Thank you for standing by and welcome to the Invivyd 2022 Year End Financial Results Update Call. [Operator Instructions] As reminder, today’s call is being recorded. I would now like to turn the conference to your host, Kyra Faircloth, Vice President, Advocacy and Corporate Communications. Please go ahead.

Thank you for joining us today. Before we get started, I wanted to attend to a few housekeeping items. I invite you to review our press release discussing our full year ended December 31, 2022 financial results, which can be found on the Investors section of the Invivyd website. I would like to remind you that during today’s discussion, we will be making several forward-looking statements. Forward-looking statements include statements concerning, among other things, the future of the COVID-19 landscape including the expectation of its continued evolution and emergence of new variants and sub-variants, our ongoing research and clinical development plans, including the timing of these plans as well as the technology and resources to develop therapeutic or preventative options for COVID-19 and other infectious diseases our regulatory and commercialization plans and opportunities and our expected cash runway and other statements that are not historical fact. Forward-looking statements are subject to a number of risks and uncertainties and that may cause our actual results to differ materially from those expressed or implied in the forward-looking statements, including those described under the heading Risk Factors in our filings made with the U.S. Securities and Exchange Commission including our most recent 10-K filed earlier today. It is now my pleasure to introduce the Invivyd management team to the call. I am joined by Dave Hering, CEO of Invivyd, Dr. Pete Schmidt, Chief Medical Officer; Dr. Lukas Dillinger, Interim Head of Discovery and Preclinical and Fred Driscoll, Interim Chief Financial Officer. With that, I will turn the call over to Dave.

Good afternoon and thanks for joining the call. We are looking forward to sharing with you financial results from this past year, along with highlights of significant progress we made during this past quarter. For those who maybe new to the Invivyd story, we are on a mission to rapidly and perpetually deliver antibody-based therapies designed to protect vulnerable people from the devastating consequences of circulating viral threats. Beginning with SARS-CoV-2. The foundation of our mission is based on three key factors: one, COVID is here to stay and represents an unacceptable medical burden on human kind. Two, the medicine cabinet to protect humanity from COVID is alarmingly limited; and three, we are uniquely positioned to keep pace with viral evolution and provide therapeutic options to people who urgently need them. We have reached a stage where SARS-CoV-2 is circulating unchecked amongst the broader population with as many as 85% of people in the U.S. having been infected. The vaccination rate for boosters is exceedingly low compared with rates of the primary series. Recent reports highlight that only 28% of the eligible people have now received the most recent COVID-19 booster. People are being infected and reinfected while the virus continues to evolve. Every day, 250 to 400 families in the U.S. lose a loved one to COVID-19, and COVID remains the third leading cause of death behind only heart disease and cancer. While most of society has accepted the status quo and are trying to live with COVID, we would argue that all are not living well, particularly vulnerable populations. Although the immediate impact of COVID-19 on many healthy adults appear mild the long-term consequences remain unknown. Preliminary data reported by the Mayo Clinic show that COVID-19 infections are linked to long-term complications that impact numerous body systems, including…

Thanks, Dave. As Dave mentioned, we recently nominated VYD-222 to advance to the clinic as a new monoclonal antibody candidate or mAb, against SARS-CoV-2. As you know, VYD-222 will be our second mAb candidate to enter clinical testing. After a Phase 1 dose ranging trial to evaluate safety and pharmacokinetics, or PK, we intend to initiate what we expect to be a larger registrational Phase 3 clinical trial to assess the efficacy of VYD-222 to prevent COVID-19, specifically in immune-compromised individuals. VYD-222 has demonstrated in-vitro neutralizing activity against SARS-CoV-2 variant of concern or VOCs, including the current dominant Omicron sub-lineage XBB.1.5. VYD-222 is an engineered version of adintrevimab, our first investigational mAb. And adintrevimab has a robust safety data package and has demonstrated clinically meaningful results in global Phase 3 clinical trials for both the prevention and treatment of COVID-19 during the Delta and Omicron BA.1 waves of SARS-CoV-2, but subsequently lost in-vitro activity against Omicron BA.2. Utilizing our expertise in protein engineering, we were able to restore in-vitro neutralization activity against BA.2 and other Omicron VOCs while maintaining activity against previous VOCs. Our precision engineering resulted in VYD-222 different from adintrevimab by only 8 amino acids in the variable region. The regulatory landscape around COVID-19 is advancing. And there has been considerable movement with the U.S. Food and Drug Administration and the European Medicines Agency as they work to establish regulatory frameworks that consider the rapidity of viral evolution. The agencies are looking for ways to accelerate development of mAbs as well. On December 15, 2022, and a joint EMA, FDA workshop entitled, efficacy of monoclonal antibodies in the context of rapidly evolving SARS-CoV-2 variants was held to discuss alternative strategies for the development of novel mAb therapies, including those based on prototype products that have demonstrated safety and…

Thank you, Pete, for that update on our near-term outlook. As Dave discussed at the beginning of the call, Invivyd’s approach to R&D for COVID-19 is one of perpetual innovation. Invivyd was created to continually develop candidates and not rely on any one candidate. The pace of viral evolution demands that our candidates need to keep pace and have the potential to address emerging modern threats. This unique perpetual discovery engine is fueled by cutting-edge viral epidemiological surveillance, identification of broadly neutralizing monoclonal antibodies and industry-leading B cell mining protein and antibody engineering as well as screening capabilities through our internal expertise and collaboration. With regards to monitoring viral resolution, we continuously maintain and improve our in-house surveillance system for new and upcoming SARS-CoV-2 variants before these become variants of concern. Furthermore, by pinpointing dominant spike glycoprotein sites targeted by human antibody repertoires and netting common mutational escape routes. We aim to predict and target future SARS-CoV-2 variants. We have industry-leading antibody mining, engineering and developability screening capabilities built with our internal expertise and enhanced with our fully operational [indiscernible] facility that we moved into in December. This is further supported by our partnership with Adimab, our industrial and academic collaborators and the council of our world class scientific advisory board, comprised of leading researchers and key opinion leaders in immunology, virology, epidemiology and the COVID-19 space. Our innovation engine leverages B cell mining capabilities to assess broadly neutralizing antibodies, followed by antibody engineering to improve the potency, breadth, biophysical properties and developability of our candidates we seek to advance into non-clinical development and IND-enabling studies. For example, where applicable we specifically engineer our antibodies to extend the half-life, modify the assimilated innate immune effective function or to introduce alternative formats, such as single domain or bispecific molecules. Our established…

Thanks, Lukas and good afternoon everyone. Let me begin by providing an update on our 2022 fiscal year P&L as compared to the comparable 2021 period and an update on cash guidance. With respect to operating expenses, R&D, including in-process R&D, was $183.6 million for the year ended December 31, 2022, and compared to $190.4 million for the comparable period of 2021. This decrease is attributable primarily to wind down of adintrevimab clinical trials partially offset by an increase in contract manufacturing, including adintrevimab commercial supply for a potential EUA and to support our pipeline programs, including VYD-222. This decrease in R&D was further offset by an increase in personnel-related expenses. Our SG&A expenses were $47 million for the year ended December 31, 2022, and compared to $36.5 million for the comparable period of 2021. This increase is attributable to higher personnel-related expenses, professional fees and costs to support our operations as a public company. In the fourth quarter of 2022, the company incurred a $17.4 million expense attributable to a one-time charge associated with warrants issued to Population Health Partners, or PHP, as compensation for consulting services to be provided by PHP to the company. The net loss for the year ended December 31, 2022, was $241.3 million compared to $226.8 million for the comparable period in 2021. Basic and diluted net loss per share was $2.23 for the year ended December 31, 2022, compared to a net loss of $5.32 for the comparable period in 2021. The net loss of $241.3 million for the year ended December 31, 2022, included a one-time charge of $17.4 million related to the fair value of the warrants issued to PHP. We finished 2022 in a strong balance sheet position with cash, cash equivalents and marketable securities of $372 million. Based on our current operating plans, which reflect the completion of a bottoms-up departmental analysis that we highlighted on the Q3 earnings call, our cash guidance has improved from our previous guidance. And we now expect our cash will enable the company to fund its operating expenses, excluding any potential revenue associated with VYD-222 into the second half of 2024. With that, operator, please open the call for questions.

Thank you. [Operator Instructions] Our first question comes from the line of Evan Wang of Guggenheim. Your line is open.

Hi, guys. Thanks for taking my questions. Can you tell us what’s remaining before the VYD-222 trial start and then expand a little bit more in terms of how you guys are thinking about trial design, both dosing, time lines, etcetera?

Yes. Thanks, Evan. Pete, do you want to talk a little bit about what remains as we’re getting ready towards the end of this quarter?

Yes. As we stated previously, we’re still anticipating dosing our first in-human study this quarter. We haven’t released a lot of details about that study. But as you heard from the call, it’s a pretty traditional dose-ranging PK and safety study. Beyond that, we will continue to release details as appropriate on our subsequent studies.

Yes. And you asked, Evan a little bit about timing, right? And so – as Pete mentioned, we still anticipate the first study starting by the end of the month, just getting clinical trial material to the sites, getting the recruitment done, etcetera. And then our plan is to continue to have ongoing data releases throughout the year.

Got it. Thanks. And then in terms of a Phase 3, I know you guys put up a paper in terms of correlates, how are you guys thinking about primary endpoints? And secondly, VYD-222 adapted from ADG20, how does that kind of benefit in terms of if you can provide some maybe a framework in terms of how that may reduce the trial size? And what kind of scope of trial are we looking at here?

Yes, I’ll take the first part and then Pete, you can take the second. So as we’ve said and shown before, ADG20, our original antibody we went from IND to pivotal clinical data in 16 months, and we utilize both treatment and prevention studies that use event-driven clinical endpoints. And what we continue to look at as a possibility is whether there is an opportunity to use coreless surrogates, immunobridging etcetera. And so those discussions continue. As Pete mentioned, as a part of the upfront on the call, this was really articulated during the December 15 joint FDA EMA meeting, and we, alongside academics and other stakeholders really commented about the need for these types of approaches, especially given the dynamic environment that we’re in, really going against a virus that continues to evolve at such a rapid pace. And so we continue to have those conversations and as we previously mentioned, as soon as we have outlined and confirmed exactly what those clinical parameters would be for pivotal studies we plan to share more details about that. Pete, any other comments?

Yes. Great question about the relationship to ADG20, the molecular relationship. And we’re still in conversations with global regulators around this, of course. But we do believe that it is an advantage to have a robust safety data set and also efficacy data from our previous Phase 3 studies in a molecule that was generated on the same manufacturing platform and is so closely structurally related to VYD – to ADG20, I’m sorry. So lots of potential there.

Great. Thanks, guys.

Thank you. [Operator Instructions] Our next question comes from the line of Sidharth Mehta of Jefferies. Your line is open.

Hi, this is Sid on for Michael Yee, Jefferies. So two quick questions. First one being, AstraZeneca, another big company, while they made a lot of money in 2022 and antibodies, have noted that they see the market going significantly down in ‘23 and beyond as we move to an endemic market. So how do you guys think about that as you move your antibody forward? And my second question is although you’ve mentioned having these kind of correlates of protection for Phase 3 studies, has there been any discussion or definitive answers from the FDA on whether or not you can use that as a part of your Phase 3 studies? Thank you.

Yes, I’ll take the first question. And so our estimates that in 2022, the sort of overall market across vaccines, oral anti-virals, monoclonal antibodies was almost $100 billion. And yes, I think that a lot of folks are predicting that, that will come down. But it’s still an incredibly sizable market, monoclonal antibodies did $8 billion about in revenue in 2022, and that was with predominantly bebtelovimab and Evusheld. And Evusheld did $500 and some million in Q3 of last year. And what we see is with a similar indication, really targeting immune compromised vulnerable populations, they only touched really a fraction of that population, and we continue to work with – these groups talk to patient advocacy groups, speak with these individuals, and they still are really clamoring for products. In particular, I spoke to a physician who works at the Mayo Clinic and said he had never been in a position that these types of patients come in and ask for products, and there is nothing available. And so based on that, we see the market for monoclonal antibodies continuing to be incredibly significant and a huge unmet need in this patient population. As it relates to your other question in terms of where regulators are and what the status is, we will provide updates, additional updates when we get them. We continue to be in dialogue with the FDA and other global regulators. And as I said, as soon as we have confirmed what that trial design will look like, we plan to provide that information.

Thank you.

Thank you. [Operator Instructions] Our next question comes from the line of Matthew Harrison of Morgan Stanley. Your line is open.

Hi, this is an [indiscernible] for Matthew. Thanks for taking our questions. I have two questions. One is – is there any update on adding kind of regulatory thresholds for new antibody therapy for COVID given the change of the pandemic setting. Could there be any flexibility in potential approval? The second is, do you have any updates on your potential progress on flu antibodies therapy development?

Sure. No, thank you for the question. So on the first one, in terms of regards to thresholds, as you’re likely aware, at least in the U.S., none of the antibodies have been fully licensed and gone through BLA, they have all been authorized through EUAs and there currently are no monoclonal antibodies on the market. And so we have not seen any specific changes in thresholds. In particular, what we continue to look at is in-vitro data ahead of time and as what we’ve seen on VYD-222 is consistently strong activity against a variety of variants, including the most recent on .1.5 and so we see that, that is really important information as it relates to getting products into clinical trials, etcetera. And as I mentioned through the presentation, while the public health emergency is ending, that does not remove the potential for the FDA to utilize the EUAs. And so, we still see that as an open possibility for VYD-222 or our additional other candidates that we have in the pipeline. As it relates to the flu component, I’ll turn it over to Lukas. You can provide an update on the status of what – of where we are with the flu program.

Yes. Thank you, Dave. So we’ve identified several interesting molecules in the flu program already. These molecules are currently being further characterized in in-vitro assays and other studies, and we will be releasing the data as soon as we have them available.

Okay, thank you.

Thank you. I’m showing no further questions at this time. I turn the call back over to Dave Hering for any closing remarks.

Thank you so much. So thanks, everyone, for joining. It was a fantastic quarter and a great 2022. So I’m very excited for where we are. And as I alluded to at the start of this discussion, I’m extremely pleased with our progress in the fourth quarter and our start to this year. We have multiple monoclonal antibody candidates that have shown in-vitro neutralizing activity against multiple current lineages of Omicron. I believe in the company’s ability to bring to market a product for COVID-19 as fast and efficiently as possible to meet this continued large unmet need in patients and to capitalize on the significant market opportunity and create value for shareholders. Given the rapid pace of viral evolution and the ongoing regulatory environment, we are positioning the company to pivot as necessary to deliver on that goal time and time again. So that concludes our meeting for today. And as always, we will be happy to follow up with analysts or investors one-on-one after the call tonight and tomorrow. Thank you.

Thank you. Ladies and gentlemen, this does conclude today’s conference. Thank you all for participating. You may now disconnect. Have a great day.