Modular Medical, Inc.

Previous wording

We are a pre-revenue 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-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, when the United States government shutdown ended. We intend to initiate our commercial launch with the Pivot product, when the required regulatory approval from the FDA is received, which we believe may occur by March 31, 2026 or shortly thereafter. We are actively working to i) obtain regulatory clearance and prepare to commence commercialization of our Pivot product, 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.

Current wording

We are a commercial-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 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 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) expand commercial activities for our Pivot 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.

Previous wording

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 of at least one year from the date that the financial statements included in Item 1 of this Report are issued exists. 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 have provided additional disclosure in Note 1 to the condensed consolidated financial statements in Item 1 of this Report and underLiquidity below.

Current wording

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. 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 revenues 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 capital 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 its report on our consolidated financial statements for fiscal 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.

Previous wording

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 the year ended March 31, 2025. As of December 31, 2025, there have been no material changes to our significant accounting policies and estimates.

Current wording

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 fiscal 2026. As of June 30, 2026, there have been no material changes to our significant accounting policies and estimates.

Previous wording

R&D expenses increased for the three months ended December 31, 2025 compared with the same period of 2024, primarily due to an increase in personnel-related costs of approximately $0.5 million, an increase in consulting and outside services costs of $0.6 million, an increase in shipping and freight costs of approximately $0.2 million, an increase in depreciation expense of approximately $0.1 million and a $0.1 million increase in stock-based compensation expenses.

Current wording

R&D expenses decreased for the three months ended June 30, 2026 compared with the same period of 2025, primarily due to decreases in personnel costs of approximately $0.3 million, stock-based compensation expenses of approximately $0.2 million, consulting 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.

Previous wording

Our full-time R&D employee headcount increased to 58 at December 31, 2025 from 44 at December 31, 2024. R&D expenses included stock-based compensation expenses of approximately $0.4 million and $0.3 million for the three-months ended December 31, 2025 and 2024, respectively, and $1.7 million and $1.5 million for the nine-month periods ended December 31, 2025 and 2024, respectively. We expect research and development expenses to remain flat to decrease in the last quarter of fiscal 2026, as we manage expenses in anticipation of expected FDA clearance and the commercialization of our Pivot pump product.

Current wording

Our full-time R&D employee headcount decreased to 42 at June 30, 2026 from 54 at June 30, 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 $0.6 million for the three-month periods ended June 30, 2026 and June 30, 2025, respectively. We expect research and development expenses to remain consistent for the remainder of fiscal 2027.

Previous wording

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

Current wording

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

Previous wording

SG&A expenses increased for the nine months ended December 31, 2025 compared with the same period of 2024, primarily as a result of increases in personnel costs of approximately $1.0 million, increases in consulting expenses of approximately $1.2 million, and a $0.3 million increase in marketing costs, which was partially offset by a $0.1 million decrease in stock-based compensation expenses.

Current wording

SG&A expenses increased for the three months ended June 30, 2026 compared with the same period of 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 $0.1 million, as partially offset by decreases in stock-based compensation expenses of approximately $0.1 million and other miscellaneous decreases of approximately $0.1 million.

Previous wording

Our full-time SG&A employee headcount increased to 11 at December 31, 2025 from 4 at December 31, 2024. SG&A expenses included stock-based compensation expenses of approximately $0.1 million for the three-month periods ended December 31, 2025 and 2024, and $0.4 million and $0.5 million for the nine months ended December 31, 2025 and 2024, respectively. We expect SG&A expenses to remain flat to decrease in the last quarter of fiscal 2026, as we manage expenses in anticipation of expected FDA clearance and the commercialization of our Pivot pump product.

Current wording

Our full-time SG&A employee headcount decreased to 9 at June 30, 2026 from 12 at June 30, 2025. SG&A expenses included stock-based compensation expenses of approximately $0.1 million for each of the three-month periods ended June 30, 2026 and June 30, 2025, respectively. We expect SG&A expenses to increase in fiscal 2027 as compared with fiscal 2026, as we continue to expand our sales and marketing organization and increase our general and administrative headcount to support the commercialization of our pump product during fiscal 2027.

Previous wording

We do not currently have revenues 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 costs incurred in connection with R&D activities and SG&A expenses associated with our operations. For the nine months ended December 31, 2025 and year ended March 31, 2025, we incurred net losses of approximately $21.9 million and $18.8 million, respectively. At December 31, 2025, we had a cash balance of $2.9 million and an accumulated deficit of $106.6 million. When considered with our current operating plan, these conditions raise 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. We currently lack sufficient liquidity to fund our operations for the next 30 days. If we do not obtain additional financing, we will be unable to meet our upcoming obligations, including employee compensation and vendor payments. In addition, our independent registered public accounting firm, in its report on our consolidated financial statements for the year ended March 31, 2025, expressed substantial doubt about our ability to continue as a going concern. The condensed consolidated financial statements presented in Part I, Item 1 of this Report have been prepared assuming that we will continue as a going concern, and do not include any adjustments that might result from the outcome of this uncertainty. Our operating needs include the planned costs to operate our business, including amounts required to fund continued research and development activities, working capital and capital expenditures. 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. There can be no assurance that such additional capital, whether in the form of debt or equity financing, will be sufficient or available and, if available, that such capital will be offered on terms and conditions acceptable to us. We are currently seeking additional financing in order to meet our cash requirements for the foreseeable future. If we are unable to obtain adequate capital to fund our operations, we would not be able to continue to operate our business pursuant to our current business plan, which would require us to modify our operations to reduce spending to a sustainable level by, among other things, delaying, scaling back or eliminating some or all of our ongoing or planned investments in our product, including but not limited to research and development and other activities, which would have a material impact on our operations or force us to discontinue our operations entirely.

Current wording

We do not currently have revenues 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 costs incurred in connection with 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. At June 30, 2026, we had a cash balance of $3.9 million and an accumulated deficit of approximately $119 million. When considered with our current operating plan, these conditions raise 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. Our financial statements do not include adjustments to the amounts and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern. Our operating needs include the planned costs to operate our business, including amounts required to fund continued research and development activities, working capital and capital expenditures. 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. In April 2026, we completed a registered direct offering of our common stock for net proceeds of approximately $3.0 million. In addition, in June 2026, we received proceeds of approximately $0.7 million from sales under our at-the-market offering program. Subsequent to June 30, 2026, we received proceeds of approximately $5.1 million from sales under our at-the-market offering program. Our future capital requirements and the adequacy of our available funds will depend on many factors, including, without limitation, our ability to successfully commercialize our product, competing technological and market developments, and the need to enter into collaborations with other companies or acquire other companies or technologies to enhance or complement our product offerings. If we are unable to secure additional capital timely, we may be required to curtail R&D initiatives, further reduce headcount and take additional measures to reduce costs in order to conserve our cash.

Previous wording

For the nine months ended December 31, 2025, we used approximately $17.9 million of cash in operating activities, which primarily resulted from our net loss of approximately $21.9 million, as adjusted for net changes in operating assets and liabilities of approximately $0.5 million, stock-based compensation expenses of approximately $2.1 million, an approximately $0.1 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 million and other immaterial adjustments.

Current wording

For the three months ended June 30, 2026, we used approximately $6.0 million of cash in operating activities, which primarily resulted from our net loss of approximately $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 $0.2 million, stock-based compensation expenses of approximately $0.7 million and depreciation and amortization expenses of approximately $0.4 million and other immaterial adjustments.

Previous wording

For the nine months ended December 31, 2025 and 2024, cash used in investing activities of approximately $2.9 million and $1.5 million, respectively, was for the purchase of property and equipment.

Current wording

For the three months ended June 30, 2026 and 2025, cash used in investing activities of approximately $0.7 million and $0.9 million, respectively, was for the purchase of property and equipment.

Previous wording

Cash provided by financing activities of approximately $10.7 million for the nine months ended December 31, 2025 was attributable to $4.8 million of net proceeds from a public offering of our common stock and warrants completed in December 2025, $4.0 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 the ATM Agreement. Cash provided by financing activities of approximately $10.7 million for the nine months ended December 31, 2024 was attributable to $7.3 million of net proceeds from the issuance of common stock in a public offering, $2.1 million of net proceeds from sales of our common stock under the ATM Agreement and $1.3 million of proceeds from exercises of common stock purchase warrants.

Current wording

Cash provided by financing activities of approximately $3.6 million for the three months ended June 30, 2026 was primarily attributable to approximately $3.0 million of net proceeds from a registered direct offering of our common stock and $0.7 million of sales of common stock under our at-the-market offering program, as partially offset by immaterial payments. Cash provided by financing activities of $0.7 million for the three months ended June 30, 2025 was attributable to proceeds from the sale of common stock under our at-the-market offering program.

Previous wording

Our primary purchase obligations include purchase orders for machinery and equipment. At December 31, 2025, we had outstanding purchase orders for machinery and equipment and related expenditures of approximately $2.0 million.

Current wording

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