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Last patient in: Laminar Pharmaceuticals S.A. completes recruitment for CLINGLIO, the phase 2b/3 Clinical Trial of idroxioleic acid (LAM561) in combination with RT and TMZ for adults with newly diagnosed glioblastoma

140 patients have been recruited at sites in Spain, Italy, France and United Kingdom.The open readout of the trial is expected by late 2024.Laminar aims to submit regulatory filings or conditional marketing authorization by early 2025. PALMA DE MALLORCA, Spain, June 12, 2024 /PRNewswire/ -- Laminar Pharmaceuticals S.A., a clinical-stage biotechnological company developing novel therapies to treat diverse pathologies with unmet clinical needs, is pleased to announce the recruitment of patients for the CLINGLIO (NCT04250922) study has been closed after 140 adult patients have been successfully enrolled. The CLINGLIO study is a multinational, phase 2b/3, randomized, placebo-controlled, double-blind clinical trial evaluating idroxioleic acid in combination with Standard of Care (combined tumour resection and chemoradiotherapy) for the treatment of newly diagnosed glioblastoma patients. The CLINGLIO trial, funded by a European Commission Grant (H2020) is being carried out in 21 hospitals in Spain, Italy, France, and United Kingdom. The investigational study drug, idroxioleic acid (LAM561, sodium; 2-OHOA) is a synthetic fatty acid with a novel therapeutic approach, administrated orally to treat this devastating type of cancer. "We are pleased to announce that the pivotal phase 2b/3 trial recruitment is completed, as this means that the results and outcome of the trial will be soon available," said Adrian McNicholl, Chief of Clinical Operations at Laminar Pharmaceuticals. The trial is expected to reach the trigger event for interim analysis in July 2024, which would provide an unblinded readout the last quarter of this year. "If idroxioleic acid is able to show compelling evidence demonstrating significant progression free survival benefit with overall survival, it could imply the first addition to the Standard of Care for glioblastoma patients since the approval of Temozolomide in 2005, 19 years ago." These unblinded results will be submitted for EMA evaluation for Conditional Marketing Authorization in early 2025, and the trial will continue until final analysis of survival in 2026. Pablo Escribá, CEO of Laminar Pharmaceuticals, said: "The completion of the recruitment is a huge milestone in our clinical trial and in the development of this potential new therapy for glioblastoma patients. We are excited about the possibility of offering a new treatment available for this fatal disease, which has some of the clearer unmet needs across the oncology field". The CLINGLIO trial, which was initiated in December 2019, has enrolled 140 participants across 4 countries in Europe. Those patients were randomized 1:1 versus placebo. Idroxioleic acid or placebo is added to Standard of Care, and continued for as long as the tumour does not progress. Idroxioleic acid has shown a favorable safety profile in pre-clinical and clinical trials so far. Additionally, no safety concerns were raised by an Independent Data Monitoring Committee (IDMC) who recommended "continue without modifications" after unblinded reviews of the available safety and efficacy data. The trial will continue until the final analysis of overall survival. The CLINGLIO trial is considered pivotal in that results showing significant clinical benefit could be sufficient for a request for conditional marketing authorization in the EU late this year; and potential full marketing authorization in 2026, for which enabling pre-submission interactions with the EMA have been initiated. About Laminar Pharmaceuticals S.A. Laminar Pharmaceuticals S.A. (Laminar) is a Spanish biotechnological company created in 2006, committed to translational health research, for the rational design and development of drugs to treat oncological and other pathologies in the form of synthetic fatty acids considered "First-in-class Health Solutions" and based on a novel technology, the Melitherapy (MLT or Membrane Lipid Therapy). Laminar controls all the processes, from the rational design of the molecules to the clinical trials that lead up to the launch of a new drug, with constant investment in R&D and high-quality standards. It is currently headquartered in Mallorca (Spain) with a subsidiary in Massachusetts (USA). About Glioblastoma Glioblastoma is the most common primary malignant brain tumour and accounts for nearly 50 percent of all gliomas and approximately 25 percent of all primary brain and CNS malignant tumours. The incidence of GBM in Europe is currently above 25,000 new cases each year, rising to over 100,000 cases per year worldwide. The prognosis for Glioblastoma patients is very poor, with a median survival time of about 14.5 months despite optimum chemo-radiation treatment. About 15% of patients survive two years after diagnosis and ca. 4% survive for five or more years. In this scenario, there is a desperate need for novel treatment alternatives that provide safe and more efficacious clinical outcomes. About idroxioleic acid Idroxioleic acid (LAM561; 2-hydroxyoleic acid (2-OHOA)) is a synthetic derivative of oleic acid and Laminar's most advanced R&D product, which is taken orally. This drug alters the composition of the plasma membrane in cancer cells, reducing the activity of membrane-associated signaling proteins that are known to promote tumour growth and affecting tumours in the brain. LAM561 is in the process of completing its last clinical development phase in adults and has shown promising preliminary clinical activity in the treatment of aggressive high-grade glioblastoma.  

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 343 加入收藏 :
Ono Announces Results of Tender Offer to Acquire Deciphera Pharmaceuticals and Completion of Acquisition of Deciphera (a Wholly Owned Subsidiary of Ono)

OSAKA, Japan and WALTHAM, Mass., June 11, 2024 /PRNewswire/ -- Ono Pharmaceutical, Co., Ltd. (Chairman and CEO: Gyo Sagara, "Ono") today announced that it has successfully completed the tender offer, previously announced on April 30, 2024 to acquire all outstanding shares of common stock of a US biopharmaceutical company, Deciphera Pharmaceuticals, Inc. (Nasdaq: DCPH, CEO: Steven L. Hoerter, "Deciphera") for US$25.60 per share (total amount of approximately US$2.4 billion) net to the seller in cash, without interest thereon and less any applicable withholding taxes, through its wholly owned subsidiary, Topaz Merger Sub, Inc. ("Merger Sub"), established in the State of Delaware, United States, solely for the purpose of engaging in the transactions contemplated in the Merger Agreement. The tender offer commenced on May 13, 2024, New York City time, and, as set forth below, expired at one minute after 11:59 p.m., New York City time, on June 10, 2024. On June 11, 2024, following the completion of the tender offer, Merger Sub merged with and into Deciphera with Deciphera continuing as the surviving corporation and a wholly owned subsidiary of Ono. In connection with the acquisition, Deciphera shares ceased to be traded on Nasdaq as of the date of closing of the acquisition and shares of Deciphera's common stock will be delisted from Nasdaq. "We are very pleased to welcome Deciphera into the family," said Gyo Sagara, Chairman and CEO of Ono. "Through this acquisition, we will leverage Deciphera's excellent research and development capabilities in the oncology field and its sales power in Europe and the United States, and work to further accelerate the expansion of our pipeline and global expansion, which are part of our growth strategies." "We are excited to enter a new phase as part of the family of Ono Pharmaceuticals, that has as its mission to contribute to society through the discovery and development of innovative drugs, under the corporate philosophy "Dedicated to the Fight against Disease and Pain,"" said Steven L. Hoerter, President and CEO of Deciphera. "By fully leveraging the research and development capabilities and commercialization platforms of both companies, we look forward to significantly contributing to the growth of the Ono Group as a global specialty pharma company." 1. Results of the tender offer (1) Overview of the tender offer Name of the tender offerer: Topaz Merger Sub, Inc. Name of the target company: Deciphera Pharmaceuticals, Inc. Types of shares, etc. subject to tender offer: Common stock Tender offer price: US$25.60 per share net to the seller in cash, without interest thereon and less any applicable withholding taxes Period of the tender offer: From May 13, 2024 to one minute after 11:59 p.m., New York City time, on June 10, 2024 Minimum condition: Consummation of the tender offer was subject to a condition that a majority of Deciphera's outstanding shares of common stock at the time of the expiration of the tender offer shall have been validly tendered and not validly withdrawn. The offer was subject to the satisfaction or waiver of various other conditions. (2) Results of the tender offer Application status (as of one minute after 11:59 p.m., New York City time, on June 10, 2024)76,413,423 shares representing 88.25% of the outstanding shares of common stock of Deciphera were validly tendered and not validly withdrawn. Outcome of the tender offerAs the number of shares of Deciphera common stock validly tendered met and exceeded the minimum condition stated in 1. (1) 6. above, the tender offer was consummated. (3) Merger procedures following the tender offer On June 11, 2024, New York City time, pursuant to Section 251(h) of the Delaware General Corporation Law, Merger Sub merged with and into Deciphera, with Deciphera continuing as the surviving corporation, and Deciphera became a wholly-owned subsidiary of Ono. As a result, as of that day, Deciphera shares not tendered in the tender offer (excluding shares of common stock held by Deciphera as treasury shares which were extinguished without consideration, Deciphera shares of common stock held by Ono or Merger Sub, and shares for which appraisal rights were exercised pursuant to Delaware law) were converted into the right to receive US$25.60 per share net to the seller in cash, without interest thereon and less any applicable withholding taxes, the same as the tender offer price. 2. Overview of Deciphera (prior to the completion of the acquisition on June 11, 2024): (1) Company Deciphera Pharmaceuticals, Inc. (2) Address 200 Smith Street Waltham, MA 02541, USA (3) Representative's Title and Name President & CEO, Steven L. Hoerter (4) Business Description R&D and Commercialization of pharmaceuticals (5) Stated Capital US $ 805 thousand (as of December 31, 2023) (6) Year of Establishment 2017 (initial company Deciphera Pharmaceuticals, LLC was formed in 2003) (7) Major shareholders and ownership ratio (as of March 31, 2024) Brightstar Associates LLC: 28.1% Redmile Group, LLC: 10.2% Blackrock Inc.: 7.3% Deerfield Mgmt, L.P.: 7.0% (8) Relationship between Ono and Deciphera Capital Relationship N.A. Personal Relationship N.A. Business Relationship N.A. Status of A Related Party N.A. (9) Deciphera's consolidated operating results and consolidated financial position for the past three years(*1) Accounting Period (Unit: thousands of US $) Fiscal year ended December 2021 Fiscal year ended December 2022 Fiscal year ended December 2023 Total Equity 304,720 341,691 350,916 Total Assets 429,484 454,039 473,566 Equity per share (US $)(*2) 5.25 4.53 4.13 Revenue 96,148 134,036 163,356 Operating Loss (300,077) (182,722) (210,958) Net Loss (299,964) (178,931) (194,942) Net loss per share (US $) (5.16) (2.37) (2.29) Dividend per share (US $) - - - *1: Information from Deciphera's Annual Report on Form 10-K, for the fiscal years ended December 31, 2022 and December 31, 2023, filed by Deciphera with the U.S. Securities and Exchange Commission (the "SEC") on February 7, 2023 and February 7, 2024, respectively. *2: Calculated by total equity divided by weighted average common shares outstanding. 3. Financial Impact of the Acquisition ONO is still reviewing the impact of this acquisition on our business performance. Should there be any events to be disclosed in the future, we will announce them in a timely manner.  

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 49 加入收藏 :
Secarna Pharmaceuticals 與 Orbit Discovery 合作開發胜肽偶聯標靶反義寡核苷酸療法

此次合作將跨越傳統抗體與糖分子的技術層面,並拓展 Secarna 在反義寡核苷酸 (ASO) 的開發能力 新平台的技術能力將擴大 Secarna 的反義寡核苷酸應用範圍,或將為多種疾病提供全新的治療選擇 德國馬丁斯里德和英國牛津 - EQS Newswire - 2024 年 5 月 31 日 - 歐洲領先的獨立反義藥物研發公司 Secarna Pharmaceuticals GmbH & Co. KG (Secarna) 和治療性胜肽研究的領導者 Orbit Discovery Ltd. (Orbit) 今日宣布雙方將攜手合作,共同研發胜肽偶聯的標靶反義寡核苷酸 (ASO) 療法。 此次合作將運用 Orbit 的專業經驗,以及基於微珠技術建構的胜肽展示引擎以進行鑑定、篩選,並挑出適用於多種疾病標的特定環肽,並將其與 Secarna 的 ASO 分子配對。透過將環肽整合至 Secarna 的專有 ASO 研發平台,將顯著擴大其治療範疇,開發出超越抗體和糖分子 (如 GalNAc) 等模式的標靶反義療法。 Secarna Pharmaceuticals 的首席商務官 Konstantin Petropoulos 表示:「我們非常高興能與 Orbit Discovery 展開此次合作,憑藉該公司在胜肽研發方面的專業經驗,將進一步提升我們開發標靶靶反義療法的能力。」另補充道:「我們期待與 Orbit 合作,擴大標靶 ASO 療法的治療潛力和範圍,為迫切需要的患者提供高度特異性、有效、安全和方便的治療方案。」 Orbit 的胜肽研發服務結合了 DNA 編碼庫以及基於微珠技術建構的展示能力,能夠在大型的胜肽資料庫中進行篩選。這項專有技術具有獨特優勢,能夠處理可溶性目標以及細胞內外的「原位」目標,並透過親和性篩選和/或功能性篩選,顯著縮短相關胜肽線索的發現時間。 此次合作不僅加強了 Secarna 在開發胜肽偶聯的標靶反義療法的能力,更將大幅擴展反義療法的應用範疇,或將為更多疾病提供全新的治療選擇。 Orbit Discovery 首席執行官 Neil Butt 博士表示:「我們很高興與 Secarna 攜手針對高效且高度特異性標靶治療,合作以滿足日益增長的廣大需求,致力為創新 ASO 療法的提供方式帶來全新的選擇。」另提到:「此次合作進一步證明了我們在標靶胜肽偶聯藥物方面的專業研發經驗,並拓展了我們持續壯大的合作夥伴組合,這些夥伴與我們共享同一目標,即提供新一代低毒性且組織特異性更佳的治療藥物,最終為全球患者提供更安全、更有效的治療方案。」 Hashtag: #SecarnaPharmaceuticals發佈者對本公告的內容承擔全部責任關於 Secarna Pharmaceuticals GmbH & Co. KGSecarna Pharmaceuticals 是歐洲領先的獨立新一代反義藥物研發公司,專注解決免疫腫瘤學和免疫學,以及病毒、神經退行性和心臟代謝疾病領域內未能滿足的醫療需求。Secarna 的使命是透過其專有的反義寡核苷酸研發平台,將治療效果與研究發現最大化,以生成高度特異性、安全和有效的最佳反義療法。Secarna 擁有 20 多個研發計劃,包括自主研發和合作項目,相較於其他治療方式,更專注於反義療法中具有明顯潛在優勢的適應症標的。www.secarna.com 關於 Orbit DiscoveryOrbit Discovery Ltd 是一家致力於胜肽研發的公司,其平台利用創新的微珠和微流控技術以提高功能篩選的通量。Orbit 的技術涵蓋標靶蛋白質的表達和純化,包括多次跨膜蛋白、親和性篩選以識別標靶相關的治療候選者;以及以細胞為基礎的功能性篩選。Orbit 的跨專業團隊由世界級的研究人員和藥物開發專家組成,致力將這些技術轉化為合作夥伴間的突破性人體治療方案,這些合作夥伴包括大型製藥和生物技術公司。Orbit Discovery 位於牛津科學園,並得益於創始人 Graham Ogg 教授 (牛津大學) 和 Terry Rabbits 教授 (癌症研究所) 的專業知識和豐富經驗。欲了解更多資訊,請訪問:www.orbitdiscovery.com

文章來源 : Media OutReach Limited 發表時間 : 瀏覽次數 : 1395 加入收藏 :
Secarna Pharmaceuticals and Orbit Discovery enter collaboration to discover and develop peptide-conjugated targeted antisense oligonucleotide therapeutics

Partnership expands spectrum of Secarna's capabilities for the development of targeted ASOs beyond antibodies and sugar molecules New platform capabilities extend the reach of Secarna's antisense approaches, potentially offering new treatment options for a wider range of diseases MARTINSRIED, GERMANY and OXFORD, UK - EQS Newswire - 28 May 2024 - Secarna Pharmaceuticals GmbH & Co. KG (Secarna), a leading independent European antisense drug discovery and development company, and Orbit Discovery Ltd. (Orbit), a leader in the discovery of therapeutic peptide hits, today announced that they have entered into a collaboration to discover and develop peptide-conjugated targeted antisense oligonucleotide (ASO) therapeutics. The collaboration will leverage Orbit's expertise and bead-based peptide display engine for the identification, screening, and selection of cyclic peptides specific to a wide range of disease targets, to be paired with Secarna's ASO molecules. The addition of cyclic peptides to Secarna's proprietary ASO discovery and development platform will expand its therapeutic spectrum, positioning it to develop targeted antisense assets beyond modalities such as antibodies and sugar molecules, like GalNAc. "We are very pleased to embark on this collaboration with Orbit Discovery, as the team's expertise in peptide discovery and development will further enhance our capabilities for the development of targeted antisense therapeutics", said Konstantin Petropoulos, CBO of Secarna Pharmaceuticals. "We look forward to working with Orbit to expand both the therapeutic potential and universe of targeted ASO therapeutics with highly specific, potent, safe and convenient therapeutic options available for patients who urgently need them." Orbit's peptide discovery services enable the screening of large libraries of peptides through the combination of DNA-encoded libraries and bead-based presentation. The proprietary technology is uniquely equipped to address soluble targets and targets in situ, both on and in cells, allowing for faster discovery times of relevant peptide leads based on affinity screens and/or functional screens. The collaboration not only strengthens Secarna's ability to create targeted antisense therapeutics, paired to cyclic peptides, but will also extend the reach of antisense approaches, potentially offering new treatment options for a wider range of diseases. "Together with Secarna, we are excited to address the growing need for effective and highly specific targeted therapeutics, focused on enabling new options for the way innovative ASO therapies are delivered", said Dr. Neil Butt, Chief Executive Officer, Orbit Discovery. "This collaboration is further validation of our expertise in the discovery of targeting peptide conjugates, and adds to our growing portfolio of partners that share our goal of delivering a generation of therapeutics with lower toxicity and better tissue specificity that will ultimately be safer and more effective for patients globally." Hashtag: #SecarnaPharmaceuticalsThe issuer is solely responsible for the content of this announcement.About Secarna Pharmaceuticals GmbH & Co. KGSecarna Pharmaceuticals is the leading independent European next-generation antisense drug discovery and development company addressing high unmet medical needs in immuno-oncology and immunology, as well as viral, neurodegenerative and cardiometabolic diseases. Secarna's mission is to maximize the performance and output of its proprietary antisense oligonucleotide discovery and development platform to generate highly specific, safe, and efficacious best-in-class antisense therapies. With over 20 discovery and development programs, including both proprietary pipeline projects and partnered programs, Secarna focuses on targets in indications where antisense-based approaches have clear potential benefits over other therapeutic modalities. www.secarna.com About Orbit DiscoveryOrbit Discovery Ltd is a peptide discovery company focused on the use of novel bead and microfluidic technology platforms to improve the throughput of functional screening. The Orbit technologies encompass target protein expression and purification, including multi-spanning membrane proteins; affinity screening to identify panels of target binding therapeutic candidates; and functional screening in cell-based assays. Orbit's multi-disciplinary team of world-class researchers and drug developers is working to translate this technology into breakthrough human therapeutics for Partners and collaborators, these parties encompass large scale pharmaceutical and biotechnology companies. Orbit Discovery is based in the Oxford Science Park and benefits from the expertise and experience of its founders, Professor Graham Ogg (University of Oxford) and Professor Terry Rabbits (the Institute of Cancer Research). For more information, please visit: www.orbitdiscovery.com

文章來源 : Media OutReach Limited 發表時間 : 瀏覽次數 : 410 加入收藏 :
Aiming for New Quality Productivity, Aiding in Reaching the Summit of Global Innovative Pharmaceuticals

Fully Human Antibody Development Platform—NeoMab Bio Officially Opens in Suzhou SUZHOU, China, May 22, 2024 /PRNewswire/ -- On May 22, 2024, NeoMab Biotechnology (Suzhou) Co., Ltd. celebrated its grand opening in Suzhou Industrial Park (BioBAY). This marks a significant milestone that will further enhance the high-quality development of Suzhou's biopharmaceutical innovation cluster. The ceremony was attended by government representatives, investors, and various industry experts and enterprise representatives from the biopharmaceutical field, all witnessing this important event together. Relying on its strong scientific research and talent capabilities and the vigorous support from the Suzhou Industrial Park government, GemPharmatech Co., Ltd. established a wholly-owned subsidiary, NeoMab Biotechnology (Suzhou) Co., Ltd., focusing on the development of fully human antibodies based on the NeoMab™ transgenic mouse platform. The company has also set up the NeoMab™ fully human antibody discovery platform. NeoMab Bio aims to provide more flexible and cost-effective solutions for research institutions, biotechnology companies, and pharmaceutical enterprises dedicated to antibody development. According to Dr. Xiang Gao, President of GemPharmatech: "The application of antibody fully humanized mice in antibody development and screening is a significant catalyst for the development of antibody drugs, providing a solid foundation for nurturing the future biopharmaceutical industry. In order to achieve a competitive position in the domestic antibody drug development field that can be comparable to leading countries in the world, we will spare no effort." According to Michael Yin, Chairman of BioBAY: "I sincerely hope that NeoMab Bio can take this as a new starting point, further deepening its roots in the Suzhou Industrial Park, accelerating the development of the biopharmaceutical industry in the park, and contributing to the advancement of antibody drug research in our country." According to Dr. Jing Zhao, CEO of GemPharmatech: "We are grateful for the strong support and care provided by the Suzhou Municipal People's Government, Suzhou Industrial Park Government, and government officials at all levels for NeoMab Bio. Throughout our development, we have consistently felt the selfless support and assistance provided by the government. We thank all our partners and customers for their trust and support. The success of the antibody discovery platform is a result of your collective efforts and sincere cooperation. In the future, we will continue to uphold the concept of win-win cooperation, work hand in hand with everyone, and jointly promote the development and application of antibody technology, contributing more to the cause of human health." As an important member of GemPharmatech, NeoMab Bio believes that with the favorable environment created by the Suzhou Industrial Park Government, it will continue to uphold the spirit and philosophy of "Models to defy the impossible" continuously enhance its scientific research capabilities, provide higher-quality services to biopharmaceutical enterprises, and become a strong force in the development of the industry. About GemPharmatech GemPharmatech Co., Ltd, founded in 2017, is a high-tech enterprise specializing in the research, production, sales, and related technical services of experimental animal mouse models. It is a member of the Asian Mouse Mutant and Resource Alliance and a co-construction unit of the National Engineering Mouse Resource Library certified by the Ministry of Science and Technology. Based on the strategy of creating experimental animals and genetic engineering modification technology, the company provides customers with commercially available mouse models with independent intellectual property rights, as well as one-stop services such as customized model breeding and functional efficacy analysis, meeting the needs of customers in the fields of basic research and new drug development, such as gene function cognition, disease mechanism analysis, drug target discovery, and drug efficacy screening and verification. About NeoMab Bio NeoMab Bio is a wholly-owned subsidiary of GemPharmatech Co., Ltd., located in the Suzhou BioBay. NeoMab Bio is committed to becoming a trusted partner in the field of antibody drug discovery by providing efficient and convenient antibody drug discovery service. NeoMab Bio has an experienced team of scientists and technical personnel dedicated to developing cutting-edge technology and innovative solutions. The company has advanced laboratories and equipment, providing a full range of antibody drug discovery services, including target validation, antibody generation and screening, and preclinical study. In addition, NeoMab Bio offers flexible business cooperation models, including NeoMab™ mouse usage authorization, fully human antibody development services, and potential molecular license-out.  

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 233 加入收藏 :
ILJIN SNT Co., Ltd. Calls for Board Restructure at Aurinia Pharmaceuticals

SEOUL, South Korea, May 21, 2024 /PRNewswire/ -- Fellow Aurinia Shareholders, ILJIN SNT Co., Ltd. and its affiliates (collectively, "ILJIN") is a long-term holder of more than 5% of Aurinia Pharmaceuticals Inc. ("Aurinia" or the "Company") and has been supportive of the Company's mission since 2010 when we invested in the predecessor company, Isotechnika. As one of the largest and longest-standing shareholders, we have had the privilege of supporting the Company through its drug development efforts and subsequent FDA approval of LUPKYNIS. We have also supported the CEO, Mr. Peter Greenleaf, having voted in prior years for his re-election to the Board. Like other shareholders, we have been greatly shocked and dismayed to see the share price plummet since the Company's announcement on February 15, 2024 of FY 2023 operational results and the unsuccessful conclusion of its 7-month long strategic review process. The Company recently announced its Q1 2024 operational results. While the Q1 2024 financials showed some improvement, there has been no sign of share price recovery despite the Q1 performance improvement. If anything, the stock performance following the recent earnings report has reinforced the market perception that there remain substantial uncertainties surrounding the Company's new corporate strategy (focused on commercial execution of LUPKYNIS) announced in February. We believe that if we choose to ignore and do not respond to these alarming developments, we may only see our shareholder value further eroding going forward. In response to these concerning developments, we wrote to management and the Board of the Company in March, and have voiced our concerns and requested changes to the management and also the Board's role as the supervisor of management's performance.  However, we only received inadequate responses from the Company reciting its prior statements. As one of the long-standing shareholders, we now believe it is imperative to demand management's accountability, in order to put the Company back on track. If the Company does not change paths despite the massive losses shareholders have suffered during the past several months, it would only mean that there is no alignment of interests between company management and shareholders, and that it is time to establish a system within the Company to enforce management's accountability.  It is simply not right that while shareholders are suffering major losses, those same executives and Board members responsible for such losses continue to collect hefty amounts of compensation -- including substantial amounts of free RSUs -- from the Company as if nothing had happened.  In our view, the only way we can enforce accountability is to make our Board an independent board, and what this means is that the Board composition must be changed, so that the Board may effectively act as a check and balance to Company management.  For these reasons, Mr. Greenleaf should no longer serve on the Board and should only serve as the CEO going forward.  As the Company's CEO, Mr. Greenleaf will be able to continue to implement his new corporate strategy (focused on commercial execution) announced in February, while the Board without Mr. Greenleaf's participation will be able to discuss and determine the validity of the new corporate strategy independently and evaluate management's performance objectively.  In addition, given the Company's continued poor performance and its single-minded focus on LUPKYNIS (by foregoing all other growth options such as AUR 200 and AUR 300), it is important and necessary that the Board's size be kept to a bare minimum and no new board member should be allowed until after the Company has showed a clear sign of a turnaround. In view of the foregoing, ILJIN's intends to vote as follows at the Company's upcoming annual meeting: As explained above, Peter Greenleaf should no longer serve on the Board and should serve only as the Company's CEO going forward.  Although we have previously supported Mr. Greenleaf's board membership, it has become patently clear that his influence over the Board's composition and operation is so significant and prominent that the Board cannot serve its critical role of providing independent oversight of management.  While we believe the ultimate responsibility for poor management performance and destruction of shareholder value lies with Mr. Greenleaf, the Board has not and is not willing to hold Mr. Greenleaf accountable for all those management mishaps. ILJIN intends to vote "withhold" on the re-election of Peter Greenleaf to the Board. In response to its letter to management and the Board in March, ILJIN has received a reply letter from the Board chairman, Daniel Billen.  Based on his reply, Mr. Billen appears unable or unwilling to exercise any meaningful oversight over management's performance.  So, in our view, Mr. Billen is unqualified to operate the Board as an independent board, and so should no longer serve on the Board. ILJIN intends to vote "withhold" on the re-election of Daniel Billen to the Board. In September 2023, the Company agreed to add yet another member to an already-excessive Board, and ILJIN believes Dr. Robert Foster should not be elected to a full term on the Board.  Given the Company's revised business strategy to focus solely on commercial execution of LUPKYNIS, ILJIN believes Dr. Foster clearly cannot add any new value to the Company's management. ILJIN intends to vote "withhold" on the election of Dr. Robert Foster to the Board. In light of the dire performance of the Company's share price, the management compensation plan must be rejected. Following a dismal 38.6% say-on-pay vote in 2023, rather than reforming management compensation to align with stockholder interests, the Board has proposed a management compensation plan that is divorced from the Company's performance metrics, and ILJIN believes options and RSUs must not be freely granted regardless of the Company's performance -- particularly when shareholder value is utterly shattered.  ILJIN believes the fact that such a management compensation plan is proposed in these dire times shows that the current Board is not performing its fiduciary duties properly and only interested in enriching corporate executives and Board members at the expense of further shareholder dilution. ILJIN intends to vote "against" the advisory resolution on executive compensation and "against" the amendment to the Company's equity incentive plan. We echo the recent message from other shareholders, such as Lucien Selce, that the Board is severely bloated and excessively compensated.  So, we agree that the Board must be downsized, and each shareholder should determine which Board members it will be voting to withhold against at this time to keep the Board to a bare minimum. While we clearly see several additional Board members having no fit for the Company's revised business strategy, we do not believe it is appropriate for us to specify those individual Board members here. ILJIN believes that the changes above are necessary to strengthen the Board's role as a supervisor of management's performance and to enforce management accountability going forward, and respectfully request other shareholders' support for the changes. Sincerely,KH SungCEO of ILJIN SNT Co., Ltd. Media contact: Yoonwha Lee, yoonhwa.lee@iljin.co.kr

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