VOLITIONRX LTD

Previous wording

ITEM 2. MANAGEMENT'SDISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Current wording

ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Previous wording

Volition is a multi-national epigenetics company. It has patented technologies that use chromosomal structures, such as nucleosomes, and transcription factors as biomarkers in cancer and other diseases. 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.

Current wording

Volition is a multi-national epigenetics company. It has patented technologies that use chromosomal structures, such as nucleosomes, and transcription factors as biomarkers in cancers and other diseases. 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.

Previous wording

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

Current wording

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

Previous wording

We aim to partner with established diagnostic companies to market, sell, and process our tests, leveraging their networks and expertise.

Current wording

We partner with established diagnostic companies to market, sell, and process our tests, leveraging their networks and expertise.

Previous wording

To this end, on March 28, 2022, Volition entered into a master license and product supply agreement with Heska Corporation (“Heska”). In exchange for granting Heska exclusive worldwide rights to sell our Nu.Q® Vet Cancer Test at the point of care for companion animals, Volition received a $10.0 million upfront payment upon signing, received $13.0 million based upon the achievement of two milestones and is eligible to receive up to an additional $5.0 million based upon the achievement of a final milestone upon the earlier of the first commercial sale by or on behalf of Heska of a screening or monitoring test for lymphoma in felines, or the nine-month anniversary of the first peer reviewed paper evidencing clinical utility for the screening or monitoring of lymphoma in felines being published in any one of a number of periodicals identified by the parties. In addition, Volition has granted Heska non-exclusive rights to sell the Nu.Q® Vet Cancer Test as a kit for companion animals through Heska’s network of central reference laboratories. In June 2023 Heska was acquired by Mars Petcare and became part of its Antech Diagnostics division. In April 2024, Antech announced the launch of the in-clinic version of the Nu.Q® Canine Cancer test in the US and Europe. In the second quarter of 2024, Volition supplied key components for 40,000 tests to Antech.

Current wording

To this end, on March 28, 2022, Volition entered into a master license and product supply agreement with Heska Corporation (“Heska”). In exchange for granting Heska exclusive worldwide rights to sell our Nu.Q® Vet Cancer Test at the point of care for companion animals, Volition received a $10.0 million upfront payment upon signing, received $13.0 million based upon the achievement of two milestones and is eligible to receive up to an additional $5.0 million based upon the achievement of a final milestone upon the earlier of the first commercial sale by or on behalf of Heska of a screening or monitoring test for lymphoma in felines, or the nine-month anniversary of the first peer reviewed paper evidencing clinical utility for the screening or monitoring of lymphoma in felines being published in any one of a number of periodicals identified by the parties. In addition, Volition has granted Heska non-exclusive rights to sell the Nu.Q® Vet Cancer Test as a kit for companion animals through Heska’s network of central reference laboratories. In June 2023 Heska was acquired by Mars Petcare and became part of it’s Antech Diagnostics division. In April 2024, Antech announced the launch of the in-clinic version of the Nu.Q® Canine Cancer test in the US and Europe. During the nine months of 2024, Volition supplied key components for 105,000 tests to Antech.

Previous wording

In October 2022, we also entered into a licensing and supply agreement with IDEXX Laboratories, Inc. (“IDEXX”), a global leader in pet healthcare innovation. This contract provides for worldwide customer reach through IDEXX’s global reference laboratory network as we continue to commercialize our transformational Nu.Q® technology within the companion animal healthcare sector and capitalize on the significant opportunities available. IDEXX launched the IDEXX Nu.Q® Canine Cancer Test in January 2023.

Current wording

In addition, in October 2022, we entered into a licensing and supply agreement with IDEXX Laboratories, Inc. (“IDEXX”), a global leader in pet healthcare innovation. This contract provides for worldwide customer reach through IDEXX’s global reference laboratory network as we continue to commercialize our transformational Nu.Q® technology within the companion animal healthcare sector and capitalize on the significant opportunities available. IDEXX launched the IDEXX Nu.Q® Canine Cancer Test in January 2023.

Previous wording

In November 2023, we launched the Nu.Q® Vet Cancer Test in the UK and Ireland through our distributor, the Veterinary Pathology Group, and in the UK through Nationwide Laboratories. In March 2024, Fujifilm Vet Systems announced the launch of the Nu.Q® Vet Cancer Test in Japan. In July 2024, VetLab announced the launch of the Nu.Q® Vet Cancer Test in Poland.

Current wording

In November 2023, we launched the Nu.Q® Vet Cancer Test in the UK and Ireland through our distributor, the Veterinary Pathology Group, and in the UK through Nationwide Laboratories. In March 2024, Fujifilm Vet Systems announced the launch of the Nu.Q® Vet Cancer Test in Japan. In July 2024, VetLab announced the launch of the Nu.Q® Vet Cancer Test in Poland. The tests are now available in sixteen countries.

Previous wording

We have financed our operations since inception primarily through private placements and public offerings of our common stock. As of June 30, 2024, we had cash and cash equivalents of approximately $6.0 million.

Current wording

We have financed our operations since inception primarily through private placements and public offerings of our common stock. As of September 30, 2024, we had cash and cash equivalents of approximately $5.4 million.

Previous wording

Net cash used in operating activities was $15.1 million for the six months ended June 30, 2024 and $16.1 million for the six months ended June 30, 2023. The decrease in cash used in operating activities for the period ended June 30, 2024 when compared to same period in 2023 can be attributed a reduction in clinical trial expenditure.

Current wording

Net cash used in operating activities was $20.5 million for the nine months ended September 30, 2024 and $24.5 million for the nine months ended September 30, 2023. The decrease in cash used in operating activities for the period ended September 30, 2024 when compared to same period in 2023 can be attributed a reduction in clinical trial expenditure.

Previous wording

Net cash used in investing activities was $0.2 million and $0.5 million for the six months ended June 30, 2024 and June 30, 2023, respectively. The decrease was mainly due to a reduction in purchases of laboratory equipment, partly offset by increased additions of licenses.

Current wording

Net cash used in investing activities was $0.4 million and $0.8 million for the nine months ended September 30, 2024 and September 30, 2023, respectively. The decrease was mainly due to a reduction in purchases of laboratory equipment, partly offset by increased additions of licenses.

Previous wording

Net cash provided by financing activities was $0.8 million for the six months ended June 30, 2024 and $25.5 million for the comparable period ended June 30, 2023. The decrease in cash provided by financing activities for the period ended June 30, 2024 when compared to same period in 2023 was primarily due to $17.6 million in net cash received from the issuance of shares of common stock in a registered public offering in June 2023, and $8.0 million in net cash received from the issuance of shares of common stock in a registered public offering in February 2023, as compared to $0.6 million in net cash received from the issuance of shares of common stock under our “at-the-market” facility during the period ended June 30, 2024.

Current wording

Net cash provided by financing activities was $6.4 million for the nine months ended September 30, 2024 and $25.2 million for the comparable period ended September 30, 2023. The decrease in cash provided by financing activities for the period ended September 30, 2024 when compared to same period in 2023 was primarily due to $17.6 million in net cash received from the issuance of shares of common stock in a registered public offering in June 2023, and $8.0 million in net cash received from the issuance of shares of common stock in a registered public offering in February 2023, as compared to $0.6 million in net cash received from the issuance of shares of common stock under our “at-the-market” facility during the period ended September 30, 2024 together with $6.3 million in net cash received from the issuance and sale of the shares of common stock, pre-funded warrants and the common warrants registered direct offering that closed in August 2024 with H.C. Wainwright & Co. acting as exclusive placement agent.

Previous wording

For additional information on our “at the market facility,” refer to Note 6,Common Stock –Equity Distribution Agreement, of the notes to the condensed consolidated financial statements included within this Report.

Current wording

For additional information on our “at-the-market” facility, and the August 2024 registered direct offering, refer to Note 6,Common Stock –Equity Distribution Agreement, and*2024 Equity Capital Raise,*of the notes to the condensed consolidated financial statements included within this Report.

Previous wording

We have not attained profitable operations and are dependent upon obtaining financing to pursue any extensive activities. For these reasons, our auditors included in their report on our audited financial statements for the year ended December 31, 2023, an explanatory paragraph regarding factors that raise substantial doubt that we will be able to continue as a going concern.*** ***

Current wording

We have not attained profitable operations and are dependent upon obtaining financing to pursue any extensive activities. For these reasons, our auditors included in their report on our audited financial statements for the year ended December 31, 2023, an explanatory paragraph regarding factors that raise substantial doubt that we will be able to continue as a going concern. For additional information regarding our going concern assessment, refer to Note 2,Liquidity and Going Concern Assessment, of the notes to the condensed consolidated financial statements included within this Report.

Previous wording

Our operations are transitioning from a research and development focused stage to a commercialization stage. Revenues during the three-months ended June 30, 2024 were $395,797, compared with $216,310 for the three-months ended June 30, 2023. Our main source of revenues during the three months ended June 30, 2024 and June 30, 2023 was product revenues from sales of the Nu.Q®Vet Cancer Test. The year on year increase in revenues was primarily driven by sales of key components of the Nu.Q®Vet Cancer Test to Antech.

Current wording

Our operations are transitioning from a research and development stage to a commercialization stage. Revenues during the three-months ended September 30, 2024 were $474,522, compared with $165,211 for the three-months ended September 30, 2023. Our main source of revenues during the three months ended September 30, 2024 and September 30, 2023 was product revenues from sales of the Nu.Q®Vet Cancer Test. The year on year increase in revenues was primarily driven by sales of key components of the Nu.Q®Vet Cancer Test to Antech.

Previous wording

Total operating expenses decreased to $7.4 million for the three months ended June 30, 2024 from $9.8 million for the three months ended June 30, 2023, as a result of the factors described below.** **

Current wording

Total operating expenses decreased to $6.3 million for the three months ended September 30, 2024 from $8.8 million for the three months ended September 30, 2023, as a result of the factors described below.

Previous wording

Research and development expenses decreased to $3.7 million from $5.5 million for the three-months ended June 30, 2024, and June 30, 2023, respectively. This decrease was primarily related to decreased direct research and development expenses as a result of reduced clinical trial activity with DXOCRO, reduced personnel expenses and reduced stock-based compensation. The number of full-time equivalent (“FTE”) personnel we employed in this division decreased by 7 to 62 compared to the prior year period.

Current wording

Research and development expenses decreased to $3.5 million from $4.7 million for the three-months ended September 30, 2024, and September 30, 2023, respectively. This decrease was primarily related to decreased personnel expenses, lower direct research and development expenses from reduced clinical trial activity and reduced stock-based compensation. The number of full-time equivalent (“FTE”) personnel we employed in this division decreased by 12 to 59 compared to the prior year period.

Previous wording

General and administrative expenses decreased to $2.3 million from $2.6 million for the three-months ended June 30, 2024, and June 30, 2023, respectively. The reduction is due to lower personnel expenses and stock-based compensation offset partly by increased legal costs during the period. The FTE personnel number within this division decreased by 1 to 20 compared to the prior year period.

Current wording

General and administrative expenses decreased to $1.8 million from $2.6 million for the three-months ended September 30, 2024, and September 30, 2023, respectively. The reduction is due to lower personnel expenses and legal costs during the period. The FTE personnel number within this division decreased by 2 to 20 compared to the prior year period.

Previous wording

Sales and marketing expenses decreased to $1.4 million from $1.7 million for the three-months ended June 30, 2024, and June 30, 2023, respectively. The reduction is due to lower personnel expenses, direct marketing and professional fees and stock-based compensation during the period. The FTE personnel number within this division decreased by 2 to 19 compared to the prior year period.

Current wording

Sales and marketing expenses decreased to $1.1 million from $1.6 million for the three-months ended September 30, 2024, and September 30, 2023, respectively. The reduction is due to lower personnel expenses and stock-based compensation, partly offset by increased direct marketing and professional fees during the period. The FTE personnel number within this division decreased by 4 to 17 compared to the prior year period.

Previous wording

For the six months ended June 30, 2024, the Company’s net loss was approximately $15.5 million in comparison to a net loss of $18.4 million for the six months ended June 30, 2023. The change was primarily a result of decreased clinical trial activity and personnel costs.

Current wording

For the three months ended September 30, 2024, the Company’s net loss was approximately $5.9 million in comparison to a net loss of $8.5 million for the three months ended September 30, 2023. The change was primarily a result of reduced personnel costs and clinical trial activity, partly reflecting the completion of certain research and development projects.

Previous wording

The following table sets forth our results of operations for the six months ended June 30, 2024 and June 30, 2023:

Current wording

The following table sets forth our results of operations for the nine months ended September 30, 2024 and September 30, 2023:

Previous wording

Our operations are still transitioning from a research and development stage to a commercialization stage. Revenues during the six-months ended June 30, 2024 were $567,332, compared with $366,118 for the six-months ended June 30, 2023. Our main source of revenue during the six-months ended June 30, 2024 and six-months ended June 30, 2023 was product revenues from sales of the Nu.Q®Vet Cancer Test. The year on year increase in revenues was primarily driven by sales of key components of the Nu.Q®Vet Cancer Test to Antech and sales of Nu.Q®Discover services.

Current wording

Our operations are transitioning from a research and development stage to a commercialization stage. Revenues during the nine-months ended September 30, 2024 were $1,041,854, compared with $531,329 for the nine-months ended September 30, 2023. Our main source of revenue during the nine-months ended September 30, 2024 and nine-months ended September 30, 2023 was product revenues from sales of the Nu.Q®Vet Cancer Test. The year on year increase in revenues was primarily driven by sales of key components of the Nu.Q®Vet Cancer Test to Antech and sales of Nu.Q®Discover services.

Previous wording

Total operating expenses decreased to $15.9 million from $19.0 million for the six months ended June 30, 2024 and June 30, 2023, respectively, as a result of the factors described below.

Current wording

Total operating expenses decreased to $22.3 million from $27.8 million for the nine months ended September 30, 2024 and September 30, 2023, respectively, as a result of the factors described below.

Previous wording

Research and development expenses decreased to $8.3 million for the six months ended June 30, 2024, from $10.4 million for the six months ended June 30, 2023. This decrease was primarily related to decreased direct research and development expenses as a result reduced clinical trial activity with DXOCRO, reduced personnel expenses and reduced stock-based compensation. The FTE personnel number decreased by 7 to 62 compared to the prior year period.

Current wording

Research and development expenses decreased to $11.8 million for the nine months ended September 30, 2024, from $15.0 million for the nine months ended September 30, 2023. This decrease was primarily related to decreased direct research and development expenses as a result of reduced clinical trial activity with DXOCRO, reduced personnel expenses and reduced stock-based compensation. The FTE personnel number decreased by 12 to 59 compared to the prior year period.

Previous wording

General and administrative expenses decreased to $4.5 million from $5.2 million for the six months ended June 30, 2024 and June 30, 2023, respectively. This decrease was primarily due to lower personnel expenses and stock-based compensation during the period. The FTE personnel number decreased by 1 to 20 compared to the prior year period.

Current wording

General and administrative expenses decreased to $6.4 million from $7.8 million for the nine months ended September 30, 2024 and September 30, 2023, respectively. This decrease was primarily due to lower personnel expenses, stock-based compensation and legal and professional fees during the period. The FTE personnel number decreased by 2 to 20 compared to the prior year period.

Previous wording

Sales and marketing expenses decreased to $3.1 million compared to $3.4 million for the six months ended June 30, 2024 and June 30, 2023. This decrease was primarily due to reduced stock-based compensation and direct marketing during the period. The FTE personnel number decreased by 2 to 19 compared to the prior year period.

Current wording

Sales and marketing expenses decreased to $4.1 million compared to $4.9 million for the nine months ended September 30, 2024 and September 30, 2023. This decrease was due to reduced personnel expenses and stock-based compensation during the period. The FTE personnel number decreased by 4 to 17 compared to the prior year period.

Previous wording

For the six months ended June 30, 2024, the Company’s other expenses were $157,257 compared to other income of $169,880 for the six months ended June 30, 2023. The increase in other expenses is due to increased interest paid partly offset by a reduction in grant income and interest received during the period.

Current wording

For the nine months ended September 30, 2024, the Company’s other expenses were $157,128 compared to other income of $369,747 for the nine months ended September 30, 2023. The increase in other expenses is due to increased interest paid partly offset by a reduction in grant income, interest received and a gain on change in fair value of warrants in the prior year period.

Previous wording

For the three months ended June 30, 2024, the Company’s net loss was approximately $7.1 million in comparison to a net loss of $9.6 million for the three months ended June 30, 2023. The change was primarily a result of reduced clinical trial and personnel costs.

Current wording

For the nine months ended September 30, 2024, the Company’s net loss was approximately $21.4 million in comparison to a net loss of $26.9 million for the nine months ended September 30, 2023. The change was primarily a result of reduced clinical trial activity and personnel costs.

Previous wording

We may seek to obtain additional capital through the sale of debt or equity securities if we deem it desirable or necessary. These sales may include the sale of equity securities from time to time through an “at the market offering program” under our Equity Distribution Agreement with Jefferies LLC. See Note 6,Common Stock – Equity Distribution Agreement, of the notes to the condensed consolidated financial statements. However, we may be unable to obtain such additional capital when needed, or on terms favorable to us or our stockholders, if at all. If we raise additional funds by issuing equity securities, the percentage ownership of our stockholders will be reduced, stockholders may experience additional dilution, or such equity securities may provide for rights, preferences or privileges senior to those of the holders of our common stock. If additional funds are raised through the issuance of debt securities, the terms of such securities may place restrictions on our ability to operate our business.

Current wording

We may seek to obtain additional capital through the sale of debt or equity securities if we deem it desirable or necessary. These sales may include the sale of equity securities from time to time through an “at the market offering program” under our Equity Distribution Agreement with Jefferies LLC or through other equity or debt financings. See Note 6,Common Stock – Equity Distribution Agreement, of the notes to the condensed consolidated financial statements. However, we may be unable to obtain such additional capital when needed, or on terms favorable to us or our stockholders, if at all. If we raise additional funds by issuing equity securities, the percentage ownership of our stockholders will be reduced, stockholders may experience additional dilution, or such equity securities may provide for rights, preferences or privileges senior to those of the holders of our common stock. If additional funds are raised through the issuance of debt securities, the terms of such securities may place restrictions on our ability to operate our business.

Previous wording

Our interim condensed consolidated financial statements and accompanying notes have been prepared in accordance with United States generally accepted accounting principles, or GAAP, applied on a consistent basis. The preparation of financial statements in conformity with 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.

Current wording

Our interim condensed consolidated financial statements and accompanying notes have been prepared in accordance with United States generally accepted accounting principles, (“GAAP”), applied on a consistent basis. The preparation of financial statements in conformity with 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.