UNITED
STATES
SECURITIES AND
EXCHANGE COMMISSION
WASHINGTON, D.C.
20549
FORM 10-Q
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE QUARTERLY PERIOD ENDED FEBRUARY 28,
2025 or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission File Number: 001-37863
BIOMERICA,
INC.
(Exact name of registrant as specified in its charter)
Delaware
95-2645573
(State or other jurisdiction of
incorporation of organization)
(I.R.S. Employer
Identification No.)
17571 Von Karman Avenue , Irvine , CA
92614
(Address of principal executive offices)
(Zip Code)
REGISTRANT’S TELEPHONE NUMBER:
(949) 645-2111
Securities registered under Section 12(b) of the
Exchange Act:
(Title of each class)
COMMON
STOCK, PAR VALUE $0.08 PER SHARE
(Name of each exchange on which registered)
The Nasdaq Capital Market
(Trading symbol)
BMRA
Indicate by check whether the registrant (1) filed
all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the
past 90 days.
Yes ☒
No ☐
Indicate by check mark whether the registrant
has submitted electronically, every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (paragraph 232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes ☒
No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.
See 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 13(a) of the Exchange Act. ☐
Indicate by check mark whether the Registrant
is a shell company (as defined in Rule 12b-2 of the Act).
Yes ☐
No ☒
The number of shares of the registrant’s
common stock outstanding as of April 14, 2025 was 20,366,005 .
BIOMERICA, INC.
INDEX
PART I
Financial Information
Item 1.
Financial Statements:
Condensed Consolidated Balance Sheets (unaudited) – February 28, 2025 and May 31, 2024
1
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) – Three and Nine Months Ended February 28, 2025 and February 29, 2024
2
Condensed Consolidated Statements of Shareholders’ Equity (unaudited) – Three and Nine Months Ended February 28, 2025 and February 29, 2024
3
Condensed Consolidated Statements of Cash Flows (unaudited) – Nine Months Ended February 28, 2025 and February 29, 2024
4
Notes to Condensed Consolidated Financial Statements (unaudited)
5
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
16
Item 3.
Quantitative and Qualitative Disclosures about Market Risk
21
Item 4.
Controls and Procedures
21
PART II
Other Information
Item 1.
Legal Proceedings
22
Item 1A.
Risk Factors
22
Item 5.
Other Information
22
Item 6.
Exhibits
23
Signatures
24
PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
BIOMERICA, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
February 28, 2025
May 31, 2024
Assets
Current Assets:
Cash and cash equivalents
$ 3,058,000
$ 4,170,000
Accounts receivable, net
1,268,000
947,000
Inventories, net
1,655,000
2,376,000
Prepaid expenses and other
223,000
238,000
Total current assets
6,204,000
7,731,000
Property and equipment, net of accumulated depreciation and amortization of $ 1,444,000 and $ 1,394,000 as of February 28, 2025 and May 31, 2024, respectively
151,000
201,000
Right-of-use assets, net of accumulated amortization of $ 1,143,000 and $ 910,000 as of February 28, 2025 and May 31, 2024, respectively
509,000
742,000
Investments
165,000
165,000
Intangible assets, net of accumulated amortization of $ 63,000 and $ 48,000 as of February 28, 2025 and May 31, 2024, respectively
234,000
212,000
Other assets
113,000
203,000
Total Assets
$ 7,376,000
$ 9,254,000
Liabilities and Shareholders’ Equity
Current Liabilities:
Accounts payable and accrued expenses
$ 632,000
$ 1,138,000
Accrued compensation
612,000
655,000
Advance from customers
55,000
85,000
Lease liabilities, current portion
350,000
326,000
Total current liabilities
1,649,000
2,204,000
Lease liabilities, net of current portion
193,000
459,000
Total Liabilities
1,842,000
2,663,000
Commitments and contingencies (Note 6)
-
-
Shareholders’ Equity:
Preferred stock, Series A 5% convertible, $ 0.08 par value, 571,429 shares authorized, none issued and outstanding as of February 28, 2025 and May 31, 2024
-
-
Preferred stock, undesignated, no par value, 4,428,571 shares authorized, none issued and outstanding as of February 28, 2025 and May 31, 2024
-
-
Preferred stock value
-
-
Common stock, $ 0.08 par value, 25,000,000 shares authorized, 20,366,005 and 16,821,646 issued and outstanding at February 28, 2025 and May 31, 2024, respectively
1,629,000
1,346,000
Additional paid-in capital
55,642,000
53,542,000
Accumulated other comprehensive loss
( 113,000 )
( 102,000 )
Accumulated deficit
( 51,624,000 )
( 48,195,000 )
Total Shareholders’ Equity
5,534,000
6,591,000
Total Liabilities and Shareholders’ Equity
$ 7,376,000
$ 9,254,000
The accompanying notes are an integral part of
these statements.
1
BIOMERICA, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS (UNAUDITED)
February 28, 2025
February 29, 2024
February 28, 2025
February 29, 2024
Three Months Ended
Nine Months Ended
February 28, 2025
February 29, 2024
February 28, 2025
February 29, 2024
Net sales
$ 1,119,000
$ 1,017,000
$ 4,562,000
$ 4,299,000
Cost of sales
( 1,100,000 )
( 1,166,000 )
( 3,820,000 )
( 3,708,000 )
Gross (loss) profit
19,000
( 149,000 )
742,000
591,000
Operating expenses:
Selling, general and administrative
1,012,000
1,508,000
3,544,000
4,204,000
Research and development
217,000
343,000
771,000
1,226,000
Total operating expenses
1,229,000
1,851,000
4,315,000
5,430,000
Loss from operations
( 1,210,000 )
( 2,000,000 )
( 3,573,000 )
( 4,839,000 )
Other income:
Interest and dividend income
43,000
86,000
140,000
317,000
Total other income
43,000
86,000
140,000
317,000
Loss before income taxes
( 1,167,000 )
( 1,914,000 )
( 3,433,000 )
( 4,522,000 )
Benefit (provision) for income taxes
4,000
( 4,000 )
4,000
( 35,000 )
Net loss
$ ( 1,163,000 )
$ ( 1,918,000 )
$ ( 3,429,000 )
$ ( 4,557,000 )
Basic net loss per common share
$ ( 0.06 )
$ ( 0.11 )
$ ( 0.18 )
$ ( 0.27 )
Diluted net loss per common share
$ ( 0.06 )
$ ( 0.11 )
$ ( 0.18 )
$ ( 0.27 )
Weighted average number of common and common equivalent shares:
Basic
19,186,282
16,821,646
18,616,979
16,821,646
Diluted
19,186,282
16,821,646
18,616,979
16,821,646
Net loss
$ ( 1,163,000 )
$ ( 1,918,000 )
$ ( 3,429,000 )
$ ( 4,557,000 )
Other comprehensive income (loss), net of tax:
Foreign currency translation
( 1,000 )
2,000
( 11,000 )
8,000
Comprehensive loss
$ ( 1,164,000 )
$ ( 1,916,000 )
$ ( 3,440,000 )
$ ( 4,549,000 )
The accompanying notes are an integral part of
these statements.
2
BIOMERICA, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’
EQUITY (UNAUDITED)
Shares
Amount
Capital
Loss
Deficit
Equity
For the Nine Months Ended February 29, 2024
Common Stock
Additional Paid-in
Accumulated Other Comprehensive
Accumulated
Total Stockholders’
Shares
Amount
Capital
Loss
Deficit
Equity
Balances at May 31, 2023
16,821,646
$ 1,346,000
$ 52,705,000
$ ( 110,000 )
$ ( 42,217,000 )
$ 11,724,000
Foreign currency translation
-
-
-
6,000
-
6,000
Share-based compensation
-
-
170,000
-
-
170,000
Net loss
-
-
-
-
( 1,132,000 )
( 1,132,000 )
Balances at August 31, 2023
16,821,646
1,346,000
52,875,000
( 104,000 )
( 43,349,000 )
10,768,000
Foreign currency translation
-
-
-
-
-
-
Share-based compensation
-
-
122,000
-
-
122,000
Net loss
-
-
-
-
( 1,507,000 )
( 1,507,000 )
Balances at November 30, 2023
16,821,646
1,346,000
52,997,000
( 104,000 )
( 44,856,000 )
9,383,000
Foreign currency translation
-
-
-
2,000
-
2,000
Share-based compensation
-
-
341,000
-
-
341,000
Net loss
-
-
-
-
( 1,918,000 )
( 1,918,000 )
Balances at February 29, 2024
16,821,646
$ 1,346,000
$ 53,338,000
$ ( 102,000 )
$ ( 46,774,000 )
$ 7,808,000
For the Nine Months Ended February 28, 2025
Common Stock
Additional Paid-in
Accumulated Other Comprehensive
Accumulated
Total Stockholders’
Shares
Amount
Capital
Loss
Deficit
Equity
Balances at May 31, 2024
16,821,646
$ 1,346,000
$ 53,542,000
$ ( 102,000 )
$ ( 48,195,000 )
$ 6,591,000
Foreign currency translation
-
-
-
( 6,000 )
-
( 6,000 )
Share-based compensation
-
-
77,000
-
-
77,000
Net loss
-
-
-
-
( 1,316,000 )
( 1,316,000 )
Balances at August 31, 2024
16,821,646
1,346,000
53,619,000
( 108,000 )
( 49,511,000 )
5,346,000
Foreign currency translation
-
-
-
( 4,000 )
-
( 4,000 )
Net proceeds from ATM
1,515,348
121,000
446,000
-
-
567,000
Share-based compensation
-
-
155,000
-
-
155,000
Net loss
-
-
-
-
( 950,000 )
( 950,000 )
Balances at November 30, 2024
18,336,994
1,467,000
54,220,000
( 112,000 )
( 50,461,000 )
5,114,000
Balance
18,336,994
1,467,000
54,220,000
( 112,000 )
( 50,461,000 )
5,114,000
Foreign currency translation
-
-
-
( 1,000 )
-
( 1,000 )
Net proceeds from ATM
2,010,011
160,000
1,288,000
-
-
1,448,000
Exercise of stock options
19,000
2,000
14,000
-
-
16,000
Share-based compensation
-
-
120,000
-
-
120,000
Net loss
-
-
-
-
( 1,163,000 )
( 1,163,000 )
Balances at February 28, 2025
20,366,005
$ 1,629,000
$ 55,642,000
$ ( 113,000 )
$ ( 51,624,000 )
$ 5,534,000
Balance
20,366,005
$ 1,629,000
$ 55,642,000
$ ( 113,000 )
$ ( 51,624,000 )
$ 5,534,000
The accompanying notes are an integral
part of these statements.
3
BIOMERICA, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
February 28, 2025
February 29, 2024
Nine Months Ended
February 28, 2025
February 29, 2024
Cash flows from operating activities:
Net loss
$ ( 3,429,000 )
$ ( 4,557,000 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
64,000
59,000
Provision (recovery) for allowance for credit losses
7,000
( 6,000 )
Inventory reserve
( 45,000 )
( 181,000 )
Share-based compensation
352,000
633,000
Amortization of right-of-use asset
232,000
218,000
Changes in assets and liabilities:
Accounts receivable
( 327,000 )
( 402,000 )
Inventories
766,000
109,000
Prepaid expenses and other
15,000
33,000
Other assets
6,000
( 26,000 )
Accounts payable and accrued expenses
( 506,000 )
( 8,000 )
Accrued compensation
( 43,000 )
6,000
Advance from customers
( 30,000 )
25,000
Reduction in lease liabilities
( 242,000 )
( 220,000 )
Net cash used in operating activities
( 3,180,000 )
( 4,317,000 )
Cash flows from investing activities:
Purchases of property and equipment
-
( 27,000 )
Expenditures related to intangibles
( 37,000 )
( 64,000 )
Net cash used in investing activities
( 37,000 )
( 91,000 )
Cash flows from financing activities:
Gross proceeds from sale of common stock
2,143,000
-
Costs from sale of common stock
( 128,000 )
-
Deferred offering costs
85,000
-
Proceeds from exercise of stock options
16,000
-
Net cash provided by financing activities
2,116,000
-
Effect of exchange rate changes in cash
( 11,000 )
8,000
Net decrease in cash and cash equivalents
( 1,112,000 )
( 4,400,000 )
Cash and cash equivalents at beginning of year
4,170,000
9,719,000
Cash and cash equivalents at end of period
$ 3,058,000
$ 5,319,000
Supplemental Disclosure of Cash Flow Information:
Cash paid during the period for:
Income taxes
$ -
$ 34,000
The accompanying notes are an integral part of
these statements.
4
BIOMERICA, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE 1: BASIS OF PRESENTATION
Biomerica, Inc. and its subsidiaries (which includes
wholly-owned subsidiaries, Biomerica de Mexico and BioEurope GmbH) is a global biomedical technology company that develops, patents, manufactures
and markets advanced diagnostic and therapeutic products used at the point-of-care (physicians’ offices and over-the-counter through
drugstores and online) and in hospital/clinical laboratories for detection and/or treatment of medical conditions and diseases. Our diagnostic
test products utilize immunoassay technology to analyze blood, urine, nasal, or fecal material from patients in the diagnosis of various
diseases, food intolerances and other medical complications, and to measure the level of specific hormones, antibodies, antigens, or other
substances, which may exist in the human body in extremely small concentrations. Our other existing products are primarily focused on
gastrointestinal diseases, food intolerances, and certain esoteric tests. Company’s products are designed to enhance the health
and well-being of people, while reducing total healthcare costs.
Our primary focus is the research, development,
commercialization and in certain cases regulatory approval, of patented, diagnostic-guided therapy (“DGT”) products to treat
gastrointestinal diseases, such as irritable bowel syndrome (“IBS”), and other inflammatory diseases. These products are directed
at chronic inflammatory illnesses that are widespread, common, and address very large markets. Our inFoods® IBS product uses a simple
blood sample and is designed to identify patient-specific foods that, when removed from the diet, may alleviate IBS symptoms such as pain,
bloating, diarrhea, and constipation. Instead of broad and difficult to manage dietary restrictions, the inFoods® IBS product works
by identifying specific foods that may be causing an abnormally high immune response in the patient, which in turn can lead to abdominal pain and cramping, bloating, diarrhea
and constipation. A food identified as positive, which
is causing an abnormal immune response in the patient, is simply removed from the diet to help alleviate IBS symptoms.
Our existing medical diagnostic products are sold
worldwide primarily in two markets: a) clinical laboratories and b) point-of-care (physicians’ offices and over-the-counter). Most of our products have been granted Conformite Europeenne (“CE”)
marked regulatory clearance for sale throughout Europe, and/or are sold for diagnostic use where they are registered by each country’s
regulatory agency. In addition, some products are cleared for sale in the United States by the FDA.
The unaudited condensed consolidated financial
statements herein have been prepared by management pursuant to the rules and regulations of the United States Securities and Exchange
Commission (“SEC”). The accompanying unaudited condensed consolidated financial statements have been prepared under the presumption
that users of the interim financial information have either read or have access to the audited consolidated financial statements for the
latest fiscal year ended May 31, 2024. Accordingly, certain information and note disclosures normally included in financial statements
prepared in accordance with United States generally accepted accounting principles (“GAAP”) have been condensed or omitted
pursuant to such rules and regulations. In the opinion of management, all adjustments considered necessary for a fair presentation have
been included. Operating results for the three and nine months ended February 28, 2025 are not necessarily indicative of the results that
may be expected for the fiscal year ending May 31, 2025. For further information, refer to the audited consolidated financial statements
and notes thereto for the fiscal year ended May 31, 2024 included in the Company’s Annual Report on Form 10-K filed with the SEC
on August 28, 2024. Management has evaluated all subsequent events and transactions through the date of filing this report.
5
NOTE 2: SIGNIFICANT ACCOUNTING POLICIES
PRINCIPLES OF CONSOLIDATION
The condensed consolidated financial statements
include the accounts of Biomerica, Inc. as well as its German subsidiary (BioEurope GmbH) and Mexican subsidiary (Biomerica de Mexico).
All significant intercompany accounts and transactions have been eliminated in consolidation.
ACCOUNTING ESTIMATES
In order to prepare our consolidated financial
statements in conformity with GAAP, we must make a number of estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of the financial statements. Such estimates and assumptions
affect the reported amounts of revenues and expenses during the reporting period. Our estimates are based on historical experience and
various other assumptions that we believe to be reasonable under the circumstances. Different assumptions or conditions may cause actual
results to differ materially from these estimates. We monitor significant estimates made during the preparation of our financial statements
on an ongoing basis. We believe our estimates and assumptions are reasonable under the current conditions; however, actual results may
differ from these estimates under different future conditions.
We believe that the estimates and assumptions
that are most important to the portrayal of our financial condition and results of operations, in that they require subjective or complex
judgments, form the basis for the accounting policies deemed to be most critical to us. These relate to revenue recognition, bad debts,
inventory overhead application, inventory reserves, lease liabilities, right-of-use assets and share-based compensation. We believe estimates
and assumptions related to these critical accounting policies are appropriate under the circumstances; however, should future events or
occurrences result in unanticipated consequences, there could be a material impact on our future financial conditions or results of operations.
We suggest that our significant accounting policies be read in conjunction with the Management’s Discussion and Analysis of Financial
Condition and Results of Operations of this Quarterly Report on Form 10-Q.
MARKETS AND METHODS OF DISTRIBUTION
The majority of the Company’s revenues come
from the sale of products it manufactures in the U.S. and Mexico, with certain raw materials sourced from the U.S. Asia and other regions.
The Company’s diagnostic business serves a diverse customer base that includes both domestic and international distributors, as
well as hospitals, clinical laboratories, medical research institutions, pharmaceutical companies, wholesalers, physicians’ offices,
and direct sales to consumers from its website. A significant portion of the Company’s revenues are derived from international sales.
The Company employs a Director of Sales and Marketing
for Europe and South America, based in Germany, who has over 20 years of experience in diagnostics and life sciences. This individual’s
international business experience and multilingual capabilities have facilitated strong relationships across Europe, Eastern Europe, Middle
East, Latin America, Canada, and the U.S. The Company expects continued growth through the addition of new distributors and product lines
in these regions.
The Company markets its diagnostic products through
distributors, advertising in medical and trade journals, trade show exhibitions, direct mailings, and through its internal sales team.
The two primary markets the Company targets are clinical laboratories and patient point-of-care testing
LIQUIDITY AND GOING CONCERN
The Company has incurred net losses and negative
cash flows from operations and has an accumulated deficit of approximately $ 52 million as of February 28, 2025. As of February 28, 2025,
the Company had cash and cash equivalents of approximately $ 3,058,000 and working capital of approximately $ 4,555,000 .
On July 21, 2020, the Company filed with the Securities
and Exchange Commission (“SEC”) a Form S-3 shelf registration statement and base prospectus which was declared effective by
the SEC on September 30, 2020. The 2020 Shelf Registration Statement registered common shares that could be issued by the Company in a
maximum aggregate amount of up to $ 90,000,000 .
On January 22, 2021, the Company filed a prospectus
supplement to the base prospectus included in a registration statement filed with the SEC on July 21, 2020, and declared effective by
the SEC on September 30, 2020, for purposes of selling up to $ 15,000,000 in “at-the-market” offerings, as defined in Rule
415 promulgated under the Securities Act (the “2021 ATM Offering”).
During the year ended May 31, 2023, the Company
sold 573,889 shares of its common stock at prices ranging from $ 3.15 to $ 4.26 pursuant to the 2021 ATM Offering, which resulted in gross
proceeds of approximately $ 2,014,000 and net proceeds to the Company of $ 1,961,000 , after deducting commissions for each sale and legal,
accounting, and other fees related to offering in the amount of $ 53,000 .
6
On March 7, 2023, the Company sold 3,333,333 shares
of common stock in a firm commitment public offering at a gross sales price of $ 2.40 per share, with net total proceeds, after deducting
issuance fees and expenses of $ 700,000 , of approximately $ 7,300,000 . As a result of this public offering, the Company terminated the 2021
ATM Offering.
As part of our financing plan, on
September 28, 2023, we filed a new “shelf” registration statement on Form S-3 with the SEC, to replace the expiring S-3
that was filed in July 2020, which was declared effective on September 29, 2023, allowing the Company to issue up to $ 20,000,000
in common shares. Under this registration statement, shares of our common stock may be sold from time to time for up to three years
from the filing date. On May 10, 2024, the Company filed a prospectus supplement with the SEC to facilitate the sale of up to $ 5,500,000
in common stock through ATM offerings, as defined in Rule 415 under the Securities Act (the “2024 ATM Offering”). As part of this transaction, the Company
incurred $ 81,000
in deferred offering costs. The amount of capital that we can raise under the ATM offering is highly dependent upon the trading
volume and the trading price of our stock. The average trading volume of our stock over the last three full calendar months is 7,798,345
shares per day and the high and low trading price of our stock during the same period of time was $ 1.03
and $ 0.27 ,
respectively. If our stock continues to trade at low volumes and price, the amount of capital that we can raise under the ATM
offering will be constrained.
The Company intends to use the net proceeds from
any funds raised through the ATM offering for general corporate purposes, including, but not limited to, sales and marketing activities,
clinical studies and product development, acquisitions of assets, businesses, companies, or securities, capital expenditures, and working
capital needs.
During the nine months ended February 28, 2025,
the Company sold 3,525,359 shares of its common stock at prices ranging from $ 0.36 to $ 1.04 pursuant to the May 2024 ATM Offering, which
resulted in gross proceeds of approximately $ 2,143,000 and net proceeds to the Company of $ 2,015,000 after deducting commissions for each
sale and legal, accounting, and other fees related to offering in the amount of $ 128,000 .
Management assesses whether the Company has sufficient
liquidity to fund its costs for the next twelve months from each financial statement issuance date to determine if there is a substantial
doubt about the Company’s ability to continue as a going concern. The Company’s ability to continue as a going concern over
the next twelve months is influenced by several factors, including:
●
Our need and ability to generate additional revenue from international opportunities and sales within the US of existing products, and from our new product launches;
●
Our need to access the capital and debt markets to meet current obligations and fund operations;
●
Our capacity to manage operating expenses and maintain or increase gross margins as we grow;
●
Our ability to retain key employees and maintain critical operations with a substantially reduced workforce; and
●
Certain SEC regulations that limit the amount of capital the Company can raise through issuance of its equity.
Management has analyzed the Company’s cash
flow requirements through May 2026 and beyond. Based on this analysis, we believe our current cash and cash equivalents are insufficient
to meet our operating cash requirements and strategic growth objectives for the next twelve months.
To address our capital needs and sustain operations
beyond the next year, we are actively pursuing strategies to increase sales, reduce expenses, sell non-core assets, seek additional financing
through debt or equity, and seek other strategic alternatives. While we are committed to these plans, there is no assurance that these
efforts will be successful or sufficient to meet our capital requirements.
As part of our efforts to reduce costs, we are
executing significant cost-cutting measures to extend our cash runway and work towards increasing revenues to cover overhead costs. These
measures included a workforce reduction of nearly 15% in July 2024 and a substantial reduction in other operating expenses. Additionally,
we have successfully raised $ 2,015,000 in net proceeds from the May 2024 ATM offering, providing additional liquidity to support our operations.
7
These factors raise substantial doubt about the
Company’s ability to continue as a going concern. Our future viability depends on the successful execution of our strategic plans,
securing additional financing, and achieving profitable operations.
The Company’s consolidated financial statements
as of February 28, 2025 were prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities
and commitments in the normal course of business.
CONCENTRATION OF CREDIT RISK
The Company maintains cash balances at certain
financial institutions in excess of amounts insured by federal agencies. From time to time, the Company has uninsured balances. The Company does not believe it is exposed to any significant credit risks from any uninsured balances held at these financial institutions.
The Company provides credit in the normal course
of business to customers throughout the U.S. and in foreign markets. The Company performs ongoing credit evaluations of its customers
and requires accelerated prepayment in some circumstances.
Consolidated net sales were approximately $ 1,119,000
and $ 1,017,000 for the three months ended February 28, 2025, and February 29, 2024, respectively, and approximately $ 4,562,000 and $ 4,299,000
for the nine months ended February 28, 2025 and February 29, 2024, respectively
For the three months ended February 28, 2025,
the Company had three key customers who are located in the United States, Middle East, and Asia which accounted for 61 % of net consolidated sales. For
the three months ended February 29, 2024, the Company had three key customer who are located in the United States and Asia which accounted
for 44 % of net consolidated sales. For the nine months ended February 28, 2025, the Company had one key customer who is located in Asia
which accounted for 35 % of net consolidated sales. For the nine months ended February 29, 2024, the Company had one key customer who is
located in Asia which accounted for 40 % of net consolidated sales.
As of February 28, 2025, and May 31, 2024, total
gross receivables were approximately $ 1,293,000 and $ 966,000 , respectively. On these dates, the Company had five and four key customers,
respectively, located in North America, Europe, Asia, and the Middle East. These customers accounted for 76 % and 64 % of the gross accounts
receivable, respectively.
For the three months ended February 28, 2025,
the Company had two key vendors who accounted for 39 % of the purchases of raw materials. In contrast, for the three months ended February
29, 2024, the Company had one key vendor who accounted for 50 % of the purchases of raw materials. For the nine months ended February 28,
2025, the Company had one vendor who accounted for 11 % of the purchases of raw materials. For the nine months ended February 29, 2024,
there was one vendor who accounted for 18 % of the purchases of raw materials.
As of February 28, 2025 and May 31, 2024, the
Company had two key vendors which accounted for 33 % and 69 % respectively, of accounts payable.
CASH AND CASH EQUIVALENTS
Cash and cash equivalents consist of demand deposits
and money market accounts with original maturities of less than three months.
ACCOUNTS RECEIVABLE
The Company extends unsecured credit to its customers
as part of its standard business practices. International customers are typically required to prepay until a credit history with the Company
is established, at which point credit levels are determined based on various criteria. Initial credit limits for distributors are approved
by designated officers or managers, while any increases require authorization from upper-level management.
The Company adopted Accounting Standards Update
(“ASU”) No. 2016-13, Financial Instruments – Credit Losses (codified as Accounting Standards Codification (“ASC”)
326) on June 1, 2023. ASC 326 adds to U.S. GAAP the current expected credit loss (“CECL”) model, a measurement model based
on expected losses rather than incurred losses. Prior to the adoption of ASC 326, the Company evaluated receivables on a quarterly basis
and adjusted the allowance for doubtful accounts accordingly. Balances over ninety days old were usually reserved for unless collection
was reasonably assured. Under the application of ASC 326, the Company’s historical credit loss experience provides the basis for
the estimation of expected credit losses, as well as current economic and business conditions, and anticipated future economic events
that may impact collectability. In developing its expected credit loss estimate, the Company evaluated the appropriate grouping of financial
assets based upon its evaluation of risk characteristics, including consideration of the types of products and services sold. Account
balances are written off against the allowance for expected credit losses after all means of collection have been exhausted and the potential
for recovery is considered remote.
8
Occasionally, certain long-standing customers
who routinely place large orders will have unusually large receivable balances relative to the total gross receivables. Management monitors
the payments for these large balances closely and very often requires payment of existing invoices before shipping new sales orders.
As of February 28, 2025 and May 31, 2024, the
Company has established a reserve of approximately $ 25,000 and $ 19,000 , respectively, for credit losses.
PREPAID EXPENSES AND OTHER
The Company occasionally prepays for items such
as inventory, insurance, and other items. These items are reported as prepaid expenses and other, until either the inventory is physically
received, or the insurance and other items are expensed.
As of February 28, 2025 and May 31, 2024, prepaids were approximately $ 223,000 and $ 238,000 , respectively, composed of prepayments to insurance and various other suppliers.
INVENTORIES, NET
The Company values inventory at the lower of cost
(determined using a combination of specific lot identification and the first-in, first-out methods) or net realizable value. Management
periodically reviews inventory for excess quantities and obsolescence. Management evaluates quantities on hand, physical condition, and
technical functionality as these characteristics may be impacted by anticipated customer demand for current products and new product introductions.
The reserve is adjusted based on such evaluation, with a corresponding provision included in cost of sales. Abnormal amounts of idle facility
expenses, freight, handling costs and wasted material are recognized as current period charges and the allocation of fixed production
overhead is based on the normal capacity of the production facilities.
Net inventories are comprised of approximately
the following:
SCHEDULE OF NET INVENTORIES
February 28, 2025
May 31, 2024
Raw materials
$ 1,157,000
$ 1,519,000
Work in progress
782,000
1,145,000
Finished products
138,000
179,000
Total gross inventory
2,077,000
2,843,000
Inventory reserves
( 422,000 )
( 467,000 )
Net inventory
$ 1,655,000
$ 2,376,000
Reserves for inventory obsolescence are recorded
as necessary to reduce obsolete inventory to estimated net realizable value or to specifically reserve for obsolete inventory. As of February
28, 2025, and May 31, 2024, inventory reserves were approximately $ 422,000 and $ 467,000 , respectively.
PROPERTY AND EQUIPMENT, NET
Property and equipment are stated at cost. Expenditures
for additions and major improvements are capitalized. Repairs and maintenance costs are charged to operations as incurred. When property
and equipment are sold, retired, or otherwise disposed of, the related cost and accumulated depreciation or amortization are removed from
the accounts, and gains or losses from sales, retirements and dispositions are credited or charged to income.
Depreciation and amortization are provided over
the estimated useful lives of the related assets, ranging from 5 to 10 years, using the straight-line method. Leasehold improvements are
amortized over the lesser of the estimated useful life of the asset or the term of the lease. Depreciation and amortization expense on
property and equipment were approximately $ 17,000 and $ 16,000 for the three months ended February 28, 2025, and February 29, 2024, respectively,
and approximately $ 50,000 and $ 46,000 for the nine months ended February 28, 2025 and February 29, 2024, respectively.
9
INTANGIBLE ASSETS, NET
Intangible assets include trademarks, product
rights, technology rights and patents, and are accounted for based on ASC 350 Intangibles – Goodwill and Other.
In that regard, intangible assets that have indefinite useful lives are not amortized but are tested annually for impairment or more frequently
if events or changes in circumstances indicate that the asset might be impaired.
Intangible assets are being amortized using the
straight-line method over the useful life, not to exceed 18 years for marketing and distribution rights, 10 years for purchased technology
use rights, and patents are based on their individual useful lives which average around 15 years. Amortization expense was approximately
$ 5,000 for the three months ended February 28, 2025, and $ 4,000 for the corresponding period ended February 29, 2024. For the nine months
ended February 28, 2025, and February 29, 2024, the expenses were approximately $ 14,000 and $ 13,000 , respectively. Amortizing intangible
assets are tested for impairment if management determines that events or changes in circumstances indicate that the asset might be impaired.
The Company assesses the recoverability of these
intangible assets by determining whether the amortization of the asset’s balance over its remaining life can be recovered through
projected undiscounted future cash flows. The Company uses a qualitative assessment to determine whether there was any impairment. During
the nine months ended February 28, 2025, management did no t identify any indicators of impairment. During the nine months ended February
29, 2024, management did no t identify any indicators of impairment.
INVESTMENTS
The Company has made investments in a privately
held Polish distributor, which is primarily engaged in distributing medical products and devices, including the distribution of the products
sold by the Company. The Company invested approximately $ 165,000 into the Polish distributor and owns approximately 6 % of the investee.
Equity holdings in nonmarketable unconsolidated
entities in which the Company is not able to exercise significant influence (“Cost Method Holdings”) are accounted for at
the Company’s initial cost, minus any impairment (if any), plus or minus changes resulting from observable price changes in orderly
transactions for the identical or a similar holding or security of the same issuer. Dividends received are recorded as other income.
The Company assesses its equity holdings for impairment
whenever events or changes in circumstances indicate that the carrying value of an equity holding may not be recoverable. Management reviewed
the underlying net assets of the Company’s equity method holding as of February 28, 2025 and determined that the Company’s
proportionate economic interest in the entity indicates that the equity holding was not impaired. There were no observable price changes
in orderly transactions for identical or a similar holding or security of the Company’s Cost Method Holdings during the nine months ended February 28, 2025 and February 29, 2024.
SHARE-BASED COMPENSATION
The Company follows the guidance of ASC 718, Share-based
Compensation, which requires the use of the fair-value based method to determine compensation for all arrangements
under which employees and others receive shares of stock or equity instruments (options). The Company grants stock options and restricted
stock units (“RSUs”) under its equity incentive plans. The Company measures all share-based payment awards at their grant-date
fair value. The fair value of each option is estimated on the date of grant
using the Black-Scholes option-pricing model that uses assumptions for expected volatility, expected dividends, expected forfeiture rate,
expected term, and the risk-free interest rate. The Company has not paid dividends historically and does not expect to pay them in the
foreseeable future. Expected volatilities are based on weighted averages of the historical volatility of the Company’s common stock
estimated over the expected term of the options. The expected forfeiture rate is based on historical forfeitures experienced. The expected
term of options granted is derived using the “simplified method” which computes expected term as the average of the sum of
the vesting term plus the contract term as historically the Company had limited exercise activity surrounding its options. The risk-free
rate is based on the U.S. Treasury yield curve in effect at the time of grant for the period of the expected term. The grant date fair
value of the award is recognized under the straight-line attribution method.
10
The following summary presents the options granted,
exercised, expired, canceled and outstanding for the nine months ended February 28, 2025:
SUMMARY OF OPTIONS ACTIVITY
Option Shares
Weighted Average
Exercise Price
Options Outstanding at May 31, 2024
3,479,616
$ 2.53
Granted
429,000
0.35
Exercised
( 19,000 )
0.82
Cancelled or expired
( 545,750 )
1.68
Options Outstanding at February 28, 2025
3,343,866
$ 2.40
During the three months ended February 28, 2025,
the Company expensed approximately $ 91,000 in share-based compensation related to stock options, compared to $ 340,000 for the same period
in 2024. For the nine months ended February 28, share-based compensation expenses for stock option grants were approximately $ 323,000
in 2025 and $ 633,000 in 2024.
The following summary presents the RSUs granted,
vested, forfeited and outstanding for the nine months ended February 28, 2025:
SCHEDULE OF RSUs ACTIVITY
RSUs
Weighted
Average Grant
Date Fair Value
RSUs Outstanding at May 31, 2024
-
$ -
Granted
780,000
0.31
RSUs Outstanding at February 28, 2025
780,000
$ 0.31
During the three and nine months
ended February 28, 2025, the Company expensed $ 29,000
related to RSUs. No
share-based compensation expense related to RSUs was recognized during the three and nine months ended February 29, 2024.
REVENUE RECOGNITION
The Company has various contracts with customers,
and these contracts specify the recognition of revenue based on the nature of the transaction.
11
Revenues from product sales are recognized at
the time the product is shipped, customarily FOB shipping point, which is when the transfer of control of goods has occurred and title
passes. This applies to clinical lab products sold to domestic and international distributors, including hospitals, clinical laboratories,
medical research institutions, medical schools, and pharmaceutical companies. OTC products are sold directly to e-commerce customers,
and distributors, while physicians’ office products are sold to physicians and distributors. The Company does not allow returns
except in cases of defective merchandise, and therefore, does not establish an allowance for returns. Additionally, the Company has contracts
with customers that provide purchase discounts contingent on achieving specified sales volumes. These contracts are regularly evaluated,
and the Company does not anticipate granting any discounts through the end of the contract period.
For diagnostic testing services sold directly
to patients or physician offices that require processing by a third-party CLIA-certified lab, we recognize revenue once the lab has completed
the test results.
For services related to contract manufacturing,
revenue is recognized when the service has been performed. Services for some contract work are invoiced and recognized as the project
progresses.
As of February 28, 2025, the Company had approximately
$ 55,000 in advances from domestic customers, which are prepayments on orders for future shipments.
Disaggregation of revenue:
The following is a breakdown of revenues according
to markets to which the products are sold:
SCHEDULE OF DISAGGREGATION REVENUE
February 28, 2025
February 29, 2024
February 28, 2025
February 29, 2024
Three Months Ended
Nine Months Ended
February 28, 2025
February 29, 2024
February 28, 2025
February 29, 2024
Clinical lab
$ 627,000
$ 404,000
$ 2,683,000
$ 2,683,000
Over-the-counter
170,000
329,000
952,000
1,078,000
Contract manufacturing
320,000
281,000
920,000
530,000
Physician’s office
2,000
3,000
7,000
8,000
Total
$ 1,119,000
$ 1,017,000
$ 4,562,000
$ 4,299,000
See Note 4 for additional information regarding
geographic revenue concentrations.
SHIPPING AND HANDLING FEES
The Company includes shipping and handling fees
billed to customers in net sales.
RESEARCH AND DEVELOPMENT
Research and development costs are expensed as
incurred. The Company expensed approximately $ 217,000 and $ 343,000 of research and development costs during the three months ended February
28, 2025 and February 29, 2024, respectively. Similarly, it expensed approximately $ 771,000 and $ 1,226,000 of research and development
costs during the nine months ended February 28, 2025 and February 29, 2024, respectively.
12
INCOME TAXES
During the three and nine months ended
February 28, 2025, the Company had a net operating loss (“NOL”) that generated deferred tax assets for NOL carryforwards.
Deferred income tax assets and liabilities are recognized for temporary differences between the financial statements and income tax carrying
values using tax rates in effect for the years such differences are expected to reverse. Due to uncertainties surrounding our ability
to generate future taxable income and consequently realize such deferred income tax assets, the Company has determined that it is more
likely than not that these deferred tax assets will not be realized. Accordingly, the Company has established a full valuation allowance
against its deferred tax assets as of February 28, 2025.
The Company’s policy is to recognize any
interest and penalties related to unrecognized tax benefits as a component of income tax expense. For the nine months ended February 28,
2025, the Company had no accrued interest or penalties related to uncertain tax positions.
ADVERTISING COSTS
The Company reports the cost of advertising as
expense in the period in which those costs are incurred. For the three months ended February 28, 2025, and February 29, 2024, advertising
costs were approximately $ 4,000 and $ 25,000 , respectively. During the nine months ended February 28, 2025, and February 29, 2024, the
costs were approximately $ 30,000 and $ 80,000 , respectively.
FOREIGN CURRENCY TRANSLATION
The subsidiary located in Mexico operates primarily
using the Mexican peso. The subsidiary located in Germany operates primarily using the U.S. dollar, with an immaterial amount of transactions
occurring using the Euro. Accordingly, assets and liabilities of these subsidiaries are translated using exchange rates in effect at the
end of the period, and revenues and costs are translated using average exchange rates for the period. The resulting translation adjustments
to assets and liabilities are presented as a separate component of accumulated other comprehensive loss. There are no foreign currency
transactions that are included in the condensed consolidated statements of operations and comprehensive loss for the three and nine months
ended February 28, 2025 and February 29, 2024.
RIGHT-OF-USE ASSETS AND LEASE LIABILITY
In February 2016, the Financial Accounting Standards
Board (“FASB”) issued an accounting standard update which requires lessees to recognize most leases on the balance sheet with
a corresponding right-of-use asset. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term
and lease liabilities represent our obligation to make lease payments arising from the lease. Right-of-use assets and lease liabilities
are recognized at the lease commencement date based on the estimated present value of fixed lease payments over the lease term. Leases
are classified as financing or operating which will drive the expense recognition pattern. The Company has elected to exclude short-term
leases. The Company leases office space and copy machines, all of which are operating leases. Most leases include the option to renew
and the exercise of the renewal options is at the Company’s sole discretion. Options to extend or terminate a lease are considered
in the lease term to the extent that the option is reasonably certain of exercise. The leases do not include the options to purchase the
leased property. The depreciable life of assets and leasehold improvements are limited by the expected lease term.
NET LOSS PER SHARE
Basic loss per share is computed as net
loss divided by the weighted average number of common shares outstanding for the period. Diluted loss per share reflects the potential
dilution that could occur from common shares issuable through stock options, warrants and other convertible securities using the treasury
stock method. A total of 3,343,866 and 3,506,616 anti-dilutive stock options were excluded
from the loss per share calculation for the nine months ended February 28, 2025, and February 29, 2024, respectively. Additionally, 780,000
restricted stock units (“RSUs”) were excluded for the nine months ended February 28, 2025, while no RSUs were excluded for
the nine months ended February 29, 2024.
RECENT ACCOUNTING PRONOUNCEMENTS
Recent ASU’s issued by the FASB and guidance
issued by the SEC did not, or are not believed by the management to, have a material effect on the Company’s present or future consolidated
financial statements.
In November 2023, the FASB issued ASU 2023-07,
“Improvements to Reportable Segment Disclosures.” The ASU includes enhanced disclosure requirements, primarily related to
significant segment expenses that are regularly provided to and used by the chief operating decision maker (“CODM”). The amendments
are to be applied retrospectively to all prior periods presented in the financial statements. ASU 2023-07 is effective for fiscal years
beginning after December 15, 2023, with early adoption permitted. We are currently evaluating the effect of adopting this pronouncement
on our financial statements and disclosures.
In December 2023, the FASB issued ASU 2023-09,
“Income Taxes (Topic 740): Improvements to Income Tax Disclosures”. The ASU includes enhanced disclosure requirements, primarily
related to the rate reconciliation and income taxes paid information. The amendments are to be applied prospectively in the financial
statements. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. We are currently
evaluating the effect of adopting this pronouncement on our financial statements and disclosures.
In November 2024, the FASB issued ASU 2024-03,
“Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40)”. The ASU
includes enhanced disclosure requirements, which mandates enhanced transparency in financial statements by requiring detailed disclosures
of specific expenses like inventory purchases, employee compensation, depreciation, and intangible asset amortization. ASU 2024-03 are
effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods within annual reporting periods
beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating the impact of this standard and intends
to include the required disclosures in its Annual Report on Form 10-K for the fiscal year ended May 31, 2025.
13
NOTE 3: SHAREHOLDERS’ EQUITY
On September 28, 2023, the Company filed a “shelf”
registration statement on Form S-3 with the SEC, which was declared effective on September 29, 2023, allowing the Company to issue up
to $ 20,000,000 in common shares. Under this registration statement, shares of our common stock may be sold from time to time for up to
three years from the filing date. On May 10, 2024, the Company filed a prospectus supplement with the SEC to facilitate the sale of up
to $ 5,500,000 in common stock through ATM offerings, as defined in Rule 415 under the Securities Act.
On February 29, 2024, the Company did not have
an open ATM offering in place. No shares of common stock or other equity securities of the Company were sold under the shelf registration
statement during the nine months ended February 29, 2024. During the nine months ended February 28, 2025, the Company sold 3,525,359 shares
of its common stock at prices ranging from $ 0.36 to $ 1.04 under its Form S-3 Registration Statement and ATM Offering which resulted in
gross proceeds of approximately $ 2,143,000 and net proceeds to the Company of $ 2,015,000 after deducting commissions for each sale and
legal, accounting, and other fees related to the ATM Offering.
NOTE 4: GEOGRAPHIC INFORMATION
The Company operates as one segment. Geographic
information regarding net sales is approximately as follows:
SCHEDULE OF GEOGRAPHIC INFORMATION
February 28, 2025
February 29, 2024
February 28, 2025
February 29, 2024
Three Months Ended
Nine Months Ended
February 28, 2025
February 29, 2024
February 28, 2025
February 29, 2024
Revenues from sales to unaffiliated customers:
North America
$ 404,000
$ 393,000
$ 1,381,000
$ 1,069,000
Asia
365,000
210,000
1,614,000
1,843,000
Europe
198,000
331,000
979,000
1,085,000
Middle East
149,000
78,000
580,000
291,000
South America
3,000
5,000
8,000
11,000
Total
$ 1,119,000
$ 1,017,000
$ 4,562,000
$ 4,299,000
Revenues
$ 1,119,000
$ 1,017,000
$ 4,562,000
$ 4,299,000
As of February 28, 2025, and May 31, 2024, approximately
$ 475,000 and $ 537,000 of the Company’s gross inventory was located in Mexicali, Mexico, respectively.
As of February 28, 2025, and May 31, 2024, approximately
$ 11,000 and $ 14,000 of the Company’s property and equipment, net of accumulated depreciation and amortization, was located in Mexicali,
Mexico, respectively.
NOTE 5: LEASES
The Company leases facilities in Irvine, California and Mexicali, Mexico
As of February 28, 2025, the Company had approximately
22,000 square feet of floor space at its corporate headquarters at 17571 Von Karman Avenue in Irvine, California. This facility includes
administration, research and development, certain manufacturing, shipping and inventory storage. The lease for its headquarters expires
in August 2026. The Company has the option to extend the lease for an additional five-year term. The Company made a security deposit of
approximately $ 22,000 .
In November 2016, the Company’s Mexican subsidiary,
Biomerica de Mexico, entered into a 10-year lease for approximately 8,100 square feet of manufacturing space. The Company has one 10-year
option to renew at the end of the initial lease period. Biomerica de Mexico also leases a smaller unit on a month-to-month basis for use
in one manufacturing process.
In addition, the Company leases a small office
in Lindau, Germany on a month-to-month basis, as headquarters for BioEurope GmbH, its Germany subsidiary.
For purposes of determining straight-line rent
expense, the lease term is calculated from the date the Company first takes possession of the facility, including any periods of free
rent and any renewal options periods that the Company is reasonably certain of exercising. The Company’s office and equipment leases
generally have contractually specified minimum rent and annual rent increases are included in the measurement of the right-of-use asset
and related lease liabilities. Additionally, under these lease arrangements, the Company may be required to pay directly, or reimburse
the lessors, for some maintenance and operating costs. Such amounts are generally variable and therefore not included in the measurement
of the right-of-use asset and related lease liabilities but are instead recognized as variable lease expense in the consolidated statements
of operations and comprehensive loss when they are incurred.
14
The following table presents information on our
operating leases for the three months and nine months ended February 28, 2025 and February 29, 2024:
SCHEDULE OF OPERATING LEASES
February 28, 2025
February 29, 2024
February 28, 2025
February 29, 2024
Three Months Ended
Nine Months Ended
February 28, 2025
February 29, 2024
February 28, 2025
February 29, 2024
Operating lease cost
$ 88,000
$ 88,000
$ 265,000
$ 265,000
Variable lease cost
3,000
3,000
8,000
8,000
Short-term lease cost
3,000
8,000
7,000
10,000
Total lease cost
$ 94,000
$ 99,000
$ 280,000
$ 283,000
The approximate maturity of lease liabilities
as of February 28, 2025 are as follows:
SCHEDULE OF FUTURE MINIMUM LEASE PAYMENTS
Year Ending May 31:
Operating Leases
2026 (excluding the nine months ended February 28, 2025)
$ 374,000
2027
195,000
Total minimum future lease payments
569,000
Less: imputed interest
26,000
Total operating lease liabilities
$ 543,000
The following table summarizes the Company’s
other supplemental lease information for the nine months ended February 28, 2025 and February 29, 2024:
SCHEDULE OF OTHER SUPPLEMENTAL LEASE INFORMATION
February 28, 2025
February 29, 2024
Nine Months Ended
February 28, 2025
February 29, 2024
Cash paid for operating lease liabilities
$ 274,000
$ 267,000
Weighted-average remaining lease term (years)
1.06
2.77
Weighted-average discount rate
6.50 %
6.50 %
The Company also has various insignificant leases
for office equipment.
NOTE 6: COMMITMENTS AND CONTINGENCIES
LITIGATION
The Company is, from time to time, involved in
legal proceedings, claims, and litigation arising in the ordinary course of business. While the amounts claimed may be substantial, the
ultimate liability cannot presently be determined because of considerable uncertainties that exist. Therefore, it is possible the outcome
of such legal proceedings, claims, and litigation could have a material effect on quarterly or annual operating results or cash flows
when resolved in a future period. However, based on facts currently available, management believes such matters will not have a material
adverse effect on the Company’s consolidated financial position, results of operations or cash flows.
There were no material legal proceedings pending
as of February 28, 2025.
NOTE 7: SUBSEQUENT EVENTS
None.
15
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and
analysis in conjunction with our unaudited condensed consolidated financial statements and the accompanying notes thereto included in
Part I, Item 1 of this Report and the audited consolidated financial statements in our Annual Report on Form 10-K for the fiscal year
ended May 31, 2024 (our 2024 Annual Report).
FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains
forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and
Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and subject to the safe harbor created by the
Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, contained in
this Quarterly Report are forward-looking statements.
Such statements include declarations regarding our intent, belief, or current expectations, and those of our management.
In some cases, you can identify forward-looking statements by terminology
such as “may,” “will,” “should, ””could,” “contemplates,” “expects,”
“intends,” “plans,” “targets,” “anticipates,” “believes,” “estimates,”
“projects,” “predicts,” “potential” or “continue” or the negative of these terms or other
comparable terminology. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and
involve a number of risks, uncertainties and other factors, some of which are beyond our control. Actual results could differ materially
from those indicated by such forward-looking statements. Important factors that could cause actual results to differ materially from those
indicated by such forward-looking statements include, but are not limited to, those risks and uncertainties identified under “Risk
Factors,” in our 2024 Annual Report on Form 10-K and the other risks detailed from time-to-time in our reports and registration
statements filed with the Securities and Exchange Commission, or SEC. Except as required by law, we undertake no obligation to revise
or update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
OVERVIEW
We are a global biomedical technology company
that develops, patents, manufactures and markets advanced diagnostic and therapeutic products. Our diagnostic test kits are used to analyze
blood, urine, nasal or fecal material from patients in the diagnosis of various diseases, food intolerances and other medical complications.
They can also be used to measure or detect the presence and levels of specific bacteria, hormones, antibodies, antigens and other substances,
which may exist in the human body in extremely small concentrations. Our products are designed to enhance the health and well-being of
people, while reducing total healthcare costs.
Our extensive range of medical diagnostic products
is sold worldwide, primarily in two markets: clinical laboratories and point-of-care settings. Most of our products are Conformite Europeenne
(“CE”) marked and/or registered with regulatory agencies in various countries for diagnostic use, with several also cleared
by the FDA for sale in the United States.
Technological advances in medical diagnostics
have enabled diagnostic tests to be performed not only in clinical laboratories but also at home and at the point-of-care in physicians’
offices. One of our key objectives has been to develop and market rapid diagnostic tests that are accurate, utilize easily obtained patient
specimens, and are simple to perform without the need for complex instrumentation. Our home use (over-the-counter) and professional use
(physicians’ office, clinics, etc.) rapid diagnostic test products help manage existing medical conditions and may save lives through
early detection and diagnosis of specific diseases. Traditionally, such tests required the expertise of medical technologists and sophisticated
equipment, with results often not available for days. We believe our rapid point-of-care tests, when properly used, can be as accurate
as laboratory tests. Our products require limited to no instrumentation, deliver reliable results in minutes, and can be performed with
confidence at home or in a physician’s office.
We invest resources in the research and development
of new products designed to diagnose and, in some cases, treat several major medical diseases. These products are either internally developed
or licensed from others. Our experienced and highly trained technical personnel, including Ph.D. holders and other scientists, are dedicated
to developing new products and managing technology transfer activities. Our technical staff, many of whom have extensive experience from
previous employment at large diagnostic manufacturing companies, bring a wealth of industry knowledge. Additionally, we rely on our Scientific
Advisory Board, comprised of leading medical doctors and clinicians, to guide our clinical studies and product development efforts.
A key outcome from our research and development
efforts is our patented diagnostic-guided therapy (“DGT”) product, developed on the inFoods® technology platform. This
innovative technology is designed to treat gastrointestinal conditions such as irritable bowel syndrome (“IBS”) and other
inflammatory diseases. The DGT product targets chronic inflammatory illnesses that are widespread and prevalent in large markets. We have
launched the inFoods® IBS product, which leverages this patented technology.
The inFoods® IBS product utilizes a simple
blood test to identify patient-specific foods that, when eliminated from the diet, may alleviate IBS symptoms such as pain, bloating,
diarrhea, cramping, and constipation. Unlike broad and difficult-to-manage dietary restrictions, the inFoods® IBS product pinpoints
a patient’s heightened immunoreactivity to specific foods known to frequently trigger IBS symptoms. By removing the foods identified
as problematic, patients can achieve relief from their IBS symptoms.
16
We began commercializing our inFoods® product
with select gastroenterology (“GI”) physician groups in various states and regions, including collaboration with one of the
largest GI groups in the U.S. This initial phase was focused on gathering real-world feedback, optimizing physician engagement, and validating
operational processes. Feedback from GI specialists has been generally positive, and we are continuing to expand our network by onboarding
additional physician practices.
Our dedicated sales team is focused on building
strong relationships within the GI segment while selectively exploring opportunities to introduce inFoods® to other medical specialties,
including integrated health practices and primary-care providers. These efforts are intended to lay the groundwork for broader adoption
by showcasing the distinct clinical value of inFoods® across multiple healthcare channels.
Concurrently, we are evaluating distribution,
partnership, and licensing opportunities with U.S.companies to support a scalable, broad market launch. These potential collaborations
could significantly enhance the commercialization trajectory of inFoods® products, both domestically and internationally.
As we continue pursue commercial opportunities in both U.S. and international markets, we remain attentive to evolving
global economic conditions, including uncertainties related to international trade policies, tariffs, and supply chain dynamics. Although
these factors have not had a material impact on our operations to date, future changes in trade regulations, tariff structures, or logistical
constraints could influence the cost, availability, or timing of materials and components used in our manufacturing processes. We continue
to monitor these developments closely and are actively implementing contingency plans, including alternative sourcing strategies and supplier
diversification, to support supply chain continuity, maintain operational efficiency, and help mitigate potential future impacts. We are
also focusing on alternative manufacturing and shipping strategies of our products through our European subsidiary (BioEurope), and our
Mexican subsidiary (BioMexico), to mitigate some of the risk these policies may have on our revenues and operations.
Beyond the inFoods® product line,
the Company has achieved a significant milestone with the development of hp+detect™, a diagnostic test designed to detect Helicobacter
pylori (“H. pylori”) bacteria in the gastrointestinal tract. H. pylori is a prevalent infection, affecting approximately
35% of the U.S. population and 45% of the population in Europe’s largest countries. This bacterium is the strongest known risk
factor for gastric cancer, which remains one of the leading causes of cancer-related deaths worldwide.
The hp+detect™ test offers physicians and
medical centers a reliable tool for diagnosing H. pylori infections and monitoring treatment efficacy. The test is marketed directly to
laboratories, where patient samples are processed to provide timely and accurate diagnoses. To support the widespread adoption and distribution
of hp+detect™, the Company is working with large reference laboratories, aiming to improve patient outcomes through early
detection and effective treatment of H. pylori infections.
Due to the slower-than-expected launch of the
Company’s key products, inFoods® IBS and hp+detect™, the Company has executed significant cost-cutting measures to extend
its cash runway and work towards increasing revenues to cover overhead costs. These measures include a workforce reduction of nearly 15%
during this fiscal year, which incurred costs such as severance, impacting typical cost trends and margins. Additionally, we raised $2,015,000
in net proceeds from the ATM offering filed in May 2024, providing additional liquidity to support our operations. The Company is actively
exploring strategic opportunities to enhance and create shareholder value.
RESULTS OF OPERATIONS
Three months ended
February 28, 2025
Net Sales and Cost of Sales
The following is a breakdown of revenues according
to markets to which the products are sold:
Three Months Ended
Increase (Decrease)
February 28, 2025
February 29, 2024
$
%
Clinical lab
$ 627,000
$ 404,000
$ 223,000
55 %
Over-the-counter
170,000
329,000
(159,000 )
-48 %
Contract manufacturing
320,000
281,000
39,000
14 %
Physician’s office
2,000
3,000
(1,000 )
-33 %
Total
$ 1,119,000
$ 1,017,000
$ 102,000
10 %
Consolidated net sales were approximately $1,119,000
for the three months ended February 28, 2025, as compared to $1,017,000 for the three months ended February 29, 2024, an increase of approximately
$102,000 or 10%. This increase for the three months ended February 28, 2025, was primarily attributed to increased sales of our food intolerance
products, reflecting a growing interest and engagement in this category. Sales in this segment are subject to periodic and infrequent
orders, contributing to potential volatility in quarterly sales.
Consolidated cost of sales were approximately
$1,100,000, or 98% of net sales, for the three months ended February 28, 2025, as compared to $1,166,000, or 115% of net sales, for the
three months ended February 29, 2024, a decrease of approximately $66,000, or 6%. The decrease for the three months ended February 28,
2025 was primarily driven by the reduction in force (“RIF”) executed in July 2024, which helped to decrease labor costs for
the quarter.
17
Operating Expenses
The following is a summary of operating expenses:
Three Months Ended
February 28, 2025
February 29, 2024
Increase (Decrease)
Operating Expense
As a % of
Total Revenues
Operating Expense
As a % of
Total Revenues
$
%
Selling, General and Administrative Expenses
$ 1,012,000
90 %
$ 1,508,000
148 %
$ (496,000 )
-33 %
Research and Development
$ 217,000
19 %
$ 343,000
34 %
$ (126,000 )
-37 %
Selling, General and Administrative
Expenses
For the three months ended February 28, 2025,
consolidated selling, general, and administrative expenses amounted to approximately $1,012,000, representing a significant reduction
of $496,000 or 33%, compared to $1,508,000 for the corresponding period in 2024. This reduction was primarily due to a $225,000 decrease
in stock compensation for the administration and a Reduction in Force (RIF) implemented in July 2024, which resulted in a $183,000 decrease
in payroll expenses. Additionally, legal expenses were reduced by $46,000. These efforts demonstrate our focus on operating discipline
and cost optimization as we align our cost structure with near-term business priorities, while preserving the resources needed to support
long-term growth.
Research and Development
For the three months ended February 28, 2025,
consolidated research and development (“R&D”) expenses totaled approximately $217,000, representing a decrease of 37%
from $343,000 in the same period of 2024. This $126,000 reduction was primarily driven by a $64,000 decline in R&D wages due to a RIF executed in July 2024, and a reduction of $39,000 in expenses related to clinical trial studies.
Interest and Dividend Income
For the three months ended February 28, 2025,
interest and dividend income totaled approximately $43,000, compared to $86,000 for the corresponding period in 2024, representing a decrease
of $43,000, or 50%. This reduction was primarily attributable to lower market interest rates affecting our lower cash balances, which
had decreased by February 28, 2025.
Nine months ended February 28, 2025
Net Sales and Cost of Sales
The following is a breakdown of revenues according
to markets to which the products are sold:
Nine Months Ended
Increase (Decrease)
February 28, 2025
February 29, 2024
$
%
Clinical lab
$ 2,683,000
$ 2,683,000
$ -
0 %
Over-the-counter
952,000
1,078,000
(126,000 )
-12 %
Contract manufacturing
920,000
530,000
390,000
74 %
Physician’s office
7,000
8,000
(1,000 )
-13 %
Total
$ 4,562,000
$ 4,299,000
$ 263,000
6 %
For the nine months ended February 28, 2025, consolidated
net sales reached approximately $4,562,000, marking a 6% increase or $263,000 from $4,299,000 in the same period of 2024. This growth
was largely driven by enhanced contract manufacturing billings and increased demand for our inFoods® IBS product. Although there was
a decline in over-the-counter (OTC) sales due to reduced retail market activity, and some volatility in clinical laboratory sales, the
company successfully maintained a positive sales trajectory through strategic diversification and bolstered demand in key sectors.
For the nine months ended February 28, 2025, consolidated
cost of sales was approximately $3,820,000, representing 84% of net sales, compared to $3,708,000, or 86% of net sales, for the same period
in 2024. This 3% increase, amounting to $112,000, was primarily driven by expanded contract manufacturing sales. Notably, the implementation
of a RIF in July 2024 effectively reduced direct labor costs, thereby contributing to improved gross margins.
18
Operating Expenses
The following is a summary of operating expenses:
Nine Months Ended
February 28, 2025
February 29, 2024
Increase (Decrease)
Operating Expense
As a % of
Total Revenues
Operating Expense
As a % of
Total Revenues
$
%
Selling, General and Administrative Expenses
$ 3,544,000
78 %
$ 4,204,000
98 %
$ (660,000 )
-16 %
Research and Development
$ 771,000
17 %
$ 1,226,000
29 %
$ (455,000 )
-37 %
For the nine months ended February 28, 2025, consolidated
selling, general, and administrative expenses totaled approximately $3,544,000, compared to $4,204,000 for the same period in 2024. This
represents a decrease of $660,000, or 16%. This notable reduction in expenses reflects our strategic financial management and can be attributed
to multiple factors: the absence of a sales reserve for OTC products from the previous year, reducing costs by $175,000;
a $262,000 decrease in stock compensation; and a $172,000 in payroll savings following a RIF implemented in July
2024. Furthermore, we reduced advertising expenses by $50,000. These overall cost reductions demonstrate our commitment to strategically
allocating capital and maintaining financial discipline as we continue to pursue growth opportunities.
Research and Development
For the nine months ended February 28, 2025, consolidated R&D expenses were approximately $771,000, a decrease of 37% from $1,226,000 during the same period in 2024.
This $455,000 reduction was largely due to a $303,000 decrease in R&D wages following a RIF implemented in July
2024. As part of our strategic cost-cutting initiatives, several clinical trials were scaled back, leading to lower expenditures. Furthermore,
with the commercialization of inFoods® IBS, we strategically reduced R&D funding in this area, which accounted for an additional
$75,000 decrease in related expenses.
Interest and Dividend Income
For the nine months ended February 28, 2025, interest
and dividend income totaled approximately $140,000, compared to $317,000 for the corresponding period in 2024, representing a decrease
of $177,000, or 56%. This reduction was primarily attributable to lower market interest rates affecting our lower cash balances, which
had decreased by February 28, 2025
LIQUIDITY AND CAPITAL RESOURCES
The following are the principal sources of liquidity:
February 28, 2025
May 31, 2024
Cash and cash equivalents
$ 3,058,000
$ 4,170,000
Working capital including cash and cash equivalents
$ 4,555,000
$ 5,527,000
As of February 28, 2025 and May 31, 2024, the
Company had cash and cash equivalents of approximately $3,058,000 and $4,170,000, respectively. As of February 28, 2025 and May 31, 2024,
the Company had working capital of approximately $4,555,000 and $5,527,000, respectively.
The Company’s ability to continue as a going
concern over the next twelve months is influenced by several factors, including:
●
Our need and ability to generate additional revenue from international opportunities and our new product launches;
●
Our need to access the capital and debt markets to meet current obligations and fund operations;
●
Our capacity to manage operating expenses and maintain gross margins as we grow;
●
Our ability to retain key employees and maintain critical operations with a substantially reduced workforce; and
●
Certain SEC regulations that limit the amount of capital the Company can raise through issuance of its equity.
Management has analyzed the Company’s cash
flow requirements through May 2026 and beyond. Based on this analysis, we believe our current cash and cash equivalents are insufficient
to meet our operating cash requirements and strategic growth objectives for the next twelve months.
19
To address our capital needs and
sustain operations beyond the next year, we are actively pursuing strategies to increase sales, reduce expenses, sell non-core
assets, seek additional financing through debt or issuance of equity, and seek other strategic alternatives. While we are committed
to these plans, there is no assurance that these efforts will be successful or sufficient to meet our capital requirements.
As part of our efforts to reduce costs, we are
executing significant cost-cutting measures to extend our cash runway and work towards increasing revenues to cover overhead costs. These
measures included a workforce reduction of nearly 15% in July 2024 and a substantial reduction in other operating expenses.
As part of our financing plan, on September 28,
2023, we filed a new “shelf” registration statement on Form S-3 with the SEC, to replace the expiring S-3 that was filed in
July 2020, which was declared effective on September 29, 2023, allowing us to issue up to $20,000,000 in common shares. Under this registration
statement, shares of our common stock may be sold from time to time for up to three years from the filing date. On May 10, 2024, we filed
a prospectus supplement with the SEC to facilitate the sale of up to $5,500,000 in common stock through at-the-market (“ATM”)
offerings, as defined in Rule 415 under the Securities Act. As part of this transaction, we incurred $81,000 in deferred offering costs.
The amount of capital that we can raise under the ATM offering is highly dependent upon the trading volume and the trading price of our
stock. The average trading volume of our stock over the last three full calendar months is 7,798,345 shares per day and the high and low
trading price of our stock during the same period of time was $0.27 and $1.03, respectively. If our stock continues to trade at low volumes
and price, the amount of capital that we can raise under the ATM offering will be constrained.
We intend to use the net proceeds from the ATM
offering for general corporate purposes, including, but not limited to, sales and marketing activities, clinical studies and product development,
acquisitions of assets, businesses, companies, or securities, capital expenditures, and working capital needs.
During the nine months ended February 28, 2025,
the Company sold 3,525,359 shares of its common stock at prices ranging from $0.36 to $1.04 pursuant to the May 2024 ATM Offering, which
resulted in gross proceeds of approximately $2,143,000 and net proceeds to the Company of $2,015,000 after deducting commissions for each
sale and legal, accounting, and other fees related to offering in the amount of $128,000.
While we are committed to these plans, there is
no assurance that these efforts will be successful or sufficient to meet our capital requirements.
These factors raise substantial doubt about our
ability to continue as a going concern. Our future viability depends on the successful execution of our strategic plans, securing additional
financing, and achieving profitable operations.
Operating Activities
During the nine months ended February 28, 2025,
cash used in operating activities totaled approximately $3,180,000. The primary contributors to this outflow were a net loss of approximately
$3,429,000, an increase in accounts receivable of $327,000, a decrease in accounts payable and accrued expenses totaling $506,000, and
a reduction in lease liabilities of $242,000. These cash outflows were partially offset by a decrease in inventories of $766,000 and non-cash
expenses of $610,000. The non-cash expenses included depreciation and amortization, provision for allowance on accounts receivable, inventory
reserves, share-based compensation, and amortization of right-of-use assets.
20
During the nine months ended February 29, 2024,
cash used in operating activities was approximately $4,317,000. The primary factors that contributed to this was a loss of approximately
$4,557,000, non-cash expenses of $723,000, primarily associated with depreciation and amortization, provision for allowance on accounts
receivable, inventory reserves, share-based compensation, and amortization of right-of-use assets. This was partially offset by changes
in asset and liability accounts of approximately $483,000.
Importantly, we have made significant progress
in reducing our underlying cost structure. When excluding the positive impact of proceeds from the ATM offering, our current quarterly
cash burn has improved to approximately $800,000 compared to approximately $1,800,000 in the same period of last year. This reduction
reflects our disciplined execution of cost saving initiatives, stronger sales from a more diverse portfolio, and tighter management of
working capital.
Investing Activities
During the nine months ended February 28, 2025,
cash used in investing activities was $0 for purchases of property and equipment, and $37,000 in expenditures related to patents.
During the nine months ended February 29, 2024,
cash used in investing activities was approximately $27,000 for purchases of property and equipment, and $64,000 in expenditures related
to patents.
Financing Activities
During the nine months ended February 28, 2025,
net cash provided by financing activities amounted to approximately $2,116,000. This influx was primarily driven by net proceeds from
the sale of common stock totaling $2,015,000 and proceeds from the exercise of stock options amounting to $16,000. These contributions
were partially offset by deferred offering costs of $85,000.
During the nine months ended February 29, 2024,
cash provided by financing activities was $0, with no net proceeds from the sale of common stock or from stock option exercises.
OFF BALANCE SHEET ARRANGEMENTS
There were no off-balance sheet arrangements as
of February 28, 2025.
CRITICAL ACCOUNTING POLICIES
The preparation of consolidated financial statements
in conformity with accounting principles generally accepted in the United States of America requires us to make a number of estimates
and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the
date of the financial statements. Such estimates and assumptions affect the reported amounts of revenues and expenses during the reporting
period. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances.
Actual results may differ materially from these estimates under different assumptions or conditions. We continue to monitor significant
estimates made during the preparation of our financial statements. On an ongoing basis, we evaluate estimates and assumptions based upon
historical experience and various other factors and circumstances. We believe our estimates and assumptions are reasonable under the current
conditions; however, actual results may differ from these estimates under different future conditions.
We believe that the estimates and assumptions
that are most important to the portrayal of our financial condition and results of operations, in that they require subjective or complex
judgments, form the basis for the accounting policies deemed to be most critical to us. These relate to revenue recognition, credit losses,
inventory overhead application, inventory reserves, right-of-use assets and lease liabilities and share-based compensation. We believe
estimates and assumptions related to these critical accounting policies are appropriate under the circumstances; however, should future
events or occurrences result in unanticipated consequences, there could be a material impact on our future financial condition or results
of operations. We suggest that our significant accounting policies be read in conjunction with this Management’s Discussion and
Analysis of Financial Condition and Results of Operations. Please refer to Note 2 for information on Significant Accounting Policies.
Our critical accounting policies are discussed in our Annual Report on Form 10-K for the fiscal year ended May 31, 2024.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISK
We are a smaller reporting company as defined
by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to provide the information under this item.
ITEM 4. CONTROLS AND PROCEDURES
Our management evaluated the effectiveness of
our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended,
or the Exchange Act, as of the end of the period covered by this report. Our management recognizes that any controls and procedures, no
matter how well designed and operated, can provide only reasonable assurance of achieving its objectives, and management is required to
apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our disclosure controls and procedures
have been designed to provide reasonable assurance of achieving its objectives.
Based on their evaluation as of February 28, 2025,
our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures (as defined in Rules
13a-15(e) and 15d-15(e) under the Exchange Act) were effective at the “reasonable assurance” level to ensure that the information
required to be disclosed by us in this Quarterly Report on Form 10-Q (our “Quarterly Report”) was (1) recorded, processed,
summarized and reported within the time periods specified in the SEC’s rules and regulations; and (2) accumulated and communicated
to the our management, including our Chief Executive Officer and Chief Financial Officer to allow timely decisions regarding required
disclosure.
There have been no changes in our internal control
over financial reporting during the quarter ended February 28, 2025 that have materially affected, or that is reasonably likely to materially
affect, our internal control over financial reporting.
21
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
From time to time, we are involved in legal proceedings,
claims, and litigation arising in the ordinary course of business, which may impact our financial results.
As of February 28, 2025, there were no pending
legal proceedings. However, the outcome of any future legal matters, claims, or litigation could potentially have a material adverse effect
on our quarterly or annual operating results or cash flows when resolved in subsequent periods. Nonetheless, based on current information,
management believes these matters will not have a material adverse effect on our consolidated financial position, results of operations,
or cash flows.
ITEM 1A. RISK FACTORS
An investment in our common stock involves risks.
Before making an investment decision, you should carefully consider all the information within this Quarterly Report, including the information
contained in Part I, Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,”
as well as in our condensed consolidated financial statements and the related notes contained in Part I, Item 1 within this Quarterly
Report. In addition, you should carefully consider the risks and uncertainties described in Part I, Item 1A, “Risk Factors,”
of our 2024 Annual Report on Form 10-K, as well as in our other public filings with the SEC. If any of the identified risks are realized,
our business, results of operations, financial condition, liquidity, and prospects could be materially and adversely affected. In that
case, the trading price of our common stock may decline, and you could lose all or part of your investment. In addition, other risks of
which we are currently unaware, or which we do not currently view as material, could have a material adverse effect on our business, results
of operations, financial condition, and prospects.
During the nine months ended February 28, 2025,
there were no material changes to the risks and uncertainties described in Part I, Item 1A, “Risk Factors,” of our 2024 Annual
Report on Form 10-K.
ITEM 5. OTHER INFORMATION
None.
22
ITEM 6. EXHIBITS.
The following exhibits are filed or furnished
as part of this quarterly report on Form 10-Q:
Exhibit No.
Description
31.1**
Certification Pursuant to Section 302 of the Sarbanes-Oxley Act — Zackary S. Irani
31.2**
Certification Pursuant to Section 302 of the Sarbanes-Oxley Act — Gary Lu
32.1**
Certification Pursuant to Section 906 of the Sarbanes-Oxley Act — Zackary S. Irani
32.2**
Certification Pursuant to Section 906 of the Sarbanes-Oxley Act — Gary Lu
101 Interactive data files pursuant to Rule 405
Regulation S-T, as follows:
101.INS-XBRL Instance Document
101.SCH-XBRL Taxonomy Extension Schema Document
101.CAL-XBRL Taxonomy Extension Calculation Linkbase
Document
101.DEF–XBRL Taxonomy Extension Definition
Linkbase Document
101.LAB-XBRL Taxonomy Extension Label Linkbase
Document
101.PRE-XBRL Taxonomy Extension Presentation Linkbase
Document
104 Cover Page Interactive Data File (formatted
as inline XBRL and contained in Exhibits 101)
* Filed herein.
** Filed herewith.
23
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the Registrant has fully caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
BIOMERICA, INC.
Date: April 14, 2025
By:
/S/ Zackary S. Irani
Zackary S. Irani
Chief Executive Officer
(Principal Executive Officer)
Date: April 14, 2025
By:
/S/ Gary Lu
Gary Lu
Chief Financial Officer
(Principal Financial Officer)
24
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.