Lyndra Therapeutics Inks $55M

The funds will be used for Phase II clinical trials, expansion of its Phase I pipeline and manufacturing scale-up. All original investors from the company's $23 million Series A round, led by Polaris Partners, resubscribed, and new investors include HOPU Investments, Gilead Sciences, Invus, the Bill & Melinda Gates Foundation and Orient Life.

"The diversity and caliber of our investors, including those who joined this round, speaks to the importance of addressing unmet therapeutic need," said Amy Schulman, CEO and co-founder of Lyndra Therapeutics. "I am proud of the speed with which the Lyndra team has moved from demonstrating feasibility to the clinic, and now we are well positioned to initiate additional Phase I clinical trials and continue our progress toward Phase II clinical trials."

"Lyndra's groundbreaking development in an oral drug delivery system is very exciting and offers real promise to patients and the healthcare system. We are delighted to be Lyndra's partner," said Cliff Chau, Partner at HOPU Investments.

Lyndra is moving toward submitting an Investigational New Drug Application (IND) for a long-acting schizophrenia pill in 2019 in anticipation of starting a Phase II clinical trial in 2020. It also plans to bring other drug candidates, including its own therapies and drugs commercialized with partners, through Phase I, II and III clinical trials.

"Lyndra's long-acting therapies have the potential to address a diversity of disease states," said Robert Langer, co-founder and Board Member of Lyndra Therapeutics. "The ability to move from daily to weekly administration of an oral drug is groundbreaking. I believe Lyndra's long-acting oral pill will be truly transformative."

"Lyndra's vision is to address unmet need for conditions that affect large patient populations, starting with schizophrenia, and this funding moves the company a step closer to late-stage clinical trials and manufacturing scale-up that will bring this vision to life," said Catherine B. Reynolds, Chair of the Board of Directors for Lyndra Therapeutics.

The announcement comes on the heels of positive early clinical study results and a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for intellectual property related to Lyndra's ultra-long-acting oral dosage form. To date the dosage form has been safely administered in 50 subjects during Phase I clinical trials in Australia.

About Lyndra Therapeutics' Platform

Lyndra Therapeutics' orally administered dosage form is designed to deliver sustained, steady-state release of one or more drugs for up to a week or longer while temporarily residing in the stomach. Taking a single, long-acting pill weekly instead of daily or more often can improve medication adherence and health outcomes while reducing burdens on individuals and their caregivers. Inside a familiar capsule is a star-shaped formulation with active pharmaceutical ingredients that are released consistently over time. The formulation, which is designed to open once inside the stomach, eventually exits safely via the gastrointestinal tract, like undigested food.

About Lyndra Therapeutics

Lyndra Therapeutics aims to improve healthcare outcomes through oral, ultra-long-acting, sustained-release therapies that change how people take medicines. Instead of taking medications daily or more frequently, doses would be administered weekly or monthly, improving medication adherence for better health outcomes and lower healthcare costs. Delivering controlled amounts of medicine would also reduce side effects and improve drug efficacy. For more information, visit the company's website www.lyndra.com.