You should read the following discussion and analysis of our financial condition
and plan of operations together with "Selected Financial Data" and our financial
statements and the related notes appearing elsewhere in this prospectus. In
addition to historical information, this discussion and analysis contains
forward-looking statements that involve risks, uncertainties and assumptions.
Our actual results may differ materially from those discussed below. Factors
that could cause or contribute to such differences include, but are not limited
to, those identified below, and those discussed in the section titled "Risk
Factors" included elsewhere in this prospectus. All amounts in this report are
in
FORWARD-LOOKING STATEMENTS
This report, including exhibits that are being filed as part of this report, as
well as other statements made by
These forward-looking statements include such things as: investment objectives and the Company's ability to make investments in a timely manner on acceptable terms; references to future success of the Company's products; the Company's business strategy; estimated future capital expenditures; sales of the Company's products; competitive strengths and goals; and other similar matters.
These forward-looking statements reflect the Company's current beliefs and
expectations with respect to future events and are based on assumptions and are
subject to risks and uncertainties and other factors outside the Company's
control that may cause actual results to differ materially from those projected.
Such factors include, but are not limited to, the following: ability to develop,
commercialize and market new products; ability to market and sell products,
whether through an internal, direct sales force or third parties; ability to
manufacture products in accordance with applicable specifications, performance
standards and quality requirements; ability to obtain, and timing and cost of
obtaining, necessary regulatory approvals for new products or new indications or
applications for existing products; ability to comply with applicable regulatory
requirements; ability to effectively resolve warning letters, audit observations
and other findings or comments from the FDA or other regulatory entities;
changes in relationships, including disputes or disagreements, with strategic
partners or other parties and reliance on strategic partners for the performance
of critical activities under collaborative arrangements; competing products and
technology changes; reduction or deferral of public funding available to
customers; competition from new or better technology or lower cost products;
market acceptance of our products; changes in market acceptance of products
based on product performance or other factors, including changes in testing
guidelines, algorithms or other recommendations by the
Although the Company believes the expectations reflected in such forward-looking statements are based upon reasonable assumptions, these are only assumptions, and forward-looking statements should not be read as a guarantee of future performance or results and will probably not be accurate indications of when such performance or results will be achieved. Investors are cautioned that forward-looking statements may not be reliable and speak only as of the date they are made and that, except as required by law, the Company undertakes no obligation to update these forward-looking statements to reflect any future events or circumstances. All subsequent written or oral forward-looking statements attributable to the Company or to individuals acting on its behalf are expressly qualified in their entirety by this section.
42
Investors should also be aware that while we do, from time to time, communicate with securities analysts, it is against our policy to disclose any material non-public information or other confidential commercial information to securities analysts unless and until we have made it publicly available. Accordingly, stockholders should not assume that we agree with any statement or report issued by any analyst irrespective of the content of the statement or report. Furthermore, we have a policy against issuing or confirming financial forecasts or projections issued by others. Thus, to the extent that reports issued by securities analysts contain any projections, forecasts or opinions, such reports are not the responsibility of the Company.
Overview
This discussion and analysis should be read in conjunction with the accompanying
Consolidated Financial Statements and related notes. The discussion and analysis
of our financial condition and results of operations are based upon our
consolidated financial statements, which have been prepared in accordance with
generally accepted accounting principles in
This management's discussion and analysis of financial condition and results of
operations ("MD&A") is intended to help you understand the business operations
and financial condition of the Company as of
Our MD&A is presented in six sections:
? Executive Overview
? Consolidated Results of Operations
? Liquidity and Capital Resources
? Recent Developments
? Significant Accounting Policies and Critical Accounting Estimates
? Recently Issued Accounting Pronouncements
Executive Overview
On
Our Business
43 Business Strategy
The healthcare market is rapidly evolving to incorporate a decentralized system
of care delivery within a broad spectrum of environments: the emergency
department, skilled nursing facilities, elderly homes, urgent care centers,
ambulances, and remote locations. While hospital central laboratories currently
are the gold standard of clinical testing, a mobile diagnostic platform offering
high-quality testing results at affordable prices is needed to serve the
decentralized testing requirements. The
Our initial product development focus is on testing for critical medical
conditions where rapidly available information is needed to help inform clinical
decision making.
Results of Operations
Results of operations for the years ended
The results of operations for the years endedDecember 31, 2022 and 2021 were as follows: NANOMIX CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS December 31, 2022 2021 Revenues$ 15,450 $ 141,778 Operating costs and expenses: Research and development 3,159,239 3,017,263 Selling, general and administrative expenses 5,293,379 2,849,666 Total operating expenses 8,452,618 5,866,929 Loss from operations (8,437,168 ) (5,725,151 ) Other income (expense): Interest income 3 2 Interest expense (3,716,544 ) (1,644,829 )
Interest expense, related, party (391,757 ) (572,347 ) Other income 212,490 - Change in fair value of derivative liability - 15,282 Change in fair value of warrant liability - 438,972 Forgiveness of PPP loan and accrued interest - 408,242 Loss on debt modification - (2,385,204 ) Total income (expense) (3,895,808 ) (3,739,882 ) Loss before income taxes (12,332,976 ) (9,465,033 ) Provision for income taxes - - Net loss$ (12,332,976 ) $ (9,465,033 ) 44 Total Revenues
Total net revenues during twelve months ended
Research and Development
This category includes costs incurred for product and process development, and
clinical & regulatory affairs. Costs for year ended
Selling, General and Administrative Expense
Selling, general and administrative expense ("SG&A") for the year ended
Other Income (Expense)
Other Expense in 2022 was
Net Loss
The Net Loss for the year ended
Liquidity and Capital Resources
Overview
Our liquidity requirements are primarily to fund our business operations, including capital expenditures and working capital requirements. Our primary sources of liquidity are additional capital investment and debt.
On
In March of 2022, the Company entered into a Convertible Preferred stock
arrangement and issued 500 shares of Preferred D stock for
In the 4th quarter of 2022, the Company issued common stock to a distribution
partner in return for a
45 Cash Flows
As of
Cash used in operating activities during the year ended
Cash provided by investing activities during the year ended
Cash provided by financing activities during year 2022 of
Off-Balance Sheet Arrangements
The Company does not have any off-balance sheet arrangements, as defined in Item 303(a)(4)(ii) of Regulation S-K under the Securities Exchange Act of 1934, as amended.
Recent Developments
In
Significant Accounting Policies and Critical Accounting Estimates
Significant accounting policies are described in Note 3 - Significant Accounting Policies to the audited consolidated financial statements included herein. Certain of our accounting policies require the application of significant judgment by management in selecting the appropriate assumptions for calculating financial estimates. By their nature, these judgments are subject to an inherent degree of uncertainty. These judgments are based on our historical experience, terms of existing contracts, our evaluation of trends in the industry, information provided by our customers and information available from other outside sources, as appropriate. We consider an accounting estimate to be critical if:
? It requires us to make assumptions about matters that were uncertain at the
time we were making the estimate, and
? Changes in the estimate or different estimates that we could have selected
would have had a material impact on our financial condition or results of
operations.
The following listing is not intended to be a comprehensive list of all of our
accounting policies. In many cases, the accounting treatment of a particular
transaction is specifically dictated by accounting principles generally accepted
in
Revenue Recognition
For certain contracts, we recognize revenue from R&D, milestone and grant revenues when earned. Grants are invoiced after expenses are incurred, as that is the depiction of the timing of the transfer of services. Performance obligations generally follow the major phases of product development processes: design feasibility & planning, product development & design optimization, design verification, design validation & process validation, and pivotal studies. Further details regarding revenue recognition are document at Note 3(b) - Summary of Significant Accounting Policies: Revenue Recognition to the Unaudited Condensed Consolidated Financial Statements.
Stock-Based Compensation
We recognize the fair value of equity-based awards as compensation expense in our statement of operations. The fair value of our stock option awards was estimated using a Black-Scholes option valuation model. This valuation model's computations incorporate highly subjective assumptions, such as the expected stock price volatility and the estimated life of each award. The fair value of the options, after considering the effect of expected forfeitures, is then amortized, generally on a straight-line basis, over the related vesting period of the option.
46 Research & Development Costs
Research and development activities consist primarily of new product development, continuing engineering for existing products, and regulatory and clinical trial costs. Costs related to research and development efforts on existing or potential products are expensed as incurred.
Income Taxes
Income taxes are accounted for under ASC 740 authoritative guidance ("Guidance"), which requires the asset and liability method of accounting for deferred income taxes. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities. Deferred tax assets or liabilities at the end of each period are determined using the tax rate expected to be in effect when taxes are actually paid or recovered.
The Guidance also requires that a valuation allowance be established when it is more likely than not that all or a portion of a deferred tax asset will not be realized. A review of all available positive and negative evidence needs to be considered, including a company's current and past performance, the market environment in which the company operates, length of carryback and carryforward periods and existing contracts that will result in future profits. The Company believes that it is more likely than not that it will not be able to utilize its net operating loss carryforwards and maintains a full valuation allowance. The Company maintains a full valuation allowance on research and development tax credits.
The Guidance also prescribes a comprehensive model for recognizing, measuring, presenting and disclosing in the consolidated financial statements tax positions taken or expected to be taken on a tax return, including a decision whether to file or not to file in a particular jurisdiction.
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