Exhibit 99.1

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS

 

You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes to those statements included in Exhibit 99.2 to this Form 6-K. This discussion and analysis contains forward-looking statements based upon current beliefs, plans and expectations related to future events and our future financial performance that involve risks, uncertainties and assumptions, such as statements regarding our intentions, plans, objectives, expectations, forecasts and projections. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under the section titled “Risk Factors” and elsewhere in our Annual Report for the Year ended December 31, 2023 on Form 20-F, filed with the U.S. Securities and Exchange Commission on April 9, 2024. You should carefully read the “Risk Factors” to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements.

 

Organization and Overview of Operations

 

We develop and sell in-vitro diagnostic (“IVD”) tests for the early detection of cancer. Our flagship ColoAlert product is being marketed and sold in European markets. We are currently developing our next generation colorectal cancer screening product and intend to launch that product in the future in the United States and in Europe. We additionally operate a clinical diagnostic laboratory and distribute our IVD kits to third-party laboratories in Europe and through our on-line store in Germany. In addition, we conduct research and development to increase and diversify our product portfolio. During 2023, we also performed government funded research and development project called PancAlert, which provide us non-refundable grant income that covers a percentage of the individual project-related costs.

 

Results of Operations

 

Comparison of the Six Months Ended June 30, 2024 and 2023

 

The following table provides certain selected financial information for the periods presented:

 

		Six Months Ended June 30,												%
		2024				2023				Change				Change
Revenue		$	520,773			$	499,049			$	21,724				4	%
Cost of revenue		$	201,735			$	211,310			$	(9,575	)			(5	)%
Gross profit		$	319,038			$	287,739			$	31,299				11	%
Gross margin			61	%			58	%
Research and development		$	3,242,622			$	5,481,229			$	(2,238,607	)			(41	)%
Sales and marketing		$	2,361,105			$	3,992,975			$	(1,631,870	)			(41	)%
General and administrative		$	4,522,639			$	5,227,181			$	(704,542	)			(13	)%
Total operating expenses		$	10,126,366			$	14,701,385			$	(4,575,019	)			(31	)%
Loss from operations		$	(9,807,328	)		$	(14,413,646	)		$	(4,606,318	)			(32	)%
Other expense		$	(1,216,434	)		$	(398,997	)		$	817,437				205	%
Net loss		$	(11,023,762	)		$	(14,812,643	)		$	(3,788,881	)			(26	)%
Total comprehensive loss		$	(11,086,128	)		$	(14,963,239	)		$	(3,877,111	)			(26	)%
Basic and dilutive loss per common share		$	(0.49	)		$	(1.00	)		$	0.51				51	%
Weighted average number of common shares outstanding – basic and diluted			22,350,033				14,803,243

 

 

 

Revenue

 

Revenue for the six months ended June 30, 2024 was $520,773 as compared to $499,049 for the six months ended June 30, 2023, an increase of 4%. This increase was attributable to ColoAlert sales, primarily in Germany. We intend to continue our efforts to grow the market for ColoAlert, both in Germany and extending to other countries in Europe.

  

Cost of Revenue

 

Cost of revenue for the six months ended June 30, 2024 was $201,735 as compared to $211,310 for the six months ended June 30, 2023, a 5% decrease. This decrease was the result of increased ColoAlert sales volume, which drove efficiencies across our fixed costs, lowering overall unit costs.

 

Gross profit

 

Gross profit increased to $319,038 in the six months ended June 30, 2024 compared to $287,739, for the six months ended June 30, 2023. This gross profit increase, resulting in an improvement of gross margin from 58% to 61%, was attributable to improved profits resulting from lowered unit cost of goods sold attributable to economies of scale with increased sales volumes.

 

Research and Development Expenses

 

Research and development expenses for the six months ended June 30, 2024 were $3,242,622 compared to $5,481,229 for the six months ended June 30, 2023, a decrease of $2,238,607. This decrease was driven by the cost of our ColoFuture and eAArly Detect feasibility studies in the U.S. and in Europe, which drove significant expenses in the first six months of 2023 compared to the same period in 2024. During the six months ended June 30, 2023, clinical study expenses and professional fees related to those studies were $2.8 million compared to $0.6 million in the six months ended June 30, 2024.

 

Sales and Marketing Expenses

 

Sales and marketing expenses for the six months ended June 30, 2024, were $2,361,105 compared to $3,992,975 for the six months ended June 30, 2023, a decrease of $1,631,870. This decrease was related to a decrease in our marketing and advertising expense of $1.3 million as we focused more of our efforts on sales to our lab partners as opposed to online marketing for consumer sales. Accompanying this decrease, we reduced labor costs (salary and consulting) in line with our shift in focus away from consumer sales.

 

General and Administrative Expenses

 

General and administrative expenses for the six months ended June 30, 2024 were $4,522,639 compared to $5,227,181 for the six months ended June 30, 2023, a decrease of $704,542. The decreased expenses were primarily the result of a decrease of $640,290 of non-cash stock option expense for the six months ended June 30, 2024 compared to the same period in 2023.

 

Other Expense

 

Other expense, net for the six months ended June 30, 2024 was $1,216,434 compared to $398,997 for the six months ended June 30, 2023, resulting in increased other expenses (net) of $817,437. This increase was primarily the result of increased interest expense of $0.6 million from the Company’s higher convertible debt balances and the increase in the fair value adjustment of $0.6 million, mitigated by a non-recurring financing expense of $0.3 million recorded in the first six months of 2023.

 

Liquidity and Capital Resources

 

Our principal liquidity requirements are for working capital and operating losses. We fund our liquidity requirements primarily through cash on hand, cash flows from operations and, debt and equity financing. As of June 30, 2024, we had $977,764 of cash and cash equivalents, with $7,070,925 as of December 31, 2023.

 

 

The following table summarizes our cash flows from operating, investing and financing activities:

 

		Six Months Ended June 30,
		2024				2023				Change
Cash used in operating activities		$	(8,144,745	)		$	(10,778,125	)		$	(2,633,380	)
Cash used in investing activities		$	(420,660	)		$	(1,524,555	)		$	(1,103,895	)
Cash provided by financing activities		$	2,551,325			$	6,192,507			$	(3,641,182	)

 

Cash Flow from Operating Activities

 

For the six months ended June 30, 2024, cash flows used in operating activities was $8,144,745 compared to $10,778,125 used during the six months ended June 30, 2023. The improvement in cash flows used in operating activities of $2,633,380 was primarily the result of our smaller operating loss for the six months ended June 30, 2024, net of non-cash stock-based compensation, depreciation and amortization, and timing differences for the settlement of assets and liabilities, as compared to the six months ended June 30, 2023.

 

Cash Flows from Investing Activities

 

During the six months ended June 30, 2024, we used $420,660 in investing activities compared to $1,524,555 used during the six months ended June 30, 2023. The decrease in cash flows used in investing activities of $1,103,895 was the primarily the result of higher capital expenditures during the six months ended June 30, 2023 related to the expansion of our office and lab space. During the first six months of 2024, the Company did not incur significant costs related to the development of the new lab space as it was awaiting local government approvals on the work done to date.

 

Cash Flows from Financing Activities

 

During the six months ended June 30, 2024, we had cash flow provided by financing activities of $2,551,325 compared to cash flow provided by financing activities of $6,192,507 for the six months ended June 30, 2023, a decrease of $3,641,182. This decrease was primarily the result of the Company closing a $5.5 million convertible note transaction in the first six months of 2023 and a $3.3 million convertible note transaction in the first six months of 2024. In addition the amount raised by the Company from the sale of ordinary shares decreased by $1.4 million in the six months ended June 30, 2024 compared to the six months ended June 30, 2023.

 

Working Capital Discussion

 

We had recurring losses, accumulated deficit totaling $80,351,783 and negative cash flows used in operating activities of $8,144,745 as of and for the six months ended June 30, 2024. We also had $977,764 of cash on hand on June 30, 2024, and a working capital deficit, excluding liabilities expected to be settled with ordinary shares, of $1,782,238.

 

These conditions are indicators that impact the Company’s ability to continue as a going concern for a period of one year from the issuance of these financial statements. If the Company is unable to obtain funding, the Company could be forced to further delay, reduce or eliminate its research and development, regulatory, and commercial efforts which could adversely affect its future business prospects and its ability to continue as a going concern.

 

We plan to fund our cash flow and working capital needs through current cash on hand and future debt and/or equity financings which we may obtain through one or more public or private equity offerings, debt financings, government or other third-party funding, strategic alliances or collaboration agreements. During 2023, the Company raised $16.5 million from a combination of sale of shares and warrants as well as the issuance of convertible debt. During the first six months of 2024, the Company raised $3.5 million of net proceeds from the issuance of a convertible note and through the sales of ordinary shares. The Company believes that it will be able to raise additional funds through a combination of the sale of ordinary shares, the sale and/or conversion of warrants, and use of the Company’s access to capital through its Controlled Equity Offering and its Pre-Paid Advance Agreement. The Company also has the ability to defer certain costs, especially those related to clinical studies, to match financing inflows. During July 2024 and October 2024, the Company restructured its operations to focus on its ColoAlert business in Europe, the development of its next generation product, and planning for the Early Detect 2 clinical study in the U.S. in 2025. In line with that focus, the Company implemented cost reduction efforts which included the reduction of its operating costs, including the reduction of personnel by 65%, reduction of external consulting costs, and the sale/closure of its European Oncology Lab (“EOL”) business in St. Ingbert, Germany. Additionally, the Company amended the employment contracts of its CEO and CFO, reducing the salaries of those officers to 60% and 50% of their original salaries, respectively, effective November 1, 2024. The Company believes that these cost reductions will best position our business for 2025 and beyond. The Company believes that its currently available cash on hand, including additional financing described above, will be sufficient to meet its planned expenditures and to meet the Company’s obligations for at least the one-year period following its consolidated financial statement issuance date.

 

 

Our consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the settlement of liabilities in the normal course of business. These consolidated financial statements do not reflect the adjustments to the carrying values of assets and liabilities, the reported revenues and expenses, and the statement of financial position classifications used, that would be necessary if the Company were unable to realize its assets and settle its liabilities as a going concern in the normal course of operations. Such adjustments could be material.

 

Critical Accounting Policies and Significant Judgments and Estimates

 

This discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are 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. Actual results may differ from these estimates under different assumptions or conditions. While our significant accounting policies are described in more detail in the notes to our financial statements included elsewhere in this prospectus, we believe that the following accounting policies are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.

 

We believe our most critical accounting policies and estimates relate to the following:

 

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Revenue Recognition;

 

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Foreign Currency Translation;

 

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Stock Option Compensation;

 

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Lease Accounting; and

 

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Financial Instruments.

 

Revenue Recognition

 

Our revenue is primarily derived through providing our ColoAlert genetic diagnostic test kits to customers. We recognize revenue in accordance with International Financial Reporting Standards (“IFRS”) 15 “Revenue from Contracts with Customers”.

 

In accordance with IFRS 15, revenue is recognized upon the satisfaction of performance obligations. Performance obligations are satisfied at the point at which control of the promised goods or services are transferred to customers, in an amount that reflects the consideration we expect to be entitled to receive for those goods and services.

 

 

We provide a genetic diagnostic testing service and testing kits which are not considered separately identifiable from each other as we use the testing kits to collect samples in order to deliver the diagnostic test results to the customer. Accordingly, we have one performance obligation which is fulfilled upon the delivery of the test results to the customer and revenue is recognized at that point in time.

 

We also receive income from government sponsored R&D grants. Income is recognized on these programs when funds are received and all performance obligations, as defined in the grant, are completed. This income is included in the Statements of Comprehensive Loss as Other Income.

 

Foreign Currency Translation

 

The functional currency is determined using the currency of the primary economic environment in which that entity operates. The functional, as determined by our management, is the Euro (EUR).

 

Foreign currency transactions are translated into functional currency using the exchange rates prevailing at the date of the transaction. Foreign currency monetary items are translated at the period-end exchange rate. Non-monetary items measured at historical cost continue to be carried at the exchange rate at the date of the transaction. Non-monetary items measured at fair value are reported at the exchange rate at the date when fair values were determined.

 

Exchange differences arising on the translation of monetary items or on settlement of monetary items are recognized in the statement of comprehensive loss in the period in which they arise, except where deferred in equity as a qualifying cash flow or net investment hedge.

 

Exchange differences arising on the translation of non-monetary items are recognized in other comprehensive income to the extent that gains and losses arising on those non-monetary items are also recognized in other comprehensive income. Where the non-monetary gain or loss is recognized in profit or loss, the exchange component is also recognized in profit or loss.

 

Our reporting currency is the US dollar. For presentation purposes, all amounts are translated from the Euro functional currency to the US dollar presentation currency for each period using the exchange rate at the end of each reporting period for the statement of financial position. Revenues and expenses are translated on the basis of average exchange rates during the year.

 

Exchange gains and losses arising from translation to our presentation currency are recorded as exchange differences on translation to reporting currency, which is included in other comprehensive income (loss).

 

Stock Option Compensation

 

We have adopted our 2021 Omnibus Incentive Plan and 2022 Omnibus Incentive Plan (the (“Plans”). Under the Plans, we are authorized to issue equity incentives in the form of incentive stock options, non-statutory stock options, restricted shares, restricted share units, share appreciation rights, performance units or performance shares under separate award agreements. Under the Plans, the aggregate number of shares underlying awards that we could issue cannot exceed, 2,800,000 ordinary shares.

 

On November 4, 2021, we awarded 1,484,650 stock options under the Plans, with a strike price of $5.00, the per share price in our November 2021 initial public offering. Such stock options were granted to all of our current employees, directors, advisors and senior management team. Such stock options for our non-senior management team, independent directors and advisors will begin vesting on November 4, 2022 and stop vesting on November 4, 2025 at the latest. Such stock options for the four members of our senior management team began vesting in portions equal to 25% of such options granted if, prior to November 4, 2025, the four-year anniversary of our initial public offering, for ten consecutive trading days (with at least 100,000 shares traded per trading day) the volume-weighted average price of the ordinary shares on the principal market is at least:

 

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$7.50;

 

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$10.00;

 

 

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$12.50, provided that such options cannot vest until the twelve-month anniversary of our initial public offering at the earliest; and

 

●

$15.00, provided that such options cannot vest until the twelve-month anniversary of our initial public offering at the earliest.

 

100% of these options were fully vested on November 5, 2022.

 

We have valued these stock options as follows: (a) for those options that have time-based vesting, we will use the Black-Scholes method to value the stock options at the time of award and record the compensation expense in our Statement of Operations over the vesting period, and (b) for options issued with milestone based vesting criteria, we will use a Monte Carlo simulation to value the options at the time of issuance and each subsequent reporting date until fully vested or expired, with any change in compensation expense measured by such method to be recorded in our Statement of Operations.

 

The Black-Scholes option pricing model considers, among other factors, the expected term of the award and the expected volatility of our stock price. Due to the lack of an adequate history of a public market for the trading of our ordinary shares, we have based our estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded with historical share price information sufficient to meet the expected life of the stock-based awards. The Monte Carlo simulation approach is a class of computational algorithms that rely on repeated random sampling to compute their results. This approach allows the calculation of the value of such stock options based on a large number of possible stock price path scenarios. Expense for the market-condition stock options will be recognized over the derived service period as determined through the Monte Carlo simulation model.

 

Lease Accounting

 

We assess at contract inception whether a contract is, or contains, a lease. That is, if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. We apply a single recognition and measurement approach for all leases, except for short-term leases and leases of low-value assets. We recognize lease liabilities to make lease payments and right-of-use assets representing the right to use the underlying assets.

 

At the commencement date of the lease, we recognize lease liabilities measured at the present value of lease payments to be made over the lease term. Lease payments include fixed payments (including in-substance fixed payments) less any lease incentives receivable, variable lease payments that depend on an index or a rate, and amounts expected to be paid under residual value guarantees. Lease payments also include the exercise price of a purchase option reasonably certain to be exercised by us and payments of penalties for terminating the lease, if the lease term reflects us exercising the option to terminate. Variable lease payments that do not depend on an index or a rate are recognized as expenses in the period in which the event or condition that triggers the payment occurs. In calculating the present value of lease payments, we use our incremental borrowing rate at the lease commencement date because the interest rate implicit in the lease is not readily determinable. After the commencement date, the amount of lease liabilities is increased to reflect the accretion of interest and reduced for the lease payments made. In addition, the carrying amount of lease liabilities is remeasured if there is a modification, a change in the lease term, a change in the lease payments (e.g., changes to future payments resulting from a change in an index or rate used to determine such lease payments) or a change in the assessment of an option to purchase the underlying asset.

 

We recognize right-of-use assets at the commencement date of the lease (i.e., the date the underlying asset is available for use). Right-of-use assets are measured at cost, less any accumulated depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities. The cost of right-of-use assets includes the amount of lease liabilities recognized, initial direct costs incurred, and lease payments made at or before the commencement date less any lease incentives received. Right-of-use assets are depreciated on a straight-line basis over the shorter of the lease term and the estimated useful lives of the assets.

 

 

Financial Instruments

 

(a) Classification

 

We classify our its financial instruments in the following categories: at fair value through profit and loss (“FVTPL”), at fair value through other comprehensive income (loss) (“FVTOCI”) or at amortized cost. We determine the classification of financial assets at initial recognition. The classification of debt instruments is driven by our business model for managing the financial assets and their contractual cash flow characteristics. Equity instruments that are held for trading are classified as FVTPL. For other equity instruments, on the day of acquisition we can make an irrevocable election (on an instrument-by-instrument basis) to designate them as at FVTOCI. Financial liabilities are measured at amortized cost, unless they are required to be measured at FVTPL (such as instruments held for trading or derivatives) or if we have opted to measure them at FVTPL.

 

(b) Measurement

 

Financial assets and liabilities at amortized cost

 

Financial assets and liabilities at amortized cost are initially recognized at fair value plus or minus transaction costs, respectively, and subsequently carried at amortized cost less any impairment.

 

Financial assets and liabilities at FVTPL

 

Financial assets and liabilities carried at FVTPL are initially recorded at fair value and transaction costs are expensed in the statements of loss and comprehensive loss. Realized and unrealized gains and losses arising from changes in the fair value of the financial assets and liabilities held at FVTPL are included in the statements of loss and comprehensive loss in the period in which they arise.

 

Debt investments at FVTOCI

 

These assets are subsequently measured at fair value. Interest income calculated using the effective interest method, foreign exchange gains and losses and impairment are recognized in profit or loss. Other net gains and losses are recognized in OCI. On derecognition, gains and losses accumulated in OCI are reclassified to profit or loss.

 

Equity investments at FVTOCI

 

These assets are subsequently measured at fair value. Dividends are recognized as income in profit or loss unless the dividend clearly represents a recovery of part of the cost of the investment. Other net gains and losses are recognized in OCI and are never reclassified to profit or loss.

 

Off-Balance Sheet Arrangements

 

We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditure or capital resources that is material to investors.