Lyndra Therapeutics Announces Leadership Changes, Update on Pivotal Trial Progress

Current President and Chief Operations Officer Jessica Ballinger Appointed CEO; Outgoing CEO Patricia Hurter, Ph.D., to Serve as Board Member and Advisor

Richard Scranton, M.D., M.P.H., Appointed President, Global Product Development; Lindsay Beaupre Appointed Chief People and Workplace Operations Officer

WATERTOWN, Mass.–(BUSINESS WIRE)–Lyndra Therapeutics, a clinical-stage biopharmaceutical company working to make daily pills a thing of the past, today announced long-time Lyndra executive President and Chief Operations Officer Jessica Ballinger has been appointed President and CEO. Additionally, the company has promoted Chief Medical Officer Richard Scranton, M.D., M.P.H. to Chief Medical Officer and President, Global Product Development, and current Senior Vice President of People and Operations Lindsay Beaupre to Chief People and Workplace Operations Officer. The company also shared that enrollment in the pivotal clinical trial of its lead asset oral weekly risperidone (LYN-005) is on track for an initial data readout in the second half of 2023.

Under the leadership of CEO Dr. Patricia Hurter, Lyndra finalized the design of its LYNX™ drug delivery platform. The LYNX platform is designed to deliver long-acting oral medicines that remain in the stomach for a full week while delivering the drug consistently, minimizing peaks and troughs of drug levels compared to daily medicines. The company also designed and built a high-tech GMP manufacturing facility to produce the LYNX platform and initiated pivotal study of its lead asset oral weekly risperidone (LYN-005). Having achieved these milestones, Dr. Hurter will remain on the board of directors and become the Science and Technology Committee Chair.

“Trish Hurter is an extraordinary leader and under her stewardship Lyndra advanced firmly towards late-stage clinical development,” said Amy Schulman, Lyndra’s Co-Founder and Executive Chair of the Board. “We are delighted to have Trish become Chair of the Science and Technology Committee, where we can continue to benefit from her knowledge and experience as the company prepares to file its first New Drug Application. Jessica Ballinger brings her deep understanding of the business, science and team to the role of CEO. The board believes the new team under Jessica’s leadership as CEO is well-placed to oversee the continued execution of the company’s strategy.”

“I’m incredibly proud of what Lyndra has accomplished over the last four years,” Dr. Hurter said, “especially the progression into pivotal trials of our lead program, which will demonstrate the potential of Lyndra’s LYNX drug delivery platform to enhance therapeutic benefit and reimagine the way people take medicine. With this milestone achieved, I believe this is the right point to transition the leadership of the company to Jessica, who has been a true partner over the past four years. I look forward to continuing to serve on the board and working closely with the executive team to help accelerate Lyndra toward commercialization.”

Ballinger joined Lyndra in 2016, was promoted to Chief Operations Officer in 2018 and added the role of President in 2021. Over the past five years, Ballinger has been essential to ensuring Lyndra’s success and growth to where it is today: raising over $260M to date through a combination of equity financing, partnerships and grants; on the cusp of interim data from its first pivotal trial; and building infrastructure and organization toward commercialization.

“Delivering our first product to the market is our top priority,” said Ballinger. “Having recently initiated our pivotal clinical trial investigating oral weekly risperidone (LYN-005), we have a clear line of sight to NDA filing and the ramp-up of manufacturing to commercial scale. Having worked with Rich and Lindsay for several years and seen their leadership in action, I’m excited to work with them in their new roles. Rich has been instrumental in delivering a well-designed, efficient pivotal clinical trial program designed for regulatory success in consultation with several key opinion leaders.”

As President of Global Product Development, Scranton will be responsible for advancing the LYNX drug delivery platform and evolving and overseeing portfolio strategy, current and future product development from preclinical through commercialization, and external partnerships and alliances. As Chief Medical Officer, Scranton will continue to manage Lyndra’s medical, pre-clinical, regulatory and quality functions. Scranton’s experience before joining Lyndra in 2020 included roles with increasing responsibility at Pacira Pharmaceuticals – including Chief Medical Officer from 2018-2020 – where he led the global development and advancement of EXPAREL®, a non-opioid long-lasting injectable local anesthetic.

“Our LYNX drug delivery platform is designed to enable a week-long dose to be delivered in a single oral capsule,” Scranton said. “We are excited to continue our work applying this platform to a pipeline of products focused on health conditions where reduced dosing frequency and consistent drug delivery could have a significant positive impact. We are pleased with the progress in enrollment for the pivotal PK study and anticipate an interim readout later this year.”

As Chief People and Workplace Operations Officer, Beaupre will oversee all aspects of human resources, information technology, communications, environmental health and safety, security and facilities management. Before joining Lyndra as Vice President, Head of Human Resources in 2021, Beaupre served as an HR leader at Vertex Pharmaceuticals where she played a key role in deploying human capital strategies for several of the company’s C-Suite and global leadership teams.

Lyndra’s LYNX™ Drug Delivery Platform

The LYNX™ drug delivery platform is one of the most significant advances in oral drug delivery in decades, creating medicines that last for a week or longer in an oral dosage form. A key aspect of the platform is its ability to deliver the drug consistently, minimizing peaks and troughs of drug levels compared to daily medicine. Based on technology invented in the Langer Lab at MIT, the LYNX platform has progressed rapidly since 2015 through preclinical and early human studies and achieved proof of concept of the platform and lead asset in a Phase 2 study. The LYNX drug delivery platform has the potential for broad applicability across multiple therapeutic areas – including approved drugs and those currently in development. The LYNX drug delivery platform offers the potential to increase adherence and improve health outcomes, while also freeing people from the burden of daily pills and simplifying their lives.​

About Lyndra Therapeutics

Lyndra Therapeutics is a clinical-stage biopharmaceutical company pioneering long-acting oral therapies. Lyndra is focused on commercializing therapies in central nervous system (CNS) disorders, which would benefit from dramatically reduced dosing frequency. Lyndra’s lead product candidate, oral weekly risperidone (LYN-005), is being developed for the treatment of people living with schizophrenia and bipolar 1 disorder. The company is also committed to advancing its platform to develop multiple oral therapeutics for a broad range of diseases including major public health and global health challenges, with therapies that include oral weekly levomethadone and oral weekly buprenorphine for opioid use disorder, a monthly oral contraception pill and oral biweekly ivermectin for malaria eradication. Since the founding of Lyndra, the company has received funding from the Bill & Melinda Gates Foundation, the National Institutes of Health (NIH), AbbVie and Gilead Sciences, Inc. Lyndra is headquartered in Watertown, MA and has a state-of-the-art GMP manufacturing facility in Lexington, MA. For more information, visit https://lyndra.com.

Contacts

Dan Boyle

Orangefiery

[email protected]
(818) 209-1692