STOCK TITAN

CapsoVision Q3 2026 loss narrows to $7.34M

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(High)

Sentiment and the balance of points

Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.

Form Type
8-K

Rhea-AI Filing Summary

CapsoVision, Inc. reported third-quarter 2026 revenue of $3.568 million, versus $3.538 million a year earlier, and a net loss of $7.339 million, compared with $7.921 million. Gross margin was 49%, versus 54%; higher flash-memory costs, a one-time inventory obsolescence charge and higher stock-based compensation contributed to the decline. Operating expenses were $9.148 million, compared with $9.933 million. Cash and cash equivalents were $21.757 million as of September 30, 2026.

AI Highlights received FDA clearance on September 25 and launched in the U.S. on November 2 for adults and children aged two and older; CapsoVision expects it to accelerate CapsoCam Plus sales growth, with full commercial impact anticipated in 2027. Enrollment and data collection in the second-generation CapsoCam Colon study are complete, with a 510(k) submission on track for year-end 2026. CapsoVision completed an $18 million registered direct offering generating approximately $17.8 million net and raised approximately $1.7 million net through its at-the-market program. Nine-month net cash used in operating activities was $21.511 million, versus $15.178 million a year earlier.

1 point · 0 major

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Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

0 major · 2 points

How the balance works

Positive

  • Moderate pointThird-quarter net loss narrowed to $7.339 million from $7.921 million.

Negative

  • Moderate pointThird-quarter gross profit fell to $1.764 million from $1.914 million.
  • Moderate pointNine-month operating cash used was $21.511 million, versus $15.178 million.

Filing Explained

The balance sheet records 53,569,896 common shares issued and outstanding at September 30, 2026, versus 46,865,051 at December 31, 2025; with the total count higher, a holder retaining the same number of shares has a smaller ownership percentage, absent offsetting changes.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Revenue $3.568 million Three months ended September 30, 2026; $3.538 million in the same 2025 period
Gross profit $1.764 million Three months ended September 30, 2026; $1.914 million in the same 2025 period
Gross margin 49% Three months ended September 30, 2026; 54% in the same 2025 period
Operating expenses $9.148 million Three months ended September 30, 2026; $9.933 million in the same 2025 period
Net loss $7.339 million Three months ended September 30, 2026; $7.921 million in the same 2025 period
Net loss per share $0.15 per share Three months ended September 30, 2026; $0.17 per share in the same 2025 period
Cash and cash equivalents $21.757 million As of September 30, 2026
Net cash used in operating activities $21.511 million Nine months ended September 30, 2026; $15.178 million in the same 2025 period
510(k) submission regulatory
"FDA 510(k) submission remains on track for year-end 2026"
A 510(k) submission is a regulatory packet sent to the U.S. Food and Drug Administration showing a medical device is substantially similar to an already-allowed device so it can be marketed without a full, new safety review. For investors, clearance via 510(k) cuts time and cost to bring a device to market and reduces regulatory risk—think of it as proving a new model is close enough to a trusted one to sell it more quickly.
FDA clearance regulatory
"Received FDA clearance for AI Highlights"
FDA clearance is the U.S. Food and Drug Administration’s official permission to market certain medical devices or diagnostic tests after reviewing evidence that they are as safe and effective as similar products already on the market. For investors, it’s like a product passing a required safety inspection — it reduces regulatory uncertainty, speeds commercial rollout, and can directly affect sales prospects, valuation, and partnership opportunities.
registered direct offering financial
"Completed an $18 million registered direct offering"
A registered direct offering is a way for a company to sell new shares of its stock directly to select investors with regulatory approval. This method allows the company to raise funds quickly and efficiently without needing a public auction, similar to offering exclusive access to a limited number of buyers. For investors, it often provides an opportunity to purchase shares at a favorable price, while giving the company immediate access to capital.
at-the-market offering program financial
"Raised approximately $1.7 million in net proceeds through the at-the-market offering program"
An at-the-market offering program lets a company sell newly issued shares directly into the open market at current trading prices through a broker, rather than issuing a large block of stock all at once. It matters to investors because it provides the company a flexible way to raise cash over time, which can dilute existing shares gradually and affect earnings per share and stock price depending on how much and when shares are sold—think of it as a faucet the company can open or close to add supply to the market.
gross margin financial
"Gross margin was 49%, compared to 54%"
Gross margin is the difference between how much money a company makes from selling its products and how much it costs to produce them, expressed as a percentage of sales. It shows how efficiently a company is turning sales into profit before other expenses like marketing or salaries. Higher gross margin means the company keeps more money from each sale, which is a good sign of financial health.
pancreatic ductal adenocarcinoma (PDAC) medical
"expertise in pancreatic ductal adenocarcinoma (PDAC)"
Pancreatic ductal adenocarcinoma (PDAC) is the most common form of pancreatic cancer, arising in the cells that line the small ducts which carry digestive juices. It behaves aggressively and is often diagnosed late, like a clogged pipe that causes widespread damage before it’s noticed. For investors, PDAC matters because its poor prognosis and limited approved treatments create a large unmet medical need—meaning successful new therapies can bring significant returns but carry high clinical and regulatory risk.
Revenue $3.568 million Compared with $3.538 million in the third quarter of 2025
Gross profit $1.764 million Compared with $1.914 million in the third quarter of 2025
Gross margin 49% Compared with 54% in the third quarter of 2025
Operating expenses $9.148 million Compared with $9.933 million in the third quarter of 2025
Net loss $7.339 million Compared with $7.921 million in the third quarter of 2025
Net loss per share $0.15 per share Compared with $0.17 per share in the third quarter of 2025
Cash and cash equivalents $21.757 million As of September 30, 2026
Net cash used in operating activities $21.511 million Compared with $15.178 million in the nine months ended September 30, 2025
Guidance

CapsoVision expects AI Highlights to accelerate CapsoCam Plus sales growth, with its full commercial impact anticipated in 2027. Related clinical expenses are expected to decline following completion of the CapsoCam Colon study.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were CapsoVision (CV)'s Q3 2026 revenue and net loss?

Revenue was $3.568 million and net loss was $7.339 million for the quarter ended September 30, 2026; the comparable 2025 figures were $3.538 million and $7.921 million.

When did CapsoVision (CV) launch AI Highlights, and who can use it?

AI Highlights received FDA clearance on September 25, 2026, and launched commercially in the U.S. on November 2, 2026. It is available for adults and pediatric patients aged two and older, through local computer and cloud-based platforms.

What is the status of CapsoVision's (CV) CapsoCam Colon study?

Enrollment and clinical data collection for the second-generation CapsoCam Colon study are complete. The study included physician review of capsule videos both with and without AI assistance, and the company said its FDA 510(k) submission remained on track for year-end 2026.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FALSE000137832500013783252026-11-122026-11-12

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_________________________
FORM 8-K
_________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 12, 2026
_________________________
CapsoVision, Inc.
(Exact name of registrant as specified in its charter)
_________________________
Delaware001-4270520-3369494
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification Number)
18805 Cox Avenue, Suite 250
Saratoga, California
95070
(Address of Principal Executive Offices)(Zip Code)
Registrant’s telephone number, including area code: (408)-624-1488
n/a
(Former Name or Former Address, if Changed Since Last Report)
_________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
oPre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading
Symbol
Name of each exchange
on which registered
common stock, $0.001 par value per shareCVThe Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐



Item 2.02.           Results of Operations and Financial Condition.
On November 12, 2026, the Company issued a press release announcing its financial results for the fiscal quarter ended September 30, 2026. A copy of the press release, dated November 12, 2026, is furnished hereto as Exhibit 99.1 and is incorporated herein by reference.
The foregoing information in this Item 2.02 (including the exhibit hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 9.01           Financial Statements and Exhibits.
The following exhibits are being filed herewith:
Exhibit
No.
Description
99.1
Press Release of CapsoVision, Inc, dated November 12, 2026.
104Cover Page Interactive Data File (embedded within the Inline XBRL document)







SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
CAPSOVISION, INC.
Date: November 12, 2026By:/s/ Kang-Huai (Johnny) Wang
Name:Kang-Huai (Johnny) Wang
TitleDirector, President and Chief Executive Officer


Exhibit 99.1
logoa.jpg
CapsoVision Reports Third Quarter 2026 Financial Results
SARATOGA, Calif., November 12, 2026 - CapsoVision, Inc. (NASDAQ: CV), a commercial-stage medical technology company developing advanced imaging and AI-enabled capsule endoscopy solutions, today reported financial results and provided a business update for its third quarter ended September 30, 2026.
Recent Highlights
•Reported third quarter 2026 revenue of $3.6 million, compared with $3.5 million in the third quarter 2025.
•CapsoCam Plus® used by more than 184,000 patients worldwide as of September 30, 2026, compared with 151,000 a year earlier.
•Received FDA clearance for AI Highlights™, the Company’s AI-assisted reading tool for CapsoCam Plus®, on September 25, 2026, followed by its U.S. commercial launch on November 2, 2026. Available for both adults and pediatric patients aged two and older, AI Highlights supports physician review through both local computer and cloud-based platforms. The Company expects the addition of AI Highlights to accelerate CapsoCam Plus sales growth, with the full commercial impact anticipated in 2027.
•Completed enrollment and clinical data collection for the second-generation CapsoCam Colon™ study, including physician review of capsule videos both with and without AI assistance. FDA 510(k) submission remains on track for year-end 2026.
•Continued expanding the clinical footprint of the CapsoCam UGI study for pancreatic cancer detection. Building on two active community-based clinical sites, the Company has executed a clinical trial agreement with a third site and is in various stages of contracting and feasibility discussions with more than a dozen larger medical centers with expertise in pancreatic ductal adenocarcinoma (PDAC), which the Company expects will help accelerate patient enrollment.
•Completed an $18 million registered direct offering with existing shareholders in September 2026, generating approximately $17.8 million in net proceeds.
•Raised approximately $1.7 million in net proceeds through the at-the-market offering program during the third quarter of 2026.
•Appointed David S. Shields, M.D., to the Board of Directors effective July 1, 2026.
Management Commentary
"The FDA clearance and subsequent U.S. launch of AI Highlights marks an important step forward for CapsoVision,” said Johnny Wang, President and Chief Executive Officer. “Our four-camera, 360-degree panoramic capsule already provides physicians with a differentiated view of the small bowel. By combining that imaging capability with AI-assisted review, we believe we can reduce reading time, improve detection accuracy compared with manual review, and give physicians an additional level of diagnostic confidence. We believe the combination of panoramic imaging and FDA-cleared AI-assisted review, approved for use in patients two years and older is a meaningful differentiator for CapsoCam Plus.
At the same time, completing enrollment in our colon clinical study brings us closer to our planned FDA submission by year end, which we believe represents a substantially larger market opportunity. With the support of our existing shareholders through our recent financing, we are focused on translating these milestones into broader adoption and long-term growth,” concluded Wang.




Third Quarter 2026 Financial Results
Total revenue was $3.6 million compared to $3.5 million in the third quarter of 2025. Average selling price was stable year over year. The Company expects the addition of AI Highlights, launched on November 2, 2026, following FDA clearance, to accelerate CapsoCam Plus sales growth, with the full commercial impact anticipated in 2027.

Gross profit was $1.8 million, compared with $1.9 million in the third quarter of 2025. Gross margin was 49%, compared to 54% in the third quarter of 2025. The decline primarily reflected higher material costs associated with increased flash memory prices, a one-time inventory obsolescence charge, and higher stock-based compensation expense.

Operating expenses decreased to $9.1 million, from $9.9 million in the third quarter of 2025, reflecting continued expense management while supporting clinical and development programs, including the CapsoCam Colon pivotal study. With the study now complete, the Company expects related clinical expenses to decline while it continues advancing its development pipeline.
Net loss was $7.3 million, or $0.15 per share, compared with a net loss of $7.9 million, or $0.17 per share, in the third quarter of 2025.
Cash and cash equivalents totaled $21.8 million as of September 30, 2026. During September, the Company completed an $18 million registered direct offering with existing shareholders, generating approximately $17.8 million in net proceeds. The Company also sold 276,446 shares through its at-the-market offering program during the quarter for approximately $1.7 million in net proceeds.

Conference Call and Webcast
CapsoVision will host a conference call today, November 12, 2026, at 4:30 p.m. ET to discuss its third quarter financial results. Individuals interested in listening to the conference call may do so by dialing (800) 715-9871 for domestic callers or (646) 307-1963 for international callers and referencing conference ID 2841803, or from the webcast link on the Events page in the investor relations section of the company's website at www.capsovision.com.
To access the replay, please register via the webcast link on the Events page. The webcast will be available for one year following the completion of the call.
About CapsoVision
CapsoVision is a commercial-stage medical technology company focused on developing advanced imaging and AI-enabled solutions to transform the detection and screening of gastrointestinal diseases. Its flagship product, CapsoCam Plus®, is a wire-free, panoramic capsule endoscope that enables high-resolution visualization of the small bowel and supports cloud-based or direct capsule video review. The Company’s next pipeline product, CapsoCam Colon™ with enhanced AI, is designed to enable non-invasive colon imaging and polyp detection. With a proprietary platform targeted to expand across multiple GI indications, including esophageal and pancreatic disorders, CapsoVision is advancing a new era in capsule-based diagnostics. For more information on CapsoVision, please visit www.capsovision.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In this context, forward-looking statements mean statements related to future events, which may impact our expected future business and financial performance, and often contain words such as “expected”, “positioned”, “on track”, “anticipate(s)”, “intend(s)”, “plan(s)”, “believe(s)”, “potential”, “will”, “should”, “could”, “would”, “may”, “continue”, “remain”, “advancing”, “approach(ing)”, “planned”, “look forward”, or “target(ed)” and other words of similar meaning. Examples of these forward-looking statements include, but are not limited to, statements concerning possible or assumed future results of operations and financial position, including the Company’s expectations regarding sales growth of CapsoCam Plus® and the timing thereof, the Company’s expectations regarding clinical and other operating expenses, the Company’s product and clinical development efforts, the timing and receipt of regulatory submissions and approvals , the Company’s plans, strategies and timing for its pipeline development (including the commercialization, physician adoption



and anticipated benefits of AI Highlights™, the continued development and anticipated 510(k) submission for CapsoCam Colon™, and the market opportunity for CapsoCam Colon™, the clinical study for CapsoCam® UGI in pancreatic cancer detection) and the success of the Company’s plans and strategies. These forward-looking statements are based on the Company’s current expectations and inherently involve significant risks and uncertainties, including those beyond the Company’s control. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, market conditions (including competition in the capsule endoscopy market, including from competitors with FDA-cleared AI products), the Company’s financial condition and the availability of cash and financing (including through the Company’s at-the-market equity offering program), the success of the Company’s product and clinical development efforts, the failure to receive regulatory clearance or approval, changes in U.S. trade policies, tariffs or other government regulations that could increase the Company’s costs or affect the Company’s supply chain, and the failure to adapt the Company’s products for new indications. These and other risks and uncertainties are described more fully in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of the Company’s most recent Form 10-K and Form 10-Q. Forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update or revise these statements, except as required by law.
Investor Relations Contact
Leigh Salvo
New Street Investor Relations
Investors@CapsoVision.com
Media Contact
Leslie Strickler and Paul Spicer
Être Communications
leslies@etrecommunications.com | (804) 240-0807
pauls@etrecommunications.com | (804) 503-9231



CAPSOVISION, INC.
CONDENSED BALANCE SHEETS (UNAUDITED)
(in thousands, except par value and share amounts)

September 30, 2026December 31, 2025
ASSETS
Current Assets
Cash and cash equivalents$21,757 $10,112 
Accounts receivable, net2,456 2,498 
Inventory4,747 2,987 
Prepaid expenses and other current assets2,086 1,072 
Total current assets31,046 16,669 
Property and equipment, net508 611 
Operating lease right-of-use assets747 843 
Other long-term assets451 41 
TOTAL ASSETS$32,752 $18,164 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities
Accounts payable$1,102 $1,143 
Accrued expenses and other current liabilities4,355 2,697 
Deferred revenue146 177 
Operating lease liabilities – current521 410 
Total current liabilities6,124 4,427 
Operating lease liabilities – long-term259 477 
Total liabilities6,383 4,904 
Commitments and contingencies - Note 8
Stockholders’ Equity
Preferred stock, $0.001 par value: 10,000,000 shares authorized and none issued and outstanding as of September 30, 2026; 10,000,000 shares authorized and none issued and outstanding as of December 31, 2025
— — 
Common stock, $0.001 par value: 300,000,000 shares authorized as of September 30, 2026; 53,569,896 and 46,865,051 issued and outstanding as of September 30, 2026 and December 31, 2025, respectively
54 47 
Additional paid-in capital203,833 168,878 
Accumulated deficit(177,518)(155,665)
Total stockholders’ equity26,369 13,260 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY$32,752 $18,164 


CAPSOVISION, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
(in thousands, except share and per-share amounts)
Three Months Ended September 30,
Nine Months Ended September 30,
2026202520262025
Net revenue$3,568 $3,538 $10,003 $9,636 
Costs of revenue1,804 1,624 5,039 4,417 
Gross profit1,764 1,914 — 4,964 5,219 
OPERATING EXPENSES
Selling and marketing2,060 1,773 6,087 5,581 
Research and development4,803 6,090 14,547 12,589 
General and administrative2,285 2,070 6,387 5,101 
Total operating expenses9,148 9,933 27,021 23,271 
Operating loss(7,384)(8,019)(22,057)(18,052)
NON-OPERATING INCOME
Interest income, net46 132 187 175 
Other non-operating income (expense), net(1)(34)17 (44)
Total non-operating income, net45 98 204 131 
Loss before income taxes(7,339)(7,921)(21,853)(17,921)
Provision for income taxes— — — — 
Net loss and comprehensive loss$(7,339)$(7,921)$(21,853)$(17,921)
Net loss per share – basic and diluted $(0.15)$(0.17)$(0.44)$(1.05)
Weighted average common shares outstanding – basic and diluted50,568,141 46,217,127 49,332,254 17,049,671 


CAPSOVISION, INC.
CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED)
(in thousands)
Nine Months Ended September 30,
20262025
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss$(21,853)$(17,921)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization173 161 
Loss on disposal of property and equipment— 1 
Amortization of operating lease right-of-use assets307 260 
Unrealized foreign exchange losses (gains)57 (170)
Stock in lieu of debt repayment— 31 
Stock-based compensation1,863 629 
Bad debt expense10 11 
Changes in operating assets and liabilities:
Accounts receivable10 151 
Inventory(1,760)(558)
Prepaid expenses and other current assets(1,014)(303)
Other long-term assets(410)— 
Accounts payable(203)596 
Accrued expenses and other current liabilities1,658 2,220 
Deferred revenue(31)(26)
Operating lease liabilities(318)(260)
Net cash used in operating activities$(21,511)$(15,178)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of property and equipment(70)(82)
Net cash used in investing activities $(70)$(82)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from IPO, net of commissions— 26,557 
Payment of IPO offering costs
— (3,184)
Repayment of promissory note— (1,000)
Proceeds from Private Placement14,000 — 
Payment of Private Placement issuance costs(601)— 
Proceeds from ATM Program, net of issuance costs1,710 — 
Proceeds from Securities Purchase Agreement18,000 — 
Payment of constructive dividend(12)— 
Proceeds from promissory note issuance— 1,000 
Proceeds from exercises of options on common stock and warrants164 216 
Net cash provided by financing activities$33,261 $23,589 
Net increase in cash and cash equivalents11,680 8,329 
Effect of exchange rate changes on cash and cash equivalents(35)139 
Cash and cash equivalents at beginning of period10,112 9,319 
Cash and cash equivalents at end of period$21,757 $17,787 


CAPSOVISION, INC.
CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED)
(in thousands)
SUPPLEMENTAL CASH FLOW DISCLOSURES
Cash paid for income taxes$10 $7 
Cash paid for interest— 15 
NON-CASH FINANCING AND INVESTING ACTIVITIES
Obtaining a right-of-use asset in exchange for a lease liability211 — 
Underwriters warrants issued in connection with the IPO— 519 
Conversion of convertible preferred stock into common stock upon initial public offering— 143,625 
Securities Purchase Agreement issuance costs in accounts payable162 — 

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