Q2 2024 Invivyd Inc Earnings Call

Yeah.

Operator: David Hering, Patrick Trucchio, Mark Wingertzahn, Good day and welcome to the second quarter Invivyd Earnings conference call. At this time, all participants are in listen-only mode.

Operator: Good day and welcome to the second quarter in Vivian Erning's conference call. At this time, all participants are in listening mode. After the speaker's presentation, there'll be a question and an intercession.

Speaker Change: Good day and welcome to the second quarter earnings Conference call. At this time, all participants are in listen only mode.

Operator: After the speaker's presentation, there will be a question and answer session. Instructions will be given at that time. As a reminder, this call may be recorded. I'd now like to turn the call over to Katie Falzone, Vice President, Corporate Controller. Please go ahead.

Speaker Change: After the Speakers' presentation, there'll be a question and answer session and instructions will be given at that time.

Operator: Instructions will be given at that time. As a reminder, the call may be recorded.

Speaker Change: As a reminder, this call maybe recorded.

Katie Falzone: I'd now like to turn the call over to Katie Falzone, Vice President Corporate Controller. Please go ahead.

Speaker Change: I would now like to turn the call over to Katie you felt Boni Vice President corporate controller. Please go ahead.

Katie Falzone: Thank you, operator. A short while ago, we issued a press release announcing our Q2 2024 financial results and recent business highlights. That press release and the slides that are being used in today's webcast can be found in the investor section of the Invivid Westbyte under the press releases and events and presentation sections, respectively.

Katie Falzone: Thank you, operator. A short while ago, we issued a press release announcing our Q2 2024 financial results and recent business highlights. That press release and the slides that are being used in today's webcast can be found in the Investor section of the Invivid Web site under the press releases and events and presentations section. Today's discussion will be led by Marc Elia, Chairperson of Invivyd's Board of Directors and Chairperson of the Executive Committee of the Board.

Katie Veltboni: Thank you operator, a short while ago, we issued a press release announcing our Q2 2024.

Speaker Change: All right.

Speaker Change: That press release and the slides that are being used in today's webcast can be found in the investors section at the end of its web site under the press releases and events and presentations section.

Katie Falzone: Today's discussion will be led by Mark Elia, Chairperson of the Invivid Board of Directors and Chairperson of the Executive Committee of the Board. He is joined by Tim Lee, Chief Commercial Officer; Phil Duke, Chief Financial Officer; Dr. Robert Allen, Chief Scientific Officer; and Dr. Mark Wingertzahn, Senior Vice President of Clinical Development and Medical Affairs.

Speaker Change: Today's discussion will be led by Mark Yeah, Jefferson level that its board of directors. The chairperson of the Executive Committee of the board.

Katie Falzone: He is joined by Tim Lee, Chief Commercial Officer, Bill Duke, Chief Financial Officer, Dr. Robert Allen, Chief Scientific Officer, and Dr. Marc Wingertzahn, Senior Vice President of Clinical Development and Medical Affairs. 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 pipeline and regulatory plans, certain financial guidance, our future prospects, and other statements that are not historical facts.

Speaker Change: I'm joined by Tim Raines, Chief Commercial officer.

Speaker Change: They'll do Chief Financial Officer Dr.

Speaker Change: Dr. Robert Allen, Chief Scientific Officer, and Dr. Martin Lingers on senior Vice President of clinical development and medical Affairs.

Katie Falzone: During today's discussion, we will be making forward-looking statements concerning, among other things, our corporate and commercial strategies, our research and development activities, our pipeline and regulatory plans, certain financial guidance, our future prospects, and other statements that are not historical facts. These forward-looking statements are covered within the meaning of the Private Securities Litigation Reform Act and are subject to various risks, assumptions, and uncertainties that may change over time and then cause our actual growth to differ materially from those expressed or implied today. These forward-looking statements seek only as-of-the-date of this call and investigate if there was no duty to update such statements. Additional information on the risk factors that could affect our business can be found in our finals made to the U.S.

Speaker Change: 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 are I find the regulatory plan certain financial guidance, our future prospects and other statements that are not historical facts.

Katie Falzone: These forward-looking statements are covered within the meaning of the Private Securities Litigation and 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.

Speaker Change: If work 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.

Speaker Change: It differ materially from those breast or implied today.

Katie Falzone: 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-Q, which is also available on our website. I will now turn it over to Mark. Good morning.

Speaker Change: These forward looking statements speak only as of the date of this call and it is it assumes no duty to update such statements additional information on the risk factors that could affect him. If it says that can be found in our filings made with the U S Securities Exchange Commission, including our most recent Form 10-Q, which is also available on our website I will now turn.

Katie Falzone: Security and the Exchange Commission, including our most recent Form 10-Q, which is also available on our website.

Mark Elia: I will now turn it over to Mark. Good morning. Thank you all for joining us.

Speaker Change: Turn it over to Mark.

Marc Elia: Thank you all for joining us. Turning to slide four in the deck you can find on our website, the second quarter of 2024 began with a leadership transition at Invivyd. Our goal for transition was and remains to expand the scope of our corporate ambition and to improve our ability to deliver major medical value for vulnerable populations at substantial risk from respiratory viruses, especially COVID-19. We immediately began several initiatives, including some not yet visible, to improve our operational posture and efficiency and to broaden the scope of our strategic aim. This morning, we're sharing our second quarter results and a broader business update.

Mark Yeah: Thank you all for joining us.

Mark Elia: Turning to slide four in the deck you can find on our website, the second quarter of 2024 began with a leadership transition at Invitable. Our goal for transition was and remains to expand the scope of our corporate ambition and to improve our ability to deliver major medical value for vulnerable populations at substantial risk from respiratory viruses, especially COVID-19. We immediately began several initiatives, including some not yet visible, to improve our operational posture and efficiency and to broaden the scope of our strategic aims. This morning, we're sharing our second quarter results in a broader business update.

Mark Yeah: Turning to slide four in the deck you can find on our website.

The second quarter of 2024 began with leadership transition that inhibits our goal for transition was and remains to expand the scope of our corporate ambition and to improve our ability to deliver major medical value for vulnerable populations at substantial risk for respiratory viruses, especially COVID-19.

Mark Yeah: We immediately began several initiatives, including some not yet visible to improve our operational posture and efficiency and to broaden the scope of our strategic games.

Mark Yeah: This morning, we're sharing our second quarter results and our broader business update.

Mark Elia: By way of executive summary, we are pleased with our rapidly expanding commercial footprint and our pipeline advancement. While we are not satisfied with our early net revenue results, we saw consistent growth against across the second quarter, and we are seeing acceleration early in 3Q. And we are leaning forward and eager to deliver as we come into our major commercial moment for 2024, the fall-winter respiratory virus season. Over the next month, starting in September, millions of Americans are likely to consider, together with HCPs, vaccine boosts for COVID-19 disease. We aim to remind certain immunocompromised people and their care teams that more is available.

Marc Elia: By way of Executive Summary, we are pleased with our rapidly expanding commercial footprint and our pipeline. While we are not satisfied with our early net revenue results, we saw consistent growth across the second quarter, and we are seeing acceleration early in 3Q, and we are leaning forward and eager to deliver as we come into our major commercial moment for 2024, the fall-winter respiratory virus. Over the next month, starting in September, millions of Americans are likely to consider, together with healthcare professionals, vaccine boosts for COVID-19 disease.

Speaker Change: They are executive summary, we are pleased with our rapidly expanding commercial footprint and our pipeline advancement, while we're not satisfied with our early net revenue results, we saw consistent growth against across the second quarter and we are seeing acceleration early in <unk> and we are leaning forward and eager to deliver as we come into our major commercial moment for 'twenty.

Speaker Change: For the fall winter respiratory viruses.

Speaker Change: Over the next months starting in September millions of Americans are likely to consider together with Hcp's vaccine boost for COVID-19 disease, we aim to remind certain immunocompromised people and their care teams that more is available.

Marc Elia: We aim to remind certain immunocompromised people and their care teams that more is available. For those immunocompromised persons who have been hopeful of accessing PEMGARTA but have been frustrated by slow motion in the broad medical establishment, we are working with the utmost urgency to educate relevant stakeholders on the risks posed by COVID-19 and the option for protection presented by antibody prophylaxis and PEMGARTA-specific. Further, we are pleased to be advancing our pipeline molecule VYD2311, which we see as having a profile that could potentially expand this field of medicine.

Mark Elia: For those immunocompromised persons who have been hopeful to access Pemgarda but have been frustrated by slow motion in the broad medical establishment, we are working with the utmost urgency to educate relevant stakeholders on the risks posed by COVID-19 and the option for protection presented by antibody prophylaxis and Pemgarda specifics. We are pleased to be advancing our pipeline molecule, VYD 2311, which we see as having a profile that could potentially expand this field of medicine. Improved molecules, combined with emerging data from contemporary antibody-profil axis studies, such as our Canopy clinical trial and our competitor AstraZeneca Supernova study, may evolve this fast emerging field of medicine.

For those immuno compromised persons who have been hopeful to access Penn Garda, but have been frustrated by slow motion and the broad medical establishment, we are working with the utmost urgency to educate relevant stakeholders on the risks posed by COVID-19, and the option for protection presented by antibody prophylaxis and <unk> specifically.

Speaker Change: Further.

We are pleased to be advancing our pipeline molecule BYD 2311, which we see as having a profile that could potentially expand this field of medicine improved molecules combined with emerging data from contemporary antibody prophylaxis studies, such as our canopy clinical trial and our competitor Astrazeneca Supernovas study may evolve this fast emerging field of medicine.

Marc Elia: Improved molecules, combined with emerging data from contemporary antibody prophylaxis studies, such as our CANOPY clinical trial and our competitor AstraZeneca's SuperNOVA study, may evolve this fast-emerging field of medicine. After all, these two studies were the first COVID-19 antibody prophylaxis studies that were conducted in humans with prior immunologic experience from vaccination or infection. We will look forward to sharing additional Canopy data with all of you soon.

Mark Elia: After all, these two studies are the first COVID-19 antibody-profil axis studies that were conducted in humans with prior immunologic experience from vaccination or infection.

Speaker Change: After all these two studies are the first COVID-19 antibody prophylaxis studies that were conducted in humans with tire hematologic experience from vaccination or infection. We will look forward to sharing additional canopy data with all of you soon.

Mark Elia: We will look forward to sharing additional canopy data with all of you soon.

Marc Elia: Turning to slide 5. As a preview of our evolving corporate posture, we are quickly sharing images such as this one from an updated corporate presentation that will be available soon. Many HCPs and indeed Americans overall are not aware of the magnitude of the medical burden to Americans presented by endemic COVID-19 unless a wave is ongoing or peaking, especially the burden on the immunocompromised. Invivyd aims to provide clear thought leadership to the community on these critical facts of the matter.

Mark Elia: Turning to slide five. As a preview of our evolving corporate posture, we are quickly today sharing images such as this one from an updated corporate presentation that will be available soon. Many HCPs and indeed Americans overall are not aware of the magnitude of medical burden to Americans presented by endemic COVID-19 and less aware the ongoing are peaking, especially the burden on the immunocompromised. Invivyd aims to provide clear thought leadership to the community on these critical facts of the matter. Moving to slide six, it should be clear by now to most, if not all, that SARS-CoV-2, while transmitted via aerosols like other respiratory diseases, is a multi-system virus capable of inflicting long-term damage to almost every key organ system.

Speaker Change: Turning to slide five.

Speaker Change: As a preview of our revolving corporate posture. We are quickly today sharing images such as this one from an updated corporate presentation that will be available soon.

Speaker Change: Many hcp's and indeed Americans overall, not aware of the magnitude of medical burden to Americans presented by endemic COVID-19, unless a wave is ongoing or peaking especially the burden on the immuno compromised in vivid aims to provide clearer thought leadership to the community on these critical facts of the matter.

Marc Elia: Moving to slide six, it should be clear by now to most, if not all, that SARS-CoV-2, while transmitted via aerosols like other respiratory diseases, is a multi-system virus capable of inflicting long-term damage to almost every key organ. It will never go away or magically get smaller, and we must face that fact head-on.

Speaker Change: Moving to slide six.

Speaker Change: It should be clear by now to most if not all that Sars Kobe too while transmitted via aerosols like other respiratory diseases is a multi system a virus capable of inflicting long term damage to almost every key organ system. It will never go away or magically get miles and we must face that fact head on.

Mark Elia: It will never go away or magically get miles, and we must face that fact head on.

Marc Elia: Moving to slide seven. Immunocompromised people may turn to vaccine boosts as their first line of defense and indeed have a recommendation from the CDC as of March 2024 to boost, quote, no more than every two months, unquote, or six times a year. Why might we wish to add more protection on top of that?

Mark Elia: Moving to slide seven. Immunocompromised people may turn to vaccine boosts as their first line of defense and indeed have a recommendation from the CDC as of March 2024 to boost "no more than every two months" or six times a year. Why might we wish to add more protection on top of boosting? The latest data presented by the FDA to the Advisory Committee on Immunization Practices or ACIP on June 28th of this year estimated vaccine efficacy or VE over the past 2023-24 season. The only VE estimate that broke out vaccine performance with immunocompromised persons specifically showed a relatively dismal 38% reduction in the risk of hospitalization compared to doing nothing, which, as you can see, is a benefit that waned quickly after 60 days.

Speaker Change: Moving to slide seven.

Speaker Change: Immunocompromised people may turn to vaccine booster as their first line of defense and indeed have a recommendation from the CDC as of March 2024 to boost quote no more than every two months unquote or six times a year.

Speaker Change: Why might we wish to add more protection on top of boosting the latest data presented by FDA to the Advisory Committee on immunization practices or <unk> on June 28 of this year estimated vaccine efficacy or V E over the past 2023 24 season.

Marc Elia: The latest data presented by FDA to the Advisory Committee on Immunization Practices, or ACIP, on June 28th of this year estimated vaccine efficacy, or VE, over the past 2023-24 season. The only VE estimate that broke out vaccine performance with immunocompromised persons, Specifically, showed a relatively dismal 38% reduction in the risk of hospitalization compared to doing nothing, which, as you can see, is a benefit that While vaccines saved millions of lives when people had no prior immune experience against SARS-CoV-2, in our endemic virus world, we may have to do more. It should be no surprise that Pemgarda was granted an emergency use authorization by the FDA, even as population-level immune experience has blunted the emergency for many Americans. Moving to slide 8.

Speaker Change: The only <unk> estimate that broke out vaccine performance with immuno compromised persons specifically showed a relatively dismal 38% reduction in the risk of hospitalization compared to doing nothing which as you can see is a benefit that waned quickly after 60 days.

Mark Elia: While vaccines saved millions of lives when people had no prior immune experience against SARS-CoV-2, in our endemic virus world, we may have to do more. It should be no surprise that Pemgarter was granted an emergency use authorization by the FDA, even as population-level immune experience has blunted the emergency from many Americans.

Speaker Change: While vaccines save millions of lives when people had no prior immune experience against Sars Cov, two and our endemic virus World. We may have to do more.

Speaker Change: It should be no surprise that <unk> was granted an emergency use authorization by the FDA, even as population level of immune experiences blunted the emergency for many Americans.

Mark Elia: Moving to slide eight. In short, In Vivid exist to make medicines that can confer protective antibody titers. Most of us learned about COVID antibodies during the pandemic in a treatment context, but in vivid we see an even more valuable use case for the category today. We know well the world that is possible today related to COVID-19 disease when our protective options are limited by the immune protection that comes from vaccination booster update or prior infection experience. In vivid, exist to try to add protection to our antibodies that can keep people both alive and well.

Speaker Change: Moving to slide eight.

Marc Elia: In short, Invivyd exists to make medicines that can confer protective antibodies. Most of us learned about COVID antibodies during the pandemic in a treatment context, but in Invivyd, we see an even more valuable use case for the category. We know well the world that is possible today related to COVID-19 disease when our protective options are limited by the immune protection that comes from vaccination booster uptake or prior infection experience. Invivyd exists to try to add protection through antibodies that can keep people both alive and, I'll now turn the call over to Tim Lee, our new chief commercial officer. Thank you, Mark. Turning to slide number 10.

Speaker Change: In short in vivid exist to make medicines that can confer protective antibody titers.

Speaker Change: Most of US learned about COVID-19 antibodies during the pandemic in a treatment context, but an exhibit we see an even more valuable use case for the category today, we know well the world that is possible today related to COVID-19 disease. When our protective options are limited by the immune protection that comes from vaccination booster uptake or prior infection experience.

Speaker Change: In vivid exists to try to add protection through antibodies that can keep people both alive and well.

Tim Lee: I'll now turn the call over to Tim Lee, our new Chief Commercial Officer. Thank you, Mark. Turning to slide number 10.

Speaker Change: I'll now turn the call over to Tim Lee, our new Chief commercial officer.

Tim Lee: Thank you Mark.

Tim Lee: Turning to slide number 10.

Tim Lee: I joined in Vivid in June of this year because I saw an extraordinary medical need for people who are you know, compromise, the technology platform with potential to serve those in need, and a newly authorized pharmaceutical that could impact millions of lives. Well, much groundwork has been laid by the prior commercial leadership team. The executive experience brought to bear with that of a vaccine commercialization rather than biopharmaceutical and critically infused biologic therapies. My own career across Alex Young, Biohaving, and most recently, Ann Alex, were organizations where we found success working with and fighting for patient communities, which led me to perceive some substantial opportunities in the coming years in Invivid.

Timothy Lee: I joined Invivyd in June of this year because I saw an extraordinary medical need for people who are..., a technology platform with potential to serve those, and a newly authorized pharmaceutical that could impact millions of lives. Will much groundwork have been laid by the prior commercial leaders? Executive experience brought to bear with that of a vaccine commercialization rather than biopharmaceuticals and critically. Fused Biologic Therapy, and my own career across Alexian, Biohaven, and most recently, Amlic, were organizations where we found success working with and fighting for the patient community, which led me to perceive substantial opportunities in the coming years at Invivyd.

Tim Lee: I joined in dividend June this year, because I saw an extraordinary medical need for people, who are immuno compromise the technology platform with potential to serve those in need and a newly authorized pharmaceutical that could impact millions of lives.

Speaker Change: Much groundwork has been laid by the prior commercial leadership team. The executive experience brought to bear was that of a vaccine commercialization rather than biopharmaceutical it critically.

Speaker Change: Hughes biologic therapies by.

Speaker Change: My own career across Alexia on biodiesel and most recently <unk>.

Speaker Change: Organizations, where we found success working with Baidu for patient communities, which led me to perceived substantial opportunities in the coming years at a dividend.

Tim Lee: I've moved quickly to onboard experienced people from my own network who are experts in commercializing therapies, but a high on met medical need, such as Tom Garda. The situation for Invivid today is markedly different than it was at the start of the second quarter. There are several key dynamics that I want to highlight. First, at the time of eway, there was a near-zero awareness of Tom Garda in the clinical community, on which work began immediately and we have been accelerating. Second, among many healthcare providers, there has been a perception that COVID-19 is a seasonal threat to be addressed in the fall.

Timothy Lee: I've moved quickly to onboard experienced people from my own network who are experts in commercializing therapies with a high unmet medical need, such as cumgardine. The situation for Invivyd today is markedly different than it was at the start of the second quarter.

Speaker Change: I've moved quickly to onboard experienced people from my own network, we're experts in commercializing therapies.

Speaker Change: High unmet medical need such as comparator.

Speaker Change: The situation.

Speaker Change: <unk> or inhibit today is markedly different than it was at the start of the second quarter. There are several key dynamics that I want to highlight.

Timothy Lee: There are several key dynamics that I want to highlight. First, at the time of E-way, there was near zero awareness of Tom Garda and the Conoco community, on which work began immediately, and we have been accelerating. Second, among many healthcare providers, there has been a perception that COVID-19 is a seasonal threat to be addressed in the fall. Zyronik, however, given this substantial summer wave that we currently find ourselves in, in his other way.

Speaker Change: First at the time of ebay there was a near zero awareness of <unk> and the clinical community.

Speaker Change: On which work began immediately and we have been accelerating.

Speaker Change: Second among many health care providers, there's been a perception that COVID-19 is a seasonable threat to be addressed in the fall.

Tim Lee: This is ironic given the substantial summer wave that we currently find ourselves in, in this other way. Third, at the eway late March into April, there was quite low ambient COVID-19 in the United States, which of course is usual, has changed quickly. Now what has not changed is the relatively robust interest and additional protection that we observe in the immunocompromised community. Since I joined, I've had the privilege of hearing directly from members of the immunocompromised community. They're very passionate about reclaiming an opportunity to live their lives without fear and risk of adverse outcomes just from normal life starts.

Speaker Change: This is ironic given the substantial summer wave that we currently find ourselves in is underway.

Timothy Lee: Third, at the EUA in late March and April, there was quite low ambient COVID-19 in the United States, which, of course, as usual, has changed quicker. But what has not changed is the relatively robust interest in additional protection that we observe in the immunocompromised community. Since I joined, I've had the privilege of hearing directly from members of the immunocompromised community. They're very passionate about reclaiming an opportunity to live their lives without fear and risk of adverse outcomes just from normal lifestyles. Their need is real. Their motivation is real,

Speaker Change: Third at the EUA in late March into April there was quite low MDA COVID-19 in the United States, which of course as usual has changed quickly.

Speaker Change: That will not change is the relatively robust interest in additional protection that we observed in the immunocompromised community.

Speaker Change: Since I joined I've had the privilege of hearing directly from members of EBIT immuno compromised community, they're very passionate about reclaiming an opportunity to live their lives without fear and risk of adverse outcomes just from normal lifestyles.

Tim Lee: Their need is real; their motivation is real, and we aim to bring an intensity to our work that matches their own. We're preparing a major activation campaign to begin, imminently, to take advantage of the habits of healthcare providers who appear more focused on respiratory disease protection in the fall and the winter time frame. Turn to slide 11. We've refined certain commercial launch metrics that will be reporting on a go-forward basis for clarity and usefulness. You'll see in these numbers a marked acceleration across both the second quarter and coming into the third quarter. As we report, and as you know, 50% of our target population is covered by Medicare and Medicaid, which provides full-time guarded reimbursement with a zero-dollar co-pay.

Speaker Change: <unk> is real.

Timothy Lee: And we aim to bring an intensity to our work that matches their own. We're preparing a major activation campaign to begin imminently to take advantage of the habits of healthcare providers, who appear more focused on respiratory disease protection in the fall and winter. Turn to slide 11.

Speaker Change: Motivation is real and we aim to bring an intensity to our work that matches thereof.

Speaker Change: We're preparing a major activation campaign to begin imminently to take advantage of the habits of health care providers, who appear more focus on respiratory disease protection in the fall and the winter timeframe.

Speaker Change: Turning to slide 11.

Timothy Lee: We've refined certain commercial launch metrics that we'll be reporting on a go-forward basis for clarity and use. You'll see in these numbers a marked acceleration across both the second quarter and coming into the third quarter. As we've reported, and as you know, 50% of our target population is covered by Medicare and Medicaid, which provides full Pemgarta reimbursement with a $0 copay.

Speaker Change: We've refined certain commercial launch metrics that we will be reporting on a go forward basis for clarity and usefulness.

Speaker Change: Youll see in these numbers a marked acceleration across both the second quarter and coming into the third quarter.

Speaker Change: As we reported and as you know 50% of our target population is covered by Medicare and Medicaid, which provides full firm garner reimbursement of a zero dollar copay.

Tim Lee: While we're not in a position yet to calculate total commercial life's covered, we're aware of successful reimbursement from the largest national and regional commercial payers. These payers collectively cover the majority of commercial lives. We expect our efforts to continue this acceleration. Turning to slide 12. Survey work that we saw early in the second quarter attuned in vivid well to some perception by healthcare providers who for amino compromised people, specifically transplant surgeons and hematologists and oncologists. This group are keenly aware of the risks that pose to their populations by COVID-19, and yet in large part regard them mandate to consider protection as seasonal and related to the fallen winter.

Timothy Lee: Well, we're not in a position yet to calculate total commercial life covered. We're aware of successful reimbursement from the largest national and regional commercial players. These pairs collectively cover the majority of commercial life.

Speaker Change: While we're not in a position yet to calculate total commercial lives covered we're aware of successful reimbursement.

Speaker Change: From the largest national and regional commercial Payors.

Speaker Change: These payers collectively cover the majority of commercial lives, we expect our efforts to continue this acceleration.

Timothy Lee: We expect our efforts to continue this acceleration. Turning to side 12 Well, surveyed work that we saw early in the second quarter that tuned Invivyd well to some perceptions by healthcare providers who care for immunocompromised people, specifically transplant surgeons, anti-metrologist, and oncologist. This group is keenly aware of the risks that COVID-19 poses to their populations. And yet, in large part, regard the mandate to consider protection as seasonal and related to the fallen winter.

Speaker Change: Turning to slide 12.

Speaker Change: Survey work that we saw early in the second quarter, attuned and vivid well to some perception by health care providers, who for immuno compromise people specifically transplant surgeons.

Speaker Change: And Hematologists and oncologists.

Speaker Change: This group are keenly aware of the risks that chose to their populations by COVID-19.

Speaker Change: And yet in large part regarding the mandate to consider protection as seasonal and related to the fall and winter.

Tim Lee: We will be engaging actively with these healthcare providers over the coming weeks and months to evolve the thinking on this pervasive, persistent disease that can substantially impact their patient population.

Timothy Lee: We will be engaging actively with these health care providers over the coming weeks and months to evolve the thinking on this pervasive, persistent disease that can substantially impact their patient population. Trojus, slide third. David Hering, David Hering, David Hering, David Hering, In June, the CDC recommended universal COVID-19 boosting for every American over six years of age at the spot. We expect updated vaccines and pharmacies within a week. And if 24 resembles anything like 2023, millions of Americans per week will begin the vaccination process. As Marc alluded earlier in his remarks, boosting is a critical protective strategy.

Speaker Change: We will be engaging actively with these health care providers over the coming weeks and months.

Speaker Change: To evolve the thinking on this per basis.

Speaker Change: Persistent disease that can substantially impact their patient population.

Turning to slide 13.

Tim Lee: In June, the CDC recommended universal COVID-19 boosting for every American over six years of age to spawn. We expect updated vaccines in pharmacies within weeks, and if 24 resembles anything like 2023, millions of Americans per week will begin the vaccination process. As Mark alluded to earlier in his remarks, boosting is a critical protective strategy, but the data on vaccine effectiveness strongly suggests considering additional protection for certain immunocompromised patients. We will look to take advantage of these dynamics.

Speaker Change: In June the CDC recommended Universal COVID-19, boosting for every American over six years of age this fall.

Speaker Change: We expect updated vaccines and pharmacies within weeks.

Speaker Change: And it's 24 resembles anything like 2023 millions of Americans per week, we will begin the vaccination process.

Speaker Change: As Mark alluded earlier in his remarks, boosting as a critical protective strategy.

Timothy Lee: But the data on vaccine effectiveness strongly suggests considering additional protection for certain and immunocompromised patients. We will look to take advantage of these dynamics. Turning slide 14, Presiding Adventurer, We have an opportunity to offer additional protection to people who are moderately to severely and at a high risk for severe COVID-19. The team is building the infrastructure to serve these communities. And our previously stated net revenue guidance represents a conversion of a small percent of all of those who are turning the side fifth [inaudible] over the next few weeks. With the commercial groundwork established in the second quarter, Invivyd will begin commercial messaging in the digital and traditional domains to drive healthcare provider awareness and immunocompromised population awareness.

The data on the vaccine effectiveness strongly suggests considering additional protection for certain immunocompromised patients.

Speaker Change: We will look to take advantage of these dynamics.

Tim Lee: Turning side 14. We have an opportunity to offer additional protection to people who are moderately to severely immunocompromised and at a high risk for severe COVID-19. The team is building the infrastructure to serve these communities, and our previously stated net revenue guidance represents a conversion of a small percentage of all of those who are in need. Turning to slide 15. Over the next few weeks, with the commercial groundwork established over the second quarter, InVivid will begin commercial messaging in the digital and traditional domains to drive healthcare provider awareness and immunocompromised population awareness. We are evaluating carefully every single opportunity to generate awareness in these critical markets and upcoming through the balance of 2024.

Mark Yeah: Turning to slide 14.

Mark Yeah: We have an opportunity to offer additional protection to people who are moderately to severely immunocompromised.

Mark Yeah: And at a high risk for severe COVID-19.

Speaker Change: The team is building the infrastructure to serve these communities.

Speaker Change: And our previously stated net revenue guidance represents a conversion of a small percentage.

Speaker Change: All of those who are in need.

Speaker Change: Turning to slide 15.

Speaker Change: Over the next few weeks with the commercial groundwork established over the second quarter and David will begin commercial messaging and the digital and traditional domains to drive health care provider awareness and immuno compromised population awareness.

Timothy Lee: We are evaluating carefully every single opportunity to generate awareness in these critical markets and upcoming through the balance of 2024. We'll look forward to hearing your feedback on our work. We are not aiming to be subtle. With that, I'd like to turn the call over to my colleague, Mark Wingertzahn, to talk about our pipeline. Mark.

David: We are evaluating carefully every single opportunity to generate awareness in these critical markets and upcoming through the balance of 2024.

Tim Lee: We'll look forward to hearing your feedback on our work. We are not aiming to be subtle.

David: We will look forward to hearing your feedback on our work.

David: We are not aiming to be subtle.

Mark Wingertzahn: With that, I'd like to turn the call over to my colleague, Mark Wingerson, to talk about our pipeline. Thank you, Tim. Turning to slide 17. As you know, we've identified VYD-2311 to be an affinity maturation of the mid-part against the XBB lineage, lineage viruses in an effort to improve on the biophysical properties, including the in vitro-measured potency of the mid-part. As you all may realize, if all other variables are equal, potency improvements in measured IC-50s for an antibody can translate directly to lower doses that are required to achieve meaningful levels of SV&A tighter. The pharmacodynamic variable that drives protection and efficacy for a COVID-19 antibody.

David: With that I'd like to turn the call over to my colleague Mark Lingers on to talk about our pipeline.

Mark Wingertzahn: Thank you, Tim. Turning to slide 17. As you know, we've identified VYD2311 via affinity maturation of the midpart against the XBB lineage viruses in an effort to improve on the biophysical properties, including the in vitro measure of Potency of Convinced Parts. As you may realize, if all other variables are equal, potency improvements in measured IC50s for an antibody can translate directly to lower doses that are required to achieve meaningful levels of SVNA These lower doses may, in turn, allow for the development of routes of administration that are more patient and system-friendly than intravenous approaches.

Mark Lingers: Thank you Tim turning to slide 17.

Mark Lingers: As you know we've identified <unk> via a minute affinity maturation of Midland Park against the STB lineage viruses in an effort to improve on the biophysical properties, including the in vitro measure potency of <unk>.

Mark Lingers: As you all may realize.

Speaker Change: All other variables are equal potency improvements and measured IC <unk> for an antibody can translate directly to lower doses that are required to achieve meaningful levels of SG&A tighter.

Speaker Change: America dynamic variable that drives protection and efficacy for a COVID-19 antibody. These.

Mark Wingertzahn: These lower doses may in turn allow for the development of routes of administration that are more patient- and system-friendly than the intravenous approach. Timing this slide 18, we are pleased to have Australian ethics approval for a first in human study with BYD 2311, with a dosing plan to begin at the end of August. This study plans to interrogate intravenous, intramuscular, and, depending upon titers achieved, subcutaneous dosing. We felt strongly that interrogating multiple routes of administration could provide flexibility and optionality for achievement titers from one antibody that could be suitable for both COVID-19 prevention and treatment if authorized.

Speaker Change: Lower doses may in turn allow for the development of routes of administration.

Speaker Change: There are more patient and system friendly and intravenous approaches.

Mark Wingertzahn: Turning to slide 18, we are pleased to have Australian ethics approval for a first in human study with BYD 2311, with those in plan to begin at the end of August. This study plans to investigate intravenous, intramuscular, and, depending upon titers achieved, subcutaneous doses. We felt strongly that interrogating multiple routes of administration could provide flexibility and optionality for achieving titers from one antibody that could be suitable for both COVID-19 prevention and treatment, if authorized.

Speaker Change: Turning to slide 18, we are pleased to have Australia and ethics approval for our first in human study with BYD 231 months with dosing planned to begin at the end of August.

Speaker Change: This study plans to interrogate intravenous intramuscular and depending upon titers achieve subcutaneous dosing, we felt strongly that interrogating multiple routes of administration could provide flexibility and optionality for achieving titers from one antibodies that could be suitable for both COVID-19 prevention and treatment.

Speaker Change: If authorized.

Mark Wingertzahn: Turning this slide 19, the BYD 2311 product profile will ultimately be determined by the observed safety across doses and administration routes, the in vitro closeness you measured by EC50 against relevant viruses, the in vivo pharmacokinetic and half-life profile demonstrated by BYD 2311 in our early human testing, and, of course, dialogue with relevant regulatory agencies. However, we can envision evolution of the field from an infused therapy to any number of permutations, including alloting intravenous dose, followed by a lower dose tighter maintenance, to perhaps elimination of intravenous delivery altogether.

Mark Wingertzahn: Turning to slide 19. The VYD-2311 product profile will ultimately be determined by the observed safety across doses and administration routes, the in vitro closeness you measured by EC50 against relevant viruses, the in vivo pharmacokinetic and half-life profile demonstrated by VYD-2311 and our early human testing, and, of course, dialogue with relevant regulatory authorities. However, we can envision evolution of the field from an infused therapy to any number of permutations, including a loading intravenous dose, followed by a lower dose titer maintenance to perhaps elimination of intravenous delivery altogether.

Speaker Change: Turning to slide 19.

Speaker Change: The <unk> 311 product profile will ultimately be determined by the observed safety across doses and administration routes. The in vitro potency measured by EC 50 against relevant viruses the in vivo pharmacokinetic and half life profile demonstrated by BYD 2311, and our early human testing.

Speaker Change: <unk> dialogue with relevant regulatory agencies. However.

Speaker Change: However, we can envision evolution of the field from an infused therapy to any number of permutations, including loading intravenous dose followed by a lower dose tighter maintenance to perhaps elimination of intravenous delivery altogether.

Mark Wingertzahn: We look forward to updating you on our progress as we move through the fall.

Mark Wingertzahn: We look forward to updating you on our progress as we move through the fall. With that, I'd like to turn the call over to our Chief Scientific Officer, Robbie Allen, to discuss the ongoing emerging biology in our field.

Robbie Allen: Look forward to updating you on our progress as we move through the fall with that I'd like to turn the call over to our Chief Scientific Officer, Robbie Allen to discuss the ongoing emerging barology in our field Ravi. Thank.

Robert Allen: With that, I'd like to turn the call over to our Chief Scientific Officer, Robbie Allen, to discuss the ongoing emerging virology in our field. Robbie. Thank you more. Turning to slide 21. Given investor interest in these topics, we thought we would quickly visit some of how we view the surrogate marker of SVNA titers that describes possible clinical performance of our molecules and then provide an update with a view on next steps. First, we call that a key consideration in the FDA's thinking on COVID antibodies has been the concept of immuno-gridding, which is a form of bio-equivalence analysis.

Robert Allen: Turning to slide 21, given an investor's interest in these topics, we thought we would quickly discuss some of how we view the surrogate marker of SVNA titers that describes the possible clinical performance of our molecules and then provide an update with a view on next steps. Recall that a key consideration in the FDA's thinking on COVID antibodies has been the concept of immunobridging, which is a form of bioequivalence analysis.

Robbie Allen: Thank you Mark.

Robbie Allen: Turning to slide 'twenty, one given investor interest in these topics. We thought we would quickly visit some of how we view the surrogate marker of SB MMA fighters that describes the possible clinical performance of.

Robbie Allen: Of our molecules and then provide an update with a view on next steps first recall that a key consideration in the fda's thinking on Covid antibodies has been the concept of immuno bridging which is a form of bioequivalence analysis.

Robert Allen: These analytics use point estimates from antibody neutralization and potent ZSAs that have marked intrinsic variability, including several full differences with suit virus assays, and up to 10 full differences with authentic virus assays. This variability, while not contemplated directly in an immunogridging analysis in the form of a range, isn't addressed directly by the FDA on the pin-guard effect sheet type, where you can see the wide range of potential bridging values like between pin-guard and at a treble map, depending on acid, from 0.82 to 0.35, according to slide 22. Single SVNA tighter point estimates can of course become obsolete quickly by virus evolution and associated evolution in estimated DC50 values from these assays.

Robert Allen: He's analytics used point estimates from antibody neutralization potency assays that had marked intrinsic variability, including several full differences with suit virus assays and up to 10 full differences with authentic virus assays. This variability, while not contemplated directly in an immunobridging analysis in the form of a range, is addressed directly by the FDA on the PEMGARTA fact sheet, where you can see the wide range of potential bridging values between PEMGARTA and trebromab, depending on asset, from 0.82 to 0.35. Turning to slide 22.

Speaker Change: Analytics use point estimates from antibody neutralization potency assays that have marked intrinsic variability, including several bolt differences with sort of virus assays and <unk>.

Speaker Change: Up to tenfold differences with authentic Barbara assays.

Speaker Change: This variability Walmart contemplated directly in immuno bridging analysis in the form of a range is addressed directly by the FDA on the Pilbara Factsheet, where you can see the wide range of potential bridging values, but between BARDA and <unk>.

Speaker Change: Mab, depending on asset from 0.820 0.35.

Speaker Change: Turning to slide 22.

Robert Allen: [inaudible] Single SVNA, tighter point estimates, can of course become obsolete quickly by virus evolution and associated evolution in estimated DC-50 values from these assets. Even more complex, before Omicron, there was a great propensity for Single Sweeping Viral Lineage as opposed to the rapidly shifting variant soup we have seen since the Omicron saltation event.

Speaker Change: Single SBA tighter point estimates can of course.

Speaker Change: <unk> also we quickly by virus evolution and associated evolution and estimated DC 50 value from these assets, even more complex or <unk>. There was a great propensity for single sweeping borrow women ages as opposed to the rapidly shifting very soon we have seen since the <unk>.

Robert Allen: Even more complex before Omicron, there was a great propensity for single sweeping viral lineages. As opposed to the rapidly shifting variant suit, we have seen since the Omicron saltation event.

Robert Allen: We therefore became interested in moving from a conception of antibody potency that indexes to one virus, to a conception that reflects an ongoing weighted average DC50 calculation. This type of analysis might yield a more complete and useful portrait of overall activity, although, of course, these analytics are limited by the disparity in underlying assay systems that intrudes into all analyses of this sort. Turning to slide 23. In furtherance of our serial monoclonal antibody approach to COVID-19, we have analyzed public suit of our old data to evaluate weighted average EC50s and reflected that analysis against observed regulatory actions of authorization and revocation of authorization.

Speaker Change: Patient events.

Robert Allen: We therefore became interested in moving from a conception of antibody potency that indexes to one virus to a conception that reflects an ongoing weighted average EC50 calculation. This type of analysis might yield a more complete and useful portrait of overall activity, although, of course, these analyses are limited by the disparity in underlying assay systems that intrudes into all analyses of this sort. Turning to slide 23. In furtherance of our serial monoclonal antibody approach to COVID-19, we have analyzed published pseudoviral data to evaluate weighted average EC50s and reflected that analysis against observed regulatory actions of authorization and revocation of authorization. In this example, you can see EvaShell depicted in its weighted average potency over time and associated deauthorization.

Unknown Executive: Good day and welcome to the second quarter in Vivian Erning's conference call. At this time, all participants are listening mode. After the speaker's presentation, there'll be a question and an intercession. Instructions will be given at that time. As a reminder, the call may be recorded.

Speaker Change: We therefore became interested in moving from a conception of antibody potency that indexes to one virus through a conception that reflects an ongoing weighted average EC 50 calculation.

This type of analysis might yield a more complete and useful portrait of overall activity.

Katie Falzone: I'd now like to turn the call over to Katie Falzone, Vice President Corporate Controller. Please go ahead. Thank you operator.

Speaker Change: Although of course these analytics are limited by the disparity in underlying assay systems have intrudes into all analyses of the sort.

Katie Falzone: A short while ago, we issued a press release announcing our Q2 2024 financial results and[inaudible] Today's discussion will be led by Mark Elia, Chairperson of the Invivid Board of Directors and Chairperson of the Executive Committee of the Board. He is joined by Tim Lee, Chief Commercial Officer, Phil Duke, Chief Financial Officer, Dr. Robert Allen, Chief Scientific Officer, and Dr. Mark Wingertzahn, Senior Vice President of Clinical Development and Medical Affairs. During today's discussion, we will be making forward-looking statements concerning, among other things, our corporate and commercial strategies, our research and development activities, our pipeline and regulatory plans, certain financial guidance, our future prospects, and other statements that are not historical facts.

Speaker Change: Turning to slide 23.

Speaker Change: In furtherance of our cereal monoclonal antibody approach to COVID-19.

Speaker Change: We have analyzed published survival data to evaluate weighted average the secret to us.

Speaker Change: Reflected that analysis against the observed regulatory actions of authorization and relocation of authorization and this example, you can see ever shell depicted in its way.

Robert Allen: In this example, you can see Evan Schell depicted in its weighted average potency over time and associated deauthorization. Turning to slide 24. To provide further insight to pass regulatory actions of authorization and revocation of authorization, we extended this analysis across historic antibodies authorized for both treatment and prevention. Turning to slide 25. When we extend the analysis to PomevoBARC and BYD-2311, a compelling portrait emerges. Over the time since the selection of V1222, dozens of virus lineages have emerged, becoming critically meaningful, and then have been outcompeted. This evolution continues to this day. PomevoBARC weighted average values fluctuate without substantial attributable change.

Speaker Change: Average potency overtime and associated with the authorization.

Robert Allen: Turning to slide 24, to provide further insight into past regulatory actions of authorization and revocation of authorization, we extended this analysis across historic antibodies authorized for both treatment and prevention. Bernie Joslade, 25 Goodbye.

Speaker Change: Turning to slide 24.

Speaker Change: To provide further insight to past regulatory actions of authorization and relocation of authorization we.

Katie Falzone: These forward-looking statements are covered within the meaning of the private security litigation reform act and our subject to various risks, assumptions and uncertainties that may change over time and then cause our actual growth to differ materially from those expressed or implied today. These forward-looking statements seek only as-of-the-date of this call and investigate if there was no duty to update such statements, additional information on the risk factors that could affect our business can be found in our finals made to the U.S.

Speaker Change: We extended this analysis across historic antibodies authorized for both treatment and prevention.

Speaker Change: Turning to slide 25.

Robert Allen: When we extend the analysis to Pemeval Bark and BYD 2311, a compelling portrait emerges. Over the time since the selection of BYD222, dozens of virus lineages have emerged, become clinically meaningful, and then have been outcompeted. This evolution continues to this day. In Memabart, weighted average values fluctuate without substantial change. This lack of medical change could be predicted by the structural biology of a conserved epitome but challenged by the inherent variability of the assing systems that define these data.

Speaker Change: When we extended the analysis <unk> and BYD 2311 compelling portrait emergence.

Speaker Change: Over the time since the selection of B went into Q2.

Speaker Change: A virus. So let me just have emerged becoming clinically meaningful and then have been our competed.

Speaker Change: This evolution continues to this day I remember Bart weighted average values fluctuate without substantial appreciable change.

Robert Allen: This lack of meaningful change could be predicted by the structural biology of a conservative epitope, but challenged by the inherent variability of the assay systems that define these data.

Speaker Change: This lack of vehicle change could be predicted by the structural biology of a conserved epitopes.

Speaker Change: But challenged by the inherent variability of the assay systems that define these data.

Katie Falzone: Security and the Exchange Commission, including our most recent form 10Q, which is also available on our website.

Robert Allen: Turning our attention to our pipeline, although it is difficult to see on this chart, do its significant potency improvement and lack of meaningful change. BYD-2311 has demonstrated early signs of potential improved potency with improved and stable IC50 values. In Vivid has built its platform to keep up with the inevitability of virus evolution. However, there are general principles around the conservation of epitopes we aim to take advantage of in order to increase the resistance of our antibodies to the effects of virus evolution. We will never be perfect, and by design we hope to innovate under the track of speed.

Robert Allen: Turning our attention to our pipeline, although it is difficult to see on this chart due to its significant potency improvement and lack of meaningful change, BYD2311 has demonstrated early signs of potential improved potency with improved and stable IC50 values. Invivyd has built its platform to keep up with the inevitability of virus evolution. However, there are general principles around the conservation of epitopes we aim to take advantage of in order to increase the resistance of our antibodies to the effects of virus evolution.

Speaker Change: Turning our attention to our pipeline, although it is difficult to see on this chart do is significant potency improvement and lack of meaningful change.

Mark Elia: I will now turn it over to Mark.

Mark Elia: Good morning. Thank you all for joining us. Turning to slide four in the deck you can find on our website, the second quarter of 2024 began with leadership transition at Invitable. Our goal for transition was and remains to expand the scope of our corporate ambition and to improve our ability to deliver major medical value for vulnerable populations at substantial risk from respiratory viruses, especially COVID-19. We immediately began several initiatives, including some not yet visible to improve our operational posture and efficiency and to broaden the scope of our strategic aims.

Speaker Change: <unk> hundred 311 has demonstrated early signs of potential improved potency with improved and stable IC 50 values.

Speaker Change: <unk> has built this platform to keep up with the inevitability of virus evolution. However, there are general principles around the conservation of Epitopes, we aimed to take advantage of in order to increase the resistance of our antibodies to the effects of virus evolution.

Mark Elia: This morning, we're sharing our second quarter results in a broader business update. By way of executive summary, we are pleased with our rapidly expanding commercial footprint and our pipeline advancement. While we are not satisfied with our early net revenue results, we saw consistent growth against across the second quarter and we are seeing acceleration early in 3Q. And we are leaning forward and eager to deliver as we come into our major commercial moment for 2024, the fall winter respiratory virus season.

Robert Allen: We will never be perfect, and by design, we hope to innovate at an attractive speed. Data such as these that accompany our structural biological insights and the power of our discovery platform will aid in this endeavor. Turning to slide 26.

Speaker Change: We will never be perfect and by design, we hope to innovate with attractive speeds with data such as these that accompany our structural biological insights and the power of our discovery platform will aid in this endeavor.

Robert Allen: The data such as these that accompany our structural biological insights and the power of our discovery platform will aid in this endeavour. Turning to slide 26. Another challenge in applied biology with rapidly evolving viruses relates to the ability to secure reliable, high-quality academic or commercial partners that can handle authentic SARS-CoV-2 virus in an appropriate BSL-3 laboratory setting and perform timely and accurate neutralization analyses for us. Recently, one of our partners, a commercial provider of such services, discovered a potential contamination event in their virus stocks, which in turn has rendered the JN.1 authentic virus value it had generated a questionable reliability.

Speaker Change: Turning to slide 26.

Robert Allen: Another challenge in applied virology, with rapidly evolving viruses, relates to the ability of Joel Brennan, Eric Greenfield, James Smith, John Singles, and Marc Ericughsohn. Discovered a potential contamination event in their virus stocks, which in turn has rendered the JN.1 authentic virus value it had generated of questionable reliability. Reassuringly, this authentic virus as a folksy value against JN.1 is very similar to the independently generated two virus folksy value estimated per per member bar against JN.1.

Speaker Change: Another challenge in applied virology with rapidly evolving viruses relates to the ability to secure reliable high quality academic or commercial partners that can handle a metrics our shelby two borrowers and an appropriate BSL three laboratory setting it performed timely and accurate neutralization of analyses for us recently.

Mark Elia: Over the next month, starting in September, millions of Americans are likely to consider together with HCPs, vaccine boosts for COVID-19 disease, we aim to remind certain immunocompromised people and their care teams that more is available. For those immunocompromised persons who have been hopeful to access Pemgarda but have been frustrated by slow motion in the broad medical establishment, we are working with the utmost urgency to educate relevant stakeholders on the risks posed by COVID-19 and the option for protection presented by antibody prophylaxis and Pemgarda specifics.

Speaker Change: One of our partners, our commercial provider of such services discovered potential contamination event, and thereby our stocks, which in turn has rendered the J about one authentic virus.

Speaker Change: Generation of questionable reliability.

Robert Allen: Reassuringly, this authentic virus has a potency value against JN.1 that is very similar to the independently generated suitivirus potency value estimated for permeable part against JN.1. The FDA and in vivid have been in dialogue on this matter for several weeks, and among other next steps in vivid will reassess promote our activity versus authentic JN.1 virus in a series of labs to determine a reliable number. Potentially also informative on the matter of JN.1 and the clinical meaning of SVNA titers generally is our preliminary analysis of the second half of the canopy study, which happened to occur during a time of JN.1 dominance in the United States in the winter of 2024.

Speaker Change: Reassuringly this authentic virus ASIC potency value against <unk>. One is very similar to the independently generated sort of iris potency value estimated for chemical Bart against Chegg at about one <unk>.

Robert Allen: The FDA and Invivid have been in dialogue on this matter for about several weeks, and among other next steps, Invivyd will reassess PrimoVar activity versus authentic J.1 virus in a series of labs to determine a reliable number. Potentially also informative on the matter of JNDOT1 and the clinical meaning of SVNA titers generally is our preliminary analysis of the second half of the canopy study, which happened to occur during a time of JN-DOT1 dominance in the United States in the winter of 2024.

Speaker Change: The FDA ended David have been in dialogue on this matter a pronounced several weeks.

Mark Elia: We are pleased to be advancing our pipeline molecule, VYD 2311, which we see as having a profile that could potentially expand this field of medicine. Improved molecules, combined with emerging data from contemporary antibody-profil axis studies, such as our canopy clinical trial and our competitor AstraZeneca supernova study, may evolve this fast emerging field of medicine. After all, these two studies are the first COVID-19 antibody-profil axis studies that were conducted in humans with prior immunologic experience from vaccination or infection.

Speaker Change: And among other next steps the debit will reassess for most of our activity versus Patrick J about one virus and a series of labs to determine a reliable number.

Speaker Change: Potentially also informative all the matter of getting about one and a clinical meeting of SG&A titers generally.

Speaker Change: Preliminary analysis of the second half of the chemical study, which happened to occur during a time of <unk> dominance in the United States in the winter of 2024.

Robert Allen: The FDA is also in receipt of these preliminary exploratory data. As Mark noted, we look forward to sharing these data soon when finalized and prepared for presentation.

Robert Allen: The FDA is also in receipt of these preliminary exploratory data. As Marc noted, we look forward to sharing these data soon when they are finalized and prepared for presentation. Overall, our goal as a company is to improve the usefulness, accuracy, and informativeness of virology data for all key signals. However, while these cellular bioassays are of clear interest and importance, they also have clear limitations that must be acknowledged by those of us in the business of making medicines to protect the vulnerable and treat diseases.

Speaker Change: The FDA has also and receipt of these preliminary exploratory data as Mark noted.

Mark Elia: We will look forward to sharing additional canopy data with all of you soon. Turning to slide five. As a preview of our evolving corporate posture, we are quickly today sharing images such as this one from an updated corporate presentation that will be available soon. Many HCPs and indeed Americans overall are not aware of the magnitude of medical burden to Americans presented by endemic COVID-19 and less away the ongoing are peaking, especially the burden on the immunocompromised.

Mark: We look forward to sharing these data assume when finalized and prepared for presentation.

Robert Allen: Overall, our goal as a company is to improve the usefulness, accuracy, and informativeness of virology data to all key stakeholders. While these cellular bioassays are of clear interest and importance, they also have clear limitations that must be acknowledged by those of us in the business of making medicines to protect the vulnerable and treat diseases. We are and for now years have been a constant dialogue with the FDA and see many opportunities to improve our collective acumen on this topic, especially when we can all see contemporary clinical data from, for example, can be and Supernova.

Mark: Overall, our goal as a company is to improve the usefulness accuracy and informative inform us.

Mark: Performance weakness of virology data to all key stakeholders.

Mark: While these cellular bio assays are a clear interest in accordance.

Mark: Also have clear limitations that must be acknowledged by both of us in the business of making medicines to protect the vulnerable and treat diseases.

Mark Elia: Invivyd aims to provide clear thought leadership to the community on these critical facts of the matter. Moving to slide six, it should be clear by now to most, if not all, that SARS-CoV-2, while transmitted via aerosols like other respiratory diseases, is a multi-system virus capable of inflicting long-term damage to almost every key organ system.

Robert Allen: We are, and for years now, in constant dialogue with the FDA and see many opportunities to improve our collective acumen on this topic, especially when we can all see contemporary clinical data from, for example, Canopy and Supervisor. I'd like to turn the call over to our CFO, Bill Duke, for final remarks prior to Q&A. Thanks, Robbie.

Speaker Change: We are in for now years have been in constant dialogue with the FDA and see many opportunities to improve our collective acumen on those topics, especially when we can all see contemporary clinical data from for example can become Super Gorilla.

Phil Duke: I'd like to turn the call over to our CFO, Duke, for final remarks prior to Q&A. Thanks Robbie, moving to slide 28. Right now, Invisited is at an exciting moment in our history. We are looking forward to rapid expansion of our commercial activities and are pleased to reaffirm the revenue and cash guidance provided previously. As we move through the fall, we will be in position to refine that guidance. But for now, we remain comfortable with the boundaries within it. In addition, although Invisited is a fully integrated biopharmaceutical company, we have been streamlining our operations over the last quarter and are starting to see the benefits of that work.

Mark Elia: It will never go away or magically get miles and we must face that fact head on. Moving to slide seven. Immunocompromised people may turn to vaccine boosts as their first line of defense and indeed have a recommendation from the CDC as of March 2024 to boost quote no more than every two months on quote or six times a year. Why might we wish to add more protection on top of boosting? The latest data presented by FDA to the advisory committee on immunization practices or ACIP on June 28th of this year estimated vaccine efficacy or VE over the past 2023-24 season.

Speaker Change: I'd like to turn the call over to our CFO Bill.

Bill: Your final remarks prior to Q&A.

William Duke: Moving to slide 28. Right now, Invisited is at an exciting moment in our history. We are looking forward to the rapid expansion of our commercial activities and our pleas to reaffirm the revenue and cash guidance provided previously. As we move through the fall, we will be in a position to refine that game. But for now, we remain comfortable with the boundaries within it. In addition, although Invivyd is a fully integrated biopharmaceutical company, we have been streamlining our operations over the last quarter and are starting to see the benefits of that work.

Thanks, Robby moving to slide 28, right now and visit us at an exciting moment in our history.

We're looking forward to rapid expansion of our commercial activities and are pleased to reaffirm the revenue and cash guidance provided previously.

Bill: As we move through the fall, we will be in position to refine that guidance, but for now we remain comfortable with the boundaries within it.

Bill: In addition, although <unk> is a fully integrated biopharmaceutical company, we've been streamlining our operations over the last quarter and are starting to see the benefits of that work.

Mark Elia: The only VE estimate that broke out vaccine performance with immunocompromised persons specifically showed a relatively dismal 38% reduction in the risk of hospitalization compared to doing nothing which as you can see is a benefit that waned quickly after 60 days. While vaccines saved millions of lives when people had no prior immune experience against SARS-CoV-2 in our endemic virus world we may have to do more. It should be no surprise that Pemgarter was granted an emergency use authorization by the FDA even as population level immune experience has blunted the emergency from many Americans.

William Duke: Of note, our burn rate includes the majority of expenses associated with the production of significant quantities of our next model, molecule, VYD2311. At this point, we have contracted to produce approximately 130,000 doses of Pemgarada. After exhausting that supply, we tend to transition rapidly to VYD2311, which may afford greater efficiency in lower COGS compared to PEMGARTA, depending upon the clinical product profile we see.

Phil Duke: Of note, our burn rate includes the majority of expenses associated with production of significant quantities of our next model, molecule, VYD2311. At this point, we have contracted to produce approximately 130,000 doses of Pemgarida. After exhausting that supply, we tend to transition rapidly to VYD2311, which may afford greater efficiency in lower clogs compared to Pemgarida, depending upon the clinical product profile we see. Our favorite source of incremental capital to strengthen our balance sheet remains product sales in operating contribution. Nonetheless, we are in discussions with multiple potential sources of non-dilutive and dilutive equity capital. Should we assess a benefit associated with raising money?

Bill: Note.

Bill: Our burn rate includes the majority of expenses associated with production of significant quantities of our next model.

Speaker Change: Collocutor BYD 2311 at this point, we are contracted to produce approximately 130000 doses.

Speaker Change: Got it after exhausting that supply.

Speaker Change: <unk> transitioned rapidly to be 12311, which may afford.

Speaker Change: Greater efficiency and lower Cogs compared to <unk>, depending upon the clinical product profile, we see.

Mark Elia: Moving to slide eight. In short, in vivid exist to make medicines that can confer protective antibody titers. Most of us learned about COVID antibodies during the pandemic in a treatment context, but in vivid we see an even more valuable use case for the category today. We know well the world that is possible today related to COVID-19 disease when our protective options are limited by the immune protection that comes from vaccination booster update or prior infection experience. In vivid exist to try to add protection to our antibodies that can keep people both alive and well.

William Duke: Our favorite source of incremental capital to strengthen our balance sheet remains product sales and operating contributions. Nonetheless, we are in discussions with multiple potential sources of non-dilutive and delutive equity capital. Should we assess the benefit associated with raising money?

Speaker Change: Our favorite source of incremental capital to strengthen our balance sheet remains product sales and operating contribution.

Speaker Change: Nonetheless, we are in discussions with multiple potential sources of non dilutive and dilutive equity capital should we assess a benefit associated with raising money.

Phil Duke: Mainly, however, we are looking forward to the upcoming commercial push in the fall with winter respiratory virus season.

William Duke: Mainly, however, we are looking forward to the upcoming commercial push in the fall with the winter respiratory virus season. I'll now turn the call over to the operator to open it up for questions. Operator, can you please open the line for questions? Well, if you'll all give us a moment, we know there are questions in the queue, so we'll work on repairing whatever's going wrong. Okay, well, we're going to try doing this ourselves, and the results should be fascinating. Evan Wang, are you on the line at this point with us for a question? Apparently not. Can you guys hear me? Hello,

Speaker Change: Mainly however, we are looking forward to the upcoming commercial push in the fall winter respiratory by our season.

Operator: I'll now turn the call over to the operator to open for this question. Operator? Operator, please open for questions. Well, if you'll all give us a moment, we know there are questions in the queue. So we'll work on repairing whatever is going wrong.

Speaker Change: I'll now turn the call over to the operator to open for <unk>.

Speaker Change: Questions.

Timothy Lee: I'll now turn the call over to Tim Lee, our new chief commercial officer. Thank you, Mark. Turning to slide number 10.

Speaker Change: Okay.

Timothy Lee: I joined in vivid in June of this year because I saw an extraordinary medical need for people who are You know, compromise, the technology platform with potential to serve those in need, and a newly authorized pharmaceutical that could impact millions of lives. Well, much groundwork have been laid by the prior commercial leadership team. The executive experience brought to bear with that of a vaccine commercialization rather than biopharmaceutical and critically infused biologic therapies.

Speaker Change: Operator.

Speaker Change: Operator can you please open for questions.

Timothy Lee: My own career across Alex Young, biohaving, and most recently, Ann Alex, were organizations where we found success working with and fighting for patient communities, which led me to perceive some substantial opportunities in the coming years in Invivid. I've moved quickly to onboard experience people from my own network who are experts in commercializing therapies, but a high on met medical need, such as Tom Garda. The situation for Invivid today is markedly different than it was at the start of the second quarter. There are several key dynamics that I want to highlight.

Speaker Change: Well, if youll give us some moment, we know there are questions in the queue. So we'll work on repair and whatever's going wrong.

Speaker Change: Great.

Speaker Change: Yes.

Speaker Change: Okay.

Right.

Speaker Change: Okay.

Operator: Okay, well, we're going to try doing this ourselves, and the results should be fascinating.

Speaker Change: Okay.

Speaker Change: Okay, well, we're going to try doing this ourselves and the results should be fascinating Evan Wang are you on the line at this point with us for a question.

Maxwell Skor: Evan Wang, are you on the line at this point with us for a question? Can you guys hear me? Hello? No, we can hear you. Okay. Okay, you can hear me. Okay, great. Yeah. Thanks, guys. Good to see all the progress.

Timothy Lee: First, at the time of eway, there was a near zero awareness of Tom Garda in the clinical community, on which work began immediately and we have been accelerating. Second, among many healthcare providers, there has been a perception that COVID-19 is a seasonal threat to be addressed in the fall. This is ironic given the substantial summer wave that we currently find ourselves in in this other way. Third, at the eway late March into April, there was quite low ambient COVID-19 in the United States, which of course is usual, has changed quickly. Now what has not changed is the relatively robust interest and additional protection that we observe in the immunocompromised community.

Operator: Now we can hear you. Okay. Okay, can you hear me?

Evan Wang: Currently not.

Evan Wang: Can you guys hear me Hello, we can hear you okay.

Operator: Okay, great. Yeah, Thanks, guys. A great deal of progress. You know, I guess, just first off, you know, with Tim, we'd love to hear, you know, now that you're two months in, you shared some of the work you've been putting in. But I guess, you know, Can you share a little bit more on your perspective on, I guess, what's needed to build off my success in terms of, I guess, what you like about existing, what kind of changes you made, and what's kind of remaining, and what's the goal ahead of some of these fall immunizations? Thank you very much; I'll see you next time.

Evan Wang: Okay can you hear me okay great.

Speaker Change: Yeah, Thanks, guys great deal of progress.

Tim Lee: You know, I guess just two or three to me, I guess just first off, you know, with Tim, you know, with both of you here, you know, I guess now you're two months in. You shared some of the work you've been putting in. But I guess, you know, some can you share a little bit more on your perspective? I guess, you know, what's needed to build off my success in terms of, I guess, what would you like existing? What kind of cases do you make? And, you know, what's kind of remaining? And what's the goal ahead of some of this fall, immunization season?

Speaker Change: Yes.

Tubular to me I guess, just first off Tim what bucket here.

Speaker Change: You shared some of the work you've been putting in.

Speaker Change: But I guess.

Speaker Change: So can you share a little bit more on your perspective on I guess.

Speaker Change: What can you still talk about success in terms of I guess, what did you like existing.

Speaker Change: What kind of cadence that you're making.

Speaker Change: Kind of remaining in the goal ahead of some of this fall immunization season.

Timothy Lee: Since I joined, I've had the privilege of hearing directly from members of the immunocompromised community. They're very passionate about reclaiming an opportunity to live their lives without fear and risk of adverse outcomes just from normal life starts. Their need is real, their motivation is real, and we aim to bring an intensity to our work that matches their own. We're preparing a major activation campaign to begin, imminently, to take advantage of the habits of healthcare providers who appear more focused on respiratory disease protection in the fall and the winter time frame.

Timothy Lee: And then can you describe, you know, some of what you're seeing in terms of the summer wave and how, I think there's some commentary on, you know, the acceleration of commercial results in early 3Q and what we're seeing there. Thanks. Yeah, thank you. Happy to.

Tim Lee: And then can you describe, you know, some of what you're seeing in terms of the summer wave? And I think there's some commentary on, you know, the acceleration of commercial results in early Q3. Well, we're seeing there. Thanks. Yeah, and thank you.

Speaker Change: And then can you describe some of what youre seeing in terms of the summer wave.

Speaker Change: And how I think there was some commentary on acceleration of commercial results in Q.

What we're seeing there thanks.

Timothy Lee: You know, I think if I look back over the last two months, one of the comments that we made was around how we're, we're rapidly starting to commercialize an infused biologic, which is just different than, you know, the vaccine world. One of those things we're doing is I really brought on a seasoned team and am excited to let them a little bit loose on the market and help us go deep, deep here. You know, we look at things through an immediate lens, what we can do right away. As we looked at it, there was not much digital work that had happened.

Tim Lee: Happy to, you know, I think if I look back over the last two months, you know, one of the comments that we made was around how we're rapidly starting to commercialize towards an infused biologic, which is just different than the vaccine world. So, one of those things we're doing is I really brought on a season team and excited to let them a little bit loose on the market and helping to go deep, deep here. You know, we look at, we're looking at things through an immediate lens, what we can do right away. As we looked at it, there was not much digital work that had happened.

Yes. Thank you you have to get.

Speaker Change: I think as I look back over the last two months.

Speaker Change: One of the comments that we made was around how we're rapidly starting to commercialize.

Speaker Change: Towards an infused biologic, which is just different than the vaccine world at one of those things where we're doing is really brought on a seasoned team and excited to let them a little bit loose on the market and helping to go deep deep here.

Timothy Lee: Turn to slide 11. We've refined certain commercial launch metrics that will be reporting on a go-forward basis for clarity and usefulness. You'll see in these numbers a marked acceleration across both the second quarter and coming into the third quarter. As we report, and as you know, 50% of our target population is covered by Medicare and Medicaid, which provides full-time-guarded reimbursement with a zero-dollar co-pay. While we're not in a position yet to calculate total commercial life's covered, we're aware of successful reimbursement from the largest national and regional commercial payers. These payers collectively cover the majority of commercial lives. We expect our efforts to continue this acceleration. Turning to slide 12.

Speaker Change: We look at we're looking at things through an immediate lens, what we can do right away as.

Timothy Lee: We've begun beginning digital work already and will continue to pull that through. We look to increase corporate campaign work. And, you know, doing just simple things like updating our Pungarda infusion locator rapidly with the latest sites that are available. You know, I think what we're seeing is that, you know, there are over, I think we've said this before, over 200 sites right now around the country and more who are rapidly coming on board. With that, there's a level of effort and work that has to be applied towards it.

Speaker Change: As we looked at it there was not much digital work that has happened.

Tim Lee: We've started beginning digital work already. Continue to pull that through. We look to increase corporate campaign work and, you know, doing just simple things like update in our, I'm going to infusion locator rapidly with the latest sites that are available. You know, I think what we're seeing is that, you know, there are over 10, we said this before, over 200 sites right now around the country and more who are rapidly coming on board. With that, there's a level of effort and work that has to be applied towards those. And that infrastructure bill is what we've been focused on.

Speaker Change: We started beginning digital work already continue to pull that through we look to increase corporate camp.

Speaker Change: <unk> paid work.

Speaker Change: And doing just simple things like updating our regard to infusion located rapidly with the latest sites that are available I think what we're seeing is that there are over I think we've said this before over 200 sites right now around the country and more who are rapidly coming on board with that there is a level of <unk>.

Timothy Lee: And that infrastructure build is what we've been focused on. And it's, and it's where we're going. I think your question about the summer wave is interesting because, you know, it's something that as you, as we start to talk to people, it's probably something that people didn't want to talk about. But I don't know if it's the algorithms that have figured out my internet history.

Speaker Change: And work that has to be applied towards those.

Speaker Change: That infrastructure build is what we've been focused on.

Tim Lee: And it's, and it's where it's where we're going.

Timothy Lee: Survey work that we saw early in the second quarter attuned in vivid well to some perception by healthcare providers who for amino compromised people, specifically transplants surgeons and hematologists and oncologists. This group are keenly aware of the risks that pose to their populations by COVID-19 and yet in large part regard them mandate to consider protection as seasonal and related to the fallen winter. We will be engaging actively with these healthcare providers over the coming weeks and months to evolve the thinking on this pervasive, persistent disease that can substantially impact their patient population.

Speaker Change: And it's and it's where it's where regarding I think your question around the summer wave.

Tim Lee: I think your question around the summer wave is interesting because, you know, it's something that, as you, as we start to talk to people, it's probably something that people didn't want to talk about. But I don't know if it's the algorithms that have figured out my, my internet history, but every single time I open the internet now, I'm noticing more articles published about this increased summer wave, the effect that's having on the general population. I think where we really lean into is that group of people who are immunocompromised, who really are looking for and needing protection.

Speaker Change: Is is interesting because.

Speaker Change: It's something that as you as we start to talk to people, it's probably something that people didn't want to talk about.

Speaker Change: But I don't know if it's the algorithms that have figured out Mike My Internet history, but every single time I open Internet.

Timothy Lee: But every single time I open the internet now, I'm noticing more articles published about this increased summer wave and the effect that it's having on the general population. I think where we really lean into is that group of people who are immunocompromised, who, really, are looking for and needing protection. I think the other thing that we're starting to do that has not been done previously is to speak to, listen to, and engage with the patient community.

Speaker Change: Noticing more articles published about.

Speaker Change: This increased summer wave the effect thats, having on the general population I think where we really lean into is that group of people who are immuno compromised.

Speaker Change: Who really are looking for in meeting.

Tim Lee: I think the other thing that we're starting to do that had not been done previously was that we're starting to speak to and listen to and engage with the patient community. I think there's so many key learnings for us that we can glean from the immunocompromised population and how we can better be better partners. And, you know, I think as Mark said, and I alluded to, you know, act with the urgency that this group needs in order to do the things that, quite honestly, many people take for granted. And, you know, I think these motivational stories are also allowing us to be a little bit more focused on what, you know, what the true opportunity is here.

Speaker Change: Needing protection I think the other thing that we're starting to do that not done and done previously was that we are starting to speak to and listen to you.

Timothy Lee: I think there are so many key learnings for us that we can glean from the immunocompromised population and how we can, you know, better, be better partners. And, you know, as Mark said, and I alluded to, act with the urgency that this group needs in order to do the things that, quite honestly, many people take for granted. And, you know, I think these motivational stories are also allowing us to be a little bit more focused on what, you know, the true opportunity is here.

Timothy Lee: In June, the CDC recommended universal COVID-19 boosting for every American over six years of age to spawn. We expect updated vaccines in pharmacies within weeks, and if 24 resembles anything like 2023, millions of Americans per week will begin the vaccination process. As Mark alluded earlier in his remarks, boosting is a critical protective strategy, but the data on vaccine effectiveness strongly suggests considering additional protection for certain immunocompromised patients. We will look to take advantage of these dynamics.

Speaker Change: And engaged with the patient community I think there's so many key learnings for us that we can.

Speaker Change: Glean from the immuno compromised population.

And how we can better be better partners.

Speaker Change: And.

Speaker Change: I think as Mark said and I alluded to act with the urgency that this group needs in order to do the things that quite honestly many people take for granted.

Mark: I think these motivational stories are also allowing us to be a little bit more focused.

Timothy Lee: So, hopefully, I touched all your points. I kind of scribbled them down, as you said, Evan, but I'm sure if I missed someone, I'm happy to clarify. We're thinking about this relative to the COVID vaccines. Is there, how do you expect some of the sales in the second half to be weighted?

Speaker Change: On what what the true opportunity is here, so hopefully I touched all your points that kind of scribble them down.

Tim Lee: So, hopefully I touched all your points. I kind of scribbled them down. As you said, I haven't, but I'm sure if I missed someone, I'm happy to clear. Thank you for thinking about this.

Speaker Change: But he said haven't but I'm sure if I missed some of them I'm happy to clarify.

Timothy Lee: Turning side 14. We have an opportunity to offer additional protection to people who are moderately to severely immunocompromised and at a high risk for severe COVID-19. The team is building the infrastructure to serve these communities, and our previously stated net revenue guidance represents a conversion of a small percentage of all of those who are in need. Turning to slide 15. Over the next few weeks, with the commercial groundwork established over the second quarter, in vivid will begin commercial messaging in the digital and traditional domains to drive healthcare provider awareness and immunocompromised population awareness.

Marc Elia: Whether, you know, whether it'll be kind of expected to be more 4-Q-weighted like some of the vaccines? And then, you know, to what degree do you expect any potential stocking here? Thanks. So let me first respond to the overall dynamic, and then Tim and others can speak to inventory and whatnot. But look, I think... We've taken advantage in multiple ways of the time period over the second quarter, which was nobly quiet on all of the dimensions that Tim alluded to.

Mark Elia: I wrote this in the COVID vaccines. Is there, how do you expect some of the sales in the second half to be weighted? Whether, you know, whether it'll be kind of expected to be more fortuitated like some of the vaccines? And then, you know, to what degree do you expect, you know, any potential stocking here? Thanks.

Speaker Change: Thinking about this high relative to some of the Covid vaccines is there I guess, how do you expect some of these sales in the second half to be weighted.

Speaker Change: Whether it'll be able to kind of expected to be more <unk> weighted on the vaccines and then.

Speaker Change: To what degree do you expect any.

Speaker Change: Any potential stocking here thanks.

Mark Elia: So, let me, let me first respond on the overall dynamic, and then Tim and others can speak to inventory and whatnot. But look, I think we've taken advantage in multiple ways of the time period over the second quarter, right, which was knowably quiet on all of the dimensions that Tim alluded to. The reality is that we are mainly geared up at this point to work on the stated habits and preference sets in the broad medical community, which frankly are not that different, I think, observably from some of our own habits. When it is summer in the northern hemisphere, people can feel disproportionately comfortable outdoors and exchanging air in seemingly non-threatening ways, and then something magical happens.

Speaker Change: So let me let me first respond on the overall dynamic and then Tim and others can speak to to inventory and whatnot.

Speaker Change: But look I think.

Speaker Change: We've.

Speaker Change: Taken advantage in multiple ways of.

Speaker Change: The time period over the second quarter, right, which was notably quiet on all of the dimensions.

Speaker Change: That that Tim alluded to the.

Speaker Change: The reality is that.

Timothy Lee: We are evaluating carefully every single opportunity to generate awareness in these critical markets and upcoming through the balance of 2024. We'll look forward to hearing your feedback on our work. We are not aiming to be subtle.

Marc Elia: The reality is that we are mainly geared up at this point to work on the stated habits and preference sets in the broad medical community, which frankly are not that different, I think, observably from some of our own habits. For example, when it is summer in the northern hemisphere, people can feel disproportionately comfortable outdoors and exchanging air in seemingly non-threatening ways, and then something magical happens.

Speaker Change: We are mainly geared up at this point to work on the stated habits and preferences in the broad medical community, which frankly are not that different I think observable from some of our own habits. When it is summer in the northern hemisphere people can feel disproportionately comfortable outdoors.

Mark Wingertzahn: With that, I'd like to turn the call over to my colleague, Mark Wingerson, to talk about our pipeline. Thank you, Tim.

Speaker Change: Exchanging air and seemingly non threatening ways and then something magical happens the back to school push begins and in this case. This summer we've had a fairly substantial summer COVID-19 wave.

Marc Elia: The back-to-school push begins, and in this case, this summer, we've had a fairly substantial summer COVID-19 wave. We're at such a fascinating and sensitive part of the growth curve. I don't think we want to particularly comment on those revenue results we achieved in early 3Q, but there was a reason we noted an acceleration. There are all these fundamental harmonics changing together, the progression of the season, the rise in ambient COVID, and of course, our own reinvigorated and re-led work. That's all gratifying, but it's not the big game.

Mark Elia: The back to school push begins. And in this case, this summer, we've had a fairly substantial summer COVID-19 wave. And, you know, look, we're at such a fascinating and sensitive part of the growth curve. I don't think we want to particularly comment on those revenue results we've achieved in early 3Q, but there was a reason we noted an acceleration. There are all these fundamental harmonics changing together, the progression of the season, the rise in ambient COVID, and of course, our own reinvigorated and re-led work. That's all gratifying, but it's not the big game. The big game is right in front of us, starting in a couple of weeks.

Mark Wingertzahn: Turning to slide 17. As you know, we've identified VYD-2311 to be a affinity maturation of the mid-part against the XBB lineage, lineage viruses in an effort to improve on the biophysical properties, including the in vitro-measured potency of the mid-part. As you all may realize, if all other variables are equal, potency improvements in measured IC-50s for an antibody can translate directly to lower doses that are required to achieve meaningful levels of SV&A tighter. The pharmacodynamic variable that drives protection and efficacy for a COVID-19 antibody. These lower doses may in turn allow for the development of routes of administrations that are more patient and system-friendly than intravenous approach.

Speaker Change: Look where we're at.

Speaker Change: As such a fascinating insensitive part of the growth curve I don't think we want to particularly comment on those revenue results. We've achieved in early <unk>, but there was a reason we noted on acceleration.

Speaker Change: There are all these fundamental harmonics changing together the progression of the season, the ryzen ambient COVID-19 and of course, our own reinvigorated and re led work that's all gratifying, but it is not the big game.

Marc Elia: The big game is right in front of us, starting in a couple of weeks, as people go back. As they go back indoors and the temperatures drop in the Northeast, it would seem as though a great, great many facets of the broad medical complex turn their attention toward prevention. And so, you know, for us, it's a little, in this first year, probably a bit more like a Christmas retailer or somebody selling Easter candy. Your business probably doesn't happen meaningfully in September, but come spring, look out right, so the whole purpose of the work over to Q was to put us into position to hit that hard. So when you think about the distribution.

Speaker Change: The Big game is right in front of US starting in a couple of weeks as people go back to school as they go back indoors and the temperatures dropped in the northeast it would seem as though a great great. Many facets of the broad medical complex turn their attention towards prevention and so for us it's a little in.

Mark Elia: As people go back to school, as they go back indoors and the temperatures drop in the Northeast, it would seem as though a great, great many facets of the broad medical complex turn their attention toward prevention. And so, you know, for us, it's a little, in this first year, probably a bit more like a Christmas retailer, or, you know, somebody selling Easter candy. Your business probably doesn't happen meaningfully in September, but come spring, look out, right? So the whole purpose of the work over 2Q was to put us into position to hit that hard. So when you think about the distribution, we're not in a position to know because this is our first year and we're launching.

Mark Wingertzahn: Timing this slide 18, we are pleased to have Australian ethics approval for a first in human study with BYD 2311, with dosing plan to begin at the end of August. This study plans to interrogate intravenous, intramuscular, and depending upon titers achieved, subcutaneous dosing. We felt strongly that interrogating multiple routes of administration could provide flexibility and optionality for achievement titers from one antibody that could be suitable for both COVID-19 prevention and treatment if authorized.

Speaker Change: This is first year, probably a bit more like a christmas retailer or.

Speaker Change: Somebody selling Easter Candy your business, probably doesn't happen meaningfully in September but come spring look out right. So the whole purpose of the Workover to Q was to put us into position to hit that hard. So when you think about the distribution.

Mark Wingertzahn: Turning this slide 19, the BYD 2311 product profile will ultimately be determined by the observed safety across doses and administration routes, the in vitro closeness you measured by EC50 against relevant viruses, the in vivo pharmacokinetic and half-life profile demonstrated by BYD 2311 in our early human testing, and, of course, dialogue with relevant regulatory agencies. However, we can envision evolution of the field from an infused therapy to any number of permutations, including alloting intravenous dose, followed by a lower dose tighter maintenance to perhaps elimination of intravenous delivery altogether.

Marc Elia: We're not in a position to know because this is our first year and we're launching. But when we look at the distribution of Vaccine Prophylaxis over this time period, you will quickly understand, I think as we do, that September, October, and November are very, very big months. And I think our expectation is that they will be for us as well.

Speaker Change: Not in a position to know because this is our first year.

Speaker Change: And we're launching.

Mark Elia: But when we look at the distribution of vaccine-profile access over this time period, you will appreciate quickly, I think, as we do, that September, October, and November are very, very big months. And I think our expectation is that they will be that for us as well.

Speaker Change: But when we look at the distribution of <unk>.

Speaker Change: Vaccine prophylaxis over this time period, you will appreciate quickly I think as we do that September October and November are very very big months, and I think our expectation is that they will be that for us as well.

Tim Lee: Tim, Inventory. Oh, yeah, I think you'll see; you won't see stocking. I think what we're continuing to do with our inventory is increase availability in the channel. You know, we want to make sure that we have inventory for those indeed, and we'll continue to provide us, you know, as needed basis in just-in-time shipping, to ensure that they have it.

Timothy Lee: Tim Inventory. Oh, yeah, I think you'll see you won't see a stocking. I think what we're continuing to do with our inventory is increased availability in the channel. We wanna make sure that we have inventory for those in need, and we'll continue to provide as needed basis and just-in-time shipping to ensure that they do. Thank you. And as a reminder, if you would like to ask a question, please press star one one to get into the queue. Again, that is star number one one.

Speaker Change: Tim inventory.

Speaker Change: Oh.

Speaker Change: Yes.

Speaker Change: You'll you'll see you won't see stocking I think what we're continuing to do with our.

Mark Wingertzahn: We look forward to updating you on our progress as we move through the fall.

Speaker Change: With our inventory is increased availability in the channel.

Robert Allen: With that, I'd like to turn the call over to our chief scientific officer, Robbie Allen, to discuss the ongoing emerging virology in our field. Robbie. Thank you more. Turning to slide 21. Given investor interest in these topics, we thought we would quickly visit some of how we view the surrogate marker of SVNA titers that describes possible clinical performance of our molecules and then provide an update with a view on next steps.

Speaker Change: We want to make sure that we have inventory for those in need and we will continue to provide us.

Speaker Change: As needed basis, and just in time shipping to ensure that they have.

Speaker Change: Okay.

Tim Lee: Thank you.

Operator: And, as a reminder, if you would like to ask a question, please press star 1-1 to get into the queue. Again, that is star 1-1 if you would like to ask a question. And one more time, again, ladies and gentlemen, that is star 1-1 if you would like to ask a question. One moment for our next question, please.

Speaker Change: Thank you.

Operator: If you would like to ask a question, And one more time again, ladies and gentlemen, that is Star 11. If you would like to ask a question, please take a moment for our next question. Our next question will come from Maxwell Skor from Morgan Stanley. Your line is open.

Speaker Change: And as a reminder, if you would like to ask a question. Please press star one one to get into the queue.

Speaker Change: Again that is star one one.

Speaker Change: I would like to ask a question.

Maxwell Skor: Great. Thank you for taking my questions. There are two for me, basically.

Robert Allen: First, we call that a key consideration in the FDA's thinking on COVID antibodies has been the concept of immunogridging, which is a form of bio-equivalence analysis. These analytics use point estimates from antibody neutralization and potent ZSAs that have marked intrinsic variability, including several full differences with suit virus assays, and up to 10 full differences with authentic virus assays. This variability, while not contemplated directly in an immunogridging analysis in the form of a range, isn't addressed directly by the FDA on the pin-guard effect sheet type, where you can see the wide range of potential bridging values like between pin-guard and at a treble map, depending on acid, from 0.82 to 0.35, according to slide 22, single SVNA tighter point estimates can of course become obsolete quickly by virus evolution and associated evolution in estimated DC50 values from these assays.

Speaker Change: And one more time again, ladies and gentlemen that is star one one if you would like to ask a question one.

Speaker Change: One moment for our next question please.

Maxwell Skor: Our next question will come from Maxwell Skor from Morgan Stanley. Your line is open. Great. Thank you for taking my questions. Two for me, basically.

Speaker Change: Our next question will come from Maxwell score from Morgan Stanley. Your line is open.

Maxwell Skor: Is it reasonable to assume you'll hear about the second EUA by year end and just directionally the magnitude of this opportunity if you were to get a positive recommendation? And then the second question regarding availability. Does the infusion site locator generally reflect availability, and what efforts are you making to get into larger academic centers?

Maxwell Score: Great. Thank you for taking my questions.

Maxwell Skor: Is it reasonable to assume you'll hear about the second EUA by year end, and just directionally the magnitude of this opportunity if you were to get a positive recommendation. And then the second question regarding availability, does the infusion site locator generally reflect availability, and what efforts are you making to get into larger academic centers? Thank you.

Maxwell Score: Two for me basically.

Maxwell Score: Is it reasonable to assume Youll hear about the second EUA by year end and just directionally the magnitude of this opportunity.

Speaker Change: Where do you get a positive recommendation and then the second question regarding availability does the infusion site locator generally.

Reflect availability and what efforts are you making to get into let's say larger academic centers. Thank you.

Mark Elia: Okay, great. So on the treatment EUA, as you will have noted, it has been submitted and indeed on a variety of topics. We are in discussion with the FDA, but it's certainly not within our purview to opine on the timing of anything that they might choose to do or not do.

Marc Elia: Thank you. Okay, great. So on the treatment EUA, as you will have noted, it has been submitted, and... Indeed, on a variety of topics, we are in discussions with FDA, but it's certainly not within our purview to comment on the timing of anything that they might choose to do or not do. I think we've always felt as though the sort of timing you're you're, you know, sort of hypothesizing would be reasonable, but let's all find out together.

Speaker Change: Okay, great. So so on the treatment EUA as you will have noted it has been submitted.

Speaker Change: Indeed on a variety of topics we are in discussion with the FDA, but it's certainly not within our purview to opine on the timing of anything.

Robert Allen: Even more complex before Omicron, there was a great propensity for single sweeping viral lineages. As opposed to the rapidly shifting variant suit, we have seen since the Omicron Saltation event. We therefore became interested in moving from a conception of antibody potency that indexes to one virus, to a conception that reflects an ongoing weighted average DC50 calculation. This type of analysis might yield a more complete and useful portrait of overall activity, although of course these analytics are limited by the disparity in underlying assay systems that intrudes into all analyses of this sort.

Speaker Change: They might choose to do or not do I think we've always felt as though the sort of timing you're.

Mark Elia: I think we've always felt as though the sort of timing you're sort of hypothesizing would be reasonable, but let's all find out together in terms of the magnitude of that opportunity. Look, I think it is clear that in multiple domains of American medicine, people will commonly reach for treatment at a higher rate than they will reach for prevention. You know, I think in the case of COVID, that's not always the best play, but so be it. So we'll have to see.

Speaker Change: Sort of Hypothesizing would be reasonable but.

Marc Elia: In terms of the magnitude of that opportunity, look, I think it is clear that in multiple domains of American medicine, people will commonly reach for treatment at a higher rate than they will reach for prevention. You know, I think in the case of COVID, that's not always the best play.

Speaker Change: Let's let's I'll find out together in terms of the magnitude of that opportunity.

Speaker Change: Look I think it is clear that in multiple domains of American medicine people will commonly reach for treatment at a higher rate than they will reach for prevention.

Speaker Change: I think in the case of Cobot, that's not always the best play but.

Speaker Change: So be it so.

Mark Elia: But of course, we feel as though our hands are really quite very full with rolling out prep, and we view, therefore, treatment, both for pomevo bars and potentially down in the future with the next molecule, like 2311, potentially quite additive. But we're not in a position yet to, I think, put numbers around that for you.

Speaker Change: We'll have to see.

Marc Elia: But, So be it. We'll have to see. But of course, we feel as though our hands are really quite very full with rolling out PrEP, and we view treatment both for Pimivibart and, potentially, down the line with the next molecule like 2311, potentially quite additive. But we're not in a position yet to, I think, put numbers around that for you. So, Mark, anything you would add to that? No, I think that was well said, Mark.

Robert Allen: Turning to slide 23. In furtherance of our serial monoclonal antibody approach to COVID-19, we have analyzed public suit of our old data to evaluate weighted average EC50s and reflected that analysis against observed regulatory actions of authorization and revocation of authorization. In this example, you can see Evan Schell depicted in its weighted average potency over time and associated deauthorization. Turning to slide 24. To provide further insight to pass regulatory actions of authorization and revocation of authorization, we extended this analysis across historic antibodies authorized for both treatment and prevention.

Speaker Change: But of course, we feel as though our hands are really quite very full with rolling out prep and we view therefore treatment both for <unk> and potentially down in the future with the next molecule like <unk> hundred 11.

Potentially quite additive, but we're not in a position yet to I think.

Speaker Change: <unk> put numbers around that for you.

Mark Elia: So, Mark, anything you would add on that? I think that was also more.

Speaker Change: So mark anything you would add on that I think that was well said mark. Thank you. Okay. So then locator.

Tim Lee: Thank you. Okay, so then locator. Thank you for the question around the infusion locator. I think what I'll tell you is it is being updated real time right now.

Marc Elia: Okay, so then, the locator. Yeah, thank you for the question around the infusion locator. I think what I'll tell you is it is being updated in real time right now, so if you were to look at it today, it's not an accurate representation of all of the sites around the country that are currently infusing and able to infuse Pengarta.

Speaker Change: Thank you for the question around the infusion locator.

Speaker Change #100: What I will tell you is is being updated in real time right. Now. So if you were to look at it today, it's not an accurate representation of all of the sites around the country that are currently using and able to you.

Tim Lee: So if you were to look at it today, it's not an accurate representation of all the sites around the country that are currently infusing and able to infuse Alberta. What we are starting to do, you know, is act on multiple paths, right? So you mentioned the major academic medical centers. It is a priority for us. We have a dedicated field team out there doing that every single day, going out to educate and create an opportunity for pomegranate for that. And that means a compromised patient population who needs it in parallel with that. You know, we've begun talks in the last two months on how we can better partner with some private infusion sites as well to ensure that there is access for this community.

Robert Allen: Turning to slide 25. When we extend the analysis to PomevoBARC and BYD-2311, a compelling portrait emerges over the time since the selection of V1222, dozens of virus lineages have emerged, becoming critically meaningful, and then have been outcompeted. This evolution continues to this day. PomevoBARC weighted average values fluctuate without substantial attributable change. This lack of meaningful change could be predicted by the structural biology of a conservative epitope, but challenged by the inherent variability of the assay systems that define these data.

Timothy Lee: What we are starting to do, you know, is act on multiple paths, right? So you mentioned the major academic medical centers. It is a priority for us. We have a dedicated field team out there doing that every single day, going out to educate and create an opportunity for PEMGARTA for that immunocompromised patient population who need it. In parallel with that, we've begun talks in the last two months on how we can better partner with some private infusion sites as well to ensure that there is access for this community. And so we're really running multiple trains on parallel tracks, but they happen to go at different speeds.

She has been Garda.

Speaker Change #100: We are starting to do.

Speaker Change #100: <unk>.

Speaker Change #101: Act on multiple paths right. So you mentioned the major academic medical centers. It is a priority for US we have a dedicated field team out there doing that every single day going out to educate.

Speaker Change #101: And create an opportunity for <unk>.

Speaker Change #101: That immunocompromised patient population who needs it.

Speaker Change #101: In parallel with that we've begun talks in the last few months on how we can better partner with some private infusion sites as well to ensure that there is access for this community.

Tim Lee: And so we're really running multiple trains on parallel tracks, but they happen to go at different speeds.

Robert Allen: Turning our attention to our pipeline, although it is difficult to see on this chart do its significant potency improvement and lack of meaningful change. BYD-2311 has demonstrated early signs of potential improved potency with improved and stable IC50 values. In vivid has built its platform to keep up with the inevitability of virus evolution. However, there are general principles around the conservation of epitopes we aim to take advantage of in order to increase the resistance of our antibodies to the effects of virus evolution.

Speaker Change #101: So we're really running multiple trains.

Timothy Lee: But if the locator is something that you monitor, I think we'll see a remarkably positive increase in numbers in the next seven days and continue as we add major national infusion centers, as well as academic centers and local infusion centers. Great, thank you. Thank you. And again, ladies and gentlemen, if you would like to ask a question at this time, please press star 111. Once again, if you would like to ask a question, please press star 11. As of now, we are not showing anyone in the queue.

Parallel tracks, but they happen to go at different speeds, but the locator is something that you monitor I think we will see.

Tim Lee: But if the locator is something that you monitor, I think we'll see remarkably positive increase in numbers in the next seven days and continue as we online major national infusion centers as well as academic centers and local infusion centers. as well.

Speaker Change #101: Markedly positive increase in numbers in the next seven days and continue as we online major national infusion centers as well as academic centers and local infusion centers as well.

Maxwell Skor: Great. Thank you.

Maxwell Skor: Yes. Thank you.

Speaker Change #101: Great. Thank you yes.

Operator: So if you would like to ask a question again, please press star one one. One moment for our next question. And our next question will come from Michael E. Jeffries. Your line is open. Hey guys, this is Kyle for Michael.

Operator: And again, ladies and gentlemen, if you would like to ask a question at this time, please press Star 11. Once again, if you would like to ask a question, please press Star 11. As of now, we are not showing anyone in the queue. So if you would like to ask a question again, please press Star 11.

Speaker Change #102: Thank you and again, ladies and gentlemen, if you would like to ask a question at this time. Please press star one one.

Robert Allen: We will never be perfect, and by design we hope to innovate under the track of speed. The data such as these that accompany our structural biological insights and the power of our discovery platform will aid in this endeavour. Turning to slide 26. Another challenge in applied biology with rapidly evolving viruses relates to the ability to secure reliable high quality academic or commercial partners that can handle authentic SARS-CoV-2 virus in an appropriate BSL-3 laboratory setting and perform timely and accurate neutralization analyses for us.

Speaker Change #102: Once again, if you would like to ask a question. Please press star one one.

Speaker Change #103: As of now we are not showing anyone in the queue. So if you would like to ask a question again, Please press star one.

Kyle: One moment for our next question.

Speaker Change #103: One moment for our next question.

Speaker Change #103: Yeah.

Mark Elia: And our next question will come from Mike Lee Jeffries. Your line is open. Hey guys, this is Kyle for Michael. Real quick question on the EU status status. Could you please give us any updates on sort of filing in the OUS? Thank you.

Michael <unk>: And our next question will come from Michael <unk> from Jefferies. Your line is open.

Kyle: Real quick question on the EU status. Could you please give us any updates on this sort of filing in the O.U.S. [inaudible] Yeah, sure. So very quickly, I think this is something that is under constant discussion here at Invivyd. But, you know, it would not surprise us, I don't think, if, over time, OUS migrated to a topic more germane to 2311 in light of the supply constraints we face on PEMGARTA. So we're always exploring those things.

Michael <unk>: Hey, guys. This is Kyle for Michael.

Speaker Change #105: A real quick question.

Speaker Change #106: The use.

Speaker Change #107: Use dana's status could you please give us any updates on.

Robert Allen: Recently, one of our partners, a commercial provider of such services, discovered a potential contamination event in their virus stocks, which in turn has rendered the JN.1 authentic virus value it had generated a questionable reliability, reassuringly, this authentic virus has a potency value against JN.1 is very similar to the independently generated suitivirus potency value estimated for permeable part against JN.1. The FDA and in vivid have been in dialogue on this matter for several weeks, and among other next steps in vivid will reassess promote our activity versus authentic JN.1 virus in a series of labs to determine a reliable number.

Speaker Change #108: Sort of filing in.

Speaker Change #108: In the U S. Thank you.

Mark Elia: Yeah, sure. So very quickly, I think this is something that is under constant discussion here at Invivid. But you know, it would not surprise us.

David: Yeah sure. So very quickly I think this is something that is under constant discussion here at <unk>, David but.

Speaker Change #109: It would not surprise us I don't think if over time.

Mark Elia: I don't think if over time, OUS migrated to a topic more germane to 2311 in light of the supply constraints we face on Pemgarda. So we're always exploring those things. And it's something that I think global regulators are probably not entirely harmonized on their conception of the field. And therefore, there's sort of a limit to what we are willing to do.

Speaker Change #110: Oh U S migrated to a topic more germane to 'twenty 311 in light of the supply constraints, we faced on Perm Garda.

Speaker Change #110: So we're always exploring those things and it's something that.

Speaker Change #111: I think global regulators are probably not entirely harmonized on their conception of the field.

Kyle: And it's something that I think global regulators are probably not entirely aligned in their conception of the field. And therefore, there's sort of a limit to what we are willing to do de novo to support the opening of a new geography, particularly for a drug with the profile offered by Pimivibart.

Speaker Change #111: Therefore, there is sort of a limit to what we are willing to do de novo to support the opening of a new geography, particularly for a drug with the profile offered by <unk>. So.

Robert Allen: Potentially also informative on the matter of JN.1 and the clinical meaning of SVNA titers generally is our preliminary analysis of the second half of the canopy study, which happened to occur during a time of JN.1 dominance in the United States in the winter of 2024. The FDA is also in receipt of these preliminary exploratory data. As Mark noted, we look forward to sharing these data soon when finalized and prepared for presentation.

Mark Elia: De novo to support the opening of a new geography, particularly for a drug with the profile offered by Pemgivobart. So, you know, I think one statement that is, well, certainly on display publicly during the Olympics. COVID is a global problem. And there are global regulatory agencies that may wish to engage with us constructively. And you would, of course, find us so constructively engaged.

Speaker Change #111: I think one statement that as well.

Marc Elia: So, you know, I think one statement that is, well, certainly on display publicly during the Olympics: COVID is a global problem, and there are global regulatory agencies that may wish to engage with us constructively. And you would, of course, find us so constructively engaged. But right now, there's nothing on the horizon that I think bears highlight.

Speaker Change #111: Well.

Speaker Change #111: Certainly on the display publicly during the Olympics Covid is a global problem and there are global regulatory agencies that may wish to engage with us constructively than you would've correspond us so constructively engaged but right now theres nothing on the horizon that I think bears highlighted.

Mark Elia: But right now, there's nothing on the horizon that I think bears highlighted.

Robert Allen: Overall, our goal as a company is to improve the usefulness, accuracy and informativeness of virology data to all key stakeholders. While these cellular bio assays are of clear interest and importance, they also have clear limitations that must be acknowledged by those of us in the business of making medicines to protect the vulnerable and treat diseases. We are and for now years have been a constant dialogue with the FDA and see many opportunities to improve our collective acumen on this topic, especially when we can all see contemporary clinical data from, for example, can be and supernova.

Marc Elia: Trucchio, thank you. And a quick follow-up question for me. So could you please briefly talk about your visibility on ordering, given we're already halfway through Q3? Sure, so you will note from our prepared remarks that we were willing to note some real acceleration in our commercial results into the quarter, but I think, as we further endeavor to clarify, the big game commercially is still, I don't know, is it two weeks until Labor Day? Somewhere in there, I think is where we expect to see, along with the availability of updated vaccines, a major, almost, I think, social and public health drive towards COVID-proof access.

Kyle: Gotcha. Thank you.

Mark Elia: And a quick call up for me. So could you please briefly talk about your visibility on ordering given we're already halfway through Q3? Thank you.

Speaker Change #112: Got you. Thank you and a quick follow up for me.

Speaker Change #113: So could you. Please briefly talk about your visibility on ordering given we're already halfway through Q3. Thank you.

Mark Elia: Sure. So you will note from our prepared remarks that we were willing to note some real acceleration in our commercial results into the quarter.

Speaker Change #114: Sure. So you will you will note from our prepared remarks that we were willing to note some real acceleration in our commercial results.

Mark Elia: But I think, as we further endeavored to clarify, the big game commercially is still, I don't know, is it two weeks until Labor Day? Somewhere in there, I think, is where we expect to see, along with the availability of updated vaccines, a major, almost, I think, social and public health drive towards COVID profile access. So, you know, we have observed, you know, is something of a step change. But that step change isn't what we view as of the most meaning. The most meaning is going to be in results that lie ahead. And the good news is we don't have a whole lot longer to wait.

Speaker Change #115: Into the quarter.

Speaker Change #116: But I think as we further endeavored to clarify is the big game commercially is still Oh I don't know is it two weeks until labor day somewhere in there I think is where we expect to see along with the availability of updated vaccines a major almost.

William Duke: I'd like to turn the call over to our CFO Duke for final remarks prior to Q&A. Thanks Robbie, moving to slide 28. Right now, Invisited is at an exciting moment in our history. We are looking forward to rapid expansion of our commercial activities and are pleased to reaffirm the revenue and cash guidance provided previously. As we move through the fall, we will be in position to refine that guidance. But for now, we remain comfortable with the boundaries within it.

Speaker Change #116: I think social and public health drive towards Covid prophylaxis. So.

Marc Elia: So, you know, we have observed something of a step change, but that step change isn't what we view as the most meaningful. The most meaningful results are going to be in the results that lie ahead, and the good news is we don't have a whole lot longer. [inaudible] All right, thank you so much. Thank you. And again, if you would like to ask a question, please press star 11. Again, if you have not asked a question and you would like to ask a question to our speakers, please press star 11 to get in the queue. And speakers, I am showing no further questions from our phone line.

Speaker Change #116: We have observed is something of a step change, but that step change isn't what we view as the most meaning the most meaning.

Speaker Change #116: Is going to be in results that lie ahead and the good news is we don't have a whole lot longer to wait.

William Duke: In addition, although Invisited is a fully integrated biopharmaceutical company, we have been streamlining our operations over the last quarter and are starting to see the benefits of that work. Of note, our burn rate includes the majority of expenses associated with production of significant quantities of our next model, molecule, VYD2311. At this point, we have contracted to produce approximately 130,000 doses of Pemgarida. After exhausting that supply, we tend to transition rapidly to VYD2311, which may afford greater efficiency in lower clogs compared to Pemgarida, depending upon the clinical product profile we see.

Mark Elia: All right.

Mark Elia: Thank you so much. Thank you.

Speaker Change #117: Alright, thank you so much.

Operator: And again, if you would like to ask a question, please press Star 11. Again, if you have not asked a question and you would like to ask a question to our speakers, please press star 11 to get in the queue.

Speaker Change #118: Thank you.

Speaker Change #119: Again, if you would like to ask a question. Please press star one.

Speaker Change #120: Again, if you have not asked a question and you would like to ask a question to our speakers. Please press star one one to get in the queue.

Operator: And speakers, I am showing no further questions from our phone lines.

Speaker Change #121: And speakers I am showing no further questions from our phone lines.

Mark Elia: Great, well thank you all very much for joining us this morning, and we'll look forward to fielding your questions later through the day. Thank you.

Operator: Great. Well, thank you all very much for joining us this morning, and we'll look forward to fielding your questions later in the day. Thank you. Thank you. This does conclude today's program. Thank you for your participation. You may now disconnect. Everyone have a wonderful day.

Speaker Change #121: Great well. Thank you all very much for joining us this morning, and we'll look forward to fielding your questions later through the day. Thank you.

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

Speaker Change #121: Thank you. This does conclude today's program. Thank you for your participation you may now disconnect everyone have a wonderful day.

Operator: Everyone have a wonderful day. Thank you.

William Duke: Our favorite source of incremental capital to strengthen our balance sheet remains product sales in operating contribution. Nonetheless, we are in discussions with multiple potential sources of non-dilutive and dilutive equity capital. Should we assess a benefit associated with raising money? Mainly, however, we are looking forward to the upcoming commercial push in the fall with winter respiratory virus season.

Speaker Change #121: Okay.

Speaker Change #121: [music].

Speaker Change #121: Okay.

Speaker Change #121: [music].

Unknown Executive: I'll now turn the call over to the operator to open for this question. Operator? Operator, please open for questions. Well, if you'll all give us a moment, we know there are questions in the queue. So we'll work on repairing whatever is going wrong.

Speaker Change #121: Okay.

Speaker Change #121: [music].

Speaker Change #121: Okay.

Speaker Change #121: [music].

Speaker Change #121: Yes.

Speaker Change #121: [music].

Speaker Change #121: So.

Speaker Change #121:

Speaker Change #121: [music].

Speaker Change #121: Okay.

Speaker Change #121: [music].

Unknown Executive: Okay, well, we're going to try doing this ourselves and the results should be fascinating.

Maxwell Skor: Evan Wang, are you on the line at this point with us for a question? Can you guys hear me? Hello? No, we can hear you. Okay. Okay, you can hear me. Okay, great. Yeah. Thanks, guys. Good to see all the progress.

Speaker Change #121: Okay.

Speaker Change #121: [music].

Timothy Lee: You know, I guess just two or three to me, I guess just first off, you know, with Tim, you know, with both of you here, you know, I guess now you're two months in. You shared some of the work you've been putting in. But I guess, you know, some, can you share a little bit more on your perspective? I guess, you know, what's needed to build off my success in terms of, I guess, what would you like existing?

Speaker Change #121: Yes.

Speaker Change #121: Okay.

Speaker Change #121: [music].

Timothy Lee: What kind of cases do you make? And, you know, what's kind of remaining? And what's the goal ahead of some of this fall, immunization season? And then can you describe, you know, some of what you're seeing in terms of the summer wave? And how I think there's some commentary on, you know, acceleration of commercial results in early three Q. Well, we're seeing there. Thanks. Yeah, and thank you.

Speaker Change #121: Okay.

Speaker Change #121: [music].

Speaker Change #121: Okay.

Speaker Change #121: [music].

Timothy Lee: Happy to, you know, I think if I look back over the last two months, you know, one of the comments that we made was around how we're rapidly starting to commercialize towards an infused biologic, which is just different than the vaccine world. So, one of those things we're doing is, I really brought on a season team and excited to let them a little bit loose on the market and helping to go deep, deep here.

Timothy Lee: You know, we look at, we're looking at things through an immediate lens, what we can do right away. As we looked at it, there was not much digital work that had happened. We've started beginning digital work already. Continue to pull that through. We look to increase corporate campaign work and, you know, doing just simple things like update in our, I'm going to infusion locator rapidly with the latest sites that are available.

Operator: ... All rights reserved.

Operator: Hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey.

Timothy Lee: You know, I think what we're seeing is that, you know, there are over 10, we said this before over 200 sites right now around the country and more who are rapidly coming on board. With that, there's a level of effort and work that has to be applied towards those. And that infrastructure bill is what we've been focused on. And it's, and it's where it's where we're going.

Timothy Lee: I think your question around the summer wave is, is interesting because, you know, it's something that as you, as we start to talk to people, it's probably something that people didn't want to talk about. But I don't know if it's the algorithms that have figured out my, my internet history, but every single time I open the internet now, I'm noticing more articles published about this increased summer wave, the effect that's having on the general population.

Timothy Lee: I think where we really lean into is that group of people who are immunocompromised, who, who really are looking for in needing, needing protection. I think the other thing that we're starting to do that had not been done previously was that we're starting to speak to and listen to and engage with the patient community. I think there's so many key learnings for us that we can glean from the immunocompromised population and how we can better be better partners.

Timothy Lee: And, you know, I think as Mark said, and I alluded to, you know, act with the urgency that this group needs in order to do the things that quite honestly, many people take for granted. And, you know, I think these motivational stories are also allowing us to be a little bit more focused on what, you know, what the true opportunity is here. So, hopefully I touched all your points. I kind of scribbled them down. As you said, I haven't, but I'm sure if I missed someone, I'm happy to clear. Thank you for thinking about this.

Mark Elia: I wrote this in the COVID vaccines. Is there, how do you expect some of the sales in the second half to be weighted? Whether, you know, whether it'll be kind of expected to be more fortuitated like some of the vaccines? And then, you know, to what degree do you expect, you know, any potential stocking here? Thanks.

Mark Elia: So, let me, let me first respond on the overall dynamic, and then Tim and others can speak to inventory and whatnot. But look, I think we've taken advantage in multiple ways of the time period over the second quarter, right, which was knowably quiet on all of the dimensions that Tim alluded to. The reality is that we are mainly geared up at this point to work on the stated habits and preference sets in the broad medical community, which frankly are not that different, I think, observably from some of our own habits.

Mark Elia: When it is summer in the northern hemisphere, people can feel disproportionately comfortable outdoors and exchanging air in seemingly non-threatening ways, and then something magical happens. The back to school push begins. And in this case, this summer, we've had a fairly substantial summer COVID-19 wave. And, you know, look, we're at such a fascinating and sensitive part of the growth curve. I don't think we want to particularly comment on those revenue results we've achieved in early 3Q, but there was a reason we noted an acceleration.

Mark Elia: There are all these fundamental harmonics changing together, the progression of the season, the rise in ambient COVID, and of course, our own reinvigorated and re-led work. That's all gratifying, but it's not the big game. The big game is right in front of us, starting in a couple of weeks. As people go back to school, as they go back indoors and the temperatures drop in the northeast, it would seem as though a great, great, many facets of the broad medical complex turn their attention toward prevention.

Mark Elia: And so, you know, for us, it's a little, in this first year, probably a bit more like a Christmas retailer, or, you know, somebody selling Easter candy. Your business probably doesn't happen meaningfully in September, but come spring look out, right? So the whole purpose of the work over 2Q was to put us into position to hit that hard. So when you think about the distribution, we're not in a position to know, because this is our first year, and we're launching.

Mark Elia: But when we look at the distribution of vaccine-profile access over this time period, you will appreciate quickly, I think, as we do, that September, October, and November are very, very big months. And I think our expectation is that they will be that for us as well.

Timothy Lee: Tim, inventory. Oh, yeah, I think you'll see, you won't see stocking. I think what we're continuing to do with our inventory is increase availability in the channel. You know, we want to make sure that we have inventory for those indeed, and we'll continue to provide us, you know, as needed basis in just-in-time shipping, to ensure that they have it.

Unknown Executive: Thank you.

Unknown Executive: And as a reminder, if you would like to ask a question, please press star 1-1 to get into the queue. Again, that is star 1-1 if you would like to ask a question. And one more time, again, ladies and gentlemen, that is star 1-1 if you would like to ask a question.

Unknown Executive: One moment for our next question, please.

Maxwell Skor: Our next question will come from Maxwell Skor from Morgan Stanley. Your line is open. Great. Thank you for taking my questions.

Mark Elia: Two for me basically. Is it reasonable to assume you'll hear about the second EUA by year end and just directionally the magnitude of this opportunity if you were to get a positive recommendation. And then the second question regarding availability, does the infusion site locator generally reflect availability and what efforts are you making to get into larger academic centers? Thank you. Okay, great. So on the treatment EUA as you will have noted, it has been submitted and indeed on a variety of topics.

Mark Elia: We are in discussion with FDA, but it's certainly not within our purview to opine on the timing of anything that they might choose to do or not do. I think we've always felt as though the sort of timing you're sort of hypothesizing would be reasonable, but let's all find out together in terms of the magnitude of that opportunity. Look, I think it is clear that in multiple domains of American medicine, people will commonly reach for treatment at a higher rate than they will reach for prevention.

Mark Elia: You know, I think in the case of COVID, that's not always the best play, but so be it. So we'll have to see. But of course, we feel as though our hands are really quite very full with rolling out prep and we view, therefore, treatment, both for pomevo bars and potentially down in the future with the next molecule, like 2311, potentially quite additive, but we're not in a position yet to, I think, put numbers around that for you. So Mark, anything you would add on that? I think that was also more. Thank you.

Timothy Lee: Okay, so then locator. Thank you for the question around the infusion locator. I think what I'll tell you is it is being updated real time right now. So if you were to look at it today, it's not an accurate representation of all the sites around the country that are currently infusing and able to infuse Alberta. What we are starting to do, you know, is act on multiple paths, right? So you mentioned the major academic medical centers.

Timothy Lee: It is priority for us. We have a dedicated field team out there doing that every single day, going out to educate and create an opportunity for pomegranate for that. And that means a compromised patient population who needs it in parallel with that. You know, we've begun talks in the last two months on how we can better partner with some private infusion sites as well to ensure that there is access for this community.

Timothy Lee: And so we're really running multiple trains on parallel tracks, but they happen to go at different speeds. But if the locator is something that you monitor, I think we'll see remarkably positive increase in numbers in the next seven days and continue as we online major national infusion centers as well as academic centers and local infusion centers, as well. Great. Thank you. Yes. Thank you. And again, ladies and gentlemen, if you would like to ask a question at this time, please press star 11.

Timothy Lee: Once again, if you would like to ask a question, please press star 11. As of now, we are not showing anyone in the queue. So if you would like to ask a question again, please press star 11. One moment for our next question.

Maxwell Skor: And our next question will come from Mike Lee Jeffries. Your line is open. Hey guys, this is Kyle for Michael. Real quick question on the EU status status. Could you please give us any updates on sort of filing in the OUS? Thank you. Yeah, sure. So very quickly, I think this is something that is under constant discussion here at Invivid. But you know, it would not surprise us. I don't think if over time, OUS migrated to a topic more germane to 2311 in light of the supply constraints we face on Pemgarda.

Maxwell Skor: So we're always exploring those things. And it's something that I think global regulators are probably not entirely harmonized on their conception of the field. And therefore, there's sort of a limit to what we are willing to do. De novo to support the opening of a new geography, particularly for a drug with the profile offered by Pemgivobart. So, you know, I think one statement that is, well, certainly on display publicly during the Olympics. COVID is a global problem. And there are global regulatory agencies that may wish to engage with us constructively. And you would of course find us so constructively engaged.

Maxwell Skor: But right now, there's nothing on the horizon that I think bears highlighted. Gotcha. Thank you. And a quick call up for me.

Mark Elia: So could you please briefly talk about your visibility on ordering given we're already halfway through Q3? Thank you. Sure. So you will you will note from our prepared remarks that we were willing to note some real acceleration in our commercial results into the quarter. But I think as we further endeavored to clarify, the big game commercially is still, I don't know, is it two weeks until Labor Day? Somewhere in there, I think is where we expect to see, along with the availability of updated vaccines, a major, almost, I think, social and public health drive towards COVID profile access.

Mark Elia: So, you know, we have observed, you know, is something of a step change. But that step change isn't what we view as of the most meaning. The most meaning is going to be in results that lie ahead. And the good news is we don't have a whole lot longer to wait.

Unknown Executive: All right. Thank you so much. Thank you. And again, if you would like to ask a question, please press star 11. Again, if you have not asked a question and you would like to ask a question to our speakers, please press star 11 to get in the queue. And speakers, I am showing no further questions from our phone lines.

Unknown Executive: Great, well thank you all very much for joining us this morning and we'll look forward to fielding your questions later through the day. Thank you.

Unknown Executive: This does conclude today's program. Thank you for your participation. You may now disconnect. Everyone have a wonderful day. Thank you. [inaudible]