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VolitionRx Limited Announces the First Sale of the Nu.Q® Cancer Assays for Clinical Certification in Preparation for Routine Clinical Use
Prnewswire· 2025-11-25 13:45
Accessibility StatementSkip Navigation HENDERSON, Nev., Nov. 25, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, today announces the first sale of its Nu.Q® Cancer assays to one of Europe's leading cancer centers, the Hospices Civils de Lyon, in Lyon, France. "Nu.Q® Cancer represents a significant advancement in lung cancer patient management, offering clinicians an additional tool to enhance precision in treatment selection and monitoring." ...
Resverlogix Appoints Bradley Glass to Board of Directors
Newsfile· 2025-11-18 22:15
Resverlogix Appoints Bradley Glass to Board of DirectorsNovember 18, 2025 5:15 PM EST | Source: Resverlogix Corp.Calgary, Alberta--(Newsfile Corp. - November 18, 2025) - Resverlogix Corp. (TSX: RVX) ("Resverlogix", or the "Company") today announces the appointment of Mr. Bradley Glass, J.D. as a member of the Company's board of directors.Mr. Glass has served as the General Counsel of Hepalink USA, Inc. and its subsidiaries ("Hepalink") for the past four years. In that role, Mr. Glass is respon ...
Volition(VNRX) - 2025 Q3 - Earnings Call Transcript
2025-11-14 14:30
Financial Data and Key Metrics Changes - Revenue for Q3 2025 grew 32% year-over-year, reaching $0.6 million [20] - Operating expenses decreased by 10% year-over-year, and net cash used in operating activities was down 33% compared to the prior year [20][21] - Net loss improved by 8% for the quarter and down 20% for the first three quarters compared to the prior year [20][21] Business Line Data and Key Metrics Changes - The company signed two significant agreements: one with Werfen for anti-phospholipid syndrome (APS) and another with Hologic for co-marketing the Nu.Q Discover service [4][8] - The Nu.Q NETs assay is being validated by Werfen for clinical utility in APS patients, with early results showing promise [5][6] - Hologic has already made its first sale of the Nu.Q Discover service, indicating strong initial traction [34] Market Data and Key Metrics Changes - The total addressable market (TAM) for APS is estimated at approximately $85 million annually, which is a strategic entry point for the company's NETs platform [8][27] - The combined TAM for cancer and sepsis diagnostics is approximately $25 billion annually, presenting substantial revenue opportunities [25] Company Strategy and Development Direction - The company aims to achieve cash neutrality by aligning income with expenditures through licensing agreements and milestone payments [21][24] - There is a focus on expanding the Nu.Q VET cancer test globally, with centralized lab automation being a key priority to accelerate revenue growth [22][23] - The company is actively pursuing additional licensing agreements in the human diagnostic space, mirroring its successful strategy in the veterinary market [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the partnerships with Werfen and Hologic, viewing them as transformative for future growth [34][36] - The company anticipates significant progress in clinical utility studies and expects to see more licensing deals in the near future [11][39] - Management acknowledged the challenges of the current market but emphasized the importance of delivering on commercialization plans [81][83] Other Important Information - The company is in discussions with around 10 leading diagnostic and liquid biopsy companies for potential partnerships [10] - The CAPTCHA-seq technology is expected to revolutionize liquid biopsy methods, with promising early results in cancer detection [12][16] Q&A Session Summary Question: Size of the anti-phospholipid syndrome market - The TAM for APS is estimated at $85-$90 million annually, which is a good starting point for the company's NETs platform [27][28] Question: Contribution of the Werfen partnership to Q3 revenue - The Werfen partnership has not yet contributed to revenue as they are still validating the assay on clinical samples [32] Question: Expectations for additional partnerships in 2026 - Management expects to close several additional partnerships in 2026, although the timing is uncertain [37][39] Question: Breakdown of product revenues - Product revenues are still lumpy, with significant contributions from both the Nu.Q VET tests and the Discover kits [45] Question: Conditions for milestone payments related to feline cancer testing - Milestone payments are contingent upon the publication of a paper, which is currently in progress [66][72]
VolitionRx Limited Announces Third Quarter 2025 Financial Results and Business Update
Prnewswire· 2025-11-13 21:10
Accessibility StatementSkip Navigation Conference call to discuss financial and operational results scheduled for Friday, November 14 at 8:30 a.m. U.S. Eastern Time HENDERSON, Nevada, Nov. 13, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, today announces financial results and a business update for the third quarter ended September 30, 2025. Volition management will host a conference call tomorrow, November 14 at 8:30 a.m. U.S. Eastern Time ...
VolitionRx Limited Schedules Third Quarter 2025 Earnings Conference Call and Business Update
Prnewswire· 2025-11-10 13:45
Core Points - VolitionRx Limited will host a conference call on November 14, 2025, at 8:30 a.m. U.S. Eastern Time to discuss its third-quarter financial and operating results and provide a business update [1][2] - The call will be hosted by key executives including the Group Chief Marketing & Communications Officer, the President and Group CEO, the Group CFO, and the Chief Scientific Officer [2] - A live audio webcast of the conference call will be available, and a telephone replay will be accessible until November 28, 2025 [3] Company Overview - Volition is a multi-national company focused on advancing the science of epigenetics, aiming to save lives and improve outcomes for individuals and animals with life-altering diseases through earlier detection and monitoring [4] - The company is developing and commercializing cost-effective blood tests for the detection and monitoring of various diseases, including certain cancers and conditions associated with NETosis, such as sepsis [5] - Volition's research and development activities are primarily based in Belgium, with additional facilities in the U.S. and London [6]
ORYZON Reports Financial Results and Corporate Update for Quarter Ended September 30, 2025
Globenewswire· 2025-11-07 13:00
Core Insights - Oryzon Genomics reported a significant financial turnaround, securing over $60 million in the first half of 2025, enabling a renewed focus on CNS clinical programs, particularly in Borderline Personality Disorder (BPD), schizophrenia, and Autism Spectrum Disorder (ASD) [3][4][8] - The company is advancing its clinical pipeline with promising data from its oncology asset iadademstat, showing a 100% overall response rate in a Phase I trial for acute myeloid leukemia (AML) [7][11] - Oryzon is enhancing its clinical and regulatory teams by incorporating experienced professionals to strengthen its late-stage pipeline and improve interactions with regulatory bodies [6][8] Financial Performance - For the nine months ended September 30, 2025, research and development expenses were $9.6 million, up from $7.1 million in the same period of 2024, while general and administrative expenses increased to $3.9 million from $3.1 million [12][13] - The net loss for the quarter was $1.2 million, compared to a loss of $1.1 million in the same quarter of 2024, reflecting the typical financial profile of a biotechnology company in the development phase [13][14] - Cash, cash equivalents, and marketable securities totaled $40.4 million as of September 30, 2025, a significant increase from $8.4 million in the previous year [14][16] Clinical Developments - The company is preparing to resubmit the revised Phase III protocol for vafidemstat in BPD following FDA feedback, which included guidance on study endpoints and non-clinical considerations [4][5] - Oryzon is expanding its clinical trials for vafidemstat in schizophrenia to additional EU countries and is preparing a new Phase II trial for aggression in ASD [5][8] - The iadademstat combination therapy has shown promising results in ongoing trials for various hematologic malignancies, with additional studies planned for sickle cell disease and essential thrombocythemia [11][22] Strategic Partnerships and Collaborations - Oryzon is exploring potential partnerships for its oncology asset iadademstat to enhance its value and ensure the drug reaches patients [3][8] - The company is collaborating with the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) to further develop iadademstat in different cancer types [11][21] Patent Portfolio - Oryzon has strengthened its patent portfolio for both vafidemstat and iadademstat, with new patents granted or allowed in multiple jurisdictions, ensuring protection for their innovative therapies until at least 2038 and 2040, respectively [8][11][22]
ORYZON Announces Positive Clinical Data of Iadademstat at ASH-2025
Globenewswire· 2025-11-04 13:00
Core Insights - Oryzon Genomics announced that three abstracts featuring iadademstat, a selective LSD1 inhibitor, have been accepted for presentation at the 67th American Society of Hematology Annual Meeting, highlighting its potential in treating acute myeloid leukemia (AML) and myeloproliferative neoplasms (MPNs) [1][2][4] Company Developments - The accepted abstracts showcase promising clinical activity and safety data from ongoing studies of iadademstat in combination with gilteritinib and venetoclax-azacitidine for AML patients [2][3] - Dr. Ana Limón emphasized that the addition of iadademstat enhances efficacy without increasing toxicity, particularly in the FLT3+ relapsed/refractory population, where 42% of patients had previously been treated with venetoclax [3][4] - Dr. Carlos Buesa expressed satisfaction with the selection of iadademstat abstracts for ASH 2025, underscoring its potential as a versatile epigenetic modulator in AML [4] Clinical Study Highlights - The FRIDA study (NCT05546580) is evaluating the safety and tolerability of iadademstat combined with gilteritinib in FLT3-mutated relapsed/refractory AML, with 34 patients enrolled and a 67% response rate reported [5][6] - A Phase Ib trial combining iadademstat with azacitidine and venetoclax in newly diagnosed, unfit AML patients showed a 100% overall response rate and 88% complete remission [7][8] - A Trial-in-progress abstract details a new randomized study of iadademstat in combination with ASTX727 for advanced MPNs, addressing the critical need for new treatments in this area [8][10] Future Directions - Oryzon is expanding the clinical development of iadademstat into non-oncological hematology indications, including trials for sickle cell disease and essential thrombocythemia [13] - The company is also exploring the use of iadademstat in solid tumors, indicating a broadening of its therapeutic applications [13]
ORYZON Announces First‑Patient‑In (FPI) in RESTORE Phase Ib Trial of Iadademstat in Sickle Cell Disease
Globenewswire· 2025-11-03 13:00
Recently approved by the European Medicines Agency, RESTORE will evaluate iadademstat’s ability to raise fetal hemoglobin (HbF) in adult patients with SCDIadademstat has demonstrated a favorable safety and tolerability profile across ~200 patients in prior oncology clinical trials MADRID and CAMBRIDGE, Mass., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, Ticker: ORY), a clinical‑stage biopharmaceutical company and global leader in epigenetics, today announced that the fir ...
ORYZON to Participate in Upcoming Events in November
Globenewswire· 2025-10-30 12:00
Core Insights - Oryzon Genomics, a clinical-stage biopharmaceutical company, is a leader in epigenetics and focuses on personalized medicine for CNS disorders and oncology [3]. Upcoming Events - Oryzon management will participate in BIO-EUROPE from November 3-5 in Vienna, Austria, and the LSX Investival Showcase Europe 2025 on November 17 in London, UK [1][2]. - One-on-one meetings will be available during these conferences [2]. Company Overview - Founded in 2000 in Barcelona, Spain, Oryzon specializes in epigenetics and has a clinical portfolio that includes two LSD1 inhibitors: vafidemstat (Phase III-ready for CNS) and iadademstat (Phase II for oncology) [3]. - The company is also developing ORY-4001, targeting HDAC-6 for potential applications in CMT and ALS [3]. - Oryzon has a robust platform for biomarker identification and target validation across various malignant and neurological diseases [3].
ORYZON Strengthens Regulatory Strategy with the Appointment of Dr. Iman Barilero as Senior Advisor for Regulatory Affairs
Globenewswire· 2025-10-28 12:00
Core Insights - Oryzon Genomics has announced a strategic collaboration with Dr. Iman Barilero as Senior Advisor for Regulatory Affairs to advance its Phase III clinical program for vafidemstat in Borderline Personality Disorder (BPD) [1][4] Company Overview - Oryzon Genomics is a clinical-stage biopharmaceutical company founded in 2000 in Barcelona, Spain, and is a leader in epigenetics, focusing on personalized medicine for CNS disorders and oncology [5] - The company has a clinical portfolio that includes two LSD1 inhibitors: vafidemstat (Phase III-ready) and iadademstat (Phase II) [5] Regulatory Expertise - Dr. Iman Barilero brings over 30 years of global regulatory leadership experience, particularly in CNS, neuropsychiatry, and rare diseases, with a successful track record in guiding Phase II-III programs and securing global approvals [2][3] - Her previous role as Vice President at Lundbeck involved leading global regulatory strategies for breakthrough therapies targeting various CNS disorders [3] Clinical Development - Vafidemstat is currently being evaluated in a double-blind, randomized, placebo-controlled Phase IIb trial (EVOLUTION) for its potential to improve negative symptoms in schizophrenia [4][8] - The company is also preparing a clinical trial for vafidemstat in Autism Spectrum Disorder (ASD) and has conducted several Phase IIa trials with positive results in psychiatric disorders [8] Strategic Goals - The collaboration with Dr. Barilero aims to enhance regulatory dialogue with the FDA and provide strategic guidance across clinical development programs [7] - Oryzon's pipeline includes programs targeting schizophrenia and ASD, with a focus on advancing its late-stage pipeline in BPD and schizophrenia [4][8]