Invivyd Q2 2023 Earnings Call Transcript

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August 10, 2023

There are 8 speakers on the call.

Operator

To the Envivid Second Quarter 2023 Business and Financial Results Update Call. I will now turn the call over to Gabriela Linville Engler, Director of External Communications.

Speaker 1

Thank you for joining us today. Before we get started, I want to tend to a few housekeeping items. I invite you to review our press release Discussing our Q2 2023 financial results and business updates, which can be found on the Investors section of the Envivid website. I would like to remind you that during today's discussion, we will be making several forward looking statements. Forward looking statements include statements concerning, among other things, the future of the COVID-nineteen landscape, Our ongoing research and clinical development plans, including the timing of these plans our regulatory and commercialization plans, Strategies and opportunities, our expected cash runway and other statements that are not historical fact.

Speaker 1

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 ks. It is now my pleasure to introduce the Envivid management team to the call. I am joined by Dave Herring, CEO of Envisit and Doctor.

Speaker 1

Pete Schmidt, Chief Medical Officer. I will now turn the call over to Dave.

Speaker 2

Thanks, Gabriela, 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 BYD222 in the near term and advancing our mission to protect vulnerable people from serious viral threats. Since our last call, we have announced positive initial safety data and robust serum neutralizing titer data from our ongoing VYD222 Phase 1 clinical trial. We believe that the initial Phase 1 results are very encouraging and speak to the potential for VYD222 to provide vulnerable people such as immunocompromised With robust protection from symptomatic COVID-nineteen. Shortly, Pete will provide additional color on the initial Phase 1 clinical trial results And our plans to rapidly initiate a 750 participant pivotal clinical trial of VYD222 For the prevention of symptomatic COVID-nineteen referred to as the CANOPY trial.

Speaker 2

With the compact size of CANOPY and a primary efficacy endpoint based On the analysis of serum neutralizing titers at day 28, the same biomarker used in our Phase 1 clinical trial, We believe that we can swiftly enroll 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 a pathway to a potential EUA for VYD222 And anticipated follow on candidates designed to prevent symptomatic COVID-nineteen. We are very encouraged by the rapid development pathway outlined by the FDA And the opportunity it provides to leverage our previous work developing inrevimab to accelerate the development of VYD222. We believe we are one of very few companies positioned to potentially meet the criteria that the FDA outlined for this streamlined development pathway.

Speaker 2

Importantly, with this pathway, we see a near term opportunity to bring much needed protection from symptomatic COVID-nineteen to immunocompromised people. Before I hand the call over to Pete to talk about our plans for the transformational period ahead, I want to briefly underscore 3 important points. First, the need to protect vulnerable populations from COVID-nineteen remains as urgent as ever. Immunocompromised people continue to be at higher risk For severe COVID-nineteen related outcomes and more broadly COVID-nineteen continues to be a deadly threat. Roughly halfway through 2020 3, before we have even entered the fall and winter months, the CDC estimates that more than 43,000 deaths in the U.

Speaker 2

S. Are attributable to COVID-nineteen this year. That is more than 43,000 deaths where COVID-nineteen was listed as the underlying cause Or a contributing cause of death on the death certificate. For context, consider that RSV is estimated to cause roughly 14,000 deaths per year in the U. S, Among the groups at highest risk for RSV and that pre COVID levels for flu related deaths have fluctuated between 23,052,000 deaths per year in the United States.

Speaker 2

COVID-nineteen remains a substantial driver of morbidity as well. The National Center For Health Statistics estimates that roughly 1 in 7 adults in the U. S. Have experienced long COVID 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 populations.

Speaker 2

2nd, we believe that protecting immunocompromised people from COVID-nineteen is a large Ongoing need and opportunity. In the U. S. Alone, there are an estimated 8000000 to 18000000 immunocompromised people who may not generate robust protection from vaccines. To our knowledge, Envivid is one of very few companies in the clinic now with a monoclonal antibody candidate in development for the prevention of COVID-nineteen in this population.

Speaker 2

Consider that Evusheld alone captured $2,200,000,000 in total revenue in 2022 With strong growth prior to its removal from the market when it lost activity against emerging SARS CoV-two variants of concern. In 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 Evusheld for the immunocompromised patients if it were still available And relevant to circulating COVID-nineteen strain. 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 or temporarily immunocompromised.

Speaker 2

3rd, we believe that Envivid is uniquely positioned to rapidly and perpetually deliver mAb 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 MAV therapies that protect against serious viral threats, a strategy that is similar to the approach used to Periodically modify vaccines in response to viral evolution. 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 pipeline of optimized mAb candidates that could be deployed in the future. We see COVID-nineteen as the optimal starting point for Envivid due to the speed with which products Can be brought to the market using the EUA pathway. From there, we believe that our platform could also be applied to protect Vulnerable people from other viral threats such as influenza, an area where we have an early discovery stage program.

Speaker 2

I will now pass the call to Pete Schmidt, our Chief Medical Officer to discuss in more detail our initial Phase 1 data, pivotal clinical trial plan and Regulatory Pathway.

Speaker 3

Thank you, Dave. We are pleased to have recently shared positive initial data From our ongoing Phase 1 clinical trial of VYD222, which enrolled 30 healthy volunteers across 3 different dosing cohorts. Cohort participants were randomized 8 to 2 to VYD222 or placebo. The initial Phase 1 clinical trial data Showed that a single administration of VYV-two twenty two 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 XBB1.5.

Speaker 3

At the lowest dose tested, 1500 milligrams, the geometric mean serum neutralizing titers were 3,245 Against Omicron XPD 1.5 at day 7, a geometric mean 39 fold rise from baseline. At the 2,500 milligram dose, the titers were 9,647. At the 4,500 milligram dose, the titers were 16,860 As a point of reference, even the lowest VY D222 dose tested resulted in higher serum neutralizing titers Against Omicron XBV 1.5, then the titer is shared at the recent Vaccines Advisory Committee meeting From investigational XBB targeted vaccines that were administered to adults who were not on immunosuppressive treatment. Higher VYD222 doses resulted as expected in higher titer levels that were well above those reported vaccine titer levels. Serum neutralizing titer data are meaningful because COVID-nineteen vaccine and MAV clinical trials, including our past Phase twothree adentrevimab clinical trial for the Prevention of COVID-nineteen referred to as Avade have demonstrated that serum neutralizing titers are correlated with the prevention of COVID-nineteen.

Speaker 3

This correlation has also been observed in immune compromised individuals receiving Evusheld, a map that targets the spike protein receptor binding domain of SARS CoV-two Like VY D222. Based on this correlation, we believe that the serum neutralizing titers seen in our Phase 1 clinical trial are highly encouraging And support the potential for VYD222 to provide clinically meaningful protection from symptomatic COVID-nineteen. With positive initial Phase 1 data in hand, we are pleased to have now solidified the design of our CANOPY trial of VYD222 For the prevention of symptomatic COVID-nineteen, which is geared to support a potential EUA submission. We plan to enroll approximately 7.50 participants Total across 2 cohorts in parallel. In Cohort A, we expect to enroll approximately 300 participants We're significantly immune compromised.

Speaker 3

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 a medical condition and or immunosuppressive treatment. All participants in Cohort A will receive VYD222 administered via IV infusion and the Co primary endpoints will be safety and tolerability and serum neutralizing titers at day 28. In this cohort, the primary efficacy analysis We'll use an immuno bridging approach comparing data obtained in Canopy for VYB-two twenty two to certain historical data From our previous clinical trial of adentrevimab, in which serum neutralizing titer is correlated with observed clinical efficacy. In Cohort B, we plan to enroll approximately 4.50 participants who are at risk for exposure to SARS CoV-two, Which is essentially anyone who has regular unmasked interaction with others. Participants in Cohort B will be randomized 2 to 1 to receive VYD222 or placebo administered via IV infusion.

Speaker 3

In Cohort B, the primary endpoint will be safety and tolerability. Secondary and exploratory endpoints will include serum neutralizing titers and clinical efficacy. We plan to initiate the CANOPY trial with the 4,500 milligram dose of VYD222. While we believe that all three doses tested in the Phase 1 clinical trial Have the potential to provide clinically meaningful protection against symptomatic COVID-nineteen. We have decided to initiate Canopy trial with the dose that provided the highest serum neutralizing titers against Omicron XPD 1.5.

Speaker 3

This decision was informed by the FDA's preference for a conservative serum neutralizing titer benchmark and the 4,500 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 CoV-two evolves over time. For context, based on our own data from EVADE and other clinical studies of COVID-nineteen mAbs and vaccines, We believe there is strong clinical evidence that antibody mediated protection against symptomatic COVID-nineteen may be achieved even at relatively low serum neutralizing titer on the order of 30 to 100. While we believe the 4,500 milligram dose of VY D222 is likely to provide titer Well above the minimum level observed to provide clinically meaningful protection for a significant period of time. We are excited to continue Rapidly advancing the VYD-two twenty two program, while exploring in parallel possible opportunities to leverage other doses in the future.

Speaker 3

As currently designed, all participants in the Canopy trial will receive a second dose of BID-two twenty two, 3 months after the initial dose. We plan to use the observed pharmacokinetic data from the trial in combination with the neutralization potency of VYD222 Against relevant circulating SARS CoV-two variants to modify our re dosing strategy as appropriate. With the size and design of Canopy, we believe that we can quickly enroll the trial given the strong interest we have seen from trial sites And immunocompromised people. To facilitate enrollment in Cohort A, we have established a registry of recruitment ready immunocompromised individuals For potential enrollment. We now have more than 1,000 potentially eligible individuals in our database, which we believe speaks to the strong unmet need.

Speaker 3

With clinical sites selected, study drug available and many other activities already completed, we are pleased to be on track to initiate the Canopy trial in the near term. Shifting to the regulatory pathway. As Dave briefly mentioned, the FDA has indicated that Use of a correlative protection or a surrogate of clinical efficacy in an immuno bridging approach to a pivotal clinical trial Maybe a reasonable approach to support an EUA request for new mAb candidates when certain criteria are met. Specifically, When clinical efficacy data from a prototype mAb is available, provided that one, the new mAb candidate is similar to the prototype mAb Such that it leverages a consistent manufacturing platform and has limited structural and functional differences. And 2, the new mAb has supportive non clinical data such as favorable in vitro neutralization data against currently circulating SARS CoV-two variants.

Speaker 3

We plan to leverage this immuno bridging pathway in the U. S. To accelerate the clinical development of BYD222 and anticipated follow on mAb candidates With our previous mAb candidate at entrevimab or future proprietary mAb serving as the prototype mAb, 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-nineteen. The use of atentrevimab as the potential prototype mAb is proprietary to Envivid and enabled by the data from our previous Phase twothree clinical trial of atentrevimab For the prevention of symptomatic COVID-nineteen, which had clinical event endpoints. In addition to utilizing previously generated adentrevimab data, We plan to use day 28 serum neutralizing titers from the immunocompromised cohort of Canopy along with safety data from both Canopy cohorts To enable the clinical data package for a potential EUA submission for BYD222.

Speaker 3

Looking outside the U. S, We continue to engage with global regulatory authorities regarding the BYD222 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, viruses that typically cause minor illness in immunocompetent people Can have devastating consequences for the immune compromised, which leads many of these individuals to self isolate from their loved ones And missed out on many important moments and activities. For the immune compromised, mAbs have the potential to provide the robust protection from viral threats that 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 and A.

Speaker 2

Thank you, Pete. The details of our 2nd quarter financials are included in the press release issued earlier today, but I won't reiterate all of the details here. Envivid ended the Q2 of 2023 with $298,400,000 in cash, cash equivalents and marketable securities. Based on our current operating plans, we expect that our cash excluding any potential revenue associated with BYD222 Will enable us to fund our operating expenses into the Q4 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 have finalized the size of our Canopy trial.

Speaker 2

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

Operator

Thank you. Our first question comes from Maxwell Skow with Morgan Stanley. Your line is open.

Speaker 4

Hi, 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? Also, did the FDA provide guidance related to how long you have to follow these patients to fulfill the safety requirements?

Speaker 4

Thank you.

Speaker 3

Hey, Max, 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 or exposure status. And the clinical endpoints for that cohort will be as they were in Aved, So symptomatic disease, anyone who gets symptomatic COVID. In terms of follow-up, we haven't really stated.

Speaker 3

We'll put those Details up on clinicaltrials.gov when we initiate the trial.

Operator

Great. Thanks. One moment for our next question. Our next question comes from Evan Wang with Guggenheim. Your line is open.

Speaker 5

Hey, guys. Great to see all the progress for Phase 3. Had some follow ups on the trowel design. Yes. It does seem significantly smaller compared to the Supernova trial.

Speaker 5

So and I know there's a focus on generating Fc data from FDA. Is this smaller trial really just driven by the platform? And if you could share more color on John Engstrom with FCU data. 2nd, on enrollment and data by year end. Can you talk about what's remaining to get the trial started, confidence in enrollment?

Speaker 5

And whether you need both cohorts to file for approval, especially it seems like it positions you pretty well versus Ask AstraZeneca with your data by year end. And then third, just Thoughts in terms of the commercial opportunity of this immunocompromised and all comers. I know the focus there has been on immunocompromised recently. So just Wondered if you have updated thoughts on some of the all commercial opportunity. Thanks.

Speaker 4

So I'll take the first part

Speaker 2

of this and then Pete you can tag 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, MAD development in against COVID-nineteen. And that's where they first started bringing up this prototype concept. And then certainly as we are into our Phase 1 study, We got further detail, which we put forward in a press release talking about this immuno bridging concept and being able to utilize Specific data from entrevlumab.

Speaker 2

I think Supernova has gone through a variety of iterations and 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 this Tighter level data quickly, in a small subset of the overall trial and then Cohort B Gives you the necessary safety and that you need to pull together to put together a package for a potential You can talk a little bit Pete about starting and enrollment, some of the other pieces that Evan asked about.

Speaker 3

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

Speaker 3

So we are very pleased to have that ready database Over a 1000 individuals and we think that a large proportion of them will be very interested in rolling quickly.

Speaker 2

Yeah, The only thing I would add, Evan, as it relates to the commercial opportunity. I mean, we are focused on 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 immunocompromised group, folks who have been contraindicated against vaccines, etcetera, Those who are at highest risk for severe outcomes from COVID-nineteen.

Speaker 3

And in terms of activities necessary To initiate Canopy, it's largely just the box checking stuff that you have to do before you start a trial. I think we've passed all the major hurdles. We haven't provided specific guidance on when we're going to start, but you can see that we did Say, we'll release some preliminary primary efficacy endpoint data by the end of by around the end of 2023.

Operator

Thank you. One moment for our next question. Our next question comes from Michael Yee with Jefferies. Your line is open.

Speaker 6

Hi, good evening. Thanks for taking our questions. This is Jenna on for Mike. We have two questions, if we may. First question is, at this upcoming year end readout of initial pivotal data, what are you looking to show and what is the bar?

Speaker 6

Are you looking to replicate the Phase 1 results, which was already great? Or are you looking to show even higher tighter levels? And then second question is from that point forward, what are the key milestones afterwards? And how soon could you expect to be on the market? Thank you.

Speaker 2

Yes. So Yes. So from the preliminary data that we're talking about around year end, it would be similar to what we saw in the Phase 1, it's the tighter values. That said, it will be based on an analysis for day 28. So it's slightly different than the day 7, Phase 1 Data that we provided there, but similar in terms of we're looking for high tighter values.

Speaker 2

They don't have to be Equivalent to the Phase 1s, but based on everything we saw from Phase 1, it's repeating that in this Cohort A And getting some of that preliminary data. And so that would confirm what we've seen in Phase 1 and what we're expecting to see In Canopy. Key milestones after, right, for an EUA submission, you need the clinical data, you need a preclinical set of activity, CMC, etcetera. We believe we can assemble all of that quite rapidly, and certainly we'll provide more information and guidance as we get closer To this clinical information, etcetera. 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, etcetera, even prior to the Fall and winter season.

Speaker 2

And so certainly, it's not lost on us that time is of the essence. And in a situation where there are no mAbs On the market, one that we're looking to rectify as quickly as we can.

Speaker 6

Great. Thank you so much.

Operator

One moment for our next question. The next question comes from Patrick Tucci with H. C. Wainwright. Your line is open.

Speaker 7

Thanks. Good afternoon and congrats on all the progress. I have a Couple of follow-up questions. The first is just I'm wondering if you can talk about the new COVID variant, EG5. What have we seen so far with these cases of COVID-nineteen?

Speaker 7

How different or similar is this variant to XBV1.5? And would you expect BYD222 to retain activity against this variant?

Speaker 4

Yes. On the first piece,

Speaker 2

right, I mean, we continue to see viral evolution. That's, I guess, one of the most Critical components of the Envivid strategy, right, which is we expect the virus to continue to evolve, which is why we see Serial innovation is the answer, continuing to update antibodies, etcetera. As it relates to EG5, 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 BYD222. And so we'll take a look at that now that it's the Predominant variant and do some additional confirmatory tests, etcetera.

Speaker 2

I do think We've seen a progression from the summer into now, which is, like I said, not 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 variants. And so that's 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 different eventualities? So That's really, like I said, embedded into how Envivid is structured in our strategy and looking to assess and then respond To the different variants as they emerge.

Speaker 7

Great. And then just a clarification question. Is the Expectation to 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 BYD222? Or Would this be primarily be commercialized through sort of traditional channels and methods?

Speaker 7

And then just lastly, can you talk about advantages of BID-two twenty two compared to some of these other antibodies in development for COVID-nineteen. 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.

Speaker 2

I can take government contracts. You want to take first the preliminary data we're expecting from the Primary endpoints at around the end of the year?

Speaker 3

Yes. That was a good question. So our understanding and plan is actually that We don't need the serum neutralizing titer data from Cohort B. That group just serves to increase the safety database, The exposure needed for an EUA. So the preliminary data you'll see will just be from the immune compromised cohort, which is cohort A.

Speaker 2

Yes. And then related to your question about government contracts based on the current environment and transition, We are not anticipating government contracts as the primary source or really putting much in terms of Our commercial readiness related to government contracts, we're preparing for a traditional market. Your Activities related to reimbursement and payers and market access, etcetera. And so that's really the focus of the team now As 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, So we continue to look at all of those.

Speaker 2

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 products. As it relates to advantages of VY D222, one of the things that we've been saying for quite a while is, 222 is A re engineered version of our original antibody ADG20. And we did this through an affinity maturation process And did it, looking at the BA. 1, BA. 2, backbone of Omicron.

Speaker 2

And so with A set of slight changes, 8 amino acids, we were able to reestablish binding where ADG20 has lost. ADG20 Came from a SARS CoV-one survivor and so we continue to see that 222 Has broad neutralizing activity and is one that we really see as an antibody that To date, has not occurred in 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 that's 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 edentrevimab, the ADG20 Data that allows this platform as well to be quite a significant advantage.

Speaker 2

As we said, we see That Envivid is one of a few companies who could utilize existing data that was done previously. And that's quite an advantage as it relates to pursuing EUAs in a much faster fashion than running full clinical endpoint studies, Especially given the current environment and looking to recruit patients.

Speaker 7

Great. Thank you so much.

Operator

And I'm not showing any further questions at this time. I'd like to turn the call back over to Dave for any closing remarks.

Speaker 2

Well, thank you all for joining the call today. It's a very exciting time for Envivid as we get closer to milestones that we believe would be Quite impactful for patients, our organization and shareholders. We thank you for your continued support and interest in Envivid and we will Look forward to catching up with any of you individually over the coming days. Thank you so much.

Operator

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

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