CapsoVision, Inc (CV) SEC Filings & Earnings Calls

Dilution from issuance of 3.16M shares; offering at 5% discount to market price.

“issuance and sale of an aggregate of 3,163,444 shares at a purchase price of $5.69 per share”

Dilution risk for existing shareholders.

“ATM offering of up to $100M could dilute existing shareholders.”

Going concern risk

“Our Quarterly Report, our unaudited financial statements for the six months ended June 30, 2026 and our audited financial statements for the year ended December 31, 2025 include a footnote raising substantial doubt about our ability to continue as a going concern” · word for word

FDA clearance delay risk

“We may not obtain or may experience delays in obtaining 510(k) clearance for our planned second generation of our CapsoCam Colon solution” · word for word

Supply chain disruption risk

“Our major assembly manufacturers are located in Taiwan. Most of our single-source suppliers of critical components of our products are located primarily in Taiwan and Japan.” · word for word

Cash burn and low cash position relative to operating expenses; reliance on ATM for funding.

“Cash $9.1M vs operating expenses $9.5M per quarter; ATM program of up to $100M.”

Gross margin pressure from pricing competition and tariffs.

“Gross margin declined from 55% to 51% due to pricing pressure and tariff costs.”

No material financial or operational risks disclosed in this filing.

“Filing is a routine board change; no risk factors discussed.”

Going Concern Risk

“The Company, having evaluated the extant facts and circumstances, concluded that the facts and circumstances raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date of issuance of these financial statements.” · word for word

Tariff Cost Pressure

“The increased costs of revenue was attributable to increased customs and tariffs due to the change in U.S. customs policy.” · word for word

Supply Chain Concentration Risk

“We rely on component suppliers and assembly manufacturers based in Asia (particularly Taiwan and Japan). Critical components found in our CapsoCam capsules include lens modules from Largan, complementary metal oxide semiconductor (“CMOS”) image sensors from Toshiba Corporation (“Toshiba”), and application-specific integrated circuits (“ASICs”) from Moai Elec”

Regulatory Approval Delay Risk

“We may not obtain or may experience delays in obtaining 510(k) clearance for our planned second generation of our CapsoCam Colon solution (with improved optics and other components), which would adversely impact our ability to commercialize this product and generate related revenue.” · word for word

Customer Concentration Risk

“Customer A represented 12% of revenue and 31% of accounts receivable; Customer B represented 10% of revenue and 12% of accounts receivable.”

Gross margin declined due to impact of U.S. trade policies and tariffs.

“Gross margin was 48%, compared to 54% in the first quarter of 2025. The decrease was due to the impact of changes in U.S. trade policies and tariffs.” · word for word

Concentrated insider ownership and related-party transactions

“Two of the Investors, Star One Global Capital Limited (wholly owned by Ching-Hang Shen) and Eliyahou Harari, were beneficial owners of more than 5% of our common stock and are therefore related persons.” · word for word

Operating expenses increased significantly due to R&D and public company costs, pressuring profitability.

“Operating expenses for FY2025 were $32.7 million, a $6.4 million increase compared to FY2024, driven by CMOS sensor development and public company costs.”

Net loss not disclosed; operating loss likely substantial given high expenses relative to revenue.

“Operating expenses $32.7M vs revenue $13.6M; net loss not stated but implied.”

Going Concern Uncertainty

“Our audited financial statements for the years ended December 31, 2025 and December 31, 2024 include a footnote raising substantial doubt about our ability to continue as a 'going concern'.” · word for word

Single-Source Supply Chain

“The critical components of our products, such as lens modules, CMOS image sensors, and ASICs are provided by single-source suppliers.” · word for word

FDA Clearance Delay for CapsoCam Colon

“Based on our communications with the FDA, we have decided not to further pursue the first generation CapsoCam Colon capsule submission and approval.” · word for word

Geopolitical Risk in Taiwan/Japan

“Our major assembly manufacturers are located in Taiwan. Most of our single-source suppliers of critical components of our products are located primarily in Taiwan and Japan.” · word for word

History of Net Losses

“We have incurred net losses since inception, and we expect to incur additional losses in the foreseeable future.” · word for word

Regulatory risk: first-gen CapsoCam Colon 510(k) abandoned; second-gen submission timeline and approval uncertain.

“the Company has decided not to further pursue the first generation CapsoCam Colon capsule submission and approval” · word for word

Dilution risk: ~2.87M new shares issued at a discount, increasing share count and potentially pressuring stock price.

“2,867,089 shares ... at $4.883 per Share, which represents a 5% discount to the March 16th closing price” · word for word

Breakthrough Device Designation denial for pancreatic cancer program; resubmission dependent on study outcomes.

“the application was not approved. The Company expects to resubmit the Breakthrough Device Designation application following the study” · word for word

Going Concern Risk

“The Company, having evaluated the extant facts and circumstances, concluded that the facts and circumstances raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date of issuance of these financial statements.” · word for word

Supply Chain Concentration Risk

“The Company’s supply concentration risk relates primarily to its materials procurement and contract manufacturing being substantially concentrated with vendors located in Asia.” · word for word

Customer Concentration Risk

“For the three and nine months ended September 30, 2025, the same customer represented 10% and 10% of our revenue, respectively, and represented 25% of our accounts receivable as of September 30, 2025.” · word for word

Regulatory Delay Risk

“Based on the FDA comments received so far, we are refining the second arm study. This revision impacts the previous expectation to have the study for the Second-Generation Product ready for FDA submission in the first quarter 2026 and the FDA submission is now planned for the second quarter of 2026.” · word for word

Tariff / Trade Policy Risk

“The U.S. government recently announced changes to its trade policies, including increasing tariffs on imports. Such changes could pose a risk to our business that could affect our revenue, cost of revenue, gross profit, and gross margin.” · word for word

Gross margin decline from 56% to 54% may indicate pricing or cost pressure.

“Gross margin was 54%, compared to 56% in Q3 2024.”

Operating expenses increased significantly due to R&D and public company costs, potentially pressuring profitability.

“Operating expenses were $9.9 million, a $2.5 million increase from Q3 2024.”

Dependence on FDA regulatory approvals for pipeline products (pancreatic cancer, colon capsule) introduces uncertainty.

“Submitted application for Breakthrough Device Designation; colon-capsule program advancing with FDA.”