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Lisata Therapeutics Announces Research License with Catalent

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Lisata Therapeutics (NASDAQ: LSTA) has entered into a research license agreement with Catalent to evaluate the combination of Lisata's certepetide with Catalent's SMARTag® antibody-drug conjugate (ADC) platform for treating advanced solid tumors.

Under the agreement, Catalent will fund all research and development while Lisata provides consulting support. Lisata will receive an upfront payment and potential future considerations based on preclinical evaluation results.

The collaboration aims to enhance ADC therapy by combining certepetide's tumor penetration capabilities with ADC's targeted delivery of cytotoxic drugs. This combination could potentially improve treatment efficacy while reducing systemic toxicity. Additionally, certepetide is expected to reduce the immunosuppressive nature of the tumor microenvironment (TME), potentially improving patient response to ADC therapy.

Lisata Therapeutics (NASDAQ: LSTA) ha stipulato un accordo di licenza di ricerca con Catalent per valutare la combinazione del certepetide di Lisata con la piattaforma SMARTag® di Catalent per coniugati anticorpo-farmaco (ADC) nel trattamento di tumori solidi avanzati.

Secondo l'accordo, Catalent finanzierà tutte le attività di ricerca e sviluppo mentre Lisata fornirà supporto consulenziale. Lisata riceverà un pagamento iniziale e potenziali compensi futuri basati sui risultati delle valutazioni precliniche.

La collaborazione punta a migliorare la terapia ADC combinando la capacità del certepetide di penetrare nei tumori con la somministrazione mirata dei farmaci citotossici degli ADC. Questa combinazione potrebbe aumentare l'efficacia del trattamento riducendo al contempo la tossicità sistemica. Inoltre, il certepetide dovrebbe attenuare la natura immunosoppressiva del microambiente tumorale (TME), migliorando potenzialmente la risposta dei pazienti alla terapia ADC.

Lisata Therapeutics (NASDAQ: LSTA) ha firmado un acuerdo de licencia de investigación con Catalent para evaluar la combinación del certepetide de Lisata con la plataforma SMARTag® de Catalent para conjugados anticuerpo-fármaco (ADC) en el tratamiento de tumores sólidos avanzados.

Según el acuerdo, Catalent financiará toda la investigación y desarrollo mientras que Lisata proporcionará apoyo consultivo. Lisata recibirá un pago inicial y posibles compensaciones futuras basadas en los resultados de la evaluación preclínica.

La colaboración busca mejorar la terapia con ADC combinando la capacidad del certepetide para penetrar tumores con la entrega dirigida de fármacos citotóxicos de los ADC. Esta combinación podría aumentar la eficacia del tratamiento mientras reduce la toxicidad sistémica. Además, se espera que el certepetide reduzca la naturaleza inmunosupresora del microambiente tumoral (TME), mejorando potencialmente la respuesta de los pacientes a la terapia con ADC.

Lisata Therapeutics (NASDAQ: LSTA)는 Catalent과 연구 라이선스 계약을 체결하여 Lisata의 certepetide와 Catalent의 SMARTag® 항체-약물 접합체(ADC) 플랫폼을 결합해 진행성 고형암 치료에 대해 평가할 예정입니다.

계약에 따라 Catalent가 모든 연구개발 비용을 지원하며 Lisata는 자문 지원을 제공합니다. Lisata는 초기 지급금과 전임상 평가 결과에 따른 잠재적 추가 보상을 받게 됩니다.

이번 협력은 certepetide의 종양 침투 능력과 ADC의 표적 세포독성 약물 전달을 결합해 ADC 치료를 향상시키는 것을 목표로 합니다. 이 조합은 치료 효과를 높이고 전신 독성을 줄일 수 있습니다. 또한 certepetide는 종양 미세환경(TME)의 면역억제 특성을 완화하여 ADC 치료에 대한 환자의 반응을 개선할 것으로 기대됩니다.

Lisata Therapeutics (NASDAQ : LSTA) a conclu un accord de licence de recherche avec Catalent afin d’évaluer la combinaison du certepetide de Lisata avec la plateforme SMARTag® de Catalent pour les conjugués anticorps-médicament (ADC) dans le traitement des tumeurs solides avancées.

Dans le cadre de cet accord, Catalent financera l’intégralité de la recherche et du développement tandis que Lisata fournira un soutien en conseil. Lisata recevra un paiement initial ainsi que des compensations potentielles futures en fonction des résultats des évaluations précliniques.

Cette collaboration vise à améliorer la thérapie par ADC en combinant la capacité du certepetide à pénétrer les tumeurs avec la délivrance ciblée des médicaments cytotoxiques par les ADC. Cette combinaison pourrait améliorer l’efficacité du traitement tout en réduisant la toxicité systémique. De plus, le certepetide devrait atténuer la nature immunosuppressive du microenvironnement tumoral (TME), améliorant potentiellement la réponse des patients à la thérapie ADC.

Lisata Therapeutics (NASDAQ: LSTA) hat eine Forschungs-Lizenzvereinbarung mit Catalent geschlossen, um die Kombination von Lisatas Certepetid mit Catalents SMARTag®-Antikörper-Wirkstoff-Konjugat (ADC)-Plattform zur Behandlung fortgeschrittener solider Tumoren zu evaluieren.

Im Rahmen der Vereinbarung übernimmt Catalent die vollständige Finanzierung von Forschung und Entwicklung, während Lisata beratende Unterstützung leistet. Lisata erhält eine Vorauszahlung sowie mögliche zukünftige Zahlungen basierend auf den Ergebnissen der präklinischen Bewertung.

Die Zusammenarbeit zielt darauf ab, die ADC-Therapie zu verbessern, indem die Tumordurchdringung von Certepetid mit der gezielten Abgabe zytotoxischer Wirkstoffe durch ADCs kombiniert wird. Diese Kombination könnte die Behandlungseffizienz steigern und gleichzeitig die systemische Toxizität verringern. Zudem wird erwartet, dass Certepetid die immunsuppressive Natur des Tumormikromilieus (TME) reduziert und so die Patientenreaktion auf die ADC-Therapie verbessert.

Positive
  • Research agreement secured with no R&D cost burden for LSTA
  • Upfront payment to be received plus potential future considerations
  • Expansion of certepetide's potential applications in oncology
  • Partnership with established player in drug delivery technology
Negative
  • Results dependent on preclinical evaluation success
  • Early-stage research with no guaranteed commercial outcome

Insights

Lisata's research license with Catalent represents a strategically advantageous partnership with favorable economics for the small-cap biotech. The agreement brings three immediate benefits to Lisata: an upfront payment (amount undisclosed), full R&D cost coverage by Catalent, and potential future considerations contingent on preclinical results.

The scientific rationale appears compelling - combining Catalent's SMARTag® ADC technology with Lisata's certepetide could address a critical limitation in current ADC therapies. While antibody-drug conjugates can precisely target tumor antigens, they often struggle with tumor penetration. Certepetide's tumor-penetrating mechanism could potentially enhance ADC efficacy by enabling deeper drug delivery into solid tumors while simultaneously reducing the immunosuppressive tumor microenvironment.

For Lisata (market cap: $16.9 million), this collaboration represents a capital-efficient strategy to expand certepetide's potential applications without diverting internal resources from their core development programs. The partnership validates external interest in certepetide's platform potential beyond its current applications, potentially creating additional value pathways for shareholders.

While promising, investors should recognize this remains in preclinical stages with uncertain commercial timelines. The real value inflection points will come if/when the collaboration generates positive preclinical data that could lead to a more substantial licensing agreement or development partnership.

Catalent to evaluate certepetide with its SMARTag® antibody-drug conjugate platform

BASKING RIDGE, N.J., April 15, 2025 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced that the Company has entered into a research license with Catalent, Inc. (“Catalent”) to evaluate, in a preclinical setting, the efficacy of Lisata's iRGD cyclic peptide product candidate, certepetide, as a payload used in the context of Catalent’s SMARTag® antibody-drug conjugate (“ADC”) dual-payload technology platform for the treatment of difficult-to-treat-diseases, including advanced solid tumors.   Under the terms of the agreement, Catalent will assume full responsibility for all research and development expenses and Lisata will provide consulting support. Further, Lisata will receive an upfront payment with the possibility of future considerations contingent upon the results of the preclinical evaluation.

“This is another obvious step in the development of Lisata and certepetide as we see great potential in combining both the technologies and the talents of the scientific teams at Lisata and Catalent to study the combination of certepetide and the SMARTag® ADC platform. While ADCs utilize monoclonal antibodies to target tumor-specific antigens ensuring precise delivery of cytotoxic drugs to cancer cells while sparing healthy tissues, combining ADC’s with certepetide should ensure that the targeted payload penetrates the tumor. The combination of ADCs and certepetide could revolutionize precision oncology delivering targeted therapies deep within tumors for improved efficacy with reduced systemic toxicity. Additionally, the presence of certepetide in the tumor microenvironment (TME) is expected to reduce the immunosuppressive nature of the TME further improving patient response and outcomes to the ADC therapy.” stated Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Lisata. “This agreement furthers our strategy of exploiting certepetide’s broad applicability and unlocking its full potential. We look forward to seeing results in the near future.”

“We are excited to partner with Lisata to investigate how certepetide and the SMARTag® technology might be used together to make ADCs with enhanced functions,” stated Penelope Drake, Head of R&D, Bioconjugates at Catalent. “We are enthusiastic about the potential of this collaboration to deliver innovative treatment options.”

About Lisata Therapeutics

Lisata Therapeutics is a clinical-stage pharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for the treatment of advanced solid tumors and other major diseases. Lisata’s cyclic peptide product candidate, certepetide, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to selectively target and penetrate solid tumors more effectively. Lisata has already established noteworthy commercial and R&D partnerships based on its CendR Platform® technology. The Company expects to announce numerous milestones over the next 1.5 years and believes that its projected capital will fund operations into the second quarter of 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. Learn more about certepetide’s mechanism of action in our short film. For more information on the Company, please visit www.lisata.com.

About Certepetide

Certepetide (formerly LSTA1), an internalizing RGD (arginylglycylaspartic acid or iRGD), cyclic peptide product candidate, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and penetrate solid tumors more effectively. Certepetide actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor. Certepetide also has been shown to modify the tumor microenvironment resulting in tumors which are more susceptible to immunotherapies. We and our collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including immunotherapies and RNA-based therapeutics. To date, certepetide has also demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to test its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer. Lisata is exploring the potential of certepetide to enable a variety of treatment modalities to treat a range of solid tumors more effectively. Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma (U.S.) and osteosarcoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.).

Forward-Looking Statements

This communication contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding the Company’s clinical development programs are forward-looking statements. In addition, when or if used in this communication, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Lisata or its management, may identify forward-looking statements. Examples of forward-looking statements include, but are not limited to, the potential of the collaboration with Catalent to develop treatment options; the potential efficacy of certepetide as a treatment for patients with solid tumors; our beliefs about the potential uses and benefits of certepetide; statements relating to Lisata’s continued listing on the Nasdaq Capital Market; expectations regarding the capitalization, resources and ownership structure of Lisata; the approach Lisata is taking to discover and develop novel therapeutics; the adequacy of Lisata’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; and the difficulty in predicting the time and cost of development of Lisata’s product candidates. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: results observed from a single patient case study are not necessarily indicative of final results and one or more of the clinical outcomes may materially change following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the safety and efficacy of Lisata’s product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in Lisata’s clinical programs, Lisata’s ability to finance its operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of Lisata’s scientific studies, Lisata’s ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in Lisata’s markets, the ability of Lisata to protect its intellectual property rights; and legislative, regulatory, political and economic developments. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in Lisata’s Annual Report on Form 10-K filed with the SEC on February 27, 2025, and in other documents filed by Lisata with the Securities and Exchange Commission. Except as required by applicable law, Lisata undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events, or otherwise.

Lisata Therapeutics Contact:

Investors:
Lisata Therapeutics
John Menditto
Vice President, Investor Relations and Corporate Communications
Phone: 908-842-0084
Email: jmenditto@lisata.com

Media:
ICR Healthcare
Elizabeth Coleman
Account Supervisor
Phone: 203-682-4783
Email: elizabeth.coleman@icrhealthcare.com

This press release was published by a CLEAR® Verified individual.


FAQ

What is the purpose of Lisata's research license agreement with Catalent?

The agreement aims to evaluate certepetide as a payload with Catalent's SMARTag® ADC platform for treating advanced solid tumors, combining tumor penetration capabilities with targeted drug delivery.

How will the development costs be handled in the LSTA-Catalent partnership?

Catalent will assume full responsibility for all research and development expenses, while Lisata will provide consulting support.

What are the financial terms of LSTA's agreement with Catalent?

Lisata will receive an upfront payment with the possibility of future considerations contingent upon preclinical evaluation results.

How could the combination of certepetide and ADCs benefit cancer treatment?

The combination could improve precision oncology by enabling targeted therapies to penetrate deeper into tumors, enhancing efficacy while reducing systemic toxicity and improving patient response through TME modulation.
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