What changed in this filing

/stocks — the workspaceLOADING

Item 7. Management’s Discussion and Analysis

2025-03-31 compared with 2024-03-25 · 30 added, 27 removed, 141 unchanged (29% of the section changed)

8 unchanged sentences

The tests in the Company’s product portfolio detect certain characteristic changes that occur from the earliest stages of disease, enabling early detection and offering a better way to monitor disease progression and a patient’s response to treatment.

The tests offered by Volition and its subsidiaries are designed to diagnose and monitor a range of life-altering diseases, including certain cancers and diseases associated with NETosis, such as sepsis and COVID-19.

The tests offered by Volition and its subsidiaries are designed to detect and monitor a range of life-altering diseases, including certain cancers and diseases associated with NETosis, such as sepsis.

Early diagnosis and monitoring have the potential to not only prolong the life of patients but also improve their quality of life.

2 unchanged sentences

The Nu.Q ® Vet Cancer Test is commercially available as a cancer screening test in dogs.

Nu.Q ® NETs - monitoring the immune system to save lives.

Nu.Q ® NETs - detects diseases associated with NETosis such as sepsis.

Nu.Q ® Discover - a complete solution to profiling nucleosomes.

Nu.Q ® Cancer - monitoring disease progression, response to treatment and Minimal Residual Disease.

Capture-PCR TM - isolating and capturing circulating tumor derived DNA from plasma samples for early cancer detection.

The Company has grown from a single two-meter lab bench at the University of Namur in Belgium to a purpose-built lab in Gembloux, Belgium, an Innovation Lab in California, and offices in California, London, Singapore and Nevada.

In 2015 the Company’s common stock was listed on the New York Stock Exchange (VNRX).

Nu.Q ® Cancer - from screening, diagnosis and staging, therapy decision, planning and treatment to monitoring response to treatment and disease progression.

Capture-PCR™ - isolating and capturing circulating tumor-derived DNA from plasma samples for early cancer detection.

The Company has grown from a single two-meter lab bench at the University of Namur in Belgium to a purpose-built 17,000 square foot lab and 10,000 square foot production facility in Gembloux, Belgium, an Innovation Lab in California, and offices in California, London and Nevada.

We now have a team of over 80 dedicated employees, spanning a wide range of disciplines;

all united in its mission to improve outcomes for patients.

all united in our mission to improve outcomes for patients.

Cultivating successful, ongoing relationships with stakeholders worldwide has been fundamental to Volition’s development.

We have fostered ties with leading academic institutions, clinical centers of excellence, multi-national diagnostic and pharmaceutical companies and financial institutions across the globe.

We have identified the specific processes and resources required to achieve the near and medium-term objectives of our business plan, including personnel, facilities, equipment, research and testing materials including antibodies and clinical samples, and the protection of intellectual property.

17 unchanged sentences

Net cash used in operating activities was $25.9 million and $18.1 million for the years ended December 31, 2024 and December 31, 2023, respectively.

The increase in cash used in operating activities during 2023 when compared to 2022 was primarily due to higher payroll costs and higher amounts paid to suppliers during the period.

The increase in cash used in operating activities during 2024 when compared to 2023 was primarily due to the deferred revenue receipt of $13 million in the prior year offset by lower payroll costs and amounts paid to suppliers during the period.

Net cash used in investing activities was $0.6 million and $1.1 million for the years ended December 31, 2024 and December 31, 2023, respectively.

1 unchanged sentence

Net cash provided by financing activities after associated costs was $8.7 million and $29.0 million for the years ended December 31, 2024 and December 31, 2023, respectively.

The increase in net cash provided by financing activities for the 2023, when compared to 2022 was primarily due to the following $8.0 million in net proceeds received from the sale and issuance of common stock in a registered public offering in February 2023, before deducting offering expenses of $0.2 million, $17.6 million in net proceeds received from the sale and issuance of common stock in a registered public offering in June 2023, before deducting offering expenses of $0.1 million and $2.7 million (€2.5 million) in net proceeds received from the sale and issuance of common stock in a private placement in December 2023, also in June 2023 a $0.2 million loan was received from Namur Invest and in December 2023 a $1.6 million loan was received from Wallonie Entreprendre S.A.

This compares with $6.4 million in net cash received from the issuance of approximately 3.5 million shares of common stock in a registered public offering in August 2022, before deducting offering expenses of $0.2 million paid by the Company and a $1.0 million (€1.0 million) loan received in August 2022 from Namur Invest, a $0.5 million loan received in December 2022 from Namur Invest, and $0.8 million in cash received from the issuance of shares of common stock under our “at-the-market” facilities during the year, before deducting offering expenses of $0.2 million.

For additional information on our “at the market facilities,” refer to Note 7, Common Stock – Equity Distribution Agreements, of the Notes to consolidated financial statements included within this Report.

Net cash provided by financing activities in 2024 consisted of $0.7 million in net cash received from the issuance of shares of common stock under our “at-the-market” facility during the period ended December 31, 2024, $6.3 million in cash received before deducting offering expenses of $0.2 million from the issuance and sale of the shares of common stock, pre-funded warrants and common warrants in a registered direct offering that closed in August 2024, and a further $1.9 million in cash received before deducting offering expenses of $0.1 million from the issuance and sale of common stock and common warrants in a registered direct offering to certain directors and executive officers of the Company as well as other investors that closed in December 2024.

This compares with $8.0 million in net proceeds received from the sale and issuance of common stock in a registered public offering in February 2023, before deducting offering expenses of $0.2 million, $17.6 million in net proceeds received from the sale and issuance of common stock in a registered public offering in June 2023, before deducting offering expenses of $0.1 million and $2.7 million (€2.5 million) in net proceeds received from the sale and issuance of common stock in a private placement in December 2023.

Additionally, in June 2023 a $0.2 million loan was received from Namur Invest and in December 2023 a $1.6 million loan was received from Wallonie Entreprendre S.A.

For additional information on our “at the market facility,” refer to Note 7, Common Stock – Equity Distribution Agreements, of the Notes to consolidated financial statements included within this Report.

The following table summarizes our approximate contractual payments due by year as of December 31, 2024.

Approximate Payments (Including Interest) Due by Year

Greater than 5 years

Financing lease liabilities

13 unchanged sentences

The following table sets forth our results of operations for the years ended on December 31, 2024, and December 31, 2023, respectively (expressed in United Stated Dollars, except outstanding share numbers and percentages).

Percentage Increase

Total Revenues

14 unchanged sentences

Operating Expenses

Total operating expenses increased to $36.8 million from $32.1 million for the years ended December 31, 2023 and December 31, 2022, respectively, as a result of the factors described below.

Total operating expenses decreased to $28.3 million from $36.8 million for the years ended December 31, 2024 and December 31, 2023, respectively, as a result of the factors described below.

Research and Development Expenses

Research and development expenses increased to $19.6 million from $15.3 million for the years ended December 31, 2023 and December 31, 2022, respectively.

The increase in overall research and development expenditures during 2023 was primarily related to higher personnel expenses and clinical research costs.

FTE personnel numbers within this division increased by three to sixty six during 2023 compared to the prior year period.

Research and development expenses decreased to $14.4 million from $19.6 million for the years ended December 31, 2024 and December 31, 2023, respectively.

The decrease in overall research and development expenditures during 2024 was primarily related to decreased clinical research costs and lower personnel expenses.

FTE personnel numbers within this division decreased by fourteen to fifty two during 2024 compared to the prior year period.

Personnel expenses

5 unchanged sentences

General and Administrative Expenses

General and administrative expenses increased to $10.4 million from $10.2 million for the years ended December 31, 2023 and December 31, 2022, respectively.

The increase in overall general and administrative expenditures during 2023 was primarily due to higher personnel expenses and legal and professional fees offset by lower stock-based compensation.

The FTE personnel number within this division remained at twenty two in 2023 compared to the prior year period.

General and administrative expenses decreased to $8.5 million from $10.4 million for the years ended December 31, 2024 and December 31, 2023, respectively.

The decrease in overall general and administrative expenditures during 2024 was primarily due to lower personnel expenses, legal and professional fees and stock-based compensation.

The FTE personnel number within this division decreased by three to nineteen during 2024 compared to the prior year period.

Personnel expenses

5 unchanged sentences

Sales and Marketing Expenses

Sales and marketing expenses increased to $6.8 million from $6.6 million for the years ended December 31, 2023 and December 31, 2022, respectively.

The increase in overall sales and marketing expenditures was primarily due to increased personnel expenses offset by lower stock-based compensation.

The FTE personnel number within this division increased by three to twenty two in 2023 compared to the prior year period.

Sales and marketing expenses decreased to $5.4 million from $6.8 million for the years ended December 31, 2024 and December 31, 2023, respectively.

The decrease in overall sales and marketing expenditures was primarily due to decreased personnel expenses and lower stock-based compensation.

The FTE personnel number within this division decreased by eight to fourteen during 2024 compared to the prior year period.

Personnel expenses

Stock-based compensation

Other sales and marketing expenses

Other Sales & Marketing expenses

Depreciation and amortization

2 unchanged sentences

For the year ended December 31, 2024, other income decreased to approximately $(0.2) million compared to other income of approximately $0.3 million for the year ended December 31, 2023.

This decrease in other income was primarily due to reduced grant income received of approximately $0.2 million during 2023 compared to $1.2 million in 2022.

For the year ended December 31, 2023, the Company’s net loss was $35.7 million, an increase of approximately $5.1 million, in comparison to a net loss of $30.6 million for the year ended December 31, 2022.

This decrease in other income was primarily due to reduced grant income received of approximately $0.1 million during 2024 compared to $0.2 million in 2023 and a gain in the fair value of the warrant liability during 2023.

For the year ended December 31, 2024, the Company’s net loss was $27.3 million, a decrease of approximately $(8.4) million, in comparison to a net loss of $35.7 million for the year ended December 31, 2023.

The change was a result of the factors described above.

16 unchanged sentences

GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods.

We also regularly evaluate estimates and assumptions related to deferred income tax asset valuation allowances, useful lives of property and equipment and intangible assets, borrowing rate used in operating lease right-of-use asset and liability valuations, impairment analysis of intangible assets and valuations of stock-based compensation.

We also regularly evaluate estimates and assumptions related to deferred income tax asset valuation allowances, useful lives of property and equipment and intangible assets, deferred revenue valuation, revenue recognition, warrant liability, borrowing rate used in operating lease right-of-use asset and liability valuations, impairment analysis of intangible assets and valuations of stock-based compensation.

We base our estimates and assumptions on current facts, historical experiences, information from third-party professionals and various other factors that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the accrual of costs and expenses that are not readily apparent from other sources.

8 unchanged sentences

The fair value of our stock options and warrants is estimated using a Black-Scholes option valuation model.

Restricted stock units are valued based on the closing stock price on the date of grant, refer to Note 8 of the consolidated financial statements for further details.

Restricted stock units are valued based on the closing stock price on the date of grant.

Impairment of Long-Lived Assets

8 unchanged sentences

An impairment loss is recognized when the carrying amount is not recoverable and exceeds fair value.

Impairment losses of $nil and $nil were recognized during the years ended December 31, 2023 and December 31, 2022, respectively.

Foreign Currency Translation

11 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis