Q2 2023 Invivyd Inc Earnings Call

August 10, 2023

Welcome to the Endeavour second quarter, 2023 business and financial results update call I will now turn the call over to Gabriel lingual angler director of external communications.

Thank you for joining us today before we get started I want to turn to a few housekeeping items.

To review our press release discussing our second quarter 2023 financial results.

D, which can be found on the investors section of the website.

I'd like to remind you that during today's discussion, we'll be making several forward looking statements forward.

Forward looking statements include statements concerning among other things the future of the COVID-19 landscape, our ongoing research and clinical development plan, including the timing of these plans.

Our regulatory and commercialization plan strategy and opportunity our expected cash runway and other statements that are not historical facts.

Forward looking statements are subject to a number of risks and uncertainties that may cause our actual results to differ materially from those expressed or implied in the forward looking statements, including those described under the heading risk factors in our filings made with the U S Securities and Exchange Commission, including our most recent Form 10-K.

It is now my pleasure to introduce the management team to the call I'm joined by Dave Henry CEO oven did it and Dr. Peter Schmidt Chief Medical Officer.

Now I'll turn the call over to Dave.

Thanks, Gabriel and thank you to everyone joining us today on our quarterly update call in Q2 in the recent weeks, we've made significant progress towards our goal of commercializing <unk> in the near term.

And advancing our mission to protect the vulnerable people from serious viral threats.

Since our last call, we've announced positive initial safety data and robust neutralizing titer data from our ongoing <unk>.

<unk> phase one clinical trial.

We believe that the initial phase one results are very encouraging and speak to the potential for <unk> to provide vulnerable people such as immuno compromised with robust protection from symptomatic COVID-19.

Shortly Pete will provide additional color on the initial phase one clinical trial results and our plans to rapidly initiate a 750 participants pivotal clinical trial of <unk> for the prevention of symptomatic COVID-19 referred to as the canopy trial.

With the compact size of canopy and a primary efficacy endpoint based on the analysis of CRM neutralizing titers at day 28, the same biomarker used in our phase one clinical trial, we believe that we can swiftly enrolled the trial and generate the clinical data necessary to enable a potential emergency use authorization or EUA submission.

We look forward to initiating the canopy trial in the near term and expect to have initial primary endpoint data by approximately the end of 2023.

In Q2, we also announced that we reached general alignment with the FDA on our pathway to a potential EUA for <unk> and anticipated follow on candidates designed to prevent symptomatic COVID-19.

We are very encouraged by the rapid development pathway outlined by the FDA and the opportunity it provides to leverage our previous work developing developing in traveling man to accelerate the development of <unk>.

We believe we are one of very few companies positioned to potentially meet the criteria that the FDA outlined for this streamlined development pathway.

Importantly, with this pathway, we see a near term opportunity to bring much needed protection from symptomatic COVID-19 to immuno immuno compromised people.

Before I hand, the call over to Pete to talk about our plans for the transformational period ahead I want to briefly underscore three important points.

First the need to protect vulnerable populations from COVID-19 remains as urgent as ever.

You don't compromise people continue to be at higher risk for severe COVID-19 related outcomes and more broadly COVID-19 continues to be a delta threat.

Roughly halfway through 2023 before we have even entered the fall and winter months. The CDC estimates that more than 43000 deaths in the U S are attributable to COVID-19 this year.

That is more than 43000 deaths, where COVID-19 was listed as the underlying cause or a contributing cause of death on the death certificate.

For context consider that RSV is estimated to cost roughly 14000 deaths per year in the U S.

The group's at highest risk for RSV and the pre COVID-19 levels for flu related deaths have fluctuated between 23000 52000 deaths per year in the United States.

COVID-19 remains a substantial driver of morbidity as well the National Center for Health Statistics estimates that roughly one in seven adults in the U S have experienced long covered at some point, which adds to the unique and unacceptable burden of this disease.

While many have accepted the status quo and are trying to live with Covid. We continue to argue that all are not living well, particularly vulnerable population.

Second we believe that protecting immunocompromised people from COVID-19, as a large ongoing need and opportunity.

In the U S alone there are an estimated $8 million to $18 million immunocompromised people, who may not generate robust protection from vaccines.

To our knowledge and vivid is one of very few companies in the clinic now with a monoclonal antibody candidate in development for the prevention of COVID-19 in this population consider.

Consider that have you sold alone captured $2 2 billion in total revenue in 2022 with strong growth prior to its removal from the market when it lost activity against emerging Sars Covid two variants of concern.

In a recent survey we conducted with nearly 200 U S physicians, who treat different types of immuno compromised patients 76% of respondents said they would be extremely likely or somewhat likely to use <unk> for their immuno compromised patients. If it were still available and relevant to circulating COVID-19 strained.

In the coming periods, we look forward to sharing more insights from the market research. We've conducted to further refine our understanding of the different immuno compromised population and the views of the clinicians who care for the different types of patients who may be chronically are temporarily immuno compromised.

Third we believe that <unk> is uniquely positioned to rapidly and perpetually deliver math therapies that can keep pace with viral evolution and protect the vulnerable.

Our company and our discovery platform are built on the premise that serial innovation will be required to provide vulnerable populations with continuous access to map therapies that protect against serious viral threats a strategy that is similar to the approach used to periodic periodically modify vaccines in response to viral.

<unk>.

Do you anticipate and quickly respond to viral evolution, we are leveraging state of the art viral surveillance predictive modeling and advanced antibody engineering techniques designed to generate a pipeline of optimized mab candidates that could be deployed in the future.

We see COVID-19, as the optimal starting point for <unk> due to the speed with which products can be brought to the market using the EUA pathway.

From there we believe that our platform can also be applied to protect vulnerable people from other viral threats such as influenza an area, where we have an early discovery stage program.

I will now pass the call the Peach meant our chief Medical officer to discuss in more detail. Our initial phase one data pivotal clinical trial plans and regulatory pathway.

Thank you Dave excuse me we are pleased to have recently shared positive initial data from our ongoing phase one clinical trial of <unk>, which enrolled 30 healthy volunteers across three different dosing cohorts.

Cohort participants were randomized <unk> to <unk> or placebo.

The initial phase <unk> clinical trial data showed that a single administration of <unk> was generally well tolerated at all three dose levels tested with no serious adverse events reported as expected we saw a dose dependent increase in serum neutralizing titers against Omicron SPV one five.

The lowest dose tested 500 milligrams the geometric mean CRM neutralizing titers were 3245 against Omicron SBB one five at day seven at geometric mean 39 fold rise from baseline.

At the 2500 milligram dose the titers were 9647 at.

At the 4500 milligram dose the titers were 16865.

As a point of reference even the lowest <unk> dose tested resulted in higher CRM neutralizing titers against Omicron SPV. One five then the tighter shared at the recent vaccines Advisory Committee meeting from investigational SPV targeted vaccines that were administered to adults who are not on.

Immunosuppressive treatment.

Higher <unk> doses resulted as expected and higher tighter levels that were well above those reported vaccine tighter levels.

Sarum neutralizing titer data are meaningful because COVID-19 vaccine and mab clinical trials, including our past phase three <unk> clinical trial for the prevention of COVID-19 referred to as debate have demonstrated that Sarah neutralizing titers are correlated with the prevention of COVID-19.

This correlation has also been observed in immune compromised individuals receiving ever shelf amount that targets. The spike protein receptor binding domain of Sars Covid two like the <unk> to two <unk>.

Just on this correlation we believe that the serum neutralizing titers seen in our phase one clinical trial are highly encouraging and support the potential for <unk> to provide clinically meaningful protection from symptomatic COVID-19.

With positive initial phase one data in hand, we are pleased to have now solidified the design of our canopy trial of <unk> for the prevention of symptomatic COVID-19, which is geared to support a potential EUA submission we plan to enroll approximately 750 participants total across two cohorts in parallel.

In cohort <unk>, we expect to enroll approximately 300 participants who are significantly immune compromised.

Cohort may include for example people who are actively being treated for solid tumors people with hematological malignancies, such as acute leukemia or multiple myeloma, regardless of treatment status as well as other groups of people who have weakened immune systems as a result of a metal medical condition and or immunosuppressive treatments.

All participants in cohort a will receive <unk> administered via IV infusion and the co product co primary endpoints will be safety and Tolerability and Sam neutralizing titers at day 28.

In this cohort the primary efficacy analysis will use in immuno bridging approach comparing data obtained in canopy for baidu to tissue to certain historical data from our previous clinical trial of that and driving that.

And which Sam neutralizing titers correlated with the observed clinical efficacy.

In cohort B, we plan to enroll approximately 450 participants who are at risk for exposure to <unk>, which is essentially anyone who has regular unmasked interaction with others participants in cohort b will be randomized two to one to receive <unk> or placebo administered via IV infusion.

In cohort B, the primary endpoint will be safety and Tolerability.

<unk> and exploratory endpoints will include CRM, neutralizing titers and clinical efficacy.

We plan to initiate the canopy trial with a 4500 milligram dose of <unk>, while we believe that all three doses tested in the phase one clinical trial have the potential to provide clinically meaningful protection against symptomatic COVID-19, we have decided to initiate the canopy trial with a dose that provided the highest serum <unk>.

Slides in titers against Omicron SPV one five.

This decision was informed by the Fda's preference for a conservative serum neutralizing titer benchmark and the 4500 milligram dose. We believe this dose has the potential to provide a significant duration of protection, while also providing protection against the potential loss of neutralization activity as <unk> evolves over time.

Got it.

For context based on our own data from <unk> and other clinical studies of COVID-19 maps and vaccines. We believe there is strong clinical evidence that antibody mediated protection against symptomatic COVID-19 may be achieved even at relatively low serum neutralizing titers on the order of 30 to 100, while we.

Please the 4500 milligram dose of <unk> is likely to provide titers well above the minimum level observed to provide minimum clinically meaningful protection for a significant period of time. We are excited to continue rapidly advancing the BYD <unk> program, while exploring in parallel possible off.

<unk> to leverage other doses in the future.

As currently designed all participants in the canopy trial will receive a second dose of the UAV to two to three months. After the initial dose we plan to use the observed pharmacokinetic data from the trial in combination with the neutralization potency of USD 222 against relevant circulating Sars COVID-19 two variance to modify.

Our re dosing strategy as appropriate.

With the size and design of canopy, we believe that we can quickly enrol the trial given the strong interest we have seen from trial sites and immuno compromised people to facilitate.

Enrollment in cohort, we have establish a registry of recruitment ready immunocompromised individuals for potential enrollment, we now have more than 1000 potential potentially eligible individuals in our database, which we believe speaks to the strong unmet need.

With clinical sites selected study drug available and many other activities already completed we are pleased to be on tract to initiate the canopy trial in the near term.

Shifting to the regulatory pathway as Dave briefly mentioned the FDA has indicated that the use of a correlate of protection or a surrogate of clinical efficacy in an immuno bridging approach to a pivotal clinical trial may be a reasonable approach to support an EUA request for new Mab candidates when certain criteria are met specific.

<unk> when clinical efficacy data from a prototype mab is available provided that one the new Mab candidate is similar to the prototype map such that it leverages.

Excuse me such that it leverages, a consistent manufacturing platform and has limited structural and functional differences and to the new Mab has supportive non clinical data such as favorable in vitro neutralization data against currently circulating Sars Covid two variance.

We plan to leverage this immuno bridging pathway in the U S to accelerate the clinical development of <unk> and anticipated follow on Mab candidates with our previous Mab candidate at and Trevor map, our future proprietary mab, serving as the prototype app.

We believe we are one of very few companies that can potentially meet all the criteria and utilize this accelerated development pathway for the prevention of COVID-19.

The use of that and Trevor map as the potential prototype map is proprietary to invigorate and enabled by the data from our previous phase two three clinical trial of that and Trevor map for the prevention of symptomatic COVID-19, which had clinical event endpoints.

In addition to utilizing previously generated Adam Trevor map data, we plan to use day 28 serum neutralizing titers from the immuno compromised cohort of canopy, along with safety data from both canopy cohorts to enable the clinical data package for a potential EUA submission for <unk>.

Looking outside the U S. We continue to engage with global regulatory authorities regarding the <unk> clinical development program.

In closing I'm very pleased with all the progress our team has made and I'm optimistic about the opportunity we have to make a meaningful difference in the lives of some of the most vulnerable people in our communities.

Iris is that typically cause minor illness, and immuno competent people can have devastating consequences for the immune compromised, which leads many of these individuals to self isolate from their loved ones and Miss out on many important moments in activities for the immune compromised maps have the potential to provide a robust protection from viral threats that <unk>.

Require and deserve.

With that I will turn the call over to Dave to provide an overview of our financials before we open up the call for Q&A.

Thank you Pete the details of our second quarter financials are included in the press release issued earlier today. So I won't reiterate all of the details here and vivid ended the second quarter of 2023 with $298 $4 million in cash cash equivalents and marketable securities.

Based on our current operating plans, we expect that our cash excluding any potential revenue associated with BYD <unk> will enable us to fund our operating expenses into the fourth quarter of 2024 as you may recall in past quarters, we guided to the second half of 2024 on runway, but have refined our guidance now that we are finalized.

Size of our canopy trial.

We believe that we are well capitalized to execute on our strategy and create value for our for our stakeholders with that operator. Please open the call for questions.

Thank you ladies and gentlemen, if you have a question or a comment at this time. Please press star one on your telephone.

Question has been answered you wished to move yourself from the queue. Please press star one again, we will pause for a moment, while we compile the Q&A roster.

Our first question comes from Maxwell score with Morgan Stanley . Your line is open.

Alright, Thank you for taking my questions and congrats on the updates.

Just can you elaborate a bit more on the profile of cohort B will these patients be vaccinated unvaccinated boosted and how do you plan to evaluate clinical efficacy.

Did the FDA provide guidance related to how long you have to follow these patients to fulfill the safety requirements. Thank you.

And that's a good question.

In terms of cohort B. This is what we call an all comers cohort. So we really aren't concerned with their vaccination our exposure status.

The clinical endpoints for that cohort will be as they werent abate, so symptomatic disease anyone who gets symptoms.

Symptomatic COVID-19.

In terms of follow up we Havent really stated we will put those.

Details up on clinical trials Dot Gov, when we initiate the trial.

Great. Thanks.

One moment for our next question.

Our next comes from Evan Wang with Guggenheim. Your line is open.

Hey, guys great deal of progress with the phase three.

Add some follow ups on <unk>.

I will resign.

Yes.

It does seem significantly smaller compared to the <unk> trial.

And I know there is a focus on garnering FC data.

From FDA so.

Is it smaller trial really just driven by the platform and.

Share more color on.

Turning to the second.

Second.

On enrollment and guided by year end.

Can you talk about whats remaining to get the trial started confidence in enrollment.

And what do you need both cohorts to file for approval.

Especially it seems like it positions you pretty well versus astrazeneca, what they are.

Guided by yearend.

And then.

Third.

In terms of the commercial opportunity.

No compromise in all comers.

The focus there has been an immunocompromised recently so just.

He has updated thoughts on all.

<unk> commercial opportunity thanks.

So I'll take the first part of this and then Pete you can.

Hang on so as it relates to the size of the study versus supernova.

I mean, I can't comment specifically on why their trial is the size that it is.

Not knowing that but I think what's key is we have started and had these conversations since that December FDA meeting, where they had a joint FDA EMA session talking specifically about how to accelerate.

Development in.

Against COVID-19.

And that's where they first started bringing up this prototype concept.

Then.

Certainly as we are into our phase one study, we got further detail, which we put forward in our press release talking about.

This immuno bridging concept and being able to utilize specific data from interim amount I think supernova has gone through a variety of iterations and clinical trial design, which may have impacted that.

Not really no but.

Specifically when we look at this.

Cohort a.

Allows you to get there.

Yes.

Tighter level data quickly.

A small subset of the overall trial and then cohort B gets you the necessary safety.

And that you need to pull together.

Put together a package for potential Yue.

You can talk a little bit Pete about.

Starting in enrollment in some of the other pieces that have been asked about.

Yes.

And to clarify in cohort B, it's exactly what Dave said I don't I don't think there's necessarily.

And intent to pursue a commercial opportunity there that's really just to provide the supportive safety database as it's.

As you can imagine it's easier to enroll all commerce and specifically the immune compromised.

And in terms of recruitment and what we expect I think it goes to what I was saying about this registry we created so every individual in that registry.

As identified as immune compromised.

<unk> has expressed interest in an intervention trial. So we are <unk>.

Very pleased to have that ready database of over 1000 individuals and we think that a large proportion of them will be very interested enrolling quickly.

Yes, the only thing I would add even as it relates to the commercial opportunity I mean, we are focused on the.

The vulnerable population, which could be argued to be just about all of us given the current state of protection and where we are with variance, but that said our initial focus has always been on this immuno compromised group folks who.

Have been contraindicated against vaccines et cetera.

Those who are at highest risk for severe outcomes from from COVID-19.

And in terms of activities necessary to initiate canopy. It's it's largely just the box checking stuff that you have to do before you start a trial I think we've we passed all the major hurdles.

We haven't provided specific guidance on when we're going to start but you can you can see that we did.

Say, we will release some.

Preliminary primary efficacy endpoint data by that by the end of by around the end of 2023.

Thank you one moment for our next question.

Our next question comes from Michael Yee with Jefferies. Your line is open.

Hi, Good evening. Thanks for taking my question. This is John on for Mike We have two questions.

If we may 1st question is at this upcoming year and without offering initial pivotal data what are you looking to show and what is the bar.

To replicate the phase one results, which was already great or are you looking to show even higher hydro levels.

And then second question is from that point forward.

What are the key milestones after work and how soon could you expect to be on the market. Thank you.

Yes so.

Yes.

Preliminary data that we're talking about around year end it would be similar to what we saw in the phase one that's the tighter values.

That it will be.

Based on.

An analysis for day 28, so it's slightly different than the <unk> seven phase one data that we provided there but similar in terms of we're looking for high titer values. They don't have to be.

Equivalent to the phase one but based on everything we saw from phase one its repeating that in this cohort a.

And getting some of that preliminary data and so that would confirm what we've seen in phase one and.

What we're expecting to see in canopy.

Key milestones after our right for an EUA submission you need the clinical data you need a preclinical set of activities CMC et cetera. We believe we can assemble all of that quite rapidly.

And certainly we will provide more information and guidance as we get closer.

Two.

Clinical information et cetera, but certainly it's something that we're looking to do as quickly as possible, especially as we're starting to see.

An uptick in Covid cases increase in hospitalizations et cetera, even prior to the fall and winter season, and so certainly it's not lost on us that time is of the essence and.

In a situation where there are no Matt on the market one that we're looking to rectify as quickly as we can.

Great. Thank you so much.

One moment for our next question.

Our next question comes from Patrick <unk> with HC Wainwright. Your line is open.

Thanks, Good afternoon, and congrats on all the progress I have a couple of follow up questions. First is just I'm wondering if you can talk about the new covert variant EG five what are we seeing so far with these cases of COVID-19, how different or similar as experienced excuse me.

$1 five and would you expect <unk> to retain activity against this variant.

Yeah on the first piece right and we continue to see viral evolution.

I guess one of the most critical components of the <unk> strategy right, which is we expect the virus to continue to evolve which is why we see serial innovation has the answer.

Continuing to update.

Antibodies et cetera, as it relates to EG five we're looking to pull in.

And get in vitro data on it but based on what we've seen so far our belief is that it wouldn't.

Cause.

A significant activity reduction to be <unk>.

And so we'll take a look at that now that it's the predominant variant and.

Do some additional.

Confirmatory tests et cetera I.

I do think.

We've seen a progression from the summer into now which is like I said not unexpected.

Unexpected we continue to do a variety of surveillance and predictive modeling on our side and look at mutations specifically, so even before they become specifically designated variance.

So thats, how we continue to look at what do we see coming.

Which ones would we like to start to test against how we start to bring in assays against those.

And prepare for <unk>.

Different eventualities.

Thats really like I said embedded into how invidious structured in our strategy and looking to assess and then respond to the different variances that variance as they emerge.

Great and then just a clarification question.

<unk> primary endpoint data from both cohorts, a and b at the end of 2023.

And.

Can you talk to us about the potential for government contracts for the RIDEA 222 or would this be primarily be commercialized through sort of traditional channels and methods and then just lastly can you talk about advantages of.

You're right in Q2 compared to some of these other antibodies in development for COVID-19.

And what are some of the advantages perhaps of the dosing schedule or other that.

You can point to relative to those approaches. Thank you very much.

I can take government contracts you want to take first the preliminary data we're expecting from the primary endpoints at the around the end of the year, Yes, Alex Good question. So.

Our understanding and planets actually that's we don't need the same neutralizing titer data from cohort B. There that group just serves to increase the safety database the exposure needed for an EUA. So the.

The preliminary data Youll see will just be from the immune compromised cohort, which is cohort day.

Yeah, and then related to your question about government contracts based on the current environment and transition.

We are not anticipating government contracts is the primary source or really putting much in terms of our commercial readiness related to government contracts, we are preparing for a traditional market.

Your activities related to reimbursement and payers and market access et cetera, and so that's really the focus of the team now.

We're preparing for a potential launch and being ready for that in a traditional market that.

Said.

A variety of the different acts that Congress took during the pandemic do provide.

Different reimbursements and things coverage for Medicare et cetera, and so we continue to look at all of those so even without government contracts as we saw during the pandemic there still is.

Variety of support that has been put in place for Covid related.

<unk> products.

As it relates to advantages of <unk> to two to one of the things that we've been saying for quite a while it's 222 is.

Our re engineered version of our original antibody <unk> and.

We did this through an affinity maturation process and did it.

Looking at the <unk>.

Backbone of omicron into with a set of slight changes.

Assets, we are able to reestablish binding where ADT 20 has lost <unk> <unk> came from our Starz Kobe, one survivor and <unk>.

And so we continue to see that <unk> has broad neutralizing activity.

And it's one that we really see.

<unk> is an antibody that to date.

Has not occurred.

A natural setting and so we feel that it provides us a higher.

Probability of duration of activity.

And so that's what we continue to look at and test, but we think thats, probably the most critical advantage, which is being able to have prolonged activity as our hypothesis for.

222 beyond that.

We continue to see that by utilizing the <unk>. The <unk> data that allows this platform as well to be quite a significant advantage as we said we see.

<unk> is one of a few companies who could utilize existing <unk>.

Data that was done previously and.

And thats quite an advantage as it relates to.

Pursuing eua's and a much faster fashion than running full clinical endpoint studies, especially.

Especially given the current.

Environment and looking to recruit patients.

Great. Thank you so much.

And im not showing any further questions I turn the call back over to Dave for any closing remarks.

Well. Thank you all for joining the call today, the very exciting timeframe vivid as we get closer to milestones that we believe would be quite.

Quite impactful for patients our organization and shareholders. We thank you for your continued support and interest in <unk> and we will look forward to catching up with any of you individually over the coming days. Thank you so much ladies.

Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.

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Welcome to the <unk> second quarter, 2023 business and financial results and update call I will now turn the call over to Gabriel <unk> director of external communications.

Thank you for joining us today before we get started I want to turn to a few housekeeping items.

To review our press release discussing our second quarter 2023 financial results and business updates, which can be found on the investors section of the <unk> website.

I'd like to remind you that during today's discussion, we'll be making several forward looking statements forward looking.

These statements include statements concerning among other things the future of the COVID-19 landscape, our ongoing research and clinical development plan, including the timing of these plans.

Our regulatory and commercialization plan strategy and opportunity our expected cash runway and other statements that are not historical fact.

It is now my pleasure to introduce <unk> management team to the call I am joined by Dave Henry CEO and.

And Dr. Piet Schmidt, Chief Medical Officer, and I will now turn the call over to Dave.

Thanks, Gabriella and thank you to everyone joining us today on our quarterly update call in Q2 in the recent weeks, we've made significant progress towards our goal of commercializing <unk> in the near term.

And advancing our mission to protect vulnerable people from serious viral threats.

Our last call, we have announced positive initial safety data and robust neutralizing titer data from our ongoing <unk> phase one clinical trial.

Shortly Pete will provide additional color on the initial phase one clinical trial results and our plans to rapidly initiate a 750 participant pivotal clinical trial of <unk> for the prevention of symptomatic COVID-19 referred to as the canopy trial.

We look forward to initiating the canopy trial in the near term and expect to have initial primary endpoint data by approximately the end of 2023.

In Q2, we also announced that we reached general alignment with the FDA on our pathway to a potential EUA for <unk> and anticipated follow on candidates designed to prevent symptomatic COVID-19.

We are very encouraged by the rapid development pathway outlined by the FDA and the opportunity it provides to leverage our previous work developing developing in <unk> to accelerate the development of <unk>.

We believe we are one of very few companies positioned to potentially meet the criteria that the FDA outlined for this streamlined development pathway.

Importantly, with this pathway, we see a near term opportunity to bring much needed protection from symptomatic over 19%.

No compromise people.

Before I hand, the call over to Pete to talk about our plans for the transformational period ahead I want to briefly underscore three important points first.

First the need to protect vulnerable populations from COVID-19 remains as urgent as ever.

Nino compromise people continued to be at higher risk for severe COVID-19 related outcomes and more broadly COVID-19 continues to be a delta threat.

Roughly halfway through 2023 before we have even entered the fall and winter months. The CDC estimates that more than 43000 deaths in the U S are attributable to COVID-19 this year.

That is more than 43000 deaths, where COVID-19 was listed as the underlying cause or a contributing cause of deaths on the death certificate.

For context consider that RSV is estimated to cost roughly 14000 deaths per year in the U S.

The group's at highest risk for RSV and the pre COVID-19 levels for flu related deaths have fluctuated between 23000 52000 deaths per year in the United States.

COVID-19 remains a substantial driver of morbidity as well the National Center for Health Statistics estimates that roughly $1 seven adults in the U S have experienced long COVID-19 at some point, which adds to the unique and unacceptable burden of this disease.

While many have accepted the status quo and are trying to live with Covid. We continue to argue that all are not living well, particularly vulnerable population.

Second we believe that protecting immunocompromised people from COVID-19, as a large ongoing need and opportunity.

In the U S alone there are an estimated $8 million to $18 million immunocompromised people, who may not generate robust protection from vaccines.

To our knowledge and vivid is one of very few companies in the clinic now with a monoclonal antibody candidate in development for the prevention of COVID-19 in this population.

Consider that have you sold alone captured $2 2 billion in total revenue in 2022 with strong growth prior to its removal from the market when it lost activity against emerging stars koby to variance of concern.

In the coming periods, we look forward to sharing more insights from the market research. We've conducted to further refine our understanding of the different immunocompromised populations and the views of the clinicians who care for the different types of patients who may be chronically are temporarily immuno compromised.

Third we believe that <unk> is uniquely positioned to rapidly and perpetually deliver Matt therapies that can keep pace with viral evolution and protect the vulnerable.

Ian.

To anticipate and quickly respond to viral evolution, we are leveraging state of the art viral surveillance predictive modeling and advanced antibody engineering techniques designed to generate a pipeline of optimized mab candidates that could be deployed in the future.

We see COVID-19, as the optimal starting point for <unk> due to the speed with which products can be brought to the market using the EUA pathway.

From there we believe that our platform can also be applied to protect vulnerable people from other viral threats such as influenza an area, where we have an early discovery stage program.

I will now pass the call to Peach meant our chief Medical officer to discuss in more detail. Our initial phase one data pivotal clinical trial plans and regulatory pathway.

Thank you Dave.

Excuse me we are pleased to have recently shared positive initial data from our ongoing phase one clinical trial of <unk>, <unk>, two which enrolled 30 healthy volunteers across three different dosing cohorts.

Cohort participants were randomized <unk> to <unk> or placebo.

The initial phase on clinical trial data showed that a single administration of <unk> <unk> was generally well tolerated at all three dose levels tested with no serious adverse events reported as expected we saw a dose dependent increase in serum neutralizing titers against omicron ex VB one five.

At the lowest dose tested 500 milligrams. The geometric mean CRM neutralizing titers were 3245 against <unk> one five at day seven at geometric mean 39 fold rise from baseline at the 2500 milligram dose the titers were 9647 at the.

<unk> 4500 milligram dose the titers were 16865.

As a point of reference even the lowest <unk> two dose tested resulted in higher CRM neutralizing titers against Omicron STB. One five then the tighter shared at the recent vaccines Advisory Committee meeting from investigational SPV targeted vaccines that were administered to adults who are not on.

Immunosuppressive treatments.

Higher <unk> doses resulted as expected and higher tighter levels that were well above those reported vaccine tighter levels.

CRM neutralizing titer data are meaningful because COVID-19 vaccine and map clinical trials, including our past phase two three <unk> clinical trial for the prevention of COVID-19 referred to as of aid have demonstrated that serum neutralizing titers are correlated with the prevention of COVID-19.

This correlation has also been observed in immune compromised individuals receiving ever shelf <unk> targets. The spike protein receptor binding domain of Sars Covid two like <unk>.

In cohort <unk>, we expect to enroll approximately 300 participants who are significantly immune compromised. This cohort may include for example people who are actively being treated for solid tumors people with hematological malignancies, such as acute leukemia or multiple myeloma, regardless of treatment status as well as other.

Groups of people, who have weakened immune systems as a result of our metal medical condition and or immuno suppressive treatments. All participants in cohort a will receive <unk> administered via IV infusion and the co product co primary endpoints will be safety and Tolerability and serum neutralizing titers that.

<unk> 28.

In this cohort the primary efficacy analysis will use in immuno bridging approach comparing data obtained in canopy for <unk> tissue to certain historical data from our previous clinical trial of <unk> in which Sam neutralizing titers correlated with observed clinical efficacy.

In cohort B, we plan to enroll approximately 450 participants who are at risk for exposure to <unk>, which is essentially anyone who has regular unmasked interaction with others.

<unk> in cohort B will be randomized two to one to receive <unk> or placebo administered via IV infusion.

Cohort B the primary endpoint will be safety and Tolerability secondary and exploratory endpoints will include CRM, neutralizing titers and clinical efficacy.

We plan to initiate the canopy trial with a 4500 milligram dose of <unk>.

While we believe that all three doses tested in the phase one clinical trial have the potential to provide clinically meaningful protection against symptomatic COVID-19, we have decided to initiate the canopy trial with a dose that provided the highest serum neutralizing titers against omicron SPV one five.

This decision was informed by the Fda's preference for a conservative serum neutralizing titer benchmark and a 4500 milligram dose. We believe this dose has the potential to provide a significant duration of protection, while also providing protection against the potential loss of neutralization activity as Sars Covid two evolves over time.

Yeah.

While we believe the 4500 milligram dose of <unk> is likely to provide titers well above the minimum level observed to provide minute minimum clinically meaningful protection for a significant period of time. We are excited to continue rapidly advancing the BYD <unk> program, while exploring in parallel.

While opportunities to leverage other doses in the future.

As currently designed all participants in the canopy trial will receive a second dose of the UAV to two to three months. After the initial dose we plan to use the observed pharmacokinetic data from the trial in combination with the neutralization potency of <unk> against relevant circulating Sars COVID-19 two variance to modify.

Our re dosing strategy as appropriate.

With the size and design of canopy, we believe that we can quickly enrol the trial given the strong interest we have seen from trial sites and immuno compromised people to facilitate enrollment in cohort we have establish a registry of recruitment ready immunocompromised individuals for potential enrollment, we now have more than 1000.

Potential potentially eligible individuals in our database, which we believe speaks to the strong unmet need.

With clinical sites selected study drug available and many other activities already completed we are pleased to be on tract to initiate the canopy trial in the near term.

Shifting to the regulatory pathway as Dave briefly mentioned the FDA has indicated that the use of a correlate protection or a surrogate of clinical efficacy in an immuno bridging approach to a pivotal clinical trial may be a reasonable approach to support an EUA request for new Mab candidates when certain criteria are met.

<unk> when clinical efficacy data from a prototype mab is available provided that one the new Mab candidate is similar to the prototype map such that it leverages.

We plan to leverage this immuno bridging pathway in the U S to accelerate the clinical development of <unk> and anticipated follow on Mab candidates with our previous Mab candidate, adding Trevor map, our future proprietary mab, serving as the prototype app.

We believe we are one of very few companies that can potentially meet all the criteria and utilize this accelerated development pathway for the prevention of COVID-19.

In addition to utilizing previously generated Adam Trevor map data, we plan to use day 28, Sarum neutralizing titers from the immuno compromised cohort of canopy, along with safety data from both canopy cohorts to enable the clinical data package for a potential EUA submission for <unk>.

Looking outside the U S. We continue to engage with global regulatory authorities regarding the <unk> clinical development program.

In closing I am very pleased with all the progress our team has made and I'm optimistic about the opportunity we have to make a meaningful difference in the lives of some of the most vulnerable people in our communities.

Viruses that typically cause minor illness, and immuno competent people can have devastating consequences for the immune compromised, which leads many of these individuals to self isolate from their loved ones and Miss out on many important moments in activities for the immune compromise maps have the potential to provide a robust protection from viral threats.

They require and deserve.

With that I will turn the call over to Dave to provide an overview of our financials before we open up the call for Q&A.

Thank you Pete the details of our second quarter financials are included in the press release issued earlier today, So I won't reiterate all of the details here.

<unk> ended the second quarter of 2023 with $298 $4 million in cash cash equivalents and marketable securities.

Based on our current operating plans, we expect that our cash excluding any potential revenue associated with <unk> will enable us to fund our operating expenses into the fourth quarter of 2024 as you may recall in past quarters, we guided to the second half of 2024 on runway, but have refined our guidance now that we are finalized.

Size of our canopy trial.

We believe that we are well capitalized to execute on our strategy and create value for our for our stakeholders.

Holders with that operator, please open the call for questions.

Thank you ladies and gentlemen, if you have a question or comment at this time. Please press star one on your telephone. If your question has been answered or you wish to move yourself from the queue. Please press star one again, we will pause for a moment, while we compile the Q&A roster.

Our first question comes from Maxwell score with Morgan Stanley . Your line is open.

Yes.

Alright, Thank you for taking my questions and congrats on the updates.

Just can you elaborate a bit more on the profile of cohort b will be patients be vaccinated unvaccinated boosted and how do you plan to evaluate clinical efficacy.

So did the FDA provide guidance related to how long you have to follow these patients to the fulfill the safety requirements. Thank you.

And that's a good question.

In terms of the cohort B. This is what we call an all comers cohort. So we really aren't concerned with their vaccination our exposure status.

The clinical endpoints for that cohort will be as they werent abate, so symptomatic disease anyone who gets symptomatic COVID-19.

In terms of follow up we Havent really stated we'll put those.

Details up on clinical trials Dot Gov, when we initiate the trial.

Great. Thanks.

One moment for our next question.

Our next comes from Evan Wang with Guggenheim. Your line is open.

Hey, guys great deal of progress with the phase three.

Add some follow ups.

Trial design.

Yes.

It does seem significantly smaller compared to the <unk> trial.

And I know there is a focus on garnering FC data.

From FDA so.

Is it smaller trial really just driven by the platform.

Share more color on.

Second.

On enrollment and done by year end.

Can you talk about whats remaining to get the trial started competence enrollment.

And what do you need both cohorts to file for approval.

Especially it seems like it positions, you pretty well versus Astrazeneca with <unk>.

Got it by year end.

And then.

But in terms of the commercial opportunity.

Improvise on all comers.

The focus there immunocompromised recently so just.

I Wonder if you have updated thoughts on all commercial commercial opportunity. Thanks.

So I'll take the first part of this and then Pete you can.

So as it relates to the size of the study versus supernova.

I mean, I can't comment specifically on why their trial is the size that it is.

Knowing that but I think what's key is we have started and had these conversations since that December FDA meeting, where they had a joint FDA EMA a session talking specifically about how to accelerate Matt.

<unk> development in.

COVID-19, and that's where they first started bringing up this prototype concept.

And then.

Certainly as we are into our phase one study, we got further detail, which we put forward in our press release talking about.

This immuno bridging concept and being able to utilize specific data from interim amount I think supernova has gone through a variety of iterations on clinical trial design, which may have impacted that I don't really know but.

Specifically when we look at this.

Cohort a.

Allows you to get there.

This tighter level data quickly.

In a small subset of the overall trial and then cohort B gets you the necessary safety.

And that you need to pull together.

Put together a package for potential Yue.

You can talk a little bit Pete about.

Starting in enrollment in some of the other pieces that Evan asked about.

Yeah and.

And to clarify in cohort B, it's exactly what Dave said I don't I don't think there's necessarily.

And intent to pursue a commercial opportunity there that's really just to provide the supportive safety database as its.

As you can imagine it's easier to enroll all commerce than specifically the immune compromised.

And in terms of recruitment and what we expect I think it goes to what I was saying about this registry we created so every individual in that registry.

Has identified as immune compromised.

And has expressed interest in an interventional trial. So we are <unk>.

Very pleased to have that ready database of over 1000 individuals and we think that a large proportion of them will be very interested enrolling quickly.

Yes, the only thing I would add even as it relates to the commercial opportunity I mean, we are focused on the.

Have been contraindicated against vaccines et cetera.

Those who are at highest risk for severe outcomes from from COVID-19.

And in terms of activities necessary to initiate cannot be it's it's largely just the box checking stuff that you have to do before you start a trial I think we passed all of the major hurdles.

We haven't provided specific guidance on when we're going to start but you can you can see that we did.

Say, we will release some.

Preliminary primary efficacy endpoint data by that by the end of by around the end of 2023.

Thank you one moment for our next question.

Our next question comes from Michael Yee with Jefferies. Your line is open.

Hi, good evening, Thanks for taking our question this.

This is John on for Mike.

Two questions. If we may 1st question is at this upcoming year and readout often initial pivotal data what are you looking to show and what is the bar.

Are you looking to replicate the phase one results, which was already great or are you looking to show even higher levels.

And then second question is from that point forward.

What are the key milestones after work and how soon could you expect to be on the market. Thank you.

Yes so.

Yes.

The preliminary data that we're talking about around year end it would be similar to what we saw in the phase one that's the tighter values.

That it will be.

Based on.

Analysis for day 28.

Lightly different than the <unk> phase one data that we provided there but similar in terms of we're looking for high titer values. They don't have to be.

Equipment to the phase ones, but based on everything we saw from phase one its repeating that in this cohort a.

And getting some of that preliminary data and so that would confirm what we've seen in phase one and.

What we're expecting to see in canopy.

Key milestones after our right for an EUA submission you need the clinical data you need a preclinical set of activities CMC et cetera. We believe we can assemble all of that quite rapidly and.

And certainly we'll provide more information and guidance as we get closer.

To this clinical information et cetera.

But certainly it's something that we're looking to do as quickly as possible, especially as we're starting to see.

An uptick in Covid cases, an increase in hospitalizations et cetera, even prior to the fall and winter season, and so certainly it is not lost on us that time is of the essence and.

In a situation where there are no <unk> on the market one that we're looking to rectify as quickly as we can.

Great. Thank you so much.

One moment for our next question.

Our next question comes from Patrick <unk> with HC Wainwright. Your line is open.

Thanks, Good afternoon, and congrats on all the progress I have a couple of follow up questions. First is just I'm wondering if you can talk about the new Covid variant EG five what are we seeing so far with these cases of COVID-19, how different or similar as experienced excuse me $1 five and would you expect <unk> to retain activity against this.

Great.

Yeah on the first piece right and we continue to see viral evolution.

I guess one of the most critical components of the <unk> strategy right, which is we expect the virus to continue to evolve which is why we see serial innovation has the answer.

Continuing to update.

Antibodies et cetera, as it relates to EG five we're looking to pull in.

And get in vitro data on it but based on what we've seen so far our belief is that it wouldn't.

Cause.

A significant activity reduction to be <unk>.

So we will take a look at that now that it's the predominant variance and.

Do you have some additional.

Confirmatory tests et cetera I.

I do think.

We've seen a progression from the summer into now which is like I said not unexpected.

Unexpected we continue to do a variety of surveillance and predictive modeling on our side and look at mutations specifically, so even before they become specifically designated variance.

So thats, how we continue to look at what do we see coming.

Which ones would we like to start to test against how we start to bring in assays against those.

And prepare for <unk>.

Different eventualities.

Thats really like I said embedded into how in vivid as structured in our strategy and looking to assess and then respond to the different variances that variance as they emerge.

Great and then just a clarification question.

Mutation that have primary endpoint data from both cohorts, a and b at the end of 2023.

And.

Can you talk to us about the potential for government contracts for <unk> or would this be primarily be commercialized through sort of traditional channels and methods and then just lastly can you talk about advantages of.

Youre right Q2 tiered compared to some of these other antibodies in development for COVID-19.

And what are some of the advantages perhaps of the dosing schedule or other that.

You can point to relative to those approaches. Thank you very much.

I can take government contracts you want to take first the preliminary data we're expecting from the primary endpoints at the around the end of the year, Yes, Alex Good question. So.

Our understanding and plan, it's actually that's we don't need the same neutralizing titer data from cohort B. There that group just serves to increase the safety database the exposure needed for an EUA. So the.

The preliminary data Youll see will just be from the immune compromised cohort, which is cohort day.

Yeah, and then related to your question about government contracts based on the current environment and transition.

We are not anticipating government contracts is the primary source or really putting much in terms of our commercial readiness related to government contracts were preparing for our traditional market.

Your activities related to reimbursement and payers and market access et cetera, and so thats really the focus of the team now.

We're preparing for a potential <unk>.

Launch and being ready for for that in a traditional market that.

Said a.

A variety of the different acts that Congress took during the pandemic do provide.

Different reimbursements and things coverage for Medicare et cetera, and so we continue to look at all of those so even without government contracts as we saw during the pandemic there still is.

A variety of support that has been put in place for Covid related.

Products.

As it relates to advantages of <unk> to two to one of the things that we've been saying for quite a while is 222 is.

Our re engineered version of our original antibody <unk> <unk> and <unk>.

We did this through an affinity maturation process.

And did it.

Looking at the <unk>.

Backbone of omicron into with a set of slight changes.

Assets, we are able to reestablish binding where ADT 20 has lost <unk> <unk> came from <unk> Koby, one survivor and <unk>.

And so we continue to see that <unk> has broad neutralizing activity.

And it's one that we really see as a as an antibody that to date.

Has not occurred in a.

A natural setting and so we feel that it provides us a higher <unk>.

<unk> ability of duration of activity.

And so that's what we continue to look at and tests, but we think thats, probably the most critical advantage, which is being able to have prolonged activity as our hypothesis for.

222 <unk>.

Beyond that.

We continue to see that by utilizing the <unk>. The <unk> data that allows this platform as well to be quite a significant advantage as we said we see.

That <unk> is one of a few companies who could utilize existing.

Data that was done previously.

That's quite an advantage as it relates to.

Pursuing <unk> in a much faster fashion than running full clinical endpoint studies, especially.

Especially given the current.

Environment and looking to recruit patients.

Okay. Thank you so much.

And im not showing any further questions I turn the call back over to Dave for any closing remarks.

Well. Thank you all for joining the call today, it's a very exciting time for and vivid as we get closer to milestones that we believe would be quite.

Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.

Q2 2023 Invivyd Inc Earnings Call

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