Q3 2022 Invivyd Inc Earnings Call
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
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Yeah.
Welcome to the ended the third quarter 2022 update call.
Now I'll turn the call over to cure a fair Clark Vice President of government affairs advocacy and corporate communication.
Thank you for joining us today before we get started I wanted to turn to a few housekeeping items.
To review our press release, and the Q3 financials included with them.
Which can be found on the investors section of our 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.
The COVID-19 landscape, including the expectation of continued evolution and the emergence of.
Yeah.
Our ongoing research and clinical development plan, including the timing.
Yes.
Technology and resources to develop therapeutic or preventative options for other infectious diseases.
Our expected cash runway and other statements that are not historical facts.
Other factors that may cause our actual results to differ materially from those expressed or implied in the forward looking statements are described under the heading risk factors.
In our filings made with the U S Securities and Exchange Commission, including our most recent quarterly report filed today.
It is now my pleasure to welcome his visit management into the call.
Joined by David Herring, CEO , David Laura Walker, Chief Scientific Officer.
Gotcha, So interim chief financial officer, with that I'd like to turn the call over to Dave.
Good afternoon, and thank you for joining the <unk> third quarter call.
It happens to be our first quarterly earnings call as a public company and my first call as Chief Executive Officer. So our agenda will be just a little different than it may be going forward.
Specifically I'd like to start by sharing my enthusiasm for inhibitor in our future.
Then our CFO al Walker will describe our unique capabilities pipeline and ongoing activities I will then come back and talk a bit about near term opportunities.
Our interim CFO Francesco.
Actual results after which we are happy to open the line for any questions as always we will be glad to follow up with analysts or investors. One on one following this call.
As you may recall prior to joining US David My role was Pfizer was the global franchise head for the mrna portfolio essentially.
Operational responsibility for the Covid vaccine in the U S, which included worldwide production allocation and the sale of the vaccine, which is now the market leading mrna vaccine for the prevention of COVID-19.
Future mrna product in development being.
Being involved in that effort with a great privilege.
Given the urgency of the medical situation and the ability to make an important vaccine broadly available.
At the same time it was made clear that there would always be practical limits to the benefit of Sars cov two vaccine could provide.
For vulnerable populations, such as the immuno compromised or other people, who may not respond responds well to vaccination.
Paul Neutralizing antibody titers in response to natural Sars Covid two infection.
<unk> relatively quickly rendering all humans vulnerable to repeat infection.
Over the past year, we alongside the broader scientific community have Martin and final evolution can challenge, even the most thoughtful we discovered therapeutic and prophylactic antibody.
The past three years <unk> seen the rise of the new human packaging first moving through naive human immune system and a series of distinct dominant area.
And then evolving to adapt to experienced human immune system and now presenting a diverse variance tomorrow.
Coin in the public commentary form are still called scramble patents omnicom. Many viruses is inspiring somewhat predictable convergent mutation and the feet of human immune pressure a 35 backwardation in prior infection.
These convergent mutations are increasingly amusement beat relative to your vaccine induced antibodies titer and increasingly challenged off hire and currently commercially available antibody therapeutics.
We are pleased that to date our candidates in late stage discovery have steel and retained in vitro activity against all current and emerging variance of concern.
Previously the company attempted to meet the pre Omicron COVID-19 challenge largely with a single molecule.
Redesign company by contrast has been created with the mission to meet the challenge of this final evolution through ongoing innovation and use of our proprietary platform.
Our integrated discovery platform offers us the possibility for high potency beneficial pharmaceutical properties and meaningful resistance of viral escape.
Aim to make quality antibodies that occur at very low or zero frequency and natural human immune responses.
In this way such engineered antibodies makes it outside the pressure that drive viral escape.
Further we as a company anticipate being able to use our platform to position ourselves for the potential obsolescence of our antibodies and believe that what is most important about and vivid is the expected productivity and efficiency of our overall discovery and development platform rather than the particulars of any.
The one single antibody developed going forward.
We believe our proprietary underlying discovery.
<unk> licensed from Adam that to be utilized in our new corporate laboratory.
Allow for unparalleled speed and molecular diversity in engineering.
Our plan broadly speaking is to continue deploying our technology over the coming years as viral evolution required and to innovate with the intent to keep pace with and indeed get ahead of COVID-19.
I will ask Laura to review, our recent progress in ongoing discovery and development activities.
Thanks, Steve it's been exciting pilot in debit.
Currently we announced that we have nominated a proprietary combination.
Sorry.
Receptor binding domain or <unk> antibody for clinical development.
<unk> and <unk>.
We look forward to describing the properties of these antibody further at the advanced clinical development, but as no. One number of that combination is indeed, a re engineered version of <unk>, our former lead molecule.
This reengineering is an important subtlety.
Ability to evolve it is from Matt <unk> with activity against on the problem and it's of miniatures with relatively few amino acid changes supports ophthalmic hypothesis that their R&D site on the third public to RBC, everyone can target with a monoclonal on multiple model Colo.
Our broad neutralization, both forward through emerging variants of concern as well as backward require third party to bearing and even more divergent beta viruses such as ours.
As Dave mentioned, our plan is to utilize our integrated discovery platform against the threat of ongoing part of EQ viral evolution with ongoing novel antibody discovery and engineering as well as to develop a best in class suite of early stage candidate antibodies and anticipate potential emerging variant.
We are.
<unk>, which we look forward to engage with global health authorities on in the coming weeks and months is that the steady stream of viable antibody therapy for patients in the face of anticipated viral variation.
And we are pleased to announce today that we have multiple candidates.
Late stage discovery on track for planned preclinical activities in the first half of 2023.
Each of the two components within our need NBD two on the combination as well as our other candidates represent unique molecules that have been shown in vitro to target distinct and in a recession the binding site on the <unk> site.
In addition, all.
All have shown in vitro varying and sometimes subtle or perhaps important differences in neutralizing potency across many of this and in fact, the same put simply it appears to be different and to interact with the RVP in different ways and grace to form a third public to variance.
<unk>.
Our view is that those differences may turn out to be a core.
In unpredictable ways going forward in both development candidates along with what we hope will be additional broadly active antibody.
We've done our anticipated growing and unique tool kit or adjusting viral variation.
First of all we can continue to evolve each of these antibody guided like eight inch of Annapolis as we engineered into <unk> is it potential backbone for continuous rapid engineering evolution demands in conclusion, our strategy, it's Pablo uniquely from our integrated discovery platform is not core.
Rely on a single molecule targeting a single epitope that may experience escape our strategy instead is to continuously discovered engineered antibody with sufficient its utilization and potency.
That patients in need of access to continuous high quality protection, even in the face of rapid viral evolution. We believe our integrated discovery platform offers a unique competitive advantage in this effort and the potential to provide a distinct benefits to patients in need caregivers and global health authorities searching for durable Felicia.
Ongoing burden imposed by COVID-19.
Thanks, Laura as you all heard we are firm believers in the potential for our integrated development platform to generate high value antibody candidates that have a high probability of providing protection to populations in need rigs.
<unk> antibody protection very recently, and then archive and currently out for review is a paper by Lora and other colleagues.
It's a very tight relationship between the protection from symptomatic COVID-19 disease mediated by both varying levels of vaccine induced polyclonal antibody neutralizing titers and varying levels of monoclonal antibody neutralizing titers.
Paper draws on sampling from vaccine recipient and participants and our recent pivot.
Pivotal clinical trial.
Abate had the scientifically for two of it is timing of studying in traveling that.
Prep setting across 2021.
The study included patients and outcomes across both pre omicron and post on the con filings, which have different in Trevor Matt Mutualization potency and a controlled study with corresponding clinical outcome.
This study data along with companion work on vaccine elicited titers all performed in a consistent assay provide a unique natural experiment for assessing the relationship between protection from disease mediated by vaccination and protection from disease mediated by monoclonal antibody.
Obviously, a vaccine engages the immune system broadly, whereas a monoclonal antibody is highly specific and its target biology.
What is unusual about the observations found within our post hoc analysis is that the underline and intuitive results. The vaccine correlation of protection neutralizing antibody titers turns out to be mechanically replicable by neutralizing monoclonal antibody titers.
The analysis found within the paper also shows that the degree of protection from symptomatic disease afforded by a neutralizing monoclonal falls nicely on the curb described by the degree of protection afforded by vaccination.
It is our belief that these data suggest that monoclonal antibody neutralization potency combined with associated dosing and pharmacokinetic information for any one antibody is a fascinating potential surrogate marker of protection from symptomatic disease.
Further as many of you have dealt with teen.
<unk> has routinely stopped distribution of antibodies under EUA.
Based on utilization post the again changing viral variant without corresponding clinical data.
These data represent the first data from a prospective controlled clinical trial of a monoclonal antibody against COVID-19, which provide consideration set of reverse pathway using neutralizing titers has the potential to be a correlate of protection. The finding is consistent with observations of high protection.
Generated from antibodies produced by other leading company, implying that at least in the case of Igt's directed against RB such as ours that inhibit a consistent biophysical principle is that we're with a consistent clinical correlate.
Our belief is that patients caregivers and global regulatory authorities are all seeking more rapid and efficient approaches to antibody development in COVID-19.
And we look forward to sharing these data and our perspective more broadly.
We are not yet able to share specifics on our planned clinical program, but we look forward to doing so in the near future.
Big picture, our goal is to rapidly demonstrate the potential protective and therapeutic benefits of our current and anticipated future molecules and to create a platform in industrial process that allows us to third patient through continuous innovation as viral evolution required.
While some have declared the pandemic over we feel that Sars COVID-19 two represents an unacceptable perpetual toll on human health and wellbeing.
According to the CDC right now each day approximately 300 people in the U S are dying from COVID-19.
That is nearly 110000 mothers and fathers grandparents spouses and other beloved family members, we will lose each year unless we do something.
How can we move forward as a nation and the world accepting that as our continuous pace it.
It is imperative that we think differently about our approach to managing COVID-19, if we are to reduce the total of this disease for the future.
<unk> is committed to being an important part of the solution in reducing debt from this buyer at the moment.
From a business perspective, we see tremendous opportunity to create value for our shareholders as we innovate for the sake of those most vulnerable.
Annually prevention and treatment of COVID-19 represents an $80 billion to $100 billion market. Our goal is to capture a portion of those revenues on an ongoing basis with our <unk> platform approach and which we strive to develop best in class antibody solution for COVID-19 and beyond.
I will turn the call over to Fred to discuss our financial results.
Thanks, Dave and good afternoon, everyone for.
For the quarter with respect to operating expenses R&D was $34 1 million for the third quarter of 2022 compared to $49 4 million for the comparable period of 2021.
The decrease is attributable to the wind down of Adam Trevor Mab clinical trials and manufacturing related activities.
This decrease was partially offset by increased contract manufacturing expenses related to the production of materials for use in the non clinical studies and planned NBD 200 clinical trials.
Our SG&A expenses were $13 2 million for the third quarter of 2022 compared to $11 1 million for the comparable period of 2021.
This increase is attributable to higher public company costs.
Personal services and personnel related expenses.
The net loss for the third quarter of 2022 was $45 1 million compared.
Compared to $60 4 million for the comparable period in 2021.
Basic and diluted net loss per share was <unk> 42 for.
For the third quarter of 2022 compared to 98 for the comparable period in 2021.
We exited the third quarter and a strong balance sheet position with cash cash equivalents and marketable securities of $419 million.
Based on our current operating plans, we expect our cash will enable the company to fund its operating expenses into the second quarter of 2024.
With that said we are currently working on a 2023 zero based budget approach looking for cost efficiency opportunities and plan to update our cash runway guidance. Once we complete our budget and close out fiscal year 2022.
With that operator, please open the call for questions.
If you'd like to ask a question at this time. Please press star one one on your telephone.
Again that is star one one if you'd like to ask a question.
Our first question comes from the line of Michael Yee with Jefferies. Your line is now open.
Yes.
Hey, good afternoon. This is hadar upon for Mikey.
Two quick questions, one when kind of thinking about the clinical pathway forward for NBD 200.
Clinical trial design are you planning given that you know may be challenging to find patients with new infections, COVID-19 or they're going to be highly vaccinated, so talk a little bit about that.
And then my second question is how are you thinking about.
Your guidance moving forward into 2023 in terms of clinical trial ramp up et.
Et cetera. Thank you.
Yeah, great. Thanks for the question.
As you know.
A very dynamic space, one that didnt, even exist three years ago, and what we've been doing here in vivid is really looking at what recent sponsors have done.
Partnering with global regulators and seeing how they bring past.
Programs forward, knowing that it's not a one size fits all so as it were.
<unk> to where we are as we guided.
We have and we did 200, which will be entering the clinic in Q1 of next year.
And what we've seen is these phase one studies can be done rapidly and while we haven't provided guidance yet on this specific clinical designs. We do anticipate ongoing data throughout calendar year 2023, and our goal is to apply the learnings that we've had.
Over the last few years as well as learnings we've seen from other companies in this space and to do this as quickly as possible given the urgent unmet need.
Yeah.
Thank you.
Our next question comes from the line of Stephen Wiley with Stifel. Your line is now open.
Hi, guys can you hear me.
Yes, hi.
Hi, This is Julia on for Stephen Willey of Stifel.
Thank you for taking my question and congrats on the quarter. So I just have a very quick question rigor.
Regarding MVD 200 so.
Given that there are new emerging variance as we all know that gets GBP be Q1, and ex BP, one et cetera, you name them. So I know that you can you guys cannot comment.
Exclusive detail Sputnik can you guys just qualitatively comment on.
Neutral neutralization activity of <unk> against.
These newly emerging variance.
Just in a qualitative manner.
Yes of course and.
Thanks for the question as we've seen.
It's becoming incredibly pressing need once again seeing the reduced activity that both <unk> and debt to love. The mab. The antibodies that are left on the market for prevention and treatment are showing and so for us.
It really validates our approach.
This focus that we have on our platform and as you've asked specifically about <unk> 200, and as I mentioned in our upfront.
Commentary, we're pleased that so far and in vitro testing that NBD 200, as well as candidates beyond that we have in late stage discovery have all shown retained activity against these current and emerging variance as you as you mentioned the ones that are there and it's a it's a really.
Fascinating space because.
Previously what we saw was this sort of singular.
Virus change from Alpha debate at the Gamba and now what we're seeing as has been put in the press as the swarm of Scrabble variant and so it's really even more critical that we utilize our underlying technology focused in engineering, not just searching for new antibodies and mining for new and.
Bodies and that is one of the areas that we feel is critically differentiator for us and why we're still excited for where we are today.
Okay. Thank you and my second question would be more related to the risk that till the key off the platform. So the so I know you guys have been just like.
Observing the.
Current evolution now like variance and I.
I mean like it's been changing.
So kind of like rapidly so with your current capabilities like how can you just say mix like maybe three months. If there is like more like more novel very intimate like how quickly can you guys actually come up with like New Portland, Kansas City.
If you guys have any.
Idea on.
Timing.
Yeah, I mean listen speed is definitely the name of the game right and what I would say is to date. The company has been incredibly successful focused on that key determinant. So the company is not even two and a half years old we already have demonstrated our.
<unk> to put forward candidates generate clinical data with meaningful clinical results manner.
Manage the curve ball of omicron.
Created new candidate and have them slated to go into the clinic again in less than a year from that change and so the whole company is now built and focused on.
That instability that is.
Been observed from the virus right I mean, we've seen the evolution in how fastest virus changes and so what we're targeting is with this platform not just NBD 200, but planning for the probability that it as well as other antibodies will eventually have obsolescence write that the virus will move past them.
And so that's where we're focused to continue.
To do this as rapidly as possible and more to come we will we will certainly showcase.
That speed as we move forward, but that is how in David with that up with that in mind to make sure that we can get ahead and stay ahead of the variant.
Alright, great. Thank you very much taking my question.
As a reminder, if you'd like to ask a question at this time that star one one.
Our next question comes from the line.
<unk> with Guggenheim.
Your line is now open.
Hi, guys. Thanks for taking the question interesting work by Laura How did you guys discuss the surrogate marker.
And other regulatory agencies.
Just wondering how the conversation with the regulators hosecock with recently.
Yeah. So we don't comment specifically on conversations that we've had with global regulators, but what we can say is that this approach is certainly something that we're hearing and seeing in the broader scientific community. We all have noted the need for increased speed and.
We are now generating this data. This paper is available on that archives will be posting it as well on our on our website. We're looking for it to eventually get published but it is available in preprint and we think it really covers a lot of these critical components that we're talking about which is how do we continue to have.
<unk> products that can meet the speed of the virus knowing that these huge populations and immuno compromised in particular et cetera are being left underserved with the current situation that we have so we are really excited about this.
Recent.
Scientific work that we've done with this paper and we look forward to having conversation both with global regulators and the weeks and months to come.
Weeks and months to come as well is that the broader scientific community.
Yeah.
Great and I had one follow up.
How should we be thinking about prioritization of prevention versus treatment opportunities.
Particularly just given the lack of available options for certain patients.
Thanks.
Yeah, No. We certainly see prevention is the most critical opportunity in particular as I mentioned.
Populations like immuno compromise. This is a group that even if the vaccines were working perfectly which they are not they would still be left underserved given their immune systems and their lack of being able to create.
Really meaningful immune responses.
So for us that is.
Key area, it's certainly one that we've seen with <unk>.
And the uptake, which continued even with their Q3 numbers.
Announcement today that just continues to grow and then necessity there it continues to grow and so what we've seen over time is a shift in antibody is being utilized for treatment and prevention and we anticipate that continuing and it certainly.
Our highest priority.
Great. Thanks, guys.
That concludes today's question and answer session I would like to turn the call back to Dave Harrington for closing remarks.
Thank you so much and thank you all for joining us for our first quarterly earnings call that concludes our meeting for today as always we're happy to follow up with analysts or investors one way.
One on one after the call Tonight and tomorrow, but thank you all for joining.
This concludes today's conference call.
You for participating you may now disconnect.
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