Participated · Series E · Dec 2023

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.

Led · Series B · Jan 2017

scPharmaceuticals is a pharmaceutical company focused on developing and commercializing products designed to reduce healthcare costs and improve health outcomes. Its lead product, FUROSCIX (furosemide injection) 80 mg/10 mL for subcutaneous use, is indicated for treatment of congestion due to fluid overload in adult patients with chronic heart failure. The company’s programs emphasize subcutaneous, self-administration of IV‑strength treatments in heart failure and infectious disease. Proceeds from the announced financings will be used to repay existing debt and to fund activities related to the ongoing commercialization of FUROSCIX and expansion of outpatient care. The company discloses a history of significant operating losses, expects to incur significant and increasing losses, and notes its credit facility places restrictions on its operating and financial flexibility. scPharmaceuticals was founded in 1999. scPharmaceuticals develops a portfolio of pharmaceutical products for subcutaneous delivery using a proprietary patch pump to convert drugs that currently require intravenous or intramuscular injections into subcutaneous formulations. Its lead products include Furoscix, the first subcutaneous formulation of furosemide, and a subcutaneous formulation of ceftriaxone. The furosemide formulation is intended to enable convenient anytime/anywhere use, for example in outpatient settings instead of the emergency room or other in-patient settings. For ceftriaxone and other antibiotics, subcutaneous administration aims to eliminate the need for peripherally inserted central catheters and their associated complications and costs. The company is led by founder, president and CEO Pieter Muntendam, MD. scPharmaceuticals also has an antibiotic pipeline it plans to advance alongside its commercial product efforts. scPharmaceuticals is developing a drug/device combination centered on the sc2Wear patch pump to enable subcutaneous delivery of medicines traditionally given by IV. The system uses a micropiston pump technology engineered by Swiss devicemaker Sensile Medical to provide a constant stream of drug from a wearable device. The company is targeting both heart failure and infectious disease indications and in November launched a pivotal trial administering the antibiotic ceftriaxone subcutaneously to compare against IV delivery. scPharmaceuticals is a Massachusetts startup. Financially, a regulatory filing shows it has raised $3.6 million of a proposed $7.5 million financing in what reporting describes as a bridge round. The company previously closed a $16 million Series A in 2014 with participation from 5AM Ventures, Gilde Healthcare Partners and Lundbeckfond Ventures. scPharmaceuticals is a biopharmaceutical company based in Lexington, Massachusetts, developing pharmaceutical products for subcutaneous delivery. It is developing drug-device combination products, including a novel furosemide-based product enabling subcutaneous delivery. It is also developing a cephalosporin antibiotic drug-device combination intended to provide subcutaneous administration where currently only intramuscular and intravenous options exist. The company intends to use the Series A proceeds to further develop its first two pharmaceutical products and its associated drug delivery technology. Leadership includes Bertram Pitt, MD, Professor of Medicine Emeritus at the University of Michigan, and Pieter Muntendam, MD, President and CEO. It closed a $16.0M Series A venture financing co-led by 5AM Ventures and Lundbeckfond Ventures.