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Lifecore Biomedical Selected by Lindy Biosciences to Support Process Development and Commercial Scale-Up for Innovative Microglassification Formulation Technology

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Lifecore Biomedical (NASDAQ: LFCR) has been selected by Lindy Biosciences as their preferred CDMO to support process development and commercial scale-up for their innovative microglassification formulation technology. The multi-year agreement could potentially bring in over $5 million in revenue for Lifecore. Lindy's technology aims to transform biologic therapeutics delivery from intravenous to subcutaneous self-administration, enabling higher concentration doses.

Lifecore was chosen after a competitive process due to their expertise in sterile injectable pharmaceuticals and complex formulations. This partnership positions Lifecore as a key player in the manufacture and fill/finish of next-generation biotherapeutic formulations, potentially benefiting patients worldwide.

Lifecore Biomedical (NASDAQ: LFCR) è stata selezionata da Lindy Biosciences come loro CDMO preferito per supportare lo sviluppo del processo e l'ampliamento commerciale della loro innovativa tecnologia di microglassificazione. L'accordo pluriennale potrebbe portare a oltre 5 milioni di dollari di entrate per Lifecore. La tecnologia di Lindy mira a trasformare la somministrazione di terapeutiche biologiche da endovenosa a auto-somministrazione sottocutanea, consentendo dosi a concentrazione più elevata.

Lifecore è stata scelta dopo un processo competitivo grazie alla loro esperienza nei farmaci iniettabili sterili e nelle formulazioni complesse. Questa partnership posiziona Lifecore come un attore chiave nella produzione e nel riempimento/finitura delle formulazioni bioterapeutiche di nuova generazione, potenzialmente a beneficio dei pazienti in tutto il mondo.

Lifecore Biomedical (NASDAQ: LFCR) ha sido seleccionada por Lindy Biosciences como su CDMO preferido para apoyar el desarrollo de procesos y la ampliación comercial de su innovadora tecnología de microglassificación. El acuerdo a varios años podría generar más de 5 millones de dólares en ingresos para Lifecore. La tecnología de Lindy tiene como objetivo transformar la entrega de terapias biológicas de intravenosa a auto-administración subcutánea, permitiendo dosis de mayor concentración.

Lifecore fue elegida después de un proceso competitivo debido a su experiencia en productos farmacéuticos inyectables estériles y formulaciones complejas. Esta asociación posiciona a Lifecore como un jugador clave en la fabricación y el llenado/terminación de formulaciones bioterapéuticas de próxima generación, beneficiando potencialmente a pacientes en todo el mundo.

Lifecore Biomedical (NASDAQ: LFCR)는 Lindy Biosciences에 의해 선택되었습니다 그들의 혁신적인 마이크로글라스화 제형 기술을 지원하기 위한 CDMO로. 이 다년 계약은 Lifecore에 500만 달러 이상의 수익을 가져올 가능성이 있습니다. Lindy의 기술은 생물학적 치료제의 전달 방식을 정맥주사에서 피하 자가 투여로 전환하여 고농축 투여가 가능하게 하는 것을 목표로 하고 있습니다.

Lifecore는 무균 주사제 및 복잡한 제형에 대한 전문성 때문에 경쟁 과정에서 선택되었습니다. 이 파트너십은 Lifecore를 차세대 생물치료제 제형의 제조 및 충전/완료의 주요 업체로 자리잡게 하여 전 세계 환자에게 혜택을 줄 수 있습니다.

Lifecore Biomedical (NASDAQ: LFCR) a été séléctionnée par Lindy Biosciences comme leur CDMO préféré pour soutenir le développement de processus et l'augmentation commerciale de leur technologie innovante de microglassification. L'accord pluriannuel pourrait rapporter plus de 5 millions de dollars de revenus pour Lifecore. La technologie de Lindy vise à transformer l'administration des thérapies biologiques de l'intraveineuse à l'auto-administration sous-cutanée, permettant des doses à plus forte concentration.

Lifecore a été choisie après un processus compétitif en raison de leur expertise dans les médicaments injectables stériles et les formulations complexes. Ce partenariat positionne Lifecore comme un acteur clé dans la fabrication et le remplissage/finition des formulations biothérapeutiques de nouvelle génération, pouvant potentiellement bénéficier aux patients du monde entier.

Lifecore Biomedical (NASDAQ: LFCR) wurde von Lindy Biosciences ausgewählt als ihr bevorzugter CDMO, um die Prozessentwicklung und den kommerziellen Ausbau ihrer innovativen Mikroglaßierungsformulierungstechnologie zu unterstützen. Der mehrjährige Vertrag könnte über 5 Millionen Dollar Umsatz für Lifecore generieren. Lindys Technologie zielt darauf ab, die Bereitstellung biopharmazeutischer Therapien von intravenöser Anwendung auf subkutane Selbstverabreichung umzustellen und höhere Konzentrationsdosen zu ermöglichen.

Lifecore wurde aufgrund ihrer Expertise in sterilen injizierbaren Arzneimitteln und komplexen Formulierungen nach einem wettbewerbsintensiven Prozess ausgewählt. Diese Partnerschaft positioniert Lifecore als wichtigen Akteur in der Herstellung und Abfüllung/Verpackung von biopharmazeutischen Formulierungen der nächsten Generation, was potenziell Patienten weltweit zugutekommen könnte.

Positive
  • Multi-year agreement with potential revenue exceeding $5 million
  • Selected as preferred CDMO for Lindy Biosciences after competitive process
  • Expands Lifecore's presence in next-generation biotherapeutic formulations
  • Potential for additional partnerships due to increased visibility in the pharmaceutical industry
Negative
  • None.

Insights

This partnership between Lifecore Biomedical and Lindy Biosciences represents a significant development in the biopharmaceutical manufacturing landscape. The multi-million dollar agreement not only provides Lifecore with a substantial revenue stream but also positions them as a key player in the production of next-generation biotherapeutic formulations.

Lindy Biosciences' microglassification technology is a game-changer, potentially transforming how biologic therapeutics are delivered. The shift from intravenous to subcutaneous administration could dramatically improve patient convenience and reduce healthcare costs. This aligns with the industry trend towards patient-centric drug delivery systems and home-based care.

For Lifecore, this deal offers an entry point into a high-growth market segment. The company's selection after a competitive process underscores its capabilities in handling complex manufacturing processes. This could lead to additional partnerships and revenue streams in the future, particularly if Lindy's technology gains wider adoption in the pharmaceutical industry.

Investors should note that while the potential $5 million revenue is significant for a company of Lifecore's size ($150 million market cap), the long-term value lies in the potential for follow-on contracts and establishing Lifecore as a leader in this niche. The partnership's success could significantly impact Lifecore's future growth trajectory and market position.

Multi-Million Dollar Development Agreement Establishes Lifecore as Lindy Biosciences’ Preferred CDMO

Offers Lifecore Key Access Point into Manufacture and Fill/Finish of Next-Generation Biotherapeutic Formulations with Potential to Deliver Significant Benefits to Patients Worldwide

CHASKA, Minn., Oct. 01, 2024 (GLOBE NEWSWIRE) -- Lifecore Biomedical, Inc. (NASDAQ: LFCR) (“Lifecore”), a fully integrated contract development and manufacturing organization (“CDMO”), today announced that the company has been selected by Lindy Biosciences to provide CDMO services focused on streamlining the formulation process for Lindy Biosciences’ innovative microglassification technology and scaling it for commercial manufacturing. Lifecore was chosen following a competitive process during which Lindy Biosciences considered several CDMOs for the project. The multi-year agreement could potentially bring in more than $5 million of revenue for Lifecore over the term of the agreement and establishes the company as the preferred CDMO for Lindy Biosciences.

Lindy Biosciences’ proprietary microglassification suspension technology has attracted significant interest from leading global pharmaceutical companies, as evidenced by the licensing and collaboration agreement that Lindy Biosciences recently signed with a global pharmaceutical company. Its novel formulation platform has the potential to transform the delivery of biologic therapeutics by shifting from intravenous administration in a clinical setting to self-administration at home with pre-filled syringes or autoinjectors. This is achieved by enabling the delivery of high concentrations of biologics, significantly increasing the maximum dose that can be administered in a single subcutaneous injection. Based on its expertise in the development and fill/finish of sterile injectable pharmaceutical products, including complex formulations, Lifecore is ideally suited to support Lindy Biosciences and its customers.

“When deciding to select Lifecore for this important work, we were particularly drawn to the company’s creativity and willingness to collaborate. The team has offered thoughtful insight into opportunities to optimize the process while effectively scaling it for commercial manufacturing,” said Deborah Bitterfield, Ph.D., founder and chief executive officer of Lindy Biosciences. “At Lindy Biosciences, we are striving to address the growing need for convenient therapies that patients can self-administer at home. By aligning with an experienced and collaborative partner like Lifecore, we are putting ourselves in the best position for success.”

“As a company focused on enhancing patient care, we are excited to align with Lindy Biosciences and support the innovative work their team is undertaking to improve the patient experience. The interest in the company’s technology within the pharmaceutical industry is significant and we believe that, coupled with our expertise, our work on this project will establish Lifecore as a go-to partner for CDMO services for this platform,” said Darren Hieber, senior vice president of corporate development and partnerships at Lifecore. “Being selected by Lindy Bioscience following a highly competitive process is gratifying and spotlights the unique solutions that Lifecore can offer through both our track record of success with complex manufacturing processes, as well as the collaborative development work we provide our customers.”

About Lifecore Biomedical

Lifecore Biomedical, Inc. (Nasdaq: LFCR) is a fully integrated contract development and manufacturing organization (CDMO) that offers highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceutical products in syringes, vials, and cartridges, including complex formulations. As a leading manufacturer of premium, injectable-grade hyaluronic acid, Lifecore brings more than 40 years of expertise as a partner for global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories. For more information about the company, visit Lifecore’s website at www.lifecore.com.

About Lindy Biosciences
Lindy Biosciences is dedicated to transforming the delivery of biologic drugs and improving patients' lives through innovative biotherapeutic formulations. Our cutting-edge solutions are designed to enhance drug formulation and delivery, specializing in the subcutaneous administration of concentrated (>400 mg/mL) biologic suspensions.

Founded in 2016 and headquartered in Morrisville, NC, Lindy Biosciences leverages core microglassification technology originated at Duke University and further developed by the company. We are committed to partnering with leading pharmaceutical companies to advance treatment accessibility for patients worldwide.

For more information, visit us at www.lindybio.com or follow us on LinkedIn.

Important Cautions Regarding Forward-Looking Statements

This press release contains forward-looking statements regarding future events and our future results that are subject to the safe harbor created under the Private Securities Litigation Reform Act of 1995 and other safe harbors under the Securities Act of 1933 and the Securities Exchange Act of 1934. Words such as “anticipate”, “estimate”, “expect”, “project”, “plan”, “intend”, “believe”, “may”, “might”, “will”, “should”, “can have”, “likely” and similar expressions are used to identify forward-looking statements. In addition, all statements regarding our anticipated future customer opportunities and relationships are forward-looking statements. All forward-looking statements involve certain risks and uncertainties that could cause actual results to differ materially, including such factors among others, as the company’s ability to successfully enact its business strategies, including with respect to installation, capacity generation and its ability to attract demand for its services, and its ability expand its relationship with its existing customers or attract new customers; the impact of inflation on the company’s business and financial condition;; changes in business conditions and general economic conditions both domestically and globally including rising interest rates and fluctuation in foreign currency exchange rates; the company’s ability to access to sufficient capital to fund its business strategies; and other risk factors set forth from time to time in the company’s SEC filings, including, but not limited to, the Annual Report on Form 10-K for the year ended May 26, 2024 (the “2024 10-K”). For additional information about factors that could cause actual results to differ materially from those described in the forward-looking statements, please refer to our filings with the Securities and Exchange Commission, including the risk factors contained in the 2024 10-K. Forward-looking statements represent management’s current expectations as of the date hereof and are inherently uncertain. Except as required by law, we do not undertake any obligation to update forward-looking statements made by us to reflect subsequent events or circumstances.


FAQ

What is the potential revenue for Lifecore Biomedical (LFCR) from the Lindy Biosciences agreement?

The multi-year agreement with Lindy Biosciences could potentially bring in more than $5 million of revenue for Lifecore Biomedical (LFCR) over the term of the agreement.

What is the focus of Lifecore Biomedical's (LFCR) CDMO services for Lindy Biosciences?

Lifecore Biomedical (LFCR) will provide CDMO services focused on streamlining the formulation process for Lindy Biosciences' innovative microglassification technology and scaling it for commercial manufacturing.

How does Lindy Biosciences' technology aim to improve biologic therapeutics delivery?

Lindy Biosciences' microglassification technology aims to transform biologic therapeutics delivery from intravenous administration in clinical settings to subcutaneous self-administration at home, enabling higher concentration doses in a single injection.

Why was Lifecore Biomedical (LFCR) chosen by Lindy Biosciences for this partnership?

Lifecore Biomedical (LFCR) was chosen due to their expertise in the development and fill/finish of sterile injectable pharmaceutical products, including complex formulations, as well as their creativity and willingness to collaborate.

Lifecore Biomedical, Inc.

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