Lyndra Therapeutics, Inc.

WATERTOWN, Mass.--( BUSINESS WIRE )-- Lyndra Therapeutics ® , a clinical-stage biopharmaceutical company pioneering long-acting oral therapies, today announced the Board of Directors has appointed Adam Sayer as President and Chief Executive Officer effective immediately. He will also serve on the company’s Board of Directors. Sayer was most recently Chief Transformation Officer at Envision Healthcare, overseeing strategy, transformation and payer negotiations. His deep understanding of the healthcare ecosystem and track record of operational excellence will be instrumental in advancing Lyndra’s pivotal program for oral weekly risperidone (LYN-005) and bringing the first long-acting oral therapeutics to patients. “I am excited to join Lyndra at this pivotal moment for the company,” said Sayer. “Lyndra’s LYNX ® platform technology has demonstrated remarkable potential to transform oral medicine delivery and make a meaningful impact on patient outcomes, and I look forward to leading this talented team as we bring the first-ever long-acting oral medicines to market.” Under the leadership of outgoing President and CEO Jessica Ballinger, Lyndra completed the pivotal efficacy study for lead asset oral weekly risperidone (LYN-005) and established a strategic collaboration with Thermo Fisher Scientific for global clinical research and commercial manufacturing. “We are grateful for Jess’ contributions and overall dedication to our mission,” said Amy Schulman, Lyndra Therapeutics co-founder and Executive Chair of the Board. “Now, under Adam’s leadership and with his focus on business execution, we are poised to achieve our goals and fundamentally change how oral medicines are delivered.” “As one of Lyndra’s first employees, I’m incredibly proud of the progress this team has made – from the development and testing of what is now the LYNX ® platform, to the successful first trial of our pivotal program and announcement of a strategic manufacturing collaboration with Thermo Fisher,” said Ballinger. “I am confident the company is well-positioned for continued success.” Lyndra’s pivotal safety study for lead asset oral weekly risperidone (LYN-005) is slated to begin in the first half of 2025. About Lyndra Therapeutics Lyndra Therapeutics is a clinical-stage biopharmaceutical company partnering to create and commercialize long-acting oral therapies. Lyndra’s LYNX ® drug delivery platform delivers medicine for a week or longer in a single oral dose. The LYNX drug delivery platform aims to optimize the way we take and deliver medicines: less frequent dosing with more stable drug exposure, enhancing the patient experience. The LYNX platform's versatility has been demonstrated through clinical proof-of-concept research across five therapeutic areas and 25 APIs. For more information on Lyndra and partnership opportunities, visit https://lyndra.com .

Lyndra’s drug delivery platform optimises the delivery of oral medicines. Credit: Stock-Asso/Shutterstock. Lyndra Therapeutics and Thermo Fisher Scientific have entered a strategic partnership to develop Lyndra’s long-acting oral therapies for conditions such as schizophrenia and bipolar disorder. Lyndra will utilise Thermo Fisher’s worldwide clinical research and commercial manufacturing services for its therapies, including its lead investigational product, oral weekly risperidone (LYN-005). LYN-005 recently achieved its primary endpoint in the pivotal Phase III STARLYNG-1 trial, showcasing its efficacy against daily risperdal. The partnership will leverage Thermo Fisher’s accelerator drug development services, which offer a suite of manufacturing, clinical research and clinical supply chain services. The services are tailored to support biotech and pharmaceutical companies from pre-clinical stages to commercialisation. Lyndra aims to harness Thermo Fisher’s pharmaceutical manufacturing capabilities in Cincinnati in the US state of Ohio. This includes the commercial line for Lyndra’s LYNX drug delivery platform, which will facilitate the manufacturing of commercial materials at scale. The platform is tailored to enhance clinical outcomes by optimising the delivery of oral medicines. The technology underpinning the LYNX platform was developed in the Traverso and Langer Laboratories, from which Lyndra has an exclusive technology licence. The partnership also opens opportunities for other pharmaceutical partners interested in creating long-acting oral therapies using LYNX platform technology. Lyndra Therapeutics global product development president and chief medical officer Dr Richard Scranton stated: “Lyndra’s clinical research and manufacturing collaboration with Thermo Fisher is a critical step in our mission to transform how patients take medicine, providing the capabilities and scale to bring long-acting oral therapies to broad markets. “Thermo Fisher will be part of our ecosystem of best-in-class partners as we execute our go-to-market strategy, allowing Lyndra to focus on what we do best – research and development for innovative long-acting oral therapeutic solutions – while ensuring reliable, scalable manufacturing and clinical trial operations.” In December 2023, Lyndra secured $101m in Series E financing to advance its pipeline of long-lasting oral therapy products.

WATERTOWN, Mass.--( BUSINESS WIRE )-- Lyndra Therapeutics , a clinical-stage biopharmaceutical company pioneering long-acting oral therapies, today announced a strategic collaboration with Thermo Fisher Scientific Inc., the world leader in serving science, in which Thermo Fisher will provide global clinical research and commercial manufacturing services to Lyndra for its long-acting oral therapies. Lyndra’s long-acting oral therapies, including lead investigational product oral weekly risperidone (LYN-005), are designed to deliver medication for a week or longer with a single oral dose. LYN-005 met its primary endpoint in the phase 3 pivotal STARLYNG-1 study , demonstrating efficacy compared to daily Risperdal. The phase 3 pivotal safety study of oral weekly risperidone is planned to be initiated in 1H 2025. “Lyndra’s clinical research and manufacturing collaboration with Thermo Fisher is a critical step in our mission to transform how patients take medicine, providing the capabilities and scale to bring long-acting oral therapies to broad markets,” said Dr. Richard Scranton, M.D., M.P.H., President of Global Product Development and Chief Medical Officer of Lyndra Therapeutics. “Thermo Fisher will be part of our ecosystem of best-in-class partners as we execute on our go-to-market strategy, allowing Lyndra to focus on what we do best – R&D for innovative long-acting oral therapeutic solutions – while ensuring reliable, scalable manufacturing and clinical trial operations.” The collaboration leverages Thermo Fisher’s Accelerator™ Drug Development services, 360° Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) drug development solutions. Accelerator™ Drug Development provides a customizable suite of manufacturing, clinical research and clinical supply chain services for emerging biotechs and large pharmaceutical companies at every stage from pre-clinical to commercialization. As part of the collaboration, Lyndra plans to utilize Thermo Fisher’s end-to-end advanced pharmaceutical manufacturing capabilities in Cincinnati, Ohio, including Lyndra’s LYNX drug delivery platform commercial line, to manufacture commercial materials at scale. “Thermo Fisher is pleased to collaborate with Lyndra on its revolutionary drug delivery platform, and we look forward to helping bring these groundbreaking, long-acting oral therapies to patients,” said Michael Shafer, Executive Vice President and President, Biopharma Services at Thermo Fisher. “Leveraging Accelerator™ Drug Development, our comprehensive CDMO and CRO drug development solutions, exemplifies our commitment to help speed and simplify the complex journey of clinical development.” Pharmaceutical partners seeking to utilize Lyndra’s LYNX platform technology to create long-acting oral therapies may also benefit from the collaboration with Thermo Fisher and its clinical research and manufacturing services, helping to accelerate development pathways and supporting commercialization. About the LYNX ® Drug Delivery Platform The LYNX ® drug delivery platform aims to improve clinical outcomes by optimizing how oral medicines are delivered and taken. The LYNX platform technology enables the stable and sustained delivery of medicine in a target therapeutic window for a week or longer in a single oral dose. This is made possible by more than 50 patented innovations in design, engineering and materials science. The technology for the LYNX platform originated in the Traverso and Langer Laboratories, with which Lyndra has an exclusive technology license. With broad applicability across multiple therapeutic areas, the LYNX platform has the potential to revolutionize oral drug delivery, enhancing the patient experience and providing meaningful value to the healthcare system. About Lyndra Therapeutics Lyndra Therapeutics is a clinical-stage biopharmaceutical company partnering to create and commercialize long-acting oral therapies. Lyndra’s LYNX ® drug delivery platform delivers medicine for a week or longer in a single oral dose. The LYNX drug delivery platform aims to optimize the way we take and deliver medicines: less frequent dosing with more stable drug exposure, enhancing the patient experience. The LYNX platform's versatility has been demonstrated through clinical proof-of-concept research across five therapeutic areas and 25 APIs. For more information on Lyndra and partnership opportunities, visit https://lyndra.com .