Latest news with #RenéeAguiar-Lucander
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4 days ago
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Inventiva Announces the Appointment of Renée Aguiar-Lucander to its Board of Directors
Daix (France), New York City (New York, United States), June 10, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) ('Inventiva' or the 'Company'), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis ('MASH'), today announced the appointment of Renée Aguiar-Lucander to its Board of Directors. The appointment was approved by shareholders at the recent Company's Annual General Meeting. Mark Pruzanski, Chairman of Inventiva: 'We are thrilled to welcome Renée to the Board at this pivotal moment in Inventiva's journey. Her exceptional track record in our industry speaks for itself and will be key as we enter the final stages of clinical development for lanifibranor and prepare for its potential approval and launch.' Renée Aguiar-Lucander: 'I'm honored to have the opportunity to join Inventiva's Board. With the NATiV3 Phase 3 trial fully enrolled, I look forward to working with the team to potentially bring lanifibranor to patients with MASH.' Mrs. Aguiar-Lucander has served as the Chief Executive Officer of Hansa Biopharma since April 2025. She was previously Chief Executive Officer of Calliditas Therapeutics, where she led the transformation of the company from a small biotech company into a NASDAQ-listed, commercial-stage leader in rare diseases, culminating in its $1.1 billion acquisition by Asahi Kasei in 2024. Under her leadership, Calliditas achieved the first-ever FDA approval for a treatment in IgA nephropathy (TARPEYO®) and successfully launched the product in the U.S. Prior to her role at Calliditas, Ms. Aguiar-Lucander held various senior roles in the field of life sciences investment and corporate finance, including Partner and COO at Omega Fund Management and Managing Director at a global investment bank. She holds an MBA from INSEAD and a BA in Finance from the Stockholm School of Economics. About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with MASH and other diseases with significant unmet medical need. The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressive chronic liver disease. Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). Contacts InventivaPascaline ClercEVP, Strategy and Corporate Affairsmedia@ +1 202 499 8937 Brunswick GroupTristan Roquet Montegon /Aude Lepreux /Julia CailleteauMedia relations inventiva@ +33 1 53 96 83 83 ICR HealthcarePatricia L. BankInvestor relations +1 415 513 1284 Important Notice This press release contains certain 'forward-looking statements' within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, Inventiva's clinical trials, including Inventiva's ongoing NATiV3 Phase 3 clinical trial of lanifibranor in MASH, including related timing and regulatory matters, Inventiva's pipeline development plans, the clinical development of and regulatory plans and pathway for lanifibranor, and future activities, expectations, plans, growth and prospects of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, 'believes', 'anticipates', 'expects', 'intends', 'plans', 'seeks', 'estimates', 'may', 'will', 'would', 'could', 'might', 'should', 'designed', 'hopefully', 'target', 'potential', 'possible', 'aim', and 'continue' and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance, or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reached on their expected timeline, or at all. Future results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates due to a number of factors, including that interim data or data from any interim analysis of ongoing clinical trials may not be predictive of future trial results, the recommendation of the DMC may not be indicative of a potential marketing approval, Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction on the results or timing of the NATiV3 trial or regulatory matters with respect thereto, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of which, Inventiva may be required to significantly curtail, delay or discontinue one or more of its research or development programs or be unable to expand its operations or otherwise capitalize on its business opportunities and may be unable to continue as a going concern, Inventiva's ability to obtain financing, to enter into potential transactions, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of lanifibranor, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's and its partners' clinical trials may not support Inventiva's and its partners' product candidate claims, Inventiva's expectations with respect to its clinical trials may prove to be wrong and regulatory authorities may require additional holds and/or amendments to Inventiva's clinical trials, Inventiva's expectations with respect to the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva's ability to identify additional products or product candidates with significant commercial potential, Inventiva's expectations with respect to its pipeline prioritization plan and related workforce reduction, including whether the plan will be implemented and the timing, potential benefits, expenses and consequences relating thereto, Inventiva's ability to execute on its commercialization, marketing and manufacturing capabilities and strategy, Inventiva's ability to successfully cooperate with existing partners or enter into new partnerships, and to fulfill its obligations under any agreements entered into in connection with such partnerships, the benefits of its existing and future partnerships on the clinical development, regulatory approvals and, if approved, commercialization of its product candidates, and the achievement of milestones thereunder and the timing thereof, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's and its partners' control, Inventiva's product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva's and its partners' business, and pre-clinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by changes in law and regulations, unfavorable conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, the conflict in the Middle East and the related risk of a larger conflict, health epidemics, and macroeconomic conditions, including developments in international trade policies, global inflation, financial and credit market fluctuations, tariffs and other trade barriers, political turmoil and natural catastrophes, uncertain financial markets and disruptions in banking systems, and the vote of Inventiva's shareholders. The review of potential financial and strategic options may not result in any particular action or transaction being pursued, entered into or consummated, and there is no assurance as to the timing, sequence or outcome of any action or transaction or series of actions or transactions. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts, and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Please refer to the Universal Registration Document for the year ended December 31, 2024, filed with the Autorité des Marchés Financiers on April 15, 2025, and the Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (the 'SEC') on April 15, 2025 for other risks and uncertainties affecting Inventiva, including those described under the caption 'Risk Factors' and in future filings with the SEC. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. All information in this press release is as of the date of the release. Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements. Attachment Inventiva - PR - Appointment Renee Aguiar Lucanter to the Board - EN - 06 10 2025
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4 days ago
- Business
- Yahoo
Inventiva Announces the Appointment of Renée Aguiar-Lucander to its Board of Directors
Daix (France), New York City (New York, United States), June 10, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) ('Inventiva' or the 'Company'), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis ('MASH'), today announced the appointment of Renée Aguiar-Lucander to its Board of Directors. The appointment was approved by shareholders at the recent Company's Annual General Meeting. Mark Pruzanski, Chairman of Inventiva: 'We are thrilled to welcome Renée to the Board at this pivotal moment in Inventiva's journey. Her exceptional track record in our industry speaks for itself and will be key as we enter the final stages of clinical development for lanifibranor and prepare for its potential approval and launch.' Renée Aguiar-Lucander: 'I'm honored to have the opportunity to join Inventiva's Board. With the NATiV3 Phase 3 trial fully enrolled, I look forward to working with the team to potentially bring lanifibranor to patients with MASH.' Mrs. Aguiar-Lucander has served as the Chief Executive Officer of Hansa Biopharma since April 2025. She was previously Chief Executive Officer of Calliditas Therapeutics, where she led the transformation of the company from a small biotech company into a NASDAQ-listed, commercial-stage leader in rare diseases, culminating in its $1.1 billion acquisition by Asahi Kasei in 2024. Under her leadership, Calliditas achieved the first-ever FDA approval for a treatment in IgA nephropathy (TARPEYO®) and successfully launched the product in the U.S. Prior to her role at Calliditas, Ms. Aguiar-Lucander held various senior roles in the field of life sciences investment and corporate finance, including Partner and COO at Omega Fund Management and Managing Director at a global investment bank. She holds an MBA from INSEAD and a BA in Finance from the Stockholm School of Economics. About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with MASH and other diseases with significant unmet medical need. The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressive chronic liver disease. Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). Contacts InventivaPascaline ClercEVP, Strategy and Corporate Affairsmedia@ +1 202 499 8937 Brunswick GroupTristan Roquet Montegon /Aude Lepreux /Julia CailleteauMedia relations inventiva@ +33 1 53 96 83 83 ICR HealthcarePatricia L. BankInvestor relations +1 415 513 1284 Important Notice This press release contains certain 'forward-looking statements' within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, Inventiva's clinical trials, including Inventiva's ongoing NATiV3 Phase 3 clinical trial of lanifibranor in MASH, including related timing and regulatory matters, Inventiva's pipeline development plans, the clinical development of and regulatory plans and pathway for lanifibranor, and future activities, expectations, plans, growth and prospects of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, 'believes', 'anticipates', 'expects', 'intends', 'plans', 'seeks', 'estimates', 'may', 'will', 'would', 'could', 'might', 'should', 'designed', 'hopefully', 'target', 'potential', 'possible', 'aim', and 'continue' and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance, or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reached on their expected timeline, or at all. Future results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates due to a number of factors, including that interim data or data from any interim analysis of ongoing clinical trials may not be predictive of future trial results, the recommendation of the DMC may not be indicative of a potential marketing approval, Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction on the results or timing of the NATiV3 trial or regulatory matters with respect thereto, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of which, Inventiva may be required to significantly curtail, delay or discontinue one or more of its research or development programs or be unable to expand its operations or otherwise capitalize on its business opportunities and may be unable to continue as a going concern, Inventiva's ability to obtain financing, to enter into potential transactions, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of lanifibranor, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's and its partners' clinical trials may not support Inventiva's and its partners' product candidate claims, Inventiva's expectations with respect to its clinical trials may prove to be wrong and regulatory authorities may require additional holds and/or amendments to Inventiva's clinical trials, Inventiva's expectations with respect to the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva's ability to identify additional products or product candidates with significant commercial potential, Inventiva's expectations with respect to its pipeline prioritization plan and related workforce reduction, including whether the plan will be implemented and the timing, potential benefits, expenses and consequences relating thereto, Inventiva's ability to execute on its commercialization, marketing and manufacturing capabilities and strategy, Inventiva's ability to successfully cooperate with existing partners or enter into new partnerships, and to fulfill its obligations under any agreements entered into in connection with such partnerships, the benefits of its existing and future partnerships on the clinical development, regulatory approvals and, if approved, commercialization of its product candidates, and the achievement of milestones thereunder and the timing thereof, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's and its partners' control, Inventiva's product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva's and its partners' business, and pre-clinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by changes in law and regulations, unfavorable conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, the conflict in the Middle East and the related risk of a larger conflict, health epidemics, and macroeconomic conditions, including developments in international trade policies, global inflation, financial and credit market fluctuations, tariffs and other trade barriers, political turmoil and natural catastrophes, uncertain financial markets and disruptions in banking systems, and the vote of Inventiva's shareholders. The review of potential financial and strategic options may not result in any particular action or transaction being pursued, entered into or consummated, and there is no assurance as to the timing, sequence or outcome of any action or transaction or series of actions or transactions. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts, and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Please refer to the Universal Registration Document for the year ended December 31, 2024, filed with the Autorité des Marchés Financiers on April 15, 2025, and the Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (the 'SEC') on April 15, 2025 for other risks and uncertainties affecting Inventiva, including those described under the caption 'Risk Factors' and in future filings with the SEC. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. All information in this press release is as of the date of the release. Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements. Attachment Inventiva - PR - Appointment Renee Aguiar Lucanter to the Board - EN - 06 10 2025Sign in to access your portfolio
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24-04-2025
- Business
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Hansa Biopharma Reports First Quarter and Interim January-March 2025 Financial Results
Strong product sales and key progress in pipeline catalysts LUND, Sweden, April 24, 2025 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" or the "Company" (Nasdaq Stockholm: HNSA), today announced its interim report for January-March 2025. Peter Nicklin, Chairman of the Board, Hansa Biopharma said, "In Q1, the Company delivered strong growth with total revenue of 66.3 MSEK and products sales of 65.7 MSEK. This represents a 39 percent increase as compared to Q1 2024 (47.4 MSEK). While the organ allocation market remains unpredictable and directly impacts our quarterly sales, we remain confident in our ability to significantly increase revenue year on year. In Q1, we completed enrollment in the Post Authorization Efficacy and Safety (PAES) study, secured access and reimbursement in three additional European markets, and saw growing repeat utilization of IDEFIRIX® (imlifidase) in key centers across Europe. In the second half of 2025, we anticipate several key pipeline catalysts, including data readouts from Hansa's U.S. ConfIdeS Phase 3 pivotal trial in kidney transplantation and the anti-GBM Phase 3 pivotal trial." "Also, of note, following the positive full results from the 15-HMedIdeS-09 single arm Phase 2 study in Guillain Barre Syndrome (GBS) shared in December 2024, the data is set to be presented at an upcoming medical congress. Finally, the development of the Company's next generation molecule for repeat dosing, HNSA-5487, remains on track. We recently had very positive interaction with BfArM confirming the clinical development plan for HNSA-5487 in myasthenia gravis (MG)." The Company also announced Renée Aguiar-Lucander has been appointed Chief Executive Officer effective immediately. Søren Tulstrup has stepped down from his position of CEO by mutual agreement after seven years of dedicated service to the Company. Financial Performance Q1 2025 product sales of IDEFIRIX® totaled 65.7 MSEK representing a 39 percent increase over Q1 2024 (47.4 MSEK). Revenue for the first quarter 2025 totaled 66.3 MSEK. The addition of new sites using IDEFIRIX combined with growing repeat utilization contributed to the performance. Hansa expects to see continued strong year-on-year product sales growth despite continued quarterly product sales fluctuation due to variations in European kidney allocation systems, which impacts the availability of organs for patients. Pipeline Progress During the first quarter of 2025, Hansa completed enrolment of the 20-HMedIdeS-19 Post Authorization Efficacy and Safety (PAES) study. The PAES study is part of the Company's obligation following conditional authorization by the European Commission for IDEFIRIX. The study is expected to read out in the second half of 2026 and is intended to support full marketing authorization in Europe. With completed enrollment, Hansa expects increased commercial utilization of imlifidase at key centers across Europe that participated in the PAES study. Following positive data from the 15-HMedIdeS-09 Phase 2 trial and indirect treatment comparison to the International Guillain-Barré Syndrome Outcome Study (IGOS), the data has been accepted for oral presentation at an upcoming medical conference in 2025. The trial and indirect treatment comparison demonstrated imlifidase's potential to address significant unmet need in GBS. The Phase 2 trial GNT-018-IDES in collaboration with Genethon in patients with Crigler Najjar syndrome with pre-existing antibodies against adeno-associated vectors (AAV) continues to progress with enrolment currently ongoing. The 20-HMedIdeS-17 study (ConfIdeS) remains on track for a data readout in the second half of 2025. This pivotal Phase 3 trial is evaluating imlifidase as a potential desensitization therapy, compared to standard of care, to enable kidney transplantation in highly sensitized patients. Financial SummaryMSEK, unless otherwise stated – unaudited Q1 2025 Q1 2024 FY 2024Total Revenue 66.3 56.0 220.9-thereof: Product sales 65.7 47.4 189.7Provision1 – – (49.6)Net revenue after provision 66.3 56.0 171.3SG&A expenses (76.0) (91.3) (344.3)R&D expenses (64.3) (103.0) (375.7)Loss from operations (93.4) (159.4) (637.9)Loss for the period (37.1) (218.6) (807.2)Net cash used in operations (151.9) (189.1) (674.9)Cash and short-term investments 250.2 541.5 405.3EPS before and after dilution (SEK) (0.55) (4.15) (12.85)Number of outstanding shares 67,814,241 52,671,796 67,814,241Weighted average number of shares before and after dilution 67,814,241 52,671,796 62,834,848No of employees at the end of the period 138 166 1351 Actual product sales for the full year 2024 totaled 189.7 MSEK. Sales were offset by a provision totaling 49.6 MSEK associated with volume discounts and rebates. Including the provision, year to date product sales totaled 140.1 MSEK. Conference Call Details Hansa Biopharma will host a telephone conference today Thursday, 24 April, 2025, at 14:00 CEST / 8:00 am EDT. The event will be hosted by Peter Nicklin, Chairman of the Board, Evan Ballantyne, CFO, and Hitto Kaufmann, CR&DO and Renée Aguiar-Lucander. The call will include a review of the interim results and a business and pipeline update. It will be held in English. Slides used in the presentation will be live on the company website during the call under Events & Presentations and will also be made available online after the call. To participate in the telephone conference, please use the dial-in details provided below:Participant Dial In (Toll Free): 1-833-821-3542Participant International Dial In: 1-412-652-1248*Please ask to be joined into the Hansa Biopharma call Join the webcast here: For the full financial calendar and list of events in 2025 please visit Contacts for more information: Evan Ballantyne, Chief Financial OfficerIR@ Stephanie Kenney, VP Global Corporate Affairsmedia@ Notes to editors About Hansa Biopharma Hansa Biopharma AB is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life-altering treatments for patients with rare immunological conditions. The company has a rich and expanding research and development program based on its proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in autoimmune diseases, gene therapy and transplantation. The company's portfolio includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients and HNSA-5487, a next generation IgG cleaving molecule with redosing potential. Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the U.S. The company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at and follow us on LinkedIn. ©2025 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved. This information was brought to you by Cision The following files are available for download: 20250423 HNSA - Q1 2025 Quarterly Report ENG View original content: Sign in to access your portfolio
