Invivyd, Inc. (Nasdaq: IVVD) announced today that it has secured a $30 million term loan facility with Silicon Valley Bank (SVB), a division of First Citizens Bank. The non-dilutive financing agreement allows the biopharmaceutical company to access capital in the future upon meeting certain conditions and milestones.
"We are pleased to have secured this term loan facility ahead of important anticipated catalysts, including gaining alignment with the FDA on the regulatory pathway of our pipeline candidate, VYD2311," said Bill Duke, Chief Financial Officer of Invivyd. "The non-dilutive nature of this financing facility supports balance sheet optionality so the company can focus on per-share value creation."
The loan facility strengthens Invivyd's financial position as it continues to advance its portfolio of monoclonal antibodies (mAbs) designed to provide protection against serious viral infectious diseases, with a primary focus on SARS-CoV-2.
VYD2311: Next-Generation COVID-19 Antibody
VYD2311 represents Invivyd's continued efforts to address the evolving COVID-19 landscape. This novel monoclonal antibody candidate is being developed to meet the ongoing need for new prophylactic and therapeutic options against the virus.
A key advantage of VYD2311 is its pharmacokinetic profile and antiviral potency, which may enable the delivery of clinically meaningful protection through a more patient-friendly intramuscular administration route, rather than intravenous infusion.
The antibody was engineered using Invivyd's proprietary integrated technology platform and developed through serial molecular evolution to optimize neutralization against contemporary SARS-CoV-2 variants. VYD2311 builds upon the company's existing antibody portfolio, sharing the same backbone as pemivibart (PEMGARDA) and adintrevimab.
PEMGARDA: Recently Authorized COVID-19 Antibody
In March 2024, Invivyd achieved a significant milestone when the U.S. FDA granted emergency use authorization (EUA) for PEMGARDA (pemivibart), a half-life extended investigational monoclonal antibody.
PEMGARDA is authorized for pre-exposure prophylaxis of COVID-19 in adults and adolescents (12 years and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to certain medical conditions or immunosuppressive treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.
The antibody has demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1, KP.3.1.1, XEC, and LP.8.1. PEMGARDA works by targeting the SARS-CoV-2 spike protein receptor binding domain, thereby inhibiting virus attachment to the human ACE2 receptor on host cells.
Healthcare providers should note that anaphylaxis has been observed with PEMGARDA, and the product's Fact Sheet includes a boxed warning for this serious adverse reaction. Common adverse events include systemic infusion-related reactions, hypersensitivity reactions, local infusion site reactions, and infusion site infiltration or extravasation.
Strategic Financial Management
The new loan facility provides Invivyd with additional financial flexibility without diluting existing shareholders. This approach aligns with the company's stated focus on per-share value creation while pursuing its clinical development and regulatory objectives.
For Invivyd, securing non-dilutive financing represents a strategic move to strengthen its balance sheet ahead of anticipated regulatory discussions regarding VYD2311's development pathway. The company's ability to access capital based on milestone achievements creates a performance-linked financing structure that can support continued innovation while maintaining fiscal discipline.
Looking Forward
As Invivyd advances its discussions with the FDA regarding VYD2311, the company continues to position itself as a leader in developing antibody-based solutions for viral infectious diseases. The company's proprietary integrated technology platform enables it to assess, monitor, develop, and adapt antibodies to address evolving viral threats.
With PEMGARDA already authorized for emergency use and VYD2311 advancing through development, Invivyd demonstrates its commitment to delivering protection against serious viral infectious diseases, beginning with SARS-CoV-2 but potentially expanding to other viral threats in the future.
The $30 million loan facility with Silicon Valley Bank represents not just a financial transaction but a vote of confidence in Invivyd's scientific approach and business strategy as it continues to build its portfolio of innovative antibody candidates.
