Using its proprietary Faros™ microspheres, Frenelle Pharma is a biotech company improving how medicines are administered and experienced by patients. Our focus is on long-acting injectable and inhaled delivery approaches that can help support better adherence, convenience, and clinical outcomes.

Frenelle Pharma’s innovative long-acting injectable (LAI) drug delivery technology, Faros™, are high precision, spherical, non-porous particles that deliver consistent drug release profiles for patients. The micro-size of the Faros™ technology, smaller than red blood cells, enables injections through very small gauge needles at ultra-high concentrations that can minimize injection site pain; and has potential to enhance the safety of soft tissue injections. Additionally, our technology is surfactant and preservative free to reduce the potential for adverse effects.

Compared to traditional PLGA-based microspheres, the Faros™ platform produces smooth, non-porous, uniformly sized particles that are approximately half the diameter of a red-blood cell. This design improves injectability, safety, and release consistency and has demonstrated favorable safety in Phase 2 clinical testing with our lumbar radiculopathy drug candidate, SX600.

Frenelle Pharma’s Faros™ proprietary drug delivery platform is protected by 7 U.S. patents with composition of matter claims independent of the active pharmaceutical ingredient (API) with numerous applications in both human and animal health.

Long-acting injectables can reduce dosing frequency, improve adherence, and support more stable drug exposure over time. For many therapies, that can mean a better patient experience and a more practical treatment option for providers.

We are focused on areas where improved delivery could meaningfully improve care, including back pain, substance use disorders, and multiple applications in animal health. We continuously evaluate opportunities where our platform can create more value.

Our differentiation comes from our proprietary long-acting injectable drug-delivery technology. We are utilizing a hub and spoke model where our talented team can develop and spin out various applications across animal and human health. Our team is capable of managing multiple product opportunities simultaneously.

No. While long-acting injectables are a major focus, we also explore other delivery concepts where our science may be applicable, including inhaled approaches. Our goal is to match the right formulation to the right therapeutic need. Because Faros™ microspheres are smaller than a red blood cell they can be injected through very small needles, as small as 30 gauge, at high concentrations leading to more precise and comfortable experience for the provider and the patient.

Inhaled delivery can offer a non-invasive way to deliver certain medicines directly to the body with fast onset or targeted exposure. For some drugs, that can create meaningful advantages in convenience, patient acceptance, and performance. Our Faros™ microspheres are ideal size and shape for dry powder inhaler applications. Inhaled drugs can also locally treat diseases of the lung by delivery drug to the lung directly.

Frenelle is in an innovation and development stage, advancing its platform and product opportunities toward clinical and commercial milestones. Our Faros™ platform technology has been clinically proven in a Phase 2 lumbar radiculopathy clinical trial. Like most biotech companies, progress is measured by technical validation, regulatory steps, partnerships, and capital-efficient execution. Frenelle has three subsidiaries as of 2026 including SpineThera, Anumio (Animal Health) and Frenelle PBC.

Frenelle PBC is Frenelle Pharma’s public benefit corporation focused on developing treatments for substance use disorders, especially opioid use disorder. It is working to advance FRN01, a long-acting injectable buprenorphine medication designed to improve access, reduce the pain of receiving a buprenorphine injection, and improve outcomes for patients. Adoption of existing monthly injectable buprenorphine formulations are constrained not by efficacy, but by operational, economic, and access friction. Frenelle PBC combines Frenelle’s Faros™ drug delivery technology with clinical expertise from Mayo Clinic to support its development efforts. Its mission is to create better treatment options that can improve both patient experience and public health. Frenelle PBC is collaborating with Dr. Tyler Oesterle from Mayo Clinic, an expert in the field of addiction medicine.

Although approximately two million people in the United States are treated with buprenorphine, fewer than 10 percent receive long-acting monthly injectable formulations. Barriers include high cost, painful injections, restricted pharmacy access, and FDA REMS requirements.

FRN01 is Frenelle PBC’s investigational long-acting injectable buprenorphine product designed for once-monthly dosing to treat opioid use disorder (OUD).

FRN01 is designed to: •              Be injected using a small, nearly pain-free needle •              Be available through standard pharmacies without high-burden REMS requirements •              Be priced competitively with daily oral buprenorphine •              Reduce peak drug exposure (Cmax), lowering the risk of precipitated withdrawal.

FRN01 is built on Frenelle’s proprietary Faros™ platform, which uses biodegradable, nano-sized, non-aggregating microspheres to deliver sustained drug release over a monthly interval.

Current monthly injectable Buprenorphine formulations are in-situ forming depots that transform from a liquid to a solid mass after injection, which is potentially fatal if injected intravenously. The Prescribing Information for Sublocade includes this statement, “Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program called the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements.” The Prescribing Information for Brixadi includes this statement, “Because of the risk of serious harm or death that could result from intravenous self-administration, BRIXADI is only available through a restricted program called the BRIXADI REMS. Healthcare settings and pharmacies that order and dispense BRIXADI must be certified in this program and comply with the REMS requirements.” In contrast, FRN01 is built on the Faros™ microsphere platform technology. Faros™ microspheres are smaller than a red-blood cell and non-aggregating, and this design is intended to mitigate the risk of intravenous injection. This design also improves injectability, safety, and release consistency and has demonstrated favorable safety in prior Phase 2 clinical testing with other drugs.

Preclinical feasibility studies and a 28-day rat study showed: •              Sustained drug release consistent with monthly dosing •              Lower peak plasma levels (Cmax) than SUBLOCADE •              No adverse safety findings •              Alignment between in vitro and in vivo pharmacokinetic profiles.

FRN01 is in preclinical development, with formulation optimization underway and a defined path toward IND submission, Phase 1 clinical trials, and eventual FDA approval.

The market for opioid use disorder treatments exceeds $2 billion annually, including $1.2 billion in sales on monthly injectable buprenorphine in 2025. FRN01 is designed to compete directly with daily oral buprenorphine by removing the barriers that have limited adoption of existing monthly injectable products.

Frenelle PBC was co-founded by Mayo Clinic Ventures, which provided 50 percent of the seed capital. The company collaborates with Dr. Tyler Oesterle, Chair of Addiction Medicine at Mayo Clinic.

Frenelle PBC has completed a seed round led by Mayo Clinic Ventures and is seeking mission-aligned investors to advance FRN01 through a clearly defined development plan.

Frenelle PBC anticipates approximately $65 million in total development costs through FDA approval, including CMC and pre-clinical work, clinical trials, NDA submission, and pre-commercial launch activities.

Anumio is Frenelle Pharma’s animal health subsidiary focused on long-acting injectable drugs for companion animals (dogs, cats, and horses). It leverages Frenelle’s Faros™ technology to develop therapeutics that improve pet care and welfare. Anumio targets the FDA’s Expanded Conditional Approval pathway to accelerate commercialization. The company aims to help companion animals live longer, happier lives alongside their human families.

SpineThera is Frenelle Pharma’s clinical-stage subsidiary focused on treating lumbar radicular pain, commonly known as sciatica. Its lead asset, SX600, uses Faros™ technology to deliver 90-day sustained release of dexamethasone from a single epidural injection. Phase 2 trial data showed clinically meaningful and durable pain reduction, with 71% of patients in the 25 mg group achieving at least 50% improvement in leg pain at 60 days versus 13% on placebo with meaningful pain reduction through 180 days. The company aims to transform sciatica treatment by offering a best-in-class efficacy profile with a favorable safety profile.

We have been advancing development work intended to support future clinical progress. The specific data package depends on the program, and we share updates as milestones are reached. Our subsidiary SpineThera has published Phase 2 data for SX600. See Ludbrook G, Houghton W, Techner L, Meyering E, Gashwiler V, Rachfal A, Missling J. Clinically meaningful radicular leg pain management via novel dexamethasone extended release microsuspension (SX600)-Phase 1/2 Results (4710). ASRA 2024 PM Scientific Abstracts Regional Anesthesia & Pain Medicine 2024;49:381-390. Presented at 22nd ASRA Annual Pain Medicine Meeting, Nov 10-11, 2023, New Orleans, Louisiana. doi: 10.1136 /rapm-2024-ASRA_PM_ABSTRACTS

The regulatory path depends on the specific product and indication. We design development plans around the most appropriate pathway for each program, with the goal of reaching key milestones efficiently and responsibly.

Partnerships can accelerate development and help bring new ideas and applications to specific programs. We view strategic collaboration as an important part of de-risking and scaling.

Our competitive advantage is the combination of proprietary delivery science, focused therapeutic applications, and the flexibility to address multiple unmet needs. We aim to create a platform that can be extended across different programs.

We look for programs with strong unmet need, a clear delivery advantage, and a realistic path to development and commercialization. We prioritize opportunities where our platform can create meaningful differentiation.

We tend to be a fit for investors who understand biotech development, platform technologies, and drug-development value-creation timelines. Investors who appreciate milestone-driven progress would find Frenelle Pharma compelling.

If you’d like to learn more, please contact us through the website www.frenellepharma.com and request corporate materials or a conversation with our team. We can also be reached through LinkedIn.  We’re always happy to share more information on the platform, current programs, and strategic direction.