Latest news with #varoglutamstat
Yahoo
18-06-2025
- Business
- Yahoo
Vivoryon Therapeutics NV (FRA:05Y) Q1 2025 Earnings Call Highlights: Significant Reduction in ...
Research and Development Expenses: EUR1.2 million in Q1 2025, down from EUR7.4 million in Q1 2024. General and Administrative Expenses: EUR1.3 million in Q1 2025, compared to EUR2.1 million in Q1 2024. Net Loss: EUR2.4 million in Q1 2025, compared to EUR9.1 million in Q1 2024. Cash and Cash Equivalents: EUR7 million as of March 31, 2025, down from EUR9.4 million as of December 31, 2024. Warning! GuruFocus has detected 3 Warning Signs with FRA:05Y. Release Date: June 17, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Vivoryon Therapeutics NV (FRA:05Y) reported statistically significant and clinically meaningful improvements in kidney function with varoglutamstat in Phase 2 studies. The company has strengthened its intellectual property position with recent patent filings, including a new US composition of matter patent for varoglutamstat, supporting market exclusivity through 2044. Varoglutamstat has shown synergistic effects when combined with standard of care therapies in preclinical studies, enhancing its potential positioning in the market. The company has a clear development pathway for varoglutamstat, with plans to initiate a Phase 2b study in diabetic kidney disease. Vivoryon Therapeutics NV (FRA:05Y) has reduced its net loss significantly from EUR9.1 million in Q1 2024 to EUR2.4 million in Q1 2025, indicating improved financial management. The primary endpoint of cognition in the Phase 2 studies failed, which could impact the perception of varoglutamstat's overall efficacy. Vivoryon Therapeutics NV (FRA:05Y) reported a decrease in cash and cash equivalents from EUR9.4 million at the end of 2024 to EUR7 million as of March 31, 2025, which may affect future operations. The company is actively pursuing additional financing and partnership opportunities, indicating potential financial constraints. There is a significant unmet need for effective treatments for kidney diseases, and current therapies can only slow disease progression, highlighting the competitive and challenging market landscape. The company needs to ensure successful execution of its development plan, including the Phase 2b study, to maintain momentum and investor confidence. Q: What steps can Vivoryon Therapeutics take with its current cash position to prepare for the planned Phase 2b trial in diabetic kidney disease (DKD), and what are the optimal funding solutions for this trial? A: Frank Weber, CEO, explained that the company is in advanced protocol design discussions with CROs and experts, focusing on understanding the full development path through Phase 3. They are also considering study medication and financial aspects to prepare for the trial. Regarding funding, they are exploring partnership opportunities and other financing options to support the trial. Q: How are partnership discussions progressing, and are they reaching a more advanced state? A: Frank Weber, CEO, stated that Vivoryon is in ongoing conversations with interested pharma companies. They are assessing whether a partnership would be in the best interest of the company and its shareholders, given the unique data they have. Q: What proportion of patients in the US and Europe are currently receiving SGLT-2 inhibitors for DKD? A: Frank Weber, CEO, noted that SGLT-2 inhibitors are recommended in guidelines and are gaining traction, with approximately 30% to 35% of the potential population currently receiving them. The market penetration is increasing, although diagnosing patients in early stages remains a challenge. Q: Were there any key takeaways from the recent ERA Congress that could be incorporated into the Phase 2b trial design? A: Frank Weber, CEO, mentioned that the ERA Congress provided supportive feedback and insights into trial design. They are considering including patients with high proteinuria in Stage 3a, as these patients have a high risk of progression. Overall, the trial design is largely confirmed, with some adjustments to exclusion criteria. Q: What are the financial highlights for Vivoryon Therapeutics in the first quarter of 2025? A: Anne Doering, CFO, reported a net loss of EUR 2.4 million for Q1 2025, compared to EUR 9.1 million in Q1 2024. The company held EUR 7 million in cash as of March 31, 2025. The decrease in expenses was due to lower clinical and manufacturing costs following the ramp-down of previous studies. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
17-06-2025
- Business
- Yahoo
Vivoryon Therapeutics N.V. Q1 2025 Financial Results and Operational Progress
Vivoryon Therapeutics N.V. Q1 2025 Financial Results and Operational Progress Continued progress in advancing varoglutamstat in kidney disease based on encouraging data and expansion of IP portfolio Varoglutamstat's pre-clinical dataset showing synergistic effect in combination with an SGLT-2 inhibitor in different treatment regimens Novel composition of matter patent for varoglutamstat granted after accelerated review in the U.S.; patent term to provide exclusivity through 2044 with subsequent opportunity for patent term extension Varoglutamstat meta-analysis data presented in oral presentation at ERA 2025 Preparations ongoing for Phase 2b of varoglutamstat in diabetic kidney disease (DKD) Management to host a conference call today at 3:00 pm CEST (9:00 am EDT) Halle (Saale) / Munich, Germany, June 17, 2025 – Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, today announced financial results for the three-month period ended March 31, 2025, and provided an update on its corporate progress. 'We have started the year 2025 focused on rounding out the evidence to support the success of varoglutamstat in kidney disease,' said Frank Weber, MD, CEO of Vivoryon. 'Building on solid Phase 2 clinical evidence of varoglutamstat's beneficial impact on eGFR, we have developed a viable clinical development strategy, with a planned Phase 2b study in diabetic kidney disease as a first step. Beyond varoglutamstat as single agent, our clinical program also includes investigation of varoglutamstat in combination with SGLT-2 inhibitors for which we have generated very promising preclinical data. On the IP side, we have been able to significantly extend protection of our key asset varoglutamstat with a new composition of matter patent in the U.S. With the groundbreaking clinical data demonstrating varoglutamstat's unique impact on kidney function, a deeper understanding of its MOA in inflammation and fibrosis, and a strengthened IP portfolio, we believe we are well on track to deliver a novel therapy that addresses a significant unmet medical need for patients suffering from kidney disease. In particular, we strive to change the likely trajectory toward kidney failure for patients with advanced DKD, who currently have little to no treatment options to halt progression of kidney failure or improve kidney function.' Q1 2025 and Post-Period Updates Varoglutamstat Clinical Program Meta-analysis of VIVIAD and VIVA-MIND study data On January 14, 2025, the Company disclosed a meta-analysis of VIVIAD and VIVA-MIND data which confirmed that treatment with varoglutamstat at 600mg twice daily significantly improved eGFR kidney function in the overall study population. Statistically significant differences between varoglutamstat and placebo were first observed at week 24 and were sustained until week 96. The meta-analysis also confirmed a substantially larger effect size in study participants with diabetes compared to those without diabetes. Data for varoglutamstat were presented at the 62nd ERA Congress of the European Renal Association in Vienna, Austria, June 6, 2025, showing consistent improvement in both trials independently, replicated in the meta-analysis and pooled analysis, thus providing converging evidence for the findings. Synergistic effect of combination treatment with varoglutamstat and SGLT-2 inhibitors in pre-clinical animal model On April 29, 2025, Vivoryon disclosed preclinical data from a series of experiments in a chronic kidney disease animal model, analyzing different treatment regimens of varoglutamstat in combination with standard of care for kidney disease, the SGLT-2 inhibitor dapagliflozin. Data analysis revealed a synergistic in vivo effect for the combination treatment of dapagliflozin and varoglutamstat over a broad panel of markers, nearly normalizing pathology vs. control across the three key areas of inflammation, fibrosis and kidney function. Substantially de-risking the Company's DKD/CKD clinical development program, the strong synergistic effects observed on multiple outcome parameters suggest that QPCT/L inhibitors could be an ideal combination partner for patients treated with SGLT-2 inhibitors. Vivoryon is currently investigating additional animal models, including a DKD model, to provide further proof points. Proposed clinical development plan in DKD Vivoryon's key strategic priority for 2025 is to advance varoglutamstat in kidney disease and confirm the previously reported compelling data from two independent Phase 2 studies, VIVIAD and VIVA-MIND, by conducting a Phase 2b clinical study in patients with advanced diabetic kidney disease (DKD) stage 3b/4. Initiation of the Phase 2b and all future studies is subject to additional funding and/or partnership, which Vivoryon continues to actively explore. Expanding intellectual property portfolio in kidney disease treatment Vivoryon announced on May 27, 2025, that the United States Patent and Trademark Office (USPTO) has granted an additional patent covering the active polymorph of varoglutamstat. The new U.S. patent (US 12,312,335) was granted after an accelerated examination process and is expected to provide exclusivity through 2044 with subsequent opportunity for patent term extension of up to five years to 2049 under the Hatch-Waxman Act. Additional patents for medical use and dosing regimens under examination for varoglutamstat and related structures in kidney disease as monotherapy and in combination with SGLT-2 inhibitors. Pipeline Updates: Early-stage Pipeline The Company has enlarged its portfolio by nominating a novel, next generation QPCT/L inhibitor showing compelling pharmacological activity. This candidate, VY2149, is a potential fast follower in DKD or could also be explored for other inflammatory and fibrotic diseases including orphan diseases and chronic kidney disease (CKD). VY2149 is expected to enter formal, late-stage pre-clinical development within this year, subject to additional funding and/or partnership, which Vivoryon continues to actively explore. Corporate Development Updates In April 2025, Vivoryon entered into a Standby Equity Purchase Agreement (SEPA) withYorkville Advisors Global, LP, allowing for the purchase of up to EUR 15 million in ordinary shares over the next 36 months. Under the terms of this agreement, Yorkville has committed to acquiring these shares, providing Vivoryon with the right, but not the obligation, to sell them in individual tranches while excluding existing shareholders' pre-emptive rights. This agreement is expected to enhance Vivoryon's financial flexibility as the company seeks optimal funding solutions for its planned Phase 2b study in diabetic kidney disease. On April 29, 2025, the Company announced the appointment of Julia Neugebauer, PhD, as Chief Operating Officer (COO), effective May 1, 2025, heading investor relations and communications activities, spearheading market analysis, and overseeing various corporate functions. On May 13, 2025, Vivoryon announced that it will hold its 2025 Annual General Meeting on June 24, 2025. The full agenda and all relevant documents are available on the Company's website ( Financial Results for the First Quarter of 2025 Revenues were zero in the three months ended March 31, 2025, as well as in the three months ended March 31, 2024. Research and development expenses decreased by EUR 6.2 million to EUR 1.2 million in the three months ended March 31, 2025, compared to EUR 7.4 million in the three months ended March 31, 2024. This decrease was largely attributable to EUR 6.1 million lower third-party expenses consisting mainly of lower manufacturing cost (EUR 1.5 million) and lower clinical costs (EUR 4.5 million), predominantly due to the ramp-down of the VIVIAD and VIVA-MIND Phase 2b clinical studies. General and administrative expenses were EUR 1.3 million in the three months ended March 31, 2025, compared to EUR 2.1 million in the three months ended March 31, 2024. The decrease by EUR 0.8 million was largely attributable to lower expenses for personnel (EUR 0.3 million) as well as legal and consulting fees (EUR 0.2 million). Net loss for the three months ended March 31, 2025, was EUR 2.5 million, compared to EUR 9.3 million for the three months ended March 31, 2024. The Company held EUR 7.0 million in cash and cash equivalents as of March 31, 2025, compared to EUR 9.4 million, as of December 31, 2024. Outlook & Financial Guidance As published on April 29, 2025, the issuance date of its annual Financial Statements 2024, the Company expects, based on its most recent financial and business plan, that its existing cash and cash equivalents will be sufficient to fund its operating plans into January 2026, subject to the occurrence of unforeseen circumstances and without taking into account the SEPA as well as other potential additional financing transactions, if any. This cash runway guidance reflects an overall reduction in cash utilization including the conclusion of the VIVIAD and VIVA-MIND studies while prudently investing in preparing to execute on the Company's kidney disease strategy. The initiation of the Phase 2b DKD study is subject to further additional funding and/or partnership, which the Company continues to actively viability of the Company's business beyond its current guidance is dependent on its ability to raise additional funds to finance its operations which also depends on the success of its research and development activities such as those focusing on exploring opportunities in kidney Company expects to have continuing operating losses for the foreseeable future and the need to raise additional capital to finance its future operations. The Company has concluded that the ability to continue as a going concern in the financial year 2026, as stated in the Company's Annual Report 2024 published on April 29, 2025, depends on the ability to generate additional funding. Please refer to the Company's Annual Report 2024 for further information. Conference call and webcast Vivoryon will host a conference call and webcast today, June 17, 2025, at 3:00 pm CEST (9:00 am EDT). A Q&A session will follow the presentation of the first quarter 2025 results. A live webcast and slides will be made available at: To join the conference call via phone, participants may pre-register and will receive dedicated dial-in details to easily and quickly access the call via the following website: It is suggested participants dial into the conference call 15 minutes prior to the scheduled start time to avoid any delays in attendance. Approximately one day after the call, a slide-synchronized audio replay of the conference will be available on: ### About Vivoryon Therapeutics is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines for the treatment of inflammatory and fibrotic disorders of the kidney. Driven by its passion for ground-breaking science and innovation, the Company strives to improve patient outcomes by changing the course of severe diseases through modulating the activity and stability of pathologically relevant proteins. Vivoryon's most advanced program, varoglutamstat, a proprietary, first-in-class orally available QPCT/L inhibitor, is being evaluated to treat diabetic kidney disease. press release includes forward-looking statements, including, without limitation, those regarding the business strategy, management plans and objectives for future operations of Vivoryon Therapeutics N.V. (the 'Company'), estimates and projections with respect to the market for the Company's products and forecasts and statements as to when the Company's products may be available. Words such as 'anticipate,' 'believe,' 'estimate,' 'expect,' 'forecast,' 'intend,' 'may,' 'plan,' 'project,' 'predict,' 'should' and 'will' and similar expressions as they relate to the Company are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance; rather they are based on the Management's current expectations and assumptions about future events and trends, the economy and other future conditions. The forward-looking statements involve a number of known and unknown risks and uncertainties. These risks and uncertainties and other factors could materially adversely affect the outcome and financial effects of the plans and events described herein. The Company's results of operations, cash needs, financial condition, liquidity, prospects, future transactions, strategies or events may differ materially from those expressed or implied in such forward-looking statements and from expectations. As a result, no undue reliance should be placed on such forward-looking statements. This press release does not contain risk factors. Certain risk factors that may affect the Company's future financial results are discussed in the published annual financial statements of the Company. This press release, including any forward-looking statements, speaks only as of the date of this press release. The Company does not assume any obligation to update any information or forward-looking statements contained herein, save for any information required to be disclosed by law. For more information, please contact: Investor ContactsVivoryon Therapeutics Manuela Bader, Director IR & CommunicationEmail: IR@ LifeSci AdvisorsSandya von der Weid Tel: +41 78 680 05 38Email: svonderweid@ Media ContactTrophic CommunicationsValeria Fisher or Verena SchossmannTel: +49 175 8041816 / +49 151 219 412 77Email: vivoryon@ Attachment 20250617_VVY Q1 2025_PRSign in to access your portfolio
Yahoo
17-06-2025
- Business
- Yahoo
Vivoryon Therapeutics N.V. Q1 2025 Financial Results and Operational Progress
Vivoryon Therapeutics N.V. Q1 2025 Financial Results and Operational Progress Continued progress in advancing varoglutamstat in kidney disease based on encouraging data and expansion of IP portfolio Varoglutamstat's pre-clinical dataset showing synergistic effect in combination with an SGLT-2 inhibitor in different treatment regimens Novel composition of matter patent for varoglutamstat granted after accelerated review in the U.S.; patent term to provide exclusivity through 2044 with subsequent opportunity for patent term extension Varoglutamstat meta-analysis data presented in oral presentation at ERA 2025 Preparations ongoing for Phase 2b of varoglutamstat in diabetic kidney disease (DKD) Management to host a conference call today at 3:00 pm CEST (9:00 am EDT) Halle (Saale) / Munich, Germany, June 17, 2025 – Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, today announced financial results for the three-month period ended March 31, 2025, and provided an update on its corporate progress. 'We have started the year 2025 focused on rounding out the evidence to support the success of varoglutamstat in kidney disease,' said Frank Weber, MD, CEO of Vivoryon. 'Building on solid Phase 2 clinical evidence of varoglutamstat's beneficial impact on eGFR, we have developed a viable clinical development strategy, with a planned Phase 2b study in diabetic kidney disease as a first step. Beyond varoglutamstat as single agent, our clinical program also includes investigation of varoglutamstat in combination with SGLT-2 inhibitors for which we have generated very promising preclinical data. On the IP side, we have been able to significantly extend protection of our key asset varoglutamstat with a new composition of matter patent in the U.S. With the groundbreaking clinical data demonstrating varoglutamstat's unique impact on kidney function, a deeper understanding of its MOA in inflammation and fibrosis, and a strengthened IP portfolio, we believe we are well on track to deliver a novel therapy that addresses a significant unmet medical need for patients suffering from kidney disease. In particular, we strive to change the likely trajectory toward kidney failure for patients with advanced DKD, who currently have little to no treatment options to halt progression of kidney failure or improve kidney function.' Q1 2025 and Post-Period Updates Varoglutamstat Clinical Program Meta-analysis of VIVIAD and VIVA-MIND study data On January 14, 2025, the Company disclosed a meta-analysis of VIVIAD and VIVA-MIND data which confirmed that treatment with varoglutamstat at 600mg twice daily significantly improved eGFR kidney function in the overall study population. Statistically significant differences between varoglutamstat and placebo were first observed at week 24 and were sustained until week 96. The meta-analysis also confirmed a substantially larger effect size in study participants with diabetes compared to those without diabetes. Data for varoglutamstat were presented at the 62nd ERA Congress of the European Renal Association in Vienna, Austria, June 6, 2025, showing consistent improvement in both trials independently, replicated in the meta-analysis and pooled analysis, thus providing converging evidence for the findings. Synergistic effect of combination treatment with varoglutamstat and SGLT-2 inhibitors in pre-clinical animal model On April 29, 2025, Vivoryon disclosed preclinical data from a series of experiments in a chronic kidney disease animal model, analyzing different treatment regimens of varoglutamstat in combination with standard of care for kidney disease, the SGLT-2 inhibitor dapagliflozin. Data analysis revealed a synergistic in vivo effect for the combination treatment of dapagliflozin and varoglutamstat over a broad panel of markers, nearly normalizing pathology vs. control across the three key areas of inflammation, fibrosis and kidney function. Substantially de-risking the Company's DKD/CKD clinical development program, the strong synergistic effects observed on multiple outcome parameters suggest that QPCT/L inhibitors could be an ideal combination partner for patients treated with SGLT-2 inhibitors. Vivoryon is currently investigating additional animal models, including a DKD model, to provide further proof points. Proposed clinical development plan in DKD Vivoryon's key strategic priority for 2025 is to advance varoglutamstat in kidney disease and confirm the previously reported compelling data from two independent Phase 2 studies, VIVIAD and VIVA-MIND, by conducting a Phase 2b clinical study in patients with advanced diabetic kidney disease (DKD) stage 3b/4. Initiation of the Phase 2b and all future studies is subject to additional funding and/or partnership, which Vivoryon continues to actively explore. Expanding intellectual property portfolio in kidney disease treatment Vivoryon announced on May 27, 2025, that the United States Patent and Trademark Office (USPTO) has granted an additional patent covering the active polymorph of varoglutamstat. The new U.S. patent (US 12,312,335) was granted after an accelerated examination process and is expected to provide exclusivity through 2044 with subsequent opportunity for patent term extension of up to five years to 2049 under the Hatch-Waxman Act. Additional patents for medical use and dosing regimens under examination for varoglutamstat and related structures in kidney disease as monotherapy and in combination with SGLT-2 inhibitors. Pipeline Updates: Early-stage Pipeline The Company has enlarged its portfolio by nominating a novel, next generation QPCT/L inhibitor showing compelling pharmacological activity. This candidate, VY2149, is a potential fast follower in DKD or could also be explored for other inflammatory and fibrotic diseases including orphan diseases and chronic kidney disease (CKD). VY2149 is expected to enter formal, late-stage pre-clinical development within this year, subject to additional funding and/or partnership, which Vivoryon continues to actively explore. Corporate Development Updates In April 2025, Vivoryon entered into a Standby Equity Purchase Agreement (SEPA) withYorkville Advisors Global, LP, allowing for the purchase of up to EUR 15 million in ordinary shares over the next 36 months. Under the terms of this agreement, Yorkville has committed to acquiring these shares, providing Vivoryon with the right, but not the obligation, to sell them in individual tranches while excluding existing shareholders' pre-emptive rights. This agreement is expected to enhance Vivoryon's financial flexibility as the company seeks optimal funding solutions for its planned Phase 2b study in diabetic kidney disease. On April 29, 2025, the Company announced the appointment of Julia Neugebauer, PhD, as Chief Operating Officer (COO), effective May 1, 2025, heading investor relations and communications activities, spearheading market analysis, and overseeing various corporate functions. On May 13, 2025, Vivoryon announced that it will hold its 2025 Annual General Meeting on June 24, 2025. The full agenda and all relevant documents are available on the Company's website ( Financial Results for the First Quarter of 2025 Revenues were zero in the three months ended March 31, 2025, as well as in the three months ended March 31, 2024. Research and development expenses decreased by EUR 6.2 million to EUR 1.2 million in the three months ended March 31, 2025, compared to EUR 7.4 million in the three months ended March 31, 2024. This decrease was largely attributable to EUR 6.1 million lower third-party expenses consisting mainly of lower manufacturing cost (EUR 1.5 million) and lower clinical costs (EUR 4.5 million), predominantly due to the ramp-down of the VIVIAD and VIVA-MIND Phase 2b clinical studies. General and administrative expenses were EUR 1.3 million in the three months ended March 31, 2025, compared to EUR 2.1 million in the three months ended March 31, 2024. The decrease by EUR 0.8 million was largely attributable to lower expenses for personnel (EUR 0.3 million) as well as legal and consulting fees (EUR 0.2 million). Net loss for the three months ended March 31, 2025, was EUR 2.5 million, compared to EUR 9.3 million for the three months ended March 31, 2024. The Company held EUR 7.0 million in cash and cash equivalents as of March 31, 2025, compared to EUR 9.4 million, as of December 31, 2024. Outlook & Financial Guidance As published on April 29, 2025, the issuance date of its annual Financial Statements 2024, the Company expects, based on its most recent financial and business plan, that its existing cash and cash equivalents will be sufficient to fund its operating plans into January 2026, subject to the occurrence of unforeseen circumstances and without taking into account the SEPA as well as other potential additional financing transactions, if any. This cash runway guidance reflects an overall reduction in cash utilization including the conclusion of the VIVIAD and VIVA-MIND studies while prudently investing in preparing to execute on the Company's kidney disease strategy. The initiation of the Phase 2b DKD study is subject to further additional funding and/or partnership, which the Company continues to actively viability of the Company's business beyond its current guidance is dependent on its ability to raise additional funds to finance its operations which also depends on the success of its research and development activities such as those focusing on exploring opportunities in kidney Company expects to have continuing operating losses for the foreseeable future and the need to raise additional capital to finance its future operations. The Company has concluded that the ability to continue as a going concern in the financial year 2026, as stated in the Company's Annual Report 2024 published on April 29, 2025, depends on the ability to generate additional funding. Please refer to the Company's Annual Report 2024 for further information. Conference call and webcast Vivoryon will host a conference call and webcast today, June 17, 2025, at 3:00 pm CEST (9:00 am EDT). A Q&A session will follow the presentation of the first quarter 2025 results. A live webcast and slides will be made available at: To join the conference call via phone, participants may pre-register and will receive dedicated dial-in details to easily and quickly access the call via the following website: It is suggested participants dial into the conference call 15 minutes prior to the scheduled start time to avoid any delays in attendance. Approximately one day after the call, a slide-synchronized audio replay of the conference will be available on: ### About Vivoryon Therapeutics is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines for the treatment of inflammatory and fibrotic disorders of the kidney. Driven by its passion for ground-breaking science and innovation, the Company strives to improve patient outcomes by changing the course of severe diseases through modulating the activity and stability of pathologically relevant proteins. Vivoryon's most advanced program, varoglutamstat, a proprietary, first-in-class orally available QPCT/L inhibitor, is being evaluated to treat diabetic kidney disease. press release includes forward-looking statements, including, without limitation, those regarding the business strategy, management plans and objectives for future operations of Vivoryon Therapeutics N.V. (the 'Company'), estimates and projections with respect to the market for the Company's products and forecasts and statements as to when the Company's products may be available. Words such as 'anticipate,' 'believe,' 'estimate,' 'expect,' 'forecast,' 'intend,' 'may,' 'plan,' 'project,' 'predict,' 'should' and 'will' and similar expressions as they relate to the Company are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance; rather they are based on the Management's current expectations and assumptions about future events and trends, the economy and other future conditions. The forward-looking statements involve a number of known and unknown risks and uncertainties. These risks and uncertainties and other factors could materially adversely affect the outcome and financial effects of the plans and events described herein. The Company's results of operations, cash needs, financial condition, liquidity, prospects, future transactions, strategies or events may differ materially from those expressed or implied in such forward-looking statements and from expectations. As a result, no undue reliance should be placed on such forward-looking statements. This press release does not contain risk factors. Certain risk factors that may affect the Company's future financial results are discussed in the published annual financial statements of the Company. This press release, including any forward-looking statements, speaks only as of the date of this press release. The Company does not assume any obligation to update any information or forward-looking statements contained herein, save for any information required to be disclosed by law. For more information, please contact: Investor ContactsVivoryon Therapeutics Manuela Bader, Director IR & CommunicationEmail: IR@ LifeSci AdvisorsSandya von der Weid Tel: +41 78 680 05 38Email: svonderweid@ Media ContactTrophic CommunicationsValeria Fisher or Verena SchossmannTel: +49 175 8041816 / +49 151 219 412 77Email: vivoryon@ Attachment 20250617_VVY Q1 2025_PR
Daily Mail
13-06-2025
- Health
- Daily Mail
I was diagnosed with Alzheimer's after ‘overused' medical procedure caused my dementia
Sean Fischer's mother had been getting sicker for decades. She would ask the same question multiple times, be bedbound from migraines and unstable on her feet. The mystery behind her decades-long ailments was seemingly solved when she was diagnosed with Alzheimer's disease in June 2022. Sean said: 'We had spent countless hours fretting over what could be wrong, but not once did I think it could be early-onset Alzheimer's. That diagnosis belongs to other families, I thought. Not ours.' The Fischers met with renowned neurologists and prepared the then-61-year-old to participate in an Alzheimer's clinical trial for the drug varoglutamstat. Then came devastating news that meant Mrs Fischer wouldn't be eligible for the trial - she was suffering from a persistent leak of spinal fluid somewhere in her spinal system, but doctors couldn't pinpoint the source - and couldn't fix it. They believed it was likely a result of epidurals she'd received during childbirth - an injection in the back that numbs a person from their belly button to their thighs. It's a common pain relief option during childbirth and an estimated 61 percent of women who give birth receive an epidural. After suffering for more than a decade, doctors said a new procedure would allos them to inject dye into Mrs Fischer's spinal fluid to search for the leak - a small spot in the middle of her back. A few weeks after they sealed it, all of her symptoms went away and doctors said she didn't actually have Alzheimer's - the tiny spot in her back was actually the source of all her symptoms. Mrs Fischer's health battle began long before her Alzheimer's diagnosis. It started in spring 2001, when Sean said he received a call from his dad: Mom had pulled over on the highway, vomiting from a sudden, crushing headache. Her doctor called it a migraine, but months later she lost hearing in one ear and was diagnosed with Ménière's disease. She adjusted — avoiding movements that triggered vertigo, wearing a hearing aid in her forties, and taking daily meds for the headaches. Even as she quietly suffered, Sean wrote for The Free Press, she stayed steady for him and his brothers, never missing a soccer game, school musical, or packed lunch. In 2010, neurologists at Columbia University diagnosed her with a Chiari malformation, a structural defect where the brain is pushed through the opening at the base of the skull. They suspected the malformation was caused by a cerebrospinal fluid leak, sparked by her three epidurals from the births of each of her sons. Epidurals are extremely safe and are administered by inserting a needle in the space of the lower spine just outside the membrane that surrounds the spinal cord. It delivers anesthetic medication, which numbs the lower half of the body and blocks pain while allowing the patient to stay awake and alert. However, it can occasionally result in a leak if the needle punctures the thin, tough membrane surrounding the spinal cord containing the CSF, called the dura mater. When this happens, some of the fluid that cushions and protects the brain and spinal cord can leak out into surrounding tissues. It can only be patched up surgically. The leak had, over the years, led to a loss in cerebrospinal fluid volume, causing her brain to sink. This can lead to severe headaches, nausea and vomiting, hearing changes, memory problems, and double vision. 'I started high school in 2015, and around that time, I began to notice the quiet dislocation of my mom's mind,' Sean wrote for The Free Press. 'When we cooked dinner together, she would have trouble following recipes. She'd stare at her calendar for long stretches of time; making sense of it seemed to require more effort than usual. She started to repeat herself. 'By the time I left for college in Rhode Island, the phrase 'You already asked me that' had become a common refrain in the house I grew up in, but at first, we blamed her, telling her she needed to pay more attention.' She was seeing doctors for headaches, hearing, and anxiety, none of whom believed there could be a common origin. Her memory problems were worsening as well, which led to Mr and Mrs Fischer to to turn to NYU Langone Health's Center for Cognitive Neurology. 'My mom was tested extensively — and two months later came the diagnosis, with the finality of a punctuation mark. Alzheimer's. When it hit her that there was no cure, my mom was bedridden for three days,' Sean said. Hope came with the study. But then doctors called the Fischers and informed them that the CSF leak would not allow her to participate. Despair took over. But a few weeks later, Mrs Fischer's doctor called to tell them about recent medical innovations that would allow surgeons to find and fix the leak, allowing her to participate in the drug trial. Six months later, doctors inserted a probe through the femoral artery in Mrs Fischer's leg, fed it upward toward her spinal system, and sealed the leak. Sean said: 'Two weeks later, I visited home, and found Mom more alert than she had been in years. There was no absent look in her eyes. As the day went on, I waited for her to start fading—but she was still wide awake at 10 p.m. 'After three weeks, her vertigo was gone, and her physical therapist told her she didn't need treatment anymore, because she no longer had any balance problems. After four weeks, she told us she felt 20 years younger.' After six weeks, her problems with memory were gone entirely. 'And eventually, Mom's neurologist confirmed: She did not have Alzheimer's. The surgeons who fixed the leak were shocked. They had never seen a recovery like it,' Sean said. The family later learned that, a year before the procedure, Cedars-Sinai Medical Center had published a newsletter with the subtitle: 'Physicians Treating Dementia Should Look for Cerebrospinal Fluid Leak—A Treatable Cause of an Otherwise Incurable Condition.' The study followed 21 patients with headaches, severe fatigue, and diagnoses of Chiari malformation and dementia; nine were found to have a cerebrospinal fluid leak, and repairing it completely resolved their symptoms. In Sean's mother's case, countless specialists across multiple hospitals treated her symptoms in isolation, overlooking the root cause. But they chose not to place blame on any doctor or institution. It was the system that misdiagnosed her, and ultimately, the system that saved her. 'More than anything, we feel grateful that a scientific breakthrough came at just the right time; that the real cause of her suffering was found,' he said.
Yahoo
06-06-2025
- Health
- Yahoo
Vivoryon Therapeutics N.V. Presents Meta-analysis Data of VIVIAD and VIVA-MIND studies at ERA 2025
Vivoryon Therapeutics N.V. Presents Meta-analysis Data of VIVIAD and VIVA-MIND studies at ERA 2025 Halle (Saale) / Munich, Germany, June 6, 2025 – Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, today announced that meta-analysis data for its lead drug in development, varoglutamstat, was presented at the 62nd ERA Congress of the European Renal Association in Vienna, Austria, today, June 6, 2025. 'We are delighted that the results of the Phase 2 program were accepted for presentation at the ERA 2025 congress. This allowed Vivoryon to share the outstanding improvements of varoglutamstat on kidney function (eGFR) with the scientific and medical expert community in the kidney space,' said Frank Weber, MD, CEO of Vivoryon. Presentation HighlightsVaroglutamstat is a first-in-class glutaminyl cyclase (QPCT/L) inhibitor with potent anti-inflammatory and anti-fibrotic effects. VIVIAD and VIVA-MIND, two independent Phase 2 studies in the EU and U.S. showed a statistically significant and clinically meaningful improvement in a prospectively defined kidney function parameter, eGFR, in an elderly patient population. This improvement was consistent in both trials independently, replicated in the meta-analysis and pooled analysis, and provides converging evidence for this finding. Statistically significant differences between varoglutamstat and placebo were first observed at week 24 and were sustained until week 96. The meta-analysis also confirmed a substantially larger effect size in study participants with diabetes compared to those without diabetes. The next step is planned to be a dedicated Phase 2b trial in patients with diabetic kidney disease (patients with diabetes and chronic kidney disease stage 3b/4). The main goal will be to investigate the efficacy on eGFR in this patient population and to obtain additional information on a potential effect on proteinuria and other kidney specific markers. Presentation Details Date: June 6, 2025Presentation time: 8:15 am CEST as part of the focused oral sessionTitle: Varoglutamstat improves eGFR and offers a new approach to treat diabetic kidney disease (DKD): meta-analysis from two independent Phase 2 studiesVenue: Vienna, Austria Presenter: Frank Weber, MD, CEO of Vivoryon Therapeutics ### About Vivoryon Therapeutics is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines for the treatment of inflammatory and fibrotic disorders of the kidney. Driven by its passion for ground-breaking science and innovation, the Company strives to improve patient outcomes by changing the course of severe diseases through modulating the activity and stability of pathologically relevant proteins. Vivoryon's most advanced program, varoglutamstat, a proprietary, first-in-class orally available QPCT/L inhibitor, is being evaluated to treat diabetic kidney disease. press release includes forward-looking statements, including, without limitation, those regarding the business strategy, management plans and objectives for future operations of Vivoryon Therapeutics N.V. (the 'Company'), estimates and projections with respect to the market for the Company's products and forecasts and statements as to when the Company's products may be available. Words such as 'anticipate,' 'believe,' 'estimate,' 'expect,' 'forecast,' 'intend,' 'may,' 'plan,' 'project,' 'predict,' 'should' and 'will' and similar expressions as they relate to the Company are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance; rather they are based on the Management's current expectations and assumptions about future events and trends, the economy and other future conditions. The forward-looking statements involve a number of known and unknown risks and uncertainties. These risks and uncertainties and other factors could materially adversely affect the outcome and financial effects of the plans and events described herein. The Company's results of operations, cash needs, financial condition, liquidity, prospects, future transactions, strategies or events may differ materially from those expressed or implied in such forward-looking statements and from expectations. As a result, no undue reliance should be placed on such forward-looking statements. This press release does not contain risk factors. Certain risk factors that may affect the Company's future financial results are discussed in the published annual financial statements of the Company. This press release, including any forward-looking statements, speaks only as of the date of this press release. The Company does not assume any obligation to update any information or forward-looking statements contained herein, save for any information required to be disclosed by law. For more information, please contact: Investor ContactsVivoryon Therapeutics Manuela Bader, Director IR & CommunicationEmail: IR@ LifeSci AdvisorsSandya von der Weid Tel: +41 78 680 05 38Email: svonderweid@ Media ContactTrophic CommunicationsValeria Fisher or Verena SchossmannTel: +49 175 8041816 / +49 151 219 412 77Email: vivoryon@ Attachment 20250606_ERA_VVYSign in to access your portfolio
