Bryn Pharma

Key People

• Sandy Loreaux - Chief Executive Officer
• Jim Borneman - Chief Operating Officer
• Nurry Hong - Chief Strategy and Business Development Officer
• Steve Killmeyer - Chief Financial Officer
• Jerry Andry - Vice President, Research and Development and Regulatory Affairs
• Jeremy Shepler - Senior Vice President, Sales and Marketing
• Karen Rance - Vice President, Head of Medical Affairs
• Jeff Evans - Vice President, Head of Manufacturing
• Lisa Lucifero - Vice President, Head of Human Resources

Assessment

Team

Aspect: Multiple successful MedTech entrepreneurs
Summary: The leadership team comprises seasoned executives with extensive experience in the pharmaceutical and biotech industries.

The leadership team includes individuals with over 20 years of experience in the pharmaceutical industry, such as CEO Sandy Loreaux and COO Jim Borneman. Their backgrounds in leading pharmaceutical companies provide a strong foundation for Bryn Pharma's strategic initiatives.

Clinical Need

Aspect: Very Strong
Summary: There is a significant demand for needle-free epinephrine delivery systems to treat anaphylaxis.

Anaphylaxis requires immediate treatment with epinephrine. Traditional auto-injectors can be intimidating due to needle use and may be cumbersome to carry. Bryn Pharma's needle-free, portable solution directly addresses these concerns, potentially improving patient compliance and outcomes.

Competition

Aspect: Somewhat crowded
Summary: The market for anaphylaxis treatments includes established products like EpiPen and other auto-injectors.

EpiPen and its generics dominate the anaphylaxis treatment market. However, Bryn Pharma's intranasal spray differentiates itself by eliminating needles and enhancing portability, which could attract patients seeking alternatives to injections.

Technical Challenge

Aspect: Moderate
Summary: Developing a reliable intranasal epinephrine delivery system presents moderate technical challenges.

Intranasal drug delivery must overcome challenges related to mucosal absorption rates and device design to ensure efficacy comparable to intramuscular injections. Bryn Pharma's development efforts focus on addressing these challenges to meet regulatory standards and patient needs.

Patent

Aspect: Strong
Summary: Bryn Pharma holds multiple patents related to its intranasal epinephrine formulations and delivery devices.

With 24 patent documents, including 9 granted patents and 11 pending applications, Bryn Pharma has established a robust IP position. This portfolio covers various aspects of their intranasal epinephrine technology, potentially deterring competitors and attracting investors.

Financing

Aspect: Well-funded
Summary: Bryn Pharma has secured significant funding to support its development and commercialization efforts.

As of July 2023, Bryn Pharma raised approximately $26.7 million in equity financing, bringing its total funding to around $83.2 million. This capital supports ongoing clinical trials, regulatory submissions, and preparations for product launch.

Regulatory

Aspect: Pivotal Trial
Summary: Bryn Pharma is conducting pivotal clinical trials to demonstrate the efficacy and safety of its intranasal epinephrine spray.

The company announced positive results from a pivotal clinical trial comparing its product to standard epinephrine auto-injectors. These results are essential for supporting regulatory submissions to agencies like the FDA, aiming for approval and subsequent commercialization.

Opportunity Rollup

Odds of Success

3.55

Peak Market Share

4.4

Segment CAGR

2.4%

Market Segment

Drug Delivery Devices

Market Sub Segment

Intranasal Epinephrine Delivery

Key Takeaway

Bryn Pharma's intranasal epinephrine spray addresses a significant clinical need with a patient-friendly solution, supported by a strong team and substantial funding, positioning it well for market entry despite competitive and regulatory challenges.