FALSE000137832500013783252026-08-132026-08-13
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 13, 2026
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CapsoVision, Inc.
(Exact name of registrant as specified in its charter)
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| Delaware | | 001-42705 | | 20-3369494 |
(State or other jurisdiction of incorporation) | | (Commission File Number) | | (IRS Employer Identification Number) |
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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:
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| o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| o | Pre-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:
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| Title of each class | | Trading Symbol | | Name of each exchange on which registered |
| common stock, $0.001 par value per share | | CV | | The 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 1.01. Entry into a Material Definitive Agreement.
On August 13, 2026, CapsoVision, Inc. (the “Company”) entered into a Controlled Equity OfferingSM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”) with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $0.001 per share (the “Common Stock”), having an aggregate offering price of up to $100,000,000 (the “Shares”) through or to Cantor as its “sales agent” or principal (the “Agent”).
Under the Sales Agreement, the Company will set the parameters for the sale of Shares, including the number of Shares to be issued, the time period during which sales are requested to be made, limitations on the number of Shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms of the Sales Agreement, the Agent may sell the Shares by any method that is deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act, including without limitation sales made directly on The Nasdaq Capital Market (“Nasdaq”) or any other trading market for the Shares.
The Company is not obligated to sell any Shares under the Sales Agreement. The Company or the Agent may suspend or terminate the offering of Shares upon notice to the other party and subject to other conditions. The Agent will act as sales agent on a commercially reasonable efforts basis consistent with its normal trading and sales practices and applicable state and federal law, rules and regulations and the rules of Nasdaq.
The Company will pay the Agent a cash commission equal to up to 3.0% of the gross sales proceeds of any Shares sold through the Agent under the Sales Agreement, and has provided the Agent with customary indemnification and contribution rights.
The Sales Agreement will terminate upon the earlier of (i) the sale of all Shares subject to the Sales Agreement or (ii) termination of the Sales Agreement in accordance with the terms and conditions set forth therein.
The Company intends to file a Registration Statement on Form S-3, including an “at-the-market offering” prospectus supplement relating to the offer and sale of the Shares, pursuant to which the shares to be offered and sold under the Sales Agreement will be issued and sold, and will file a Current Report on Form 8-K relating to it shortly.
Item 2.02. Results of Operations and Financial Condition.
On August 13, 2026, the Company issued a press release announcing its financial results for the fiscal quarter ended June 30, 2026. A copy of the press release, dated August 13, 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:
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Exhibit No. | | Description |
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| 10.1* | | Controlled Equity OfferingSM Sales Agreement, dated August 13, 2026, by and between CapsoVision, Inc. and Cantor Fitzgerald & Co. |
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| 99.1 | | Press Release of CapsoVision, Inc, dated August 13, 2026. |
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| 104 | | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
* Certain personally identifiable information of this exhibit has been omitted pursuant to Item 601(a)(6) of Regulation S-K.
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.
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| CAPSOVISION, INC. |
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| Date: August 13, 2026 | By: | /s/ Kang-Huai (Johnny) Wang |
| Name: | Kang-Huai (Johnny) Wang |
| Title | Director, President and Chief Executive Officer |
Exhibit 99.1
CapsoVision Reports Second Quarter 2026 Financial Results
SARATOGA, Calif., August 13, 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 second quarter ended June 30, 2026.
Recent Highlights
•Reported second quarter 2026 revenue was $3.6 million, up 10% year over year.
•CapsoCam Plus® used by over 176,000 patients as of June 30, 2026.
•Launched AI Highlights™, the AI-assisted reading feature for CapsoCam Plus®, commercially in the European Union and other international markets to support physician review of small bowel capsule endoscopy studies using the CapsoCam Plus® system.
•Anticipate FDA clearance of AI Highlights™ by the end of the third quarter of 2026, with U.S. commercial launch expected shortly thereafter.
•Continued commercial momentum with expanding adoption across large hospital systems and GI networks, including key customer renewals and growing traction with new customers.
•Pipeline continues to advance with CapsoCam Colon™ on track for 510(k) submission in the fourth quarter of 2026, with ongoing enrollment in the CapsoCam UGI clinical study for pancreatic cancer detection.
•Appointed David S. Shields, M.D., to the Board of Directors, effective July 1, 2026.
•Entered into a sales agreement of up to $100 million providing for an at-the-market equity offering program with Cantor.
Management Commentary
"The second quarter marked another important step in the evolution of CapsoVision as we advanced both our commercial execution and product innovation. We were pleased to launch AI Highlights™ internationally, providing physicians in Europe with an AI-assisted workflow solution that complements our CapsoCam Plus® platform and reinforces our long-term vision of integrated, AI-enabled capsule endoscopy," said Johnny Wang, President and Chief Executive Officer of CapsoVision.
"Commercially, we continue to see encouraging momentum across our business. Revenue growth was in line with our expectations, hospital network adoption continues to expand, and we are adding new customers who recognize the value of our panoramic capsule platform. We also continue to hear strong interest from customers awaiting the U.S. launch of AI Highlights™, which we now anticipate following FDA clearance expected this fall. As we look toward the second half of the year, we remain focused on executing against our commercial strategy while advancing our broader product pipeline."
Second Quarter 2026 Financial Results
Total revenue was $3.6 million compared to $3.3 million in the second quarter of 2025. The primary driver for the revenue growth was a 13% increase in the number of CapsoCam Plus capsules sold offset by a period-over-period decrease of approximately 3% in the average selling price.
Gross profit was 1.9 million, an increase of $0.1 million, or 3% compared to the second quarter of 2025. Gross margin was 51%, compared to 55% in the second quarter of 2025. The decrease was due to a pressure on selling prices we have when operating in a highly competitive market and changes the U.S. government made to the trade policies and tariffs at the beginning of the year resulting in an increase in expenses for customs and tariffs.
Operating expenses were $9.5 million, a $3.0 million increase from the second quarter of 2025, driven primarily by expenses associated with the colon pivotal study and other clinical trials, non-recurring engineering services for the Canon development project, expenses for operating as a public company, and stock-based compensation.
Cash and cash equivalents totaled $9.1 million as of June 30, 2026.
Conference Call and Webcast
CapsoVision will host a conference call today, August 13, 2026, at 4:30 p.m. ET to discuss its second 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 9178774, 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 retrieval. 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 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 anticipated timing of FDA clearance of AI Highlights™ and its subsequent U.S. commercial launch, the continued development and anticipated 510(k) submission for CapsoCam Colon™, and 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), 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)
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| June 30, 2026 | | December 31, 2025 |
| ASSETS | | | |
| Current Assets | | | |
| Cash and cash equivalents | $ | 9,077 | | | $ | 10,112 | |
| Accounts receivable, net | 2,265 | | | 2,498 | |
| Inventory | 4,704 | | | 2,987 | |
| Prepaid expenses and other current assets | 1,234 | | | 1,072 | |
| Total current assets | 17,280 | | | 16,669 | |
| Property and equipment, net | 562 | | | 611 | |
| Operating lease right-of-use assets | 651 | | | 843 | |
| Other long-term assets | 76 | | | 41 | |
| TOTAL ASSETS | $ | 18,569 | | | $ | 18,164 | |
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| LIABILITIES AND STOCKHOLDERS’ EQUITY | | | |
| Current Liabilities | | | |
| Accounts payable | $ | 475 | | | $ | 1,143 | |
| Accrued expenses and other current liabilities | 4,101 | | | 2,697 | |
| Deferred revenue | 140 | | | 177 | |
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| Operating lease liabilities – current | 442 | | | 410 | |
| Total current liabilities | 5,158 | | | 4,427 | |
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| Operating lease liabilities – long-term | 245 | | | 477 | |
| Total liabilities | 5,403 | | | 4,904 | |
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| Commitments and contingencies - Note 8 | | | |
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| Stockholders’ Equity | | | |
Preferred stock, $0.001 par value: 10,000,000 shares authorized and none issued and outstanding as of June 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 June 30, 2026; 50,032,148 and 46,865,051 issued and outstanding as of June 30, 2026 and December 31, 2025, respectively | 50 | | | 47 | |
| Additional paid-in capital | 183,295 | | | 168,878 | |
| Accumulated deficit | (170,179) | | | (155,665) | |
| Total stockholders’ equity | 13,166 | | | 13,260 | |
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 18,569 | | | $ | 18,164 | |
CAPSOVISION, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
(in thousands, except share and per-share amounts)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2026 | | 2025 | | 2026 | | 2025 |
| | | | | | | |
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| Net revenue | $ | 3,643 | | | $ | 3,315 | | | $ | 6,435 | | | $ | 6,098 | |
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| Costs of revenue | 1,772 | | | 1,504 | | | $ | 3,235 | | | $ | 2,793 | |
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| Gross profit | 1,871 | | | 1,811 | | — | | 3,200 | | | 3,305 | |
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| OPERATING EXPENSES | | | | | | | |
| Selling and marketing | 1,936 | | | 1,847 | | | 4,027 | | | 3,808 | |
| Research and development | 5,309 | | | 3,392 | | | 9,744 | | | 6,499 | |
| General and administrative | 2,206 | | | 1,223 | | | 4,102 | | | 3,031 | |
| Total operating expenses | 9,451 | | | 6,462 | | | 17,873 | | | 13,338 | |
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| Operating loss | (7,580) | | | (4,651) | | | (14,673) | | | (10,033) | |
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| NON-OPERATING INCOME | | | | | | | |
| Interest income, net | 82 | | | 37 | | | 141 | | | 43 | |
| Other non-operating income (expense), net | 17 | | | (11) | | | 18 | | | (10) | |
| Total non-operating income, net | 99 | | | 26 | | | 159 | | | 33 | |
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| Loss before income taxes | (7,481) | | | (4,625) | | | (14,514) | | | (10,000) | |
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| Provision for income taxes | — | | | — | | | — | | | — | |
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| Net loss and comprehensive loss | $ | (7,481) | | | $ | (4,625) | | | $ | (14,514) | | | $ | (10,000) | |
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| Net loss per share – basic and diluted | $ | (0.15) | | | $ | (2.02) | | | $ | (0.30) | | | $ | (4.49) | |
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| Weighted average common shares outstanding – basic and diluted | 49,937,525 | | | 2,292,230 | | | 48,704,069 | | | 2,225,301 | |
CAPSOVISION, INC.
CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED)
(in thousands)
| | | | | | | | | | | |
| Six Months Ended June 30, |
| 2026 | | 2025 |
| CASH FLOWS FROM OPERATING ACTIVITIES | | | |
| Net loss | $ | (14,514) | | | $ | (10,000) | |
| Adjustments to reconcile net loss to net cash used in operating activities: | | | |
| Depreciation and amortization | 114 | | | 107 | |
| Loss on disposal of property and equipment | — | | | — | |
| Amortization of operating lease right-of-use assets | 192 | | | 171 | |
| Unrealized foreign exchange losses (gains) | 15 | | | (158) | |
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| Stock-based compensation | 911 | | | 322 | |
| Bad debt expense | — | | | 11 | |
| Changes in operating assets and liabilities: | | | |
| Accounts receivable | 245 | | | 167 | |
| Inventory | (1,717) | | | (413) | |
| Prepaid expenses and other current assets | (162) | | | (939) | |
| Other long-term assets | (35) | | | — | |
| Accounts payable | (685) | | | 408 | |
| Accrued expenses and other current liabilities | 1,404 | | | 1,019 | |
| Deferred revenue | (37) | | | (35) | |
| Operating lease liabilities | (200) | | | (172) | |
| Net cash used in operating activities | $ | (14,469) | | | $ | (9,512) | |
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| CASH FLOWS FROM INVESTING ACTIVITIES | | | |
| Purchases of property and equipment | (48) | | | (70) | |
| Net cash used in investing activities | $ | (48) | | | $ | (70) | |
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| CASH FLOWS FROM FINANCING ACTIVITIES | | | |
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| Proceeds from promissory note issuance | — | | | 1,000 | |
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| Proceeds from Private Placement | 14,000 | | | — | |
| Payment of Private Placement issuance costs | (600) | | | — | |
| Payment of constructive dividend | (12) | | | — | |
| Proceeds from exercises of options on common stock and warrants | 121 | | | 202 | |
| Net cash provided by financing activities | $ | 13,509 | | | $ | 1,202 | |
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| Net decrease in cash and cash equivalents | (1,008) | | | (8,380) | |
| Effect of exchange rate changes on cash and cash equivalents | (27) | | | 127 | |
| Cash and cash equivalents at beginning of period | 10,112 | | | 9,319 | |
| Cash and cash equivalents at end of period | $ | 9,077 | | | $ | 1,066 | |
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| SUPPLEMENTAL CASH FLOW DISCLOSURES | | | |
| Cash paid for income taxes | $ | 11 | | | $ | 7 | |
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