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Volition(VNRX) - 2024 Q1 - Quarterly Report
2024-05-13 20:24
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36833 VolitionRx Limited (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization ...
Volition(VNRX) - 2024 Q1 - Quarterly Results
2024-05-13 20:13
FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): May 13, 2024 VolitionRx Limited (Exact name of registrant as specified in its charter) | Delaware | 001-36833 | 91-1949078 | | --- | --- | --- | | (State or other jurisdiction | (Commission | (IRS Employer | | of Incorporation) | File Number) | Identification Number) | 1489 West Warm Springs Road, Suite 110 Henderson, Nevada 89014 (Address of Principal Executive Of ...
Volition(VNRX) - 2023 Q4 - Earnings Call Transcript
2024-03-26 16:43
Financial Data and Key Metrics Changes - The company recorded revenue of $244,000 for Q4 2023, a 104% increase year-over-year [27] - Full-year revenue for 2023 was $775,000, reflecting a 153% increase compared to the previous year [28] - The net loss for Q4 2023 was $8.8 million, compared to $7.3 million for Q4 2022, with a full-year net loss of $35.7 million, up from $30.6 million in 2022 [30] Business Line Data and Key Metrics Changes - Revenue from the Nu.Q Vet cancer test for 2023 was $475,000, a 194% increase year-over-year, primarily due to sales through IDEXX [28] - Nu.Q Discover generated $300,000 in revenue for 2023, representing a 107% growth over 2022 [28] - The company supplied kits for over 58,000 tests in 2023, five times the number from the previous year [31] Market Data and Key Metrics Changes - The Nu.Q Vet cancer test is now available in multiple countries, including the U.S., U.K., Ireland, Portugal, Singapore, Taiwan, and Italy [42] - The company has signed a supply agreement with Fujifilm Vet Systems for the Nu.Q Vet Cancer Test in Japan, indicating significant market expansion [33][54] Company Strategy and Development Direction - The company aims to achieve cash positivity from existing milestone payments and expected revenue growth as more partners launch the Nu.Q Vet test [67] - There is a focus on non-dilutive funding strategies to support the Nu.Q NET pillar, targeting $25 million [68] - The company is exploring licensing opportunities for its CTCF and Nu.Q cancer technologies, anticipating ongoing royalties and milestone payments [69] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about revenue acceleration in 2024 as additional distributors come online with the Nu.Q Vet cancer test [28] - The company is confident in the potential of the Nu.Q NET and Capture-PCR technologies, with expectations for significant data publication and commercial discussions in the coming months [49][63] - Management highlighted the importance of education for veterinarians to incorporate the Nu.Q test into routine wellness visits [52] Other Important Information - The company ended 2023 with cash and cash equivalents of approximately $20.7 million, up from $10.9 million at the end of 2022 [29] - The company received $13 million in milestone payments from Heska Corporation in December 2023 [41] Q&A Session Summary Question: What is the status of IDEXX's marketing launch? - Management confirmed that IDEXX has completed preparations for the marketing launch and that the revenue from the kits is approximately $10 per kit [71][73] Question: What is the timeline for achieving revenues on the sepsis side? - Management indicated that significant data will be generated throughout the year, with expectations for revenues from the Nu.Q NET test within the next 12 months [89][91] Question: What types of cancer are most promising for detection with Capture-PCR? - Management noted that transcription factors are indicative of all types of cancer, with initial focus on prevalent cancers like lung and colorectal [92] Question: Will there be interim analyses available for the 500-patient study? - Management stated that while the full study won't be finished this year, there may be interim analyses available for presentation at upcoming conferences [108] Question: What is the expected profitability between Discover and Vet? - Management indicated that both segments are highly profitable, with Vet expected to be more profitable once scaled [113]
Volition(VNRX) - 2023 Q4 - Annual Report
2024-03-25 20:19
FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to (I.R.S. Employer Identification No.) 1489 West Warm Springs Road, Suite 110 Henderson, Nevada 89014 (Address of principal executive offices) +1 (646) 650–1351 (Registrant's t ...
Volition(VNRX) - 2023 Q4 - Annual Results
2024-03-25 20:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): March 25, 2024 VolitionRx Limited (Exact name of registrant as specified in its charter) (Registrant's telephone number, including area code ) Not applicable (Former name or former address, if changed since last report.) Check the appropriate box below if the Form 8-K filing is intended to simu ...
Volition(VNRX) - 2023 Q3 - Earnings Call Transcript
2023-11-15 20:41
VolitionRx Limited (NYSE:VNRX) Q3 2023 Earnings Conference Call November 15, 2023 8:30 AM ET Company Participants Scott Powell - Executive Vice President, Investor Relations Cameron Reynolds - President and Group Chief Executive Officer Terig Hughes - Group Chief Financial Officer Tom Butera - Chief Executive Officer, Volition Veterinary Subsidiary Andrew Retter - Medical Consultant, Volition Louise Batchelor - Chief Marketing and Communications Officer Conference Call Participants Ross Osborn - Cantor Fitz ...
Volition(VNRX) - 2023 Q3 - Quarterly Report
2023-11-14 21:22
PART I - FINANCIAL INFORMATION This section presents the unaudited financial statements and management's discussion of the company's financial condition and operational results [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20FINANCIAL%20STATEMENTS%20(UNAUDITED)) This section presents VolitionRx Limited's unaudited condensed consolidated financial statements, highlighting a significant net loss and a 'going concern' warning [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2023, the company reported **$10.8 million** in cash, **$18.0 million** in total assets, and a **$2.9 million** stockholders' deficit Condensed Consolidated Balance Sheet Highlights (in USD) | Balance Sheet Item | Sep 30, 2023 (Unaudited) | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $10,808,747 | $10,867,050 | | Total Current Assets | $12,197,319 | $12,172,145 | | Total Assets | $18,040,868 | $18,295,054 | | **Liabilities & Equity** | | | | Deferred revenue | $10,000,000 | $10,000,000 | | Total Current Liabilities | $17,654,144 | $17,386,087 | | Total Liabilities | $20,892,177 | $21,422,016 | | Total Stockholders' Equity (Deficit) | ($2,851,309) | ($3,126,962) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the nine months ended September 30, 2023, revenues increased to **$531,329**, but operating expenses and net loss also rose significantly Statement of Operations Summary (in USD) | Metric | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Total Revenues | $531,329 | $186,677 | | Research and development | $15,007,623 | $11,202,902 | | Total Operating Expenses | $27,778,450 | $23,956,085 | | Operating Loss | ($27,247,121) | ($23,769,408) | | Net Loss | ($26,877,374) | ($23,262,281) | | Net Loss Per Share (Basic & Diluted) | ($0.39) | ($0.42) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to **$24.5 million**, while financing activities provided **$25.2 million**, resulting in stable cash balances Cash Flow Summary (Nine Months Ended Sep 30, in USD) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net Cash Used In Operating Activities | ($24,510,735) | ($9,474,055) | | Net Cash Used In Investing Activities | ($775,027) | ($991,430) | | Net Cash Provided By Financing Activities | $25,212,215 | $6,012,068 | | Net change in cash and cash equivalents | ($58,303) | ($4,165,244) | | Cash and cash equivalents – End of Period | $10,808,747 | $16,416,069 | [Notes to the Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) The notes detail accounting policies, 'going concern' issues, equity transactions, and significant future commitments, including deferred revenue and public offerings - The company has incurred **losses of $193.9 million** since inception and has had negative cash flows from operations, which raises **substantial doubt about its ability to continue as a going concern**[75](index=75&type=chunk) - The company received a **$10.0 million upfront payment** from Heska Corporation in 2022, which is recorded as deferred revenue as of September 30, 2023[49](index=49&type=chunk)[51](index=51&type=chunk) - In 2023, the company raised **approximately $25.6 million in net proceeds** from two underwritten public offerings of its common stock[94](index=94&type=chunk)[95](index=95&type=chunk) - As of September 30, 2023, the company has **significant future commitments, including $3.7 million for long-term debt, $1.3 million for collaborative agreements, and $0.6 million for lease liabilities**[197](index=197&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses the company's commercialization strategy across five key pillars, highlighting increased revenues and operating expenses, and reliance on future financing [Company Overview and Commercialization Strategy](index=29&type=section&id=Company%20Overview%20and%20Commercialization%20Strategy) VolitionRx, an epigenetics company, focuses on monetizing its IP through licensing and distribution partnerships for its blood tests, including agreements with Heska and IDEXX - **The company's focus is on five key pillars: Cancer detection, Nu.Q® Vet, Nu.Q® NETs (immune system monitoring), Nu.Q® Capture (sample concentration), and Nu.Q® Discover (nucleosome profiling)**[180](index=180&type=chunk)[185](index=185&type=chunk) - **A key part of the strategy is forming partnerships, such as the master license and supply agreement with Heska Corporation, which included a $10 million upfront payment and potential for $18 million in milestones**[187](index=187&type=chunk) - **The company also has a licensing and supply agreement with IDEXX Laboratories to commercialize its Nu.Q® technology for companion animals through IDEXX's global reference laboratory network**[188](index=188&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) The company held **$10.8 million** in cash, with significant cash used in operations offset by financing activities, and faces 'going concern' doubts due to reliance on future funding - **Cash and cash equivalents were approximately $10.8 million as of September 30, 2023**[192](index=192&type=chunk) - **Net cash used in operating activities increased to $24.5 million for the nine months ended Sep 30, 2023, from $9.5 million in the prior year period, largely because a $10.0 million payment from Heska was received in 2022**[193](index=193&type=chunk) - **The company's auditors have expressed substantial doubt about its ability to continue as a going concern due to its history of losses and reliance on external financing**[199](index=199&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) **Revenues grew over 180%** due to product sales, but **R&D expenses increased by 34%**, widening the net loss for both the nine and three-month periods Comparison of Nine Months Ended September 30 (in USD) | Metric | 2023 | 2022 | Change (%) | | :--- | :--- | :--- | :--- | | Total Revenues | $531,329 | $186,677 | >100% | | Research and development | $15,007,623 | $11,202,902 | 34% | | Total Operating Expenses | $27,778,450 | $23,956,085 | 16% | | Net Loss | ($26,877,374) | ($23,262,281) | 16% | - The increase in R&D expenses was primarily driven by costs associated with clinical trials with DXOCRO and higher personnel expenses[217](index=217&type=chunk) Comparison of Three Months Ended September 30 (in USD) | Metric | 2023 | 2022 | Change (%) | | :--- | :--- | :--- | :--- | | Total Revenues | $165,211 | $32,714 | >100% | | Research and development | $4,650,658 | $4,002,212 | 16% | | Total Operating Expenses | $8,818,266 | $8,025,670 | 10% | | Net Loss | ($8,453,188) | ($7,812,271) | 8% | [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=35&type=section&id=Item%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) As a smaller reporting company, VolitionRx is not required to provide quantitative and qualitative disclosures about market risk - **As a smaller reporting company, VolitionRx is not required to disclose quantitative and qualitative information about market risk**[232](index=232&type=chunk) [Item 4. Controls and Procedures](index=35&type=section&id=Item%204.%20CONTROLS%20AND%20PROCEDURES) Management concluded that disclosure controls were ineffective due to material weaknesses in internal control over financial reporting, with remediation steps underway and planned - **The Principal Executive Officer and Principal Financial Officer concluded that disclosure controls and procedures were not effective as of September 30, 2023, due to material weaknesses in internal control over financial reporting**[235](index=235&type=chunk) - **Remediation steps taken include hiring specialists, changing reporting lines to improve segregation of duties, engaging additional resources for control design, and implementing additional month-end review procedures**[237](index=237&type=chunk)[241](index=241&type=chunk) - **Future remediation plans include hiring additional finance resources and strengthening internal processes and documentation**[238](index=238&type=chunk)[241](index=241&type=chunk) PART II - OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, other disclosures, and exhibits [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20LEGAL%20PROCEEDINGS) **The company is not aware of any material, existing, or pending legal proceedings against it** - **The company knows of no material, existing or pending legal proceedings against it**[245](index=245&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20RISK%20FACTORS) There have been **no material changes to the company's risk factors since its last Annual Report on Form 10-K** - **There have been no material changes in the company's assessment of risk factors since its last Annual Report**[246](index=246&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) **The company reported no unregistered sales of equity securities during the period** - **None**[247](index=247&type=chunk) [Item 5. Other Information](index=37&type=section&id=Item%205.%20OTHER%20INFORMATION) **The company reported no other information under this item for the period** - **None**[250](index=250&type=chunk) [Item 6. Exhibits](index=37&type=section&id=Item%206.%20EXHIBITS) This section lists the exhibits filed with the quarterly report, including CEO and CFO certifications and Inline XBRL documents - **Key exhibits filed include Certifications of the Chief Executive Officer and Chief Financial Officer pursuant to Rule 13a-14(a) and Section 906 of the Sarbanes-Oxley Act of 2002**[251](index=251&type=chunk)[252](index=252&type=chunk) [Signatures](index=38&type=section&id=SIGNATURES) This section contains the official signatures authorizing the report - **The report was duly signed and authorized by the Chief Financial Officer and Treasurer**[254](index=254&type=chunk)
Volition(VNRX) - 2023 Q2 - Earnings Call Transcript
2023-08-15 16:27
VolitionRx Limited (NYSE:VNRX) Q2 2023 Results Conference Call August 15, 2023 8:30 AM ET Company Participants Scott Powell - Executive Vice President of Investor Relations Cameron Reynolds - Founder, CEO, President and Director Terig Hughes - CFO & Treasurer Tom Butera - CEO, Volition Veterinary Diagnostics Development LLC Conference Call Participants Bruce Jackson - Benchmark Company Steven Ralston - Zacks Operator Good morning, ladies and gentlemen. Thank you for standing by. Welcome to VolitionRx Limite ...
Volition(VNRX) - 2023 Q2 - Quarterly Report
2023-08-14 20:31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36833 VOLITIONRX LIMITED (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) ...
VolitionRx (VNRX) Presents At Inaugural Global Conference - Slideshow
2023-05-18 14:49
Company Overview - Volition is a diagnostic company focused on epigenetic markers for human and veterinary use, targeting a total addressable market (TAM) of $70 billion[4, 50] - The company's Nu.Q® tests are simple, low-cost blood tests adaptable to various diagnostic workflows, supported by 96 granted and 120 pending patents[5] Veterinary Cancer Diagnostics - The Nu.Q® Vet Cancer Test targets an $11 billion TAM for canine and feline cancer screening and monitoring[10] - In the U.S., approximately 6 million dogs are diagnosed with cancer annually, and nearly 50% of dogs over 10 will develop cancer[9] - The Nu.Q® Vet Cancer Test has a specificity of 97% in detecting cancer in dogs, with detection rates of 82% for Hemangiosarcoma, 77% for Lymphoma, and 76% for Systemic Cancers[11] Sepsis Diagnostics - The Nu.Q® NETs assay is being developed for early detection and risk stratification of sepsis, a condition with an estimated economic burden of $62 billion annually in the U.S[27] - The annual total addressable market for Nu.Q® NETs in sepsis risk stratification and monitoring is estimated to be over $22 billion, with $14.8 billion for screening on admission to hospitals and $7.3 billion for monitoring disease in the Intensive Treatment Unit (ITU)[43] Commercial Strategy and Financials - Volition has signed a global supply agreement with IDEXX Laboratories Inc and an agreement of up to $28 million with Heska[45] - As of May 9, 2023, Volition's market capitalization was $123.1 million, with cash-on-hand of approximately $10 million as of March 31, 2023[51]