report (10-K) with the SEC on March 7, 2024. SolenO Therapeutics Inc. filed its 2023 Form 10-K on March 7, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal executive offices are located at 203 Redwood Shores Parkway, Suite 500, Redwood City, CA 94065. SolenO Therapeutics Inc. was formerly known as Capnia, Inc., with a name change effective February 19, 2010. The filing includes references to various financial instruments and equity plans, including convertible debt, stock options, and warrants.

Why It Matters

For investors and stakeholders tracking SOLENO THERAPEUTICS INC, this filing contains several important signals. This 10-K filing provides a comprehensive overview of SolenO Therapeutics' financial health, operational activities, and strategic direction for the fiscal year 2023, which is crucial for investors to assess the company's performance and future prospects. The detailed financial statements and risk factors disclosed in the 10-K are essential for stakeholders to understand the company's financial position, potential risks, and compliance with regulatory requirements.

Risk Assessment

Risk Level: medium — SOLENO THERAPEUTICS INC shows moderate risk based on this filing. The company's financial statements and disclosures in the 10-K indicate a need for further capital and ongoing operations, suggesting potential financial risks.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand SolenO Therapeutics' financial position and future capital needs.

Key Numbers

• 20231231 — Fiscal Year End (Conformed period of report)
• 20240307 — Filing Date (Filed as of date)
• 001-36593 — SEC File Number (SEC file number)

Key Players & Entities

• SOLENO THERAPEUTICS INC (company) — Filer name
• Capnia, Inc. (company) — Former company name
• 203 Redwood Shores Parkway, Suite 500, Redwood City, CA 94065 (company) — Business address
• 0000950170-24-027500 (other) — Accession number
• 20231231 (date) — Conformed period of report
• 20240307 (date) — Filed as of date

FAQ

Industry Context

SolenO Therapeutics Inc. operates in the electromedical and electrotherapeutic apparatus industry, focusing on the development and commercialization of therapeutic products.

Regulatory Implications

The company is subject to standard SEC regulations for public companies, including the requirement to file annual reports (10-K) detailing financial performance and business operations.

What Investors Should Do

1. Review the detailed financial statements and disclosures within the 10-K for SolenO Therapeutics Inc.
2. Analyze the risk factors section to understand potential challenges and uncertainties facing the company.
3. Compare the 2023 financial performance with previous years to identify trends and assess growth or decline.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-03-07: Filing Date — Date the 10-K was officially filed with the SEC.

Year-Over-Year Comparison

This is the initial 10-K filing for the fiscal year 2023, providing a baseline for future comparisons.

Key Financial Figures

• $0.001 — nge on which registered Common Stock, $0.001 par value SLNO NASDAQ Securities
• $4.29 — 30, 2023, based on the closing price of $4.29 for shares of the registrant's common s

Filing Documents

• slno-20231231.htm (10-K) — 2789KB
• slno-ex10_58.htm (EX-10.58) — 96KB
• slno-ex10_59.htm (EX-10.59) — 33KB
• slno-ex21_1.htm (EX-21.1) — 5KB
• slno-ex23_1.htm (EX-23.1) — 4KB
• slno-ex31_1.htm (EX-31.1) — 13KB
• slno-ex31_2.htm (EX-31.2) — 13KB
• slno-ex32_1.htm (EX-32.1) — 6KB
• slno-ex32_2.htm (EX-32.2) — 6KB
• slno-ex97_1.htm (EX-97.1) — 47KB
• img175354480_0.jpg (GRAPHIC) — 30KB
• img175354480_1.jpg (GRAPHIC) — 23KB
• 0000950170-24-027500.txt (&nbsp;) — 9933KB
• slno-20231231.xsd (EX-101.SCH) — 1379KB
• slno-20231231_htm.xml (XML) — 1529KB

Business

Business 2 Item 1A

Risk Factors

Risk Factors 15 Item 1B Unresolved Staff Comments 52 Item 1C Cybersecurity 53 Item 2

Properties

Properties 54 Item 3

Legal Proceedings

Legal Proceedings 54 Item 4 Mine Safety Disclosures 54 PART II Item 5 Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 55 Item 6 [Reserved] 55 Item 7

Management's Discussion and Analysis of Financial Condition and Results of Operation

Management's Discussion and Analysis of Financial Condition and Results of Operation 56 Item 7A

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 62 Item 8

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 63 Item 9 Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 89 Item 9A

Controls and Procedures

Controls and Procedures 89 Item 9B Other Information 90 Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 90 PART III Item 10 Directors, Executive Officers and Corporate Governance 91 Item 11

Executive Compensation

Executive Compensation 91 Item 12

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 91 Item 13 Certain Relationships and Related Transactions, and Director Independence 91 Item 14 Principal Accounting Fees and Services 91 PART IV Item 15 Exhibits, Financial Statement Schedules 92

Signatures

Signatures 102 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS The following discussion and analysis should be read in conjunction with our audited consolidated financial statements and the related notes that appear elsewhere in this Annual Report on Form 10-K. This Annual Report on Form 10-K contains "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, particularly in Part I, Item 1: "Business," Part I, Item 1A: "Risk Factors" and Part 2, Item 7: "Management's Discussion and Analysis of Financial Condition and Results of Operations." These statements are often identified by the use of words such as "may," "will," "expect," "believe," "anticipate," "intend," "could," "should," "estimate," "plan" or "continue," and similar expressions or variations. All statements other than statements of historical fact could be deemed forward-looking, including, but not limited to: any statements regarding the timing of any regulatory process or ultimate approvals and determining a path forward for DCCR (Diazoxide Choline) Extended-Release tablets for the treatment of Prader-Willi syndrome; any projections of financial information; any statements about historical results that may suggest trends for our business; any statements of the plans, strategies, and objectives of management for future operations; any statements of expectation or belief regarding future events, technology developments, our products, product sales, expenses, liquidity, cash flow, market growth rates or enforceability of our intellectual property rights and related litigation expenses; and any statements of assumptions underlying any of the foregoing. Such forward-looking statements are subject to risks, uncertainties and other factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. Accordingly, we caution yo

B USINESS

ITEM 1. B USINESS Company Overview We are focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. Our lead candidate, DCCR (Diazoxide Choline) Extended-Release tablets, is a potent ATP-sensitive potassium (K ATP ) channel activator. The K ATP channel plays a central role in the regulation of a number of physiological processes which may otherwise be dysregulated, contributing to the pathophysiology of several diseases. In the context of the underlying genetic or structural defects in many forms of hyperphagic obesity, including Prader-Willi syndrome (PWS), these pathophysiological processes may cumulatively contribute to increases in appetite and aggressive food seeking, lack of satiety, accumulation of excess body fat and the establishment and perpetuation of the obese state. DCCR's unique mode of action with targets in the brain, pancreas and fat tissue has the potential to broadly impact complex diseases like PWS to reduce appetite, reduce food seeking, improve satiety, improve insulin and leptin resistance and reduce body fat. It appears that many of the problematic behaviors in conditions like PWS may have hyperphagic drive as a root cause and may therefore be improved by addressing hyperphagia. We have a Fast-Track designation for DCCR in PWS and orphan designation for the drug in the United States (U.S.) and European Union (E.U.). DCCR has been evaluated in a Phase 3 study (C601 or DESTINY PWS), a 13-week randomized, double-blind placebo-controlled study, which completed enrollment in January 2020, with 127 randomized participants at 29 sites in the U.S. and United Kingdom (U.K.). Participants who completed DESTINY PWS and sought continued treatment with DCCR were eligible to receive DCCR in a long-term open-label safety extension study (C602). Top line results from DESTINY PWS were announced in June 2020. Although the trial did not meet its primary endpoint of change from baseline in hyperphagia, sig

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