Part I [ITEM 1. BUSINESS](index=6&type=section&id=Item%201.%20Business) Modular Medical, Inc. is a development-stage medical device company focused on commercializing the MODD1 insulin pump to expand market adoption for diabetes patients - Modular Medical is a development-stage medical device company focused on the design, development, and commercialization of an innovative insulin pump (**MODD1**) to increase pump adoption in the diabetes marketplace by simplifying the user experience and addressing cost and complexity[14](index=14&type=chunk)[15](index=15&type=chunk)[19](index=19&type=chunk) - The MODD1 pump is designed for affordability and ease of use, featuring a two-part system (reusable/disposable), a one-button interface, and a slim profile[20](index=20&type=chunk)[22](index=22&type=chunk) - The company targets 'Almost Pumpers' deterred by existing device costs and complexity, representing a **$1.9 billion** growth opportunity in the Type 1 diabetes market alone[25](index=25&type=chunk)[26](index=26&type=chunk)[32](index=32&type=chunk) - MODD1 offers technological advantages including **50% lower estimated manufacturing cost**, **50% more insulin capacity** (3mL vs. 2mL for Omnipod) in a smaller volume, and removable design[51](index=51&type=chunk)[53](index=53&type=chunk)[54](index=54&type=chunk)[56](index=56&type=chunk) - The commercialization strategy involves offering a **20% discount** to payors, utilizing existing PBM codes, providing free clinician samples and training, and integrating telehealth support[68](index=68&type=chunk)[70](index=70&type=chunk)[71](index=71&type=chunk) - Future product roadmap includes **MODD1+** with phone-based control and AID capability, and **MODD2** for fully autonomous closed-loop insulin delivery and pre-filled drug cartridges[79](index=79&type=chunk)[80](index=80&type=chunk) Key Competitors and Market Share (2020) | Company | Product Type | US Market Share (2020) | | :----------- | :------------- | :----------------------- | | Medtronic | Durable Pump | 51% | | Tandem | Durable Pump | 28% | | Insulet | Patch Pump | 19% | - As of March 31, 2023, the company had **38 employees**, with **34** in research and development and manufacturing operations[81](index=81&type=chunk) - The company held **three U.S. utility patents** and **22 pending applications** as of March 31, 2023, covering proprietary fluid movement and insulin delivery technology[90](index=90&type=chunk) - The MODD1 insulin pump is regulated by the FDA as a **Class II medical device**, requiring 510(k) clearance, and the company has engaged in **three pre-submission conferences** with the FDA[76](index=76&type=chunk)[77](index=77&type=chunk)[98](index=98&type=chunk) [ITEM 1A. RISK FACTORS](index=22&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including its ability to continue as a going concern, successful development and regulatory approval of MODD1, intense competition, and reliance on third-party manufacturing - The company's consolidated financial statements are prepared under the assumption of continuing as a going concern, but significant operating losses and cash burn raise substantial doubt about this ability, requiring additional capital[120](index=120&type=chunk)[121](index=121&type=chunk) - As a development-stage company, it has a history of significant operating losses (**$13.9 million** in fiscal 2023, **$18.6 million** in fiscal 2022) and expects to continue incurring losses, with future success dependent on raising additional capital[122](index=122&type=chunk)[123](index=123&type=chunk) - The company is highly dependent on obtaining FDA 510(k) clearance for its insulin pump, a process that can be expensive, lengthy, and uncertain, with potential delays or denials significantly harming commercialization efforts[140](index=140&type=chunk)[141](index=141&type=chunk)[142](index=142&type=chunk) - The diabetes treatment market is intensely competitive and subject to rapid technological change; breakthroughs by competitors could render the MODD1 insulin pump obsolete, materially affecting the business[132](index=132&type=chunk)[148](index=148&type=chunk) - Reliance on third-party manufacturers and suppliers for components and production exposes the company to risks of quality control issues, supply shortages, price increases, and inability to scale manufacturing[152](index=152&type=chunk)[153](index=153&type=chunk)[154](index=154&type=chunk) - The company's success depends on obtaining and maintaining intellectual property protection (patents, trade secrets) and avoiding infringement claims from third parties, which can be costly and time-consuming[161](index=161&type=chunk)[163](index=163&type=chunk)[165](index=165&type=chunk) - Future commercial success is substantially dependent on obtaining adequate reimbursement and insurance coverage from third-party payors (Medicare, Medicaid, private insurers), which is highly uncertain for new medical devices[181](index=181&type=chunk) [ITEM 1B. UNRESOLVED STAFF COMMENTS](index=36&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) There are no unresolved staff comments from the SEC [ITEM 2. PROPERTIES](index=36&type=section&id=Item%202.%20Properties) In January 2023, the company entered into a new 48-month lease for approximately 24,000 square feet of office and operating space in San Diego, California - In January 2023, the company signed a new **48-month lease** for approximately **24,000 square feet** in San Diego, California, effective February 1, 2023, and occupied the space in March 2023[193](index=193&type=chunk) [ITEM 3. LEGAL PROCEEDINGS](index=36&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings expected to have a significant adverse effect on its financial position or operations - The company is not a party to any material legal proceeding likely to have a material adverse effect on its consolidated financial position or results of operations[194](index=194&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURES](index=36&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company Part II [ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES](index=37&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock is listed on Nasdaq under 'MODD', with approximately 70 stockholders, and it has never paid cash dividends, intending to retain earnings for growth - The company's common stock is listed on the Nasdaq Capital Market under the symbol '**MODD**'[197](index=197&type=chunk) - As of March 31, 2023, there were approximately **70 stockholders of record**[197](index=197&type=chunk) - The company has never declared or paid cash dividends and does not anticipate doing so in the foreseeable future, planning to retain all earnings for growth and operations[199](index=199&type=chunk) - The company issued common stock to non-employee directors for compensation on multiple dates in fiscal years 2021, 2022, and 2023[201](index=201&type=chunk) - In May 2022, the company issued warrants in a private placement to purchase **1,438,202 shares** of common stock at an exercise price of **$6.60 per share**[204](index=204&type=chunk) - Between February and May 2021, the company issued **$6,610,550** in **12% unsecured convertible promissory notes** and warrants to purchase **761,912 shares** of common stock in a private placement[206](index=206&type=chunk) [ITEM 6. RESERVED](index=38&type=section&id=Item%206.%20Reserved) This item is reserved and contains no information [ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=38&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company, a development-stage medical device firm, continues to incur operating losses and negative cash flows, raising substantial doubt about its going concern ability without additional capital - The company is a development-stage medical device company focused on an innovative insulin pump, MODD1, aiming to expand the wearable insulin delivery device market[209](index=209&type=chunk) - The company has historically financed operations through private placements and public offerings of common stock and convertible promissory notes[210](index=210&type=chunk) - Substantial doubt exists about the company's ability to continue as a going concern for at least one year from the financial statement issuance date due to expected operating losses and cash burn[210](index=210&type=chunk)[222](index=222&type=chunk) Research and Development Expenses (YoY Change) | Metric | Fiscal 2023 ($) | Fiscal 2022 ($) | YoY Change ($) | YoY Change (%) | | :------------------------- | :-------------- | :-------------- | :------------- | :------------- | | Research and Development | 9,061,744 | 7,729,240 | 1,332,504 | 17.2% | - R&D expenses increased primarily due to a **$1.8 million** increase in engineering and operations personnel costs, a **$0.6 million** increase in stock-based compensation, and a **$0.4 million** increase in materials and supplies, partially offset by a **$1.4 million** decrease in consulting costs[217](index=217&type=chunk) General and Administrative Expenses (YoY Change) | Metric | Fiscal 2023 ($) | Fiscal 2022 ($) | YoY Change ($) | YoY Change (%) | | :------------------------- | :-------------- | :-------------- | :------------- | :------------- | | General and Administrative | 4,816,567 | 7,197,162 | (2,380,595) | (33.1)% | - G&A expenses decreased mainly due to a **$1.9 million** decrease in stock-based compensation, a **$0.5 million** decrease in personnel costs, and a **$0.3 million** reduction in consulting fees[220](index=220&type=chunk) Interest Expense (YoY Change) | Metric | Fiscal 2023 ($) | Fiscal 2022 ($) | YoY Change ($) | YoY Change (%) | | :------------- | :-------------- | :-------------- | :------------- | :------------- | | Interest Expense | — | 2,752,229 | (2,752,229) | (100)% | - Interest expense decreased to zero in fiscal 2023 as outstanding convertible and bridge promissory notes were retired in February 2022[221](index=221&type=chunk) - In May 2023, the company completed a public offering for net proceeds of approximately **$9.7 million**, which is crucial for funding future operations[222](index=222&type=chunk) Cash Flow Summary | Activity | Fiscal 2023 ($) | Fiscal 2022 ($) | | :----------------------- | :-------------- | :-------------- | | Net cash used in operating activities | (11,011,644) | (10,259,528) | | Net cash used in investing activities | (1,637,751) | (54,764) | | Net cash provided by financing activities | 7,372,347 | 17,922,199 | [ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=42&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This item is not required for the company [ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA](index=60&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The consolidated financial statements for Modular Medical, Inc. as of March 31, 2023, and 2022, present the company's financial position, operations, stockholders' equity, and cash flows, with the auditor highlighting going concern doubt - The independent auditor's report expresses substantial doubt about the company's ability to continue as a going concern due to incurred losses and the need for additional funds[246](index=246&type=chunk)[251](index=251&type=chunk) Consolidated Balance Sheet Highlights (March 31) | Metric | 2023 ($) | 2022 ($) | | :---------------------- | :---------- | :---------- | | Cash and cash equivalents | 3,799,324 | 9,076,372 | | Total Assets | 7,245,248 | 9,846,446 | | Total Liabilities | 2,169,272 | 1,009,656 | | Total Stockholders' Equity | 5,075,976 | 8,836,790 | | Accumulated Deficit | (48,458,707)| (34,579,771)| Consolidated Statements of Operations Highlights (Year Ended March 31) | Metric | 2023 ($) | 2022 ($) | | :---------------------- | :------------ | :------------ | | Research and development | 9,061,744 | 7,729,240 | | General and administrative | 4,816,567 | 7,197,162 | | Total operating expenses | 13,878,311 | 14,926,402 | | Net loss | (13,878,936) | (18,632,761) | | Net loss per share (Basic and diluted) | (1.28) | (2.74) | Consolidated Statements of Cash Flows Highlights (Year Ended March 31) | Activity | 2023 ($) | 2022 ($) |\n| :----------------------- | :------------ | :------------ | | Net cash used in operating activities | (11,011,644) | (10,259,528) | | Net cash used in investing activities | (1,637,751) | (54,764) | | Net cash provided by financing activities | 7,372,347 | 17,922,199 | | Cash and cash equivalents, at end of year | 3,799,324 | 9,076,372 | - The company expenses research and development expenditures as incurred and recognizes stock-based compensation using the Black-Scholes pricing model[278](index=278&type=chunk)[290](index=290&type=chunk) - A full valuation allowance has been recorded against net deferred tax assets, as management believes it is more likely than not that these assets will not be fully realized[296](index=296&type=chunk)[331](index=331&type=chunk) - The company had net operating loss carryforwards of approximately **$29.5 million** (federal) and **$36.6 million** (state) as of March 31, 2023[328](index=328&type=chunk) - In May 2023, the company completed an underwritten offering, selling **8,816,900 shares** of common stock and warrants to purchase **4,408,450 shares**, generating approximately **$9.4 million** in gross proceeds[342](index=342&type=chunk) [ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE](index=43&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) There have been no changes in or disagreements with the company's accountants on accounting and financial disclosure matters [ITEM 9A. CONTROLS AND PROCEDURES](index=43&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of March 31, 2023, with no material changes in the fourth fiscal quarter - As of March 31, 2023, the company's disclosure controls and procedures were evaluated and deemed effective[349](index=349&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of March 31, 2023, based on the COSO framework[353](index=353&type=chunk) - No material changes in internal control over financial reporting occurred during the fourth fiscal quarter of 2023[354](index=354&type=chunk) [ITEM 9B. OTHER INFORMATION](index=44&type=section&id=Item%209B.%20Other%20Information) This item contains no other information [ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS](index=44&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company Part III [ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE](index=45&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) The company's leadership includes key executives and independent directors, with the board overseeing risk management through established committees, though some Section 16(a) reports were delinquent Directors and Executive Officers (as of March 31, 2023) | Name | Age | Position | | :-------------- | :-- | :-------------------------------------------- | | James Besser | 47 | Chief Executive Officer | | Paul DiPerna | 64 | President, CFO, Treasurer, Chairman of Board | | Kevin Schmid | 63 | Chief Operating Officer | | William J. Febbo| 54 | Director | | Steven Felsher | 74 | Director | | Morgan C. Frank | 51 | Director | | Philip Sheibley | 64 | Director | | Carmen Volkart | 62 | Director | | Ellen O'Connor Vos| 67 | Director | - Paul DiPerna, a co-founder of Tandem Diabetes Care, Inc., holds approximately **70 patents** in medical device and microfluidic technology and has extensive experience in the diabetes industry[361](index=361&type=chunk) - Kevin Schmid, COO since July 2022, has over **19 years of experience** in medical device senior management and high-volume global manufacturing operations[362](index=362&type=chunk) - The board of directors oversees risk management and has established independent Audit, Compensation, and Nominating and Governance Committees[385](index=385&type=chunk)[386](index=386&type=chunk)[388](index=388&type=chunk)[389](index=389&type=chunk)[391](index=391&type=chunk) - The company has adopted a Code of Business Conduct and Ethics applicable to all employees, executive officers, and directors[393](index=393&type=chunk) - Several directors and executive officers (Mr. Felsher, Mr. Frank, Mr. Sheibley, Mr. Schmid, Ms. Volkart, and Ms. Vos) had delinquent Section 16(a) reports in fiscal 2023[396](index=396&type=chunk)[397](index=397&type=chunk) [ITEM 11. EXECUTIVE COMPENSATION](index=53&type=section&id=Item%2011.%20Executive%20Compensation) Executive compensation for fiscal years 2023 and 2022 is detailed, with Paul DiPerna as the highest-compensated executive in 2023 and non-employee directors receiving annual retainers and equity awards Summary Compensation Table (Fiscal Years 2023 and 2022) | Name and Principal Position | Year | Salary ($) | Option Awards ($) | Total ($) | | :-------------------------- | :--- | :--------- | :---------------- | :-------- | | James E. Besser, CEO | 2023 | — | — | — | | | 2022 | — | — | — | | Paul DiPerna, President, CFO, Treasurer, Chairman | 2023 | 300,000 | 189,413 | 489,413 | | | 2022 | 370,833 | — | 370,833 | | Kevin Schmid, COO | 2023 | 176,121 | 701,945 | 878,066 | | | 2022 | — | — | — | | Ellen O'Connor Vos, CEO | 2023 | — | — | — | | | 2022 | 133,654 | 4,414,645 | 4,957,961 | - Paul DiPerna's 2022 salary included **$70,833** of deferred salary[402](index=402&type=chunk) - Kevin Schmid was appointed COO in July 2022 with an annual base salary of **$250,000** and was granted a stock option to purchase **175,000 shares**[381](index=381&type=chunk)[403](index=403&type=chunk) - Ellen O'Connor Vos resigned as CEO in February 2022 and received separation payments totaling **$375,000**[380](index=380&type=chunk)[404](index=404&type=chunk) Non-Employee Director Compensation (Fiscal 2023) | Name | Fee Compensation ($) | Option Awards ($) | Total ($) | | :---------------- | :------------------- | :---------------- | :-------- | | William Febbo | 30,000 | — | 60,795 | | Steven Felsher | — | 84,135 | 97,474 | | Morgan Frank | — | 114,734 | 114,734 | | Philip Sheibley | 30,000 | — | 60,795 | | Carmen Volkart | — | 84,135 | 95,254 | | Ellen O'Connor Vos| 6,250 | 59,530 | 65,780 | - Non-employee directors receive annual retainers (**$25,000** for board service, **$5,000** for committee chairs) and an annual service equity award of **$100,000**, payable in cash, options, or common stock[419](index=419&type=chunk)[424](index=424&type=chunk) [ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS](index=57&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of June 15, 2023, executive officers, directors, and certain affiliates beneficially owned approximately 32.33% of outstanding common stock, with key individuals and entities holding significant stakes Security Ownership (as of June 15, 2023) | Name | Number of Shares Beneficially Owned (Excluding Options and Warrants) | Number of Shares Issuable on Exercise of Outstanding Options and Warrants | Percent of Class | | :------------------------------------ | :------------------------------------------------------------------- | :------------------------------------------------------------------------ | :--------------- | | JEB Partners, L.P. | 2,720,577 | 653,511 | 15.52% | | Manchester Explorer, L.P. | 2,720,577 | 653,511 | 15.52% | | Manchester Management Company, LLC | 2,720,577 | 653,511 | 15.52% | | Sio Capital Management, LLC | 689,352 | 1,348,314 | 9.08% | | James Besser | 2,720,577 | 653,511 | 15.52% | | Paul DiPerna | 2,553,586 | 204,512 | 12.95% | | Morgan C. Frank | 2,720,577 | 793,469 | 16.06% | | All current directors and executive officers as a group (9 persons) | 5,533,188 | 1,441,459 | 32.33% | - Beneficial ownership is based on **21,088,823 shares** of common stock outstanding as of June 15, 2023[427](index=427&type=chunk) - James Besser and Morgan C. Frank, through Manchester Management Company, LLC, have shared voting and dispositive power over shares held by Manchester Explorer, L.P. and JEB Partners, L.P.[430](index=430&type=chunk) - Paul DiPerna's beneficial ownership includes shares held by the Paul DiPerna Irrevocable Trust and Paul DiPerna Trust, over which he has sole voting power[430](index=430&type=chunk) [ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE](index=59&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The company engaged in various related party transactions, and the board determined most directors are independent according to NASDAQ and SEC standards - Paul DiPerna's daughter is an employee and was paid **$201,275** in fiscal 2023, including stock option fair value[432](index=432&type=chunk) - Mr. DiPerna and Manchester Explorer, L.P. (represented by Mr. Frank) purchased convertible notes and received warrants, which later converted into common stock and additional warrants[433](index=433&type=chunk) - Mr. Febbo purchased convertible notes and received warrants, which also converted into common stock and additional warrants[434](index=434&type=chunk) - Mr. DiPerna and Ms. Vos purchased common stock in a private placement in October 2021[435](index=435&type=chunk) - All current directors, except Paul DiPerna, Morgan C. Frank, and Ellen O'Connor Vos, are considered 'independent' by NASDAQ and SEC standards[437](index=437&type=chunk) [ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES](index=59&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Farber Hass Hurley LLP billed $58,600 in total audit and audit-related fees for fiscal year 2023, an increase from $53,200 in fiscal 2022 Principal Accountant Fees and Services | Fee Type | Year Ended March 31, 2023 ($) | Year Ended March 31, 2022 ($) | | :---------------- | :---------------------------- | :---------------------------- | | Audit fees | 52,500 | 43,000 | | Audit-related fees| 6,100 | 10,200 | | Total | 58,600 | 53,200 | - Audit fees increased by **$9,500** (**22.1%**) from fiscal 2022 to fiscal 2023[439](index=439&type=chunk) - Audit-related fees decreased by **$4,100** (**40.2%**) from fiscal 2022 to fiscal 2023[439](index=439&type=chunk) - Farber Hass Hurley LLP did not provide any non-audit or other services beyond audit and audit-related fees[439](index=439&type=chunk) Part IV [ITEM 15. EXHIBITS](index=60&type=section&id=Item%2015.%20Exhibits) This section lists all exhibits filed as part of the Form 10-K, including underwriting agreements, corporate documents, equity incentive plans, and employment agreements - The exhibits include key corporate documents such as the Underwriting Agreement (May 15, 2023), Reorganization and Share Exchange Agreement (July 24, 2017), and Amended and Restated Articles of Incorporation[442](index=442&type=chunk) - Equity-related exhibits include the 2017 Equity Incentive Plan, various forms of warrants (Common Stock, Pre-Funded, Private Placement, Underwriter's), and Common Stock Purchase Agreements[442](index=442&type=chunk) - Employment and related agreements for key executives like Paul DiPerna, Ellen O'Connor Vos, and Kevin Schmid are also listed[442](index=442&type=chunk) [ITEM 16. FORM 10K SUMMARY](index=61&type=section&id=Item%2016.%20Form%2010K%20Summary) This item is not applicable to the company

As filed with the Securities and Exchange Commission on May 12, 2023 Registration No. 333-271413 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MODULAR MEDICAL, INC. (Exact name of registrant as specified in its charter) | Nevada | | --- | (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Nevada 3841 87-0620495 (I.R.S. Employer Ide ...

As filed with the Securities and Exchange Commission on May 5, 2023 Registration No. 333-271413 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MODULAR MEDICAL, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Nevada 3841 87-0620495 (I.R.S. Employer Identification Number) ...

As filed with the Securities and Exchange Commission on April 24, 2023 Registration No. 333-[●] UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MODULAR MEDICAL, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Nevada 3841 87-0620495 (I.R.S. Employer Identification Number) 10740 Thornmint Dri ...

PART I — FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents unaudited condensed consolidated financial statements, including balance sheets, statements of operations, equity, and cash flows, with notes on accounting policies, leases, debt, and equity [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased from **$9.85 million** to **$8.74 million**, driven by reduced cash; liabilities and equity also declined ASSETS | ASSETS | | | :--- | :--- | | **CURRENT ASSETS** | | | Cash and cash equivalents (Dec 31, 2022) | $7,690,957 | | Cash and cash equivalents (Mar 31, 2022) | $9,076,372 | | **TOTAL ASSETS** | | | December 31, 2022 | $8,738,842 | | March 31, 2022 | $9,846,446 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | **TOTAL LIABILITIES** | | | December 31, 2022 | $715,297 | | March 31, 2022 | $1,009,656 | | **TOTAL STOCKHOLDERS' EQUITY** | | | December 31, 2022 | $8,023,545 | | March 31, 2022 | $8,836,790 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a net loss of **$(3.36 million)** for the three months ended December 31, 2022, an improvement from **$(4.84 million)** in the prior year period Condensed Consolidated Statements of Operations | Metric | Three Months Ended Dec 31, 2022 | Three Months Ended Dec 31, 2021 | Nine Months Ended Dec 31, 2022 | Nine Months Ended Dec 31, 2021 | | :-------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Research and development | $2,196,546 | $1,849,399 | $6,804,069 | $5,742,911 | | General and administrative | $1,161,351 | $1,981,665 | $3,502,029 | $5,156,152 | | Total operating expenses | $3,831,064 | $3,357,897 | $10,306,098 | $10,899,063 | | Loss from operations | $(3,831,064) | $(3,357,897) | $(10,306,098) | $(10,899,063) | | Net loss | $(3,358,484) | $(4,841,307) | $(10,307,682) | $(14,058,154) | | Net loss per share (Basic and diluted) | $(0.31) | $(0.76) | $(0.95) | $(2.22) | [Condensed Consolidated Statements of Stockholders' Equity (Deficit)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficit)) Stockholders' equity decreased from **$8.84 million** to **$8.02 million**, primarily due to net losses, partially offset by equity offerings and stock-based compensation Stockholders' Equity (Deficit) | Metric | March 31, 2022 | December 31, 2022 | | :-------------------------- | :--------------- | :---------------- | | Common Stock Amount | $10,462 | $10,932 | | Additional Paid-In Capital | $43,406,099 | $52,900,066 | | Accumulated Deficit | $(34,579,771) | $(44,887,453) | | Total Stockholders' Equity | $8,836,790 | $8,023,545 | - Issuance of common stock and warrants in equity offering, net, contributed **$7,372,347** to additional paid-in capital as of June 30, 2022[15](index=15&type=chunk) - Stock-based compensation recognized during the nine months ended December 31, 2022, totaled **$2,043,641**[15](index=15&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$(8.18 million)**, while financing activities provided **$7.37 million**, primarily from equity offerings Cash Flow Summary | Cash Flow Activity | Nine Months Ended Dec 31, 2022 | Nine Months Ended Dec 31, 2021 | | :------------------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(8,184,696) | $(7,128,787) | | Net cash used in investing activities | $(573,066) | $(22,779) | | Net cash provided by financing activities | $7,372,347 | $5,887,199 | | Net decrease in cash and cash equivalents | $(1,385,415) | $(1,264,367) | | Cash and cash equivalents at end of period | $7,690,957 | $204,098 | - Financing activities in 2022 were primarily driven by **$7,372,347** from the issuance of common stock and warrants, net[17](index=17&type=chunk) - Financing activities in 2021 included **$4,137,199** from convertible notes, **$250,000** from private placement, and **$1,500,000** from a promissory note[17](index=17&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed disclosures on the Company's business, accounting policies, lease obligations, debt, equity, stock-based compensation, income taxes, commitments, and subsequent events [NOTE 1 – THE COMPANY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=8&type=section&id=NOTE%201%20%E2%80%93%20THE%20COMPANY%20AND%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) Modular Medical, Inc. is a development-stage medical device company focused on an innovative insulin pump, facing substantial doubt about its going concern ability due to expected operating losses - Modular Medical, Inc. is a development-stage medical device company focused on the design, development, and eventual commercialization of an innovative insulin pump[21](index=21&type=chunk) - The Company expects to continue to incur operating losses and cash outflows, raising substantial doubt about its ability to continue as a going concern within one year, requiring additional capital[24](index=24&type=chunk) Fixed Assets | Fixed Assets | | | | :------------------------------------ | :------------------ | :----------------- | | | December 31, 2022 | March 31, 2022 | | Machinery and equipment | $487,855 | $346,358 | | Construction-in-process | $427,670 | $— | | Leasehold improvements | $139,197 | $139,197 | | Total property and equipment | $1,054,722 | $485,555 | | Less: accumulated depreciation and amortization | $(338,313) | $(249,596) | | Total property and equipment, net | $716,409 | $235,959 | Anti-Dilutive Securities (Nine Months Ended Dec 31) | Anti-Dilutive Securities (Nine Months Ended Dec 31) | | | | :------------------------ | :--------- | :--------- | | | 2022 | 2021 | | Options to purchase common stock | 2,174,198 | 1,967,188 | | Common stock warrants | 7,565,588 | 767,796 | | Total | 9,739,786 | 2,734,984 | [NOTE 2 – LEASES](index=13&type=section&id=NOTE%202%20%E2%80%93%20LEASES) The Company leases its corporate facility in San Diego, California, with a 39-month term commencing April 1, 2020, and lease liabilities are measured using an 11% discount rate - The Company accounts for its corporate facility lease in San Diego, California, in accordance with ASC No. 842, with a 39-month term commencing April 1, 2020[52](index=52&type=chunk) Future Minimum Lease Payments (as of Dec 31, 2022) | Future Minimum Lease Payments (as of Dec 31, 2022) | | | :------------------ | :-------------- | | Annual Fiscal Years | Operating Lease | | 2023 | $39,507 | | 2024 | $40,692 | | Less: Imputed interest | $(2,527) | | Present value of lease liabilities | $77,672 | - Rent expense was **$80,698** for both the nine-month periods ended December 31, 20

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: September 30, 2022 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-41277 MODULAR MEDICAL, INC. (Exact name of registrant as specified in its charter) Nevada 87-0620495 (State or other juris ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: June 30, 2022 o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-41277 MODULAR MEDICAL, INC. (Exact name of registrant as specified in its charter) Nevada 87-0620495 (State or other jurisdiction of ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: March 31, 2022 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-41277 MODULAR MEDICAL, INC. (Exact name of registrant as specified in its charter) Nevada 87-0620495 (State or Other Jurisdiction of I ...

| --- | --- | --- | --- | --- | --- | |------------------------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | O MODULAR | | | | | | | MEDICAL | | | | | | | Investor Presentation. | | | | | | | | | | | | | | NASDAQ:MODD | | | | | | 2 | Forward Looking Statements, Other Disclaimers. THIS SUMMARY IS PROVIDED ON A CONFIDENTIAL AND LIMITED BASIS, SOLELY FOR YOUR USE AS A PART OF YOUR DETERMINATION OF WHETHER TO INVEST IN THE OPPORTUNITY. THIS SUMMARY IS BEING ...

PART I: FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, including the balance sheets, statements of operations, stockholders' equity (deficit), and cash flows, along with detailed notes explaining significant accounting policies, debt instruments, equity changes, and subsequent events [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights | Metric | December 31, 2021 (Unaudited) (USD) | March 31, 2021 (USD) | | :-------------------------- | :------------------------------ | :--------------- | | Cash and cash equivalents | $204,098 | $1,468,465 | | Total Current Assets | $268,651 | $1,649,089 | | Total Assets | $751,839 | $2,248,171 | | Total Current Liabilities | $8,921,262 | $3,296,965 | | Total Liabilities | $8,998,474 | $3,523,320 | | Total Stockholders' Deficit | $(8,246,635) | $(1,275,149) | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Condensed Consolidated Statements of Operations Highlights | Metric | Three Months Ended Dec 31, 2021 (USD) | Three Months Ended Dec 31, 2020 (USD) | Nine Months Ended Dec 31, 2021 (USD) | Nine Months Ended Dec 31, 2020 (USD) | | :------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Research and development | $1,849,399 | $1,086,669 | $5,742,911 | $3,150,149 | | General and administrative | $1,981,665 | $783,898 | $5,156,152 | $2,453,808 | | Total operating expenses | $3,831,064 | $1,870,567 | $10,899,063 | $5,603,957 | | Loss from operations | $(3,831,064) | $(1,870,567) | $(10,899,063) | $(5,603,957) | | Interest expense | $(1,010,247) | $0 | $(2,204,917) | $0 | | Net loss | $(4,841,307) | $(1,870,545) | $(14,058,155) | $(5,605,431) | | Net loss per share (Basic and diluted) | $(0.76) | $(0.30) | $(2.22) | $(0.91) | [Condensed Consolidated Statements of Stockholders' Equity (Deficit)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity%20(Deficit)) Stockholders' Deficit Changes (Nine Months Ended Dec 31, 2021) | Item | Amount (USD) | | :------------------------------------ | :----------- | | Balance as of March 31, 2021 | $(1,275,149) | | Shares issued for services | $172,200 | | Warrants issued with convertible notes| $3,700,632 | | Stock-based compensation | $2,740,073 | | Net loss | $(14,058,155)| | Balance as of December 31, 2021 | $(8,246,635) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows Highlights (Nine Months Ended) | Cash Flow Activity | December 31, 2021 (USD) | December 31, 2020 (USD) | | :----------------- | :---------------- | :---------------- | | Operating | $(7,128,787) | $(4,570,713) | | Investing | $(22,779) | $(109,541) | | Financing | $5,887,199 | $2,154,662 | | Net decrease | $(1,264,367) | $(2,525,592) | | Cash at end of period | $204,098 | $596,542 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed explanations and disclosures for the condensed consolidated financial statements, covering the company's business, significant accounting policies, lease obligations, PPP loan forgiveness, convertible and promissory notes, stockholders' equity, income taxes, related party transactions, commitments, contingencies, and subsequent events [NOTE 1 – THE COMPANY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=8&type=section&id=NOTE%201%20%E2%80%93%20THE%20COMPANY%20AND%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) - Modular Medical, Inc. is a development-stage medical-device company focused on designing, developing, and commercializing an innovative two-part insulin patch pump for both type 1 and type 2 diabetes markets[23](index=23&type=chunk) - The Company expects to continue incurring operating losses and cash outflows, raising substantial doubt about its ability to continue as a going concern within one year, necessitating additional capital raises[25](index=25&type=chunk) - A **1-for-3 reverse stock split** was effective November 29, 2021, combining every three shares of common stock into one, with proportionate adjustments to voting rights, options, and warrants[29](index=29&type=chunk) [NOTE 2 – LEASES](index=11&type=section&id=NOTE%202%20%E2%80%93%20LEASES) Future Minimum Lease Payments (as of December 31, 2021) | Annual Fiscal Years | Operating Lease (USD) | | :------------------ | :-------------- | | 2022 | $38,358 | | 2023 | $158,028 | | 2024 | $40,692 | | Less: Imputed interest | $(20,049) | | Present value of lease liabilities | $217,029 | - Cash paid for lease liabilities was **$115,073** for the nine months ended December 31, 2021[47](index=47&type=chunk) [NOTE 3 – PPP NOTE](index=12&type=section&id=NOTE%203%20%E2%80%93%20PPP%20NOTE) - The Company received a **$368,780 PPP Note** in April 2020, which was fully forgiven in May 2021, and recorded as a gain on extinguishment in other income[48](index=48&type=chunk)[49](index=49&type=chunk) [NOTE 4 – CONVERTIBLE PROMISSORY NOTES](index=12&type=section&id=NOTE%204%20%E2%80%93%20CONVERTIBLE%20PROMISSORY%20NOTES) - In April and May 2021, the Company sold **$4,250,000 in convertible promissory notes** and warrants, bearing **12% annual interest** (16% upon default) and convertible at **$8.61 per share** after 270 days[51](index=51&type=chunk)[52](index=52&type=chunk) - The fair value of warrants issued with convertible notes was **$3,700,632**, with **$2,379,182** recorded as a debt discount and **$1,321,450** as a loss on debt extinguishment[57](index=57&type=chunk) - Interest expense attributable to debt discount (issuance costs and warrants) was **$630,323** for the three months and **$1,454,762** for the nine months ended December 31, 2021[58](index=58&type=chunk) [NOTE 5 – PROMISSORY NOTE](index=13&type=section&id=NOTE%205%20%E2%80%93%20PROMISSORY%20NOTE) - On October 28, 2021, the Company issued a secured promissory note (Bridge Note) to Manchester Explorer, L.P., providing a **$3,000,000 revolving credit facility** due March 15, 2022, with a **12% interest rate**[60](index=60&type=chunk) - During the quarter ended December 31, 2021, the Company drew **$1,500,000** on the Bridge Note and incurred **$180,000** in interest charges[64](index=64&type=chunk) [NOTE 6 – STOCKHOLDERS' DEFICIT AND STOCK-BASED COMPENSATION](index=14&type=section&id=NOTE%206%20%E2%80%93%20STOCKHOLDERS%27%20DEFICIT%20AND%20STOCK-BASED%20COMPENSATION) - During the three months ended December 31, 2021, the Company sold **30,865 common shares** to officers, issued **8,334 shares** to a service provider, and **5,775 shares** to non-employee directors[65](index=65&type=chunk) - Stock-based compensation expense for the nine months ended December 31, 2021, was **$1,769,805**, with an unamortized cost of **$7,419,022** expected to be recognized over approximately two years[67](index=67&type=chunk)[68](index=68&type=chunk) Stock Option Activity (Nine Months Ended Dec 31, 2021) | Metric | Number of Shares | | :-------------------------------- | :--------------- | | Balance at March 31, 2021 | 1,197,252 | | Options granted | 723,269 | | Options cancelled and returned | (67,990) | | Balance at December 31, 2021 | 1,845,953 | | Options Exercisable (Dec 31, 2021)| 1,011,586 | | Weighted Average Exercise Price (Outstanding) | $7.57 | | Weighted Average Exercise Price (Exercisable) | $5.10 | [NOTE 7 – INCOME TAXES](index=16&type=section&id=NOTE%207%20%E2%80%93%20INCOME%20TAXES) - The Company has recorded a full valuation allowance against its federal and state net deferred tax assets, as management believes it is more likely than not that they will not be fully realized[75](index=75&type=chunk) [NOTE 8 – RELATED PARTY TRANSACTIONS](index=16&type=section&id=NOTE%208%20%E2%80%93%20RELATED%20PARTY%20TRANSACTIONS) - Related parties, including the chairman/president and an investor, held convertible notes totaling **$1,129,293** in principal and accrued interest as of December 31, 2021[77](index=77&type=chunk)[78](index=78&type=chunk) - The CEO and Chairman/CFO purchased **30,864 shares** of common stock for **$250,000** in October 2021[79](index=79&type=chunk) [NOTE 9 – COMMITMENTS AND CONTINGENCIES](index=17&type=section&id=NOTE%209%20%E2%80%93%20COMMITMENTS%20AND%20CONTINGENCIES) - The Company is involved in legal proceedings, claims, and assessments in the normal course of business but has not made any payments or received claims under indemnification agreements with officers and directors[81](index=81&type=chunk)[82](index=82&type=chunk) [NOTE 10 – SUBSEQUENT EVENTS](index=17&type=section&id=NOTE%2010%20%E2%80%93%20SUBSEQUENT%20EVENTS) - Subsequent to December 31, 2021, the Company made additional draws totaling **$600,000** under the Bridge Note[83](index=83&type=chunk) - On February 9, 2022, the Company completed a public offering of **2,500,000 common shares** and **2,500,000 warrants** at **$6.00 per unit**, generating **$15 million in gross proceeds**, and listed on Nasdaq Capital Market under 'MODD'[84](index=84&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition, results of operations, and liquidity for the reported periods. It highlights the company's development-stage status, the impact of COVID-19, critical accounting policies, and detailed analysis of operating expenses and capital resources, emphasizing the going concern risk and need for future financing - The Company is a development-stage medical device company focused on an innovative insulin pump, targeting both type 1 and type 2 diabetes markets[90](index=90&type=chunk) - Substantial doubt exists about the Company's ability to continue as a going concern due to ongoing operating losses and negative cash flows, necessitating additional capital raises[91](index=91&type=chunk)[102](index=102&type=chunk) [Company Overview](index=18&type=section&id=Company%20Overview) - Modular Medical, Inc. is a development-stage medical device company focused on designing, developing, and commercializing an innovative two-part patch insulin pump (MODD1) to expand the wearable insulin delivery device market[90](index=90&type=chunk) [Impacts of COVID-19](index=19&type=section&id=Impacts%20of%20COVID-19) - COVID-19 has negatively affected the economy, supply chains, and financial markets, leading to longer lead times for components and potential delays for FDA submission[92](index=92&type=chunk)[93](index=93&type=chunk) - The Company's ability to raise additional capital to support future operations may be impacted by continued disruption and volatility in global capital markets[94](index=94&type=chunk) [Critical Accounting Policies and Estimates](index=19&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) - As of December 31, 2021, there have been no material changes to the Company's significant accounting policies and estimates[96](index=96&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) [Research and Development](index=19&type=section&id=Research%20and%20Development) Research and Development Expenses (YoY Change) | Period | 2021 (USD) | 2020 (USD) | Change (USD) | Change (%) | | :------------------------- | :---------- | :---------- | :----------- | :--------- | | Three months ended Dec 31 | $1,849,399 | $1,086,669 | $762,730 | 70.2% | | Nine months ended Dec 31 | $5,742,911 | $3,150,149 | $2,592,762 | 82.3% | - The increase in R&D expenses was primarily due to increased engineering and manufacturing consulting costs, personnel, prototype and production component costs, and stock-based compensation expenses[98](index=98&type=chunk) [General and Administrative](index=20&type=section&id=General%20and%20Administrative) General and Administrative Expenses (YoY Change) | Period | 2021 (USD) | 2020 (USD) | Change (USD) | Change (%) | | :------------------------- | :---------- | :---------- | :----------- | :--------- | | Three months ended Dec 31 | $1,981,665 | $783,898 | $1,197,767 | 152.8% | | Nine months ended Dec 31 | $5,156,152 | $2,453,808 | $2,702,344 | 110.1% | - The increase in G&A expenses was mainly driven by higher stock-based compensation expense and increased consulting and legal fees[100](index=100&type=chunk) [Interest Expense](index=20&type=section&id=Interest%20Expense) Interest Expense (YoY Change) | Period | 2021 (USD) | 2020 (USD) | Change (USD) | | :------------------------- | :---------- | :--------- | :----------- | | Three months ended Dec 31 | $1,010,247 | $0 | $(1,010,225) | | Nine months ended Dec 31 | $2,204,917 | $0 | $(2,204,791) | - Interest expense significantly increased due to interest incurred from convertible promissory notes and the promissory (bridge) note[101](index=101&type=chunk) [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) - The Company incurred a net loss of approximately **$14.1 million** for the nine months ended December 31, 2021, and had an accumulated deficit of approximately **$29.9 million**[102](index=102&type=chunk) - Cash used in operating activities was **$7,128,787** for the nine months ended December 31, 2021, compared to **$4,570,713** for the same period in 2020[104](index=104&type=chunk) - Cash provided by financing activities was **$5,887,199** for the nine months ended December 31, 2021, primarily from convertible notes (**$4,137,199 net**) and a promissory note (**$1,500,000**), and private placement of common stock (**$250,000**)[19](index=19&type=chunk)[106](index=106&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=21&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This item is not required for the Company - This item is not required[107](index=107&type=chunk) [Item 4. Controls and Procedures](index=21&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the Company's disclosure controls and procedures were effective as of December 31, 2021, and reported no material changes in internal control over financial reporting during the nine months ended December 31, 2021 - Management concluded that disclosure controls and procedures were **effective** as of December 31, 2021[109](index=109&type=chunk) - There were **no material changes** in internal control over financial reporting during the nine months ended December 31, 2021[110](index=110&type=chunk) PART II: OTHER INFORMATION [Item 1. Legal Proceedings](index=22&type=section&id=Item%201.%20Legal%20Proceedings) The Company reported no legal proceedings - There are no legal proceedings[113](index=113&type=chunk) [Item 1A. Risk Factors](index=22&type=section&id=Item%201A.%20Risk%20Factors) This section reiterates significant business risks, including the ongoing and uncertain adverse effects of the COVID-19 pandemic on operations, supply chains, and the ability to raise capital, which could materially impact the Company's financial condition and results - The full effects of COVID-19 are uncertain and could materially and adversely affect the Company's business, financial condition, operating results, and cash flows, particularly impacting supply chains and workforce effectiveness[115](index=115&type=chunk)[116](index=116&type=chunk)[117](index=117&type=chunk) - The Company may be unable to access capital markets or secure additional capital on favorable terms, which is crucial for future operations, given the ongoing disruption and volatility caused by COVID-19[118](index=118&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=22&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details recent unregistered sales of common stock, including issuances to non-employee directors, service providers, and executive officers, totaling 30,864 shares to officers for $250,000 - On December 31, 2021, **5,775 shares** of common stock were issued to non-employee directors[119](index=119&type=chunk) - On October 22, 2021, **8,834 shares** of common stock were issued to service providers[119](index=119&type=chunk) - On October 28, 2021, **30,864 shares** of common stock were sold to two executive officers for gross proceeds of **$250,000**[121](index=121&type=chunk) [Item 3. Defaults Upon Senior Securities](index=23&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The Company reported no defaults upon senior securities - There are no defaults upon senior securities[122](index=122&type=chunk) [Item 4. Mine Safety Disclosures](index=23&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the Company - This item is not applicable[123](index=123&type=chunk) [Item 5. Other Information](index=23&type=section&id=Item%205.%20Other%20Information) The Company reported no other information - There is no other information to report[124](index=124&type=chunk) [Item 6. Exhibits](index=23&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, debt agreements, stock purchase agreements, and certifications Key Exhibits Filed | Exhibit No. | Description of Document | | :---------- | :---------------------- | | 3.1 | Certificate of Amendment and Second Amended and Restated Articles of Incorporation | | 3.2 | Certificate of Amendment to the Amended and Restated Articles of Incorporation | | 10.27 | Promissory Note dated October 28, 2021 | | 10.28 | Security Agreement dated October 28, 2021 | | 10.29 | Form of Common Stock Purchase Agreement dated October 28, 2021 | | 31.1 | Certification of Ellen O'Connor Vos pursuant to Section 302 of SOX | | 31.2 | Certification of Paul M. DiPerna pursuant to Section 302 of SOX | | 32.1 | Certification of Ellen O'Connor Vos and Paul M. DiPerna pursuant to 18 U.S.C. Section 1350 | | 101.INS | XBRL Instance Document | [Signatures](index=24&type=section&id=Signatures) This section contains the official signatures of the Company's Chief Executive Officer and Chief Financial Officer, certifying the accuracy and completeness of the quarterly report - The report is signed by Ellen O'Connor Vos, Chief Executive Officer, and Paul M. DiPerna, Chief Financial Officer, on February 14, 2022[130](index=130&type=chunk)