APPLIED DNA SCIENCES INC
For the period ended Dec 31, 2023. Filed Feb 8, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Dec 31, 2023 · Filed Feb 8, 2024
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Item 1. - Condensed Consolidated Financial Statements (unaudited)
Item 1 - Financial Statements
CONDENSED CONSOLIDATED BALANCE SHEETS
| | | | | | | |
|---|---|---|---|---|---|---|
| · December 31, · September 30, | ||||||
| · · 2023 · · 2023 | ||||||
| ASSETS · · (unaudited) · · · | ||||||
| Current assets: · · | ||||||
| Cash and cash equivalents | | $3,359,045 | | $7,151,800 | ||
| Accounts receivable, net of allowance of $75,000 at December 31, 2023 and September 30, 2023, respectively | | 450,757 | | 255,502 | ||
| Inventories | | 377,291 | | 330,027 | ||
| Prepaid expenses and other current assets | | 402,953 | | 389,241 | ||
| Total current assets | | 4,590,046 | | 8,126,570 | ||
| | | | | | | |
| Property and equipment, net | | 539,319 | | 838,270 | ||
| Other assets: | | | | | ||
| Restricted cash | | | 750,000 | | | 750,000 |
| Intangible assets | | | 2,698,975 | | | 2,698,975 |
| Operating right of use asset | | | 1,117,317 | | | 1,237,762 |
| Capitalized transaction costs | | | 217,553 | | | — |
| Total assets | | $9,913,210 | | $13,651,577 | ||
| | | | | | | |
| LIABILITIES AND EQUITY | | | ||||
| | | | | | | |
| Current liabilities: | | | | |||
| Accounts payable and accrued liabilities | | $2,023,876 | | $2,270,388 | ||
| Operating lease liability, current | | | 510,028 | | | 498,598 |
| Deferred revenue | | 54,035 | | 76,435 | ||
| Total current liabilities | | 2,587,939 | | 2,845,421 | ||
| | | | | | | |
| Long term accrued liabilities | | 31,467 | | 31,467 | ||
| Deferred revenue, long term | | | 227,999 | | | 194,000 |
| Operating lease liability, long term | | | 607,288 | | | 739,162 |
| Deferred tax liability, net | | | 684,115 | | | 684,115 |
| Warrants classified as a liability | | | 1,646,000 | | | 4,285,000 |
| Total liabilities | | 5,784,808 | | 8,779,165 | ||
| | | | | | | |
| Commitments and contingencies (Note G) | | | ||||
| | | | | | | |
| Applied DNA Sciences, Inc. stockholders’ equity: | | | ||||
| Preferred stock, par value $0.001 per share; 10,000,000 shares authorized; -0- shares issued and outstanding as of December 31, 2023 and September 30 2023, respectively | | — | | — | ||
| Series A Preferred stock, par value $0.001 per share; 10,000,000 shares authorized; -0- issued and outstanding as of December 31, 2023 and September 30, 2023, respectively | | — | | — | ||
| Series B Preferred stock, par value $0.001 per share; 10,000,000 shares authorized; -0- issued and outstanding as of December 31, 2023 and September 30, 2023, respectively | | — | | — | ||
| | | | | | | |
| Common stock, par value $0.001 per share; 200,000,000 shares authorized as of December 31, 2023 and September 30, 2023, 13,721,820 and 13,658,520 shares issued and outstanding as of December 31, 2023 and September 30, 2023, respectively | | 13,722 | | 13,659 | ||
| Additional paid in capital | | 307,848,612 | | 307,384,647 | ||
| Accumulated deficit | | (303,630,004) | | (302,447,147) | ||
| Applied DNA Sciences, Inc. stockholders’ equity | | 4,232,330 | | 4,951,159 | ||
| Noncontrolling interest | | | (103,928) | | | (78,747) |
| Total equity | | | 4,128,402 | | | 4,872,412 |
| | | | | | | |
| Total liabilities and equity | | $9,913,210 | | $13,651,577 | ||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Three Months Ended December 31, | ||||||
| · 2023 · 2022 | ||||||
| Revenues · · | ||||||
| Product revenues | | $307,317 | | $516,396 | ||
| Service revenues | | | 247,147 | | | 232,061 |
| Clinical laboratory service revenues | | | 336,700 | | | 4,514,295 |
| Total revenues | | | 891,164 | | | 5,262,752 |
| | | | | | | |
| Cost of product revenues | | | 282,545 | | | 365,378 |
| Cost of clinical laboratory service revenues | | | 377,522 | | | 2,519,691 |
| Total cost of revenues | | | 660,067 | | | 2,885,069 |
| | | | | | | |
| Gross profit | | | 231,097 | | | 2,377,683 |
| | | | | | | |
| Operating expenses: | | | | | | |
| Selling, general and administrative | | | 3,084,348 | | | 2,625,357 |
| Research and development | | | 935,815 | | | 971,304 |
| Total operating expenses | | | 4,020,163 | | | 3,596,661 |
| | | | | | | |
| LOSS FROM OPERATIONS | | | (3,789,066) | | | (1,218,978) |
| | | | | |||
| Interest income | | | 33,323 | | | 3,686 |
| Unrealized gain (loss) on change in fair value of warrants classified as a liability | | | 2,639,000 | | | (2,637,800) |
| Other (expense) income, net | | | (13,538) | | | 8,846 |
| | | | | | | |
| Loss before provision for income taxes | | | (1,130,281) | | | (3,844,246) |
| | | | | | | |
| Provision for income taxes | | | — | | | — |
| | | | | | | |
| NET LOSS | | $(1,130,281) | | $(3,844,246) | ||
| | | | | | | |
| Less: Net loss attributable to noncontrolling interest | | | 25,181 | | | 874 |
| NET LOSS attributable to Applied DNA Sciences, Inc. | | $(1,105,100) | | $(3,843,372) | ||
| Deemed dividend related to warrant modifications | | | (77,757) | | | — |
| NET LOSS attributable to common stockholders | | $(1,182,857) | | $(3,843,372) | ||
| Net loss per share attributable to common stockholders-basic and diluted | | $(0.09) | | $(0.30) | ||
| | | | | | | |
| Weighted average shares outstanding- basic and diluted | | 13,673,433 | | 12,908,520 | ||
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
| | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three-Month Period Ended December 31, 2022 | |||||||||||||||||
| | | | | | | | | | | | | | | | | | |
| · · · · Common · · Additional · · · · · · · · | |||||||||||||||||
| · · Common · · Stock · · Paid in · · Accumulated · · Noncontrolling · · | |||||||||||||||||
| · Shares · Amount · Capital · Deficit · Interest · Total | |||||||||||||||||
| Balance, October 1, 2022 | 12,908,520 | | $12,909 | | $305,399,008 | | $(292,500,088) | | $(2,890) | | $12,908,939 | ||||||
| Stock based compensation expense | — | | — | | 93,748 | | — | | | — | | 93,748 | |||||
| Net loss | | — | | | — | | | — | | | (3,843,372) | | | (874) | | | (3,844,246) |
| Balance, December 31, 2022 | 12,908,520 | | $12,909 | | $305,492,756 | | $(296,343,460) | | $(3,764) | | $9,158,441 | ||||||
| | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three-Month Period ended December 31, 2023 | |||||||||||||||||
| | | | | | | | | | | | | | | | | | |
| · · · · Common · · Additional · · · · · · · · · | |||||||||||||||||
| · · Common · · Stock · · Paid in · · Accumulated · · Noncontrolling · · | |||||||||||||||||
| · Shares · Amount · Capital · Deficit · Interest · Total | |||||||||||||||||
| Balance, October 1, 2023 | 13,658,520 | | $13,659 | | $307,384,647 | | $(302,447,147) | | $(78,747) | | $4,872,412 | ||||||
| Exercise of warrants, cashlessly | | 2,100 | | | 2 | | | (2) | | | — | | | — | | | — |
| Stock based compensation expense | | — | | | — | | | 340,705 | | | — | | | — | | | 340,705 |
| Common stock issued in ATM, net of offering costs | | 61,200 | | | 61 | | | 45,505 | | | — | | | — | | | 45,566 |
| Deemed dividend - warrant repricing | | — | | | — | | | 77,757 | | | (77,757) | | | — | | | — |
| Net loss | | — | | | — | | | — | | | (1,105,100) | | | (25,181) | | | (1,130,281) |
| Balance, December 31, 2023 | | 13,721,820 | | $13,722 | | $307,848,612 | | $(303,630,004) | | $(103,928) | | $4,128,402 | |||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Three Months Ended December 31, | ||||||
| · 2023 · 2022 | ||||||
| Cash flows from operating activities: · · | ||||||
| Net loss | | $(1,130,281) | | $(3,844,246) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | | | | | ||
| Depreciation and amortization | | 298,951 | | 338,918 | ||
| Gain on sale of property and equipment | | | — | | | (6,083) |
| Unrealized (gain) loss on change in fair value of warrants classified as a liability | | | (2,639,000) | | | 2,637,800 |
| Stock-based compensation | | 340,705 | | 93,748 | ||
| Change in provision for bad debts | | — | | (290,022) | ||
| Change in operating assets and liabilities: | | | | | | |
| Accounts receivable | | | (195,254) | | | (695,912) |
| Inventories | | | (47,264) | | | 125,230 |
| Prepaid expenses, other current assets and deposits | | | (13,712) | | | 133,374 |
| Accounts payable and accrued liabilities | | | (383,423) | | | (586,236) |
| Deferred revenue | | | 11,599 | | | (289,677) |
| | | | | | | |
| Net cash used in operating activities | | (3,757,679) | | (2,383,106) | ||
| | | | | | | |
| Cash flows from investing activities: | | | | |||
| Proceeds from sale of property and equipment | | | — | | | 45,000 |
| Net cash used in investing activities | | | — | | | 45,000 |
| | | | | | | |
| Cash flows from financing activities: | | | | | | |
| Net proceeds from issuance of common stock | | | 45,566 | | | — |
| Capitalized transaction costs | | | (80,642) | | | — |
| | | | | | | |
| Net cash used in financing activities | | | (35,076) | | | — |
| | | | | | | |
| Net decrease in cash, cash equivalents and restricted cash | | | (3,792,755) | | | (2,338,106) |
| Cash, cash equivalents and restricted cash at beginning of period | | | 7,901,800 | | | 15,215,285 |
| Cash, cash equivalents and restricted cash at end of period | | $4,109,045 | | $12,877,179 | ||
| | | | | | | |
| Supplemental Disclosures of Cash Flow Information: | | | | | | |
| Cash paid during period for interest | | $— | | $— | ||
| Cash paid during period for income taxes | | $— | | $— | ||
| | | | | | | |
| Non-cash investing and financing activities: | | | | | | |
| Capitalized transaction costs included in accounts payable | | $136,911 | | $— | ||
| Deemed dividend warrant modifications | | $77,757 | | $— | ||
| Property and equipment acquired and included in accounts payable | | $— | | $20,619 | ||
NOTE A — NATURE OF THE BUSINESS
Applied DNA Sciences, Inc. (“Applied DNA” or the “Company”) is a biotechnology company developing and commercializing technologies to produce and detect deoxyribonucleic acid (“DNA”) and ribonucleic acid (“RNA”). Using polymerase chain reaction (“PCR”) to enable the production and detection of DNA and RNA, the Company currently operates inthree primary business markets: (i) the enzymatic manufacture of synthetic DNA for use in the production of nucleic acid - based therapeutics (including biologics and drugs) and, through the Company’s recent acquisition of Spindle Biotech, Inc. (“Spindle”), the development and sale of a proprietary RNA polymerase (“RNAP”) for use in the production of messenger RNA (“mRNA”) therapeutics (“Therapeutic DNA Production Services”); (ii) the detection of DNA and RNA in molecular diagnostics and genetic testing services (“MDx Testing Services”); and (iii) the manufacture and detection of DNA for industrial supply chain security services (“DNA Tagging and Security Products and Services”). To date, the Company has continued to incur expenses in expanding its business to meet current and anticipated future demand and it has limited sources of liquidity.
NOTE B — BASIS OF PRESENTATION AND SUMMARY OF ACCOUNTING POLICIES
Interim Financial Statements
The accompanying condensed consolidated financial statements as of December 31, 2023, and for the three-month periods ended December 31, 2023, and 2022 are unaudited. These unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and are presented in accordance with the requirements of Regulation S-X of the Securities and Exchange Commission (the “SEC”) and with the instructions to Form 10-Q. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements.
In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three-month period ended December 31, 2023 are not necessarily indicative of the results that may be expected for the fiscal year ending September 30, 2024. The unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements as of and for the fiscal year ended September 30, 2023 and footnotes thereto included in the Annual Report on Form 10-K of the Company filed with the Securities and Exchange Commission (“SEC”) on December 7, 2023, as amended. The condensed consolidated balance sheet as of September 30, 2023 contained herein has been derived from the audited consolidated financial statements as of September 30, 2023 but does not include all disclosures required by GAAP.
Principles of Consolidation
The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, APDN (B.V.I.) Inc., Applied DNA Sciences Europe Limited, Applied DNA Sciences India Private Limited, Applied DNA Clinical Labs, LLC (“ADCL”), Spindle and its majority-owned subsidiary, LineaRx, Inc. (“LRx”). Significant inter-company transactions and balances have been eliminated in consolidation.
Going Concern and Management’s Plan
The Company has recurring net losses. The Company incurred a net loss of $1,130,281 and generated negative operating cash flow of $3,757,679 for the three-month period ended December 31, 2023. At December 31, 2023, the Company had cash and cash equivalents of $3,359,045. These factors raise substantial doubt about the Company’s ability to continue as a going concern for one year from the date of issuance of these financial statements. The ability of the Company to continue as a going concern is dependent on the Company’s ability to further implement its business plan, raise capital, and generate revenues. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.
Going Concern and Management’s Plan, continued
The Company’s current capital resources include cash and cash equivalents, accounts receivable and inventories. Historically, the Company has financed its operations principally from the sale of equity and equity-linked securities.
Use of Estimates
The preparation of the financial statements in conformity with Accounting Principles Generally Accepted in the United States of America (“GAAP”) requires management to make estimates and assumptions that affect certain reported amounts and disclosures. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. The most significant estimates include revenue recognition, recoverability of long-lived assets, including the values assigned to intangible assets and property and equipment, fair value calculations for warrants, contingencies, and management’s anticipated liquidity. Management reviews its estimates on a regular basis and the effects of any material revisions are reflected in the consolidated financial statements in the period they are deemed necessary. Accordingly, actual results could differ from those estimates.
Revenue Recognition
The Company follows Financial Accounting Standards Board (“FASB”) Accounting Standards Codifications (“ASC”), Revenue Recognition (“ASC 606” or “Topic 606”).
The Company measures revenue at the amounts that reflect the consideration to which it is expected to be entitled in exchange for transferring control of goods and services to customers. The Company recognizes revenue either at the point in time or over the period of time that performance obligations to customers are satisfied. The Company’s contracts with customers may include multiple performance obligations (e.g. taggants, maintenance, authentication services, research and development services, etc.). For such arrangements, the Company allocates revenues to each performance obligation based on their relative standalone selling price.
Due to the short-term nature of the Company’s contracts with customers, it has elected to apply the practical expedients under Topic 606 to: (1) expense as incurred, incremental costs of obtaining a contract and (2) not adjust the consideration for the effects of a significant financing component for contracts with an original expected duration of one year or less.
Product Revenues and Authentication Services
The Company’s PCR-produced linear DNA product revenues are accounted for/recognized in accordance with contracts with customers. The Company recognizes revenue upon satisfying its promises to transfer goods or services to customers under the terms of its contracts. These performance obligations are satisfied at the point in time the Company transfers control of the goods to the customer, which in nearly all cases is when title to and risk of loss of the goods transfer to the customer. The timing of transfer of title and risk of loss is dictated by customary or explicitly stated contract terms. The Company invoices customers upon shipment, and its collection terms range, on average, from 30 to 60 days.
Authentication Services
The Company recognizes revenue for authentication services upon satisfying its promises to provide services to customers under the terms of its contracts. These performance obligations are satisfied at the point in time the Company services are complete, which in nearly all cases is when the authentication report is released to the customer.
Clinical Laboratory Testing Services
The Company records revenue for its clinical laboratory testing service contracts, which includes its COVID-19 Testing Services, upon satisfying its promise to provide services to customers under the terms of its contracts. These performance obligations are satisfied at the point in time that Company services are complete, which in nearly all cases is when the testing results are released to the customer. For those customers with a fixed monthly fee, the revenue is recognized over-time as the services are provided.
Research and Development Services
The Company records revenue for its research and development contracts using the over-time revenue recognition model. Revenue is primarily measured using the cost-to-cost method, which the Company believes best depicts the transfer of control to the customer. Under the cost-to-cost method, the extent of progress towards completion is measured based on the ratio of actual costs incurred to the total estimated costs expected upon satisfying the identified performance obligation.
Revenues are recorded proportionally as costs are incurred. For contracts where the total costs cannot be estimated, revenues are recognized for the actual costs incurred during a period until the remaining costs to complete a contract can be estimated. The Company has elected not to disclose the value of unsatisfied performance obligations for contracts with an original expected duration of one year or less.
Disaggregation of Revenue
The following table presents revenues disaggregated by our business operations and timing of revenue recognition:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Three Month Period Ended: | ||||||
| · · December 31, · · December 31, | ||||||
| · 2023 · 2022 | ||||||
| Research and development services (over-time) | | $77,535 | | $126,058 | ||
| Clinical laboratory testing services (point-in-time) | | | 12,120 | | | 3,074,414 |
| Clinical laboratory testing services (over-time) | | | 324,580 | | | 1,439,881 |
| Product and authentication services (point-in-time): | | | | | ||
| Supply chain | | 467,487 | | 411,765 | ||
| Large Scale DNA Production | | | — | | | 127,506 |
| Asset marking | | 9,442 | | 83,128 | ||
| Total | | $891,164 | | $5,262,752 | ||
NOTE B — BASIS OF PRESENTATION AND SUMMARY OF ACCOUNTING POLICIES, continued
Revenue Recognition, continued
Contract balances
As of December 31, 2023, the Company has entered into contracts with customers for which revenue has not yet been recognized. Consideration received from a customer prior to revenue recognition is recorded to a contract liability and is recognized as revenue when the Company satisfies the related performance obligations under the terms of the contract. The Company’s contract liabilities, which are reported as deferred revenue on the condensed consolidated balance sheet, consist almost entirely of research and development contracts where consideration has been received and the development services have not yet been fully performed.
The opening and closing balances of the Company’s contract balances are as follows:
| · · · · · · · · · · · | |||||||
|---|---|---|---|---|---|---|---|
| · · · · October 1, · · December 31, · · $ | |||||||
| · Balance sheet classification · 2023 · 2023 · change | |||||||
| Contract liabilities | Deferred revenue | | $270,435 | | $282,034 | | $11,599 |
For the three-month period ended December 31, 2023, the Company recognized $40,035 of revenue that was included in Contract liabilities as of October 1, 2023.
Inventories
Inventories, which consist primarily of raw materials, work in progress and finished goods, are stated at the lower of cost or net realizable value, with cost determined by using the first-in, first-out (FIFO) method.
Net Loss Per Share
The Company presents loss per share utilizing a dual presentation of basic and diluted loss per share. Basic loss per share includes no dilution and has been calculated based upon the weighted average number of common shares outstanding during the period. Dilutive common stock equivalents consist of shares issuable upon the exercise of the Company’s stock options, restricted stock units and warrants.
Securities that could potentially dilute basic net loss per share in the future that were not included in the computation of diluted net loss per share because to do so would have been anti-dilutive for the three-month periods ended December 31, 2023 and 2022 are as follows:
| | | | | |
|---|---|---|---|---|
| · 2023 · 2022 | ||||
| Warrants | | 5,213,213 | | 7,295,588 |
| Restricted Stock Units | | 282,640 | | — |
| Stock options | | 2,189,019 | | 1,006,141 |
| Total | | 7,684,872 | | 8,301,729 |
Concentrations
Financial instruments and related items, which potentially subject the Company to concentrations of credit risk, consist primarily of cash, cash equivalents and trade receivables. The Company places its cash and cash equivalents with high credit quality institutions. At times, such investments may be in excess of the FDIC insurance limit. As of December 31, 2023, the Company had cash and cash equivalents of approximately $3.1 million in excess of the FDIC insurance limit.
The Company’s revenues earned from sale of products and services for the three-month period ended December 31, 2023 included an aggregate of 25% fromone customer within the MDx Testing Services segment and an aggregate of 22% fromone customer within the DNA Tagging and Security Products and Services segment.
The Company’s revenues earned from sale of products and services for the three-month period ended December 31, 2022 included an aggregate of 83% fromtwo customers within the MDx Testing Services segment.
Two customers accounted for 56% of the Company’s accounts receivable at December 31, 2023 andthree customers accounted for 60% of the Company’s accounts receivable at September 30, 2023.
Warrant Liabilities
The Company evaluated the Common Warrants and the Series A and Series B Warrants (collectively the “Warrants) in accordance with ASC 480 “Distinguishing Liabilities from Equity” and ASC 815-40, “Derivatives and Hedging — Contracts in Entity’s Own Equity” and concluded that due to the terms of the warrant agreements, the instruments do not qualify for equity treatment. As such, the Warrants were recorded as a liability on the condensed consolidated balance sheet and measured at fair value at inception and at each reporting date in accordance with ASC 820, “Fair Value Measurement”, with changes in fair value recognized in the condensed consolidated statement of operations in the period of change.
Segment Reporting
The Company hasthree reportable segments. (1) Therapeutic DNA Production Services (2) MDx Testing Services, and (3) DNA Tagging and Security Products and Services. Resources are allocated by our CEO, COO, CFO and CLO whom, collectively the Company has determined to be our Chief Operating Decision Maker (“CODM”). The following is a brief description of our reportable segments.
Therapeutic DNA Production Services — Segment operations consist of the enzymatic manufacture of synthetic DNA for use in the production of nucleic acid - based therapeutics and, through the development and sale of a proprietary RNAP for use in the production of mRNA therapeutics.
MDx Testing Services— Segment operations consist of performing and developing clinical molecular diagnostic and genetic tests and clinical laboratory testing services. Under the Company’s MDx testing services, ADCL provides COVID-19 testing solutions under its safeCircle TM trademark, as well as its pharmacogenomics testing services that are currently waiting for approval from the New York State Department of Health (“NYSDOH”).
DNA Tagging and Security Products and Services — Segment operations consist of the manufacture and detection of DNA for industrial supply chain security services.
The Company evaluates the performance of its segments and allocates resources to them based on revenues and operating income (losses). Operating income (loss) includes intersegment revenues, as well as a charge allocating all corporate headquarters costs. Since each vertical has shared employee resources, payroll and certain other general expense such as rent, and utilities were allocated based on an estimate by management of the percentage of employee time spent in each vertical. Segment assets are not reported to, or used by, the CODM to allocate resources to, or assess performance of, the segments and therefore, total segment assets have not been disclosed.
NOTE B – BASIS OF PRESENTATION AND SUMMARY OF ACCOUNTING POLICIES, continued
Fair Value of Financial Instruments
The valuation techniques utilized are based upon observable and unobservable inputs. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect internal market assumptions. These two types of inputs create the following fair value hierarchy:
Level 1 — Quoted prices in active markets for identical assets or liabilities.
Level 2 — Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related asset or liabilities.
Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of assets or liabilities.
The Company utilizes observable market inputs (quoted market prices) when measuring fair value whenever possible.
For fair value measurements categorized within Level 3 of the fair value hierarchy, the Company’s accounting and finance department, which reports to the Chief Financial Officer, determine its valuation policies and procedures. The development and determination of the unobservable inputs for Level 3 fair value measurements and fair value calculations are the responsibility of the Company’s accounting and finance department and are approved by the Chief Financial Officer.
As of December 31, 2023, there were no transfers between Levels 1,2 and 3 of the fair value hierarchy.
Recent Accounting Standards
In August 2020, the FASB issued ASU No. 2020-06, “Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40).” The objective of this update is to simplify the accounting for convertible preferred stock by removing the existing guidance in ASC 470-20, “Debt: Debt with Conversion and Other Options,” that requires entities to account for beneficial conversion features and cash conversion features in equity, separately from the host convertible debt or preferred stock. The guidance in ASC 470-20 applies to convertible instruments for which the embedded conversion features are not required to be bifurcated from the host contract and accounted for as derivatives. In addition, the amendments revise the scope exception from derivative accounting in ASC 815-40 for freestanding financial instruments and embedded features that are both indexed to the issuer’s own stock and classified in stockholders’ equity, by removing certain criteria required for equity classification. These amendments are expected to result in more freestanding financial instruments qualifying for equity classification (and, therefore, not accounted for as derivatives), as well as fewer embedded features requiring separate accounting from the host contract. This amendment also further revises the guidance in ASU 260, “Earnings per Share,” to require entities to calculate diluted earnings per share (EPS) for convertible instruments by using the if-converted method. In addition, entities must presume share settlement for purposes of calculating diluted EPS when an instrument may be settled in cash or shares. The amendments in ASU 2020-06 are effective for fiscal years beginning after December 15, 2023, with early adoption permitted. The Company does not expect the adoption of ASU 2020-06 to have a significant impact on its condensed consolidated financial statements.
NOTE C — INVENTORIES
Inventories consist of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, · · September 30, | ||||||
| · 2023 · 2023 | ||||||
| · · (unaudited) · · · | ||||||
| Raw materials | | $172,404 | | $212,079 | ||
| Work-in-progress | | | 36,866 | | | 19,859 |
| Finished goods | | 168,021 | | 98,089 | ||
| Total | | $377,291 | | $330,027 | ||
NOTE D — ACCOUNTS PAYABLE AND ACCRUED LIABILITIES
Accounts payable and accrued liabilities are as follows:
| · · · · · · | ||||
|---|---|---|---|---|
| | | December 31, | | September 30, |
| · 2023 · 2023 | ||||
| · · (unaudited) · · · | ||||
| Accounts payable | | $1,017,057 | | $1,072,161 |
| Accrued salaries payable | | 907,777 | | 1,138,235 |
| Other accrued expenses | | 99,042 | | 59,992 |
| Total | | $2,023,876 | | $2,270,388 |
NOTE E – CAPITAL STOCK
On November 7, 2023, the Company entered into an Equity Distribution Agreement (the “Agreement”) with Maxim Group LLC, as sales agent (the “Agent”), pursuant to which the Company may, from time to time, issue and sell shares of its common stock, par value $0.001 per share, in an aggregate offering price of up to $6,397,939 (the “Shares”) through the Agent.
The offer and sales of the Shares made pursuant to the Agreement, will be made under the Company’s effective “shelf” registration statement on Form S-3. Under the terms of the Agreement, the Agent may sell the Shares at market prices by any method that is deemed to be an “at the market offering” as defined in Rule 415 under the Securities Act of 1933, as amended. As of December 31, 2023, the Company has issued 61,200 shares of its common stock for net proceeds of approximately $45,480 under this Agreement. Effective January 30, 2024, the Company terminated the Agreement by providing notice of termination to the Agent in accordance with the terms of the Agreement.
As a result of the issuance of common stock under this Agreement, the exercise price of the 457,813 remaining warrants issued during November 2019 was reduced to$1.47 per share, the exercise price of 159,000 warrants issued during October 2020 was reduced to$1.51 per share and the exercise prices of 100,000 warrants issued during December 2020 was reduced to an exercise price of$1.31 per share for 50,000 and an exercise price of$1.29 per share for the remaining 50,000 warrants. These exercise price adjustments are in accordance with the adjustment provision contained in their respective warrant agreements. The incremental change in fair value of these warrants as a result of the triggering event was$77,757 and is recorded as a deemed dividend in the condensed consolidated statement of operations for the three-month period ended December 31, 2023.
NOTE F —WARRANTS
Warrants
The following table summarizes the changes in warrants outstanding. These warrants were granted as part of financing transactions, as well as in lieu of cash compensation for services performed or as financing expenses in connection with the sales of the Company’s common stock.
| · · · · · | ||||
|---|---|---|---|---|
| | | | | Weighted |
| | | | | Average |
| | | | | Exercise |
| | | Number of | | Price Per |
| · Shares · Share | ||||
| Balance at October 1, 2023 | | 5,220,588 | | $3.68 |
| Granted | | — | | — |
| Exercised | | (3,000) | | 5.60 |
| Cancelled or expired | | (4,375) | | 2.82 |
| Balance at December 31, 2023 | | 5,213,213 | | $3.32 |
NOTE G — COMMITMENTS AND CONTINGENCIES
Operating Leases
The Company leases office space under an operating lease in Stony Brook, New York for its corporate headquarters. The lease is for a 30,000 square foot building. The Company entered into an amended lease agreement on February 1, 2023. The initial term is forthree years and expires on February 1, 2026. The lease for the corporate headquarters requires monthly payments of$48,861, which is adjusted annually based on the US Consumer Price Index (“CPI”). In lieu of a security deposit, the Company provided a standby letter of credit of$750,000. In addition, the Company also has 2,500 square feet of laboratory space, which it entered into an amended lease agreement for on February 1, 2023. The initial lease term for the laboratory space isone year from the commencement date. The lease requires monthly payments of$8,750. On January 10, 2024, the Company renewed this lease for another twelve-months, expiring on January 31, 2025. The base rent for the new lease term will be monthly payments of$10,417 and the lease is now terminable by the Company uponone month’s written notice to the landlord. The Company also has a satellite testing facility in Ahmedabad, India, which occupies 1,108 square feet for athree-year term beginning November 1, 2017. During August 2023, the Company renewed this lease with a new expiration date of July 31, 2024. The base rent is approximately$6,500 per annum. The laboratory lease, as well as the testing facility in Ahmedabad are both considered short-term lease obligations. The total rent expense for the three-month periods ended December 31, 2023 and 2022 was$174,419 and$148,826, respectively.
Employment Agreement
The employment agreement with Dr. James Hayward, the Company’s President and CEO, entered into in July 2016 provides that he will be the Company’s CEO and will continue to serve on the Company’s Board of Directors. The initial term was from July 1, 2016 through June 30, 2017, with automaticone-year renewal periods. On July 28, 2017, the employment agreement was renewed for a successiveone-year term and the employment agreement has been renewed for successiveone-year terms, most recently as of June 30, 2023. The Board of Directors, acting in its discretion, may grant annual bonuses to the CEO. The CEO will be entitled to certain benefits and perquisites and will be eligible to participate in retirement, welfare and incentive plans available to the Company’s other employees.
NOTE G — COMMITMENTS AND CONTINGENCIES continued
Employment Agreement, continued
The employment agreement with the CEO also provides that if he is terminated before the end of the initial or a renewal term by the Company without cause or if the CEO terminates his employment for good reason, then, in addition to previously earned and unpaid salary, bonus and benefits, and subject to the delivery of a general release and continuing compliance with restrictive covenants, the CEO will be entitled to receive apro rata portion of the greater of either (X) the annual bonus he would have received if employment had continued through the end of the year of termination or (Y) the prior year’s bonus; salary continuation payments for two years following termination equal to the greater of (i) three times base salary or (ii) two times base salary plus bonus; Company-paid COBRA continuation coverage for 18 months post-termination; continuing life insurance benefits (if any) for two years; and extended exercisability of outstanding vested options (for three years from termination date or, if earlier, the expiration of the fixed option term). If termination of employment as described above occurs within six months before or two years after a change in control of the Company, then, in addition to the above payments and benefits, all of the CEO’s outstanding options and other equity incentive awards will become fully vested and the CEO will receive a lump sum payment of the amounts that would otherwise be paid as salary continuation. In general, a change in control will include a 30% or more change in ownership of the Company.
Upon termination due to death or disability, the CEO will generally be entitled to receive the same payments and benefits he would have received if his employment had been terminated by the Company without cause (as described in the preceding paragraph), other than salary continuation payments.
On October 29, 2021, the Board of Directors amended the existing compensatory arrangement with the CEO to increase his salary to $450,000, effective November 1, 2021. On January 1, 2024, the CEO voluntarily reduced his salary to $250,000 until March 31, 2024. On January 4, 2024, in connection with certain cost management efforts, the Company entered into a letter agreement with the CEO to amend the CEO’s employment agreement with the Company and to provide for a temporary 45% reduction to the CEO’s annual base salary, from $450,000 to $250,000, for a period of three months, effective as of January 1, 2024 through March 31, 2024. The CEO also agreed to waive any right to resign for “good reason” under his employment agreement with the Company as a result of the foregoing salary reduction. While the compensation committee determined that the CEO was eligible to receive a discretionary bonus in the amount of $500,000 with respect to his performance for fiscal 2023, on January 19, 2024, the CEO elected not to receive any cash incentive or other bonus for fiscal 2023, in light of the Company’s cash position.
Litigation
From time to time, the Company may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. When the Company is aware of a claim or potential claim, it assesses the likelihood of any loss or exposure. If it is probable that a loss will result and the amount of the loss can be reasonably estimated, the Company will record a liability for the loss. In addition to the estimated loss, the recorded liability includes probable and estimable legal costs associated with the claim or potential claim. Litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm the Company’s business. There is no pending litigation involving the Company at this time.
NOTE H – SEGMENT INFORMATION
As detailed in Note B above, the Company hasthree reportable segments; (1) Therapeutic DNA Production Services, (2) MDx Testing Services, and (3) DNA Tagging and Security Products and Services. Resources are allocated by our CEO, COO CFO and CLO whom, collectively the Company has determined to be our CODM.
Information regarding operations by segment for the three-month period ended December 31, 2023 is as follows:
| · · · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| | | Therapeutic DNA | | MDx Testing | | DNA Tagging and | | |
| · Production · Services and Kits · Security Products · Consolidated | ||||||||
| Revenues · · · · | ||||||||
| Product revenues | | $— | | $— | | $307,317 | | $307,317 |
| Service revenues | | 77,535 | | — | | 169,612 | | 247,147 |
| Clinical laboratory service revenues | | — | | 342,740 | | — | | 342,740 |
| Less intersegment revenues | | — | | (6,040) | | — | | (6,040) |
| Total revenues | | $77,535 | | $336,700 | | $476,929 | | $891,164 |
| Gross profit | | $77,535 | | $(62,958) | | $216,520 | | $231,097 |
| (Loss) from segment operations (a) | | $(1,259,046) | | $(496,512) | | $(784,303) | | $(2,539,861) |
NOTE H – SEGMENT INFORMATION, continued
Information regarding operations by segment for the three-month period ended December 31, 2022 is as follows:
| · · · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| | | Therapeutic DNA | | MDx Testing | | DNA Tagging and | | |
| · Production · Services · Security Products · Consolidated | ||||||||
| Revenues: · · · · | ||||||||
| Product revenues | | $127,506 | | $— | | $388,890 | | $516,396 |
| Service revenues | | 121,743 | | — | | 110,318 | | 232,061 |
| Clinical laboratory service revenues | | — | | 4,565,815 | | — | | 4,565,815 |
| Less intersegment revenues | | — | | (51,520) | | — | | (51,520) |
| Total revenues | | $249,249 | | $4,514,295 | | $499,208 | | $5,262,752 |
| Gross profit | | $170,924 | | $1,933,219 | | $273,540 | | $2,377,683 |
| (Loss) income from segment operations (a) | | $(852,253) | | $1,109,884 | | $(474,715) | | $(217,084) |
Reconciliation of segment loss from operations to consolidated loss before provision for income taxes is as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, | ||||||
| · 2023 · 2022 | ||||||
| Loss from operations of reportable segments | | $(2,539,861) | | $(217,084) | ||
| General corporate expenses (b) | | (1,249,205) | | (1,001,894) | ||
| Interest income | | 33,323 | | 3,686 | ||
| Unrealized gain (loss) on change in fair value of warrants classified as a liability | | 2,639,000 | | (2,637,800) | ||
| Other (expense) income, net | | | (13,538) | | | 8,846 |
| Consolidated loss before provision for income taxes | | $(1,130,281) | | $(3,844,246) | ||
| (a) | Segment operating loss consists of net sales, less cost of sales, specifically identifiable research and development, and selling, general and administrative expenses. |
| (b) | General corporate expenses consist of Selling, general and administrative expenses that are not specifically identifiable to a segment. |
NOTE I – FAIR VALUE OF FINANCIAL INSTRUMENTS
The Company’s financial instruments at fair value are measured on a recurring basis. Related unrealized gains or losses are recognized in unrealized gain (loss) on change in fair value of the warrants classified as a liability in the condensed consolidated statements of operations. For additional disclosures regarding methods and assumptions used in estimating fair values of these financial instruments, see Note B.
The following table presents the fair value of the Company’s financial instruments as of December 31, 2023 and summarizes the significant unobservable inputs in fair value measurement of Level 3 financial assets and liabilities as of December 31, 2023. The Company did not have any assets or liabilities categorized as Level 1 or 2 as of December 31, 2023.
| · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| | | Fair value at | | Valuation | | Unobservable | | Volatility |
| · December 31, 2023 · Technique · Input · Input | ||||||||
| Liabilities: · · · | ||||||||
| Common Warrants | | $581,000 | | Monte Carlo simulation | Annualized volatility | | 140.00% | |
| Series A Warrants | | $1,065,000 | | Monte Carlo simulation | | Annualized volatility | | 140.00% |
NOTE I – FAIR VALUE OF FINANCIAL INSTRUMENTS,** continued**
The change in fair value of the Common Warrants and the Series A Warrants for the three-month period ended December 31, 2023 is summarized as follows:
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · Common Warrants · Series A Warrants · Totals | |||||||||
| Fair value at October 1, 2023 | | $1,468,000 | | $2,817,000 | | $4,285,000 | |||
| Change in fair value | | | (887,000) | | | (1,752,000) | | | (2,639,000) |
| Fair Value at December 31, 2023 | | $581,000 | | $1,065,000 | | $1,646,000 | |||
NOTE J – SUBSEQUENT EVENTS
On January 31, 2024, the Company closed on a registered direct public offering (the “Offering”) of 3,228,056 shares (“Shares”) of the Company’s common stock, par value $0.001 (“Common Stock”) and pre-funded warrants (“Pre-Funded Warrants”) to purchase up to 2,416,005 shares of Common Stock, and in a concurrent private placement, unregistered common warrants (“Private Common Warrants”) to purchase up to 11,288,122 shares of Common Stock. The Company received gross proceeds from the Offering, before deducting placement agent fees and other estimated offering expenses payable by the Company, of approximately $3.4 million.
The Pre-Funded Warrants have an exercise price of $0.0001 per share and are immediately exercisable and can be exercised at any time after their original issuance until such Pre-Funded Warrants are exercised in full. Each Share was sold at an offering price of $0.609 and each Pre-Funded Warrant was sold at an offering price of $0.6089 (equal to the purchase price per Share minus the exercise price of the Pre-Funded Warrant). Pursuant to the Purchase Agreements, the Company also agreed to issue to the Purchasers, in a concurrent private placement, the Private Common Warrants. Each Private Common Warrant has an exercise price of $0.609 per share, will become exercisable upon Shareholder Approval, and will expire on thefive-year anniversary of the Shareholder Approval. “Shareholder Approval” means the first trading day after the filing of a Form 8-K disclosing the approval pursuant to the applicable rules and regulations of Nasdaq from the shareholders of the Company with respect to the issuance of all of the shares underlying the Private Common Warrants and the reduction in exercise price and extension of expiration dates of the warrants described below.
The Private Common Warrants and the shares of Common Stock issuable upon the exercise of the Private Common Warrants are not registered under the Securities Act. The Private Common Warrants and the shares of Common Stock issuable upon exercise thereof were issued or will be issued, respectively, in reliance on the exemptions from registration provided by Section 4(a)(2) under the Securities Act and Regulation D promulgated thereunder, for transactions not involving a public offering. Pursuant to the Purchase Agreements, within 45 calendar days from the date of the Purchase Agreements, the Company agreed to file a registration statement on Form S-3 (or other appropriate form if the Company is not then S-3 eligible) providing for the resale by the Purchasers of the Shares issuable upon exercise of the Private Common Warrants. The Company agreed to use commercially reasonable efforts to cause such registration statement to become effective within 90 days following the closing date of the Purchase Agreements and to keep such registration statement effective at all times until no Purchaser owns any Private Common Warrants or Shares issuable upon exercise thereof.
In connection with the Offering and the Purchase Agreements, the Company agreed to reduce the exercise price of warrants previously issued to the Purchasers with exercise prices ranging from $1.29 to $4.00 per warrant to $0.609 per warrant. The Company also agreed to extend the expiration dates for such warrants to August 2028. In addition,58,074 outstanding common stock warrants held by other investors who did not participate in the Offering will have their exercise price reduced to $0.609 per warrant share and will have their warrant expiration dates extended to August 2028. The foregoing reductions of the exercise price and extension of expiration dates of such warrants is subject to Shareholder Approval.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.