Osteal Therapeutics – a clinical-stage biopharmaceutical company developing a new category of combination therapies for orthopedic infections – recently announced the completion of an oversubscribed $23 million Series C equity financing. The proceeds will leave Osteal well-funded to submit its New Drug Application (NDA) submission to the FDA and accelerate preparation for the commercial launch of VT-X7, its lead therapy for treating periprosthetic joint infection (PJI).
Asteroid Partners led the funding round, joined by new investor Gideon Strategic Partners and returning investors Johnson and Johnson Development Corporation (JJDC), HM Capital, Prism Ventures, and Medvest Capital. In conjunction with the financing, Martin Sands and Steven Sands of Asteroid Partners will join the board as board member and observer respectively.
The company is also rapidly approaching completion of enrollment in APEX-2, a multicenter, randomized controlled clinical trial of VT-X7. APEX-2 is intended to build upon the safety and efficacy evidence obtained from APEX-1, a similarly designed Phase 2 study that successfully met its primary endpoint earlier this year. And both studies were designed in consultation with the FDA following receipt of orphan drug and qualified infectious disease product designations. The company expects to seek NDA approval once APEX-2 reaches its planned endpoints.
KEY QUOTES:
“This is a very exciting time at Osteal as we expect to achieve a number of critical value-creating milestones in the coming months. This capital raise places Osteal in an excellent position to continue our progress with the VT-X7 program, while also leveraging our technical and scientific expertise to strategically expand our pipeline.”
- David Thompson, President and Chief Executive Officer
“Today, hip and knee replacements are extremely common. An aging population that is seeking to stay active will drive a roughly three-fold increase in annual procedures between now and 2040. PJIs, while rare, closely track the number of primary and revision joint replacements. The current standard of care for treatment of PJI is associated with significant morbidity, risk of early death and reduced quality of life, driving both the clinical community and regulators to search for better treatment options. Osteal is addressing this significant unmet medical need with a highly novel approach.”
- Martin Sands of Asteroid Partners
“I am impressed with the progress this team has made, especially with their clinical program. What I find the most compelling is that when I speak to clinicians, they universally describe the serious unmet need in PJI treatment and quickly understand the potential value of VT-X7. They recognize this solution affords the possibility to both save and change lives. I believe Osteal’s therapeutic platform will dramatically improve quality of life and outcomes for patients with serious orthopedic infections. I look forward to supporting the team to achieve multiple key milestones over the next 18 months.”
- Steven Sands of Asteroid Partners
