Osteal Therapeutics Closes an Oversubscribed $30 Million Series B Financing to Advance Platform Therapy for Treatment of Musculoskeletal Infection

Series B financing led by HM Capital and joined by returning investors JJDC and Medvest Capital

Proceeds will support clinical development of lead candidate, VT-X7 for periprosthetic joint infection.

DALLAS, March 08, 2022 (GLOBE NEWSWIRE) — Osteal Therapeutics, Inc. (“Osteal”), a clinical-stage biopharmaceutical company developing a new category of combination therapies for musculoskeletal infections, announced today the completion of an oversubscribed $30 million Series B equity financing. The proceeds will enable Osteal to continue development of its integrated technologies, advance the clinical development of its lead candidate, VT-X7 for treatment of periprosthetic joint infection and fund new research programs.

HM Capital led the round with full participation by existing investors Johnson and Johnson Development Corporation (JJDC) and Medvest Capital. In conjunction with the financing, Robert Luo, M.D., Managing Partner at HM Capital and Judson Cooper, Founding Principal of Prism Ventures LLC, joined the Board of Directors.

The Series B funding will be used primarily to advance Osteal’s lead program, VT-X7 for periprosthetic joint infection (PJI), into later-stage clinical trials. Following the successful completion of an open-label Phase 2 trial, the company recently commenced enrollment of APEX, a randomized controlled study of VT-X7 in patients with chronic periprosthetic infections of the hip or knee.

“This is a very exciting time at Osteal as we expect to achieve a number of critical value-creating milestones in the coming months,” said David Thompson, president and chief executive officer. “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.”

“Osteal is addressing a significant unmet medical need with a highly novel approach. I am impressed with the strength of the team and positive data to date,” said Robert Luo, founder and managing partner of HM Capital. “I believe Osteal’s therapeutic platform will dramatically improve quality of life and outcomes for patients with serious musculoskeletal infections, and I look forward to supporting the team to achieve multiple key milestones over the next 15 months.”

About Periprosthetic Joint Infection (PJI)

Affecting over 40,000 people in the U.S annually, periprosthetic joint infection (PJI) is a rare but potentially devastating complication of joint replacement surgery in which pathogenic bacteria colonize the joint prosthesis forming difficult to remove structures called biofilms. Biofilm infections are challenging to resolve, requiring long, invasive and expense treatments that are often unsuccessful, resulting in high rates of permanent disability and early death. Recent evidence demonstrates that the current gold standard for treatment of PJI, two-stage exchange arthroplasty, takes an average of 16 weeks has a success rate under 50% after 12 months, highlighting the unmet need for faster more reliable treatment options.

About VT-X7

VT-X7 (vancomycin HCL and tobramycin sulfate for irrigation) is a novel drug/device combination product designed to deliver therapeutic concentrations of vancomycin and tobramycin, well-established, broad-spectrum antibiotics, directly to the joint space and surrounding tissue to treat chronic periprosthetic joint infection. VT-X7 is a seven-day therapy designed to address the unmet clinical need for a rapid, reliable treatment for these rare but challenging infections. In a Phase 2 clinical trial, 100% of VT-X7 patients were treated and received a new permanent joint prosthesis in seven days with 93% remaining infection free at one year. Osteal Therapeutics is currently conducting APEX, a randomized controlled trial of VT-X7 compared to the current standard of care for treatment of chronic PJI, two-stage exchange arthroplasty. The FDA granted VT-X7 Orphan Drug, Fast Track and Qualified Infectious Disease Product designations. This initial application of VT-X7 represents a first-of-its-kind, multibillion dollar opportunity to dramatically improve outcomes for an underserved patient population.

About Osteal Therapeutics, Inc.

Osteal Therapeutics is a privately held, clinical-stage biopharmaceutical company developing novel musculoskeletal therapeutics to treat orthopedic infections and their consequences. The company is leveraging the ability of concentrated, locally delivered antimicrobials to treat the bacterial biofilms typically responsible for musculoskeletal infections while minimizing off-target tissue exposure and associated adverse effects. Osteal employs a low-risk development strategy by using approved drugs with long histories of safety and efficacy as candidates for new routes of local delivery. The company’s lead candidate, VT-X7, is in Phase 2 development to treat chronic periprosthetic joint infections, a serious complication of joint replacement surgery. For more information, please visit: www.ostealtx.com