Volition(VNRX)
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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]
Volition(VNRX) - 2023 Q1 - Earnings Call Transcript
2023-05-11 17:29
Financial Data and Key Metrics Changes - The company ended Q1 2023 with cash and cash equivalents of approximately $10 million, down from $10.9 million at the end of 2022 [8] - Total operating expenses for Q1 2023 were $9.2 million, an increase from $7.8 million in Q1 2022, primarily due to increased R&D expenditures related to U.S. clinical trials [10] - Revenue for the Nu.Q Vet Cancer Test grew by 381% to $124,000, contributing to total revenue of approximately $150,000 in Q1 2023, compared to $114,000 in Q1 2022 [11] Business Line Data and Key Metrics Changes - The Nu.Q Vet Cancer Test is now available through IDEXX's reference lab network and Heska's Veterinary Diagnostics Laboratory, marking significant commercial progress [14][15] - The company is focusing on expanding the Nu.Q Vet product into the mainstream market, targeting approximately 84 million pet dogs in the U.S. [16] Market Data and Key Metrics Changes - IDEXX plans to roll out the Nu.Q Vet Cancer Test to Canada, the UK, EU, and Australia in the second half of 2023, with potential interest in Asia [41] - The SAGE partnership has facilitated access to the Asian market, with ongoing discussions with reference labs in Southeast Asia [42] Company Strategy and Development Direction - The company aims to make canine cancer screening and monitoring accessible worldwide, with a strong focus on the Nu.Q Vet and Nu.Q NETs products [20] - The company is also investing in the background of epigenetics and the development of its Nu.Q platform for human cancer diagnostics [33] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the positive reception of the Nu.Q Vet Cancer Test among veterinarians and the potential for significant revenue generation [27] - The company anticipates a gradual increase in orders for the Nu.Q Vet Cancer Test, although it may be somewhat lumpy due to the rollout schedule [28][29] Other Important Information - The company received approximately $8 million in net proceeds from a public offering in February 2023 and expects to receive an additional $13 million in milestone payments [9] - A peer-reviewed paper on the Nu.Q Vet Cancer Test was published, highlighting its utility in monitoring canine lymphoma, which could open new market opportunities [17][18] Q&A Session Summary Question: Insights into ordering patterns from vet labs - Management does not have formal data but reports positive feedback from partners regarding the utilization of the test across over 45 states [27] Question: Ordering trends and potential lumpiness - Management expects ordering trends to be somewhat lumpy as labs roll out the test at different times, with a gradual increase anticipated [28][29] Question: R&D expenditure increase - The increase in R&D expenses is primarily due to U.S. clinical trial activities focused on Nu.Q NETs, with expectations for Q2 expenditures to be lower than Q1 [31] Question: Update on Heska pre-sales - Management is unable to provide an update on Heska pre-sales at this time but anticipates being able to do so in the next quarter [36] Question: IDEXX commercialization plan outside the U.S. - IDEXX is targeting Canada, the UK, EU, and Australia for the Nu.Q Vet Cancer Test rollout, with potential interest in Japan [41] Question: Update on the SAGE partnership - The SAGE partnership has been beneficial, leading to significant interest and discussions with other reference labs in Asia [42] Question: Status of the Discover program - The Discover program is not a primary focus currently, but the company continues to pursue contracts and partnerships in this area [44]
Volition(VNRX) - 2023 Q1 - Quarterly Report
2023-05-10 20:22
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, 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 incorporat ...
VolitionRX (VNRX) Investor presentation - Slideshow
2023-03-29 15:45
© © Corporate Deck March 2023 Property of Volition 2023 Slide 1 Forward Looking Statements and Disclaimer Statements in this document may be "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as " ...