Invivyd, Inc.

Thank you for standing by and welcome to InVivid's first quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. To remove yourself from the queue, you may press star 1-1 again. I would now like to hand the call over to Katie Fazzoni, SVP Finance. Please go ahead.

Thank you, Operator. A short while ago, we issued a press release announcing our Q1 2025 financial results and business highlights. That press release and the slides that are being used on today's webcast can be found in the investor section of the InVivid website under the press release and events and presentation sections respectively. Today's discussion will be led by Mark Olia, Chairman of InVivid's Board of Directors. He is joined by Tim Lee, Chief Commercial Officer, Bill Duke, Chief Financial Officer, Dr. Robert Allen, Chief Scientific Officer, and Dr. Mark Wingertzahn, Senior Vice President of Clinical Development. During today's discussion, we will be making forward-looking statements concerning, among other things, our corporate and commercial strategy, our research and development activities, our regulatory plans, certain financial expectations, our future prospects, and other statements that are not historical facts. These forward-looking statements are covered within the meaning of the Private Securities Litigation Reform Act and are subject to various risks, assumptions, and uncertainties that may change over time and cause our actual results to differ materially from those expressed or implied today. These forward-looking statements speak only as of the date of this call and InVivid assumes no duty to update such statements. Additional information on the risk factors that could affect InVivid's business can be found in our filings made with the U.S. Securities and Exchange Commission. including our most recent form 10K and 10Q, which are also available on our website. I will now turn the call over to Mark.

Good morning, and thank you all for joining us. Turning to slide four, the first quarter and our early second quarter has been a very busy and productive time marked by transition. Our commercial organization is now wholly internalized, new in the field, and reflects an intentional bet by this management team that our new internal team will drive broader adoption of Pemgarda with associated commercial results. While it is early, our leading indicators are promising and we remain targeting near-term breakeven with continued revenue growth and operating expense management. Scientifically, we're very pleased with what we see in the evolutionary journey of SARS-CoV-2 relative to the epitope we are exploiting with Pemibobard. and as now, we see no obstacle to long-term growth in our commercial Pemgarda business. We have secured access to additional non-dilutive capital to grow if certain conditions and milestones are met, and we are expanding our pipeline to multiple disease areas in which we believe our scientific approach can add value to patients in need. Specifically, We have added discovery programs against new viral targets with the potential for identifying best in-class medicines for diseases outside of COVID-19. Our previous work in influenza continues at a low intensity, but bird flu with pandemic potential has not meaningfully emerged. And in the very recent short time, we have actually seen more US deaths from measles outbreaks than we have seen from avian influenza over the past year or so. At this point, it is reasonable to expect that trend to continue, and our focus has shifted accordingly toward early measles discovery. Last year, we initiated a new discovery program for an RSV monoclonal antibody that Robbie Allen, our CSO, will describe in a bit more detail. RSV presents a very clear high-value competitive landscape and some molecular properties we believe we can target to generate a potential best-in-class monoclonal antibody with blockbuster commercial potential. As we grow and expand our COVID franchise, We will accordingly want to make targeted financially responsible investments in discovery that can yield drugs we can capitalize for development, either in concert with the equity markets or with potential strategic partners. There has been no shortage of interest in our work from potential partners, particularly those with a vaccine footprint. It's important to note that our corporate goals, including targeting near-term break-even, are audacious by design and reflective of our integrated strategic and operational choices. In the big picture, we want to create as much medical value for patients and society as fast as possible. And then we want to translate that value into per share shareholder value as efficiently as possible. In an easy biotech financing environment characterized by low interest rates and long return horizons with blue skies for investors, it is much easier for companies to raise large quantities of dilutive equity that may enable a mediocre or far-fetched biological premise to survive to the next catalyst. But such a business strategy rarely translates into long-term per share compounding of shareholder value. We are taking the opposite approach and trying to be highly disciplined with our expenditures and capital base to the maximum extent, and not just because these days the biotech investing backdrop and equity cost of capital has been tougher. We've been taking our approach because we see full operational proof of concept, in our ability to make medicines rapidly and efficiently, and we wish to exploit that advantage, which we see as unique in the industry, as we grow our business so that our shareholders can benefit accordingly. Turning to slide five, in the bigger social picture, it is important to note that our fundamental corporate strategy reflects a great many macro-level realities that have also undergone transition, specifically a US election result and new public health leadership focused on chronic disease, who are moving in directions on multiple fronts that comport well with our business strategy. As a quick reminder, InVivid was started based on a simple reality, that SARS-CoV-2 was a unique virus designed to prey on a distinctly vulnerable human population. It was clear early that vaccines for COVID-19 disease would work over the short term, but that waning responses would be problematic for every person, especially for immunocompromised persons. And on top of that, Immunovasive Omicron viruses have added another headwind, as has the growing underlying burden of long COVID. More, given the handling of COVID-19 vaccine policies, there is a regrettable secular shift underway with respect to American attitudes toward vaccination as a whole. Reviewing the last year's events with respect to COVID-19 vaccines, such a shift is indeed regrettable, but perhaps not surprising. Monoclonal antibodies can be designed to overcome challenges with vaccination. After all, we are all born immunocompromised and preloaded with a suite of non-self monoclonal antibodies from our mothers. And yet, in the pursuit of freedom from the burden of SARS-CoV-2, our regulatory and public health complex for four years was single-mindedly focused on exposing humans serially and broadly to spike protein, largely in mRNA form, in an effort to get us our protective antibodies the hard way, rather than, as mom and mother nature might suggest, providing mechanisms for humans to access additional antibody support so that humans don't need to choose between dangerous infections and increasingly debatably effective vaccination. Unique in the industry, InVivit has now fully developed, through multiple placebo-controlled RCTs, two monoclonal antibodies against SARS-CoV-2, adentrevumab against ancestral viruses like Delta, and now Pomivibart against contemporary immune-invasive Omicron viruses. More, In our recent Canopy Phase 3 clinical study assessing safety, immunobridging, and exploratory clinical efficacy analyses, we are reporting clinical results from a modern American population, specifically a population that has preexisting immune experience or seropositivity in both study and placebo arms. To some observers of the vaccine industry, conducting such studies is undoable or unthinkable. And yet to us and others in the monoclonal antibody business, those studies are business as usual. You will see elements of our recent citizen petition to the US FDA that focuses in on these issues. Because to us, there is clearly within reach a mechanism to scale access to monoclonal antibodies if and when regulators so choose. As you will see later in this morning's call, we have multiple parallel conversations with public health authorities designed to expand the consequences of our discovery and development work. With that, I'll turn the call over to Tim Lee to discuss our commercial progress in the quarter.