CapsoVision (NasdaqCM:CV) FY Conference March 23, 2026 01:30 PM ET Company ParticipantsDavid Garcia - Senior VP of FinanceDoug Atkinson - Senior VP of Global SalesJohnny Wang - Co-Founder, President, and CEOConference Call ParticipantsKyle Bauser - Senior Research AnalystKyle BauserMy name is Kyle Bauser, and I'm a Senior Research Analyst with Roth covering the medical device sector. Today we have CapsoVision here for a fireside chat. We are joined by Johnny Wang, Co-founder, President, and CEO, David Garci ...

Securities Purchase Agreement - The Company is entering into a Securities Purchase Agreement with multiple Investors for the sale of shares of its common stock[2]. - The shares being sold have a par value of $0.001 per share, and the total purchase price will be specified in Exhibit A[3]. - The Closing Date for the transaction is set to occur no later than five Business Days after the date of the Agreement[27]. - The Company will issue the Shares in book-entry form, free and clear of all restrictive legends, upon receipt of the Aggregate Purchase Amount[27]. - The Company has confirmed that all issued shares of Common Stock are fully paid and non-assessable, and were issued in compliance with applicable laws[30]. - The Company is relying on the exemption from securities registration under Section 4(a)(2) of the Securities Act for this transaction[3]. - The Registration Rights Agreement will be executed concurrently, providing certain registration rights for the Shares[3]. - The Company has filed all required forms and reports with the SEC, and all SEC Reports complied in all material respects with applicable requirements of the Exchange Act[38]. - The Company acknowledges that the Securities are being offered in a transaction not involving any public offering under the Securities Act[75]. - The Investor understands that the Securities have not been registered under the Securities Act and must continue to be held unless registered or exempt from registration[75]. - The Company must execute and deliver the Registration Rights Agreement to the Investors[104]. - The Agreement constitutes a legal, valid, and binding obligation of the Company, enforceable in accordance with its terms[33]. - The Agreement is governed by the laws of the State of New York, with specific jurisdiction in New York Supreme Court[118]. - The Agreement constitutes the entire agreement between the parties and supersedes all prior agreements[130]. - The Agreement may be executed in multiple counterparts, including electronic signatures[128]. Compliance and Regulatory Matters - There are currently no outstanding rights or obligations to register any of the Company's securities under the Securities Act, except as disclosed in the SEC Reports[31]. - The Company has taken all necessary corporate actions to authorize the issuance and sale of the Securities as outlined in the Transaction Agreements[32]. - The Company is in compliance with all applicable laws and has all required licenses and permits necessary for its operations[43]. - The Company is required to issue a press release or file a Current Report on Form 8-K disclosing all material terms of the transactions within five business days following the agreement date[83]. - The Company has conducted preclinical tests and clinical trials in accordance with applicable laws and regulations, with no material adverse effects reported[54]. - The Company is compliant with anti-bribery and anti-money laundering laws, with no pending actions involving violations of such laws[62]. - The Company has taken reasonable steps to ensure compliance with the Foreign Corrupt Practices Act and related financial recordkeeping requirements[62]. - The Company will take reasonable steps to ensure future compliance with the Sarbanes-Oxley Act of 2002[53]. - There are no outstanding or unresolved comments from the SEC staff regarding the SEC Reports[38]. Financial Statements and Reporting - The consolidated financial statements included in the SEC Reports fairly present the financial position of the Company and have been prepared in accordance with GAAP[39]. - Since December 31, 2025, the Company has conducted its business only in the ordinary course and has not entered into any material transactions not disclosed in the SEC Reports[40]. - The Company has not incurred any material liabilities, contingent or otherwise, except those incurred in the ordinary course of business[39]. - The Company maintains a system of internal control over financial reporting designed to comply with the Exchange Act and provide reasonable assurance regarding the reliability of financial reporting[55]. - There have been no material weaknesses identified in the Company's internal control over financial reporting[56]. Investor Relations and Obligations - The Company agrees to indemnify and hold harmless each Investor from any losses or claims resulting from breaches of representation or warranty under the Transaction Agreements[91]. - The Company will not take any action that would conflict with its obligations to the Investors under the Transaction Agreements[90]. - The Investor has relied solely on independent investigation and SEC Reports in making its decision to purchase the Securities[78]. - Each Investor's obligations are several and not joint, meaning no Investor is responsible for another's obligations[126]. - The Company may request additional information from Investors to evaluate their eligibility to acquire Securities[124]. - Each Investor consents to receive stockholder notices electronically at the provided email address[116]. Conditions Preceding Closing - The Company must perform all material obligations required prior to the Closing Date to fulfill the conditions of the transaction[98]. - The Company must obtain all necessary consents, permits, approvals, registrations, and waivers for the consummation of the purchase and sale of the Securities[99]. - The Company must deliver a legal opinion from O'Melveny & Myers LLP addressing legal matters agreed upon with the Investors[101]. - The Company must provide a compliance certificate confirming the fulfillment of specified conditions at the Closing Date[102]. - The Secretary of the Company must deliver a certificate certifying the Amended and Restated Certificate of Incorporation and Bylaws[103]. - The Common Stock must be listed on a National Exchange without any suspension or trading halt as of the Closing Date[105]. - The Company must receive payment in full for the aggregate purchase price of the Securities being purchased by each Investor at the Closing[107]. - The Company will pay all Transfer Agent fees and taxes related to the delivery of Securities to the Investors[121]. Miscellaneous - The Company has good and marketable title to all real property owned and valid rights to lease or use all other material properties[49]. - The Company carries adequate insurance coverage, and all insurance policies are in full force and effect[51]. - The issued and outstanding shares of Common Stock are registered and listed for trading on Nasdaq under the symbol "CV"[52]. - The Company has not engaged in any actions to stabilize or manipulate the price of its Common Stock[57]. - The Company is not classified as an "investment company" under the U.S. Investment Company Act of 1940[57]. - The Company has not retained any brokers or finders in connection with the transactions contemplated by the Agreement[59]. - There are no undisclosed relationships between the Company and its directors, officers, or significant stakeholders that are required to be described in SEC Reports[63]. - The Company will not disclose the name of any Investor or its Affiliates without prior written consent, except as required by law[83]. - No event should occur that would reasonably be expected to have a Material Adverse Effect since the date of the Agreement[100]. - The terms of the Securities were determined through arm's-length negotiations[133].

Reports Preliminary, Unaudited Fourth-Quarter and Full Year 2025 Financial ResultsSARATOGA, Calif., March 20, 2026 (GLOBE NEWSWIRE) -- CapsoVision, Inc. (the “Company”) (NASDAQ: CV), a commercial-stage medical technology company developing advanced imaging and AI-enabled capsule endoscopy solutions, today announced the closing of a $14 million private placement in public equity financing (the “Private Placement”) pursuant to a securities purchase agreement entered into by the Company with selected accredite ...

Core Viewpoint - CapsoVision, Inc. is set to release its fourth quarter and full year 2025 financial results on March 26, 2026, and will host a conference call to discuss these results and provide a corporate update [1]. Group 1: Financial Results Announcement - The financial results will be announced after the market closes on March 26, 2026 [1]. - A conference call and live webcast will take place at 1:30 pm PT / 4:30 pm ET on the same day [1]. Group 2: Company Overview - CapsoVision is a commercial-stage medical technology company focused on advanced imaging and AI-enabled solutions for gastrointestinal disease detection and screening [3]. - The flagship product, CapsoCam Plus®, is a wire-free, panoramic capsule endoscope that provides high-resolution visualization of the small bowel [3]. - The upcoming product, CapsoCam Colon™, features enhanced AI for non-invasive colon imaging and polyp detection [3]. - The company aims to expand its proprietary platform across multiple gastrointestinal indications, including esophageal and pancreatic disorders [3].

- Company to participate in a fireside chat and 1x1 investor meetings on March 23, 2026 - SARATOGA, Calif., March 09, 2026 (GLOBE NEWSWIRE) -- CapsoVision, Inc. (NASDAQ: CV), a commercial-stage medical technology company developing advanced imaging and AI-enabled capsule endoscopy solutions, today announced that Johnny Wang, President and Chief Executive Officer, David Garcia, Senior Vice President of Finance, and Doug Atkinson, Senior Vice President of Global Sales, will participate in the 38th Annual ROTH ...

Core Insights - CapsoVision, Inc. has submitted a 510(k) application to the FDA for an AI-based reading feature for its CapsoCam Plus capsule endoscopy system, aimed at improving diagnostic accuracy and workflow efficiency for clinicians [1][2] - The company believes that the integration of advanced imaging and AI models positions CapsoCam Plus as a next-generation solution for small bowel diagnostics [2] - Following the announcement, CapsoVision's shares declined by 7.7%, despite a significant increase of 205.4% over the past six months [3][8] Company Developments - The AI feature is designed to enhance the image review process, addressing lengthy review times and variability in diagnosing gastrointestinal diseases [4] - CapsoVision's market capitalization currently stands at $580.39 million [5] - The AI-assisted CapsoCam Plus aims to provide clearer images of the digestive tract, reducing the chance of missed problems and improving the experience for both doctors and patients [9][10] Technological Advancements - The AI-assisted reading module utilizes an in-house image dataset to improve diagnostic accuracy while reducing clinician workload [10] - CapsoVision's fully cloud-based system eliminates the need for on-site servers, lowering costs and maintenance requirements for GI practices [11] Industry Outlook - The capsule endoscopy market is projected to reach $479.13 million by 2025, with a CAGR of 7.95% through 2034, driven by the adoption of minimally invasive diagnostics and AI-enabled image interpretation [12] - Factors such as increasing use of capsule endoscopy in pediatric and geriatric populations and growing clinical trials for oncology screening are expected to contribute to market growth [12] Future Prospects - CapsoVision is also pursuing FDA Breakthrough Device Designation for its CapsoCam UGI capsule, aimed at early detection of pancreatic ductal adenocarcinoma [13] - The company is developing CapsoCam Colon, which will utilize advanced AI for non-invasive imaging of the colon [13]

Group 1 - TEN Holdings Inc. announced a $2.25 million private placement of 991,000 shares at $2.27 per share, resulting in a 17% increase in shares to $1.65 in after-hours trading [1] - Fonar Corp. shares surged 24% to $18.18 after announcing a definitive agreement for a "take private" sale [1] - CapsoVision Inc. submitted its 510(k) application to the FDA for its AI-assisted module for CapsoCam Plus, leading to an 11% decline in shares to $11.58 [1] - Verastem Inc. intends to discontinue the RAMP 203 clinical study in advanced KRAS G12C-mutated non-small cell lung cancer, causing shares to fall 2.7% to $7.55 [1] - Dermata Therapeutics Inc. closed a $12.4 million private placement priced at-the-market under Nasdaq rules, with shares jumping 10.2% to $2.05 in after-hours trading [1]

Core Insights - CapsoVision, Inc. has received FDA 510(k) clearance for its AI-assisted module for CapsoCam Plus, marking a significant step towards commercialization in the U.S. [1] - The CapsoCam Plus system is designed for visualizing the small bowel mucosa to detect abnormalities in both adults and children aged two years and older, positioning it as a more advanced solution compared to competitors [2][4] - The company emphasizes its unique in-house AI capabilities and a cloud-based architecture that enhances efficiency, accuracy, and accessibility in gastrointestinal diagnostics [3] Company Overview - CapsoVision is focused on developing advanced imaging and AI-enabled solutions for gastrointestinal disease detection and diagnosis, with its flagship product being the CapsoCam Plus, a wire-free capsule endoscope [4] - The upcoming product, CapsoCam Colon, aims to enhance non-invasive colon imaging and polyp detection, indicating the company's commitment to expanding its product pipeline across various GI indications [4]

Group 1: Market Overview - U.S. stocks experienced an upward trend, with the Dow Jones index increasing by approximately 200 points on Wednesday [1] Group 2: Dynavax Technologies Corp - Shares of Dynavax Technologies Corp rose significantly after Sanofi SA announced its acquisition for $15.50 per share in cash, totaling an equity value of around $2.2 billion [1] - The acquisition enhances Sanofi's position in the adult immunization market [1] - Dynavax shares surged by 38.6% to close at $15.44 on Wednesday [1] Group 3: Other Notable Stock Movements - Omeros Corp shares increased by 66.8% to $14.60 following FDA approval of YARTEMLEA for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy [3] - Edgewise Therapeutics Inc gained 23.8% to $26.94 after updates from the ongoing CIRRUS-HCM Phase 2 trial of EDG-7500 [3] - Agios Pharmaceuticals Inc shares surged by 17.9% to $29.00 after FDA approval of AQVESME for treating anemia in adults with thalassemia, priced at approximately $425,000 per patient per year [3] - Wheels Up Experience Inc saw a gain of 14.8% to $0.73 [3] - Travere Therapeutics Inc increased by 14.3% to $40.41 [3] - Coincheck Group NV shares rose by 12.5% to $2.88 [3] - Polestar Automotive Holding UK Plc jumped 11.8% to $16.92 after announcing a $300 million equity investment [3] - CapsoVision Inc gained 11.6% to $14.39 [3] - X4 Pharmaceuticals Inc increased by 9.5% to $4.52 [3] - Falcon's Beyond Global Inc shares rose by 9.4% to $18.35 following a $100 million mixed shelf offering [3] - BIOAGE Labs Inc jumped 8.8% to $14.37 [3] - Kodiak Sciences Inc gained 8.6% to $29.81 [3] - UiPath Inc increased by 7.9% to $17.23 after being announced as a replacement for Synovus Financial in the S&P MidCap 400 [3] - Immuneering Corp rose by 6.8% to $6.83, with an upcoming update on a clinical trial scheduled for January 7, 2026 [3] - Nike Inc shares gained 4.7% to $60.03 amid mixed investor sentiment regarding insider purchases and concerns over tariffs and demand in China [3] - Micron Technology Inc increased by 3.5% to $286.01 [3]

Group 1 - U.S. stock futures were mostly flat, with Nasdaq 100 futures slipping around 0.01% [1] - Sidus Space, Inc. announced a public offering of 19,230,800 shares at $1.30 per share, leading to a 39.2% decline in its shares to $1.39 in pre-market trading [1] Group 2 - Starfighters Space Inc shares dipped 23.2% to $24.19 after a significant gain of over 370% on Monday [2] - ECD Automotive Design, Inc. fell 15.4% to $0.1650 following a 1-for-5 reverse stock split announcement [2] - CapsoVision Inc dipped 5.6% to $12.35, while Rocket Lab Corp fell 5.3% to $73.46 after a previous 10% jump [2] - Intuitive Machines Inc declined 5.2% to $15.82 despite a price target increase from $14 to $20 by B. Riley Securities [2] - Firefly Aerospace Inc shares declined 4.4% to $27.33 after a 16% increase due to joining the Russell 2000 and Russell 3000 indexes [2] - AST SpaceMobile Inc shares declined 3.1% to $83.82 after a 14% surge related to new satellite details [2]