MODD 最新10-K变化

相对上期新增的文字 · 来源:10-K · 2026-06-29

• While our initial target market is people with Type 1 diabetes, we believe there is a substantial opportunity to penetrate the Type 2 marketplace, through our Pivot product, which would be the only 3 milliliter, tubeless removable patch pump on the market. People with Type 2 diabetes tend to use mor…

• In September 2024, we received clearance from the FDA to market and sell our MODD1 product in the United States, and, in August 2025, we demonstrated the first human use of our MODD1 pump delivering insulin to a human patient. We announced our next-generation patch pump, branded as Pivot, in August …

• We have established our initial production line with our manufacturing partner, Phillips Medisize, a Molex company, a large tier-one medical device manufacturer, which will manage and operate our production for human use. We believe that Phillips Medisize will be able to rapidly scale our production…

• Our current goal is to expand commercialization of our Pivot pump product across metropolitan markets in the United States and obtain all required regulatory approvals to offer the product for sale in multiple international markets.

• Our long-term goal is to become a leading provider of insulin pump therapy by focusing on both consumer and clinical needs.

相对上期删除的文字 · 来源:10-K · 2025-06-20

• While our initial target market is people with Type 1 diabetes, we believe there is a substantial opportunity to penetrate the type 2 marketplace, first through our initial MODD1 pump, and then with the future introduction of Pivot, which would be the only 3 milliliter, tubeless removable patch pump…

• A proprietary survey of American healthcare payors representing 50 million covered lives (approximately one-third of total U.S. covered lives) performed for us by industry leading survey firm ISA in 2019 has demonstrated that payors are willing to grant equivalent or preferential coverage for a prod…

• According to the National Diabetes Health Care Provider Survey conducted by Seagrove Partners, LLC, or Seagrove, in 2021, approximately 25% of the 1.6 million highly insulin intensive individuals with T2D have considered going “on pump.”

• In September 2024, we received clearance from the FDA to market and sell our MODD1 product in the United States. We plan to launch this pump in a single region during the quarter ending September 30, 2025. We expect to submit our successor product, our Pivot pump, which is a tubeless pump product, f…

• Our current goal is to commercialize our MODD1pump product and successfully obtain all required regulatory approvals for our Pivot pump product. Our long-term goal is to become a leading provider of insulin pump therapy by focusing on both consumer and clinical needs.

相对上期新增的文字 · 来源:10-K · 2026-06-29

• ●We have a limited operating history upon which to evaluate our business and forecast our future sales and operating results and may face difficulties frequently encountered by companies in competitive and rapidly-evolving markets.

• ●We have a limited commercial history and limited experience marketing and selling our products. We only recently launched our commercial product, which may make it difficult to evaluate the prospects for our future viability and predict our future performance.

• ●The effective increase in the number of shares of our common stock available for issuance as a result of our reverse stock split could result in further dilution to our existing stockholders and have antitakeover implications.

• Our consolidated financial statements as of March 31, 2026 have been prepared under the assumption that we will continue as a going concern twelve months from the date of issuance of this Report. At March 31, 2026, we had cash and cash equivalents of $6.9 million and an accumulated deficit of $113.0…

• We are an early commercial-stage medical device company and have a history of significant operating losses; we expect to continue to incur operating losses, and we may never achieve or maintain profitability.

相对上期删除的文字 · 来源:10-K · 2025-06-20

• ●If the beneficial ownership of our common stock continues to be concentrated, it may prevent our stockholders from influencing significant corporate decisions.

• ●Future sales of our securities could adversely affect the market price of our common stock and our future capital-raising activities could involve the issuance of equity securities, which would dilute your investment and could result in a decline in the trading price of our common stock.

• Our consolidated financial statements as of March 31, 2025 have been prepared under the assumption that we will continue as a going concern twelve months from the date of issuance of this Report. At March 31, 2025, we had cash and cash equivalents of $13.1 million and an accumulated deficit of $84.8…

• If we are unable to generate sustainable operating profit and sufficient cash flows, then our future success will depend on our ability to raise capital. We intend to seek additional financing and evaluate financing alternatives in order to meet our cash requirements for the foreseeable future. We c…

• We are a pre-revenue medical device company and have a history of significant operating losses; we expect to continue to incur operating losses, and we may never achieve or maintain profitability.

相对上期新增的文字 · 来源:10-K · 2026-06-29

• Item 5 Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 41

• Item 7 Management’s Discussion and Analy sis of Financial Condition and Results of Operations 42

• Item 7A Quantitative and Qualitative Disclosures about Market Risk 45

• Item 9 Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 46

• Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 47

相对上期删除的文字 · 来源:10-K · 2025-06-20

• We are not a party to any material legal proceeding that we believe is likely to have a material adverse effect on our consolidated financial position or results of operations. From time to time, we may be subject to legal proceedings and claims in the ordinary course of business. These claims, even…

相对上期新增的文字 · 来源:10-K · 2026-06-29

• On April 19, 2026, we entered into a placement agency agreement with Maxim Group LLC (“Maxim”), relating to a registered direct offering (the “April 2026 Offering”) of 750,000 shares of our common stock, par value $0.001 per share. The gross proceeds to us from the April 2026 Offering were approxima…

• Historically, we have financed our operations principally through private placements and public offerings of our common stock and warrants and sales of convertible promissory notes. Based on our current operating plan, there is substantial doubt about our ability to continue as a going concern for a…

• Our research and development, or R&D, expenses include personnel, consulting, testing, materials and supplies, depreciation and amortization and other operational costs associated with the production of our insulin pump products. We expense R&D costs as they are incurred. R&D expenses increased in f…

• We expect R&D expenses will increase in fiscal 2027, as we continue to hire additional engineering, quality assurance, and operations personnel, optimize our manufacturing process at our medical device contract manufacturer and continue to advance the product development roadmap for our pump product…

• G&A expenses increased in fiscal 2026 compared with fiscal 2025 primarily due to increases in general and administrative personnel costs of $1.5 million, consulting expenses of $1.3 million, sales and marketing activities of $0.5 million, The increase in personnel costs was attributable to increased…

相对上期删除的文字 · 来源:10-K · 2025-06-20

• In March 2025, we completed a private placement (the “Private Placement”) of 6,247,656 units (each a “Unit”), with each Unit consisting of (A) two shares of our common stock and (B) one warrant to purchase one share of common stock, at an offering price of $1.92 per Unit. The Private Placement provi…

• Historically, we have financed our operations principally through private placements and public offerings of our common stock and warrants and sales of convertible promissory notes. Based on our current operating plan, substantial doubt about our ability to continue as a going concern for a period o…

• Our research and development, or R&D, expenses include personnel, consulting, testing, materials and supplies, depreciation and amortization and other operational costs associated with the production of our insulin pump products. We expense R&D costs as they are incurred.

• R&D expenses increased in fiscal 2025 compared with fiscal 2024 primarily due to increases in engineering and operations personnel costs of $1.6 million, depreciation and amortization of $0.7 million and travel-related and other costs of approximately $0.3 million. The increase in personnel costs wa…

• We expect R&D expenses will increase in fiscal 2026, as we continue to hire additional engineering, quality assurance, and operations personnel, bring-up our manufacturing process at our medical device contract manufacturer and continue the development and prepare for the submission of our Pivot pro…