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Orosur Mining Inc Announces Investor Webinar

Orosur Mining Inc Announces Investor Webinar

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LONDON, UNITED KINGDOM / / May 28, 2025 / Orosur Mining Inc (TSXV:OMI)(AIM:OMI), the mineral explorer and developer with current operations in Columbia, Argentina and Nigeria, announces that Louis Castro, Executive Chairman and Brad George, Chief Executive Officer, will be holding a live Investor Webinar Q&A session via the Investor Meet Company platform on 2rd June 2025 at 5.00 pm (UK local time).
The presentation is open to all existing and potential shareholders. Questions can be submitted pre-event via your Investor Meet Company dashboard up until 9am (UK Local Time) the day of the meeting or at any time during the live presentation.
Investors can sign up to the Investor Meet Company platform via:
https://www.investormeetcompany.com/orosur-mining-inc/register-investor
Investors who already follow Orosur on the Investor Meet Company platform will automatically be invited.
For further information visit www.orosu.ca,follow on X @orosurm or contact:
Orosur Mining Inc.Louis Castro, Executive Chairman,Brad George, CEOinfo@orosur.caTel: +1 (778) 373-0100
SP Angel Corporate Finance LLP - Nomad & Joint Broker
Jeff Keating / Jen Clarke / Devik MehtaTel: +44 (0)20 3470 0470
Turner Pope Investments (TPI) Ltd - Joint Broker
Andy Thacker/James PopeTel: +44 (0)20 3657 0050
Flagstaff Strategic and Investor Communications
Tim ThompsonMark EdwardsFergus Mellonorosur@flagstaffcomms.comTel: +44 (0)207 129 1474
This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.
SOURCE: Orosur Mining Inc
View the original press release on ACCESS Newswire

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Northern Graphite Announces First Quarter 2025 Results
Northern Graphite Announces First Quarter 2025 Results

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Northern Graphite Announces First Quarter 2025 Results

Record-High Average Sales Prices, Volumes Impacted by Maintenance Shutdown France/Namibia BAM Project Wins "Strategic" Status Under EU Critical Raw Material Act Mill Maintenance Completed at Lac des Iles Mine Ottawa, Ontario--(Newsfile Corp. - May 30, 2025) - Northern Graphite Corporation (TSXV: NGC) (OTCQB: NGPHF) (FSE: 0NG) (XSTU:0NG) (the "Company" or "Northern") is pleased to provide an operating summary and financial highlights for the three month period ending March 31, 2025. The Company's Financial Statements and Management's Discussion and Analysis for the period have been filed on SEDAR+ and posted to the Company website. "In a challenging market environment, Northern Graphite is pushing forward on its growth catalysts. Our Battery Materials Division marked its one-year anniversary by winning 'Strategic Project' status under the EU's Critical Raw Materials Act for a proposal to build a BAM facility in France. This recognition reinforces our broader strategy to build a fully integrated, mine-to-market company supplying processed natural graphite to the lithium-ion battery sector," said Chief Executive Officer Hugues Jacquemin. "At our Lac des Iles ("LDI") mine, we are continuing strict cost controls to preserve cash and working to boost output and satisfy more customer demand than we can currently supply. While commanding record average sales prices for our graphite, cutting costs and increasing income from operations, we completed a major maintenance shutdown in Q1. At the same time, we have yet to secure financing to extend the LDI pit and add about eight years of life to the mine before it runs out of ore by the end of this year. As global markets continue to evolve, we remain flexible, focused, and ready to pivot where necessary to drive our vision forward." To view an enhanced version of this graphic, please visit: Operational Highlights: Driving Battery Strategy The Company experienced strong demand through the first quarter of the year, even amid geopolitical uncertainty and after negotiating higher pricing with customers for 2025; Production for the quarter was hampered by a mill maintenance shutdown completed in mid-January and by a lack of ore availability, however it began to improve in the second quarter; A year after its launch, the NGC Battery Materials division ("NGCBM") achieved some important milestones: On March 31, 2025, the Company announced that its proposal to upgrade graphite from the Okanjande project in Namibia into Battery Anode Material ("BAM") in France was selected as one of 47 Strategic Projects under the European Union's Critical Raw Materials Act ("CRMA"); The Company advanced plans to build a BAM plant in Baie-Comeau with an agreement with The BMI Group to evaluate the feasibility of a brownfield facility at a former paper mill which could reduce overall capex and time to market; In January, the Company began providing samples of three standard BAM products made from LDI graphite and according to the requirements of leading battery makers; The Company announced key management changes in the quarter, appointing Maximillian Meier as Chief Operating Officer and Michael Grimm, the President of Northern's Battery Materials Division, as Chief Commercial Officer; and The Company is in ongoing, active discussions with various government organizations at the federal and provincial level, and internationally, to gain support for its projects and to speed up development of the battery anode supply chain. Financial Highlights: The Company realized record-high average sales prices in the first quarter of $2,550 per tonne (US$1,776 per tonne), 37% above the first quarter of 2024, mainly due to price increases implemented in 2025 and a product mix that included a higher percentage of higher priced flake sizes. This favorable trend is continuing into the second quarter; Revenue fell 27% in the quarter to $4.0 million, based on 1,585 tonnes of graphite concentrate sold. This represents a 47% decrease in volume compared to the first quarter of 2024 as sales were negatively impacted by a maintenance shutdown and production issues after the restart in mid-January; Cash costs of $1,797 (US$1,252) per tonne of graphite concentrate sold increased by 10% compared to costs of $1,628 per tonne (US$1,207) in the first quarter of 2024, primarily due to changes in the sales mix that resulted in more, higher-cost inventory being sold in the 2025 quarter and higher mine and plant costs per tonne produced; Income from mine operations of $0.3 million, compared to a loss from mine operations of $0.5 million during the prior year's first quarter; General and administrative expenses during the first quarter of 2025 increased to $2.5 million versus $2.3 million in the first quarter of 2024, primarily due to legal expenditures and costs related to NGCBM which was just starting up in the prior year period, but were partially offset by the impact of strict overhead cost control measures and lower Namibian costs; During the fourth quarter of 2024 the Company placed the LDI plant and mine under a temporary shutdown for maintenance and repairs and resumed mining and milling operations in mid-January 2025. Costs incurred during the first quarter of 2025 during the shutdown were $0.4 million. During the first quarter of 2024, the LDI mine was on shutdown with costs of $0.6 million. These amounts were recorded in the condensed interim consolidated statements of loss and other comprehensive loss as care and maintenance expenses; The Okanjande plant was temporarily placed in care and maintenance in the third quarter of 2023. Holding costs of $0.3 million incurred during the first quarter of 2025 (2024 - $0.5 million) were recorded in the condensed interim consolidated statements of loss and other comprehensive loss as care and maintenance expenses; Finance costs were $3.2 million in the quarter (2024 - $3.1million). They increased as the impact of higher accretion rates were only partially offset by gains on a revaluation of the Company's royalty liability and senior debt of $0.2 million and $0.2 million, respectively, due to modifications to the anticipated timing of royalty and interest payments. Almost all of the finance costs were non-cash items; A net loss of $5.3 million ($0.04 per share) which included significant non-cash charges relating to depletion and depreciation, finance costs, impairment expenses and drawdown of inventories. Cash used in operating activities was $0.3 million, compared to 0.4 million used in the fourth quarter of 2024; As of March 31, 2025, in line with previous quarters, the Company continued to report its senior secured loan ($26.1 million) and its royalty financing ($15.8 million) as current liabilities as the Company has not met the following covenants related to these instruments: Senior secured loan - As at March 31, 2025, the Company had not paid accrued interest of $3.5 million (US$2.5 million), maintained, at all times, on a consolidated basis, positive working capital, and maintained, at all times, on a consolidated basis, a minimum cash balance of US$750,000; Royalty Financing - As at March, 2025, the Company had not paid royalty amounts with respect to 2024 totaling $2.9 million (US$2.0 million), and has not paid royalty amounts with respect to the first quarter of 2025 of $0.5 million (US$0.4 million) which were due on April 30, 2025; The Company's lender and royalty holder have waived all defaults as of May 29, 2025 effective March 31, 2025. Discussions continue with respect to amending the terms of the senior secured loan and royalty financing to better align them with project timelines that have shifted with markets that are evolving at a slower pace than forecast; The Company's working capital optimization efforts on inventories and receivables offset by the above noted senior debt and royalty classification to current liabilities ($41.8 million in total), resulted in a negative working capital balance of $41.2 million as at March 31, 2025. To view an enhanced version of this graphic, please visit: Northern is advancing toward its goal of becoming a vertically integrated, mine-to-market supplier to traditional downstream customers and to the emerging ‎‎market for battery anode material. The Company's strategy is to expand production at its Lac des Iles ("LDI") mine, resume and expand production at the Okanjande project in Namibia, advance the Bissett Creek and the Mousseau projects towards development, develop downstream capacity to produce anode material for use in LiBs and EVs in North America and Europe and upgrade graphite mine concentrate into value added industrial products. Market Commentary Amid ongoing geopolitical uncertainty, trade turbulence, and supply chain pressures that continue to underscore the need for secure and diversified sources of graphite, industrial demand for the Company's graphite products remained strong through the first quarter as Northern sold LDI graphite at record-high average prices. This demand trend is expected to continue through 2025, even amid trade tariffs introduced by the administration of US President Donald Trump and with price increases implemented in January of this year. Under the terms of the United States-Mexico-Canada Agreement (USMCA), graphite from Canada remains exempt from new tariffs and Northern's customers have not experienced any negative tariff-related impacts to date. Northern is a key supplier of graphite to U.S. industrial markets, which account for approximately 85 percent of sales. With an estimated 20 percent share of U.S. industrial markets, Northern continues to benefit from strong demand in the refractory industry, where graphite is essential in the production of crucibles, casting molds, and blast furnace linings. Large and jumbo flake graphite — critical to these applications — has become increasingly scarce after China, the dominant producer of graphite, reduced mining activity due to elevated inventories of anode material, effectively removing much of its large-flake supply from the market. At the same time, supply from Western producers was constrained in the quarter by operational challenges, compounding tight global markets. Longer-term, the momentum behind graphite and critical minerals is building, and the Company is actively engaging with governments from the United States and Canada to the European Union as they map out strategies to ensure stable and sustainable supply chains. In early May, Northern participated in high-level discussions with industry and government policymakers in Washington and in Paris where discussions were led by French President Emmanuel Macron. The global industry is especially attuned to developments in U.S. trade policy as the administration of President Trump continues to shape the critical minerals landscape with its evolving tariff regime. In a move that could eventually boost demand for North America-sourced natural and synthetic graphite, on May 20 the U.S. Department of Commerce announced a preliminary decision to impose tariffs of up to 721% on imports of natural and artificial graphite active anode material ("AAM") — used to produce lithium-ion battery anode material — from China after investigating allegations that China is subsidizing production and supply of AAM to the United States. While preliminary, the decision sets the stage for meaningful anti-subsidy duties on Chinese graphite active anode material and marks a major step toward leveling the playing field and creating local demand. Commerce is due to issue a separate, preliminary ruling in July on an antidumping investigation into Chinese graphite imports. Final determinations for both investigations are expected to be issued in December, 2025. Mining Operations Northern's mining projects create a competitive advantage in terms of both current production and the ability to increase output in a relatively quick, modular, low-cost manner by leveraging existing permitting and infrastructure at both LDI and Okanjande. Lac des Iles Mine - Quebec The Company completed a two-month maintenance shutdown of the Lac des Iles processing plant in January as it continued efforts to boost mill output capacity and extend the mine life of its cornerstone asset in Quebec in the short-, medium- and long-term. LDI is the only producing graphite mine in North America, but the existing pit will be mined out and stockpiles used up by the fall of this year. The Company requires an investment of up to $10 million to extend the existing pit, based on a resource estimate published in January 2024 that showed potential to add approximately eight years to the current mine life. The Company continues to seek support from federal, provincial and US government agencies as well as EV and battery manufacturers but has not yet been successful. These efforts have been complicated by difficult financial markets, especially given the current share price. Because there is a lead time from an investment decision to production of approximately six months, the goal is to be able to break ground as soon as possible and ensure a continuous flow of ore to the plant. The new mineral resource estimate also supports the Company's intention to meet rising demand stimulated by EV sales, Chinese export controls and US tariffs on Chinese graphite. Northern is working to permanently move the LDI mill to a seven-days-per week operation, targeting annual nameplate capacity of 25,000 tonnes per year ("tpy"). Demand for LDI's high-quality graphite rose continuously through 2024 and into the first quarter of 2025. It commanded record-high average prices in the January-through-March period, up 37 percent versus the first quarter of last year. LDI processing and production volumes were hampered in the quarter by the mill and mine restart, weather conditions and high strip ratios but began to improve in the second quarter. On the resource front, Northern completed an additional drilling program in the fourth quarter with the objective of further identifying and expanding LDI resources with a lower strip ratio. Core logging and data compilation have been delayed due to the financial constraints the Company is experiencing. Longer-term, LDI has the potential to further extend its life by developing its Mousseau project, which is located approximately 80 km away and represents Northern's fourth significant graphite project along with LDI, Bissett Creek in Ontario and Okanjande in Namibia. The Company is also exploring other avenues to grow production and on April 2 announced an agreement with Graphano Energy Ltd. ("Graphano") to share technical knowledge and expertise to further the exploration and development of their respective properties. The agreement covers the LDI graphite mine and processing facility and Graphano's Lac Aux Bouleaux ("LAB") and Standard properties. The LAB Property is contiguous to the LDI graphite mine and covers the southern extensions of the productive graphite horizons, and the Standard property is between Northern's Mousseau exploration project and the LDI plant. All exploration costs will continue to be borne by the owners of each property. Okanjande Project - Namibia The Okanjande project in Namibia, which has been on care and maintenance since the third quarter of 2023, represents an opportunity to substantially increase graphite production at a lower cost and with a shorter time to market than most competing projects. The project has easy maritime access to European and North American markets and can be used to supply Northern's planned Battery Anode Material facilities in France and at Baie-Comeau, Quebec. Northern continues to evaluate options to fund the Okanjande project through the use of a royalty/stream/debt structure and equity contributed by a strategic partner without having to go to the market at current share prices. A technical report in respect of a preliminary economic assessment ("PEA") for the Okanjande project prepared in accordance with NI 43 101 was filed under the Company's profile on SEDAR+ ( on August 28, 2023. The PEA indicated that the economics are attractive under a plan to move the processing plant from Okorusu to the mine site with higher capital costs but lower operating costs. In addition, greenhouse gas emissions are reduced, sustainability is improved, and the expansion potential of the project is substantially enhanced. The Company plans to restart Okanjande in early 2027, pending financing, to coincide with plans to supply its proposed processing facility in France. With the resumption of production at the Okanjande Project, Northern would become one of the world's largest non-Chinese natural graphite producers. Mine-to-Market-Battery Strategy Northern continued in the quarter to advance its strategy to become one of the world's few integrated producers of natural graphite-based battery anode material outside of China. In March, the Company's proposal to build a BAM facility in France using graphite concentrate from its Okanjande project in Namibia, was granted "Strategic Project" status under the European Union's Critical Raw Materials Act ("CRMA"). The designation enhances its credibility and visibility, will help to accelerate timelines, facilitates faster permitting and improves access to financing while ensuring compliance with the highest environmental and social standards. The designation came barely a year after Northern launched its Battery Materials division ("NGCBM") to lead the Company's downstream expansion. The proposed French facility, requiring an estimated investment of €159 million, is targeted to begin operations in 2028 with an initial capacity of 20,000 tonnes per year of battery-grade anode material. Northern is currently in active discussions with potential off-take partners for its initial production. The mining of graphite at Okanjande is not covered under the scope of the Strategic Project, although Northern intends to file a subsequent proposal that will include extraction activities at the Namibia site. NGCBM also advanced its plans to build a BAM facility in Baie-Comeau, Québec, announcing in April a collaboration with The BMI Group to evaluate a brownfield site at a former paper mill that could accelerate permitting and construction timelines as well as reduce capex compared to the previously announced greenfield alternative. Battery anode material is the single largest component of lithium-ion batteries and is made by upgrading graphite mine concentrate to the exacting specifications of EV battery manufacturers. Northern's planned BAM facilities are intended to address this critical need that is currently missing from the energy transition supply chain in the West. Independent testing has determined that graphite from all of Northern's assets, which are all located close to infrastructure and in politically stable jurisdictions, is battery grade. The Company is also pursuing opportunities to move downstream into non-EV applications in the electronics, construction, graphene and hydrogen fuel cell markets. These markets provide the opportunity to increase revenues and profits through further processing of the Company's graphite mine concentrates. Balance Sheet and Corporate Update Northern continues to report as current liabilities its senior secured loan ($26.1 million) and its royalty financing ($15.8 million) as a result of the Company not meeting certain covenants related to these instruments. The lender and royalty holder have waived all defaults as of May 29, 2025 effective March 31, 2025, and discussions continue with the parties relating to amending the terms of the senior secured loan and royalty financing to better align with project timelines that have shifted with markets that are evolving at a slower pace than forecast. While discussions continue, the lender and royalty holder are supportive of Northern's growth plans and keen to work with the Company to find ways to capitalize on the new resource and extended mine life potential at LDI and allow the Company to benefit from a strong industrial market for graphite in North America as well as coming demand from EV markets. Going forward, the Company intends to maintain strict overhead cost controls that were implemented in 2024, as well as consider a number of other strategies until support for the only operating graphite mine in North America materializes or equity markets improve. The Company also continues to seek support from federal, provincial, US and European government agencies as well as EV and battery manufacturers. Closing Remarks "There's been a clear shift in the global critical minerals narrative, and graphite — as the essential material in lithium-ion batteries — is starting to gain the strategic recognition it deserves as governments in the West look to reduce dependency on Chinese supply chains for critical battery inputs by implementing tariffs or subsidies or strategic raw materials acts," said Mr. Jacquemin. "This is being reflected in customer demand for our graphite and the record prices we realized in the first quarter, and it's only a matter of time before capital markets reflect the reality on the ground. Northern Graphite is positioning itself for that turn by building a company that can deliver an integrated, secure, and local graphite supply chain solution for our customers in Europe and North America , from mine to battery, and from resource to resilience." About Northern Graphite Northern, the only flake graphite producing company in North America, is a Canadian, TSX Venture Exchange listed company that is focused on becoming a world leader in producing natural graphite and upgrading it into high-value products critical to the green economy, including anode material for lithium-ion batteries/EVs, fuel cells and graphene, as well as advanced industrial technologies. The Company's mine-to-battery strategy is spearheaded by its Battery Materials Division, which has a fully equipped, state-of-the-art laboratory in Frankfurt and is focused on developing advanced anode materials to improve the cycle life and increase the charging rate of lithium ion batteries. Northern's graphite assets include the producing Lac des Iles mine in Quebec where the Company plans to increase production to meet growing demand from industrial customers and coming demand from North American battery makers. The Company also owns the large-scale, advanced stage Bissett Creek project in Ontario, the Mousseau Project in Quebec and the fully permitted Okanjande graphite mine in Namibia that is currently on care and maintenance. All projects have "battery quality" graphite and are located close to infrastructure in politically stable jurisdictions. For media inquiries, contactPav Jordan, VP of CommunicationsEmail: pjordan@ For further information, contactNiall Moore, CFOTelephone: (613) 271-2124Email: info@ Qualified PersonGregory Bowes, MBA the Chairman of Northern, is a "qualified person" as defined under NI 43-101 and has reviewed and approved the content of this news release. For additional informationPlease visit the Company's website at the Company's profile on our Social Channels listed below or contact the Company at (613) 271-2124. LinkedInYouTubeXFacebook Cautionary Note Regarding Non-IFRS Performance Measures This news release includes certain non-IFRS performance measures that do not have a standardized meaning prescribed by International Financial Reporting Standards ("IFRS"). The Company believes that these measures, in addition to measures prepared in accordance with IFRS, provide investors with an improved ability to evaluate the underlying performance of the Company and to compare it to information reported by other companies. The non-IFRS measures are intended to provide additional information and should not be considered in isolation or as a substitute for measures of performance prepared in accordance with IFRS. These measures do not have any standardized meaning prescribed under IFRS, and therefore may not be comparable to other issuers. The calculation and an explanation of these measures is provided in the Company's Management's Discussion and Analysis and such measures should be read in conjunction with the Company's Management's Discussion and Analysis and financial statements. Cautionary Note Regarding Forward-Looking Statements This news release contains certain "forward-looking statements" within the meaning of applicable Canadian securities laws. Forward-looking statements and information are frequently characterized by words such as "plan", "expect", "project", "intend", "believe", "anticipate", "estimate", "potential", "possible" and other similar words, or statements that certain events or conditions "may", "will", "could", or "should" occur. Forward-looking statements in this news release include statements regarding, among others, plans for extending the mine life and increasing output at LDI, bringing the Company's Namibian operations back online, advancing other developments projects to production, developing the capacity to manufacture value added products and raising the financing to complete any or all of these initiatives. All such forward-looking statements are based on assumptions and analyses made by management based on their experience and perception of historical trends, current conditions and expected future developments, as well as other factors they believe are appropriate in the circumstances. However, these statements are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected including, but not limited to, unexpected changes in laws, rules or regulations, or their enforcement by applicable authorities; the failure of other parties to perform as agreed; social or labour unrest; changes in commodity prices; unexpected failure or inadequacy of infrastructure and the failure of ongoing and contemplated studies to deliver anticipated results or results that would justify and support continued studies, development or operations, and the inability to raise the required financing. Readers are cautioned not to place undue reliance on forward-looking information or statements. Although the forward-looking statements contained in this news release are based on what management believes are reasonable assumptions, the Company cannot assure investors that actual results will be consistent with them. These forward-looking statements are made as of the date of this news release and are expressly qualified in their entirety by this cautionary statement. Subject to applicable securities laws, the Company does not assume any obligation to update or revise the forward-looking statements contained herein to reflect events or circumstances occurring after the date of this news release. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release. To view the source version of this press release, please visit

ORIC Pharmaceuticals, Inc. (ORIC) Secures $125M to Advance ORIC-944 Phase 3 Trials
ORIC Pharmaceuticals, Inc. (ORIC) Secures $125M to Advance ORIC-944 Phase 3 Trials

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ORIC Pharmaceuticals, Inc. (ORIC) Secures $125M to Advance ORIC-944 Phase 3 Trials

ORIC Pharmaceuticals, Inc. (NASDAQ:ORIC) has unveiled promising early results from its Phase 1b trial of ORIC-944, a novel PRC2 inhibitor, in combination with androgen receptor inhibitors for metastatic castration-resistant prostate cancer (mCRPC). The study reported broad and deep prostate-specific antigen (PSA) responses, with a 59% PSA50 response rate (47% confirmed, plus one pending) and a 24% confirmed PSA90 response rate. These robust responses were seen across all dose levels and with both apalutamide and darolutamide combinations. Most patients remain on therapy, with several approaching one year or more of treatment. A scientist examining cells in a lab, representing the company's dedication to developing specialty pharmaceuticals. Safety data were also encouraging: the vast majority of adverse events were mild or moderate (Grade 1 or 2), primarily gastrointestinal, supporting long-term dosing suitability. Only one patient experienced a Grade 3 event, and there were no severe (Grade 4 or 5) treatment-related adverse events. ORIC Pharmaceuticals, Inc. (NASDAQ:ORIC) plans to advance two recommended Phase 2 doses for each combination into further study, with a global Phase 3 trial set to begin in the first half of 2026. To support these efforts, ORIC Pharmaceuticals, Inc. (NASDAQ:ORIC) announced a $125 million private placement financing led by top healthcare investors, extending its cash runway into the second half of 2027 and through the anticipated Phase 3 trial readout. While we acknowledge the potential of ORIC to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than ORIC and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None.

TG Therapeutics Announces Data Presentations for BRIUMVI in Multiple Sclerosis at the 2025 Consortium of Multiple Sclerosis Centers Annual Meeting
TG Therapeutics Announces Data Presentations for BRIUMVI in Multiple Sclerosis at the 2025 Consortium of Multiple Sclerosis Centers Annual Meeting

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TG Therapeutics Announces Data Presentations for BRIUMVI in Multiple Sclerosis at the 2025 Consortium of Multiple Sclerosis Centers Annual Meeting

NEW YORK, May 30, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the presentations of data highlighting BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting. Links to each presentation are included below. 'We were pleased to present three encore presentations yesterday during the CMSC conference. We continue to be impressed by the BRIUMVI data and look forward to continuing to present updated data throughout the year.'TG PRESENTATIONS:Title: No Association between Decreases in Serum Immunoglobulin Levels and Serious Infections with Long-Term Ublituximab Treatment in Patients with Relapsing Multiple Sclerosis Presenting Author: Dr. Bruce Cree - Weill Institute for Neurosciences, University of California, San Francisco, CA Title: Retrospective Evaluation of Infusion Tolerability: Ublituximab Real-World Observational Survey (ENAMOR) Presenting Author: Dr. Edward Fox – TG Therapeutics - National Physician Liaison – VP, MS Global Operations Title: Safety and Tolerability of 30-Minute Ublituximab Infusions: Updates from the ENHANCE Study Presenting Author: Dr. John Foley – Rocky Mountain Multiple Sclerosis, Salt Lake City, Utah Following the presentations, the data presented will be available on the Publications page, located within the Pipeline section, of the Company's website at ABOUT THE ULTIMATE I & II PHASE 3 TRIALSULTIMATE I & II are two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either BRIUMVI, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour, with oral placebo administered daily; or teriflunomide, the active comparator, given orally as a 14 mg daily dose with IV placebo administered on the same schedule as BRIUMVI. Both studies enrolled patients who had experienced at least one relapse in the previous year, two relapses in the previous two years, or had the presence of a T1 gadolinium (Gd)-enhancing lesion in the previous year. Patients were also required to have an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline. The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University. Additional information on these clinical trials can be found at (NCT03277261; NCT03277248). ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection for IVBRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses. BRIUMVI is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing- remitting disease, and active secondary progressive disease. A list of authorized specialty distributors can be found at IMPORTANT SAFETY INFORMATIONContraindications: BRIUMVI is contraindicated in patients with: Active Hepatitis B Virus infection A history of life-threatening infusion reaction to BRIUMVI WARNINGS AND PRECAUTIONS Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization. Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment. Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI- treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved. Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI. HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HB surface antigen (HBsAg) and anti-HB tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment. Although no cases of PML have occurred in BRIUMVI-treated MS patients, JCV infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies. If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis. If PML is confirmed, treatment with BRIUMVI should be discontinued. Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines at least 4 weeks and, whenever possible at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted. Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. A pregnancy test is recommended in females of reproductive potential prior to each infusion. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose. Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins. Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections. Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit ABOUT BRIUMVI PATIENT SUPPORTBRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at ABOUT MULTIPLE SCLEROSISRelapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing- remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.1 ABOUT TG THERAPEUTICSTG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. For more information, visit and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn. BRIUMVI® is a registered trademark of TG Therapeutics, Inc. Cautionary StatementThis press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the below. Such forward looking statements include but are not limited to statements regarding the results of the ULTIMATE I & II Phase 3 studies, the ENHANCE Phase 3b study, and BRIUMVI as a treatment for relapsing forms of multiple sclerosis (RMS). Additional factors that could cause our actual results to differ materially include the following: the risk that the data from the ULTIMATE I & II or ENHANCE trials that we announce or publish may change, or the product profile of BRIUMVI may be impacted, as more data or additional endpoints are analyzed; the risk that data may emerge from future clinical studies or from adverse event reporting that may affect the safety and tolerability profile and commercial potential of BRIUMVI; the risk that any individual patient's clinical experience in the post-marketing setting, or the aggregate patient experience in the post-marketing setting, may differ from that demonstrated in controlled clinical trials such as ULTIMATE I and II; the risk that BRIUMVI will not be commercially successful; our ability to expand our commercial infrastructure, and successfully market and sell BRIUMVI in RMS; the Company's reliance on third parties for manufacturing, distribution and supply, and a range of other support functions for our commercial and clinical products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI; the failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements; the uncertainties inherent in research and development; and general political, economic and business conditions. i Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our other filings with the U.S. Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. CONTACT: Investor RelationsEmail: ir@ (8489), Option 4 Media Relations:Email: media@ (8489), Option 6 1. MS Prevalence. National Multiple Sclerosis Society website: Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Datamonitor 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

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