Q3 2023 Invivyd Inc Earnings Call
Yeah.
Yeah.
Welcome to the envision third quarter 2023 financial results and recent business highlights call.
At this time all participants are in a listen only mode. After the Speakers' prepared remarks, there'll be a question and answer session. Please be advised that today's conference call is being recorded.
Like to hand, the conference over to you Scott Young Senior Vice President of Investor Relations and corporate Communications. Please go ahead.
Thank you operator, a short while ago, we issued a press release announcing our third quarter 2023 financial results and business highlights that press release and the slides, we're using today and the webcast can be found in the investors section of the exhibit website under news and events.
Today's discussion will be led by Dave Harry <unk>, Chief Executive Officer.
He is joined by Dr. Piet Schmidt, Chief Medical Officer, Jeremy <unk>, Chief operating and commercial officer, and build to Chief Financial Officer.
During today's discussion, we will be making forward looking statements concerning among other things the future of the COVID-19 landscape, our ongoing research and clinical development plans, including the timing of these plans are regulatory and commercialization plans strategies and opportunities, including the timing.
Are these plants, our expected cash runway and other statements that are not historical fact.
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 cause our actual results to differ materially from those expressed or implied today.
These forward looking statements speak only as of the date of this call and <unk> assumes no duty to update such statements.
Additional information on the risk factors that could affect <unk> business can be found in our filings made with the U S Securities and Exchange Commission, including our most recent Form 10-K, which is also available on our website.
I will now turn the call over to Dave.
Thanks, Scott and thank you all for joining.
As you can see on slide three we have a full agenda for today's call I'll begin by reviewing a few of our recent business highlights and key achievements in the third quarter and then I'll provide some color on the current COVID-19 landscape and the very real and continued threat the disease presents to the immuno compromised and other vulnerable individuals.
Pete will then discuss canopy, our phase III pivotal clinical trial investigating <unk> for the prevention of symptomatic COVID-19.
And review our latest in vitro data demonstrating the antibodies in vitro neutralizing activity against recent Sars Covid two variance.
Jeremy will then provide an update on some of the critical work that he and his team have been doing in preparation for a potential emergency use authorization or EUA, which is issued could enable a commercial launch of <unk>. In 2024. This is the first time Jeremy has joined an earnings call. So by way of quick introduction.
He has served as our chief operating and commercial officer since December of 2022.
Jeremy has more than 20 years of commercial leadership experience.
Ross all stages of product lifecycle, he joined us from Sandoz, where he served as the global commercial head of the Biopharma business and had responsibility for the launches of their late stage pipeline assets as well as the established commercial portfolio.
Before we open the call for Q&A BELBUCA will review, our third quarter financial performance and share our latest cash runway guidance.
Bill joined US in September as Chief Financial Officer, and it is a pleasure to have them with us today.
Bill brings more than 25 years of experience, including more than a decade of senior leadership experience in the biotechnology industry during.
During this short time within vivid he has already proven himself to be a tremendous addition to our executive team and his knowledge and leadership will be invaluable to us as we prepare for a potential transition to a revenue generating commercial company.
Moving to slide four I am tremendously proud of the progress. Our team has made this year executing to plan as referenced in today's earnings release in September less than six months after initiating a phase one clinical trial of <unk> two we dosed the first participant in canopy, our phase III pivotal trial investigating BYD.
<unk> for the prevention of symptomatic COVID-19 today just eight weeks later, we are pleased to announce that we've completed enrollment in the <unk> trial with approximately 750 participants enrolled including approximately 300 immunocompromised individuals.
We cannot be advancing swiftly we continue to anticipate having initial primary endpoint data from this study in late 2023 or early Q1 2024, given the pressing unmet medical need our goal remains to apply for an EUA in the U S. As soon as practicable, assuming the data we see as supportive for the requisite clinical.
<unk> non clinical and CMC data packages.
The speed and.
Efficiency of our progress are a testament to the dedication and focus of the outstanding team, we have assembled and speak clearly to the fact that COVID-19 remains a significant health concern, particularly for immunocompromised individuals in the U S. Who currently have no authorized monoclonal antibodies available for them for pre exposure prophylaxis or pep.
Of COVID-19.
This large unmet medical need is yet another consequence of the virus's relentless ability to mutate and overtime render therapeutics ineffective.
Precisely why we have strategically positioned ourselves to keep pace with viral viral evolution through our proprietary platform approach, which we have trademarked in the mab.
<unk> is an important near term value driver for in vivid.
We believe <unk> is the engine, which holds the potential to power our success for years to come the <unk> platform combines state of the art viral surveillance and predictive modeling with advanced antibody engineering through our internal expertise and collaborations such as our partnership with Adam Adam while working to advance <unk> two.
Through to a potential EUA submission in parallel we have also been working to identify and optimize mab candidates that can be deployed in response to ongoing stars <unk> evolution.
We also continue to engage in constructive dialogue with the FDA regarding potential pathways that will enable us to fully leverage our <unk> platform approach to rapidly and perpetually deliver monoclonal antibody candidates.
We are pursuing an approach that would in some respects mirror the process used to authorize the annual flu and Covid vaccine. While there is much work ahead of US. We are very pleased with our progress to date and look forward to sharing more details in the quarters ahead.
Before I turn the call over to Pete I would just make a few points about the current state of Covid and the clear and urgent need for new monoclonal antibodies.
While many people with healthy immune systems have learned to live with Covid and accepted as a part of the new normal that simply isn't an option for the immuno compromised they faced distinct risks and challenges, which remain as acute today as they did during the height of the pandemic.
As you can see on slide five new data continue to emerge that highlight the disproportionate burden that COVID-19 has on vulnerable populations in October real World evidence was published from the inform study which looked at the impact of COVID-19 in 2022 using data from a sample of nearly 12 million people in England.
<unk>.
Our results show that immunocompromised individuals accounted for only three 9% of the overall study population, but roughly 25% of all COVID-19, hospitalizations ICU admissions and death.
Even though more than 80% of this population had received three or more COVID-19 vaccine <unk>.
Furthermore, certain immunocompromised populations, such as solid Oregon in stem cell transplant recipients and those recently treated for blood cancers had greater than tenfold increases and risk compared to those without these conditions.
Also in October real World evidence was published from a study referred to as the Epic study, which looked at a sample of nearly 17 million people and a large U S. Commercial health insurance plan and COVID-19 infections between early 2020 and early 2022.
In this study immunocompromised individuals accounted for two 7% of the population Unsurprisingly epic found that people who are immunocompromised, we're more likely to get COVID-19 than people, who are not with about 14% of the immuno compromised people being diagnosed with COVID-19 infection.
Of those individuals' 24, 24% were hospitalized with amines day up 15 days and the mean cost of $64000 per patient.
These data underscore the heavy human and financial toll that COVID-19 takes on this population and serve as a powerful motivation for us to get <unk> and future antibodies authorized and available as quickly as possible for vulnerable individuals.
With that I'll turn it over to Pete.
Thank you Dave.
As Dave mentioned mutation is an expected an inherent characteristic of <unk> as it continues to circulate with regards to the recent variance as you can see on slide six we are pleased to report that our latest in vitro sooner virus testing shows that <unk> retains neutralization activity against.
The recent Sars Covid two variance tested such as ex TV, one five SBB, one six and SBB, one $5 10, which is an SPV variant with the same spike glycoprotein sequence as EG five including the F 456, <unk> mutation in the Spike.
Based on the now cast estimates provided by the CDC, we estimate that approximately 80% of the current CDC tracked variance are now ex BB lineage variance with the F 456 al mutation movie.
Moving to slide seven I am very proud of the impressive progress that our team and our study partners have made this quarter to advance our canopy trial as Dave mentioned, we recently completed enrollment in our canopy trial and continue on plan continue on plan to have initial primary endpoint data in late 2023.
Our early Q1 2024.
As a reminder, canopy has two cohorts cohort we enrolled approximately 300 individuals who are significantly immune compromised all participants in cohort <unk> received <unk>.
For cohort a co primary endpoints are safety and Tolerability and CRM neutralizing titers at day 28 against relevant Sars Covid, two variance, which will be calculated based on the pharmacokinetic concentration of <unk> <unk> from the immunocompromised participants and the IC 50 value for <unk>.
Two against relevant Sars Covid two variance.
In cohort B, we enrolled approximately 450 individuals who are at risk for exposure to <unk>, which is essentially anyone who has regular unmasked interactions with others.
<unk> in cohort B were randomized two to one to receive <unk> or placebo. The primary endpoint for cohort B is safety and Tolerability and the primary purpose of this cohort is to build out the safety database for <unk>.
The primary efficacy analysis for canopy will use in immuno bridging approach comparing data obtained from the immunocompromised cohort to certain historical data from our previous clinical trial of <unk> for the prevention of symptomatic, Covid, 19, and which Sam neutralizing titers correlated with observed clinical efficacy.
Our team is laser focused on executing mechanically trial and preparing for a potential EUA submission as soon as practicable.
As we've anticipated the FDA continues to utilize the EUA pathway to authorize new products, including the latest mrna vaccines for certain age groups. Furthermore, the design of our canopy trial reflects the input we've received from the FDA on an immuno bridging pathway to a potential EUA for new mab candidates that meet certain criteria.
Syria, which we believe <unk> satisfies.
To prepare for the potential launch of <unk>. Our teams have also been engaging in appropriate scientific exchange with the medical community and key opinion leaders and we are raising awareness of monoclonal antibodies for COVID-19, with various patient groups to date, we've engaged with more than 35 different patient organizations many of that advocate.
For populations that may have a reduced immune response to vaccines.
With that I will now pass the call to Jerry.
Thank you, Steve as BYD Q2 to rapidly advance through the clinic and approaches the potential EUA submission, our commercial plans and preparation or feature more prominently internally as well as hunter discussion with investors. So it was a pleasure to join today's call to share a bit more color about the market opportunity and the many activities. We are undertaking as we gear.
For a potential launch.
Turning to slide eight based on our extensive market research. We believe there is a significant market opportunity with more than $9 million immunocompromised people at risk for severe COVID-19 in the U S.
Looking at the chart on the left the X axis shows the risk of severe COVID-19, and the Y axis is expected uptick if a COVID-19 map based on aggregated results from a survey we conducted with specialty HCP in the U S.
Importantly, this market is comprised of different subgroups with varying degrees of risk and expected uptake.
At the top far right of the chart you can see that there are approximately 485000 people who are at the highest risk even at the highest expected uptick based on our market research. We can further refine the population into several key subgroups, including approximately 67000 stem cell transplant recipients 86000 solid order.
Transplant recipients and 332000 people with hematologic lymphatic cancer with <unk>.
See a clear opportunity to impact fully enter the market utilizing an efficient sales footprint to target certain subgroups of patients and providers initially and expand to additional groups over time.
Turning to slide nine we have many activities underway to prepare for a potential <unk> launch if authorized for example go to market planning is underway such as market research with Hcp's market sizing and segmentation brand strategy and field force sizing work with regards to our market research and a recent.
Survey, we conducted with nearly 200 U S physicians, who treat different types of immunocompromised patients.
76% of respondents said, they would be extremely likely or somewhat likely to use every show a previously authorized.
For COVID-19 for their immunocompromised patients if it were still available and relevant circulating.
Strength.
We believe that this result, underscores the ongoing market opportunity.
With regard to market access if authorized we expect to commercialize <unk> under the traditional sales model rather than through the large government purchases and stockpiling as we saw with COVID-19 products in the past in anticipation of launch we have payor and pricing work underway and are preparing our distribution models and chat.
Yes.
With a step wise approach, we believe that we can be very effective in getting BYD. Two Q2 to key health systems in populations with a relatively small sales footprint.
We have also started manufacturing would be white <unk> commercial inventory, the wuxi and they continue to be an outstanding partner to us as we make excellent progress preparing for the CMC package that will be part of our anticipated EUA submission.
With respect to the caliber of our commercial organization from the top we have Dave who played a pivotal role in the launch of the first COVID-19 vaccine as the global mrna business with franchise leave for Pfizer.
And we have brought onboard experienced leaders to head up our market access sales and marketing functions.
The seasoned team has collectively launched multiple successful products to address infectious disease.
Our team has been working diligently and I'm very pleased with all of the progress we've made to prepare for the potential emergency use authorization and we are excited for the potential launch of <unk> in 2024, if authorized while we are currently focused on launching in the U S by ourselves with a contract field force we are actively exploring potential.
Gartner ships in collaborations.
With that I will now turn it over to bill to provide an overview of our financials.
Thank you Jeremy I'm excited to have enjoyed joined the <unk> team at such a potentially transformative period for the company.
I've been very impressed by the team's ability to execute to plan and buy the nimble highly motivated teams that are driving and visits work forward at a remarkable pace.
I see great potential in and visit strategy and platform based approach and believe that <unk> is poised to make a meaningful difference in the lives of thousands of vulnerable people in United States, who have been without access to a map for COVID-19 prevention for far too long.
Turning to the financials on slide 10.
The details of our third quarter financials are included in the press release, we issued earlier today.
So I won't reiterate all the members here.
<unk> ended the third quarter of 2023 with approximately $265 million in cash cash equivalents and marketable securities.
Based on current operating plans, we continue to expect that our cash excluding any potential revenue associated with the <unk> two <unk> will enable us to fund our operating expenses into the fourth quarter of 2024.
Regarding our efforts and resources as you have heard today, we are actively preparing for the potential authorization and launch a BYD two to two <unk>.
Including the manufacturing of an additional commercial supply.
We will continue to deliberately manage our expenses as we rapidly advanced our work on timelines that are significantly compressed compared to traditional biotech programs.
With that operator, please open the call for questions.
Thank you so I'll ask a question. Please press star one on your telephone and wait for name.
To be announce toy draw. Your question. Please press star one again.
Hey, Sam bilingual compile the Q&A roster.
One moment for our first question.
Our first question comes from the line of Patrick <unk> from H C. Wainwright. Your line is open.
Thanks.
Evening and congrats on all the progress.
The first question is just on the enrollment completion in the kind of the phase III trial can you remind us what we need to see in terms of day 28 PM neutralizing titers and at each dose that would give confidence in the <unk> submission and then just on the EUA submission of clarification. It sounds like you are.
Submit following the primary endpoint data from cohort.
Is that accurate and separately what role if any with the one three re dosing data in cohort and data from cohort b have in terms of gaining or maintaining the EUA.
Yes, Thanks, Patrick I'll, let Pete answer the first of all the question I can tackle the one about.
As we're preparing for a potential EUA submission.
Yes, the primary endpoint at day 28 is that immuno bridging endpoint of serum neutralizing titers as compares to historical data from the outage up in that trial.
Right.
We've talked about the EUA submission package that we're working on is a combination of clinical non clinical and CMC.
Pivotal data from canopy is one element of that and it's certainly one of the components that we're looking at and pulling this together.
And then and in parallel we're working on the additional supportive data.
From the from the other elements as we work towards this potential EUA submission.
Got it that's helpful and then if I could just a few on the commercial launch preparations.
Follow up on that in greater detail, specifically with regard to the scale up in manufacturing and payer discussions are there any particular reimbursement codes or other aspects of the launch that are unique for this type of launch, particularly with regard to payer coverage and then just as it regards slide.
As a broad group of patients who could benefit from <unk>. So I'm wondering if you can discuss the expected launch trajectory, how you're kind of deciding how to manufacture at this stage.
And if there is any particular immuno compromised patients that would be the focus or would this be a broader effort for the launch of <unk> received authorization.
Yes, I'll, let Jeremy talk to the first question about payers and I can help a little bit more with the.
Focus for the launch yes. Thanks, Patrick there are several steps were taken to ensure that we have the appropriate market access plan in place, which includes coding et cetera.
We don't.
At this time its premature for us to really give specifics on that but we are working to be ready when it comes to launch given we're still pre EUA.
Yes, just as it regards to slide eight.
So we've now through our own market research really catalog this $9 million.
Immune compromised.
The population we've talked about this is really a subset of vulnerable which can include people who are contra indicated for vaccines et cetera, but where we really.
Our planning the focus of the initial launches in that upper right quadrant that 485000 people and as it lifts here folks who are stem cell transplant recipients solid organ transplants and the variety of blood cancer.
Patients in those areas.
As Jeremy mentioned, partly that's because these are the people who are the highest risk and certainly.
Also the ones who are expected to have the highest uptake and then it also represents an efficient.
Way for us to bring the product to market looking at contract sales forces et cetera, given the relatively consolidated grew.
Group of people that these folks are that we could we could look to target.
Alright.
Great. Thank you very much.
One moment for our next question.
And our next question comes from the line of Michael <unk> from.
Jefferies. Your line is open.
Hi, Good evening. This is John on for Mike Thanks for taking our questions.
Good to get your take.
Sure.
Why do you think are the gating factors for submission.
Even that 28 days is either really soon or when to actually pass.
Since the end of Q3.
So how should we think about when you'll be able to put everything together to submit.
And then the next step from there and.
Ultimately how confident you are that.
<unk>.
Just based on tighter thank you.
Yes. So the first part of the question is in terms of the gating item to we're very excited to have fully enrolled the study we are collecting that data.
To move forward and as we stated what we're looking for is that preliminary primary endpoint data by the end of this year or early Q1 next year into for US the gaining components are collecting that information and assuming it's positive combining that with the rest of the data package that I've mentioned.
<unk> CMC, non clinical et cetera, and given the continued unmet need and the lack of products available. Our goal continues to be to put that submission together as soon as practicable and we feel that the agency would be quite.
Interested in receiving that submission given the current state of where we are.
As it relates to.
Your question about what was the second yours titers.
And whether the assay. So we had talked to the FDA previously about using tighter values. That's what led to this immuno bridging as we had stated earlier in our press release, we had reached general alignment with the FDA on that as a surrogate endpoint being able to use that tighter value is calculated from teekay.
<unk> and bringing it back to the original evade trials from in <unk> and so.
We are very confident that using that as an endpoint with something that the FTA.
Aligned on for an EUA submission.
Again, assuming that the data supports.
The outcome.
Got it okay. Thank you.
One moment for our next question.
Thanks.
And our next question comes from the line of Mexico score from Morgan Stanley. Your line is open.
Great Thanks, and congrats on the progress.
So with regards to your EUA data package, how often are you required to update your in vitro neutralization assay to include currently circulating variance.
And also given the design of your cannot be trial would you expect to be authorized in both the pre and post exposure setting. Thank you.
Yes, I'll, let Pete answer you can take both those questions if you like.
So in terms of how frequently we update neutralization against circulating variance.
As quickly as possible and real time, there is no set schedule that we've received.
That demands on a certain schedule as you know this is a kind of a collaborative approach with the FDA and the CDC and all the other monitoring authorities. So we updated in real time as soon as we get the data and in terms of prep versus perp.
We are pursuing the prep indication only so we won't be generating any pep data or post exposure prophylaxis data.
Great. Thanks.
Thank you one moment our next question.
And our last question for today will come from the line of Evan Wang from Guggenheim Securities. Your line is open.
Great I had a follow up in terms of some of the pre commercial planning ongoing can.
Can you provide a samsung.
Or at least initial thoughts on the size of the salesforce needed for that targeted population approach.
Sure Jeremy I'll, let you tackle that one.
Sure. Thanks, Evan so we're still in that sizing exercise, but as we said, it's a very relatively concentrated market. So we believe it will be a relatively small commercial footprint that we would need to ultimately capitalize on the market that we would enter into with the immuno compromised most at risk.
But we will give a little more detail as we get closer to launch.
Yes, the only thing I'd add there avenues right, we've talked about this being able to utilize in a more of a sort of key account type model.
To go and call on these various systems and accounts and as Jeremy said.
Focusing in that upper right quadrant, you can really go after a lot of these different individuals in a targeted way given the sort of concentrated nature of where they are and where are they.
Steve Kerr from their various acp's.
Great and then in terms of some of the pre.
Pre commercial manufacturing lab.
Can you provide any color in terms of some estimates or how.
How extensively you plan to sell that inventory.
Two more follow ups.
Yes, so on the inventory side.
We've begun to prepare and have a variety of commercial material at risk, while we continued to balances both making sure that we're being as.
As cost effective as we can with the cash in our balance sheet, but also making sure that we have doses available what were really looking to do is use a gated approach, though as we move forward.
Continuing to ramp that up as we start to see data or get to a point of a potential EUA submission <unk>. The launch we have a great partner in Wuxi and we continue to look at ways that we.
We can really optimize when those doses would be available on how we commit to them. So that's really the plan and approach now is start to prime the pump and have some of those doses available for a potential launch and then continue to.
Add to that as we see more information and track further in the process.
Got it and in terms of some of the.
Phase one data I think you guys are tracking ahead of time. So I'm just wondering how the cemex are looking over there and if there's any implications or kind of thoughts on.
Yes, hi.
Re dosing could look in the future.
Pete you want to take that one yes.
None in recent updates from the phase one data we will look at the totality of data coming out of that study and of course cannot be to make our conclusions and recommendations about re dosing.
Got it and last one for me.
Great to see all the market research.
I'm, just wondering how I guess payors.
And Kols are looking at.
How much how should we value clinical data versus a surrogate.
Acceptance of this surrogate beyond FDA. Thanks.
Jeremy you want to look at Cowen I think it's a good question for Matt that certainly is a new concept, but it's not a new concept in infectious disease vaccines using surrogate endpoint. So we believe that there will be acceptability of this data beyond just the FDA with practitioners payers.
Great. Thank you.
Thank you.
The conference back to Dave for closing remarks.
Thank you all for joining the call today is a very exciting time for and vivid as we approach a potential EUA submission and authorization of BYD <unk> two for the prevention of symptomatic COVID-19.
Which would represent a significant achievement for <unk>, but more importantly, it will be a major advancement for the immuno compromised people we serve.
We thank you for your continued support and interest in vivid and we look forward to sharing additional updates with you. Soon thank you very much and have a good evening.
And this concludes today's conference call. Thank you for participating you may now disconnect everyone have a great day.
[music].
Okay.
Yes.
Okay.
Okay.
Okay.
Okay.
Okay.
[music].
Okay.
Sure.
Yes.
Okay.
[music].
Okay.
Yes.
Yes.
[music].
Welcome to the envision third quarter 2023 financial results and recent business highlights call. At this time all participants are in a listen only mode. After the Speakers' prepared remarks, there'll be a question and answer session. Please be advised that today's conference call is being recorded I would now like to hand, the conference over to Scott Young Senior Vice President.
<unk> of Investor Relations and corporate Communications. Please go ahead.
Thank you operator, a short while ago, we issued a press release announcing our third quarter 2023 financial results and business highlights that press release in the slides, we're using today and the webcast can be found in the investors section of <unk> website under news and events.
Today's discussion will be led by Dave Herring inhibits Chief Executive Officer.
He is joined by Dr. Piet Schmidt Chief Medical Officer, Jeremy <unk>, Chief operating and commercial officer, and Bill to Chief Financial Officer.
During today's discussion, we will be making forward looking statements concerning among other things the future of the COVID-19 landscape, our ongoing research and clinical development plans, including the timing of these plans are regulatory and commercialization plans strategies and opportunities, including the timing.
Are these plants, our expected cash runway and other statements that are not historical fact.
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 cause our actual results to differ materially from those expressed or implied today.
These forward looking statements speak only as of the date of this call and <unk> assumes no duty to update such statements.
Additional information on the risk factors that could affect <unk> business can be found in our filings made with the U S Securities and Exchange Commission, including our most recent Form 10-K, which is also available on our website.
I will now turn the call over to Dave.
Thanks, Scott and thank you all for joining.
As you can see on slide three we have a full agenda for today's call I'll begin by reviewing a few of our recent business highlights and key achievements in the third quarter and then I'll provide some color on the current COVID-19 landscape and the very real and continued threat the disease presents to the immuno compromised and other vulnerable individuals.
Pete will then discuss canopy, our phase III pivotal clinical trial investigating <unk> for the prevention of symptomatic COVID-19.
And review our latest in vitro data demonstrating the antibodies in vitro neutralizing activity against recent Sars Covid two variance.
Jeremy will then provide an update on some of the critical work that he and his team have been doing in preparation for a potential emergency use authorization or EUA, which is issued could enable a commercial launch of <unk>. In 2024. This is the first time Jeremy has joined an earnings call. So by way of quick introduction.
He has served as our chief operating and commercial officer since December of 2022.
Jeremy has more than 20 years of commercial leadership experience across all stages of the product lifecycle. He joined us from Sandoz, where he served as the global commercial head of the Biopharma business and had responsibility for the launches of their late stage pipeline assets as well as the established commercial portfolio.
Before we open the call for Q&A, Bill, Duke will review, our third quarter financial performance and share our latest cash runway guidance Bill.
Bill joined US in September as Chief Financial Officer, and it is a pleasure to have him with us today.
Dell brings more than 25 years of experience, including more than a decade of senior leadership experience in the biotechnology industry during.
During the short time within vivid he has already proven himself to be a tremendous addition to our executive team and his knowledge and leadership will be invaluable to us as we prepare for a potential transition to a revenue generating commercial company.
Moving to slide four I am tremendously proud of the progress. Our team has made this year executing to plan as referenced in today's earnings release in September less than six months after initiating a phase one clinical trial of <unk> two we dosed the first participant in canopy, our phase III pivotal trial investigating <unk>.
<unk> for the prevention of symptomatic COVID-19 today just eight weeks later, we are pleased to announce that we have completed enrollment in the canopy trial with approximately 750 participants enrolled including approximately 300 immunocompromised individuals.
We cannot be advancing swiftly we continue to anticipate having initial primary endpoint data from this study in late 2023 or early Q1 2024, given the pressing unmet medical need our goal remains to apply for an EUA in the U S. As soon as practicable, assuming the data we see as supportive for the requisite clinical.
<unk> non clinical and CMC data packages.
The speed and efficiency.
Efficiency of our progress are a testament to the dedication and focus of the outstanding team, we have assembled and speak clearly to the fact that COVID-19 remains a significant health concern, particularly for immuno compromised individuals in the U S. Who currently have no authorized monoclonal antibodies available for them for pre exposure prophylaxis or pep.
Of COVID-19.
This large unmet medical need is yet another consequence of the virus's relentless ability to mutate and overtime render therapeutics ineffective.
Precisely why we have strategically positioned ourselves to keep pace with viral viral evolution through our proprietary platform approach, which we have trademarked in the mab.
<unk> is an important near term value driver for in vivid.
We believe <unk> is the engine, which holds the potential to power our success for years to come the <unk> platform combines state of the art viral surveillance and predictive modeling with advanced antibody engineering through our internal expertise and collaborations such as our partnership with Adam Adam while working to advance <unk> two.
Through to a potential EUA submission in parallel we have also been working to identify and optimize mab candidates that can be deployed in response to ongoing stars koby to evolution.
We also continue to engage in constructive dialogue with the FDA regarding potential pathways that will enable us to fully leverage our <unk> platform approach to rapidly and perpetually deliver monoclonal antibody candidates.
We are pursuing an approach that would in some respects mirror the process used to authorize the annual flu and Covid vaccines. While there is much work ahead of US. We are very pleased with our progress to date and look forward to sharing more details in the quarters ahead.
Before I turn the call over to Pete I would just make a few points about the current state of Covid and the clear and urgent need for new monoclonal antibodies.
While many people with healthy immune systems have learned to live with Covid and accepted as a part of the new normal that simply isn't an option for the immuno compromised they faced distinct risks and challenges, which remain as acute today as they did during the height of the pandemic.
As you can see on slide five new data continue to emerge that highlight that.
Disproportionate burden that COVID-19 has on vulnerable populations in October real World evidence was published from the informed study, which looked at the impact of COVID-19 in 2022 using data from a sample of nearly 12 million people in England.
Our results show that immunocompromised individuals accounted for only three 9% of the overall study population, but roughly 25% of all COVID-19, hospitalizations ICU admissions and death, even though more than 80% of this population had received three or more COVID-19 vaccine <unk>.
And more certain immunocompromised populations, such as solid Oregon in stem cell transplant recipients and those recently treated for blood cancers had greater than 10 fold increases in risk compared to those without these conditions.
Also in October real World evidence with published from a study referred to as the Epic study, which looked at a sample of nearly 17 million people and a large U S. Commercial health insurance plan and COVID-19 infections between early 2020 and early 2022.
In this study immunocompromised individuals accounted for two 7% of the population.
Unsurprisingly epic found that people, who are immunocompromised, we're more likely to get COVID-19 than people, who are not with about 14% of the immunocompromised people being diagnosed with COVID-19 infection.
Those individuals' 24, 24% were hospitalized with the means day up 15 days and the mean cost of $64000 per patient.
These data underscore the heavy human and financial toll that COVID-19 takes on this population and serve as a powerful motivation for us to get <unk> and future antibodies authorized and available as quickly as possible for vulnerable individuals with that I'll turn it over to Pete.
Thank you Dave.
As Dave mentioned mutation is an expected an inherent characteristics of <unk> as it continues to circulate with regards to the recent variance as you can see on slide six we are pleased to report that our latest in vitro sooner virus testing shows that <unk> retains neutralization activity against the <unk>.
Recent Sars Covid two variance tested such as X VB, one five SPV, one six and SBB, one $5 10, which is an SPV variant with the same spike glycoprotein sequence as EG five including the F 456, <unk> mutation in the Spike.
Just on the now cast estimates provided by the CDC, we estimate that approximately 80% of the current CDC tracked variance are now ex BB lineage variance with the F 456 <unk> mutation.
Moving to slide seven I am very proud of the impressive progress that our team and our study partners have made this quarter to advance our canopy trial as Dave mentioned, we recently completed enrollment in our canopy trial and continue on plans continue on plan to have initial primary endpoint data in late 2023.
Our early Q1 2024.
As a reminder, canopy has two cohorts cohort we enrolled approximately 300 individuals who are significantly immune compromised all participants in cohort <unk> received <unk>.
For cohort a the co primary endpoints are safety and Tolerability and CRM neutralizing titers at day 28 against relevant Sars Covid, two variance, which will be calculated based on the pharmacokinetic concentration of <unk> <unk> from the immunocompromised participants and the IC 50 value for <unk>.
Two against relevant Sars Covid two variance.
In cohort B, we enrolled approximately 450 individuals who are at risk for exposure to <unk>, which is essentially anyone who has regular unmasked interactions with others.
<unk> in cohort B were randomized two to one to receive <unk> or placebo. The primary endpoint for cohort B is safety and Tolerability and the primary purpose of this cohort is to build out the safety database for <unk>.
The primary efficacy analysis for canopy will use in immuno bridging approach comparing data obtained from the immuno compromised cohort to certain historical data from our previous clinical trial of <unk> for the prevention of symptomatic, Covid, 19, and which Sam neutralizing titers correlated with observed clinical efficacy.
Our team is laser focused on executing mechanically trial and preparing for a potential EUA submission as soon as practicable.
As we've anticipated the FDA continues to utilize the EUA pathway to authorize new products, including the latest mrna vaccines for certain age groups. Furthermore, the design of our canopy trial reflects the input we've received from the FDA on an immuno bridging pathway to a potential EUA for new mab candidates that meet certain criteria.
Syria, which we believe <unk> satisfies.
To prepare for the potential launch of <unk>. Our teams have also been engaging in appropriate scientific exchange with the medical community and key opinion leaders and we are raising awareness of monoclonal antibodies for COVID-19, with various patient groups to date, we've engaged with more than 35 different patient organizations many of that advocate.
For populations that may have a reduced immune response to vaccines.
With that I will now pass the call to Jerry.
Thank you, Steve as BYD Q2 to rapidly advance through the clinic and approaches the potential EUA submission, our commercial planning and preparation of our future and more prominently internally as well as hunter discussion with investors. So it was a pleasure to join today's call to share a bit more color about the market opportunity and the many activities. We are undertaking as we gear.
We're up for a potential launch.
Turning to slide eight based on our extensive market research. We believe there is a significant market opportunity with more than $9 million immunocompromised people at risk for severe COVID-19 in the U S.
Looking at the chart on the left the X axis shows the risk of severe COVID-19, and the Y axis is expected uptick of a COVID-19 map based on aggregated results from a survey we conducted with specialty HCP in the U S.
Importantly, this market is comprised of different subgroups with varying degrees of risk and expected uptake.
At the top far right of the chart you can see that there are approximately 485000 people who are at the highest risk and have the highest expected uptake based on our market research. We can further refine the population into several key subgroups, including approximately 67000 stem cell transplant recipients 86000 solid organ.
Transplant recipients and 332000 people with hematologic lymphatic cancer with <unk>.
See a clear opportunity to impact fully entered the market utilizing an efficient sales footprint to target certain subgroups of patients and providers initially and expand to additional groups over time.
Turning to slide nine we have many activities underway to prepare for a potential <unk> launch if authorized for example go to market planning is underway such as market research with Hcp's market sizing and segmentation brand strategy and field force sizing work with regards to our market research and a recent.
Survey, we conducted with nearly 200 U S physicians, who treat different types of immunocompromised patients.
76% of respondents said, they would be extremely likely or somewhat likely to use every show a previously authorized.
For COVID-19 for their immunocompromised patients if it were still available and relevant to circulating COVID-19 strength.
We believe that there was this result underscores the ongoing market opportunity.
With regard to market access if authorized we expect to commercialize <unk> under the traditional sales model rather than through the large government purchases and stockpiling as we saw with COVID-19 products in the past in anticipation of launch we have payor and pricing work underway and are preparing our distribution models and chat.
Yes.
With a step wise approach, we believe that we can be very effective in getting <unk> to key health systems in populations with a relatively small sales footprint.
We have also started manufacturing would be wise to do commercial inventory the wuxi and they continue to be an outstanding partner to us as we make excellent progress preparing for the CMC package that will be part of our anticipated EUA submission.
With respect to the caliber of our commercial organization from the talk we have Dave who played a pivotal role in the launch of the first COVID-19 vaccine as the global mrna business and franchise loop for Pfizer and we have brought onboard experienced leaders to head up our market access sales and marketing functions.
<unk> team has collectively launched multiple successful products to address infectious disease.
Our team has been working diligently and I'm very pleased with all the progress we've made to prepare for the potential emergency use authorization and we are excited for the potential launch of <unk> in 2024, if authorized while we are currently focused on launching in the U S by ourselves with a contract field force we are actively exploring potential.
Partnerships and collaborations.
With that I will now turn it over to bill to provide an overview of our financials.
Thank you Jeremy I'm excited to have enjoyed joined the <unk> team at such a potentially transformative period for the company.
I've been very impressed by the <unk> team's ability to.
To execute to plan and buy the nimble highly motivated teams that are driving and visits work forward at a remarkable pace I.
I see great potential in and visit strategy and platform based approach and believe that <unk> is poised to make a meaningful difference in the lives of thousands of vulnerable people in United States, who have been without access to a map for COVID-19 prevention for far too long.
Turning to the financials on slide 10.
The details of our third quarter financials are included in the press release, we issued early today.
So I won't reiterate all the numbers here.
<unk> ended the third quarter of 2023 with approximately $265 million in cash cash equivalents and marketable securities.
Based on current operating plans, we continue to expect that our cash excluding any potential revenue associated with the <unk> two <unk> will enable us to fund our operating expenses into the fourth quarter of 2024.
Regarding our efforts and resources as you have heard today, we are actively preparing for the potential authorization and launch a BYD 222.
Including the manufacturing of an additional commercial supply.
We will continue to deliberately manage our expenses as we rapidly advanced our work on timelines that are significantly compressed compared to traditional biotech programs.
With that operator, please open the call for questions.
Thank you. So I'll ask a question. Please press star one on your telephone and wait for name to be announced towards drilling a question. Please press star one again.
Please standby.
The Q&A roster.
One moment for our first question.
Our first question comes from the line of Patrick <unk> from H C. Wainwright. Your line is open.
Thanks.
Good evening and congrats on all the progress just the first question is just on the enrollment completion in the kind of the phase III trial can you remind us what we need to see in terms of day 28 PM neutralizing titers and at each dose that would give confidence in the <unk> EUA submission.
And then just on the EUA submission of clarification. It sounds like you can submit following the primary endpoint data from cohort.
Is that accurate and separately what role if any with the one three re dosing data in cohort and data from cohort do you have in terms of gaining or maintaining the EUA.
Yes, Thanks, Patrick I'll, let Pete answer the first part of the question I can tackle the one about.
As we're preparing for a potential EUA submission.
Yes, the primary endpoint at day 28 is that immuno bridging endpoint of serum neutralizing titers as compares to historical data from the outage up in that trial.
Right.
We've talked about the EUA submission package that we're working on is a combination of clinical non clinical and CMC. The pivotal data from canopy is one element of that and it's certainly one of the components that we're looking at and pulling this together.
And then and in parallel we're working on the additional supportive data.
From the other elements as we work towards this potential EUA submission.
Got it that's helpful and then if I could just a few on the commercial launch preparations.
Follow up on that in greater detail, specifically with regard to the scale up in manufacturing and payer discussions are there any particular reimbursement codes or other aspects of the launch that are unique for this type of launch, particularly with regard to payer coverage and then just as it regards slide this is a broad group of patients who could benefit from <unk>.
<unk>. So I'm wondering if you can discuss the expected launch trajectory, how you're kind of deciding how to manufacture at this stage.
And if there is any particular immuno compromised patients that would be the focus or would this be a broader effort for the launch of <unk> received authorization.
Yes, I'll, let Jeremy talk to the first question about payers and I can help a little bit more with.
Our.
Our focus for the launch yes. Thanks, Patrick there are several steps were taken to ensure that we have the appropriate market access plan in place, which includes coding et cetera.
We don't.
At this time its premature for us to really give specifics on that but we are working to be ready when it comes to launch given we're still for us.
Yeah, and just as it regards to slide eight.
So we've now through our own market research really catalog this $9 million.
Immune compromised.
The population we've talked about this is really a subset of vulnerable which can include people who are contra indicated for vaccines et cetera, but where we really.
Our planning the focus of the initial launches in that upper right quadrant that 485000 people and as it lifts here folks who are stem cell transplant recipients solid organ transplants and <unk>.
A variety of blood cancer.
<unk> in those areas and as Jeremy mentioned, partly that's because these are the people who are the highest risk and certainly.
Are also the ones who are expected to have the highest uptake and then it also represents an efficient.
Way for us to bring the product to market looking at contract sales forces et cetera, given the relatively consolidated.
Group of people that these folks are that we could we could look to target.
Alright.
Great. Thank you very much.
One moment our next question.
And our next question comes from the line of Michael <unk> from.
Jefferies. Your line is open.
Hi, Good evening. This is an agenda on for Mike Thanks for taking our questions.
Good to get your take.
Why do you think are the gating factors for submission.
That 28 days is either really soon or when to actually pass.
Since the end of Q3.
So how should we think about when you'll be able to put everything together to submit.
And then the next step from there and.
Ultimately how confident you are that FDA what tools.
Just based on tighter thank you.
Yes. So the first part of the question is in terms of the gating item to we're very excited to have fully enrolled the study we are collecting that data.
To move forward and as we stated what we're looking for is that preliminary primary endpoint data by the end of this year or early Q1 next year into for US the gaining components are collecting that information and assuming it's positive combining that with the rest of the data package that Ive mentioned <unk>.
<unk> CMC, non clinical et cetera, and given the continued unmet need and the lack of products available. Our goal continues to be to put that submission together as soon as practicable and we feel that the agency would be quite.
Interested in receiving that submission given the current state of where we are as it relates to.
Your question about what was the second yours titers.
And whether the assay. So we had talked to the FDA previously about using tighter values. That's what led to this immuno bridging as we had stated earlier in our press release, we had reached general alignment with the FDA on that as a surrogate endpoint being able to use that tighter value is calculated from teekay.
<unk> and bringing it back to the original evade trials from in <unk> and so.
We are very confident that using that as an endpoint with something that the FTA.
Aligned on for an EUA submission.
Again, assuming that the data supports.
The outcome.
Got it okay. Thank you.
One moment for our next question.
Okay.
And our next question comes from the line of Mexico score from Morgan Stanley. Your line is open.
Great Thanks, and congrats on the progress.
So with regards to your EUA data package, how often are you required to update your in vitro neutralization assay to include currently circulating variance.
And also given the design of your cannot be trial would you expect to be authorized in both the pre and post exposure setting. Thank you.
Yes, I'll, let Pete answer you can take.
Take both those questions if you like.
So in terms of how frequently we update neutralization against circulating variance.
As quickly as possible and real time, there is no set schedule that we've received.
That demands on a certain schedule as you know this is a kind of a collaborative approach with the FDA and the CDC and all the other monitoring authorities. So we updated in real time as soon as we get the data and in terms of prep versus path.
We are pursuing the prep indication only so we won't be generating any pep data or post exposure prophylaxis data.
Great. Thanks.
Thank you one moment our next question.
And our last question for today will come from the line of Evan Wang from Guggenheim Securities. Your line is open.
Great I had a follow up in terms of some of the pre commercial planning ongoing can.
Can you provide a samsung.
Or at least initial thoughts on the size of the salesforce needed for that targeted population approach.
Sure Jeremy I'll, let you tackle that one.
Sure. Thanks, Evan so we're still in that sizing exercise, but as we've said, it's a very relatively concentrated market. So we believe it will be a relatively small commercial footprint that we would need to ultimately capitalize on the market that we would enter into with immunocompromised most at risk group.
But we will give a little more detail as we get closer to launch.
Yes, the only thing I'd add there avenues right, we've talked about this being able to utilize in a more of a sort of key account type model.
To go and call on these various systems and accounts and as Jeremy said focusing in that upper right quadrant. You can really go after a lot of these different individuals in a targeted way given the sort of concentrated nature of where they are and where are they.
Steve Kerr from their various acp's.
Great and then in terms of some of the pre.
Pre commercial manufacturing lab.
Can you provide any color in terms of some estimates or how.
How extensively you plan to sell that inventory.
Two more follow ups.
Yes, so on the inventory side.
We've begun to prepare and have a variety of commercial material at risk, while we continued to balances both making sure that we're being as.
As cost effective as we can with the cash in our balance sheet, but also making sure that we have doses available what were really looking to do is use a gated approach, though as we move forward.
Continuing to ramp that up as we start to see data or get to a point of a potential EUA submission <unk>. The launch we have a great partner in Wuxi and we continue to look at ways that we.
We can really optimize when those doses would be available on how we commit to them. So that's really the plan and approach now is start to prime the pump and have some of those doses available for a potential launch and then continue to.
Add to that as we see more information and track further in the process.
Got it and in terms of some of the.
Phase one data I think you guys are tracking ahead of time. So I'm just wondering how the cemex are looking over there and if there's any implications or kind of thoughts on I guess, how re dosing could look in the future.
Pete you want to take that one yes no.
None in recent updates from the phase one data we will look at the totality of data coming out of that study and of course canopy to make our conclusions and recommendations about re dosing.
Got it and last one for me.
Great to see all the market research.
I'm, just wondering how I guess payors.
And Kols are looking at.
How much how should we value clinical data versus a surrogate.
Acceptance of this surrogate beyond FDA. Thanks.
Jeremy you want to look at Cowen I think it's a good question for Matt that certainly is a new concept, but it's not a new concept in infectious disease vaccines using surrogate endpoint. So we believe that there will be acceptability of this data beyond just the FDA with practitioners payers.
Great. Thank you.
Thank you I'd like to turn the conference back to Dave for closing remarks.
Thank you all for joining the call today is a very exciting time for and vivid as we approach a potential EUA submission and authorization of <unk> for the prevention of symptomatic COVID-19.
Which would represent a significant achievement for <unk>, but more importantly, it will be a major advancement for the immuno compromised people we serve.
We thank you for your continued support and interest in vivid and we look forward to sharing additional updates with you. Soon thank you very much and have a good evening.
And this concludes today's conference call. Thank you for participating you may now disconnect everyone have a great day.