Frenelle Private Investor Briefing - NYC
Dear Investors,
Join Opus8 for an exclusive investor briefing with Frenelle. Frenelle is developing FRN01, a once-monthly subcutaneous buprenorphine injection for Opioid Use Disorder (OUD), and is backed by Mayo Clinic Ventures.
Long-acting injectable buprenorphine works, but fewer than 10% of patients treated for OUD use it. Adoption is held back by cost, injection pain, and restricted distribution. FRN01 is designed to remove those barriers.
The Opportunity
Frenelle is raising $3–5M in preferred stock at a $13M pre-money valuation. Proceeds fund formulation lock, mini-pig PK and toxicology studies, payer research, and a pre-IND meeting with FDA.
Why Investors Are Taking Notice
Underpenetrated Market: The global long-acting injectable buprenorphine market exceeded $1.2B in 2025, yet reaches under 10% of treated OUD patients. More than 90% remain on daily sublingual buprenorphine.
Patient-Friendly by Design: FRN01 is delivered through a fine 30-gauge needle to reduce injection pain. It is priced to expand access across Medicaid, safety-net, and criminal-justice channels.
Streamlined Regulatory Path: FRN01 is pursuing a 505(b)(2) pathway guided by FDA's product-specific guidance for depot buprenorphine. It builds on Frenelle's Faros™ microsphere platform, which has been clinically tested and backed by roughly $20M of prior development.
Proven Team: Leadership has more than 10 drug launches across Adapt Pharma, Indivior, Allergan, Pfizer, and others. Dr. Tyler Oesterle of Mayo Clinic Addiction Medicine serves as clinical chair.
Minimum Check Size: $200K
Event Details:
Date: October 5
Time: 5:30 PM EDT
Location: New York City
Please note that this meeting is for DIRECT and ACTIVE Accredited investors only. All RSVPs are subject to review and approval.
Request investor materials by contacting Skylar Rallison at srallison@opus8.com.
Thanks much and all the best,
Tien Wong
CEO
Opus8, Inc.