Q1 2024 Invivyd Inc Earnings Call

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Operator: Welcome to the Invivyd conference call. At this time, all participants are in a listen-only mode. After the speaker's prepared remarks, there will be a question and answer session. Please be advised that today's conference call is being recorded. I would now like to hand the call over to Scott Young, Senior Vice President of Investor Relations and Corporate Communications. Please go ahead.

Welcome to the envisaged conference call at this time, all participants are in a listen only mode.

Scott Young: After the Speakers' prepared remarks, there'll be a question and answer session. Please be advised that today's conference call is being recorded.

Operator: I'd now like to hand, the conference over to Scott Young Vice President of Investor Relations and corporate Communications. Please go ahead.

Scott Young: Thank you, Operator. A short while ago, we issued a press release announcing our Q1 2024 financial results and recent 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 Invivyd website under the press release and events and presentation sections respectively. Today's discussion will be led by Mark Aliyah, Chairman of Invivyd's Board of Directors and Chairman of the Executive Committee of the Board. He's joined by Jeremy Gowler, Interim CEO and Chief Operating and Commercial Officer; Bill Duke, Chief Financial Officer; Dr. Robert Allen, Chief Scientific Officer; and Dr. Mark Wingerzan, Senior Vice President of Clinical Development and Medical Affairs.

Speaker Change: Thank you operator, a short while ago, we issued a press release announcing our Q1 2024 financial results and recent business highlights.

Scott Young: That press release and the slides that are being used in today's webcast can be found in the investors section of the website under the press release and events and presentations section perspective.

Scott Young: Today's discussion will be led by Mark Alere Chairman of <unk> Board of directors and chairman of the Executive Committee of the board.

Scott Young: He is joined by Jeremy <unk> interim CEO, and Chief operating and commercial Officer Bill.

Scott Young: Bill do Chief Financial Officer Dr.

Scott Young: Dr. Robert Allen, Chief Scientific Officer, and Dr. Mark <unk> Senior Vice President of clinical development and medical Affairs.

Scott Young: 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 guidance, our future prospects, and other statements that are not historical. 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.

Scott Young: During today's discussion, we'll be making forward looking statements concerning among other things, our corporate and commercial strategy, our research and development activities, our regulatory plans certain financial guidance, our future prospects and other statements that are not historical fact.

Scott Young: 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.

Scott Young: These forward-looking statements speak only as of the date of this call, and Invivyd assumes no duty to update such statements. Additional information on the risk factors that could affect Invivyd's business can be found in our filings made with the U.S. Securities and Exchange Commission, including our most recent Form 10-K, which is also available on our website.

Scott Young: These forward looking statements speak only as of the date of this call and in debit assumes no duty to update such statements additional information.

Scott Young: Information on the risk factors that could affect <unk> business can be found in our filings made with the U S Securities and Exchange Commission, including our most recent Form 10-K, which is also available on our website.

Scott Young: I will now turn the call over to Mark.

Mark Aliyah: Thanks, Scott, and thank you all for joining the call. A quick housekeeping note: this will be Scott's last quarterly call. He is moving on from InVivyd to spend the summer enjoying his boat prior to potentially starting his own business. We wish him the best and thank him for his help in getting us here.

Scott Young: I'll now turn the call over to Mark.

Mark Aliyah: Thanks, Scott and thank you all for joining the call a quick housekeeping note. This will be Scott's last quarterly calls he is moving on from endeavor to spend the summer enjoying his boat prior to potentially starting his own business, we wish him the best and thank him for his help in getting US here. Thank you Scott.

Mark Aliyah: Thank you, and to business, turning to slide four. The last few months have been transformational for Invivyd. Invivyd has been built to address head-on the unique scientific, medical, and social challenges presented by SARS-CoV-2 and potentially other viruses in the future. In 2023, SARS-CoV-2 remained a leading cause of death for Americans, and that is to say nothing of the broad medical misery imposed by this uniquely transmissible and dangerous multi-organ virus. When we talk about building a company to meet the challenges of SARS-CoV-2, what we mean is that we believe we are pioneering a still brand new approach to antibody prophylactics and therapeutics.

Mark Aliyah: To business turning to slide four.

Mark Aliyah: The last few months have been transformational firm debit and vivid has been built to address head on the unique scientific medical and social challenges presented by <unk> and potentially other viruses in the future in 2023 <unk> two remains a leading cause of death for Americans and that is to say nothing of the broad medical Missouri imposed by this uniquely transmissible.

Mark Aliyah: And dangerous multi organ virus.

Mark Aliyah: When we talk about building a company to meet the challenges of <unk>. What we mean is that we believe we are pioneering is still brand new approach to antibody prophylactic and therapeutics engineered antibodies represent the promise of conferring to vulnerable populations. The immune response to viral threats that we all wish we could have following vaccination of infection and immune responses.

Mark Aliyah: Engineered antibodies represent the promise of conferring on vulnerable populations the immune response to viral threats that we all wish we could have following vaccination or infection. An immune response that may be necessary for staying safe and well, rather than the immune response that keeps us alive but at continuous risk. Obviously, the risk of SARS-CoV-2 is highest for the immunocompromised population who today benefit least from vaccination and represent a high disproportionate share of ongoing hospitalizations and deaths.

Mark Aliyah: It may be necessary for saying for staying safe well rather than the immune response that keeps us alive, but continuous risk.

Mark Aliyah: Asleep the risk of Sars Cov, two is highest for immunocompromised populations, who today benefit at least from vaccination and represent a high disproportionate share of ongoing hospitalizations and deaths were starting our journey serving their needs, but see the possibility of serving broader populations as we advance our technology and strategy.

Mark Aliyah: We're starting our journey serving their needs, but we see the possibility of serving broader populations as we advance our technology and strategy. Broadly, our strategy is to combine the potential for high efficacy and attractive safety of modern monoclonal antibodies directed against the SARS-CoV-2 spike protein with the opportunity for product evolution one commonly sees in the vaccine industry. We set out on this mission because, to us, it so far represents the only viable approach for bringing high-value medical options to populations in need.

Mark Aliyah: Broadly our strategy is to combine the potential for high efficacy and attractive safety of modern monoclonal antibodies or maps directed against the Sars Cov, two spike protein with the opportunity for product evolution, one commonly season, the vaccine industry. We set out on this mission because to US. It's so far represents the only viable approach for bringing high valley.

Mark Aliyah: At this point, we see an attractive commercial opportunity for Pemgarda in the near term. A rapid, compact, capital-efficient pathway to generating novel options for two distinct use cases, PrEP and potentially treatment, and a scientific engine devoted to repeatable, reliable, best-in-class molecule generation. However, major questions have surrounded this strategy for almost two years, in large part regulatory and operational.

Mark Aliyah: New medical options to populations in need at this point, we see an attractive commercial opportunity for <unk> in the near term a rapid compact capital efficient pathway to generating novel options for two distinct use cases prep and potentially treatment and a scientific engine devoted to repeatable reliable best in class molecule.

Mark Aliyah: Generation.

Mark Aliyah: Of course major questions have surrounded the strategy for now almost two years in large part regulatory and operational.

Mark Aliyah: We're thrilled that over the last year, we have started to answer those questions more definitively in partnership with a highly motivated and thoughtful regulator in the U.S. Food and Drug Administration, through the recent emergency use authorization for PEMGARTA for PrEP of COVID-19 in certain adults and adolescents who have moderate to severe immune compromises. And now, the opportunity to file an application for EUA for treatment of mild to moderate symptomatic COVID-19 in a similar immunocompromised patient.

Mark Aliyah: We're thrilled that over the last year, we have started to answer those questions more definitively in partnership with a highly motivated and thoughtful regulator in the U S food and drug administration. The recent emergency use authorization for <unk> for prep with COVID-19, and certain adults and adolescents with moderate to severe immune compromised and now the opportunity to file an application for EUA.

Mark Aliyah: For treatment of mild to moderate symptomatic COVID-19 in a similar immuno compromised population both represent the growing alignment between the core of our strategy and the posture of the major U S Medical authority.

Mark Aliyah: Both represent the growing alignment between the core of our strategy and the posture of the major U.S. medical device companies. Our aim is to build on and expand these early successes now by innovating to improve our products on all dimensions. The resistance to evasion that can be built into the, the potency of our antibodies and accompanying improvements in dose, therapeutic index, and form factor they might offer.

Mark Aliyah: Our aim is to build on and expand these early successes now by innovating to improve our products in all dimensions that resistance to a vision that can be built into them. The potency of our antibodies and accompanying improvements in dose therapeutic index and form factor they might offer.

Mark Aliyah: And the clinical data that we hope can substantiate broad use of antibody products in the future. Our agenda today is unique for a regular quarterly call. While we will review certain elements of our recent business progress, we will also provide context for the scientific and clinical thinking that underpins our corporate and commercial strategy and our enthusiasm for the future of Invivyd. Because this is not an R&D day, we will move relatively quickly through some concepts and hope that as you reflect on what you hear and read, you can engage with us on a follow-up basis if it is of further use following today's call.

Mark Aliyah: The clinical data that we hope can substantiate broad use of antibody products in the future.

Mark Aliyah: Our agenda today is unique for our regular quarterly call. While we will review certain elements of our recent business progress. We will also provide context to the scientific and clinical thinking that underpins, our corporate and commercial strategy and our enthusiasm for the future.

Mark Aliyah: Because this is not an R&D day, we will move relatively quickly through some concepts and hope that as you reflect on what you hear and read you can engage with us on a follow up basis. If it is a further use following today's call. We have heard clearly from many of you that there are gaps in your understanding of our technologies and we.

Mark Aliyah: We have heard clearly from many of you that there are gaps in your understanding of our technologies, and we would like to take this opportunity to fill in those gaps so you can understand our company better moving forward through the launch. We believe that Invivyd's bespoke, proprietary, and fully integrated discovery technologies, combined with potential rapid development pathways, represent an impressive competitive advantage designed to keep Invivyd serving vulnerable populations with high-value commercial products engineered to treat and protect them from serious viral threats in perpetuity.

Mark Aliyah: I'd like to take this opportunity to fill in those gaps. So you can understand our company better moving forward through the launch.

Mark Aliyah: We believe that inhibits bespoke proprietary and fully integrated discovery technologies combined with potential rapid development pathways represents an impressive competitive advantage designed to keep and visit serving vulnerable populations with high value commercial products engineered to treat and protect from serious viral threats in perpetuity.

Mark Aliyah: We see the technological core of this engine as substantiating the economic vision for our firm, which is to advance high-value novel medicines with high speed, high capital efficiency, and high confidence to ensure that shareholders also benefit from the substantial medical value we aim to create for vulnerable populations. A few final notes before we move on with our agenda. We are well engaged in a search for a permanent CEO, but we will not comment further at this time.

Mark Aliyah: We see the technological Corp. This engine is substantiate the economic vision for our firm, which is to advance high value novel medicines with high speed high capital efficiency and high confidence to ensure that shareholders also benefit from the substantial medical value, we aimed to create for vulnerable populations. A few final notes before we move on with our agenda.

Mark Aliyah: We are well engaged in a search for a permanent CEO, but we will not comment further at this time.

Mark Aliyah: Jeremy Gowler will comment on multiple elements of the early Pemgarda launch, but we will not be disclosing any more granular details than that which he will walk through in his prepared remarks, nor will we comment on any early sales trends other than to say that at this point, we are pleased with the organic demand we believe we are observing in the We have been moving quickly to establish the mechanical infrastructure, the institutional knowledge, and the experience base that will I'll now turn the call over to Bill Duke, the CFO of Invivyd, to discuss our financial results and guidance.

Mark Aliyah: Also <unk>.

William E. Duke: Jeremy Gallagher will comment on multiple elements of the early Perm guard at launch, but we will not be disclosing any more granular detail than that which you will walk through in his prepared remarks, nor will we comment on any early sales trends other than to say that at this point. We are pleased with the organic demand. We believe we are observing in the field, we have been moving quickly to establish the.

William E. Duke: <unk> infrastructure, the institutional knowledge and the experience base that will allow appropriate vulnerable populations, there hcp's and broad health systems to access Penn Guard it routinely.

William E. Duke: I'll now turn the call over to Bill, Duke the CFO and David to discuss our financial results and guidance.

William E. Duke: Turning to slide 5, we ended Q1 2024 with cash and cash equivalents of $189.4 million. We did not record any Pemgarda revenue in the first quarter as orders and shipments began in April.

William E. Duke: Thank you Mark.

William E. Duke: Turning to slide five we ended Q1 2024 with cash and cash equivalents of $189 4 million.

William E. Duke: We did not record any <unk> revenue in the first quarter as orders and shipments began in April.

William E. Duke: In April 2024, we announced that following a comprehensive strategic review, the company is improving its projected 2024 year-end cash position by approximately $20 to $25 million. Our updated cash guidance improvement was built to include the anticipated spend on 2024 incremental clinical commitments associated with our potential treatment EUA. The improvements were realized through comprehensive resource realignment, ensuring robust investment in the commercial launch of Pemgarda and the discovery of novel monoclonal antibodies. We have recently undertaken an engagement to file a second EUA application for Pemgarda focusing on the treatment of mild to moderate symptomatic COVID-19 for certain immunocompromised people.

William E. Duke: In April 2024, we announced that the follow that following a comprehensive strategic review the company is improving its projected 2020 for year end cash position by approximately 20% to $25 million.

William E. Duke: Our updated cash guidance improvement was built to include the anticipated spend on 2020 for incremental clinical commitments associated with our potential treatment <unk>.

William E. Duke: The improvements were realized through comprehensive resource realignment, ensuring robust investment in the commercial launch of <unk> in the discovery of novel monoclonal antibodies.

William E. Duke: We have recently undertaken a commitment to filing a second EUA application for Penn Garda focusing on the treatment of mild to moderate symptomatic COVID-19 for certain immuno compromised people.

William E. Duke: This is a potentially transformational opportunity for Invivyd in the near term as we move into the summer and fall, and we consider this route as a future cornerstone for the rapid development of an innovative model. We will not, however, alter our year-end cash and top-line revenue guidance, even if we achieve EUA2 treatment. At this point, we feel very comfortable with our near-term economic opportunity and look forward to updating our estimates in the fall at the earliest.

William E. Duke: This is a potentially transport transformational opportunity for exhibit near term as we moved into summer and fall and we consider this route as a future cornerstone for rapid development of innovative molecules.

William E. Duke: We will not however, alter our yearend cash and top line revenue guidance, even if we achieve E waste treatment.

William E. Duke: At this point, we feel very comfortable with our near term economic opportunity.

William E. Duke: Look forward to updating our estimates in the fall at the earliest.

William E. Duke: Finally, as Mark mentioned, we look forward to continuing to innovate and introduce additional novel antibodies. We have studied the time and cost associated with generating the PEMGARTA clinical package that supports PrEP and potential treatment. Going forward, we believe we can significantly reduce our clinical development time and costs, and we will look forward to sharing more details soon, as you have seen from our prior descriptions of the target population and our recently disclosed commercial pricing.

William E. Duke: Finally, as Mark mentioned, we look forward to continuing to innovate and introduce additional novel antibodies.

William E. Duke: We have studied the time and costs associated with generating the comparator clinical package that support prep and potential treatment.

William E. Duke: Going forward, we believe we can significantly reduce our clinical development time and costs and we will look forward to sharing more details soon.

William E. Duke: As you have seen from our prior descriptions of the target population and our recently disclosed commercial pricing easier.

William E. Duke: These use cases represent a total addressable market measured in billions of annual revenue when considering the roughly 500,000 people in the U.S. who are the most vulnerable and our initial focus. We are working to realize that potential and aim to expand the populations we can serve as our technology and strategy allow. With that, I'll turn the call over to Jeremy to update you on our launch.

Jeremy: These use cases represent a total addressable market.

Jeremy: And billions of annual revenue when considering the roughly 500000 people in the U S who are the most vulnerable and our initial focus.

Jeremy: We are working to realize that potential and aim to expand the populations. We can serve as our technology and strategy.

William E. Duke: With that I will turn the call over to Jeremy to update you on our lunch.

Jeremy Gowler: Thanks Bill. Moving on to slide six. Emgarda is a high-value medicine for moderately to severely immunocompromised individuals who are in urgent need of protection from COVID-19. It fills a critical need not otherwise addressed in the marketplace today. Overall, we are very pleased with the strong interest we've seen thus far from patients and providers. Since authorization, we have so far received a surprising and gratifying level of unsolicited inquiries into our call center.

Jeremy Gowler: Thanks, Bill moving to slide six <unk> is a high value medicines for moderately to severely immunocompromised individuals who are in urgent need of protection from COVID-19, it fills a critical need not otherwise addressed in the marketplace today overall.

Jeremy Gowler: Overall, we are very pleased with the strong interest we've seen thus far from patients and providers since authorization. We have so far received a surprising and gratifying level of unsolicited inquiries into our call center. Our field teams are having many positive interactions with our customers and are experiencing a high degree of interest in Penn Garda.

Jeremy Gowler: Our field teams are having many positive interactions with our customers and are experiencing a high degree of interest in Pembroke. Now we are going through the logistics phase of the launch, where we are managing the processes around institution and payer access to ensure that PEMGARTA is broadly and conveniently available to those for whom it is authorized. We are moving to ensure that PENGARTA awareness and logistical support are in place prior to the broadest activation of HCP and patient interest in the coming months. Of note, Pemgarda represents our first generation technology.

Jeremy Gowler: Now we are going through the logistics space with the launch where we are managing the processes around institution and payer access to ensure that Penn Garda is broadly and convene the available to those who it is authorized we are moving to ensure that Penn garner awareness and logistical support our in place prior to the broadest activation of HCP.

Jeremy Gowler: And patient interest in the coming months.

Jeremy Gowler: Of note Perm Garner represents our first generation technology and as we will discuss later on in the call. We already have a follow up map and <unk> to 311, which we believe holds the potential to have an improved product profile. The work. We are doing today with them Garner we believe will pave the way for BYD 2311 to seamlessly.

Jeremy Gowler: And, as we will discuss later in the call, we already have a follow-up map in VYD2311, which we believe holds the potential to have an improved product profile. The work we are doing today with Pemgarda, we believe, will pave the way for VYD2311 to seamlessly slot in behind it and build on Pemgarda's anticipated success. Turning to slide 7, we are a little more than 6 weeks post-authorization, and the commercial organization and functions supporting it have been hard at work to execute on the PEMGAR launch.

Jeremy Gowler: Slot in behind it and build them I'll build on pet and garden as anticipated success.

Jeremy Gowler: Turning to slide seven we are a little more than six weeks post authorization and the commercial organization and function supporting it had been hard at work to execute underpin guard to watch our manufacturing colleagues worked very quickly to have product available within a week of authorization in parallel we contracted with three major distributors to ensure.

Jeremy Gowler: Our manufacturing colleagues worked very quickly to have the product available within a week of authorization. In parallel, we contracted with three major distributors to ensure that our customers could procure Pengarta via their preferred procurement partner, and subsequently, we shipped our first order.

Jeremy Gowler: And that our customers could procure Penn Garda via their preferred procurement partner and subsequently shipped our first order.

Jeremy Gowler: As of late, our focus has been on securing reimbursement and access. In mid-April, we announced that the U.S. Centers for Medicare and Medicaid Services, or CMS, published two Healthcare Common Procedure Coding System codes, or HCPCS codes, a Q code covering product reimbursement for PEMGARTA, and a product-specific M code covering administration. This is critical because CMS provides coverage for nearly half of the moderately to severely immunocompromised people at higher risk for severe COVID-19 among whom we are targeting.

Jeremy Gowler: As of late our focus has been on securing reimbursement and access in mid April we announced that the U S centers for Medicare and Medicaid services or CMS published two healthcare common procedure coding system codes or <unk> codes.

Jeremy Gowler: Q code covered product reimbursement for Perm, Garda and a product specific m-code covering the administration.

Jeremy Gowler: This is a critical this is critical because CMS provides coverage for nearly half of the moderately to severely immunocompromised people at higher risk for severe COVID-19, whom we're targeting.

Jeremy Gowler: In parallel, our national account management team has been working to secure commercial reimbursement for PEMGARDA, as well as with private payers, to ensure that the other half of the moderately to severely immunocompromised people who are eligible for PEMGARDA can access it. Our team of key account managers recently hit the ground running after completing extensive training, and they are now all fully deployed and calling on our roughly 1,150 targeted accounts to build awareness for the product and drive updates. Their early focus is on securing the inclusion of PANGARTA on institutional formularies as needed.

Jeremy Gowler: In parallel our National account management team has been working to secure commercial reimbursement reimbursement for <unk> as well with private payers to ensure that the other half of the moderately to severely immunocompromised people who are eligible.

Jeremy Gowler: For Penn Garda excesses.

Jeremy Gowler: Our team of key account managers recently hit the ground running after completing extensive training and they are now all fully deployed and calling on our roughly 150 targeted accounts to build awareness for the product and drive uptake.

Jeremy Gowler: The early focus is on securing inclusion of him Garda on institutional formularies as needed.

Jeremy Gowler: We have had positive engagement, and we see institutions taking it through their formulary committee processes already, and some have already ordered products. With respect to patient experience and access, we're putting an even greater focus on building out logistical support to assist moderate to severe immunocompromised people who are seeking PEMGARDA. This work includes the creation of an online infusion site finder to help those people trying to access them. This new tool, which will be accessible in the future on PemGarda.com, is under active development and parallel.

Jeremy Gowler: We have had positive engagement and we see institutions, taking it through the formulary committee processes already in some of already ordered product.

Jeremy Gowler: With respect to the patient experience and access we are putting an even greater focus on building out logistical support to assist moderate to severe immunocompromised people, who are seeking Penn Garda.

Jeremy Gowler: This work includes the creation of an online infusion site finder to help those people trying to access Perm Garner this new tool, which will be accessible in the future on <unk> Dot com is under active development and a parallel we are engaging with infusion providers outside of traditional institutions to support patient access to the product.

Jeremy Gowler: And finally, we are excited about the potential to submit and receive an additional EUA for PEMGARTA focused on the treatment of mild to moderate symptomatic COVID-19 in certain immunocompromised people, should it be granted by the FDA. Since the commercial pathway and infrastructure already exist for antivirals like Vecluri, we are excited to have this additional use case for the product, BeyondPrep, as another potential way to capitalize on the work done to bring Pemgarda to market.

Jeremy Gowler: And finally, we are excited about the potential to submit and receive an additional EUA for <unk> focused on the treatment of mild to moderate symptomatic COVID-19.

Jeremy Gowler: Immuno compromise people should it be granted by the FDA.

Jeremy Gowler: Since the commercial pathway and infrastructure already exists for the Antivirals like Laurie we are excited to have this additional use cases for the product beyond as another potential way to capitalize on the work done to bring <unk> to market.

Mark Vincardzon: We will look forward to updating you more on our sales and relevant trends as the launch progresses. I will now turn the call over to Mark Vincardzon, SVP of Clinical Development and Medical Affairs. Over to you, Mark. Thanks, Jeremy.

Mark Vincardzon: We will look forward to updating you more on our sales and relevant trends as the launch progresses I will now turn the call over to Mark Victor It's an SVP of clinical development and medical affairs over to you Mark Thanks Jeremy.

Mark Vincardzon: Thanks, Jeremy. It's been great to join Invivyd at a fascinating time for the company and patients in need. Turning to slide eight, as a reminder, our EUA for PrEP for COVID-19 in certain adults and adolescents who have moderate to severe immune compromise is based upon the ongoing canopy phase three clinical trial that includes two cohorts. First, we have a single-arm, open-label cohort of an immunocompromised subject, the so-called Cohort A. Second, there is a randomized, double-blind safety cohort in people at risk of SARS-CoV-2 infection from regular face-to-face meetings with exploratory clinical event endpoints, the so-called Cohort B.

Mark Vincardzon: Been great to join and visited a fascinating time for the company and patients in need.

Mark Vincardzon: We have collected exploratory information on COVID events in both arms on an ongoing basis, although obviously, the lack of a placebo arm renders the interpretation of events in Cohort A a bit more opaque. Moving to slide 9, as a reminder, in order to meet the immunobridging endpoint agreed to with FDA, we dosed to very high titers and then allowed the titers to decay with ordinary antibody PK subject to the half-life of VYD222, nalpengarda. You can well imagine that a redose will produce another major boost to titers, which we then expect will fall at a similar rate

Mark Vincardzon: Turning to slide eight as a reminder, our EUA for prep for COVID-19 in certain of adults and adolescents, who have moderate to severe immune compromise is based upon the ongoing canopy phase III clinical trial that includes two cohorts first we have a single arm open label cohort in immuno <unk>.

Mark Vincardzon: <unk> subjects, the so called cohort.

Mark Vincardzon: Second there is a randomized double blind safety cohort and people at risk of Sars Cov, two infection from regular face to face meetings with exploratory clinical event endpoint.

Mark Vincardzon: The so called cohort B we.

Mark Vincardzon: We have collected exploratory information on Covid events in both arms on an ongoing basis basis.

Mark Vincardzon: Although obviously the lack of a placebo arm renders the interpretation of events in the cohort.

Mark Vincardzon: A bit more opaque.

Mark Vincardzon: Moving to slide nine as a reminder, in order to meet the immuno bridging endpoints agreed to with FDA, we dose to very high titers, and then allowed the titers to decay with ordinary antibody PK subject to the half life of <unk> to now pet and garden.

Mark Vincardzon: Well imagine that a re dose will produce another major boost to titers, which we then expect will fall at a similar rate.

Mark Vincardzon: As every dose involves a phase with very high titers, which then descend to lower levels, we look forward to seeing how we accrue any events we collect after our day 90 calculation in trough titers, perhaps prior to a second dose, a time period that may give us information that could help us calibrate dose optimization going forward. Turning to slide 10, as a reminder, we began the Canopy clinical trial going into and then through the fall-winter 2023-2024 JN.1 wave. As a result, we saw a relatively robust attack rate in our study of about 3 to 5 percent.

Mark Vincardzon: Every dose involves a phase with very high titers, which then decided to lower levels. We look forward to seeing how we accrue any events. We collect after our day 90 calculation in trough titers, perhaps prior to a second dose a time period that may give us information that could help us calibrate dose opt.

Mark Vincardzon: <unk> going forward.

Mark Vincardzon: Turning to slide 10, as a reminder, we began the canopy clinical trial going into and then through the fall Winter 2023, 2000, 2024, <unk> Dot one wave.

Mark Vincardzon: As a result, we saw a relatively robust attack rate in our study of about 3% to 5%.

Mark Vincardzon: Although Canopy was not prospectively designed or powered to demonstrate protection from symptomatic COVID-19 and that analysis of exploratory endpoints of symptomatic COVID-19 events in Canopy were unrelated to FDA's review of our EUA application, we note the events have exploratory value as we consider the titers that may be associated with various levels of protection and think about dose and product profile going forward. We have previously disclosed that in Cohort B, our double-blind placebo-controlled cohort, we observed protection of 100% through Day 67, a period that overlapped with a very high SVNA titer.

Mark Vincardzon: Although canopy was not prospectively designed or power to demonstrate protection from symptomatic <unk> 19, and that analysis of exploratory endpoints of symptomatic COVID-19 events and canopy or unrelated to Fda's review of our EUA application.

Mark Vincardzon: We note the events have exploratory value as we considered the titers that may be associated with various levels of protection and think about dose and product profile going forward.

Mark Vincardzon: We have previously disclosed that in cohort b, our double blind placebo controlled cohort, we observed protection of 100% through day 67, a period that overlap with very high as CNA titers.

Mark Vincardzon: Through day 90, we saw one breakthrough infection in the Pimivibart arm, compared to eight in the placebo arm, yielding a relative risk reduction of approximately 94%. As highlighted on the previous slide, while we are aware that additional cases of COVID-19 have occurred in Cohort A and Cohort B post-A90, we are awaiting the upcoming analysis of the second dose blinded 90-day interval that will add additional resolution to our thinking We look forward to sharing these data with you later this summer.

Mark Vincardzon: Through day 90, we saw one breakthrough infection in the <unk> arm compared to eight in the placebo arm.

Mark Vincardzon: Yielding a relative risk reduction of approximately 94%.

Mark Vincardzon: As highlighted on the previous slide while we are aware that additional cases of COVID-19 have occurred in cohort a and cohort B post day 90, we are awaiting the upcoming analysis of the second dose blinded 90 day interval that will add additional resolution to our thinking.

Mark Vincardzon: We look forward to sharing these data later this summer.

Mark Vincardzon: Turning to slide 11, importantly, we recently announced our intention to submit an EUA request for PEMGARTA for the treatment of mild to moderate symptomatic COVID-19 in certain immunocompromised people. As described in our press release, we view this as a logical and welcome complement to our overall serial monotherapy bridging paradigm and a reassuring reminder of the intellectual alignment between Invivyd and the U.S. FDA. The anticipated treatment EUA submission will leverage existing datasets from our STAMP and Canopy clinical trials.

Mark Vincardzon: Turning to slide 11, importantly, we received recently announced our intention to submit an EUA request for Perm Garda for the treatment of mild to moderate symptomatic COVID-19, and certain immuno compromised people.

Mark Vincardzon: As described in our press release, we view this as a logical and welcome complement to our overall cereal mono therapy bridging paradigm and a reassuring reminder of the intellectual alignment between and vivid and the U S. FDA.

Mark Vincardzon: The anticipated treatment EUA submission will leverage already existing datasets from our stamp and canopy clinical trials.

Mark Vincardzon: In parallel to the anticipated submission of the EUA request, we plan to design and initiate a compact clinical trial focused on generating confirmatory safety, pharmacokinetic, and clinical virology data. Importantly, treatment of mild to moderate symptomatic COVID-19 in certain immunocompromised people is a second use case for PEMGARNA and possibly follow-up molecules with shorter-term endpoints than PrEP, which may substantiate rapid Turning to slide 12, this additional use case is important because even with vaccination, immunocompromised people are disproportionately impacted by severe COVID-19 outcomes and remain a major driver of ongoing hospitalization and death in the U.S. despite current small-molecule treatment options.

Mark Vincardzon: In parallel to the anticipated submission of the EUA request, we plan to design and initiate a compact clinical trial focused on generated confirmatory safety pharmacokinetic and clinical virology data.

Mark Vincardzon: Importantly treatment of mild to moderate symptomatic COVID-19, and certain immuno compromised people is a second use case for Kevin Garnett and possibly follow up molecules with shorter term endpoints, then prep, which may substantiate rapid innovation moving forward.

Mark Vincardzon: Turning to slide 12. This additional use case is important because even with vaccination.

Mark Vincardzon: Immuno compromised people are disproportionately impacted by severe COVID-19 outcomes and remain a major driver of ongoing hospitalization and death in the U S. Despite current small molecule treatment options.

Mark Vincardzon: Moving to slide 13, if authorized, PEMGARDA could be a welcome addition to the Therapeutic Armamentarium and a valuable potential option for certain people with moderate to severe immunocompromised when alternative COVID-19 treatment options are not clinically appropriate or accessible. At present, there is no authorized antibody treatment for COVID-19, and among existing options, some are complicated by drug-drug interactions, and others are mainly used in a hospital setting requiring burdensome repeat intravenous infusions on consecutive days.

Mark Vincardzon: Moving to slide 13, if authorized garlic could be a welcome addition to the therapeutic armamentarium and a valuable potential option for certain people with moderate to severe immuno immune compromise when alternative COVID-19 treatment options are not clinically appropriate or accessed.

Mark Vincardzon: <unk>.

Mark Vincardzon: At present, there is no authorized antibody treatment of COVID-19, and among existing options. Some are complicated by drug drug interactions and others are mainly mainly deployed in a hospital setting requiring burdensome repeat intravenous infusions on consecutive days.

Mark Vincardzon: Turning to slide 14, as we have seen since the beginning of COVID therapies, treatment option utilization ebbs and flows with overall viral presence. Nonetheless, in year five of the pandemic, COVID treatments remain heavily utilized. We are moving with considerable urgency, as we believe that immunobridging provides us with a more rapid and efficient pathway to deliver an important COVID-19 treatment option, complementing our efforts with PrEP. I am now pleased to turn the call over to Robbie to discuss our analytics and discovery technology. Thank you, Mark.

Mark Vincardzon: Turning to slide 14, as we have seen since the beginning of Covid therapies treatment option utilization ebbs and flows with overall viral presence.

Robbie: Nonetheless in year five of the pandemic.

Robbie: <unk> treatments remain heavily utilized.

Robbie: We are moving with considerable urgency as we believe that immuno bridging provides us with a more rapid and efficient pathway to deliver an important COVID-19 treatment option complementing our efforts with prep.

Robbie: I am now pleased to turn the call to Ravi to discuss our analytics and discovery technologies. Thank you Mark.

Robbie: Good afternoon. Many of you have expressed an interest in hearing more about our work on virus evolution and the confidence we have in the quality and durability of PEMGARTA and our pipeline molecules. To start on slide 15, I want to introduce Invivyd Tools, which is our in-house proprietary software that tracks virus variation across SARS-CoV-2 from multiple sources, including clinical sample sequence data and the sequencing data collected from wastewater. As a general rule, variants that become clinically relevant are detected in wastewater well in advance of their broad emergence.

Robbie: Good afternoon. Many of you have expressed interest in hearing more about our work on virus evolution and the confidence we have in the quality and durability of Garda and our pipeline molecules. So starting on slide 15, I want to introduce David tools, which is our in house proprietary software that tracks virus variation.

Robbie: <unk> from multiple sources, including clinical sample sequence data and the sequencing data collected from wastewater.

Robbie: General rule various have become clinically relevant arent detecting wastewater well in advance of their broad emergence.

Robbie: Wastewater data also includes sequences of viruses that do not ultimately rise to high prevalence in the clinic, but these data provide a broad view of the mutational space that has been explored by the virus over time. We use this tool for two purposes.

Robbie: Wastewater data also includes sequences of viruses that do not ultimately rise high prevalence in the clinic.

Robbie: These data provide a broad view of the mutational space that's been explored by the virus over time.

Robbie: Firstly, in furtherance of activity prediction and monitoring, but also, as you will see, increasingly to power highly proprietary discovery approaches that we think give us a unique advantage in the field. As you can see on the left side of the panel on slide 16, at Invivyd, we log and analyze variation observed across the spike protein down to very low-frequency polymorphic exploration. In this small excerpt, you are seeing graphs which depict the various changes on an amino acid by amino acid basis across positions 403 to 432.

Robbie: We use this tool for two purposes, firstly in furtherance of activity prediction and monitoring but also as you will see increasingly to power highly proprietary discovery approaches that we think give us a unique advantage in the field.

Robbie: On slide as you can see on the left side of the panel on slide 16, and endeavored, we Marc and then analyze variation observed across the spike protein down to very low frequency polymorphic explorations in this small expert youre seeing graphs, which depicts the various changes on the <unk>.

Robbie: Offset by amino acid basis across positions or zero, 3% to 4321.

Robbie: While this view of the data allows you to appreciate multiple data sets simultaneously, the sharp eye among you may notice that some of these graphs do not have a lot of color and noise on them, whereas others do.

Robbie: This view of the data allows you to appreciate multiple datasets simultaneously.

Robbie: <unk> eyed among you may notice that some of these graphs do not have a lot of color and noise on them, whereas others do.

Robbie: That reflects the degree to which less or more polymorphic exploration has taken place at a given residue as the virus has evolved. By evaluating the epitope sites for our antibodies, including BYD222, we can assess how mutable or polymorphic our epitopes are. Gratifyingly, in the areas we track as part of the assigned epitope of DYD222, we have observed polymorphic stability since the emergence of omicron through to the present day.

Robbie: That reflects the degree to which less or more polymorphic exploration has taken place at a given our residue as the virus has evolved.

Robbie: By evaluating the topic sites for our antibodies, including BYD to Q2, we can assess how durable are polymorphic our epitope.

Robbie: Finally in the areas, we track as part of the assigned October BYD Q2, we have observed polymorphic stability since the emergence of <unk> through to the present day.

Robbie: Of course, once we pick an antibody to develop it, we cannot change it. And so monitoring and analysis of variation becomes much more valuable when we can incorporate it into the design of our screens and the selection of our antibody candidates. In a moment, I will describe how this practice has been integrated into our pipeline. But for now, I will simply note the following.

Robbie: Turning to slide 17.

Robbie: Of course, once we pick an antibody to develop it we cannot change it and so monitoring and analysis of variation gets much more valuable when we incorporated into the design of our screens in the selection of our antibody candidates.

Robbie: In a moment I will describe how this practice has been integrated into our pipeline.

Robbie: When we look at the variation across SPIKE and RBD, the area we want to contact on a map... we see evolution, sometimes saltation or large structural shifts, and then we see reconvergence along previously documented exploratory paths. In simplest terms, while we cannot expressly predict variation, we are beginning to better understand the nature of SARS-CoV-2 evolution. If we can create some level of data-driven intelligence in predicting future potential changes, we can identify future theoretical or synthetic viruses by proteins that may not even exist yet as variants but which represent probabilistic futures for which we want to prepare.

Robbie: For now I will simply note the following.

Robbie: When we look at the variation across bike and RPG area, we want to contact with a map.

Robbie: We see evolution, sometimes saltation or large structural shifts.

Robbie: And then we see Reconvergence, along previously documented exploratory pathways and.

Robbie: In simplest terms, while we cannot expressly predict variation we are beginning to better understand the nature of <unk> evolution if.

Robbie: If we can create some level of data driven intelligence and predicting future potential changes, we can identify future theoretical or synthetics by proteins that may not even exist yet as variants of which represent probabilistic futures for which we want to prepare.

Robbie: And, if we can do that, we can deploy our proprietary discovery technology that takes advantage of the high-throughput e-space map optimization platform from Atomab, directing it to perform operations that would be practically impossible with less advanced technology.

Robbie: And if we can do that we can deploy our proprietary discovery technology that takes advantage of a high throughput espace mab optimization platform from Allomap.

Robbie: Directing it to perform operations that would be practically impossible with less advanced technology.

Robbie: What that means is that, armed with information about viruses that have circulated, are now circulating, and then armed with synthetic depictions about what might circulate, we can execute Boolean or logic-driven discovery screens in which we direct the platform to identify predefined antibodies, all based on the original frameworks of adenotrebumab and nalpamivibar, which, for example, neutralize XBB and J We can then select those candidate antibodies and indeed confirm the activity we believe we wish them to have, both against the current virus, but also which embraces the anticipation of single or multiple future convergently evolved variants. Moving to slide 19.

Robbie: Turning to slide 18.

Robbie: What that means is that armed with information about viruses that have circulated are now circulating and then onward synthetic depictions about what Mike circulate, we can execute bullion or logic, driven discovery screens, and which we direct the platform to identify a predefined antibodies all based on the original frameworks about in some amount.

Robbie: Now from Evercore, which for example, neutralize SBB and J S. One and so on but which do not interact with the rest of it we may worry about from our probabilistic work.

Robbie: We can then select one candidate antibodies and indeed confirm the activity. We believe we wish them to have both against current virus, but also which embraced the anticipation of single or multiple future convergent we evolved variants.

Robbie: We are looking for antibodies that are not limited by mammalian immune suites, such as we might see in convalescent serum or a mouse. We are seeking novel molecules that can go through rapid, highly efficient development paths, and in each generation of molecule, we are looking to increase our design level competence in resistance to variation and improve the overall pharmaceutical properties of our product. This approach started with adenotrebumab, which was made early as the maturation of a SARS-CoV-1 antibody against Wuhan lineage virus.

Robbie: Going to slide 19.

Robbie: We are looking for antibodies that are not limited by mammalian immune suite, such as we might see in convalescent serum or amounts. We are seeking novel molecules that can go through rapid highly efficient development path and in each generation of molecule. We're looking to increase our design level confidence in resistance to variation and improve the overall.

Robbie: Pharmaceutical properties of our products.

Robbie: Practice this approach starting with having trouble map, which was made early maturation of Src will be one antibody against Wuhan, maybe it's virus.

Robbie: The critical product attribute at that time was thought to have been achieved through conservation of ACE2-access, although the Omicron shift taught us and other sponsors that there was sufficient permissiveness in ACE2-access to make immune evasion a second critical dimension of the discovery process. Then we go to Penevra, which is adenotrepimab optimized against DA.2, but leaving as a criterion the backwards That constraint appears to be driving, so far, a highly encouraging conservation of the Pemebobar epitope across evolution but imposing at least a modest potency penalty on recent circulating viruses.

Robbie: The critical product attribute at that time was thought to have been achieved through conservation of eggs to access although the omicron shift taught us and other sponsors.

Robbie: Were sufficient permissiveness in H, two access to make immune evasion.

Robbie: Critical dimension of the discovery process.

Robbie: When we go to <unk>.

Robbie: Which is Adam Trevor amount optimize against <unk>, two but leaving as a criterion backwards looking neutralization of ancestral pre omicron lineages that constraint appears to be driving so far are highly encouraging conservation of the <unk> epitope across evolution.

Robbie: Imposed on at least a modest potency penalty on recently circulating viruses are next anticipated clinical candidate <unk> 2311.

Robbie: Our next anticipated clinical candidate, BYD2311, takes Pimivibart and optimizes it further for increased potency and assessed variation resistance. We will look forward to introducing you to 2311 more fully soon, but the early profile is very encouraging as it goes to improvement over Pemevibar in terms of possible dose, therapeutic index, and route of administration. A bit earlier still in discovery, we are now integrating our forward-looking synthetic antigens to create antibodies that we believe have some in-built anticipatory intelligence, a process we expect to monitor and refine as we go.

Robbie: Takes pimentel, Bart and Optimizes. It further for increased potency and assessed variation resistance. We will look forward to introducing you to 2311 more fully see but the early profile was very encouraging as it goes to improvement over <unk> in terms of possible dose therapeutic index and route of administration.

Robbie: A bit earlier still in discovery, we are now integrating our forward looking synthetic antigens to create antibodies that we believe have some inbuilt anticipatory intelligence a process, we expect to monitor and refine as we go.

Robbie: In these, we are now operating out past the frontier of what is, and we are actually discovering and qualifying molecules that are designed on multiple dimensions to address what we believe is likely in the future. A very unique approach in biopharmaceuticals as far as we are aware. Next, I'd like to turn it back over to Mark for some closing thoughts before we move to Q&A.

Mark: In the US we are now operating out past the frontier of what is and we are actually discovering and qualifying molecules that are designed on multiple dimensions to address what we believe is likely in the future of our unique approach and biopharmaceutical and as far as we are aware next.

Robbie: Next I'd like to turn it back over to Mark for some closing thoughts before we move to Q&A.

Mark Aliyah: In summary, as shown on slide 20, we're constantly tracking, analyzing, and considering variation. We do it both to monitor the probable activity of our current drug, Pamivibart, to monitor the stability of epitopes for candidate drugs, including 2311 and others, and now also to generate analytic findings that allow us to build antibodies that anticipate probable changes and clearly retain activity. You will have, and will in the future, see various results of neutralization assays on our and others' antibodies.

Mark: Thanks Ravi.

Mark Aliyah: In summary, as shown on slide 20, we're constantly tracking analyzing and considering variation we do it both to monitor the probable activity of our current drug <unk> to monitor the stability of epitopes for candidate drugs, including 23, 11, and others and now also to generate analytic findings that allow us to build antibodies, which anticipate probable changes and clear.

Mark Aliyah: We would encourage you to interpret those data with caution. Our colleagues at AstraZeneca, on the Evie Sheld Fact Sheet, characterized changes in neutralizing potency of less than five-fold as, quote, "no change," which speaks to the variable nature of these assays and the tenuous, uncertain relationship between those precise assay results and overall clinical activity. Worse, when and if an assay is changed or a laboratory is switched as a vendor, comparability becomes more difficult.

Mark Aliyah: <unk> retain activity.

Mark Aliyah: You will have and will in the future see various results of neutralization assays on our and others antibodies. We would encourage you to interpret those data with caution.

Mark Aliyah: Colleagues at Astrazeneca on the Abbvie shelf factsheet characterize changes in neutralizing potency of less than five fold as quote no change unquote, which speaks to the variable nature of these assays in the tenuous uncertain relationship between those precise assay results and overall clinical activity.

Mark Aliyah: Worse, when and if an assay has changed or laboratory is switched as a vendor comparability becomes more fraud as a consequence, while we had exhibit we'll continue monitoring.

Mark Aliyah: As a consequence, while we at Invivyd will continue monitoring neutralization carefully, we will not update you all on an ad hoc basis. Rather, we will communicate our findings with the FDA and update our product fact sheet when we do. The sum of all this work is that we believe we have excellent and growing evolutionary intelligence on SARS-CoV-2 and a unique ability to operationalize that intelligence. Our work can never be perfect, as we are up against Mother Nature, and she always has some tricks up her sleeve.

Mark Aliyah: Neutralization carefully we will not update you all on an AD hoc basis.

Mark Aliyah: Rather we will communicate our findings with the FDA and update our product factsheet when applicable.

Mark Aliyah: The sum of all this work is that we believe we have excellent and growing evolutionary intelligence on Sars Covid, two and a unique ability to operationalize that intelligence. Our work can never be perfect. As we are up against mother nature and she always has tricks up firstly however, we.

Mark Aliyah: However... We are highly encouraged by our recent progress in our basic science, our clinical development, our growing regulatory alignment, and our commercial efforts. Our goal with innovation over time will be to substantially expand the populations to whom we can offer COVID-19 protection and treatment, improve the profile of our products, and thereby substantially increase the medical value of our products for patients and providers and, therefore, our value creation for shareholders. I'd like to ask the operator to open the line for questions.

Mark Aliyah: We are highly encouraged by our recent progress in our basic science, our clinical development are growing regulatory alignment and our commercial efforts our goal with innovation over time will be to substantially expand the populations to whom we can offer COVID-19 protection and treatment to improve the profile of our products and thereby to substantially increase the medical <unk>.

Mark Aliyah: <unk> of our products for patients and providers and therefore, our value creation for shareholders.

Operator: Thank you. At this time, we will conduct the question and answer session. Please stand by while we compile the Q&A roster. Our first question comes from the line of Maxwell Skor of Morgan Stanley. Your line is now open.

Mark Aliyah: Like to ask the operator to open the line for questions.

Maxwell Nathan Skor: Thank you at this time, we will conduct a question and answer session. Please standby, while we compile the Q&A roster.

Maxwell Nathan Skor: Our first question comes from the line of Maxwell score of Morgan Stanley. Your line is now open.

Maxwell Nathan Skor: Great, thank you, and congratulations on the progress. So to start with, can you elaborate a bit more on your marketing strategy, including whether you're exploring direct-to-consumer campaigns and which physician specialty is most likely to prescribe Pemgarda? And then, finally, you announced plans to initiate a compact clinical trial. I'm wondering how you'll leverage your data, and whether you're running this trial in response to specific FDA feedback. Thank

Maxwell Nathan Skor: Great. Thank you and congratulations on the progress so as far as can you elaborate a bit more on your marketing strategy, including whether youre exploring direct to consumer campaigns in which physician specialty is most likely to prescribe Garda and then finally, you announced plans to initiate a compact clinical trial.

Maxwell Nathan Skor: I'm wondering how you leverage these data and whether youre running this trial in response to specific FDA feedback. Thank you.

Mark Aliyah: Thanks, Max. Let me quickly touch on the second question you raised first, and I'll ask Mark to add anything I forgot, which is to say our reference to a compact trial is, I think, described a bit in our original press release, but the basis for the EUA submission is largely analytics and a little bit of incremental work from our prior clinical development. Stampp and Canopy, specifically, as it goes to the treatment DUA, which I think is what you're referring to.

Mark Aliyah: Thanks, Max let me quickly touch on the second question you raised first and I'll ask Mark to add anything I forgot which is to say our reference to our compact trial is I think described a bit in our original press release, but.

Mark: The basis for EUA submission.

Mark Aliyah: Is largely analytics and a little bit of incremental work from our prior clinical development work stamp and canopy, specifically as it goes to the treatment of UA, which I think is what youre referring to.

Mark Aliyah: So the nature of that confirmatory study embraces elements of pharmacokinetic safety and clinical virology. You know, that study is under active development. I'm sure as we refine those elements, we'll share some more details with you. But very quickly, Mark, did I leave anything out of that? No, it's I mean, just to dovetail on what you said, it's really going to be the evaluation, first and foremost, of that emergent resistance, if any, to move to Pomiva Bard and the collection of that safety and PK data.

Mark: So the nature of that confirmatory study embraces elements of pharmacokinetics safety and clinical virology.

Mark Aliyah: That study is under active development I'm sure as we refine those elements will share some more details with you, but very quickly Mark did I leave anything after that no I mean, just to dovetail on what you said, it's really going to be the evaluation first and foremost of that treatment emergent resistance if any.

Mark: <unk> and the collection of that safety and PK data soon largely incremental to the studies that we've already done.

Mark Aliyah: So, largely incremental to the studies that we've already done. So I think, Max, Jeremy can now give you a little more color on EUA, which is a pretty unique concept in pharmaceuticals and, I think, has some boundaries and advantages that bear on your specific question about marketing. Yeah, thanks, Max and Mark.

Jeremy Gowler: So so.

Jeremy Gowler: I think Max Jeremy can now give you a little more color on EUA, which is a pretty unique concept in pharmaceuticals, and I think has some boundaries and advantages to bear on your on your specific question about marketing, yes, Thanks, Max and Mark for the introduction here. So I would say the early days, we're focused on raising HC.

Jeremy Gowler: Yeah, thanks Max and Mark for the introduction here. So I would say the early days were focused on raising HCP awareness about the product, and that's a really critical part because if patients go in to access a product and the HCP knows nothing about it, then you know it kind of ends up at a dead end. So the early days were focused on that as part of the launch. We have not ruled out doing DTC in the future, and we're exploring that, and we do run some targeted patient campaigns.

Jeremy Gowler: Awareness for the product and that's a really critical part because the patients go into access a product.

Jeremy Gowler: The HP knows nothing about it then.

Jeremy Gowler: Kind of ends up with a debit. So early days, we're focused on that as part of the launch we have not ruled out not doing DTC in the future and we are exploring that and we do do some targeted.

Jeremy Gowler: What we also know a little bit about patients is that these kind of sick, sick patients that we see, the immunocompromised, are very active in their management of their health. And so we've seen a lot of organic interest, you know, online and chat groups, etc. Where there is a fair amount of interest in trying to access the product already. So we feel sometimes patients are actually a little bit ahead of the HCPs in this regard, and we really do want to inform the HCPs early on. So that's the primary focus around the time of launch, and we'll explore expanding beyond that as time progresses.

Jeremy Gowler: Patient campaigns, but we also know a little bit of a patients as these kind of sick.

Jeremy Gowler: Patients that we see the immuno compromised they're very active.

Jeremy Gowler: And their management of their health and so we've seen a lot of organic interest online to chat groups et cetera, where there is a fair amount of interest in trying to access the product already so we feel sometimes the patients are actually a little bit ahead of the hdds in this regard and we really do want it for the Hcp's early on so thats. The primary focus around the time of launch and we will explore.

Jeremy Gowler: Expanding beyond that as time progresses.

Speaker Change: Helpful. Thank you.

Speaker Change: One moment for our next question.

Operator: One moment for our next question. Thank you. Our next question comes from the line of Patrick Trucchio of H.C. Wainwright & Co. Your line is now open.

Jeremy Gowler: Yes.

Speaker Change: Thank you.

Patrick Ralph Trucchio: Our next question comes from the line of Patrick <unk> of HC Wainwright <unk> co. Your line is now open.

Patrick Ralph Trucchio: Thanks. Good evening and congratulations on all the progress at the launch and pipeline.

Patrick Ralph Trucchio: Thanks, Good evening and congrats on all the progress.

Patrick Ralph Trucchio: Just a couple of follow-up questions from me. The first is, I think it was noted that the reimbursement codes, Q code and M code, cover reimbursement for half the moderate to severe immunocompromised people at highest risk for severe COVID-19 that you're targeting. So I'm wondering how we should think about reimbursement for the other half of the target patient population, the timing of reimbursement, and just, you know, how we should anticipate, you know, kind of the launch going with that other half.

Patrick Ralph Trucchio: <unk> pipeline just a couple of follow up questions from me. The first is I think we've noted that the reimbursement codes Q current m-code cover reimbursement, perhaps moderate to severe immuno compromise people at highest risk.

Patrick Ralph Trucchio: Severe COVID-19, you're targeting so I'm wondering how do we think about reimbursement for the other half of the target patient population timing.

Patrick Ralph Trucchio: Timing of reimbursement and just how we should anticipate.

Patrick Ralph Trucchio: And then separately, can you discuss the potential approval pathway for PEMGARDA's treatment in immunocompromised individuals and when you would imagine being able to submit for an EUA and maybe clarify the timeline, including, you know, time to submission for potential authorization. And separately, just how meaningful you anticipate this label expansion may be for peak sales potential of PEMGARDA.

Patrick Ralph Trucchio: Kind of the launch going with that other half and then separately.

Patrick Ralph Trucchio: Can you discuss the.

Patrick Ralph Trucchio: A potential approval pathway for <unk> treatment in immunocompromised individuals when you would envision being able to submit for an EUA and maybe clarify the timeline, including timing of submission to potential authorization and separately just how meaningful you anticipate this label expansion may be for peak sales potential can garner.

Mark Aliyah: Let me again, this is Mark. Let me start with the second one and then I'll pass it back to Jeremy on your coverage question. You know, look, I think in our press release we explicitly said that our submission of the EUA would be imminent. In our language, that is generally a time frame that would embrace Let's say, rather than, you know, months or quarters, which would have caused us to pick those words instead.

Patrick Ralph Trucchio: Let me again this is mark let me again start with the second one and then I'll pass it back to Jeremy on your coverage question look I think in our press release, we explicitly said that are.

Mark Aliyah: Our submission of <unk> would be imminent.

Mark Aliyah: Our language that is generally a timeframe that would embrace weeks, let's say rather than months or quarters, which would have caused us to pick those words instead so.

Jeremy Gowler: So, as we tried to convey, this is an exercise rooted in intellectual alignment that draws from the same route of administration. The same titers, in effect, substantiated both a PrEP and a treatment use. And so what we're simply doing is we're moving that fundamental posture into the broader PEMGARDA program while simultaneously noting that it is a potentially very interesting addition to future antibodies, which, of course, have been traditionally highly effective in both use cases.

Jeremy Gowler: As we've tried to convey this is an exercise rooted in intellectual alignment that draws from common material common clinical experience as our prep EUA at some level. All of these use cases are driven by SPN, a tighter and if you think back to evade and stamp.

Jeremy Gowler: The let's call them parents clinical studies that leveraged at <unk> at the same dose. The same route of administration. The same titers in effect substantiated, both a prep and a treatment use case.

Jeremy Gowler: So what we're simply doing is we're moving that fundamental posture into the broader <unk> Garda program, while simultaneously, noting that it is a potentially very interesting addition to.

Jeremy Gowler: Future antibodies, which of course have been traditionally highly effective in both.

Jeremy Gowler: So, hope that helps and stay tuned. Obviously, we hope to be back to you with more color shortly. Jeremy, back to the CMS and coverage. Yeah. On the commercial reimbursement side, we have our national account management team out there earnestly working away to get that for us. We understand the criticality of it, given the other half of the population, as you mentioned. And so we're encouraged by the initial engagement we're getting, but of course, there's process and time that formularies need to go through, and payers go through on their formularies. So we're working through that right now, but more to come as we go.

Jeremy Gowler: Both use cases, so hope that hope that helps and stay tuned obviously, we hope to be back to you with more color shortly Jeremy back to the CMS and cover yes on the commercial reimbursement side, we have our national account management team out there earnestly working away at getting that for US we understand the criticality of it given the other half of the population that you mentioned.

Jeremy Gowler: So we're encouraged by the initial engagement, we're getting but of course, there is process and time that formulary is going to go through the payers go through on their formularies. So we're working through that right now, but more to come as we go through this launch.

Jeremy Gowler: Great. Thank you so much.

Jeremy Gowler: Yes.

Jeremy Gowler: Great. Thank you so much.

Operator: One moment for our next question. Thank you. Our next question comes from the line of Evan Wang of Guggenheim Securities. Your line is now open.

Jeremy Gowler: Yes.

Boran Wang: One moment for your next question.

Boran Wang: Thank you.

Operator: Our next question comes from the line of Evan Wang of Guggenheim Securities. Your line is now open.

Boran Wang: Hey guys, T from me. With some of the pipeline development, I know you guys spent some time on the discovery engine and next-gen products and how you. It seems like there's been plenty of discussion with the FDA recently, just with the support of the EUA for PrEP and then with these new treatment discussions. So can you help provide some framework around the development for VUID 2311 and how you're thinking about development there?

Speaker Change: Hey, guys two for me.

Boran Wang: With some of the developed pipeline development I know you guys spent some time on the discovery engine and Nextgen products and how you can.

Boran Wang: We are approaching with zero approach going forward.

Boran Wang: So it seems like there's been plenty of discussion with FDA recently.

Boran Wang: With the support of EUA for perhaps and then.

Boran Wang: These new treatment discussion. So can you help provide some framework around the development for <unk> 311, and how youre thinking that development there.

Boran Wang: And then second, you know, again, on the treatment opportunity, you know, just wondering how we should be thinking about this opportunity, understanding tax livid and vocabulary are pretty robust markets, but, you know, just given that the language is around alternative treatments or alternative options, unless one alternative is not appropriate or accessible. Thanks.

Boran Wang: And then second again on the treatment.

Boran Wang: I'm just wondering how we should be thinking about this opportunity understanding pack fluid into Macquarie are pretty robust markets, but just given that the languages around alternative treatments for alternative options.

Boran Wang: One alternative options are not appropriate or careful.

Mark Aliyah: Hey Evan, this is Mark. You know, I think the fun part of defining and leading a brand new field of medicine is probably a little bit of the frustrating part for you as you look for specificity and precision that is, as you note, the topic of ongoing dialogue and collaboration. So, you know, when we're in a position to tell you exactly how we think these things will look, we'll certainly tell you.

Mark Aliyah: Hey, Kevin this is mark.

Mark Aliyah: I think the.

Mark Aliyah: The fun part of defining and leading a brand new field of medicine is probably a little bit of the frustrating part for you as you look for specificity and precision that is as you note the topic of ongoing dialogue and collaboration.

Mark Aliyah: No.

Mark Aliyah: When we're in a position to tell you exactly how we think these things will look we will certainly tell you.

Mark Aliyah: As now, what we've experienced over, I would say, a 12 to 18-month period, starting with, and it actually goes all the way back to the December FDA-EMA joint discussion on the use of surrogates for rapid trialing of COVID-19 antibody therapeutics and prophylactics.

Mark Aliyah: Now what what we've experienced over I would say a 12 to 18 month period, starting with it actually goes all the way back to the December FDA EMA joint discussion on the use of surrogates for rapid Trialing of COVID-19 antibody therapeutics in prophylactic, what we are.

Mark Aliyah: What we are watching is a growing congruence and a growing concordance that we believe opens up certain novel pathways, and we are gonna be designing those in real time. And indeed, that's what has been going on. And it is not meant to be evasive or not give you the color you're looking for, but rather to note that these things are evolving as Invivyd builds the real opportunities to evolve them.

Mark Aliyah: <unk> is a growing congruence and a growing concordance that we believe opens up certain novel pathways and.

Mark Aliyah: We are going to be designing those in real time and indeed, that's what has been going on and it is not meant to.

Mark Aliyah: To be evasive or not give you the color you're looking for but rather to note. These things are evolving as in visit builds the real opportunities to evolve them, we have Pam Garda, hence we have an opportunity to use it more broadly.

Mark Aliyah: We have PEMGARTA, and hence we have an opportunity to use it more broadly. What we have noticed with the FDA is that they are very thoughtful, very engaged, and very attuned to the magnitude of the unmet needs. And so as we continue and expand that collaboration, as noted in some of the prepared remarks, we're really looking forward to continuing to innovate these paths and establish bespoke and proprietary pathways that may be, to some extent, really enabled by our unique molecules, OK, and our unique discovery engine.

Mark Aliyah: What we have noticed with the FDA.

Mark Aliyah: They are very thoughtful very engaged and very attuned to the magnitude of the unmet needs and so as we continue and expand that collaboration as noted in some of the prepared remarks, we're really looking forward to continuing to innovate these pathways and establish bespoke and proprietary pathways that.

Mark Aliyah: Maybe maybe to some extent.

Mark Aliyah: Really enabled by our unique molecules okay in our unique discovery engine. So that is what you're really watching in real time and I think we're looking forward over the next weeks and months to seeing how this new Avenue takes shape and so on treatment I'll ask mark to comment a little.

Mark Aliyah: So that is what you're really watching in real time, and I think we're looking forward over the next weeks and months to seeing how this new avenue takes shape. And so on treatment, I'll ask Mark to comment a little more on what he sees as the opportunity, but, you know, we elected not to change our guidance, so we're probably not going to give you the quantitation you would hope for on the size of the opportunity. However, it is something about which we are quite excited. Thanks, Mark. This is Mark's car.

Mark: More on what he sees as the opportunity, but we elected to not change our guidance. So we're probably not going to give you a quantitative you would hope on the size of the opportunity. However, it is something about which we're quite excited thanks.

Mark Vincardzon: And, you know, I've been a drug developer for almost 30 years, and what I can say is, we're going to certainly iterate and optimize based upon the skeletal framework outlined by the FDA to date, not only for prevention, but also for treatment. And where I do think that this potentially fits is that remdesivir is very burdensome for not only healthcare practitioners but also for patients because of the multiple infusions that they need within a very, very short period of time, and again, are mostly relegated to those in-hospital use cases.

Mark Vincardzon: Thanks, Mark. This is Mark's partner in crime over here.

Speaker Change: Thanks Mark.

Mark Vincardzon: This is mark partner in crime over here.

Mark Vincardzon: But.

Mark Vincardzon: Drug developer from US 30 years, and what I can say is we're going to certainly iterate and optimized based upon the skeletal framework outlined by the FDA to date not only for prevention, but also for treatment and where I do think that this potentially fits as we certainly know from disappear.

Mark Vincardzon: Very burdensome to not only health care practitioners, but also to patients the multi infusions that they need within a very very short period of time and again are mostly relegated to those in hospital use cases, and certainly pack slow, but will not go away with <unk> with their drug drug interactions and with a lot of the Blake breakthrough SIMP.

Mark Vincardzon: And certainly Paxlovid will not go away, but Paxlovid with their drug-drug interactions, and with a lot of the breakthrough symptomology due to the fact that they're really not being able to abolish the titers to a level that perhaps MAP gets you to, provides, I think, a very, very nice use case there, especially in those patients who are immunocompromised and have a lot of comorbid conditions, as well as on a lot of other drugs that could interact unfavorably with the current drugs that are available.

Mark Vincardzon: The Molla <unk> due to the fact that they are really not being able to abolish the titers to a level that perhaps a map get it gets you to provide I think a very very nice use case, there, especially in those patients who are immunocompromised and have a lot of co morbid conditions as well as on a lot of a lot of.

Mark Vincardzon: Other drugs that could interact unfavorably with with the current drugs that are available.

Mark Vincardzon: Thanks.

Mark Vincardzon: One moment for our next question. Thank you. Our next question comes from the line of Michael Yee of Jeffreys. Your line is now open. Bye, thanks for taking our questions.

Speaker Change: One moment for our next question.

Michael Jonathan Yee: Thank you.

Mark Vincardzon: Our next question comes from the line of Michael Yee of Jefferies. Your line is now open.

Michael Jonathan Yee: Hi, Thanks for taking our question Jana answer Mike.

Michael Jonathan Yee: <unk> is.

Michael Jonathan Yee: What magnitude of Warner or potential order if are you seeing right now.

Michael Jonathan Yee: One where are they coming have you shipped any theme.

Michael Jonathan Yee: When would you start booking.

Operator: Thanks for the question. You know, we have made some very preliminary disclosures in prior press releases that I'll ask you to take a read through one last time, but at this point, we're not going to go into any incremental detail. This is the early phase of the launch, but it is very quickly going to be the middle phase of the launch. And I think as we look forward to the summer and then the fall, we're obviously going to be in a position to give you some feedback and some information that is useful to you, right?

Michael Jonathan Yee: Thank you.

Michael Jonathan Yee: Thanks for the question.

Operator: We have made some some very preliminary disclosures disclosures in prior press releases, but I'll ask you to take a read through one last time, but at this point, we're not going to go into any incremental detail. This is the early phase of the launch it is very quickly.

Operator: At this point, I think it's a little bit early, although we over here are quite encouraged. I don't know that anything we could respond to you with today would be particularly informative as it goes to understanding how the balance of the year is likely to play out. So stay tuned, and we are looking forward, just as you are, to getting into more of that detail at the launch.

Operator: Going to be the middle phase of the launch and I think as we look forward to the summer and then the fall, we're obviously going to be in a position to give you some feedback and some information that is useful to you right. At this point I think it's a little bit early although we over here are quite encouraged I don't know that anything we could <unk>.

Operator: Spawn to you with today would be.

Operator: Particularly informative as it goes to understanding how the balance of the year is likely to play out so stay tuned and we are looking forward just as you are to getting into more of that detail as the launch progresses.

Speaker Change: Thank you that's helpful.

Mark Aliyah: I am showing no further questions at this time. I would now like to turn it back to Mark Aliyah, Chairman of Invivyd's Board of Directors and Chairman of the Executive Committee of the Board, for closing remarks.

Speaker Change: I am showing no further questions at this time.

Mark Aliyah: I'd now like to turn it back to Mark <unk>, Chairman and David's point, if you go back home and chairman of the Executive Committee of the board for closing remarks.

Mark Aliyah: Thank you, and thanks to all of you for joining the call today and for your interest in Invivyd.

Mark Wingertzahn: Thank you and thanks to all of you for joining the call today and for your interest in and visit.

Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

Mark Wingertzahn: Thank you for your participation in today's conference. This does conclude the program you may now disconnect.

Operator: Okay.

Operator: [music].