CASI Pharmaceuticals Appoints David Cory as Chief Executive Officer to Lead U.S. Company Focused on Clinical Development of CID-103, a Potential Best in Class Anti-CD38 Program
CASI Pharmaceuticals (NASDAQ:CASI) has appointed David Cory as its new Chief Executive Officer and Board member, while former CEO Wei-Wu He transitions to Executive Chairman. Cory brings over 30 years of operational experience in biotech and pharma, with a track record of raising over $1B in capital markets and multiple successful company exits.
The appointment aims to focus CASI's U.S. operations on developing CID-103, a potential best-in-class anti-CD38 monoclonal antibody. The drug is currently in Phase 1/2 trials for chronic immune thrombocytopenia (ITP), with an IND submitted for trials in renal allograft antibody-mediated rejection (AMR).
Cory's previous roles include CEO positions at LIB Therapeutics and Eiger BioPharmaceuticals, where he led successful drug developments and regulatory approvals. His experience spans startups like InterMune and CoTherix, which saw collective exits of approximately $9 billion.
CASI Pharmaceuticals (NASDAQ:CASI) ha nominato David Cory come nuovo Amministratore Delegato e membro del Consiglio di Amministrazione, mentre l'ex CEO Wei-Wu He assume il ruolo di Presidente Esecutivo. Cory vanta oltre 30 anni di esperienza operativa nel settore biotech e farmaceutico, con un curriculum che include la raccolta di più di 1 miliardo di dollari nei mercati finanziari e numerose uscite aziendali di successo.
La nomina mira a concentrare le operazioni statunitensi di CASI sullo sviluppo di CID-103, un potenziale anticorpo monoclonale anti-CD38 di classe superiore. Il farmaco è attualmente in fase 1/2 di sperimentazione per la trombocitopenia immunitaria cronica (ITP), con una richiesta IND presentata per studi sul rigetto anticorpale mediato da trapianto renale (AMR).
Tra i precedenti incarichi di Cory figurano ruoli da CEO presso LIB Therapeutics ed Eiger BioPharmaceuticals, dove ha guidato con successo sviluppi farmaceutici e approvazioni regolatorie. La sua esperienza comprende startup come InterMune e CoTherix, le quali hanno registrato uscite complessive per circa 9 miliardi di dollari.
CASI Pharmaceuticals (NASDAQ:CASI) ha nombrado a David Cory como su nuevo Director Ejecutivo y miembro del Consejo, mientras que el ex CEO Wei-Wu He pasa a ser Presidente Ejecutivo. Cory aporta más de 30 años de experiencia operativa en biotecnología y farmacéutica, con un historial de recaudar más de 1.000 millones de dólares en mercados de capital y múltiples salidas exitosas de empresas.
El nombramiento tiene como objetivo enfocar las operaciones de CASI en EE.UU. en el desarrollo de CID-103, un anticuerpo monoclonal anti-CD38 potencialmente de primera clase. El fármaco se encuentra actualmente en ensayos de fase 1/2 para trombocitopenia inmune crónica (ITP), con una IND presentada para ensayos en rechazo mediado por anticuerpos de trasplante renal (AMR).
Los roles anteriores de Cory incluyen puestos de CEO en LIB Therapeutics y Eiger BioPharmaceuticals, donde lideró desarrollos farmacéuticos exitosos y aprobaciones regulatorias. Su experiencia abarca startups como InterMune y CoTherix, que lograron salidas colectivas por aproximadamente 9 mil millones de dólares.
CASI Pharmaceuticals (NASDAQ:CASI)는 David Cory를 새로운 최고경영자(CEO) 겸 이사로 임명했으며, 전 CEO Wei-Wu He는 집행 의장으로 전환했습니다. Cory는 바이오텍 및 제약 분야에서 30년 이상의 운영 경험을 보유하고 있으며, 10억 달러 이상의 자본 조달과 여러 성공적인 기업 매각 실적을 갖추고 있습니다.
이번 임명은 CASI의 미국 사업을 잠재적 최고급 항-CD38 단클론항체인 CID-103 개발에 집중하기 위한 것입니다. 이 약물은 현재 만성 면역 혈소판 감소증(ITP)을 대상으로 1/2상 임상시험 중이며, 신장 이식 항체 매개 거부 반응(AMR) 시험을 위한 IND가 제출된 상태입니다.
Cory는 LIB Therapeutics와 Eiger BioPharmaceuticals에서 CEO를 역임하며 성공적인 약물 개발과 규제 승인에 기여했습니다. 그의 경력은 InterMune과 CoTherix 같은 스타트업을 포함하며, 이들 기업의 총 매각 가치는 약 90억 달러에 이릅니다.
CASI Pharmaceuticals (NASDAQ:CASI) a nommé David Cory en tant que nouveau Directeur Général et membre du Conseil d'Administration, tandis que l'ancien CEO Wei-Wu He devient Président Exécutif. Cory apporte plus de 30 ans d'expérience opérationnelle dans les secteurs de la biotechnologie et de la pharmacie, avec un historique de levée de plus d'un milliard de dollars sur les marchés financiers et plusieurs sorties d'entreprises réussies.
Cette nomination vise à concentrer les opérations américaines de CASI sur le développement de CID-103, un anticorps monoclonal anti-CD38 potentiellement de premier ordre. Le médicament est actuellement en essais de phase 1/2 pour la thrombocytopénie immunitaire chronique (ITP), avec une demande IND soumise pour des essais sur le rejet anticorps médié par greffe rénale (AMR).
Parmi les précédents postes de Cory figurent des fonctions de CEO chez LIB Therapeutics et Eiger BioPharmaceuticals, où il a conduit avec succès des développements pharmaceutiques et des approbations réglementaires. Son expérience inclut des startups telles qu'InterMune et CoTherix, qui ont réalisé des sorties collectives d'environ 9 milliards de dollars.
CASI Pharmaceuticals (NASDAQ:CASI) hat David Cory als neuen Chief Executive Officer und Vorstandsmitglied berufen, während der ehemalige CEO Wei-Wu He zum Executive Chairman wechselt. Cory bringt über 30 Jahre operative Erfahrung im Biotech- und Pharmabereich mit und kann auf eine Erfolgsbilanz von über 1 Milliarde US-Dollar an Kapitalbeschaffung sowie mehreren erfolgreichen Unternehmensverkäufen verweisen.
Die Ernennung zielt darauf ab, CASIs US-Geschäft auf die Entwicklung von CID-103 zu konzentrieren, einem potenziellen erstklassigen Anti-CD38 monoklonalen Antikörper. Das Medikament befindet sich derzeit in Phase 1/2 Studien zur Behandlung der chronischen immunologischen Thrombozytopenie (ITP), mit einem eingereichten IND für Studien zum antikörpervermittelten Abstoßungssyndrom bei Nierentransplantaten (AMR).
Corys frühere Positionen umfassen CEO-Posten bei LIB Therapeutics und Eiger BioPharmaceuticals, wo er erfolgreiche Arzneimittelentwicklungen und behördliche Zulassungen leitete. Seine Erfahrung erstreckt sich auf Startups wie InterMune und CoTherix, die zusammen Verkaufsabschlüsse von rund 9 Milliarden US-Dollar erzielten.
- Appointment of seasoned CEO with over 30 years of operational experience
- New CEO's track record includes raising over $1B in capital markets
- CID-103 program advancing with Phase 1/2 trials in progress
- New CEO's previous exits through acquisitions totaled approximately $9 billion
- Strategic focus on potentially best-in-class anti-CD38 program
- Management transition period could create temporary uncertainty
- Clinical trials still in early/mid stages with no guaranteed success
Insights
CASI appoints industry veteran David Cory as CEO to focus on advancing their potential best-in-class anti-CD38 antibody program.
CASI Pharmaceuticals has made a significant leadership transition by appointing David Cory as CEO, a strategic move that signals a refined focus on their CID-103 program. This appointment represents more than just a personnel change – it indicates a deliberate corporate strategy shift toward concentrating resources on their potentially high-value anti-CD38 monoclonal antibody currently in clinical development.
Cory brings impressive credentials that align well with CASI's development stage needs. His 30+ years of experience spans both emerging biotech and large pharmaceutical companies, with particular strength in two critical areas: operational leadership and capital raising (over
The press release strategically emphasizes the company's narrowed focus on CID-103, which is currently in a Phase 1/2 study for chronic immune thrombocytopenia (ITP). The company has also submitted an IND for renal allograft antibody-mediated rejection trials, indicating a dual-pathway development strategy. The anti-CD38 antibody class has proven commercially successful in multiple myeloma (exemplified by Darzalex/daratumumab), but CASI is pursuing different indications, suggesting they see market opportunities in autoimmune and transplant rejection spaces.
This leadership transition, with former CEO Wei-Wu He remaining as Executive Chairman, appears designed to transform CASI's operations into a more focused U.S.-based entity centered around advancing CID-103. The emphasis on "CASI U.S." suggests a potential corporate restructuring or market repositioning that may have significant strategic implications for the company's direction and valuation going forward.
-- David Cory is an industry veteran, bringing more than 30 years of operational experience, in private and public, emerging-stage biotech and large pharma companies with an established track record of building and leading high performing operating teams and financing in the capital markets with over
-- CID-103 is a potential best in class, anti-CD38 monoclonal antibody, currently dosing in a multi-center Phase 1/2 study in adults with chronic immune thrombocytopenia (ITP); IND submitted to support future clinical trials in adults with renal allograft antibody-mediated rejection (AMR)
BEIJING, CN / ACCESS Newswire / July 21, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announced the appointment of David Cory as Chief Executive Officer and a member of the Board of Directors. Wei-Wu He, Ph.D. will step down as the CEO and will remain as Executive Chairman of the Board of Directors.
"We are pleased to welcome David as our new CEO and Board member," said Dr. He, Executive Chairman. "David's extensive operating background and capital markets experience make him the ideal candidate to lead the CASI U.S. business, focus management and concentrate resources on the advancement of the CID-103 program for organ transplant rejection and autoimmune diseases. Under David's leadership, CASI U.S. will be well-positioned to deliver long term value for both patients and shareholders."
David Cory added, "The CASI U.S. operation is an important opportunity to introduce a focused company and the CID-103 program. I look forward to joining the team and engaging with the healthcare and investment community to discuss the CASI U.S. operating plan focused on maximizing the broad therapeutic potential of targeting CD38 with the CID-103 program."
Most recently, Mr. Cory was CEO and Director of LIB Therapeutics which completed Phase 3 registration-enabling trials for its lead cardiovascular disease program and filed for regulatory approval. Previously, Mr. Cory was CEO and Director of Eiger BioPharmaceuticals which obtained FDA and EMA approval and launched the first therapy to extend survival in Hutchinson-Gilford progeria syndrome, an ultra-rare, ultimately fatal disease. Mr. Cory began his emerging-stage biotech career as a founding member and/or executive in multiple start-up companies including InterMune, CoTherix, and Prestwick Pharmaceuticals which resulted in exits by acquisition of approximately
About CID-103
CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated an encouraging pre-clinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies, and for which CASI owns exclusive global rights. Peer-reviewed medical literature, including publications in the New England Journal of Medicine, point to the therapeutic promise of targeting CD38 in autoimmune diseases including immune thrombocytopenia (ITP) and organ transplant rejection. In May 2024, CASI announced the clearance of a U.S. IND application with the FDA for the initiation of a Phase 1/2 study of CID-103 in adults with ITP, which was followed by clearance from the China Center for Drug Evaluation (CDE) within the National Medical Products Administration (NMPA) of China in October 2024. The Chinese ITP study is part of the global multi-center study that was approved by the U.S. FDA and is enrolling and dosing patients. A U.S. IND application for renal allograft antibody-mediated rejection (AMR) has been filed with FDA. The Company plans to initiate a Phase 1/2 study in adults with AMR pursuant to regulatory clearance.
About CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the U.S., and throughout the world. The Company is focused on acquiring, developing, and commercializing products that augment its focus on hematology oncology therapeutics and therapeutics for organ transplant rejection and autoimmune disease, as well as other areas of unmet medical need. The Company intends to execute its plan to become an industry leader by launching medicines in the Greater China market, leveraging the Company's China-based regulatory and commercial competencies and its global drug development expertise. The Company's operations in China are conducted through its wholly-owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., located in Beijing, China. More information on CASI is available at www.casipharmaceuticals.com.
Forward Looking Statements
This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Among other things, the business outlook and quotations from management in this announcement, as well as the Company's strategic and operational plans, contain forward-looking statements. The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the "SEC"), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: uncertainties related to the possibility that the transaction for the divestiture of certain assets in China (the "Transaction") will not occur as planned if events arise that result in the termination of the Equity and Assets Transfer Agreement, or if one or more of the various closing conditions to the Transaction are not satisfied or waived; the possibility that our plan with respect to our business operations after the consummation of the Transaction can be implemented successfully; our recurring operating losses have raised substantial doubt regarding our ability to continue as a going concern; the possibility that we may be delisted from trading on The Nasdaq Capital Market if we fail to satisfy applicable continued listing standards; the volatility in the market price of our ordinary shares; the risk of substantial dilution of existing shareholders in future share issuances; the difficulty of executing our business strategy on a global basis including China; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; legal or regulatory developments in China that adversely affect our ability to operate in China; our lack of experience in manufacturing products and uncertainty about our resources and capabilities to do so on a clinical or commercial scale; risks relating to the commercialization, if any, of our products and proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); our inability to predict when or if our product candidates will be approved for marketing by the U.S. Food and Drug Administration, European Medicines Agency, PRC National Medical Products Administration, or other regulatory authorities; our inability to receive approval for renewal of license of our existing products; the risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; the risks associated with our product candidates, and the risks associated with our other early-stage products under development; the risk that result in preclinical and clinical models are not necessarily indicative of clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; our ability to protect our intellectual property rights; the lack of success in the clinical development of any of our products; and our dependence on third parties; the risks related to our dependence on Juventas to conduct the clinical development of CNCT19 and to partner with us to co-market CNCT19; risks related to our dependence on Juventas to ensure the patent protection and prosecution for CNCT19; the risk related to the Company's ongoing development of and regulatory application for CID-103 with respect to the treatment of antibody-mediated rejection for organ transplant and the license arrangements of CID-103; risks relating to interests of our largest shareholder and our Chairman and CEO that differ from our other shareholders; risks related to the development of a new manufacturing facility by CASI Pharmaceuticals (Wuxi) Co., Ltd. and risks related to our disagreement with Acrotech with respect to the termination of agreements regarding EVOMELA®. Further information regarding these and other risks is included in the Company's filings with the SEC. All information provided herein is as of the date of this announcement, and the Company undertakes no obligation to update any forward-looking statement, except as required under applicable law. We caution readers not to place undue reliance on any forward-looking statements contained herein.
EVOMELA® is proprietary to Acrotech Biopharma Inc. and its affiliates. FOLOTYN®is proprietary to Acrotech Biopharma Inc and its affiliates. The Company is currently involved in disputes and legal proceedings related to certain pipeline products, including EVOMELA® and CNCT-19.Please refer to the Company's earlier SEC filing for further information.
COMPANY CONTACT:
Larry Zhang
CASI Pharmaceuticals, Inc.
240.864.2643
ir@casipharmaceuticals.com
SOURCE: CASI Pharmaceuticals
View the original press release on ACCESS Newswire
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