S-1 1 ea175878-s1_modularmedical.htm REGISTRATION STATEMENT

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)

Nevada		3841		87-0620495
(State or other jurisdiction of incorporation or organization)		(Primary Standard Industrial Classification Code Number)		(I.R.S. Employer Identification Number)

10740 Thornmint Drive

San Diego, California 92127

(858) 800-3500

(Address, including zip code, and telephone number, including

area code, of registrant’s principal executive offices)

James E. Besser

Chief Executive Officer

10740 Thornmint Drive

San Diego, California 92127

(858) 800-3500

(Name, address, including zip code, and telephone

number, including area code, of agent for service)

With copies to:

Joseph Lucosky

Lawrence Metelitsa

Lucosky Brookman LLP

101 Wood Avenue South

Woodbridge, NJ 08830

(732) 395-4400

Stephen E. Older

David S. Wolpa

McGuireWoods LLP

1251 Avenue of the Americas, 20th Floor

New York, NY 10020

(212) 548-2100

As soon as practicable after the effective date of this registration statement

(Approximate date of commencement of proposed sale to the public)

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐	Accelerated filer ☐
Non-accelerated Filer ☒	Smaller reporting company ☒
	Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act, or until the registration statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

SUBJECT TO COMPLETION, DATED , 2023

PRELIMINARY PROSPECTUS

Units

Each Unit Consisting of Two Shares of Common Stock and

One Warrant to Purchase One Share of Common Stock

We are offering units (each a “unit” and collectively, the “units”) of Modular Medical, Inc. (the “Company,” “Modular Medical,” “we,” “our” or “us”) with each unit consisting of two shares of our common stock, par value $0.001 per share, which we refer to as the “common stock,” and one warrant (a “warrant”) to purchase one share of our common stock. The public offering price is $ per unit. The units have no stand-alone rights and will not be certificated or issued as stand-alone securities. We do not intend to apply for listing of the warrants on any national securities exchange. The shares of our common stock and the warrants comprising the units will be issued separately. The warrants included in the units are exercisable immediately, will expire five years from the date of issuance and have an exercise price of $ per share ( % of the price per unit sold in this offering.) This offering also includes the shares of common stock issuable from time to time upon exercise of the warrants. The warrants will be issued in book-entry form pursuant to a warrant agency agreement between us and Colonial Stock Transfer Company, Inc. as warrant agent.

Our common stock is listed on the Nasdaq Capital Market, or Nasdaq, under the symbol “MODD.” On April 21, 2023, the last reported sale price of our common stock was $1.90 per share. The public offering price per unit will be determined at the time of pricing and may be at a discount to the current market price. The recent market price used throughout this prospectus may not be indicative of the final offering price. There is no established trading market for the warrants, and we do not expect a market to develop.

	Effective Price Per Share and Accompanying Warrant	Total
Public offering price⁽¹⁾	$	$
Underwriting discounts and commissions⁽²⁾	$	$
Proceeds to us (before expenses)	$	$

⁽¹⁾

Based on a price of $ per unit, with each unit consisting of two (2) shares of common stock and one warrant to purchase one share of common stock.

⁽²⁾

The underwriter will receive compensation in addition to the underwriting discount. See “Underwriting” beginning on page 70.

⁽³⁾

The amount of offering proceeds to us presented in this table does not give effect to any exercise of the: (i) over-allotment Option we have granted to the underwriter as described below and (ii) the Underwriter’s Warrants (as defined herein) being issued to the underwriter as described below.

Investing in our securities involves a high degree of risk. See “Risk Factors,” beginning on page 10.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.

The underwriter expects to deliver the units to investors on or about , 2023.

Sole Book-Running Manager

Newbridge Securities Corporation

The date of this prospectus is , 2023

TABLE OF CONTENTS

PROSPECTUS SUMMARY	1
THE OFFERING	6
SUMMARY FINANCIAL DATA	7
RISK FACTORS	10
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS	26
USE OF PROCEEDS	27
DIVIDEND POLICY	28
CAPITALIZATION	29
DILUTION	30
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	31
BUSINESS	35
MANAGEMENT	56
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS	67
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT	68
DESCRIPTION OF SECURITIES WE ARE OFFERING	70
UNDERWRITING	71
LEGAL MATTERS	74
EXPERTS	74
WHERE YOU CAN FIND MORE INFORMATION	74
INDEX TO FINANCIAL STATEMENTS	F-1
PART II INFORMATION NOT REQUIRED IN PROSPECTUS	II-1

We have not authorized anyone to provide any information or to make any representations other than those contained in this prospectus or in any free writing prospectuses we have prepared. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus is an offer to sell only the units offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. The information contained in this prospectus is current only as of its date.

For investors outside the United States: We have not, and the underwriter has not, done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than the United States. Persons outside of the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the units and the distribution of this prospectus outside of the United States.

Market and Other Industry Data

Unless otherwise indicated, market data and certain industry forecasts used throughout this prospectus were obtained from various sources, including from internal surveys, market research, consultant surveys, publicly available information and industry publications and surveys. While we believe these sources to be reliable, the accuracy and completeness of such information is not guaranteed. We have not independently verified any of the data from third-party sources nor have we ascertained the underlying economic assumptions relied upon therein. Similarly, internal surveys, industry forecasts and market research, which we believe to be reliable based upon our management’s knowledge of the industry, have not been independently verified. The future performance of the industry and markets in which we operate and intend to operate is necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the sections titled “Risk Factors” and “Special Note Regarding Forward-looking Statements” and elsewhere in this prospectus. These and other factors could cause results to differ materially from those expressed in these publications and reports.

All brand names or trademarks appearing in this prospectus are the property of their respective holders. Use or display by us of other parties’ trademarks, trade dress, or products in this prospectus is not intended to, and does not, imply a relationship with, or endorsements or sponsorship of, us by the trademark or trade dress owners.

PROSPECTUS SUMMARY

This summary highlights selected information contained elsewhere in this prospectus and does not contain all the information that you should consider before making your investment decision. Before investing in our securities, you should carefully read this entire prospectus, including the information set forth under the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of this prospectus and our consolidated financial statements and the accompanying notes included in this prospectus. Except as otherwise indicated herein or as the context otherwise requires, references in this prospectus to “Modular Medical,” the “Company,” “we,” “us,” and “our” refer to Modular Medical, Inc. and its wholly-owned subsidiary, Quasuras, Inc.

Overview

Modular Medical is a development-stage, medical device company focused on the design, development, and commercialization of an innovative insulin pump using modernized technology to increase pump adoption in the diabetes marketplace. Through the creation of a novel two-part patch pump, our MODD1 product candidate, or “MODD1,” the Company seeks 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 candidate seeks to serve both the type 1 and the rapidly growing, especially in terms of device adoption, type 2 diabetes markets.

Differentiation

We believe that there are a number of shortcomings and issues with currently available insulin pumps that prevent a substantial number of people who require insulin on a daily basis from choosing an insulin pump to treat their diabetes. We believe that by tailoring our insulin pump to address such factors, we can expand the scope and adoption rate of insulin pump usage. We believe that to achieve broader market acceptance, an insulin pump must improve the clinical experience of the user, be easier to learn and use, less time-consuming to operate, more intuitive to both patients and physicians, and meet the standards for coverage by insurance providers so that co-payments required from patients are affordable and the hurdles to insurance coverage are significantly reduced.

Among the more prominent issues are:

●

Complexity: Many existing pumps are highly complex and require significant technical expertise to use effectively. We believe such pumps were designed for “super users,” who have high levels of motivation, technical competence and premium insurance coverage. The complexity of pumps proves daunting to less technically inclined users.

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Cumbersome: We believe that a majority of existing pumps are bulky and difficult to manage, in many cases requiring a pouch to hold the pump and up to 48 inches of tubing. The tubing and the cartridge, which holds the insulin, must be replaced every few days. This requires users to carry spare parts and other equipment adding to the difficulty of using the pump. In comparison, our product only requires a cartridge change every few days.

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Cost: Costs associated with insulin pump therapy are high and can be prohibitive, especially for those on fixed or limited incomes. These costs vary by pump, but multi-thousand-dollar upfront payments, often with substantial co-payments in addition to co-payments on consumables, can easily place current pumps out of reach for patients. This can lead to limited or restricted reimbursement/coverage and high hurdles for the patients, whom could benefit the most, to gain access.

Our team has substantial knowledge of the diabetes industry and experience in developing, obtaining regulatory authorization for, and bringing insulin pumps to market. Based on this experience, we believe that our innovative insulin pump, using a new, low cost and proprietary method of pumping insulin, can address most or all of these shortcomings. It provides a state-of-the-art insulin pump capable of both basal (steady flow) and bolus (mealtime dosing) insulin disbursement. It also has been designed considering a natural migration path to multi-chamber/multi-liquid pumps, potentially offering an exciting array of new therapies to patients with diabetes and other conditions in the future.

Our goal is to become the leader in expanding access to insulin pump technology to a wider portion of diabetes sufferers and provide not just care for the super users, but “diabetes care for the rest of us.”

The MODD1 is a high-precision product that we believe represents the best choice for new pump patients because it is easy to afford, easy to learn, easy to use, and has a revolutionary design and technology that enable precision with low-cost manufacture and high reproducibility.

Diabetes Classifications and Therapies

Diabetes is typically classified as either type 1, or “T1D,” or type 2, or “T2D”:

●

T1D is an auto-immune condition characterized by the body’s nearly complete inability to produce insulin. It is frequently diagnosed during childhood or adolescence, but can also onset in adulthood. Individuals with T1D require daily insulin therapy to survive.

●

T2D represents over 90% of all individuals diagnosed with diabetes and is characterized by the body’s inability to either properly utilize insulin or produce sufficient insulin. Initially, many people with T2D attempt to manage their condition with improvements in diet and exercise and/or the use of oral medications and/or injection of glucagon-like peptide-1 (GLP-1) drugs. However, as their diabetes advances, patients often progress to requiring insulin therapies such as once-daily long-acting insulin and ultimately to intensified mealtime rapid-acting insulin therapy. This represents an important portion of the diabetes market in the United States with an estimated 1.6 million T2D intensively treated (multiple daily injections) with insulin.

Glucose, the primary source of energy for cells, must be maintained at certain levels in the blood in order to permit optimal cell function and health. In people with diabetes, blood glucose levels are not well controlled and frequently become very high, a condition known as hyperglycemia, and very low, a condition called hypoglycemia. Hyperglycemia can lead to serious long-term complications, including blindness, kidney disease, nervous system disorders, occlusive vascular diseases, lower-limb amputation, stroke, cardiovascular disease, and death. Hypoglycemia can lead to confusion or loss of consciousness, often requiring a visit to the emergency room or, in certain cases, result in seizures, coma, and/or death.

All people with T1D, which is our primary market, require daily insulin. According to the Seagrove 2021 Diabetes Blue Book, approximately 18% of people with T2D in the United States, or approximately 4.7 million people, also require insulin. These 4.7 million people comprise 3.1 million who require multiple daily injections (“MDI”) and the remainder, 1.6 million, who require basal delivery only to manage their diabetes. In this prospectus, we refer to people with T1D and people with T2D who require mealtime insulin as “insulin-requiring people with diabetes.”

Currently, there are two primary therapies available for insulin-requiring people with diabetes: multiple daily insulin injections directly into the body through syringes or insulin pens (a type of syringe) or the use of an insulin pump to deliver mealtime insulin boluses (single doses) to help with glucose absorption after carbohydrate consumption along with a continuous subcutaneous insulin infusion, or “CSII therapy,” into the body. Generally, CSII therapy is considered to provide a number of advantages over MDI therapy, primarily an improvement in glycemic control, as measured by certain diabetes management tests such as hemoglobin A1c (HbA1c) measure and more recently Time in Range (TIR) where a continuous glucose measuring device is used to calculate this test. Among other clinical benefits, a study conducted by Tandem Diabetes Care, Inc. in 2021 demonstrated that insulin pump use can decrease glucose variability, reduce the number of hypoglycemia events, and reduce the fear of hypoglycemia.

Notwithstanding these advantages, the difficulty in use resulting from the complexity and cumbersome design of available insulin pumps, optimized for the well-motivated, educated and well-insured, as well as high and often prohibitive costs for both the patient and insurance provider has resulted not only in dissatisfaction among many existing pump users (fewer than half purchase a replacement pump after the warranty expires per a Seagrove Partners estimate in 2020), but also has severely limited the adoption rate of insulin pumps by a large segment of the MDI diabetes population, whom we refer to in this prospectus as “Almost Pumpers.”

We define Almost Pumpers as individuals who treat their diabetes with MDI. These individuals are aware of pumps, may have been on pumps and understand the potential benefits, however, for a variety of reasons, they choose to continue giving themselves shots. In 2018, we undertook one-on-one interviews with over 200 of these individuals to understand their past experiences on or considering pumps, existing pump shortcomings, the cost and insurance hurtles challenges, complexity to learn and time and complexity to operate that drives them to remain on MDI. With this detailed understanding, we brought a series of prototype models to them to react to, so we could refine the design and include features that would motivate them to be able to use this technology to better care for their diabetes. To date, the MODD1 pump has been well received by these individuals and our clinical advisors.

It is estimated that 33% of Americans with T1D use insulin pump therapy. Clinicians were surveyed on potential pump users and identified that 28% of Americans with T1D, including 44% of those who currently utilize MDI, can be classified as i) having an interest in pump adoption and ii) meeting the American Diabetes Association guidelines for required glucose control. These individuals often do not want to closely manage their glucose levels and incur the considerable time and effort involved with the existing offerings - they are the Almost Pumpers. We have developed what we believe to be the most technologically advanced delivery system to overcome their objections and perform with the motivation level they can provide.

Our initial focus for our insulin pump is the Almost Pumper segment population located in the United States. We will then focus on a European introduction, and we believe our cost position and reuse of part of the product, which eliminates waste, will have significant environmental and financial appeal.

We believe this conversion process, engaging people to try and thereby receive the benefits of our technology will substantially increase adoption of insulin pumps among both those with T1D and T2D who remain reliant upon multiple daily injections. Diabetes is a disease that appears throughout the world. Therefore, we cannot segment the market by socioeconomics, education or level of care. We intend to create an insulin pump that appeals to all Almost Pumpers.

Risk Factor Summary

Our business is subject to many significant risks, as more fully described in the section titled “Risk Factors” immediately following this prospectus summary. You should read and carefully consider these summary risks, together with the risks set forth under the section titled “Risk Factors” and all of the other information in this prospectus, including the financial statements and the related notes included elsewhere in this prospectus, before deciding whether to invest in our securities. If any of the risks discussed in this prospectus actually occur, our business, prospects, financial condition or operating results could be materially and adversely affected. In particular, our risks include, but are not limited to, the following:

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We might not be able to continue as a going concern;

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We are a developmental-stage, medical-device company and have a history of significant operating losses; we expect to continue to incur operating losses for the foreseeable future, and we may never achieve or maintain profitability;

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We will need substantial additional funding to complete subsequent phases of our insulin pump product candidate and to operate our business, and such funding may not be available or, if it is available, is likely to substantially dilute our existing stockholders;

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We have a limited operating history and historical financial information upon which you may evaluate our performance;

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The amount of financing we require will depend on a number of factors, many of which are beyond our control. Our results of operations, financial condition and stock price are likely to be adversely affected if our funding requirements increase or are otherwise greater than we expect;

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We are subject to extensive regulation by the FDA, which could restrict the sales and marketing of our insulin pump product candidate and could cause us to incur significant costs;

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Even if we are able to obtain all regulatory approvals and have completed all other steps needed to be taken to commercialize our insulin pump, if we or any contract manufacturers we select fails to comply with the FDA’s quality system regulations, the manufacturing and distribution of our product candidate could be interrupted, and our product sales and operating results could suffer;

●

We will need to outsource and rely on third parties for various aspects relating to the development, manufacture, sales and marketing of our insulin pump as well as in connection with assisting us in the preparation and filing of our FDA submission, and our future success will be dependent on the timeliness and effectiveness of the efforts of these third parties;

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Our future cash requirements may differ significantly from our current estimates;

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We may not receive the necessary regulatory clearance or approvals for our insulin pump, and failure to timely obtain necessary clearances and/or approvals could harm our then operations, including our ability to commercialize our product candidate;

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Obtaining marketing authorization in the United States will not obviate the need to obtain marketing authorization in other jurisdictions We must obtain approval from foreign regulatory authorities before we can market and sell any of our product candidates in countries outside the United States. We will incur additional costs in seeking such approvals, may experience delays in obtaining such approvals and cannot be certain that such approvals will be granted;

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Although our product candidate does not presently require clinical trials to apply to the FDA for clearance, and even if a clinical trial is conducted, the results of our clinical testing may not demonstrate the safety and efficacy of the device or may be equivocal or otherwise not be sufficient for us to obtain approval of our product candidate;

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We expect to rely on third-party manufacturers and will be dependent on their quality and effectiveness;

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We may not be able to successfully scale-up manufacturing of our product candidate in sufficient quality and quantity, which would delay or prevent us from developing our product candidate and commercializing our product candidate;

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Our competitors may develop products that are more effective, safer and less expensive than ours;

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Sales of a significant number of shares of our common stock in the public markets, or the perception that such sales could occur, could depress the market price of our common stock;

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We have limited internal research and development personnel, making us dependent on consulting relationships;

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Technological breakthroughs in diabetes monitoring, treatment or prevention could render our insulin pump obsolete;

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We may not be able to identify, negotiate and maintain the strategic alliances necessary to develop and commercialize our products and technologies, and we will be dependent on our corporate partners if we do;

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Intellectual property rights do not necessarily address all potential threats to our competitive advantage;

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We may be subject to potential product liability and other claims that could materially impact our business and financial condition;

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If we are sued for infringing on third-party intellectual property rights, it will be costly and time-consuming, and an unfavorable outcome would have a significant adverse effect on our business;

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If we are unable to protect the confidentiality of our proprietary information, the value of our technology and products could be adversely affected;

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Healthcare reform laws could adversely affect our product candidate and financial condition;

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We may bring infringement claims or other legal proceedings against third parties, causing us to spend substantial resources on litigation and exposing our own intellectual property portfolio to challenge;

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Assuming our insulin pump receives FDA clearance or approval, our insulin pump will still be subject to recalls, which would harm our reputation, business operations and financial results;

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Because our current insulin pump is still in the pre clearance stage with the FDA, it does not have reimbursement and is not approved for insurance coverage. If in the future we are cleared for and are otherwise able to commercialize our insulin pump, but are unable to obtain adequate reimbursement or insurance coverage for such product candidate from third-party payors, we will be unable to generate significant revenue;

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If we fail to establish and maintain an effective system of internal controls, we may not be able to report our financial results accurately or prevent fraud. Any inability to report and file our financial results accurately and timely could harm our reputation and adversely affect the trading price of our common stock;

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Our board of directors is able to adopt recapitalizations through forward or reverse splits of our outstanding shares of common stock without stockholder approval;

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We are a “smaller reporting company” and, as a result of the reduced disclosure and governance requirements applicable to smaller reporting companies, our common stock may be less attractive to investors;

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As we have broad discretion in how we use the proceeds from this offering, we may use the proceeds in ways with which you disagree;

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Holders of our warrants will have no rights as a common stockholder until they acquire our common stock;

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Provisions of the warrants offered by this prospectus could discourage an acquisition of us by a third party;

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The warrants offered by this prospectus are speculative in nature and may not have any value;

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There is no public market for the warrants being offered in this offering;

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You will experience immediate and substantial dilution in the net tangible book value per share of the common stock you purchase; and

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You may experience future dilution as a result of future equity offerings and other issuances of our common stock or other securities. In addition, this offering and future equity offerings and other issuances of our common stock or other securities may adversely affect the price of our common stock.

Corporate Information

Our principal executive offices are located at 10740 Thornmint Drive, San Diego, CA 92127 and our telephone number is (858) 800-3500. We maintain a website at www.modular-medical.com. Information contained on, or accessible through, our website does not constitute a part of this prospectus or our other filings with the SEC, and you should not consider any information contained on, or that can be accessed through, our website as part of this prospectus or in deciding whether to purchase our securities.

THE OFFERING

Securities offered by us:		units, each consisting of two shares of common stock and one warrant to purchase one share of our common stock. The units will not be certificated or issued in stand-alone form. The shares of our common stock and the warrants comprising the units will be issued separately, but will be purchased together in this offering.

Description of warrants included in units:		Warrants to purchase shares of common stock. Warrants may only be exercisable for a whole number of shares of common stock and, because the warrants will only be sold in units with two shares of common stock, no fractional shares or warrants to purchase fractional shares will be issued in this offering. The exercise price of the warrants is $ per share ( % of the public offering price per unit). Each warrant will be exercisable immediately upon issuance and will expire five years after the initial issuance date. This prospectus also relates to the offering of the shares of common stock issuable upon exercise of the warrants. For more information regarding the warrants, you should carefully read the section titled “Description of Our Securities - Warrants” in this prospectus.

Common stock outstanding prior to this offering⁽¹⁾:		10,949,389 shares of common stock outstanding as of April 24, 2023.

Common stock to be outstanding after this offering⁽¹⁾:		shares, or shares, if the over-allotment option granted to the underwriter is exercised in full.

Use of proceeds:		We estimate that the net proceeds from this offering will be approximately $ , after deducting underwriting discounts and commissions and the estimated offering expenses payable by us. We intend to use the net proceeds of this offering for general corporate purposes, including working capital, to fund our operations through the approval of our product by the FDA, develop our initial sales and marketing infrastructure, to fund additional research and development activities, to develop our initial manufacturing and production capabilities and make related capital expenditures. See “Use of Proceeds” for additional information.

Over-allotment option		We have granted a 30-day option to the underwriter, exercisable one or more times in whole or in part, to purchase up to an additional shares of common stock at a price per share of $ and/or additional warrants to purchase up to additional shares of common stock at a price of $0.01 per warrant, to cover over-allotments, if any.

Risk factors:		Investing in our securities involves substantial risk. You should read the “Risk Factors” section beginning on page 10 and other information included in this prospectus for a discussion of factors to consider carefully before deciding to invest in our securities.

Lock-ups		We and our directors and officers and holders of more than 5.0% of the Company’s outstanding shares of common stock have agreed with the underwriter not to offer for sale, issue, sell, contract to sell, pledge or otherwise dispose of any of our common stock or securities convertible into common stock for a period of three months after the date of this prospectus. See “Underwriting” section.

Nasdaq Capital Market Symbol		MODD

The number of shares of our common stock outstanding before and after this offering is based on 10,949,389 shares of our common stock outstanding as of April 24, 2023 and excludes:

●

shares of our common stock issuable upon the exercise of the warrants to be issued as part of the units;

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shares of common stock issuable upon exercise by the underwriter of the Underwriter’s Warrants;

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767,796 shares of our common stock issuable upon the exercise of warrants with an exercise price of $6.00 per share;

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5,449,478 shares of our common stock issuable upon the exercise of warrants with an exercise price of $6.60 per share;

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1,348,314 shares of our common stock issuable upon exercise of pre-funded warrants with an exercise price of $0.01 per share;

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2,647,700 shares of our common stock issuable upon exercise of outstanding stock options with a weighted average exercise price of approximately $4.94 per share; and

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1,996,055 shares of our common stock reserved for issuance pursuant to future awards under our Amended and Restated 2017 Equity Incentive Plan, or the 2017 Plan.

SUMMARY FINANCIAL DATA

The following tables summarize our financial data for the periods presented and should be read together with the sections of this prospectus titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and our financial statements and related notes thereto appearing elsewhere in this prospectus. The following summary statements of operations data for the nine months ended December 31, 2022 and 2021 have been derived from our unaudited consolidated financial statements and footnotes included elsewhere in this prospectus and the summary statements of operations data for the years ended March 31, 2022 and 2021 have been derived from our audited consolidated financial statements and footnotes included elsewhere in this prospectus. The summary balance sheet information as of December 31 and March 31, 2022 has been derived from our unaudited condensed consolidated financial statements and footnotes included elsewhere in this prospectus. Our historical results are not necessarily indicative of our future results or of the results we expect in the future and results of interim periods are not necessarily indicative of results for the entire year.

	Twelve Months Ended March 31,
	2022			2021
Operating expenses
Research and development	$	7,729,240		$	4,083,303
General and administrative		7,197,162			3,253,412
Total operating expenses		14,926,402			7,336,715
Loss from operations		(14,926,402	)		(7,336,715	)

Other income		368,920			130
Interest expense		(2,752,229	)		(39,791	)
Loss on debt extinguishment		(1,321,450	)		—

Loss before income taxes		(18,631,161	)		(7,376,376	)

Provision for income taxes		1,600			1,600

Net loss	$	(18,632,761	)	$	(7,377,976	)

Net loss per share
Basic and diluted	$	(2.74	)	$	(1.20	)

Shares used in computing net loss per share
Basic and diluted		6,807,710			6,211,562

Three Months Ended
December 31,

Nine Months Ended
December 31,

2022

SEC Form S-1 filed by Modular Medical Inc.