KALA BIO Announces Chief Executive Officer Transition
KALA BIO (NASDAQ:KALA) announced a leadership transition with CEO Mark Iwicki stepping down and Todd Bazemore, the company's President and Chief Operating Officer, appointed as interim CEO, effective immediately. Iwicki will continue as Chair of the Board of Directors.
Bazemore, who has served as KALA's President since December 2021 and COO since November 2017, brings over 30 years of experience in the pharmaceutical industry. The transition comes as the company approaches topline data from its Phase 2b clinical trial of KPI-012 for PCED (Persistent Corneal Epithelial Defect) in the second quarter of 2025.
Prior to KALA, Bazemore held executive positions at Santhera Pharmaceuticals, Dyax Corp, and Sunovion Pharmaceuticals. The company continues to focus on developing innovative therapies for rare and severe eye diseases using its MSC-S platform.
KALA BIO (NASDAQ:KALA) ha annunciato un cambiamento nella leadership con le dimissioni del CEO Mark Iwicki e la nomina di Todd Bazemore, Presidente e Chief Operating Officer dell'azienda, come CEO ad interim, con effetto immediato. Iwicki continuerà a ricoprire il ruolo di Presidente del Consiglio di Amministrazione.
Bazemore, che ricopre il ruolo di Presidente di KALA dal dicembre 2021 e di COO dal novembre 2017, porta con sé oltre 30 anni di esperienza nell'industria farmaceutica. Il cambiamento avviene mentre l'azienda si avvicina ai dati preliminari del suo studio clinico di fase 2b su KPI-012 per il PCED (Difetto Epiteliale Corneale Persistente) nel secondo trimestre del 2025.
Prima di entrare in KALA, Bazemore ha ricoperto posizioni dirigenziali presso Santhera Pharmaceuticals, Dyax Corp e Sunovion Pharmaceuticals. L'azienda continua a concentrarsi sullo sviluppo di terapie innovative per malattie oculari rare e gravi utilizzando la sua piattaforma MSC-S.
KALA BIO (NASDAQ:KALA) anunció una transición en el liderazgo con la renuncia del CEO Mark Iwicki y la designación de Todd Bazemore, Presidente y Director de Operaciones de la compañía, como CEO interino, con efecto inmediato. Iwicki continuará como Presidente de la Junta Directiva.
Bazemore, quien ha sido Presidente de KALA desde diciembre de 2021 y COO desde noviembre de 2017, aporta más de 30 años de experiencia en la industria farmacéutica. La transición se produce mientras la empresa se acerca a los datos preliminares de su ensayo clínico de fase 2b de KPI-012 para el PCED (Defecto Epitelial Corneal Persistente) en el segundo trimestre de 2025.
Antes de unirse a KALA, Bazemore ocupó puestos ejecutivos en Santhera Pharmaceuticals, Dyax Corp y Sunovion Pharmaceuticals. La empresa sigue centrada en desarrollar terapias innovadoras para enfermedades oculares raras y severas utilizando su plataforma MSC-S.
KALA BIO (NASDAQ:KALA)는 CEO Mark Iwicki가 사임하고 회사의 사장 겸 COO인 Todd Bazemore가 즉시 임시 CEO로 임명되는 리더십 전환을 발표했습니다. Iwicki는 이사회 의장직을 계속 유지할 것입니다.
Bazemore는 2021년 12월부터 KALA의 사장으로, 2017년 11월부터 COO로 재직하고 있으며, 제약 산업에서 30년 이상의 경험을 보유하고 있습니다. 이 전환은 회사가 2025년 2분기에 KPI-012의 PCED(지속성 각막 상피 결손)에 대한 2b 임상 시험의 주요 데이터를 접근하고 있는 가운데 이루어집니다.
KALA에 합류하기 전 Bazemore는 Santhera Pharmaceuticals, Dyax Corp 및 Sunovion Pharmaceuticals에서 임원직을 역임했습니다. 회사는 MSC-S 플랫폼을 사용하여 희귀하고 심각한 안질환을 위한 혁신적인 치료법 개발에 집중하고 있습니다.
KALA BIO (NASDAQ:KALA) a annoncé une transition de leadership avec la démission du PDG Mark Iwicki et la nomination de Todd Bazemore, président et directeur des opérations de l'entreprise, en tant que PDG par intérim, avec effet immédiat. Iwicki continuera en tant que président du conseil d'administration.
Bazemore, qui est président de KALA depuis décembre 2021 et COO depuis novembre 2017, apporte plus de 30 ans d'expérience dans l'industrie pharmaceutique. Cette transition intervient alors que l'entreprise s'approche des données préliminaires de son essai clinique de phase 2b sur KPI-012 pour le PCED (Défaut Épithélial Cornéen Persistant) au deuxième trimestre de 2025.
Avant de rejoindre KALA, Bazemore a occupé des postes de direction chez Santhera Pharmaceuticals, Dyax Corp et Sunovion Pharmaceuticals. L'entreprise continue de se concentrer sur le développement de thérapies innovantes pour les maladies oculaires rares et graves en utilisant sa plateforme MSC-S.
KALA BIO (NASDAQ:KALA) gab einen Führungswechsel bekannt, bei dem CEO Mark Iwicki zurücktritt und Todd Bazemore, Präsident und Chief Operating Officer des Unternehmens, sofort als interimistischer CEO ernannt wird. Iwicki wird weiterhin als Vorsitzender des Board of Directors tätig sein.
Bazemore, der seit Dezember 2021 Präsident von KALA und seit November 2017 COO ist, bringt über 30 Jahre Erfahrung in der Pharmaindustrie mit. Der Wechsel erfolgt, während das Unternehmen auf die vorläufigen Daten seiner Phase-2b-Studie mit KPI-012 für PCED (Persistierender Epitheldefekt der Hornhaut) im zweiten Quartal 2025 zugeht.
Vor KALA hatte Bazemore Führungspositionen bei Santhera Pharmaceuticals, Dyax Corp und Sunovion Pharmaceuticals inne. Das Unternehmen konzentriert sich weiterhin auf die Entwicklung innovativer Therapien für seltene und schwere Augenkrankheiten mit seiner MSC-S-Plattform.
- Approaching completion of Phase 2b clinical trial for KPI-012 with topline data expected in Q2 2025
- Smooth leadership transition with experienced internal candidate
- None.
Insights
The CEO transition at KALA BIO warrants careful analysis, particularly given its timing ahead of important Phase 2b clinical trial results for KPI-012. The appointment of Todd Bazemore as interim CEO represents more than a routine leadership change - it signals a potential shift in strategic focus toward commercialization readiness.
Bazemore's extensive background in rare disease commercialization, particularly his experience at Dyax Corp (acquired by Shire) and Santhera Pharmaceuticals, suggests KALA may be positioning itself for a potential commercial phase, assuming positive Phase 2b results for KPI-012 in PCED (Persistent Corneal Epithelial Defect). His track record in managing both ultra-rare diseases and larger market conditions aligns well with KALA's focus on rare and severe eye diseases.
The retention of Mark Iwicki as Board Chair provides important continuity during this transition period, particularly for the ongoing CHASE trial. This dual leadership structure - with Iwicki's strategic oversight and Bazemore's operational expertise - could prove advantageous as KALA approaches critical milestones.
The timing of this transition, while potentially concerning to some investors given the proximity to topline data readout, may actually be strategic. If KPI-012 shows positive results, having a CEO with strong commercialization experience could accelerate the path to market. Bazemore's seven-year tenure as COO suggests he's deeply familiar with KALA's MSC-S platform and clinical programs, which should ensure minimal disruption to ongoing operations.
ARLINGTON, Mass., Feb. 12, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today announced the resignation of Chief Executive Officer (CEO) Mark Iwicki, and the appointment of Todd Bazemore, KALA’s President and Chief Operating Officer, as interim CEO, effective immediately. Mr. Iwicki will continue to serve as Chair of the Board of Directors of KALA following the transition. Mr. Bazemore has served as KALA’s President since December 2021 and as KALA’s Chief Operating Officer since November 2017.
Mr. Iwicki stated, “I am proud of the work we have done at KALA utilizing our MSC-S platform, and I am very excited about the potential of our lead product candidate, KPI-012 for the treatment of PCED. As we approach our topline data from the ongoing Phase 2b clinical trial of KPI-012 in the second quarter of 2025, it is the right time to transition leadership to Todd, who I have had the privilege of working closely with for the past seven years. I look forward to continuing to partner with him as Chair of the Board and supporting our mission of delivering innovative therapies for rare and severe diseases of the eye.”
“It is a privilege to continue to build on the strong foundation that Mark and the rest of our team established at KALA. As a leader in the emerging field of mesenchymal stem cell secretomes, we are committed to developing and delivering therapies with the ultimate goal of preserving vision and changing lives,” said Mr. Bazemore, interim CEO of KALA. “I look forward to working closely with the cross-functional team towards the completion of the CHASE trial of KPI-012 in PCED and advancing this important program for patients and physicians.”
Mr. Bazemore brings over 30 years of experience spanning from ultra-rare orphan diseases to large primary care conditions. He has served as KALA’s President since December 2021 and as KALA’s Chief Operating Officer since November 2017. Prior to joining the company, Todd served as Executive Vice President and Chief Operating Officer of Santhera Pharmaceuticals (USA), Inc. responsible for U.S. operations from September 2016 to November 2017. Before that, between April 2014 and January 2016, Todd served as Executive Vice President and Chief Commercial Officer of Dyax Corp. where he was responsible for global commercial strategy and oversight of all commercial functions up until Dyax was acquired by Shire plc. Prior to joining Dyax, Todd was at Sunovion Pharmaceuticals, Inc. where he served in several roles of increasing responsibility including Vice President, Managed Markets, Vice President of Sales, and Vice President of the Respiratory Business Unit.
About KALA BIO, Inc.
KALA is a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye. KALA’s biologics-based investigational therapies utilize KALA’s proprietary mesenchymal stem cell secretome (MSC-S) platform. KALA’s lead product candidate, KPI-012, is a human MSC-S, which contains numerous human-derived biofactors, such as growth factors, protease inhibitors, matrix proteins and neurotrophic factors that can potentially correct the impaired corneal healing that is an underlying etiology of multiple severe ocular diseases. KPI-012 is currently in clinical development for the treatment of persistent corneal epithelial defect (PCED), a rare disease of impaired corneal healing, for which it has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration. KALA is also targeting the potential development of KPI-012 for the treatment of Limbal Stem Cell Deficiency and other rare corneal diseases that threaten vision and has initiated preclinical studies to evaluate the potential utility of its MSC-S platform for retinal degenerative diseases, such as Retinitis Pigmentosa and Stargardt Disease.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. Any statements in this press release about KALA’s future expectations, plans and prospects, including but not limited to statements about KALA’s expectations with respect to potential advantages of KPI-012 and its MSC-S platform; the clinical utility of KPI-012 for PCED; anticipated timelines to report topline data for the CHASE Phase 2b clinical trial of KPI-012; KALA’s chief executive officer transition; and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: market conditions; uncertainties regarding availability and timing of data from clinical trials; whether results of early clinical trials or trials in different disease indications will be indicative of the results of ongoing or future trials; whether results of the Phase 1b clinical trial of KPI-012 will be indicative of results for any future clinical trials and studies of KPI-012, including the CHASE trial; whether interim data from a clinical trial will be predictive of the results of the trial; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; and other factors discussed in the “Risk Factors” section of KALA’s Annual Report on Form 10-K, most recently filed Quarterly Report on Form 10-Q and other filings KALA makes with the Securities and Exchange Commission. These forward-looking statements represent KALA’s views as of the date of this press release and should not be relied upon as representing KALA’s views as of any date subsequent to the date hereof. KALA does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Investor Contact:
Taylor Steiner
taylor.steiner@precisionaq.com
212-362-1200
FAQ
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