
Aurinia: Q1 Earnings Snapshot
EDMONTON, Alberta — EDMONTON, Alberta — Aurinia Pharmaceuticals Inc. (AUPH) on Monday reported first-quarter net income of $23.3 million, after reporting a loss in the same period a year earlier.
The Edmonton, Alberta-based company said it had net income of 16 cents per share.
The biotechnology company posted revenue of $62.5 million in the period, which topped Street forecasts. Three analysts surveyed by Zacks expected $60.9 million.
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Associated Press
an hour ago
- Associated Press
Zealand Pharma submits Marketing Authorization Application to the European Medicines Agency for glepaglutide in short bowel syndrome
Press release – No. 10 / 2025 Zealand Pharma submits Marketing Authorization Application to the European Medicines Agency for glepaglutide in short bowel syndrome Copenhagen, Denmark, June 2, 2025 – Zealand Pharma A/S (Nasdaq: ZEAL) ('Zealand') (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for glepaglutide, a long-acting GLP-2 analog, for the treatment of adult patients with short bowel syndrome (SBS). The submission of the MAA to the EMA for glepaglutide administered twice weekly for the treatment of SBS is based on results from a pivotal Phase 3 trial (EASE-1), supported by interim results from two ongoing long-term extension trials (EASE-2 and EASE-3) and results from a mechanistic trial (EASE-4). 'We are pleased to bring our potential best-in-class GLP-2 analog, glepaglutide, one step closer to patients in Europe living with short bowel syndrome with intestinal failure, who urgently need more effective and more convenient treatment options,' said David Kendall, MD, Chief Medical Officer of Zealand Pharma. 'We believe that glepaglutide, administered twice weekly, offers meaningful potential to reduce both the burden of parenteral support and the inconvenience of daily dosing required with the only currently available GLP-2 therapy. Looking ahead, we expect to initiate the EASE-5 Phase 3 trial in the second half of the year to obtain further confirmatory safety and efficacy data on the twice weekly dosing regimen, supporting regulatory submission in the U.S.' About glepaglutide Glepaglutide is a long-acting GLP-2 analog in development as a potential treatment option for short bowel syndrome (SBS). Glepaglutide is developed as a liquid product in an autoinjector designed for subcutaneous administration by twice weekly dosing, aimed to reduce, or eliminate, the need for parenteral support in people living with SBS. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for glepaglutide for the treatment of SBS. About the EASE Clinical Trial Program The Phase 3 program, named EASE, is designed to evaluate the potential for glepaglutide to reduce or eliminate the need for parenteral support in SBS patients with intestinal failure. EASE-1 (NCT03690206) was a randomized, double-blind Phase 3 trial that enrolled a total of 106 SBS patients with intestinal failure who were dependent on parenteral support for at least three days per week. Patients were evenly randomized to receive treatment with 10 mg glepaglutide administered either once or twice weekly, or placebo. The primary endpoint in the trial was the absolute change in weekly parenteral support volume from baseline at 24 weeks. At 24 weeks, glepaglutide administered twice weekly significantly reduced the total weekly volume of PS by 5.13 liters/week, compared to a reduction of 2.85 liters/week in the placebo group (p=0.0039). When administered once weekly, glepaglutide treatment resulted in a reduction in weekly PS of 3.13 liters/week, however this did not achieve statistical significance. A total of 9 patients treated with glepaglutide were completely weaned off PS (achieving enteral autonomy), while no placebo-treated patients were able to discontinue PS. For patients treated with glepaglutide twice weekly, 14% of patients (n=5) achieved enteral autonomy. In total, 102 of 106 participating patients completed EASE-1, of which 96 continued into the ongoing two-year, long-term safety and efficacy extension trial, EASE-2. EASE-2 (NCT03905707) is a randomized, double-blind trial in which SBS patients continued their randomly assigned treatment from EASE-1 with glepaglutide 10 mg once- or twice-weekly. Patients who received placebo in EASE-1 were re-randomized to treatment with either glepaglutide 10 mg once- or twice-weekly. In an interim analysis conducted after at least six months of treatment, clinical response to glepaglutide across the key efficacy endpoints was generally maintained or showed continued improvement, including additional patients on both doses weaning off PS. Patients who complete EASE-2 are eligible to participate in EASE-3 (NCT04881825), evaluating glepaglutide administered once weekly using an autoinjector. An interim analysis of EASE-3, conducted with the first 57 patients rolled over from EASE 2, showed that the reduction in prescribed PS was generally maintained. EASE-4 (NCT04991311) was a Phase 3b trial to assess mechanistic effects of glepaglutide on intestinal fluid and energy uptake. The trial provides evidence of the pharmacodynamic effects of glepaglutide in improving intestinal absorption. In the second half of 2025, Zealand Pharma expects to initiate EASE-5, a single Phase 3 clinical trial that is anticipated to provide further confirmatory evidence for a regulatory submission in the U.S. About Zealand Pharma A/S Zealand Pharma A/S (Nasdaq: ZEAL) ('Zealand') is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products. Zealand was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the United States. For more information about Zealand's business and activities, please visit Forward looking statements This press release contains 'forward-looking statements', as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma's expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products, the timing of the company's pre-clinical and clinical trials and the reporting of data therefrom. These forward-looking statements may be identified by words such as 'aim,' 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'intend,' 'may,' 'plan,' 'possible,' 'potential,' 'will,' 'would' and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events, patient recruitment or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems at third party manufacturers; dependency on third parties, for instance contract research or development organizations; unexpected growth in costs and expenses; our ability to affect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this company announcement and are based on information available to Zealand Pharma as of the date of this announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice. Contacts Adam Lange (Investors) Vice President, Investor Relations [email protected] Neshat Ahmadi (Investors) Investor Relations Manager [email protected] Anna Krassowska, PhD (Investors and Media) Vice President, Investor Relations & Corporate Communications [email protected]


Associated Press
an hour ago
- Associated Press
E3 Lithium Provides Progress Update for the Demonstration Facility
CALGARY, Alberta--(BUSINESS WIRE)--Jun 2, 2025-- E3 LITHIUM LTD. (TSXV: ETL) (FSE: OW3) (OTCQX: EEMMF), 'E3', 'E3 Lithium' or the 'Company,' a leader in Canadian lithium, is pleased to provide a progress update on its Demonstration Facility ('Demo Facility'). The Demo Facility is planned to be brought on stream in three phases through the second half of 2025 and into 2026. The lithium extraction equipment comprising of the 30-column Direct Lithium Extraction (DLE) system (the '30-Column System'), as well as the purification and concentration equipment is now fully fabricated and undergoing final checks. The heart of the lithium production equipment is comprised of five separate skids, each containing a specific operation: Skids one and two host the 30-columns and the value control for the DLE system, skids 3 and 4 host the filtration and purification equipment and skid 5 houses the control center. The skids are expected to arrive and be assembled on site in the Clearwater Project area over the next six to eight weeks. E3 Lithium has also received the sorbent for the DLE columns and completed the majority of the payments for this equipment. Following arrival on site, the equipment will be assembled and undergo operational and safety checks, followed by final leak checks. Phase 1 will use brine hosted on site for the commissioning and operation of the 30-column system equipment to produce battery-grade lithium carbonate. It is expected that shortly after the drilling of the wells in Phase 2, the production well will be tied directly into the 30-column equipment and operate using a 'live' brine feed. Operation of a fully integrated system will enable E3 Lithium to optimize the process for factors such as recovery and flow rates and will provide important data for use in the design and costing of the commercial facility. The lithium carbonate produced will be used for customer interrogation and to potentially begin pre-qualification. Each phase of the Demo Facility is an important step towards validating the process technology and E3 Lithium's ability to produce battery-grade lithium carbonate from Leduc Brines at scale. The key objective of the Demo Facility is to de-risk the project design for E3 Lithium's full commercial scale Clearwater Project as the Company progresses towards completion of the Feasibility Study and securing of project financing. 'The team is very excited to see the equipment arrive on site,' commented E3 Lithium's CEO, Chris Doornbos. 'The Demo Facility will be one of the few systems of this kind globally to operate at this scale. It is a significant achievement for E3 Lithium to turn this design into a reality, and a major step forward to see it operate in the very near future.' Preparation for Phase 3 will increase as the first phase begins field operations and is expected to be installed in early 2026. ON BEHALF OF THE BOARD OF DIRECTORS Chris Doornbos, President & CEO E3 Lithium Ltd. About E3 Lithium E3 Lithium is a development company with a total of 16.2 million tonnes of lithium carbonate equivalent (LCE) Measured and Indicated 1 as well as 0.9 million tonnes LCE Inferred mineral resources 2 in Alberta and 2.5 million tonnes LCE Inferred mineral resources 3 in Saskatchewan. The Clearwater Pre-Feasibility Study outlined a 1.13 Mt LCE proven and probable mineral reserve with a pre-tax NPV8% of USD 5.2 Billion with a 29.2% IRR and an after-tax NPV8% of USD 3.7 Billion with a 24.6% IRR 1. 1: The Clearwater Project NI 43-101 Pre-Feasibility Study, effective June 20, 2024, is available on the E3 Lithium's website ( ) and SEDAR+ ( ). 2: The mineral resource NI 43-101 Technical Report for the North Rocky Property, effective October 27, 2017, identified 0.9 Mt LCE (inferred) and is available on the E3 Lithium's website ( ) and SEDAR+ ( ). 3: The mineral resource NI 43-101 Technical Report for the Estevan Lithium District, effective May 23, 2024, identified 2.5 Mt LCE (inferred) and is available on the E3 Lithium's website ( ) and SEDAR+ ( ). Unless otherwise indicated, Kevin Carroll, P. Eng., Chief Development Officer and a Qualified Person under National Instrument 43-101, has reviewed and is responsible for the technical information contained on this news release. Forward-Looking and Cautionary Statements This news release includes certain forward-looking statements as well as management's objectives, strategies, beliefs and intentions or forward-looking information within the meaning of applicable securities laws. Forward-looking statements are frequently identified by such words as 'believe', 'may', 'will', 'plan', 'expect', 'anticipate', 'estimate', 'intend', 'project', 'potential', 'possible' and similar words referring to future events and results. Forward-looking statements are based on the current opinions, expectations, estimates and assumptions of management in light of its experience, perception of historical trends, and results of the PFS, but such statements are not guarantees of future performance. In particular, this news release contains forward-looking information relating to: the estimated mineral resources and mineral resources at the Clearwater Project; expectations regarding the PFS, including statements regarding the results of the PFS and interpretations thereof; expectations concerning the Clearwater Project, including extraction, production, pretreatment, purification, volume reduction and conversion process and features and the expected outcomes thereof; the expected economic performance of the Clearwater Project, including capital costs, operating costs, water usage, land use and carbon emissions; statements regarding the Company's strategy for minimizing environmental impact and liquid waste and maximizing water reuse, with no planned tailings or waste piles; the potential for a secondary revenue stream should the Company be able to sell the calcium carbonate generated during the production of lithium hydroxide; plans and objectives of management for the Company's operations and the Clearwater Project; and the inherent hazards associated with mineral exploration and mining operations. In preparing the forward-looking information in this news release, the Company has applied several material assumptions, including, but not limited to, that any additional financing needed will be available on reasonable terms; the exchange rates for the U.S. and Canadian currencies will be consistent with the Company's expectations; that the current exploration, development, environmental and other objectives concerning the Clearwater Project can be achieved and that its other corporate activities will proceed as expected; that the current price and demand for lithium will be sustained or will improve; that general business and economic conditions will not change in a materially adverse manner and that all necessary governmental approvals for the planned activities on the Clearwater Project will be obtained in a timely manner and on acceptable terms; the continuity of the price of lithium. All forward-looking information (including future-orientated financial information) is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of mineral exploration and development, fluctuating commodity prices, the effectiveness and feasibility of emerging lithium extraction technologies which have not yet been tested or proven on a commercial scale or on the Company's brine, risks related to the availability of financing on commercially reasonable terms and the expected use of proceeds; operations and contractual obligations; changes in estimated mineral reserves or mineral resources; future prices of lithium and other metals; availability of third party contractors; availability of equipment; failure of equipment to operate as anticipated; accidents, effects of weather and other natural phenomena and other risks associated with the mineral exploration industry; the Company's lack of operating revenues; currency fluctuations; risks related to dependence on key personnel; estimates used in financial statements proving to be incorrect; competitive risks and the availability of financing, as described in more detail in our recent securities filings available under the Company's profile on SEDAR+ at Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law. View source version on CONTACT: E3 Lithium - Investor Relations Alexis de la Renaudiere Investor Relations [email protected] 587-324-2775E3 Lithium - Media Inquiries Kati Dolyniuk External Relations [email protected] 587-324-2775 KEYWORD: NORTH AMERICA CANADA INDUSTRY KEYWORD: NATURAL RESOURCES OTHER NATURAL RESOURCES MINING/MINERALS SOURCE: E3 Lithium Ltd. Copyright Business Wire 2025. PUB: 06/02/2025 03:15 AM/DISC: 06/02/2025 03:13 AM

Associated Press
an hour ago
- Associated Press
SolGold PLC Announces Voluntary Delisting from Toronto Stock Exchange
BISHOPSGATE, LONDON / ACCESS Newswire / June 2, 2025 / SolGold plc (LSE:SOLG)(TSX:SOLG) announces that it has applied for a voluntary delisting of its ordinary shares from the Toronto Stock Exchange (the 'TSX'). The delisting is intended to be effective as of the close of trading on June 18, 2025. The ordinary shares in the Company will continue to trade on the Main Market of the London Stock Exchange (the 'LSE') under the symbol 'SOLG'. Since SolGold obtained its TSX listing in 2017 to April 30, 2025, while daily trading activity in the Company's ordinary shares on such exchange increased somewhat, it only accounted for less than 3% of the aggregate trading volume on both platforms. As a result of these relatively low trading volumes on the TSX, the Company believes that the financial costs and administrative requirements associated with maintaining its TSX listing are no longer justified. Shareholder approval is not required for the delisting because the Company's ordinary shares trade on the LSE, which is an acceptable alternative market in accordance with Section 720(b) of the TSX Company Manual. Additional Information for Shareholders on SolGold's Canadian Registrar Following the delisting from the TSX, Canadian shareholders holding shares with their broker ('CDS participant') and wishing to trade their shares on the LSE will need for such shares to be made eligible to be transferred and settled through CREST, the United Kingdom ('UK') based share transfer and settlement system. CDS participants may initiate instructions to Computershare Trust Company of Canada ('Computershare') via its xSettle web service. Shares cannot be transferred and settled through CREST until a shareholder's CDS participant broker or the shareholder initiates a cross-border request. If the shares are held in certificated or Direct Registration form, as applicable, shareholders may instruct Computershare to arrange for the shares to be held by a CREST participant broker. This can be done by completing a 'Register Removal Request - Canada to United Kingdom' form, with valid CREST participant account details, and submitting such form to Computershare via email at [email protected]. For any questions on this process please contact Computershare's global transaction unit by phone at +1 (877) 624-5999. The Company intends to maintain CDS eligibility for its shares until July 18, 2025 in order to allow Canadian shareholders time to complete the process contemplated above. CONTACTS ABOUT SOLGOLD SolGold is a leading resources company focused on the discovery, definition and development of world-class copper and gold deposits and continues to strive to deliver objectives efficiently and in the interests of shareholders. See for more information. Follow us on X @SolGold_plc. CAUTIONARY NOTICE News releases, presentations and public commentary made by SolGold plc (the 'Company') and its officers may contain certain statements and expressions of belief, expectation or opinion which are forward looking statements, and which relate, inter alia, to the Company's plans to delist its ordinary shares from the TSX and the timing thereof, interpretations of exploration results to date and the Company's proposed strategy, plans and objectives or to the expectations or intentions of the Company's Directors, including the plan for developing the Project currently being studied as well as the expectations of the Company as to the forward price of copper. Such forward-looking and interpretative statements involve known and unknown risks, uncertainties, and other important factors beyond the control of the Company that could cause the actual performance or achievements of the Company to be materially different from such interpretations and forward-looking statements. Accordingly, the reader should not rely on any interpretations or forward-looking statements, and save as required by the exchange rules of the TSX and LSE or by applicable laws, the Company does not accept any obligation to disseminate any updates or revisions to such interpretations or forward-looking statements. The Company may reinterpret results to date as the status of its assets and projects changes with time expenditure, metals prices and other affecting circumstances. This release may contain 'forward looking information'. Forward looking information includes, but is not limited to, statements regarding the Company's plans for developing its properties. Generally, forward looking information can be identified by the use of forward- looking terminology such as 'plans', 'expects' or 'does not expect', 'is expected', 'budget', 'scheduled', 'estimates', 'forecasts', 'intends', 'anticipates' or 'does not anticipate', or 'believes', or variations of such words and phrases or state that certain actions, events or results 'may', 'could', 'would', 'might' or 'will be taken', 'occur' or 'be achieved'. Forward looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward looking information, including but not limited to: transaction risks; general business, economic, competitive, political and social uncertainties; future prices of mineral prices; accidents, labour disputes and shortages and other risks of the mining industry. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Factors that could cause actual results to differ materially from such forward-looking information include, but are not limited to, risks relating to the ability of exploration activities (including assay results) to accurately predict mineralization; errors in management's geological modelling and/or mine development plan; capital and operating costs varying significantly from estimates; the preliminary nature of visual assessments; delays in obtaining or failures to obtain required governmental, environmental or other required approvals; uncertainties relating to the availability and costs of financing needed in the future; changes in equity markets; inflation; the global economic climate; fluctuations in commodity prices; the ability of the Company to complete further exploration activities, including drilling; delays in the development of projects; environmental risks; community and non-governmental actions; other risks involved in the mineral exploration and development industry; the ability of the Company to retain its key management employees and skilled and experienced personnel; and those risks set out in the Company's public documents filed on SEDAR+ at Accordingly, readers should not place undue reliance on forward looking information. The Company does not undertake to update any forward-looking information, except in accordance with applicable securities laws. The Company and its officers do not endorse, or reject or otherwise comment on the conclusions, interpretations or views expressed in press articles or third-party analysis. SolGold plc UK Company No. 5449516 ARBN 117 169 856 Email: [email protected] Website: Corporate Postal Office: PO Box 7059, Cloisters Square PO, Perth, WA 6850 Australia Registered office: 1 Cornhill, London, EC3V 3ND, UK Phone: +44 (0) 20 3807 6996 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 [email protected] or visit SOURCE: SolGold PLC press release