Lyndra Therapeutics is a clinical-stage biopharmaceutical company developing long-acting oral therapies using its LYNX drug delivery platform. The LYNX platform creates weekly oral medicines enabled by over 50 patented innovations and is licensed exclusively from the Bob Langer and Gio Traverso laboratories at MIT. Lyndra’s lead product candidate is oral weekly risperidone (LYN-005), which is near completion of a pivotal Phase 3 study, and the company is also advancing weekly formulations of dapagliflozin (LYN-045) and aripiprazole (LYN-006). Proceeds from recent financings are intended to support completion of the risperidone Phase 3 trials and continued development of the pipeline of oral weekly therapies. Since its founding, Lyndra has received product funding from the Bill & Melinda Gates Foundation, the NIH, AbbVie, and Gilead Sciences. The company is headquartered in Watertown, MA and operates a GMP manufacturing facility in Lexington, MA. Lyndra Therapeutics develops long-acting oral therapies using its proprietary LYNX drug delivery platform. Its lead candidate, LYN-005 (oral weekly risperidone), has dosed the first participant in a pivotal trial for schizophrenia and schizoaffective disorder. The LYNX platform is designed to deliver a week’s worth of medication in a single oral capsule. The company recently raised capital as part of a larger offering and previously completed a $60.5 million Series C in 2021. Financial updates include a $20.3 million placement from investors as part of the current offering. Lyndra Therapeutics is a clinical-stage biotechnology company pioneering an oral ultra-long-acting, extended-release capsule designed to reside in the stomach and provide linear drug release for a week or longer. Its lead candidate, LYN-005, is a once-weekly oral risperidone formulation that showed encouraging Phase 2 proof-of-concept data indicating a more consistent pharmacokinetic profile and reduced dosing frequency. The company plans to advance LYN-005 into pivotal trials and prepare for U.S. commercialization, with an expected pivotal start later this year and a launch a few years thereafter. Lyndra is expanding its CNS pipeline assets and actively evaluating high-value partnerships across a broad range of disease states. The platform targets areas where non-adherence is a major driver of outcomes, including schizophrenia, diabetes, cardiovascular disease and opioid use disorder. Lyndra has collaborations and funding engagements including the Bill & Melinda Gates Foundation and the NIH, and has raised almost $250 million in total financing inclusive of the most recent round. Lyndra Therapeutics is developing once-monthly oral dosage forms, including a combination contraceptive designed to deliver continuous estrogen and progestin. Its core technology is a star-shaped formulation contained inside a capsule that opens in the stomach, releases active pharmaceutical ingredients consistently for up to a week or longer, and then exits via the gastrointestinal tract. The current program is focused on demonstrating once-monthly gastric residence and building a once-monthly oral combination therapy. Preclinical evaluation will be conducted in collaboration with Routes2Results through additional funding from the Bill & Melinda Gates Foundation. The foundation awarded Lyndra a $13M grant for the contraceptive program and also awarded a separate grant for a long-acting malaria drug. The foundation invested in Lyndra’s recent Series B; those Series B proceeds will be used for Phase II clinical trials, expansion of the Phase I pipeline, and manufacturing scale-up. Lyndra is led by CEO and co-founder Amy Schulman and is based in Watertown, MA. Lyndra Therapeutics develops orally administered ultra-long-acting, sustained-release therapies designed to deliver steady-state release of one or more drugs for up to a week or longer while temporarily residing in the stomach. Its platform uses a star-shaped formulation inside a capsule that opens in the stomach, releases active pharmaceutical ingredients consistently over time, and then exits the gastrointestinal tract safely. The company aims to replace daily dosing with weekly or monthly pills to improve medication adherence, reduce side effects, and lower healthcare costs. To date the dosage form has been safely administered in 50 subjects during Phase I clinical trials in Australia, and Lyndra received a Notice of Allowance from the U.S. Patent and Trademark Office for related intellectual property. Lyndra is moving toward submitting an IND for a long-acting schizophrenia pill in 2019 and anticipates starting a Phase II clinical trial in 2020 while advancing other candidates through Phase I–III. The company recently raised new financing to support clinical development and manufacturing scale-up.

Total raised

$353M

Funding rounds

7

Latest round

Series E

Latest activity

Dec 2023