Ankündigung • May 29
Talisman Metals PLC Announces Significant Channel Sample Results At Tirzzit Copper-Silver Project Talisman Metals PLC announced the results from recent channel sampling activities completed at the Tirzzit copper-silver project in April 2026. Highlight sample results include: Channel TZ-CH001: 2.65m@1.71% Cu and 22.25ppm Ag - ended in mineralisation. Channel TZ-CH003: 0.94m@1.11% Cu and 6.00ppm Ag. Channel TZ-CH005: 1.63m@1.06% Cu and 4.25ppm Ag. Assay Results: Malachite mineralisation at surface within the Basal Series was channel sampled along strike over approximately 700m of the interpreted 4.6km trend, with approximately one channel sample collected every 100m. Along the 700m strike length the average intercept is 1.25m thick with grade of 1.21% Cu and 12.25ppm Ag (weighted average) and the alteration halo is about 2.00m thick on average. Intercepts usually sit on the top of the Basal Series and the hanging wall coincides with the contact on dolomite material. Results confirm that the mineralised horizon in the Basal Series identified during historical mapping shows lateral continuity, with values above cut-off grade (Cu Cut-Off Grade=0.3%) in all seven of seven channels over a strike length of 700m with copper (Cu) grades ranging from 0.75% to 1.74% and silver (Ag) grades ranging from 3 to 22ppm. Note that all the intervals are reported as true width. The sampling was done using channel sampling, with sub-vertical groves against outcrops dipping 30 Degrees to the North-North-West, cut with a circular saw on 63.5mm wide grove (HQ Core Diameter). True thickness of the sampling intervals were measured with a Jacob Staff. A total of 6 QA/QC samples were inserted into the original samples, comprising approximately 5% blanks, 5% field duplicates, and 5% certified reference materials. Samples were submitted to the ONHYM laboratory for sample preparation (crushing at 3mm, 85% pass and pulverised at 75microns) and multi-element analysis using a three-acid digestion (HCl-HNO3-HF) with ICP-AES finish. The analytical method has a lower detection limit of 5 ppm for copper (Cu) and 1 ppm for silver (Ag). Blank samples showed no evidence of contamination above three times the detection limit for Cu or Ag. Field duplicates demonstrated an acceptable repeatability, with an R² value of 0.93. Certified reference materials consistently returned copper values approximately 14% below certified values, and the Company is reviewing the potential analytical bias; however, the Company does not currently consider this issue to materially impact the interpretation of the results. For the reporting of each intercept stated comprised of more than one sample and samples are of differing lengths. In this case the average grade for the full interval length was calculated by length-weighted averaging, a standard method for determining average grades. The Tirzzit Project is a sediment-hosted stratiform Cu-Ag system, located 225km east of the city of Agadir, Morocco. The acquisition transaction of the Project was announced February 16, 2026 from a wholly owned subsidiary of Aya Silver & Gold Inc. (TSX: AYA; OTCQX: AYASF), the Company's 4.7% shareholder. The Project consists of two mining licenses covering a surface area of 16.5km2. Historic drilling results, as reported by Moroccan Government agency Bureau of Research and Mining Participations (BRPM) between 1972 and 1976 include drill intersections of 3.16% Cu over 2.5m and 0.60% Cu over 11.4m. Presently the Company is reviewing the extensive BRPM Reports and past collected geophysical data for exploration planning slated to commence in Third Quarter 2026. Talisman continues to process with Aya the formal transfer of the Tirzzit licences on the back of the sale agreement announced February 16, 2026. The technical disclosure in this news release has been approved by Fabien Linares, MSc, MAusIMM, a Qualified Person as defined in JORC 2012. The scientific and technical information summarized in this disclosure and related to historic exploration was reviewed by Mr. Linares and he has visited the Project area. Mr. Linares is Head Geologist of Talisman Metals PLC and has sufficient experience that is relevant to the commodity, style of mineralisation or type of deposit under consideration and activity which he is undertaking to qualify as a Competent Person under the JORC code (2012 Edition). The information in this announcement that relates to historical reported exploration results is based on, and fairly represents, information and supporting documentation prepared by previous operators and/or extracted from historical reports. The historical exploration results referred to in this announcement were reported prior to the introduction of the JORC Code (2012) and have not been reported in accordance with the JORC Code (2012). A Competent Person has not done sufficient work to disclose the historical exploration results in accordance with the JORC Code (2012). It is possible that following further evaluation and/or exploration work, the accuracy and reliability of the historical exploration results may not be confirmed. The Company has not independently verified the historical exploration results, and no assurance can be given that future exploration work will result in the confirmation or upgrade of the historical results to JORC Code (2012) compliant Mineral Resources or Ore Reserves. The Company considers the historical exploration results to be relevant as they provide an indication of the potential of the project. However, the information should not be relied upon as a representation of the current mineral resource or exploration potential. Ankündigung • May 20
Talisman Metals plc Reports Positive Stream Sediment Sampling Results At Fougnar Project Talisman Metals PLC reported the results of its recently completed stream sediment sampling program at the Company's Fougnar licenses, which are 25km west of the Tizert copper-silver mine. The stream sediment work, in combination with historical field work and mapping, confirms the priority of established drill targets. Additionally, a previously unknown area of potential mineralisation has been discovered and will be added to the anticipated drill program scheduled for the summer 2026. Talisman believes that the sediment rock formations at Fougnar have excellent potential to host a large sediment-hosted copper-silver deposit, similar to other such deposits in the Anti-Atlas area of central Morocco. The main work focus at the Fougnar Project to date has been on the northern section, due to outcropping mineralisation. However, significantly copper-anomalous samples were collected on the southern part of the Fougnar Project over a 1km long interval. A total of 132 stream sediment samples were collected across the Fougnar Project. Multiple anomalous catchments were identified, with assay results of up to: 200 ppm Cu (Copper), 6,510 ppm Ba (Barium), 502 ppm Pb (Lead), 161 ppm Zn (Zinc). Newly identified target corridors extend over approximately 4 km across six distinct target areas, in addition to the existing 2.5 km mineralised trend identified along strike. Historical trenching areas containing known mineralisation were successfully confirmed by stream sediment sampling and used as orientation areas to establish threshold values for copper geochemical anomalies. Several geochemical anomalies are spatially associated with mapped structural features identified in the field and interpreted from ground TEM surveys and favourable lithological units within the basal series stratigraphy. Stream sediment samples were collected from fine sediment traps within active drainage channels over intervals of approximately 20-30 m along stream courses, while avoiding areas affected by anthropogenic contamination or stream disturbance. Sample locations were recorded using handheld GPS devices. Samples were dried and sieved to <63 µm prior to analysis. A total of 23 QA/QC samples were inserted into the sample stream, comprising approximately 5% blanks, 5% field duplicates, and 5% certified reference materials. Samples were submitted to the ONHYM laboratory in Rabat, Morocco for multi-element analysis using a three-acid digestion (HCl-HNO3-HF) with ICP-AES finish. The analytical method has a lower detection limit of 5 ppm for copper (Cu) and 1 ppm for silver (Ag). Blank samples showed no evidence of contamination above three times the detection limit for Cu or Ag. Field duplicates demonstrated excellent repeatability, with an R² value of 0.99. Certified reference materials consistently returned copper values approximately 10-20% below certified values, and the Company is reviewing the potential analytical bias; however, the Company does not currently consider this issue to materially impact the interpretation of the results. Follow-up work programmes underway including: Detailed geological mapping and rock-chip sampling; Trenching across priority target areas; Follow-up drilling of any significant trench results to test mineralisation at depth and along strike. The information in this announcement that relates to historical reported exploration results is based on, and fairly represents, information and supporting documentation prepared by previous operators and/or extracted from historical reports. The historical exploration results referred to in this announcement were reported prior to the introduction of the JORC Code (2012) and have not been reported in accordance with the JORC Code (2012). A Competent Person has not done sufficient work to disclose the historical exploration results in accordance with the JORC Code (2012). It is possible that following further evaluation and/or exploration work, the accuracy and reliability of the historical exploration results may not be confirmed. The Company has not independently verified the historical exploration results, and no assurance can be given that future exploration work will result in the confirmation or upgrade of the historical results to JORC Code (2012) compliant Mineral Resources or Ore Reserves. The Company considers the historical exploration results to be relevant as they provide an indication of the potential of the project. However, the information should not be relied upon as a representation of the current mineral resource or exploration potential. The technical disclosure in this news release has been approved by Fabien Linares, MSc, MAusIMM, a Qualified Person as defined in JORC 2012. The scientific and technical information summarized in this disclosure and related to historic exploration was reviewed by Mr. Linares and he has visited the Project area. Mr. Linares is Head Geologist of Talisman Metals PLC and has sufficient experience that is relevant to the commodity, style of mineralisation or type of deposit under consideration and activity which he is undertaking to qualify as a Competent Person under the JORC code (2012 Edition). HCl-HNO3-HF Hydrochloric-hydrofluoric acid material that is used in elemental laboratory testing of rock samples. ICP-AES Inductively Coupled Plasma Atomic Emission Spectrometer is a type of elemental analysis used in laboratories. Ppm Parts per million. R² value A statistical measure regarding how well a data set forms a trend. Ankündigung • Apr 29
Talisman Metals plc Provides Update on Tirzzit Project Sampling and Exploration Results Talisman Metals PLC reported it has collected 7 channel samples at the Tirzzit Project, for a total length of 23m and 38 Trench samples including 5 QAQC samples and 3 Grab samples which have been sent for assaying. The first phase of fieldwork at Tirzzit consists of testing the grade and thickness of mineralisation along strike, from west to east, on outcrop in order to confirm: lateral continuity; historical Copper (Cu) and Silver (Ag) grades; and the location of thicker intervals for channel sampling at approximately 100m spacing, using a Jacob staff to determine true thickness and improve understanding of the controls on mineralisation. The initial 700m of strike targeted a horizon 1 to 5m thick from surface, exhibiting malachite mineralisation at surface amongst the 4.6 kilometres mineralized horizons that has been historically identified. The next phases of sampling will include: continuing channel sampling of the basal series from west to east, from Licence LE393478 to LE393507; channel sampling of the basal series within historical adits developed by the BRPM; conducting mapping of the lower limestone units to identify gossans, followed by grab sampling-initially above historically successful drill holes and subsequently across untested areas; and infill sampling of historical stream sediment coverage within previously untested watersheds. The preparation of a drill programme to redrill historical short holes that have missed mineralisation and drill out open extensions of mineralisation. The Tirzzit Project is a sediment-hosted stratiform Cu-Ag system, located 225km east of the city of Agadir, Morocco. The acquisition transaction of the Project was announced February 16, 2026 from a wholly owned subsidiary of Aya Silver & Gold Inc. (TSX: AYA; OTCQX: AYASF), the Company's 4.7% shareholder. The Project consists of two mining licenses covering a surface area of 16.5km2. Historic drilling results as reported by Moroccan Government agency Bureau of Research and Mining Participations (BRPM) between 1972 and 1976 include drill intersections of 3.16% Cu over 2.5m and 0.60% Cu over 11.4m. Presently the Company is reviewing the extensive BRPM Reports and past collected geophysical data for exploration planning slated to commence in Second Half 2026. Talisman is processing with Aya the formal transfer of the Tirzzit licences on the back of the acquisition agreement announced February 16, 2026. The technical disclosure in this news release has been approved by Fabien Linares, MSc, MAusIMM, a Qualified Person as defined in JORC 2012. The scientific and technical information summarized in this disclosure and related to historic exploration was reviewed by Mr. Linares and he has visited the Project area. Mr. Linares is Head Geologist of Talisman Metals PLC and has sufficient experience that is relevant to the commodity, style of mineralisation or type of deposit under consideration and activity which he is undertaking to qualify as a Competent Person under the JORC code (2012 Edition). The information in this announcement that relates to historical reported exploration results is based on, and fairly represents, information and supporting documentation prepared by previous operators and/or extracted from historical reports. The historical exploration results referred to in this announcement were reported prior to the introduction of the JORC Code (2012) and have not been reported in accordance with the JORC Code (2012). A Competent Person has not done sufficient work to disclose the historical exploration results in accordance with the JORC Code (2012). It is possible that following further evaluation and/or exploration work, the accuracy and reliability of the historical exploration results may not be confirmed. The Company has not independently verified the historical exploration results, and no assurance can be given that future exploration work will result in the confirmation or upgrade of the historical results to JORC Code (2012) compliant Mineral Resources or Ore Reserves. The Company considers the historical exploration results to be relevant as they provide an indication of the potential of the project. However, the information should not be relied upon as a representation of the current mineral resource or exploration potential. Ankündigung • Feb 25
Talisman Metals plc Announces Commencement of Exploration Work At Fougnar Cu-Ag Project Talisman Metals PLC announced the commencement of a preliminary exploration programme at its Fougnar Copper-Silver Project (the "Project") within the Tizert group of licenses that Talisman recently acquired. The exploration work is focused on improving the Company's understanding of structural geography at the Project and establishing drill-ready targets for subsequent campaigns later in 2026. The exploration programme integrates trenching, ground geophysics, and stream sediment sampling, designed to define priority targets across the Project area. Additionally, a modest scout drill work program will be conducted to improve Project stratigraphy understanding. Exploration Programme Overview 1-Ground geophysics, 2 phases: Phase 1: Transient Electromagnetics (TEM) surveys on a 250m x 250m grid over the southern permit area and Higher-Resolution TEM surveys on a 250m x 100m grid over the northern permit area to map out structures that control mineralisation (Paleorelief of basement rock) and resistive profiles to track conductive "horizons" up to 500m deep. Phase 2: Four-pole dipole-dipole Induced Polarisation (IP) 1km profiles across priority targets in the northern permit area to track mineralised/conductive and chargeable sulphide rich horizons up to 300m deep. Scout reverse circulation drilling to test geological stratigraphy associated with mapped data and outcropping Cu-Ag down dip from previous trench results (FO-CH09 with 1.1m @ 1.16% Cu and 53g/t Au, FO-CH02 with 0.6m @ 0.41% Cu and FO-CH04 0.7m @ 0.70% Cu and 17g/t Au. Geological Rationale The current programme is designed to test both strike and depth continuity of mineralised Cu-Ag zones and to assess the broader prospectivity of the Project area. Next steps Mobilisation and field activities have commenced and will be completed over the coming weeks. Results from trenching, geophysics, and geochemical sampling will be used to refine drill targets, with further updates to be provided as data become available. The technical disclosure in this news release has been approved by Fabien Linares, MSc, MAusIMM, a Qualified Person as defined in JORC 2012. The scientific and technical information summarized in this disclosure and related to historic exploration was reviewed by Mr. Linares and he has visited the Project area. Mr. Linares is Head Geologist of Talisman Metals PLC and has sufficient experience that is relevant to the commodity, style of mineralisation or type of deposit under consideration and activity which he is undertaking to qualify as a Competent Person under the JORC code (2012 Edition). Mineralisation observed in the outcropping sedimentary host units on Trench CH09 (left). Malachite and Azurite (copper-carbonate) mineralisation from FO-CH09 (left). Ankündigung • Feb 12
Talisman Metals PLC Appoints Fabien Linares as Head Geologist Talisman Metals PLC announced it has appointed Fabien Linares as Head Geologist. Mr. Linares is a professional geologist with 20 years of experience and is a member of the AusIMM with a Master's Degree in management of Geo Resources from ENSEGID - Bordeaux INP. His most recent work was with SRK Consulting UK where he managed a 30-drill-rig exploration program for resource generation in Saudi Arabia. His career includes previous roles at CSA Global, Endeavour Mining Corporation and Fortescue Metals Group. Mr. Linares has extensive experience working throughout Africa managing exploration and resource development programs. Ankündigung • Jan 01
Ovoca Bio plc has filed a Follow-on Equity Offering in the amount of £1.155 million. Ovoca Bio plc has filed a Follow-on Equity Offering in the amount of £1.155 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 4,545,454
Price\Range: £0.077
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 10,454,546
Price\Range: £0.077
Transaction Features: Subsequent Direct Listing Ankündigung • May 08
An undisclosed buyer acquired Silver Star Ltd. from Ovoca Bio plc (ISE:OVXA). An undisclosed buyer acquired Silver Star Ltd. from Ovoca Bio plc (ISE:OVXA) on May 7, 2025. Ovoca sold its subsidiary, Silver Star Limited, to exit the biopharmaceutical business after unsuccessful Phase II trials led to the value of IVIX being written down to zero.
An undisclosed buyer completed the acquisition of Silver Star Ltd. from Ovoca Bio plc (ISE:OVXA) on May 7, 2025. Ankündigung • May 07
Ovoca Bio plc (ISE:OVXA) entered into a conditional Letter of Intent to acquire Tadeen International Limited for $1.5 million. Ovoca Bio plc (ISE:OVXA) entered into a conditional Letter of Intent to acquire Tadeen International Limited for $1.5 million on May 7, 2025. Pursuant to the Proposed Acquisition, Ovoca will acquire all of the issued Ordinary Shares of Tadeen together with Tadeen's debts and liabilities in exchange for the ordinary shares in the capital of Ovoca (the "Ovoca Ordinary Shares"), resulting in a takeover by Ovoca of Tadeen; It is intended that the current shareholders and creditors of Tadeen will receive an aggregate maximum of $1.53 million ("Consideration") in the form of Ovoca Ordinary Shares; The Company also today announces its intention to cancel its admission to trading on Euronext Growth, Concurrent to closing of the RTO, if considered reasonable to be done, Ovoca will do a three for one share consolidation of the outstanding Ovoca Ordinary Shares; Following the Proposed Acquisition and completion of the RTO the enlarged group will be renamed "Talisman Metals plc" or such other name as by may determined by Ovoca, to align the with the future business strategy and operations of the Company going forward; and The LOI contains a number of conditions including completion of mutual satisfactory due diligence, compliance with all regulatory requirements, the entering into of an agreeable Definitive Agreement ("SPA) along with other standard terms. The Company expects to undertake a fundraise in connection with the RTO. Should the Acquisition be completed, it is anticipated that Tadeen shareholders would own approximately 40% of the enlarged issued share capital of the group on Admission. Ovoca and the shareholders of Tadeen expect to agree to the terms of a binding Share Purchase Agreement ("SPA") in Q2 2025.
Ovoca has appointed Beaumont Cornish Limited as its new Financial and Nominated Adviser, or "Nomad" to lead the RTO and re-admission to AIM of the enlarged group as well as its Broker. New Risk • Apr 13
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2024. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 16% per year over the past 5 years. Revenue is less than US$1m. Market cap is less than US$10m (UK£1.34m market cap, or US$1.76m). Minor Risk Latest financial reports are more than 6 months old (reported June 2024 fiscal period end). Ankündigung • Mar 03
Ovoca Bio plc Announces Chief Financial Officer Changes Ovoca Bio plc announced the appointment of Ms. Leah O'Donovan as its Chief Financial Officer with immediate effect. Ms. O'Donovan is a professional accountant with over 15 years' experience working in the accounting and financial services industries. Prior to joining Ovoca, she was a Senior Financial Controller at Grant Thornton, Senior Financial Accountant at CNP Santander Insurance, and worked at such institutions as MetLife and Maples Fiduciary Services. The company would like to thank Dmitriy Nikitashenko for his service and wish him well in his future endeavors. The role of Chief Financial Officer is not a Board position at present. Board Change • Feb 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 2 experienced directors. 1 highly experienced director. Independent Non-Executive Director Kristina Zakurdaeva was the last director to join the board, commencing their role in 2022. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Ankündigung • Nov 19
Ovoca Bio plc, Annual General Meeting, Dec 18, 2024 Ovoca Bio plc, Annual General Meeting, Dec 18, 2024. Location: buswells hotel, 23-27 molesworth street, dublin 2, Ireland New Risk • Apr 15
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (14% average weekly change). Earnings have declined by 27% per year over the past 5 years. Revenue is less than US$1m. Market cap is less than US$10m (UK£453.2k market cap, or US$564.1k). Minor Risk Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). New Risk • Apr 12
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of British stocks, typically moving 14% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (14% average weekly change). Earnings have declined by 27% per year over the past 5 years. Revenue is less than US$1m. Market cap is less than US$10m (UK£453.2k market cap, or US$564.1k). Ankündigung • Nov 07
Ovoca Bio plc, Annual General Meeting, Nov 30, 2023 Ovoca Bio plc, Annual General Meeting, Nov 30, 2023, at 16:00 Coordinated Universal Time. Ankündigung • Sep 01
Ovoca Bio plc Announces Summary Results of Phase II Dose Ranging Study Assessing Orenetide for HSDD Ovoca Bio announced a summary conclusion of the top-line results from its Phase II dose ranging study assessing Orenetide conducted in Australia and New Zealand. The Study did not show statistically significant superiority of Orenetide versus placebo on the co-primary endpoints of (1) sexual desire, as measured by the Female Sexual Function Index (FSFI) desire domain, and (2) the degree to which a participant is bother by low sexual desire, asasured by the Female Sexual Distress Scale (FSDS-DAO). Other secondary efficacy endpoints were also shown not to have statistically significant difference vs. placebo. The safety profile of the Orenetide observed in the Study was consistent with its previously known safety profile, and no new safety signals were identified. The Phase II dose ranging study was conducted in Australia and New Zealand throughout 2021 and 2022 in order to evaluate the effect of a range of daily administered Orenetide doses on a lack or loss of sexual desire experienced by Study participants prior to the Study. In total, 667 women were screened in the double-blind placebo-controlled Study, with a final 453 participants were randomized and started treatment across 13 sites. Of them, 425 participants have completed treatment with Orenetide or placebo, and 390 participants have completed the whole Study. The co-primary objectives of the Study were to evaluate the effect of three different doses of Orenetide and placebo, on (1) sexual desire, As measured by the Female Sexual Function index (FSFI) desire domain; and, (2) the degree towhich a participant is contacted by low sexual desire, as measured by The Female Sexual Distress Scale. All study participants were female and had a diagnosis of acquired, generalised HSDD. Orenetide is a synthetic peptide administered through a nasal spray and has been supplied for this study by well-established peptide manufacturers in Switzerland and the UK. New Risk • Jul 21
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of British stocks, typically moving 12% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€5.2m free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings have declined by 41% per year over the past 5 years. Revenue is less than US$1m. Market cap is less than US$10m (UK£5.64m market cap, or US$7.25m). Ankündigung • Oct 07
Ovoca Bio plc, Annual General Meeting, Oct 27, 2022 Ovoca Bio plc, Annual General Meeting, Oct 27, 2022, at 15:00 Coordinated Universal Time. Ankündigung • Jul 29
Ovoca Bio plc Announces Completion of Enrollment in Phase II Study Ovoca Bio plc announces the successful completion of the enrollment of participants in a Phase II dose ranging study assessing Orenetide, a novel treatment for premenopausal women with hypoactive sexual desire disorder. HSDD is a condition characterized by a distressing lack or loss of sexual desire. Despite a challenging global environment due to COVID-19 restrictions, the company is pleased to have successfully completed the enrollment in accordance with the previously announced timeline and schedule. This Phase II dose ranging Study is being conducted in Australia and New Zealand in order to investigate Orenetide administered daily at a range of doses, evaluating the effect of the drug on lack or loss of sexual desire experienced by Study participants. 667 women have been screened in this double-blind placebo-controlled Study to allow up to 462 participants to be treated across 13 sites. TheOvoca management team currently expects that all enrolled participants will complete the Study in the next four months, which will allow the assessment of study results in First Quarter 2023. The co-primary objectives of the Study are to evaluate the effect of three different doses of Orenetide and placebo, on (1) sexual desire, as measured by the Female Sexual Function Index desire domain; and, (2) the degree to which a participant is bothered by low sexual desire, as measured by the Female Sexual Distress Scale. The change in those clinically relevant and validated endpoints will be assessed between a four-week baseline period and after four weeks of daily dosing. All study participants are female and have a diagnosis of acquired, generalised HSDD. Orenetide is a synthetic peptide administered through a nasal spray and has been supplied for this study by well-established peptide manufacturers in Switzerland and the UK. Ankündigung • Feb 24
Ovoca Bio Receives Marketing Approval for Orenetide for the Treatment of Hypoactive Sexual Desire Disorder in Premenopausal Women in Russian Federation Ovoca Bio announces that it has received a Marketing Authorisation ("MA") approval for Orenetide (BP-101), a novel synthetic peptide, by the Russian Ministry of Health ("Minzdrav"), for the treatment of hypoactive sexual desire disorder (or "HSDD") in premenopausal women. Minzdrav has approved the medical prescription of Orenetide, administered through a nasal spray, to patients in the Russian Federation under the trade name 'Desirix' for the treatment of HSDD, a condition characterized by a distressing lack or loss of sexual desire. The MA was approved based on data from two Phase 1 studies, a Phase 2a study and the pivotal Phase 3 study completed in 2019, conducted in Russia, which established the safety and efficacy of Orenetide. The approved manufacturing site for Orenetide will be operated by two reputable pharmaceutical manufacturers - Nativa and OncoTarget, with commercial production of Orenetide expected to start in Spring 2022. Ovoca Bio is currently in discussions with a number of partners to explore a potential license partnerships for sales of Orenetide on the Russian market. Ankündigung • Jan 31
Ovoca Bio plc Announces Board Changes Ovoca Bio plc announced the appointment of Dr. Kristina Zakurdaeva, MD, PhD as an Independent Non-Executive Director effective immediately. Dr. Zakurdaeva succeeds Chris Wiltshire on the Board. Mr. Wiltshire has resigned from the Board and role of Chief Business Officer with immediate effect to pursue other business interests. Dr. Zakurdaeva currently serves as CEO of New York-based Incuron (Buffalo, NY), a drug development company in the oncology sector. Before Incuron, she served as Chief Medical Officer at Gero (Singapore/Russia), a drug discovery company focused on aging and aging-related diseases, where she developed clinical strategy for the company's pipeline. Prior to Incuron, Kristina worked as a Scientific Advisor at Bristol-Myers Squibb and later headed oncology and immunology R&D projects in the Biomed Cluster of the Skolkovo Foundation (Moscow) where she successfully launched the Cancer Center of Excellence. Dr. Zakurdaeva is a Founder and Chair of the Foundation Board for the Foundation for Cancer Research Support (Russia) and has authored numerous, recent, peer-reviewed publications and co-authored a scientific discovery in genetics. Kristina holds a medical doctor degree in internal medicine and hematology, as well as a PhD in genetics of acute leukemia. Recent Insider Transactions • Nov 06
Non-Executive Director recently sold UK£1.1m worth of stock On the 1st of November, Leonid Skoptsov sold around 12m shares on-market at roughly UK£0.093 per share. This was the largest sale by an insider in the last 3 months. This was the only on-market transaction from insiders over the last 12 months. Ankündigung • Jan 06
Ovoca Bio plc Announces Resubmission of Marketing Authorisation Application with Russian Ministry of Health for BP-101 Ovoca Bio plc announced that a new Marketing Authorisation application for BP-101, a novel synthetic peptide administered through a nasal spray, was filed by its subsidiary, IVIX LLC, with the Russian Ministry of Health (the Minzdrav) on 30 December 2020. IVIX submitted the BP-101 MA application for the treatment of hypoactive sexual desire disorder (or "HSDD"), a condition characterized by a distressing lack or loss of sexual desire, in premenopausal women. The MA application is based on data from two Phase 1 studies, a Phase 2a study and the pivotal Phase 3 study conducted in Russia, which establish the safety and efficacy of BP-101 in the proposed indication. In October 2020 IVIX's previous MA submission filed with the Minzdrav for BP-101 was not granted following the identification of issues relating to the chemistry, manufacturing and controls (CMC) and labelling sections of the MA submission dossier. Ovoca is satisfied that the concerns raised by the Minzdrav have now been fully addressed. Upon confirmation that the submission is complete, the Minzdrav will automatically commence a review process, which is expected to be a minimum of nine months duration. Ankündigung • Nov 28
Ovoca Bio plc, Annual General Meeting, Dec 17, 2020 Ovoca Bio plc, Annual General Meeting, Dec 17, 2020, at 11:00 Coordinated Universal Time. Location: 17 Pembroke Street Upper Dublin 2 Ireland Ankündigung • Oct 10
Ovoca Bio Appoints Christopher Wiltshire as Chief Business Officer and Executive Director of the Board Ovoca Bio announced the appointment of Christopher Wiltshire as Chief Business Officer and Executive Director of the Board, effective immediately. Mr. Wiltshire previously served as Non-Executive Director of the Board of Ovoca Bio. Mr. Wiltshire is an experienced senior pharmaceutical and biotechnology executive with over 25 years of international experience. He currently serves as the Chief Executive of Hematherix LLC which is developing a recombinant clotting factor, and is former head of Business Development and Licensing at La Jolla Pharmaceutical. Ankündigung • Oct 04
Ovoca Bio plc Update on Marketing Authorisation application for BP-101 in Russian Federation Ovoca Bio provided an update on the Marketing Authorisation ("MA") application for BP-101, a novel synthetic peptide administered through a nasal spray, that was submitted to the Russian Ministry of Health ("the Minzdrav") in September 2019. The MA was filed for the treatment of decreased sexual desire in women, including hypoactive sexual desire disorder (or "HSDD"), a condition characterised by a distressing lack or loss of sexual desire. Ovoca has been informed that the Minzdrav has not granted the MA to BP-101 following the identification of certain issues relating to the chemistry, manufacturing and controls (CMC) and labelling sections of the MA submission dossier. The Company notes that no issues were highlighted by the Minzdrav regarding the safety or efficacy of BP-101 in the acquired generalized form of HSDD, which has been established by clinical data from two Phase 1 studies, a Phase 2a study and the pivotal Phase 3 study completed in 2019, all as conducted in the Russian Federation. Ovoca is undertaking an internal review of the comments received from the Minzdrav, in order to understand the changes required to the label to make approvable and the required scope of work to CMC-related processes. This will include an assessment of how best to address the identified CMC issues with the current Russia based contract manufacturer or through different suppliers. An update will be provided in due course on this review and Ovoca's plans for a full resubmission for MA in the Russian Federation. The Company is presently investigating alternative producers of active pharmaceutical ingredient (API) situated in major markets for global commercial drug supply, as well as the establishment of a CMC operational unit located in the Republic of Ireland. Clinical drug supply for Ovoca's upcoming Phase II trial of BP-101 in Australia is being provided by Swiss and British contract manufacturers with extensive experience in supplying clinical trials. Ankündigung • Sep 28
Ovoca Bio Announces Board Changes Ovoca Bio announced that Dr. Mikhail Mogutov, Executive Chairman of the Board, passed away suddenly on September 24, 2020. Dr. Mikhail Mogutov joined the Board of Ovoca in June 2006 and was appointed Chairman of the Board in 2008. Kirill Golovanov, Chief Executive, will be stepping in as Interim Chairman of the Board.