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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, unce

Key Takeaway: 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

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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, 2024 on Form 20-F, filed with the U.S. Securities and Exchange Commission on March 31,
2025. 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. In addition, we conduct research and development to increase
and diversify our product portfolio. Since 2020 we have also been developing a IVD test for the early detection of pancreatic cancer.
During July 2024 and October 2024, we restructured
our operations to focus on our ColoAlert business in Europe, the development of our next generation product, the development of PancAlert,
and the Early Detect 2 clinical study in the U.S. In line with that focus, we implemented cost reduction efforts which included the reduction
of our operating costs, including the reduction of personnel by 65%, reduction of external consulting costs, and the sale of our
European Oncology Lab ("EOL") business in St. Ingbert, Germany to a related party. Additionally, we amended the employment
contracts of our CEO and CFO, reducing the salaries of those officers to 60% and 50% of their then current salaries, respectively,
effective November 1, 2024. During the six months ended June 30, 2025 and 2024, we recorded expenses of $113,113 and $186,601, respectively,
for the cost of royalties and other associated costs owed to ColoAlert AS (and its successor, Uni Targeting Research AS, collectively
"ColoAlert AS"), the company from which we exclusively licensed the ColoAlert product. A non-executive director of the Company
is also an owner of ColoAlert AS. During the six months ended June 30, 2025 and 2024, we paid ColoAlert AS $113,113 and $155,450,
December 3, 2024, we effectuated a 1:40 reverse stock split of our ordinary shares. All share and per share amounts in this discussion
and analysis account for this reverse stock split.
of the Six Months Ended June 30, 2025 and 2024
following table provides certain selected financial information for the periods presented:
Six Months Ended June 30, %
2025 2024 Change Change
Total Revenue $ 286,717 $ 520,773 $ (234,056 ) (45 )%
Cost of revenue $ 97,128 $ 201,735 $ (104,607 ) (52 )%
Gross profit $ 189,589 $ 319,038 $ (129,449 ) (41 )%
Gross margin 66 % 61 %
Research and development $ 3,055,088 $ 3,242,622 $ (187,534 ) (6 )%
Sales and marketing $ 2,349,005 $ 2,361,105 $ (12,100 ) (1 )%
General and administrative $ 2,876,845 $ 4,522,639 $ (1,645,794 ) (36 )%
Total operating expenses $ 8,280,938 $ 10,126,366 $ (1,845,428 ) (18 )%
Loss from operations $ (8,091,349 ) $ (9,807,328 ) $ (1,715,979 ) (17 )%
Other expense $ (252,862 ) $ (1,216,434 ) $ 963,572 79 %
Net loss $ (8,344,211 ) $ (11,023,762 ) $ (2,679,551 ) (24 )%
Total comprehensive loss $ (8,403,064 ) $ (11,086,128 ) $ (2,683,064 ) (24 )%
Basic and dilutive loss per common share $ (2.65 ) $ (19.73 ) $ 17.08 87 %
Weighted average number of common shares outstanding - basic and diluted 3,144,409 558,751
revenue for the six months ended June 30, 2025 was $286,717 as compared to $520,773 for the six months ended June 30,
2024, a decrease of 45%. This decrease was attributable to our strategic decisions to cease direct to consumer sales and to sell our
EOL business in 2024. The result of these decisions decreased revenue by approximately $234,000. During the six months ended June
30, 2025 sales to lab partners increased by approximately $60 thousand, or 30%, compared to the six month period ended June 30, 2024.
of revenue for the six months ended June 30, 2025 was $97,128 as compared to $201,735 for the six months ended June 30, 2024, a 52% decrease.
This decrease was the result of decreased ColoAlert sales volume stemming from our decision to cease selling online direct to consumer,
which drove efficiencies across our fixed costs, lowering overall unit costs.
profit decreased by $129,449 to $189,589 in the six months ended June 30, 2025 compared to $319,038, for the six months
ended June 30, 2024. This gross profit decrease, resulting in an improvement of gross margin from 61% to 66%, was attributable to
improved profits resulting from lowered unit cost of goods sold attributable to economies of scale with increased sales volumes and
the improved margin profile generated in our sales to lab partners.
and Development Expenses
and development expenses for the six months ended June 30, 2025 were $3,055,088 compared to $3,242,622 for the six months ended June
30, 2024, a decrease of $187,534. This decrease was driven by the reduction of staffing levels from our 2024 restructuring efforts, which
reduced payroll and related expenses of $1.4 million. Additionally, our costs related to clinical studies increased by $1.2 million for
the six months ended June 30, 2025 compared to the same period 2024 as the result of our eAArly Detect 2 study in the U.S. which began
and Marketing Expenses
and marketing expenses for the six months ended June 30, 2025, were $2,349,005 compared to $2,361,105 for the six months ended June 30,
2024, a decrease of $12,100. This small change was the result of an increase in our marketing and advertising expense of $1.0 million
as the result of non-cash equity expenses related to marketing campaigns in 2025, mitigated by a $0.9 million decrease in 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, 2025 were $2,876,845 compared to $4,522,639 for the six months ended
June 30, 2024, a decrease of $1,645,794. The decreased expenses were primarily the result of a decrease of $1.1 million in payroll and
consulting fees driven by the reduction of staffing levels from our 2024 restructuring efforts. Additionally, non-cash stock option expense
for the six months ended June 30, 2025 decreased $0.4 million compared to the same period in 2024.
expense, net for the six months ended June 30, 2025 was $252,862 compared to $1,216,434 for the six months ended June 30, 2024, resulting
in decreased other expenses (net) of $963,572. This decrease was primarily the result of decreased interest expense of $0.4 million from
our lower convertible debt balances and the decrease in the fair value adjustment of $0.5 million.
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, 2025, we had $1,911,069 of cash and cash equivalents,
with $6,235,670 as of December 31, 2024.
following table summarizes our cash flows from operating, investing and financing activities:
Six Months Ended June 30,
2025 2024 Change
Cash used in operating activities $ (6,531,975 ) $ (8,144,745 ) $ 1,612,770
Cash used in investing activities $ (451,123 ) $ (420,660 ) $ (30,463 )
Cash provided by financing activities $ 2,675,458 $ 2,551,325 $ 124,133
Flow from Operating Activities
the six months ended June 30, 2025, cash flows used in operating activities was $6,531,975 compared to $8,144,745 used during the six
months ended June 30, 2024. The improvement in cash flows used in operating activities of $1,612,770 was primarily the result of our
smaller operating loss for the six months ended June 30, 2025, 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, 2024.
Flows from Investing Activities
the six months ended June 30, 2025, we used $451,123 in investing activities compared to $420,660 used during the six months ended
June 30, 2024. The cash flows used in investing activities were primarily related to payments for the acquisition of intellectual property
for our PancAlert product under development and the acquisition of the ColoAlert intellectual property.
Flows from Financing Activities
the six months ended June 30, 2025, we had cash flow provided by financing activities of $2,675,458 compared to cash flow provided by
financing activities of $2,551,325 for the six months ended June 30, 2024, an increase of $124,133. During the six months ended June
30, 2025 the cash flows from the sale of ordinary shares and warrants increased by approximately $3.0 million compared to the same period
in the prior year while cash flows (net) from the issuance and repayments of convertible debt decreased by approximately $2.8 million.
had recurring losses, accumulated deficit totaling approximately
$99.3 million and negative cash flows used in operating activities of approximately
$6.5 million as of and for the six months ended June 30, 2025. We also had approximately
$1.9 million of cash on hand on June 30, 2025, and a working capital deficit, of approximately
conditions are indicators that impact our ability to continue as a going concern for a period of one year from the date of
these financial statements. If we are unable to obtain funding, we could be forced to further delay, reduce or eliminate our research
and development, regulatory, and commercial efforts which could adversely affect our future business prospects and our ability to continue
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 2022, we raised $24.2 million of net proceeds from common stock sales and warrant proceeds.
During 2023, we raised $16.5 million from a combination of sale of shares and warrants as well as the issuance of convertible debt.
During 2024, we raised $18.2 million from a combination of sale of shares and warrants as well as the issuance of convertible debt.
During the first half of 2025, we raised $4 million through the sale of units including ordinary shares and warrants. In August 2025,
we raised an additional $3 million through the sale of units including ordinary shares and warrants.
believe that we 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 our access to capital through our Controlled Equity Offering and our Pre-Paid Advance Agreement. We also have
the ability to defer certain costs, especially those related to clinical studies, to match financing inflows. During July 2024 and October
2024, we restructured our operations to focus on our ColoAlert business in Europe, the development of our next generation product, the
development of PancAlert and planning for the Early Detect 2 clinical study in the U.S. in 2025. In line with that focus, we implemented
cost reduction efforts which included the reduction of our operating costs, including the reduction of personnel by 65%, reduction of
Last updated: Sep 26, 2025