Invivyd, Inc. is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. The company's proprietary INVYMAB™ platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering. INVYMAB is designed to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs) to address evolving viral threats.
Recent Developments
In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for PEMGARDA™ (pemivibart) injection, a half-life extended investigational mAb, for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents who have moderate-to-severe immune compromise. This represents a significant milestone, as PEMGARDA is the company's first mAb in a planned series of innovative candidates designed to keep pace with SARS-CoV-2 viral evolution.
Business Strategy
Invivyd's strategy is to combine the potential for high efficacy and attractive safety of modern mAbs directed against the SARS-CoV-2 spike protein with the opportunity for product evolution, similar to the approach commonly seen in the vaccine industry. The company believes this represents the only viable approach for bringing high-value medical options to populations in need, particularly immunocompromised individuals who are disproportionately impacted by severe COVID-19 outcomes.
In May 2024, Invivyd announced its intention to submit an EUA application to the FDA for pemivibart for the treatment of mild to moderate symptomatic COVID-19 in certain immunocompromised people. This potential treatment EUA request would leverage data from the company's previous Phase 2/3 clinical trial (STAMP) of adintrevimab, the prototype mAb, and the ongoing CANOPY Phase 3 clinical trial of VYD222 (pemivibart) for pre-exposure prophylaxis of COVID-19. The company plans to initiate a compact clinical trial focused on confirmatory safety, pharmacokinetics, and clinical virology to support the treatment EUA submission.
Financials
Invivyd's financial performance has been marked by significant investments in research and development, as the company has prioritized the advancement of its pipeline and the commercialization of PEMGARDA. For the fiscal year ended December 31, 2023, the company reported an annual net loss of $198,643,000, with no revenue generated. The company's annual operating cash flow was -$173,164,000, and its annual free cash flow was -$173,779,000.
In the first quarter of 2024, Invivyd reported a net loss of $43,496,000. The company's research and development expenses for the quarter were $31,160,000, while selling, general, and administrative expenses were $14,929,000. Invivyd ended the first quarter of 2024 with $189,388,000 in cash and cash equivalents.
Despite the significant investments required to advance its pipeline and commercialize PEMGARDA, Invivyd has taken steps to improve its projected 2024 year-end cash position by approximately $20 million to $25 million. This was achieved through comprehensive resource realignment, ensuring robust investment in the commercial launch of PEMGARDA and the discovery of novel mAbs.
Outlook
The recent EUA for PEMGARDA in pre-exposure prophylaxis and the opportunity to pursue an EUA for COVID-19 treatment in certain immunocompromised individuals represent significant milestones that align with the company's core strategy.
The company's INVYMAB platform approach, which combines viral surveillance, predictive modeling, and advanced antibody engineering, is designed to facilitate the rapid, serial generation of new mAbs to address evolving viral threats. Invivyd's next pipeline candidate, VYD2311, is a mAb optimized for neutralization potency against recent SARS-CoV-2 lineages such as BA.2.86 and JN.1, and the company expects it will be the next program to advance into clinical development.
Invivyd's commitment to delivering protection from serious viral infectious diseases is further evidenced by its plans to apply the INVYMAB platform approach to produce lead molecules for other viral diseases, such as influenza. The company believes its bespoke, proprietary, and fully integrated discovery technologies, combined with potential rapid development pathways, represent a significant competitive advantage.
Commercial Launch
The commercial launch of PEMGARDA is a critical focus for Invivyd, as the company works to ensure that the product is broadly and conveniently available to the target population of moderately to severely immunocompromised individuals. The company has made progress in securing reimbursement and access, with the Centers for Medicare and Medicaid Services (CMS) publishing codes for PEMGARDA reimbursement, and the national account management team working to secure commercial reimbursement with private payers.
The potential to submit and receive an additional EUA for PEMGARDA focused on the treatment of mild-to-moderate symptomatic COVID-19 in certain immunocompromised people represents another opportunity. This additional use case, leveraging the existing commercial pathway and infrastructure for antivirals like Veklury, could be another potential way to capitalize on the work done to bring PEMGARDA to market.
Conclusion
Overall, Invivyd's focus on innovative antibody prophylactics and therapeutics, its proprietary INVYMAB platform, and the recent regulatory and commercial milestones position the company as a leader in the fight against SARS-CoV-2 and potentially other viral threats in the future. While the company's financial performance has been marked by significant investments in research and development, Invivyd's strategy appears focused on delivering high-value medical options to vulnerable populations and creating value for shareholders.