We are a biopharmaceutical company leveraging our innovative virus-like particle (VLP) platform technology to develop vaccines against infectious diseases, with an initial focus on life-threatening respiratory diseases. Our VLP platform technology is designed to enable multivalent, particle-based display of complex viral antigens, which we believe will induce broad, robust and durable protection against the specific viruses targeted.

Our pipeline includes vaccine candidates targeting some of the most prevalent viral causes of pneumonia. We are developing these candidates for older adults, a patient population with high unmet need. Our vaccine candidate IVX-A12 is a bivalent candidate, or a mixture of two different VLP candidates. IVX-A12 combines IVX-121, a vaccine candidate designed to target respiratory syncytial virus (RSV), and IVX-241, a vaccine candidate designed to target human metapneumovirus (hMPV). There are currently no vaccines approved for either RSV or hMPV, which are two common causes of pneumonia in older adults. We filed a clinical trial application (CTA) for IVX-121 with the regulatory authority in Belgium (FAMHP) in June 2021 and plan to initiate a clinical trial of IVX-121 in the second half 2021, with topline data expected in the first half of 2022. Assuming favorable results from the IVX-121 clinical trial and favorable preclinical data for IVX-241, we plan to submit an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA) in the first half of 2022 and, thereafter, initiate a clinical trial of our combination vaccine candidate, IVX-A12.

Additionally, we are developing two severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine candidates, IVX-411 and IVX-421, and initiated a Phase 1/2 clinical trial of IVX-411 in Australia in June 2021, with proof-of-concept data expected in the first half of 2022. We believe that our pipeline and platform can deliver a meaningful impact globally in preventing life-threatening infectious diseases.

Note: We have not generated any revenue from the sale of our products. We were awarded a $10 million grant from the Bill & Melinda Gates Foundation (BMGF)on Sept. 24, 2020, to develop the SARS-CoV-2 vaccine. We recognized $3.617 million in grant revenue for the last 12 months that ended March 31, 2021. The grant agreement goes through March 31, 2022.