Full Press Release Details
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
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.
and Overview of Operations
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.
of the Six Months Ended June 30, 2024 and 2023
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 |
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.
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
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.
and Development Expenses
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.
and Marketing Expenses
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.
and Administrative Expenses
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.
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.
and Capital Resources
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.
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 | ) |
Flow from Operating Activities
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.
Flows from Investing Activities
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.
Flows from Financing Activities
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.
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.
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.
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
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.
Accounting Policies and Significant Judgments and Estimates