Core Insights - VolitionRx Limited has signed an agreement with a leading pharmaceutical company to utilize its Nu.Q® Discover biomarkers in a longitudinal Phase 1/2b study, marking a significant milestone for the company [1][3] - The study is expected to generate substantial revenue for Volition over a 12-18 month period, with further projects under discussion [2] Company Developments - The Nu.Q® Discover program offers advanced assays for rapid epigenetic profiling, aiding drug developers and scientists from discovery to market readiness [1][9] - The collaboration allows Volition to leverage its nucleosome expertise to enhance clinical research, potentially improving patient selection for treatment [5][6] Market Positioning - This partnership highlights the growing recognition of Volition's nucleosome-based biomarkers in clinical development, aligning with the company's long-term goal of enabling precision therapy [4][7] - The application of Nu.Q® Discover in clinical trials positions Volition to expand its role in precision medicine and targeted therapeutic approaches [8]

Core Points - VolitionRx Limited will participate in the 97th Annual Western Veterinary Conference (WVC) from March 2-5, 2025, in Las Vegas, NV, attracting approximately 20,000 veterinary professionals [1][5] - The company will showcase its Nu.Q® Vet Cancer Test, which aids in the detection of seven common cancers in dogs, emphasizing its accessibility, affordability, and ease of use [3][4] - Volition's strategic commercialization efforts in North America aim to expand awareness and education regarding the Nu.Q® Vet Cancer Test [3] Event Details - Presentation 1: "Detect, Treat, Monitor: Navigating the Canine Cancer Journey with Nu.Q® Vet Cancer Test" by Dr. Sue Ettinger on March 3, 2025, from 2:00 PM to 2:50 PM [4] - Presentation 2: "Utilizing the Nu.Q® Vet Cancer Test in Practice" by Dr. Brett Cordes on March 4, 2025, from 10:30 AM to 11:00 AM [4] - Presentation 3: "The Nu.Q® Vet Cancer Test - Early Detection with Canine Cancer Screening" by Dr. Tom Butera on March 5, 2025, from 12:10 PM to 1:00 PM [4] Company Overview - Volition is a multi-national epigenetics company focused on advancing the science of epigenetics and improving outcomes for people and animals with life-altering diseases through earlier detection and monitoring [5][6] - The company is developing cost-effective blood tests to diagnose and monitor various diseases, including cancers and conditions associated with NETosis, such as sepsis [6][7] - Volition's research and development activities are centered in Belgium, with additional facilities in the U.S. and London [7]

Core Insights - VolitionRx Limited has announced its first commercial sale of a High Throughput Synthetic Sepsis method that measures Neutrophil Extracellular Traps (NETs) activation and inhibition in real time, aiding in the development of new therapeutics for sepsis and related diseases [1][4] Company Overview - Volition is a multi-national epigenetics company focused on advancing the science of epigenetics and dedicated to improving outcomes for people and animals with life-altering diseases through earlier detection and monitoring [8][9] Technology and Innovation - The High Throughput NETs model represents a significant breakthrough in understanding neutrophil biology, allowing for more precise measurement of NETs formation in whole blood, which is crucial for therapeutic interventions [2][3] - The innovative approach addresses technical limitations in previous research by measuring NETs directly in whole blood, avoiding alterations in neutrophil responses caused by isolation procedures [3][7] Market Relevance - Sepsis, characterized by a dysregulated host response to infection, results in approximately 370,000 deaths annually in the U.S., highlighting the urgent need for effective diagnostic and therapeutic solutions [4][5] - The understanding of NETs has become increasingly relevant in disease contexts, with overproduction leading to tissue damage and disease progression during inflammatory responses [5][6] Research and Development - Volition is developing cost-effective blood tests aimed at diagnosing and monitoring a range of diseases, including cancers and conditions associated with NETosis, which could significantly improve patient outcomes [6][9]

Core Insights - VolitionRx Limited will host a virtual investor event on February 14, 2025, featuring key management personnel [1] - The event will focus on the Nu.Q® NETs H3.1 biomarker, which shows promise for early detection of mortality and organ dysfunction in sepsis [2] - An update on commercialization efforts through licensing and sales will be provided by the Chief Commercial Officer [3] Company Overview - Volition is a multi-national company dedicated to advancing epigenetics and improving outcomes for patients with life-altering diseases through early detection [7] - The company is developing cost-effective blood tests for diagnosing and monitoring various diseases, including cancers and sepsis-related conditions [8] - Research and development activities are primarily based in Belgium, with additional facilities in the U.S. and London [8] Key Personnel - Dr. Andrew Retter, Chief Medical Officer, has extensive experience in critical care and has published over 50 articles in peer-reviewed journals [4] - Gael Forterre, Chief Commercial Officer, has a strong background in commercialization and investment, previously serving as CEO of Pathify [5][6]

Core Insights - VolitionRx Limited announced that its Nu.Q® NETs H3.1 biomarker is an independent predictor of 28-day mortality and the need for renal replacement therapy in sepsis and septic shock patients [1][2] Group 1: Study Findings - The study indicates that Nu.Q® NETs H3.1 shows significantly higher levels in septic shock patients compared to those with sepsis, establishing a clear dose-response relationship with acute kidney injury severity [2][3] - The research involved a secondary analysis of plasma samples from 971 patients with sepsis and septic shock, part of the SISPCT trial [3] Group 2: Clinical Implications - The findings suggest that Nu.Q® NETs H3.1 could enhance risk stratification and early intervention in critically ill patients, potentially improving patient outcomes [2][4] - The ability to predict a sepsis patient's clinical course early using Nu.Q® NETs could significantly improve sepsis management [4] Group 3: Company Developments - Volition is engaged in commercial discussions with major players in the diagnostic space, leveraging the study's findings to support ongoing licensing processes [5] - The company is focused on developing cost-effective blood tests for diagnosing and monitoring various diseases, including sepsis [7]

Core Insights - VolitionRx Limited is positioned to revolutionize the diagnosis and monitoring of life-altering diseases for both animals and humans as it enters 2025 [1] Achievements in 2024 - Expanded access to the Nu.Q® Vet Cancer Test, now available in 20 countries, with over 110,000 tests sold in the first three quarters of 2024 [7] - Hosted a Satellite Symposium at the European Society of Intensive Care Medicine 2024, showcasing the clinical utility of Nu.Q® NETs in over 3,000 intensive care sepsis patients [7] - Strengthened the strategic patent portfolio and made significant progress in clinical and research programs within the cancer pillar [7] - Initiated commercial discussions for out-licensing opportunities in large markets such as sepsis and oncology liquid biopsy [7] - Appointed Timothy Still as Chair and Dr. Ethel Rubin as Independent Director to enhance the Board of Directors with significant commercial and financing experience in the diagnostic sector [7] Research and Development Focus - Volition is dedicated to developing cost-effective blood tests for diagnosing and monitoring diseases, including cancers and conditions associated with NETosis, such as sepsis [4] - The company's research and development activities are primarily based in Belgium, with additional offices in the U.S., London, and Singapore [5]

Core Insights - VolitionRx Limited is participating in the 14th Annual LifeSci Partners Corporate Access Event on January 15, 2025, in San Francisco, coinciding with the J.P. Morgan Health Care Conference [1][3] - The company has engaged LifeSci Advisors, LLC to enhance investor relations and awareness, particularly focusing on institutional money managers and family funds in the life sciences sector [1][3][4] - In 2024, Volition has achieved significant milestones, including the launch of the Nu.Q® Vet Cancer Test in the U.S. and Europe [2][3] Company Overview - Volition is a multinational company dedicated to advancing epigenetics, aiming to improve outcomes for patients and animals through early disease detection and monitoring [5][6] - The company is developing cost-effective blood tests for diagnosing and monitoring various diseases, including cancers and conditions related to NETosis, such as sepsis [6] Strategic Focus - Volition's research and development activities are primarily based in Belgium, with additional offices in the U.S., London, and Singapore [7] - The company is focused on creating financial and operational milestones in the human health space for cancer and sepsis in 2025 [3]

Financial Data and Key Metrics - Revenue for the first nine months of 2024 reached $1 million, a 96% increase compared to the same period in 2023 [34] - Q3 2024 revenue grew by 187% year-on-year, reaching $475,000, driven by Nu Q Vet cancer test sales [34] - Nu Q Vet cancer test sales grew by 100% year-to-date and 307% in Q3 2024 compared to 2023 [34] - Over 110,000 Nu Q Vet cancer tests were sold in the first three quarters of 2024, nearly double the total sold in 2023 [8][34] - Operating expenses decreased by 28% in Q3 2024 compared to the same quarter in 2023 [35] - Cash used in operating activities was $5 4 million in Q3 2024, down 36% year-on-year [35] - Cash and cash equivalents at the end of Q3 2024 totaled approximately $5 4 million [36] Business Line Data and Key Metrics - Nu Q Vet cancer test is now available in 17 countries, with revenue growth accelerating quarter-on-quarter [10] - Year-to-date revenue growth for Nu Q Vet is 100%, with Q3 revenue up 307% compared to 2023 [10] - Revenue from veterinary kits and key components reached approximately $730,000 year-to-date [10] - Fujifilm Vet Systems achieved nearly 10% market penetration among veterinarians in Japan within a quarter of launching Nu Q Vet [11] - VetLab Poland and Heska (under Antech) have also made significant progress in distributing Nu Q Vet in their respective markets [12][13] Market Data and Key Metrics - Nu Q Vet is now available in 15 countries through Antech's distribution channels [13] - Japan represents a significant market for Nu Q Vet, with Fujifilm Vet Systems achieving rapid market penetration [11][45] - The U S market for Nu Q Vet is estimated at 25 million dogs, with a global opportunity of a similar size [48] Company Strategy and Industry Competition - The company aims to be cash-neutral by 2025, with significant progress made toward this goal through revenue growth and cost reduction [33][37] - The focus is on securing licensing deals in the human clinical space, with strong interest from key industry players in sepsis and oncology liquid biopsy [38][39] - The company is leveraging its success in veterinary diagnostics to commercialize human-focused technologies, including Nu Q NETs and Nu Q Cancer [40][41] - Non-dilutive funding from the Walloon Region, Belgium, and anticipated future funding support the company's financial strategy [36][37] Management Commentary on Operating Environment and Future Outlook - Management highlighted the strong progress in revenue growth and cost reduction, positioning the company well for cash neutrality in 2025 [33][37] - The company is optimistic about the potential for licensing deals in the human space, which could provide significant milestone payments and ongoing revenue [40][51] - The Nu Q NETs test for sepsis has generated significant interest, with potential to be a game-changer in sepsis management [28][31] - The company is exploring opportunities to include Nu Q Cancer tests in national lung cancer screening programs, particularly in Taiwan and other Asian markets [21][51] Other Important Information - The company welcomed new board members, Timothy Still and Dr Ethel Rubin, who bring extensive experience in the diagnostics sector [42] - The company is actively publishing scientific papers and presenting at conferences to strengthen its data room and support licensing discussions [30][31] - The feline testing milestone for Nu Q Vet is still in progress, with ongoing optimization for lower nucleosome levels in cats [78][80] Q&A Session Summary Question: Market dynamics and penetration in Japan - Fujifilm Vet Systems has achieved nearly 10% penetration among veterinarians in Japan, with strong marketing and distribution efforts [44][45] - Japan is a significant market, comparable to a large U S state like California, with high spending on pet care [45] Question: Revenue guidance and growth potential - Revenue growth is strong but can be lumpy due to the nature of distributor stocking and sell-through [47][63] - The company expects to ramp up to millions of tests annually, with a target market of 25 million dogs in the U S and a similar opportunity globally [48][49] Question: Cash neutrality and business segment self-sufficiency - The goal is for each business pillar to support itself through revenue and licensing deals, with significant progress made toward cash neutrality [54][55] - Licensing deals in the human space are expected to contribute to cash flow neutrality in 2025 [55][56] Question: Cost reduction progress - Operating expenses have been reduced by 28% in Q3 2024, with further reductions expected [57][58] - Approximately half of the $10 million cost-cutting program has been implemented, with full savings expected in 2025 [68][69] Question: Feline testing progress - Feline testing is still in development, with optimization for lower nucleosome levels in cats nearing completion [78][80] - Clinical utility studies for feline testing are expected to follow once the technical challenges are resolved [80] Question: Data rooms and licensing discussions - The company is using ShareVault to track data room activity, with significant interest from large diagnostic and oncology players [72][74] - Licensing discussions are progressing well, with potential for milestone payments and ongoing revenue from human-focused deals [74][75] Question: Upcoming data publications and presentations - Two large publications on sepsis are expected to be submitted by the end of Q4 2024 and early Q1 2025 [83] - Additional papers on oncology, particularly lung cancer, are also in progress [85]

Financial Performance - Total revenues for Q3 2024 reached $474.5 million, a significant increase of 187% compared to $165.2 million in Q3 2023[17]. - Product revenues surged to $406.1 million in Q3 2024, up 218% from $127.5 million in Q3 2023[17]. - For the nine months ended September 30, 2024, total revenues increased to $1,041,854, a 96% increase from $531,329 for the same period in 2023[149]. - Total revenues for the three months ended September 30, 2024, were $474,522, a significant increase of over 100% compared to $165,211 for the same period in 2023, primarily driven by sales of the Nu.Q® Vet Cancer Test[136]. Losses and Deficits - The accumulated deficit increased to $(223,750,970) from $(202,576,507), reflecting a worsening of approximately 10.4%[16]. - Net loss attributable to VolitionRx Limited stockholders was $(5.82) million in Q3 2024, compared to $(8.37) million in Q3 2023, showing a reduction in losses[17]. - The net loss for the nine months ended September 30, 2024, was approximately $21.4 million, compared to a net loss of $26.9 million for the same period in 2023, reflecting a 20% improvement[157]. - The company has not attained profitable operations and is dependent on obtaining external financing to continue its operational and strategic plans[158]. Cash and Assets - As of September 30, 2024, total current assets decreased to $6,800,941 from $21,854,095 as of December 31, 2023, representing a decline of approximately 68.9%[16]. - Cash and cash equivalents significantly dropped to $5,414,146 from $20,729,983, a decrease of about 73.9%[16]. - The total assets decreased to $12,680,255 from $27,950,498, a decline of approximately 54.5%[16]. - As of September 30, 2024, the company had cash and cash equivalents of $5.4 million, a decrease from $10.8 million at the end of the previous period[23]. Expenses and Cost Management - Operating loss decreased to $(5.87) million in Q3 2024, compared to $(8.65) million in Q3 2023, reflecting improved operational efficiency[17]. - Research and development expenses were $3.47 million in Q3 2024, down from $4.65 million in Q3 2023, indicating a focus on cost management[17]. - Total operating expenses decreased to $6.34 million in Q3 2024 from $8.82 million in Q3 2023, highlighting effective cost control measures[17]. - The company recognized depreciation expenses of $815,824 and $792,232 for the nine-month periods ended September 30, 2024, and September 30, 2023, respectively, reflecting a year-over-year increase of approximately 3.9%[12]. Financing and Capital Structure - The company plans to address its financial challenges by obtaining additional financing through debt or equity transactions and securing grant funds[41]. - The company generated net proceeds from issuances of common stock totaling $6.6 million during the nine months ended September 30, 2024, compared to $25.8 million in the same period of 2023[23]. - The company raised net proceeds of $6.4 million from the 2024 Equity Capital Raise, which included the issuance of 9,170,000 shares of common stock and various warrants[58]. - The company may seek additional capital through the sale of debt or equity securities, which could dilute existing stockholders' ownership[160]. Stock and Warrants - The total number of outstanding Series A and Series B common stock warrants is 25,836,364 with a weighted average exercise price of $0.57[66]. - The total intrinsic value of warrants outstanding as of September 30, 2024, is $nil, indicating no current value for the warrants[72]. - Stock-based compensation expense related to warrants was $25,447 for the nine months ended September 30, 2023, compared to $5,238 for the same period in 2024, reflecting a decrease[72]. - The total number of options outstanding as of September 30, 2024, is 4,662,748, with a weighted average exercise price of $3.88[72]. Research and Development - The company has patented technologies that utilize nucleosomes and transcription factors as biomarkers for early disease detection, focusing on various life-altering diseases[118]. - The company offers a range of tests, including Nu.Q® Vet for cancer screening in dogs, and Nu.Q® Cancer for monitoring disease progression and treatment response[119]. - Research and development expenses decreased to $3.5 million for the three months ended September 30, 2024, down 25% from $4.7 million in the same period in 2023, due to reduced clinical trial activity and lower personnel expenses[138]. - Research and development expenses decreased by 21% to $11,819,106 from $15,007,623 for the nine months ended September 30, 2023[150]. Future Outlook - The company expects to rely on future financing through licensing, distribution rights, and equity or debt securities to fund its strategic plan, as it has not attained profitable operations[132]. - The Company has implemented short-term cash preservation and cost-saving initiatives to mitigate substantial doubt about its ability to continue as a going concern[43]. - The company has not generated significant revenues and expects to incur further losses in the future, particularly from the development of clinical-stage diagnostic tests[41].

Core Insights - VolitionRx Limited reported significant growth in revenue and product sales for the third quarter of 2024, highlighting the success of its Nu.Q® Vet Cancer Tests and advancements in human diagnostic tests [2][4][3] Financial Performance - Year-to-date revenue reached $1 million in 2024, representing a 96% increase compared to the previous year [4] - Third-quarter revenue was $475,000, up 187% year-over-year [4] - Nu.Q® Vet revenue doubled year-to-date and surged 307% in the third quarter compared to the same periods in 2023 [4] - Operating cash usage decreased by 36% year-over-year to $5.4 million in the third quarter [4] - Cash and cash equivalents as of September 30, 2024, totaled approximately $5.4 million [4] - The company received a commitment of over $2.2 million in non-dilutive funding from Belgian agencies, with more expected in Q1 2025 [4] Product and Market Developments - Over 110,000 Nu.Q® Vet Cancer Tests were sold in the first three quarters of 2024, expanding access to 17 countries [2][3] - Positive data from studies involving over 3,000 sepsis patients were showcased at a major intensive care conference, indicating the potential of Nu.Q® NETs in sepsis management [3][2] - The company is focused on securing its first licensing deal in the human clinical space, with ongoing discussions with key industry players [3] Corporate Governance - The Board of Directors was strengthened with the appointment of Timothy Still as Chair and Dr. Ethel Rubin as Independent Director, both bringing extensive experience in the diagnostic sector [2]