MODD 10-K & 10-Q changes, risk factors and insider trading

Our consolidated financial statements as of March 31, 20252026 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, 2026, we had cash and cash equivalents of $13.1$6.9 million and an accumulated deficit of $84.8$113.0 million. InSubsequent to March 2025,31, 2026, in April 2026, we completed a private placement of common stock and warrants for net proceeds to us of approximately $11.4 million. In addition, in November 2024, we completedclosed a public offering of common stock for net proceeds to us of approximately $7.3$3.0 million. Even with these offering proceeds, we do not believe that our cash and cash equivalents will be sufficient to fund our operations for the period ofnext 12 months from the date of issuance of this report,months, and we wouldwill need to raise additional capital. As a result of our expected operating losses and cash burn for the foreseeable future and recurring losses from operations, if we are unable to raise sufficient capital through additional debt or equity arrangements, there will be uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt as to our ability to continue as a going concern. If we cannot continue as a viable entity, our stockholdersshareholders would likely lose most or all of their investment in us. 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 cannot be certain that raising additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to us or, if available, will be on terms acceptable to us. If we issue additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of our common stock, and our current stockholders may experience dilution. If we are unable to obtain funds when needed or on acceptable terms, we may be required to curtail our current product development programs, cut operating costs, forego future development and other opportunities or even terminate our operations.

We are aan pre-revenueearly 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 achieve or maintain profitability.

We do not currently have revenues to generate cash flows to cover operating expenses. Since our inception, we have incurred operating losses in each year due to costs incurred in connection with research and development activities and general and administrative expenses associated with our operations. For the years ended March 31, 20252026 and,and 2024,2025, we incurred net losses of approximately $18.9$28.2 million and $17.5$18.8 million, respectively. As a result, we will need to raise additional capital in the future, which may or may not be available to us at all or only on unfavorable terms.

We expect to incur losses for the foreseeable future as we continue theto development of,commercialize and seek regulatoryto clearanceexpand andmarket approvalsacceptance for,of our insulin pump.pump products. Our MODD1Pivot insulin pump is currently currently our only commercial product, and, if it fails to gain market acceptance, we willmay not be able to generate anysufficient revenue, or explore other opportunities to enhance stockholder value, such as through a sale. If we fail to generate sufficient revenue and eventually become profitable, or if we are unable to fund our continuing losses, our stockholders could lose all or a substantial part of their investment.

The discovery, development, and commercialization of new medical devices, such as our insulin pump, entails significant costs. We have completed the engineering and mechanical development of our insulin pump and cartridge, and obtained FDA clearance.clearance for our Pivot product. In addition, we have also implemented a production-level manufacturing manufacturing process,process including purchasing required equipment for low-level manufacturing. We have developedwith a follow-ontier-one product,manufacturing partner. In June 2026, we announced commercial availability of our Pivot pump, to, among other things, meet the general needsproduct and commenced preferencesinitial ofshipments. the Almost Pumper marketplace and the guidelines of third-party payors. To enable us to accomplishexpand thesecommercial and other related itemsactivities and continue to operate our business, we will need to raise substantial additional capital and/or enter into strategic partnerships or joint ventures to enable us to:

Until we can generate a sufficient amount of product revenue to finance our cash requirements, which we may never achieve, we expect to finance our cash needs primarily through public or private equity offerings, debt financings or through the establishment of possible strategic alliances. We may in the future seek additional capital from public or private offerings of our capital stock or borrow additional amounts under new credit lines or from other sources. If we issue equity or debt securities to raise additional funds, our existing stockholders may experience dilution, we may incur significant financing costs, and the new equity or debt securities may have rights, preferences and privileges senior to those of our existing stockholders. In addition, if we raise additional funds through collaborations, licensing, joint ventures, strategic alliances, partnership arrangements or other similar arrangements, it may be necessary to relinquish valuable rights to the MODD1our pump products or our potential future products or proprietary technologies or grant licenses on terms that are not favorable to us.

Our business depends on the skills, performance, and dedication of our directors, executive officers and key engineering, scientific and technical advisors. Many of our current engineering or scientific advisors are independent contractors and are either self-self employed or employed by other organizations. As a result, they may have conflicts of interest or other commitments, such as consulting or advisory contracts with other organizations, which may affect their ability to provide services to us in a timely manner. We will need to recruit additional directors, executive management employees, and advisers, particularly engineering, scientific and technical personnel, which will require additional financial resources. In addition, there is currently intense competition for skilled directors, executives and employees with relevant engineering, scientific and technical expertise, and this competition is likely to continue. If we are unable to attract and retain persons with sufficient engineering, scientific, technical and managerial experience, we may be forced to limit or delay our product development activities or may experience difficulties in successfully conducting our business, which would adversely affect our business, prospects, results of operations and financial condition.

We may seek to enter into a strategic alliance with a diabetes-related service providing company for the further development and approval of our insulin pump product candidate. At this time, we have not entered into any such strategic alliance. Strategic alliances, if entered into, could potentially provide us with additional funds, expertise, access, and other resources in exchange for exclusive or non-exclusive licenses or other rights to the product that we are currently developing or a product we may explore in the future. We cannot give any assurance that we will be able to enter into strategic relationships with a diabetes-related service providing company or others in the near future or at all. In addition, we cannot assure you that any agreements that we do reach will allow us to achieve our goals or that such grants will be on terms that prove to be economically beneficial to us. When we do enter into strategic or contractual relationships, we become dependent on the successful performance of our partners or counter-parties. If they fail to perform as expected, such failure could adversely affect our financial condition, lead to increases in our capital needs, or hinder or delay our development efforts. See “Our BusinessBusiness-Employees” -Employees” below.

Before we can market a new medical device, such as our insulin pump, we must first receive clearance under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, or the “FDCA.” In the 510(k) clearance process, before a device may be marketed, the FDA must determine that such proposed device is “substantially equivalent” to a legally-marketed “predicate” device, which includes a device that has been previously cleared through the 510(k) process, a device that was legally marketed prior to May 28, 1976 (pre- amendments preamendments device), a device that was originally on the U.S. market pursuant to a premarket approval (PMA) and later down-down classified, or a 510(k)-exempt device. To be “substantially equivalent,” the proposed device must have the same intended use as the predicate device, and either have the same technological characteristics as the predicate device or have different technological characteristics and not raise different questions of safety or effectiveness than the predicate device. InWe September 2024, wehave received FDA clearance to market and sell our initial pump product,products, our MODD1, MODD1 and Pivot, in the United States. Our Pivot product is the product that we intend to commercialize in the fall of 2026.

OurWe expect Pivotthat product,future whichversions will beof our secondpump product after our MODD1 product,products will require a newFDA 510(k) clearance.approvals. The 510(k) clearance process can be expensive, lengthy and uncertain. The FDA’s 510(k) clearance process usually takes less than 12 months, but it can last longer. Despite the time, effort and cost, a device may not be approved or cleared by the FDA. Any delay or failure to obtain necessary regulatory authorizations could harm our business, including our ability to commercialize our future product candidates and our stockholders could lose their entire investment. Furthermore, even if we are granted the required regulatory authorizations, such authorizations may be subject to significant limitations on the indicated uses for the device, which may limit the market for our future product candidates.

The development, manufacture, and marketing of our product candidates outside the United States is subject to government regulation. In most foreign countries, we must complete rigorous pre-clinical testing and extensive human clinical trials that demonstrate the safety and efficacy of a product in order to apply for regulatory approval to market the product. If foreign regulatory authorities grant regulatory approval of a product, the approval may be limited to specific indications or limited with respect to its distribution. Expanded or additional indications for approved devices may not be approved, which could limit our potential revenues. Foreign regulatory authorities may refuse to grant any approval. Consequently, even if we believe that pre- clinicalpreclinical and clinical data are sufficient to support regulatory approval for our products, foreign regulatory authorities may not ultimately grant approval for commercial sale in any jurisdiction. If our product candidates are not approved in such jurisdictions, our ability to generate revenues will be limited and our business will be adversely affected.

In order to conduct larger-scale or late-stage clinical studies and for commercialization of our insulin pump products, if 510(k) clearance is granted for any product, we will need to manufacture it in larger quantities. We may not be able to successfully increase the manufacturing capacity for our MODD 1Pivot product or future product candidates in a timely or cost-effective manner, or at all. In addition, quality issues may arise during scale-up activities. If we are unable to successfully scale up the manufacture of our product candidatecandidates in sufficient quality and quantity, the development and testing of our product candidates and regulatory approval or commercial launch may be delayed, which could significantly harm our business.

The future manufacture of our product will require the timely delivery of sufficient amounts of components from multiple suppliers in various countries. We intendhave tobeen workworking closely with our suppliers to ensure continuity of supply, but we cannot guarantee these efforts will be successful. Due to the supply chain issues experienced by the semiconductor industry, at times, we have experienced delays obtaining integrated circuits from certain suppliers. We may need to enter into “take or pay” contracts with suppliers. We have also seen price increases for various components. We do not have supply agreements with any of our suppliers, and we make purchases based on individual purchase orders. An interruption, delay, or inability to obtain components from our third-party suppliers at acceptable prices in a timely manner, could hinder our ability to manufacture our products and have a material adverse effect on our business, prospects, financial condition and results of operations.

The marketing and sale of our insulin pump exposes us to the risk of significant damages from product liability and other claims, and the use of our product in clinical studies may result in adverse effects from liability claims. We cannot predict all the possible harms or adverse effects that may result. We intend tohave obtainobtained product liability insurance to provide some protection from potential claims. Nonetheless, we may not have sufficient resources to pay for any liabilities resulting from a personal injury or other claim, even if it is partially covered by insurance. In addition to the possibility of direct claims, we may be required to indemnify third parties against damages and other liabilities arising out of our development, commercialization and other business activities, which would increase our liability exposure. If third parties that have agreed to indemnify us fail to do so, we may be held responsible for those damages and other liabilities as well.

Our insulin pump products are subject to extensive regulation by the FDA. These regulations relate to manufacturing, labeling, sale, promotion, distribution and shipping. Before a new medical device, or a new intended use of a legally marketed device, can be marketed in the United States, it must be cleared or approved by the FDA through the applicable premarket review process (510(k), PMA, or de novo classification), unless an exemption applies. While we have received 510(k) clearance for our initial insulin pump product,products, the MODD1,MODD1 and Pivot, we may be required to obtain new 510(k) clearances for significantsignificant, post-market modifications to the pump. For example, our Pivotpump product, which we expect over time to replace the MODD1 product, will require 510(k) clearance.products. Each premarket submission and review process can be expensive and lengthy, and entail significant user fees, unless exempt.

We have applied to the U.S. Patent and Trademark Office, or the USPTO, and various foreign patent agencies for patents on our proprietary fluid movement technology and our insulin delivery methodology. To date, the USPTO has granted fivesix patents to us, and we have been awarded two four patents by foreign jurisdictions. We have additional applications pending and in various stages of review by the USPTO and foreign patent agencies. There can be no assurance that we will be issued additional patents by the USPTO or foreign patent agencies and that any of our patents will prevent other companies from competing with us. We will continue to attempt to patent our innovations, as appropriate, to help ensure a sustainable competitive advantage.

These and other healthcare reform measures that may be adopted in the future may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any current product or future product candidate. Any reduction in reimbursement from Medicare or other government healthcare programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our products. Legislative and regulatory proposals have been made to expand post-post approval requirements and restrict sales and promotional activities for drugs. We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of any current or future product candidates, if any, may be. In addition, increased Congressional scrutiny of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements.

We have established initial, low-volume manufacturing capability in our facility and with a tier one medical device contract manufacturer. We and the contract manufacturer of our insulin pump products will be required to comply with the FDA’s quality system regulations, which impose a complex regulatory framework that covers the procedures and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of medical devices. The FDA enforces its quality system regulations through periodic unannounced inspections. We cannot assure youthat, that, in the future, any manufacturing facilities owned by us or any contract manufacturer will pass any quality system inspection. In the event that our or any contract manufacturer’s facilities fails a quality system inspection, the manufacturing or distribution of our products could be interrupted and our operations disrupted. Failure to take adequate and timely corrective action in response to an adverse quality system inspection could force a suspension or shutdown of any packaging and labeling operations or then manufacturing operations of any contract manufacturers, or a recall of our insulin pump products. If any of these events were to occur, we at such time would not be able to provide our customers with the quantity of insulin pumps that they require on a timely basis, our reputation could be harmed and we could lose any customers we then have, any or all of which could have a material adverse effect on our business, financial condition and results of operations.

Our insulin pump products will may be subject to recalls, which would harm our reputation, business operations and financial results.

Our current insulin pump product does not not yet have reimbursement and is not approved for insurance coverage. IfIf, in the futurefuture, we are otherwise able to commercialize our insulin insulin pump products, but are unable to obtain adequate reimbursement or insurance coverage for such product from third-party payors, we will be unable to generate significant revenue.

Our current Pivot insulin pump is not yet eligible for reimbursement and is not approved for insurance coverage. The future availability of insurance coverage and reimbursement for newly approved medical devices is highly uncertain. In the United States, patients using insulin pumps are generally reimbursed for all or part of the product cost by Medicare or other third-party payors. Any future commercial success of our insulin pump products will be substantially dependent on whether third-party coverage and reimbursement is available for future customers. Medicare, Medicaid, health maintenance organizations and other third-party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement of new medical devices, and, as a result, they may not cover or provide adequate reimbursement for our insulin pump, assuming we are able to fully develop and obtain all regulatory approval to market it in the United States. In addition, in certain countries, no uniform policy of coverage and reimbursement for medical device products and services exists among third- party payors. Therefore, coverage and reimbursement for medical device products and services can differ significantly from payor to payor. In addition, payors continually review new technologies for possible coverage and can, without notice, deny coverage for these new products and procedures. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained or maintained, if obtained. Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtained on a country-by-country basis. In many international markets, a product must be approved for reimbursement before it can be approved for sale in that country. Further, many international markets have government-managed healthcare systems that control reimbursement for new devices and procedures. Accordingly, unless government and other third-party payors provide coverage and reimbursement for our insulin pump products, patients may not use it, which would cause investors to lose their entire investment.

Negative economic conditions and instability or uncertainty in the financial markets could have a negative impact on our ability to access the capital markets, and thus have a negative impact on our then operations and liquidity. We face certain risks in the event of a sustained deterioration of financial market liquidity, as well as in the event of sustained deterioration in the liquidity, or failure, of our banking, cash management and custodial financial institutions. A general shortage of liquidity and credit combined with the substantial losses in worldwide equity markets could lead to an extended worldwide recession in the future. If such occurred, we would face significant challenges if conditions in the capital markets did not improve. Our ability to access the capital markets under such circumstances could be severely restricted at a time when we need to access such markets, which could have a negative impact on our business plans. Even if we are able to raise capital under such circumstances, it may not be at a price or on terms that are favorable to us. We cannot predict the occurrence of future disruptions or how long such negative conditions might continuecontinue.

From time to time, we may encounter attempts at gaining unauthorized access to our network, and we periodically run security checks. While we seek to detect and investigate unauthorized attempts and attacks against our network and products of which we become aware, and to prevent their recurrence where practicable through changes to our internal processes and tools and/or changes to our products, we remain potentially vulnerable to additional known or unknown threats. In addition to intentional security breaches, the integrity and confidentiality of Company and customer data and our intellectual property may be compromised as a result of human error, product defects, or technological failures. Different geographic markets may have different regulations regarding data protection, raising potential compliance risks. Further, retaliatory acts by foreign governments or terrorist organizations in response to policies of the United States government could include cyber attackscyber-attacks that could disrupt the economy more generally or that could also impact our operations directly or indirectly. Any failure or perceived failure by us or our service providers to prevent information security breaches or other incidents or system disruptions, or any compromise of security that results in or is perceived or reported to result in unauthorized access to, or loss, theft, alteration, release or transfer of, our information, or any personal information, confidential information, or other data could result in loss or theft of proprietary or sensitive data and intellectual property, could harm our reputation and competitive position and could expose us to legal claims, regulatory investigations and proceedings, and fines, penalties, and other liability. Any such actual or perceived security breach, incident or system disruption could also divert the efforts of our personnel, and could require us to incur significant costs and operational consequences in connection with investigating, remediating, eliminating and putting in place additional tools, devices, policies, and other measures designed to prevent actual or perceived security breaches and other incidents and system disruptions, and in, for example, rebuilding internal systems, reduced inventory value, providing modifications to our products and services, defending against claims and litigation, responding to regulatory inquiries or actions, paying damages, or taking other remedial steps with respect to third parties. Moreover, we could be required or otherwise find it appropriate to expend significant capital and other resources to respond to, notify third parties of, and otherwise address the incident or breach and its root cause, and to notify individuals, regulatory authorities and others of security breaches involving certain types of data.

If we are unable to satisfy the continued continued listing requirements of the Nasdaq, our common stock could be delisted and the price and liquidity of our common stock may be adversely affected.

As of March 31, 2025,2026, our executive officers, directors and certain persons, who may be deemed affiliates, beneficially owned approximately 14%5.4% of our issued and outstanding common stock. Specifically, James Besser, our chief executive officer, and Morgan Frank, a member of our board of directors, are the principals of Manchester Explorer, L.P., our largest stockholder. As of March 31, 2025,2026, in the aggregate, Messrs. Besser and Frank were the beneficial owners of approximately 9% 3.4% of our outstanding common stock. As a result, such persons may exercise substantial influence over the outcome of corporate actions requiring stockholder approval including, without limitation, the election of directors, certain mergers, consolidations and sales of all or substantially all of our assets or any other significant corporate transactions. Such persons may also vote against a change of control, even if such a change of control would benefit our other stockholders. Thus, investors in our common stock cannot reasonably expect to have any influence over the election of our directors or other matters submitted to a vote of our stockholders. Instead, our existing significant stockholders may exert a substantial influence on the election of our directors and any actions requiring or otherwise put to a stockholder vote, potentially in a manner that you do not support. The concentrated amount of control over our affairs held by a relatively few significant investors could serve to reduce the attractiveness or liquidity of our common stock, and thereby depress its trading price. Additionally, conflicts of interest may arise between these executive officers, directors and other affiliates, on the one hand, and us and our other stockholders, on the other hand. In resolving these conflicts of interests, these investors may favor their own interests and the interests of their affiliates, over the interests of our other stockholders, which could cause a material adverse effect on our business, prospects, financial condition and results of operations.

Effective internal controls are necessary for for us to provide reliable financial reports and prevent fraud. If we cannot provide reliable financial reports or prevent fraud, we may not not be able to manage our business as effectively as we would if an effective control environment existed, and our business and reputation with investors may be harmed. If we are unable to maintain effective internal controls, we may not have adequate, accurate or timely financial information, and we may be unable to meet our reporting obligations as a public company, including the requirements of the Sarbanes-Oxley Act of 2002 (the Sarbanes-Oxley Act). In addition, we may be unable to accurately report our financial results in future periods or report them within the timeframes required by the requirements of the SEC or the Sarbanes-Oxley Act. Failure to comply with the Sarbanes-Oxley Act, when and as applicable, could also potentially subject us to sanctions or investigations by the SEC or other regulatory authorities. Any failure to maintain or implement required new or improved controls, or any difficulties we encounter in their implementation, could result in identification of additional material weaknesses or significant deficiencies, cause us to fail to meet our reporting obligations or result in material misstatements in our financial statements. As previously reported in our Form 10-Q for the period ended December 31, 2025, we identified a material weaknesses in our internal control over financial reporting. We did not design and maintain effective controls related to the accounting for the warrants issued in the public offering completed in December 2025. In response to this identified material weakness, our management, with the oversight of the Audit Committee of our board of directors, has been actively engaged in remediating the above material weakness. During the quarter ended March 31, 2026, we implemented remediation measures designed to remediate this material weakness. Furthermore, Section 404 of the Sarbanes-Oxley Act and related regulations require our management to evaluate the effectiveness of our internal control over financial reporting as of the end of each fiscal year. Based on its evaluation, our management concluded that our internal controls over financial reporting were effective as of March 31, 2026. We cannot provide assurance that, in the future, a material weakness or significant deficiency will not exist or otherwise be discovered. If that were to happen, it could harm our operating results and cause stockholders to lose confidence in our reported financial information. Any such loss of confidence would have a negative effect on the trading price of our securities.

Inflation rates in the United States have remained remained elevated and may continue to rise. Inflation over the last several months has led us to experience higher costs, including, among others, others, labor and transportation. Some of our suppliers have raised their prices and may continue to raise prices, and, assumingas we achieve FDA clearance and commenceexpand commercialization of our product, in the future, we may not be able to make corresponding price increases to obtain adequate gross margins and achieve profitability. If inflation rates continue to rise or remain elevated for a sustained period of time, they could have a material adverse effect on our business, financial condition, results of operations and liquidity.

Company Overview

We are a pre-revenuecommercial-stage medical device company focused on the design, development and commercialization of innovative insulin pumps using modernized technology to increase pump adoption in the diabetes marketplace. Through the creation of a novel two-parttwo part patch pump, our initial product, the MODD1, we seek to fundamentally alter the trade-offs between cost and complexity and access to the higher standards of care that presently-available insulin pumps provide. By simplifying and streamlining the user experience from introduction, prescription, reimbursement, training and day-to-day use, we seek to expand the wearable insulin delivery device market beyond the highly motivated “super users” and expand the category into the mass market. The product seeks to serve both the type 1 and the rapidly growing, especially in terms of device adoption, type 2 diabetes markets. In January 2024, we submitted a 510(k) premarket notification to the United States Food and Drug Administration (the “FDA”) for our MODD1initial insulin pump,product, our MODD1, and, in September 2024, we received FDA clearance to market and sell our MODD1 pump in the United States. In August 2025, we announced the first human use of our MODD1 pump delivering insulin to a human patient. In addition, in August 2025, we announced our next-generation patch pump, branded as Pivot. We submitted a 510(k) premarket notification to the FDA for our Pivot product on November 13, 2025, and we received regulatory approval on April 9, 2026. In June 2026, we announced commercial availability of our Pivot product and commenced initial shipments. We are actively working to i) commercializeexpand commercial activities for our MODD1Pivot product andacross commencemetropolitan initial shipments in the quarter ending September 30, 2025,markets, ii) obtain regulatory clearance to market and sell our Pivot Product in 2026, iii) obtain regulatory clearance to market and sell our pumpPivot productsproduct in foreign jurisdictions, iv iii) improve the manufacturability and usability of our pumpPivot productsproduct and viv) develop new pump products.

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 period of at least one year from theJune date29, that the financial statements included in Item 8 of this Report are issued exists.2026. Our ability to continue as a going concern depends on our ability to raise additional capital, through the sale of equity or debt securities, to support our future operations. If we are unable to secure additional capital, we will be required to curtail our research and development initiatives and take additional measures to reduce costs. We do not currently have providedrevenues additionalto disclosuregenerate cash flows to cover operating expenses. Since our inception, we have incurred operating losses and negative cash flows in Noteeach 1year due to operating expenses and capital expenditures incurred to conduct our operations. We incurred net losses of approximately $28.2 million and $18.8 million for the years ended March 31, 2026 and 2025, respectively, and we had an accumulated deficit of approximately $113.0 million as of March 31, 2026. These and prior year losses have resulted in significant negative cash flows and have necessitated that we raise substantial amounts of additional capital during this period. This raises significant doubt about our ability to continue as a going concern, which was also expressed by our independent registered public accounting firm in its report on our consolidated financial statements infor Itemthe 1year ended March 31, 2026. Our ability to continue as a going concern depends on our ability to raise additional capital, through the sale of thisequity or debt Reportsecurities andto undersupport Liquidityour below.future operations.

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 20252026 compared with fiscal 20242025 primarily due to increases in engineering and operations personnel costs of $1.6$2.9 million, consulting expenses of $1.2 million, depreciation and amortization of $0.7$0.6 million, shipping expenses $0.5 million and travel-relatedmaterials and othersupply costsexpenditures of approximately $0.3$0.4 million. The increase in personnel costs was attributable to increased average headcount year over year, salary increases effected during fiscal 2025,2026 paymentand higher payroll taxes. The increase in consulting expenditures and material and supply expenditures was primarily due to an increase in utilization of bonusesconsultants and material and job supplies, in support of our FDA submission of our new Pivot product in fiscal 2025year and higher payroll taxes. Our R&D employee headcount increased to 48 at March 31, 2025 from 36 at March 31, 2024.2026. The increase in depreciation and amortization expenses was primarily due to an increase in machinery and equipment purchased and placed in service to further develop and expand our manufacturing capabilities. The increases in R&D expense were partially offset by decreases in consulting costs of $0.6, materials and supplies expenditures of $0.1 million and stock-based compensation of $0.1 million. The decrease in consulting expenditures was primarily due to a reduction in utilization of consultants, as we increased our employee headcount, and a decrease in utilization ofstock-based outsidecompensation testing and other third parties in supportexpenses of our$0.5 FDA submission in the fourth quarter of 2024.million. R&D expenses included stock-based compensation compensation expenses of approximately $1.8$1.3 million and $1.9$1.8 million for fiscal 20252026 and fiscal 2024,2025, respectively.

We expect R&D expenses will increase in fiscal 2026, 2027, as we continue to hire additional engineering, quality assurance, and operations personnel, bring-upoptimize our manufacturing process at our medical device contract manufacturer and continue to advance the product development and prepareroadmap for the submission of our Pivotpump product, as we expect to transition our MODD1 product to the new Pivot product in 2026.products.

G&A expenses decreasedincreased in fiscal 2025 2026 compared with fiscal 20242025 primarily as a result of reductions in stock-based compensation expense of $0.2 million, marketing expense of $0.1 million (due to a participant study for our product performedincreases in fiscalgeneral 2024),and travel-relatedadministrative personnel costs of $1.5 million, consulting expenses of $0.1$1.3 millionmillion, sales and shippingmarketing expensesactivities of $0.1$0.5 million.million, The decreasesincrease in personnel costs was attributable to increased average headcount year over year, salary increases effected during fiscal 2026 and higher payroll taxes. The increases in G&A expense were partially offset by increaseda consultingdecrease feesin stock-based compensation expenses of $0.1$0.2 million and personnel costs of $0.1 million. G&A expenses included stock-based compensation expenses of approximately $0.6$0.4 million and $0.8 $0.6 million for fiscal 20252026 and fiscal 2024,2025, respectively. We expect G&A expenses to increase in fiscal 2026,2027, as we expect to increase headcount, as we developcontinue a to expand our limited sales and marketing organization, add finance and administration personnel and implement additional systems to support our anticipated growth and commercialization of our product during fiscal 2026.2027.

Our primary purchase obligations include purchase purchase orders for machinery and equipment. At March 31, 2025,2026, we had outstanding purchase orders for machinery and equipment and related expenditures expenditures of approximately $1.5$1.6 million. In December 2023, we signed a device integration agreement with a provider of connected-care and remote monitoring diabetes technology solutions. As ofAt March 31, 2025,2026, we had aoutstanding remainingpurchase obligationorders underfor thesupplies deviceand integration agreementinventory components of approximately $400,000 over three years for technology license fees. $431,000.

In fiscal 2025,2026, we used approximately $15.7$23.8 million in operating activities, which primarily resulted from our net loss of approximately $18.8$28.2 million, as increased by changes to operating assets and liabilities of approximately $0.4$0.2 million, and as adjusted for non-cash charges and gains, which included approximately $2.4$1.8 million of stock-based compensation expenses, depreciation and amortization expenses of approximately $1.1$1.7 million, change in fair value of warrant liabilities of approximately $0.8 million and other immaterial adjustments. The changes in operating assets and liabilities primarily related to the timing of payments to vendors.

Cash provided by financing activities for fiscal 2025 2026 totaled approximately $22.1 $21.5 million and was primarily attributable to net proceeds of approximately $15.7 million from a public offering of common stock and warrants, which closed in March 2026, net proceeds of approximately $4.0 million from the issuance of common stock and warrants in a warrant inducement offering in September 2025 and proceeds of approximately $1.9 million from the sale of shares under the ATM Agreement Cash provided by financing activities for fiscal 2025 totaled approximately $22.1 million and was primarily attributable to proceeds of approximately $11.4 million from a private placement of common stock and warrants, which closed in March 2025, net proceeds of approximately $7.3 million from the issuance of common stock and warrants in a public offering, which closed in November 2024, proceeds of approximately $1.3 million for the exercise of common stock purchase warrants and proceeds of approximately $2.1 million from the sale of shares under the ATM Agreement.

We account for uncertain tax positions in accordance with ASC Topic 740, Income Taxes. When tax returns are filed, it is likely that some positions taken would be sustained upon examination by the taxing authorities, while others are subject to uncertainty about the merits of the position taken or the amount of the position that would be ultimately sustained. The benefit of a tax position is recognized in the consolidated financial statements in the period during which, based on all available evidence, management believes it is more likely than not that the position will be sustained upon examination, including the resolution of appeals or litigation processes, if any. Tax positions taken are not offset or aggregated with other positions. Tax positions that meet the more- likely-than-notmore-likely-than-not recognition threshold are measured as the largest amount of tax benefit that is more than 50 percent likely of being realized upon settlement with the applicable taxing authority. The portion of the benefits associated with tax positions taken that exceeds the amount measured as described above is reflected as a liability for unrecognized unrecognized tax benefits in the accompanying consolidated balance sheets along with any associated interest and penalties that would be payable to the taxing authorities upon examination. Interest associated with unrecognized tax benefits is classified as interest expense and penalties are classified in general and administrative expenses in the consolidated statements of operations.

Our condensed consolidated financial statements as of DecemberJune 31, 202530, 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 DecemberJune 31,30, 2025,2026, we had cash and cash equivalents of $2.9$3.9 million and an accumulated deficit of $106.6approximately $119.4 million. AsFrom disclosed ina Notefinancing 4 to the condensed consolidated financial statementsperspective, in thisApril Report, in December 2025,2026, we closedcompleted a publicregistered direct offering for net proceeds of approximatelyour $4.8common million,stock and, during the three months ended December 31, 2025, we generatedfor net proceeds of approximately $1.2$3.0 million. In addition, in June 2026, we received net proceeds of approximately $0.7 million from sales under our at-the-market offering program. Subsequent to June 30, 2026, we received net proceeds of approximately $5.1 million from sales under our at-the-market offering program. Even with these proceeds, we do not believe that our cash and cash equivalents will be sufficient to fund our operations for the nextperiod 30of days,12 months from the date of issuance of this report, and we would need to raise additional capital. As a result of our expected operating losses and cash burn for the foreseeable future and recurring losses from operations, if we are unable to raise sufficient capital through additional debt or equity arrangements, there will be uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt as to our ability to continue as a going concern. If we cannot continue as a viable entity, our stockholders would likely lose most or all of their investment in us. 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 cannot be certain that raising additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to us or, if available, will be on terms acceptable to us. If we issue additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of our common stock, and our current stockholders may experience dilution. If we are unable to obtain funds when needed or on acceptable terms, we may be required to curtail our current product development programs, cut operating costs, forego future development and other opportunities or even terminate our operations.

We are a pre-revenuecommercial-stage medical device company focused on the design, development and commercialization of innovative insulin pumps using modernized technology to increase pump adoption in the diabetes marketplace. Through the creation of a novel two-parttwo part patch pump, we seek to fundamentally alter the trade-offs between cost and complexity and access to the higher standards of care that presently-available insulin pumps provide. By simplifying and streamlining the user experience from introduction, prescription, reimbursement, training and day-to-day use, we seek to expand the wearable insulin delivery device market beyond the highly motivated “super users” and expand the category into the mass market. The product seeks to serve both the type 1 and the rapidly growing, especially in terms of device adoption, type 2 diabetes markets. In January 2024, we submitted a 510(k) premarket notification to the United States Food and Drug Administration (the “FDA”) for our initial product, our MODD1, and, in September 2024, we received FDA clearance to market and sell our MODD1 pump in the United States. In August 2025, we announced the first human use of our MODD1 pump delivering insulin to a human patient. In addition, in August 2025, we announced our next-generation patch pump, branded as Pivot. We intend to commercialize our Pivot product, and will not commercialize our MODD1 product. We submitted a 510(k) premarket notification to the FDA for our Pivot product on November 13, 2025, whenand thewe United States government shutdown ended. We intend to initiate our commercial launch with the Pivot product, when the requiredreceived regulatory approval from theon FDAApril is9, received,2026. whichIn June 2026, we believeannounced maycommercial occuravailability byof Marchour 31,Pivot 2026product orand shortlycommenced thereafter.initial shipments. We are actively working to i) obtainexpand regulatorycommercial clearanceactivities and prepare to commence commercialization offor our Pivot product,product across certain metropolitan markets, ii) obtain regulatory clearance to market and sell our Pivot product in foreign jurisdictions, iii) improve the manufacturability and usability of our Pivot product and iv) develop new pump products.

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 period of at least one year from the date that the financial statements included in Item 1 of this Report are issued exists.issued. Our ability to continue as a going concern depends on our ability to raise additional capital, through the sale of equity or debt securities, to support our future operations. If we are unable to secure additional capital, we will be required to curtail our research and development initiatives and take additional measures to reduce costs. We do not currently have providedrevenues to generate cash flows to cover operating expenses. Since our inception, we have incurred operating losses and negative cash flows in each year due to operating expenses and capital expenditures incurred to conduct our operations. For the three months ended June 30, 2026 and year ended March 31, 2026, we incurred net losses of approximately $6.5 million and $28.2 million, respectively, and we had an accumulated deficit of approximately $119.4 million as of June 30, 2026. These and prior year losses have resulted in significant negative cash flows and have necessitated that we raise substantial amounts of additional disclosurecapital during this period. This raises substantial doubt about our ability to continue as a going concern, which was also expressed by our independent registered public accounting firm in Noteits 1 toreport theon condensedour consolidated financial statements infor Itemfiscal 12026. Our ability to continue as a going concern depends on our ability to raise additional capital, through the sale of thisequity Reportor anddebt undersecurities Liquidityto below.support our future operations.

The discussion and analysis of our financial condition and results of operations are based upon our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these condensed consolidated financial statements requires us to make certain estimates and judgments that affect the reported amounts of assets, liabilities, and expenses. On an ongoing basis, we make these estimates based on our historical experience and on assumptions that we consider reasonable under the circumstances. Actual results may differ from these estimates and reported results could differ under different assumptions or conditions. Our significant accounting policies and estimates are disclosed in Note 1 of the Notes to Consolidated Financial Statements in our Annual Report on Form 10-K for thefiscal year ended March 31, 2025.2026. As of December 31,June 2025,30, 2026, there have been no material changes to our significant accounting policies and estimates.

R&D expenses increaseddecreased for the three months ended DecemberJune 31,30, 20252026 compared with the same period of 2024,2025, primarily due to an increasedecreases in personnel-relatedpersonnel costs of approximately $0.5 $0.3 million, anstock-based increasecompensation in consulting and outside services costsexpenses of $0.6approximately $0.2 million, an increase in shipping and freightconsulting costs of approximately $0.2 million, and material costs of approximately $0.2 million, as partially offset by an increase in depreciation expense of approximately $0.1 million and a $0.1 million increase in stock-based compensation expenses.million.

Our full-time R&D employee headcount increased decreased to 5842 at DecemberJune 31,30, 20252026 from 4454 at DecemberJune 31,30, 2024.2025, primarily as a result of a reduction of force effected in March 2026. R&D expenses included stock-based compensation expenses of approximately $0.4 million and $0.3$0.6 million for the three-months ended December 31, 2025 and 2024, respectively, and $1.7 million and $1.5 million for the nine-monththree-month periods ended DecemberJune 31,30, 20252026 and 2024,June 30, 2025, respectively. We expect research and development expenses to remain flatconsistent to decrease infor the last quarterremainder of fiscal 2026, as we manage expenses in anticipation of expected FDA clearance and the commercialization of our Pivot pump product.2027.

Selling, general and administrative, or SG&A, expenses consist primarily of personnel and related overhead costs for facilities,sales, marketing, finance, human resources, legal, sales,and marketing and general management.

SG&A expenses increased for the three months ended DecemberJune 31,30, 20252026 compared with the same period of 2024,2025, primarily as a result of increases in sales and marketing expenses of approximately $0.3 million, professional services and investor relations fees of approximately $0.3 million and personnel costs of approximately $0.4 $0.1 million, increasesas partially offset by decreases in consultingstock-based compensation expenses of approximately $0.6$0.1 million, which was partially offset by a decrease in legalmillion and professional servicesother miscellaneous decreases of $0.2approximately $0.1 million.

Our full-time SG&A employee headcount increased decreased to 119 at DecemberJune 31,30, 20252026 from 412 at DecemberJune 31,30, 2024.2025. SG&A expenses included stock-based compensation expenses of approximately $0.1 million for each of the three-month periods ended DecemberJune 31,30, 20252026 and 2024,June and30, $0.4 million and $0.5 million for the nine months ended December 31, 2025 and 2024,2025, respectively. We expect SG&A expenses to remain flat to decreaseincrease in thefiscal last quarter2027 ofas compared with fiscal 2026, as we managecontinue expensesto inexpand anticipationour of expected FDA clearancesales and marketing organization and increase our general and administrative headcount to support the commercialization of our Pivot pump product.product during fiscal 2027.

For the ninethree months ended DecemberJune 31,30, 2025,2026, we used approximately $17.9$6.0 million of cash in operating activities, which primarily resulted from our net loss of approximately $21.9$6.5 million and net changes in operating assets and liabilities of approximately $0.4 million, as adjusted for stock-based compensation expenses of approximately $0.4 million, depreciation and amortization expenses of approximately $0.5 million and other immaterial adjustments. For the three months ended June 30, 2025, we used approximately $5.4 million of cash in operating activities, which primarily resulted from our net loss of approximately $6.7 million as adjusted for net changes in operating assets and liabilities of approximately $0.5$0.2 million, stock-based compensation expenses of approximately $2.1 million, an approximately $0.1$0.7 million change in fair value of warrant liabilities and depreciation and amortization expenses of approximately $1.2 million. For the nine months ended December 31, 2024, we used approximately $11.4 million of cash in operating activities, which primarily resulted from our net loss of approximately $13.9 million and net changes in operating assets and liabilities of approximately $0.3 million, as adjusted for stock-based compensation expenses of approximately $2.0 million, depreciation and amortization expenses of approximately $0.7$0.4 million and other immaterial adjustments.

For the ninethree months ended DecemberJune 31,30, 20252026 and 2024, 2025, cash used in investing activities of approximately $2.9$0.7 million and $1.5$0.9 million, respectively, was for the purchase of property and equipment.

Cash provided by financing activities of approximately $10.7 $3.6 million for the ninethree months ended DecemberJune 31,30, 20252026 was primarily attributable to $4.8approximately $3.0 million of net proceeds from a publicregistered direct offering of our common stock and warrants completed in December 2025, $4.0$0.7 million of net proceeds from a warrant inducement offering completed in September 2025 and $1.9 million of net proceeds from sales of common stock under theour ATMat-the-market Agreement.offering program, as partially offset by immaterial payments. Cash provided by financing activities of approximately $10.7$0.7 million for the ninethree months ended DecemberJune 31,30, 20242025 was attributable to $7.3 million of net proceeds from the issuancesale of common stock in a public offering, $2.1 million of net proceeds from sales of our common stock under theour ATMat-the-market Agreementoffering and $1.3 million of proceeds from exercises of common stock purchase warrants.program.

Our primary purchase obligations include purchase orders for machinery and equipment. At DecemberJune 31,30, 2025,2026, we had outstanding purchase orders for machinery and equipment and related expenditures of approximately $2.0$0.8 million. At June 30, 2026, we had outstanding purchase orders for supplies and inventory components of approximately $0.2 million.