Q4 2022 Invivyd Earnings Conference Call

March 23, 2023

Speaker 1: Million individuals, depending on how their status is class classified.

The threat, we are facing from COVID-19 is constantly changing as viral evolution has continued through omicron sub lineages. In fact hundreds of new variants have been identified in the U S. In the last five months.

Speaker 2: The threat we are facing from coa.

Speaker 2: faciing from COVID-19 is.

Speaker 1: ly changing as viral evolution has continued through omacon sublineages.

Speaker 1: This continual viral evolution mandates that drug discovery and development must keep pace. However, as of January 2023, there are no longer any monool antibodies for the treatment or prevention of COVID-19 authorized in the U S.

This continual viral evolution mandates that drug discovery and development must keep pace. However, as of January 2023, there are no longer any monoclonal antibodies for the treatment or prevention of COVID-19 authorized in the U S.

Speaker 1: We consider this market an open opportunity for invivid to target near term. For reference, the last full quarter, with all antibodies authorized in the U's and or approved globally, represented approximately $1.1 billion in revenue. Importantly, we see this category growing because, although many populations have been served by vaccination and treatment with antiviral medication, as we referred to, there are many populations who have not benefited from these approaches and which will require ongoing protection and treatment outside of the major options.

We consider this market and open opportunity for invigorate to target near term for.

For reference the last full quarter with all antibodies authorized in the U S. <unk> approved globally represented approximately $1 $1 billion in revenue.

Importantly, we see this category growing because although many populations have been served by vaccination and treatment with antiviral medication as we've referred to there are many populations who have not benefited from these approaches and which will require ongoing protection and treatment outside of the major options.

Michael antibodies for COVID-19 alone generated almost $8 billion in revenue in 2022.

Speaker 1: markelo antibodies for COVID-19 alone generated almost $8 billion in revenue in 2020 -two.

While the bad news is there are no monoclonal antibodies are available for treatment or prevention, and then ongoing high burden of disease. The good news is we believe <unk> is uniquely positioned to respond to this need having generated a pipeline of multiple next generation engineered antibody candidates for COVID-19 designed to keep pace.

Speaker 1: While the bad news is there are no monal antibodies available for treatment or prevention and an ongoing hibden of disease, the good news is, we believe invivid is uniquely positioned to respond to this need, having generated a pipeline of multiple next-generation engineered antibody candidates for COVID-19, designed to keep pace with viral evolution.

Speaker 1: Our pipeline assets are engineered to be broadly neutralizing antibodies affected across multiple members of the coronavirus family to support their prolonged utilities.

Viral evolution, our pipeline assets are engineered to be broadly neutralizing antibodies effective across multiple members of the Corona virus family to support their prolonged utility.

Earlier this month, we announced plans to advance <unk>. Our next pipeline candidate into the clinic first Sars Covid two <unk>.

Speaker 1: Earlier this month we announced plans to advance vy two two 2, our next pipeline candidate, into the clinic for SAR COV two vy Q Q2 is one of the components of MVD two hundred, a mAb combination candidate that previously elected to advance in development. The company chose to prioritize the clinical development of vyd two two two monotherapy instead of nvd two hundred combination product because we believe this strategy will enable us to provide patients with a much needed therapeutic option as quickly as possible in a capital efficient way.

<unk> is one of the components of <unk> 200, a mab combination candidate that David previously elected to advance in development the.

The company chose to prioritize the clinical development of <unk> monotherapy instead of NV EV 200 combination product because we believe this strategy will enable us to provide patients with a much needed therapeutic option as quickly as possible in a capital efficient way.

Speaker 1: Importantly, we have selected a combination of drug candidate prior to the emergence of potential expedited regulatory pathways which may allow invivid to develop multiple new antibodies, staggered in time, to take advantage of data from new SAR COV two variants.

Importantly.

We have selected a combination drug candidate prior to the emergence of potential expedited regulatory pathways, which may allow <unk> to develop multiple new antibodies staggered in time to take advantage of data from new Sars Covid two variance.

We see <unk> as a highly attractive candidate for clinical advancement for several reasons.

Speaker 3: We see VID two two two as a highly attractive candidate for clinical advancements for several reasons. Vid two two two targets, despite protein of sarcov 2, a well-understood mechanism with a safety, with a safety profile established by multiple FDA approved antibodies, which we feel reduces clinical risk.

<unk> targets, despite protein of <unk>, a well understood mechanism with the safety.

With a safety profile established by multiple FDA approved antibodies, which we feel reduces clinical risk Adil.

Speaker 1: Additionally, vy two two two is an engineered version of our first monocluol antibody product called intrubimab, which demonstrated clinically meaningful results across its three primary endpoints and large global Phase three trials. Our strong data package from intrimab has the potential to support accelerated development of VID Q2 two

Additionally, <unk> is an engineered version of our first monoclonal antibody product called <unk>, which demonstrated clinically meaningful results across its three primary endpoints and large global phase III trials.

Our strong data package from Intrepid Nab has the potential to support accelerated development of <unk>.

Importantly, and standardized in vitro assays <unk> showed neutralizing activity against multiple currently circulating <unk> variance of concern, including those that led to the obsolescence of products previously authorized in the U S that have since been pulled from the market we continue to plan.

Speaker 1: Importantly, in standardized in vitro assays, VID two 2- Q showed neutralizing activity against multiple currently circulating variance of concern, including those that led to the obsolescence of products previously authorized in U's that have since been told from the market. We continue to plan to initiate a Phase I clinical trial and Q1 of 2020 -three and, assuming positive Phase I data, we anticipate rapidly initiating the Phase through tiivotal trials that could support regulatory filings globally.

To initiate a phase one clinical trial in Q1 of 2023, and assuming positive phase one data, we anticipate rapidly initiating the phase III pivotal trials that could support regulatory filings globally.

Recently, there have been several positive external developments that indicate momentum for a faster development of next generation COVID-19 treatments, including <unk> we are.

Speaker 1: Recently there have been several positive external developments that indicate momentum for faster development of next-generation COVID-19 treatments, including VID Q Q2. We are often asked about the White House's decision to end the COVID-19 public health emergency and how this could impact the FDA's emergency use authorization for COVID-19 and the development of monoclal antibodies like vy Q Q2.

We're often asked about the white house's decision to end the COVID-19 public health emergency and how this could impact the fda's emergency use authorization for Covid and the development of monoclonal antibodies like <unk>.

Speaker 1: We do not see this impacting our development strategy. Soon after the Biden administration announced that the public health emergency will end on May eleventh, the FDA confirmed that existing EAS for vaccines, tests and treatments will not be affected and confirms that it may continue to issue EAS for new products that meet the required criteria.

We do not see this impacting our development strategy soon after the buy and the administration announced that the public health emergency will end on May 11th the FDA confirmed that existing EUA for vaccines tests and treatments will not be affected and confirmed that it may continue to issue <unk> for new products that meet the required criteria.

Speaker 1: Additionally the industry.

Additionally, the industry remains hopeful that alternative efficient regulatory strategies to support the development of novel monoclonal antibody therapies will be utilized for this critical unmet need.

Speaker 2: Remains hopeful that alternative efficient regulatory strategies to support the development of novel monoclcle antibody therapies will be utilized for this critical unmet.

While we are optimistic about <unk> potential to serve the critical need for therapeutic option for COVID-19 continued viral evolution dictates that we also continue to evolve our assets and further add to our pipeline leveraging our proprietary discovery platform approach, we are perpetually monitoring emerging viral threats.

Speaker 2: While we are optimistic about V Y D 2- two two's potential to serve the critical need for therapeutic options for COVID-19, continued viral evolution dictates that we also continue to evolve our assets and further add to our pipeline, leveraging our proprietary discovery platform approach. We are perpetually monitoring emerging viral threats, discovering engineering and avaluing new monoal add bodies for their ability to mutualize stars co by two in addition to V Y two 2- 2, we have three other COVID-19 candidates in our pipeline at the preclinical stage.

Discovering engineering <unk>, new monoclonal bodies.

Bodies for their ability to neutralize Sars Covid. Two in addition to <unk>, we have three other COVID-19 candidates in our pipeline at the preclinical stage.

Speaker 2: The message is clear.

Message is clear there remains a large persistent medical and commercial opportunity outside of Covid I am not aware of any other opportunity in biotech that is larger offers a faster path to authorization and has a higher probability of meaningful clinical results given our mechanistic understanding.

Speaker 4: There remains.

Speaker 1: A large, persistent medical and commercial opportunity outside of COVID-19. I am not aware of any other opportunity in biotech that is larger, offers a faster path to authorization and has a higher probability of meaningful clinic co results. Given our mechanistic understanding of the virus, we believe we are well positioned to capitalize on this opportunity time and time again with our proprietary discovery technology.

<unk> of the virus.

We believe we are well positioned to capitalize on this opportunity time and time again with our proprietary discovery technology I will now turn it over to our Chief Medical Officer, Pete Smith to review, our recent pipeline progress in ongoing discovery and development activities.

Speaker 2: I will now turn it over to our Chief Medical Officer peachment, to review our recent pipeline progress and ongoing discovery and development activity.

Speaker 5: Thanks you, D. as D have mentioned, we recently nominated VID two 2, two to advance for the clinic as a new monoclonal antibody candidate. Or math against ourscoobe two as you know, VID two 2, two will be our second map candidate to enter cllobal protesting.

Thanks, Dave as Dave mentioned, we recently nominated BYD Q2, two to advance to the clinic as a new monoclonal antibody candidate or map against Sars Covid. Two as you know BYD <unk> will be our second half candidate to enter clinical testing.

Speaker 6: After Phase I dose ranging trial to evaluate safety and pharmacokinetics, or PK, we intend to initiate what we expect to be a larger registrational Phase three clinical trial to assess the efficacy of BID two to two to prevent COVID-19, specifically in Aimmune compromised individuals.

<unk> phase one dose ranging trial to evaluate safety and pharmacokinetics or PK, we intend to initiate what we expect to be a larger registrational phase III clinical trial to assess the efficacy of <unk> to prevent COVID-19, specifically in immune compromised individuals.

Speaker 6: vite two to two has demonstrated in vitro neutralizing activity against ours cobe two variants of concern or bocs, including the current dominant aacad subid H, xtb. One point five.

<unk> has demonstrated in vitro neutralizing activity against Sars Covid, two variance of concern or voc's, including the current dominant omicron sublet each SPV one five <unk>.

<unk> is an engineered version of <unk>, our first investigational mab.

And <unk> has a robust safety data package and has demonstrated clinically meaningful results in global phase III clinical trials for both the prevention and treatment of COVID-19 during the Delta and Omicron VA, one waves of Sars Cov, two but subsequently lost in vitro activity against <unk>.

Speaker 6: Utilizing our expertise in protein engineering, we were able to restore inviTro utilization activity against B two and other omacron bocs, while maintaining activity against previous VC.

Utilizing our expertise in protein engineering, we were able to restore in vitro neutralization activity against <unk> and other omicron voc's, while maintaining activity against previous Vlccs are precision engineering resulted in BYD Q2, too different from that of Trevor map by only eight.

Speaker 6: Our precision engineering resulted in VID Q to 2, differentfer from manotream by only eight amino acids in the variable region.

Acids and the variable region.

Speaker 6: The regulatory landscape around COVID-19 is an.

The regulatory landscape around COVID-19 is advancing and there has been considerable movement with the U S food and drug administration and the European Medicines agency as they work to establish regulatory frameworks that consider the rapidity of viral evolution.

Speaker 6: And there has been considerable movement with the? U's food and drug administration in the European Medicine agency as they work to establish regulatory frameworks that consider the rapidity of viral evolution.

Speaker 6: The agencies are looking for ways to accelerate development of MTS as well. On December fifteenth 2022, a joint EMA FDA workshop and title efficacy of moncoral antibodies in the context of rapidly evolving sarars cooby two variants was held to discuss alternative strategies for the development of novel map therapies, including those based on prototype products that have demonstrated safety and efficacy in clinical trials.

The agencies are looking for ways to accelerate development of mounts as well on December 15, 2022 joined EMA FCA workshop entitled efficacy of monoclonal antibodies in the context of rapidly evolving Sars Covid two variance was held to discuss alternative strategies for the development of <unk>.

Novel map therapies, including those based on prototype products that have demonstrated safety and efficacy in clinical trials and David with US, 2% alongside Eli Lilly and Regeneron at this workshop to discuss ways of accelerating development against COVID-19.

Speaker 6: didavbit with us to present alongside eliilum Regeneron at this workshop to discuss ways of accelerating maap development against COVID-19 and.

Speaker 6: As part of the joint industry presentation and utilizing data from our ad-intrpermap prevention trial debate. Neutralizing antibiotic tiiters were composed as a surrogate marker protection.

As part of the joint industry presentation, and utilizing data from our in sharper map prevention trial debate neutralizing antibody titers were proposed as a surrogate marker protection.

It is our belief that these neutralizing antibody titers combined with associated PK and safety information could be used for a streamlined development pathway and the prevention of COVID-19 incurred.

Speaker 6: Is our belief that these neutralizing antibody titers, combined with associated PK and safety information.

Speaker 6: Could be used for a streamlined development pathway in the prevention of COVID-19.

Speaker 6: Encouragingly, we have seen other companies in the COVID-19 map space refer to the use of biomarker circuit endpoints to expedite their clinical development, which may suggest that the FDA and other major regulatory bodies have agreed in principle to such a trial design for a next-generation map product.

Encouragingly, we have seen other companies in the COVID-19, Mab space referred to the use of Biomarkers surrogate endpoints to expedite their clinical development, which may suggest that the FDA and other major regulatory bodies have agreed in principle to such a trial design for our next generation map product.

Speaker 6: We see this as an important advancement, not only for vby two to two but also for future maps we anticipate generally against sarars COB 2, to allow us to rapidly shift from one map to another as the virus meanates.

We see this as an important advancement not only for <unk>, but also for future maps, we anticipate generating against Sars Covid two to allow us to rapidly shift from one map to another as the virus mutates.

Speaker 6: After demonstrating clinical development success without aminhuvaab by generating clinically meaningful results, we are leveraging and applying this expertise to new therapeutic candidates. Furthermore, targeting miss SAR' coy two receptor binding domain, or RBD, is a well-validated mechanism of action per maps with robust safety and efficacy. Data generated across the class.

After demonstrating clinical development success with admin sharper mab by generating clinically meaningful results, we are leveraging and applying this expertise to new therapeutic candidates. Furthermore, targeting the <unk> receptor binding domain or RVP is a well validated mechanism of action for maps with robust safety and efficacy.

Yossi data generated across the class.

Speaker 6: We expect that these data supporting the broader class of RBD targeted antibodies will also enable regulatory authorities, including the FDA EMA, to apply CIT endpoints as a correlative of protection in future clinical trials.

We expect that these data supporting the broader class of our BD targeted antibodies will also enable regulatory authorities, including the FDA and EMA to apply surrogate endpoints as a correlate of protection in future clinical trials.

Speaker 6: I know many of you want more details about our clinical trial design and time L.

I know many of you want more details about our clinical trial design and timelines review IV to tissue. We are planning a standard phase one PK and dose ranging trial. This trial, which will be conducted in Australia is on track to dose the first patient this quarter.

Speaker 6: For VID two to 2, we are planning a standard Phase one PK and dose raming trial. This trial, which will be conducted in Australia, is on track to dose the first patient this quarter.

Consistent with the <unk> program, we are planning to initiate a phase III pivotal trial that could support global regulatory filings rapidly on the heels of completing this phase one trial.

Speaker 6: Consistent with the aage heap program, we are planning to initiate Phase three pivotal trial that could support global regulatory filings rapidly on the heels of completing this Phase I trial.

Speaker 6: With regards to to CMC, to support manufacturing of our clinical materials and commercial drug product, we have but the partnership with ouci, which has FDA approved manufacturing facilities and has delivered 100% of our drug substance lots on time.

With regards to CMC to support manufacturing of our clinical materials and commercial drug product we have.

The partnership with Wuxi, which has FDA approved manufacturing facilities and has delivered 100% of our drug substance lots on time.

Speaker 6: Through this relationship we have already manufactured the drug substance needed for clinical trials of VID two two two in support of an EA.

Through this relationship we have already manufactured the drug substance needed for clinical trials of BYD Q2, two in support of an EUA.

Speaker 6: I am confident in our ability to work with speed, agility and efficiency, to reduce traditional clinical timelines and to get to top line data as quickly as possible.

I am confident in our ability to work with speed agility and efficiency to reduce traditional clinical timelines and to get to top line data as quickly as possible.

Speaker 6: I will now pass the call over to Lucas villinger to vivid' interim Head of discovery preclinical, who will discuss our ongoinging surveillance and antibody discovery, screening and engineering EF.

I will now pass the call over to Lukas Dillinger exhibits interim head of discovery and preclinical who will discuss our ongoing surveillance and antibody discovery screening and engineering.

Speaker 5: thankqupied for the update on our near-term outlook. As theyaveve discussed at the beginning of the call, in vivid approach to RD for COVID-19 is one of perpetual innovation. In vivid was created to continually develop candidates and not rely on any one candidate. The pace of viral evolution demands that our candidates need to keep paid and has the potential to address emerging viral threats.

Thank you Pete for the update on our near term outlook effective cost at the beginning of the call and visits approach to R&D for COVID-19 is one of perpetual innovation.

And Vivek was created to continually develop candidates and not rely on any one candidate the.

The pace with viral evolution demands that our candidates to keep pace and has the potential to address emerging viral threats.

Speaker 5: This unique perpetual discovery engine is fueled by cutping hgeboral epigenological surveillance, identification of broadly neutralizing monocl antibodies and industry-leading diesa mining, proteine and antibody engineering, as well as screen capabilities through our internal expertise and collaboration.

This unique perpetual discovery engine is fueled by.

Cutting edge model epidemiological surveillance.

Densification of broadly neutralizing monoclonal antibodies.

And industry, leading detailed mining protein and antibody engineering.

Well as screening capabilities through our internal expertise and collaboration.

Speaker 5: With regards to monitoring viral evolution, we continuously maintain and improve our in-house alayment system for new and outcoming price coed-to variants before this become variants of concern.

With regards to moan importing borrowing evolution.

Continuously maintain and improve our in house maintenance system for new and upcoming Colby to Permian.

For these become variance of concern.

Furthermore, by pinpointing dominant spike glycoprotein sites targeted by human antibody repertoire, and netting common mutation escape route.

Speaker 5: Furthermore, by pinpoints in dominant byike dry ofprote sites targeted by human antibody weper, toass and netic common mutational escape groupps. We aim to predict and target future startge covidto variant.

We aim to predict and target future Sars Covid two variant.

Speaker 5: We have industry-leading antibody mining engineering, antdevelopabilities screening capabilities, built with our internal expertise and enhanced with our fully operational better leabilities that we moved into in December . This is further supported by our partnership with adima, our industrial and academic collaborators and the Council of, our world-class scientific advice report comprised of leading researchers and keyopinion leaders in immunology biology, epigimmmunology and the COVID-19 space.

We have industry, leading antibody mining engineering and develop ability screening capabilities built with our internal expertise and enhanced with our fully operational facilities that you've moved into in December .

As further support the partnership with <unk>, our industrial and academic collaborators and the council of our World Class Scientific Advisory Board comprised of leading researches and key opinion leaders in immunology virology epidemiology and the COVID-19.

Space.

Our innovation engine Leverages data mining capabilities to.

Speaker 5: Our innovation engine leverages thesea mining capabilities to isset broadly neutralizing antibodies, followed by antibodyied engineering to improve the proly bread biophysical properties and developabilities of our candidates. We seek to advance into nonclinical development and indineating studies.

Broadly neutralizing antibodies.

<unk> antibody engineering to improve the potency breath biophysical properties.

<unk> developed the ability of our candidates we seek to advance into non clinical development.

Our IND, enabling studies.

Speaker 5: For example verapclicable. We specifically engineering our antibodies to extend the halflights modified a semediated innate immuniffect D function or to introduce alternative format such as single domain of b-specific molecules.

For example, British.

Clickable is specifically engineered antibodies to extend the half life modify the FC mediated innate immune effector function or to introduce alternative formats.

Such as single domain of bi specific molecules.

Speaker 5: Our established platform and key learnings from our work without in trmon helped to accelerate our path to the clinic and beyond.

Our established platform and key learnings from our work with Robin Treasury month helped to accelerate our path to the clinic and beyond.

Speaker 5: Through this approach we are generating not just V by B two to 2, but the robust pipeline of discovery stage canvas with potential to use in both prevention and or treatment of serious viral diseases, starting with COVID-19.

This approach via generating not just <unk>, but the robust pipeline of discovery stage candidates with potential for use in both prevention and treatment of serious viral diseases, starting with COVID-19.

Speaker 5: From there we are expanding discovery efforts into high need indication, including influenza.

From there we are expanding discovery efforts into high need indications, including influenza.

Speaker 5: Beyond vvid 2: 2, we have already initiated new antibody campaigns. The target reengineering and definitity maturations of our current molecules.

Beyond <unk>, we have already initiated new antibody campaigns that target reengineering and affinity maturation of our current molecules against the most recent COVID-19 variance of concern such as <unk> <unk> five.

Speaker 5: Against the most recent co VID 19. variance of concern such as xppp, point one, point five.

Speaker 5: We are currently evaluating several of these candidates in preclinical studies to support nomination of additional candidates for IND-enabling and clinical development.

We are currently evaluating several of these candidates in preclinical studies to support nomination of additional candidates for IND, enabling in clinical development.

The ambition further product development opportunities emerging from Sars Covid two discovery efforts for the prevention Endo treatment of COVID-19.

Speaker 5: We amition further product development opportunities emerging from startars COVID-19 to discovery efforts for the prevention and treatment of COVID-19 and.

Speaker 5: We believe the discovery of additional broadly neutralizing mono antibodies that target new viral epbittops both within and outside the RBD will support durable products.

<unk> believes the discovery of additional broadly neutralizing monoclonal antibodies that target new viral epitopes, both within and outside the RBC will support durable products.

Speaker 5: For COVID-19, as new variance of concern continue to arise.

For COVID-19, if new variance of confirm continue to arise.

In conclusion, our strategy is to predict and respond to bearing before they become variance of concern and continuously this covenant in the engineered antibodies with neutralization breath and potency such that patients who need may have access to high quality protection, even in the face of rapid evolution.

Speaker 5: We do not rely on a single molecule targeting the single epitop that may experience wireless CAPE.

We do not rely on a single molecule targeting the single epitopes that many experienced wild escape.

We believe our integrated discovery platform linked to our drug development and manufacturing expertise offers a unique competitive advantage in this effort and the potential to provide a distinct benefit to patients and caregivers and global household priorities searching for durable.

<unk> to the ongoing burden imposed by COVID-19.

Speaker 1: With that, I will turn the call over to frre clisco in viits, interim Chief Financial Officer, who will discuss our financials.

With that I will turn the call over to Francesco inhibits interim Chief Financial Officer, who will discuss our financials.

Thanks, Lucas and good afternoon, everyone.

Speaker 1: Thanks Lucas, and good afternoon everyone. Let me begin by providing an update on our 2022 fiscal year pnl as compared to the comparable 2021 period and an update on cash guidance.

Let me begin by providing an update on our 2022 fiscal year P&L as compared to the comparable 2021 period and an update on cash guidance.

With respect to operating expenses R&D, including in process R&D was $183 6 million for the year ended December 31, 2022, compared to $194 million for the comparable period of 2021.

Speaker 1: With respect to operating expenses RND, including in-process RND, was 183.6 million for the year ended December thirty-first 2022, compared to $190.4 million for the comparable period of 2021.

Speaker 1: This decrease is attributable primarily to wind down of adandtreva mAb clinical trials, partially offset by increase in contract manufacturing, including adandtreva mAb commercial supply for a potential EA, and to support our pipeline programs, including void two 2, two

This decrease is attributable primarily to wind down of Adam Trevor Mab clinical trials, partially offset by an increase in contract manufacturing, including Adam Trevor math commercial supply for a potential EUA and to support our pipeline programs, including <unk>.

This decrease.

Speaker 1: This decrease in R was further offset by an increase in personnel-related expenses.

Kris and R&D was further offset by an increase in personnel related expenses.

Speaker 1: Our SGNA expenses were $47 million for the year ended December thirty-first 2022, compared to $36.5 million for the comparable period of twotwentthousand and 21. this increase is attributable to higher personnel-related expenses, professional fees and cost to support our operations as a public company.

Our SG&A expenses were $47 million for the year ended December 31, 2022, compared to $36 5 million for the comparable period of 2021. This increase was attributable to higher personnel related expenses professional fees and costs to support our.

<unk> as a public company.

Speaker 2: In the fourth quarter of 2022, the company incurred a $17.4 million expense attributable to a onetime charge associated with warrants issued to population health partners, or php, as compensation for consulting services to be provided by php to the company.

In the fourth quarter of 2022, the company incurred a $17 4 million dollar expense attributable to a onetime charge associated with warrants issued to population health partners or PHP as compensation for consulting services to be provided by PHP to the company.

Speaker 2: The net loss for the year ended December thirty-first twent thousand and 22 was $241.3 million, compared to $226.8 million for the comparable period in 2021.

The net loss for the year ended December 31, 2022 was $241 3 million compared to $226 8 million for the comparable period in 2021.

Speaker 2: Basic and diluted net loss per share was $2 in 23 cents for the year ended December thirty-first 2020 -two, compared to a net loss of $5 in thirtyy-two cents for the comparable period in two twentthousand and 21. the net loss of two hundred and forty-one point three million for the year ended December thirty-first 2020 -two included a onetime charge of $17.4 million related to the fair value of the warr issued to php.

Basic and diluted net loss per share was $2 23 for the year ended December 31, 2022, compared to a net loss of $5 32 for.

For the comparable period in 2021.

The net loss of $241 3 million for the year ended December 31, 2022 included a onetime charge of $17 $4 million related to the fair value of the warrants issued to PHP.

Speaker 2: We finished 2022 in a strong balance sheet position, with cash, cash equivalents and marketable securities of $372 million.

We finished 2022 and a strong balance sheet position with cash cash equivalents and marketable securities of $372 million.

Speaker 2: Based on our curren operating plans, which reflect the completion of a bottoms up departmental analysis that we highlighted on the Q3 earnings call. Our cash guidance has improved from our previous guidance and we now expect that cash will enable the company to fund its operating expenses, excluding any potential revenue associated with the right to 2: two into the second half of 2020 -four.

Based on our current operating plans, which reflect the completion of a bottoms up departmental analysis that we highlighted on the Q3 earnings call. Our cash guidance has improved from our previous guidance and we now expect our cash will enable the company to fund its operating expenses excluding.

Any potential revenue associated with <unk> into the second half of 2024.

Speaker 1: With that operator. Please open the call for questions.

With that operator, please open the call for questions.

Speaker 7: Thank you againlad.

Thank you again, ladies and gentlemen, if you'd like to ask a question. Please press star one on your telephone again to ask a question. Please press star one one.

Speaker 8: Gentlemen, if you like to ask a question, Please P Star one one on your telephone again to ask. Ask a question, Please P Star one one

One moment please for our first question.

Speaker 8: one moment please for our first question.

Our first question comes from that line of Evan Wang of Guggenheim. Your line is open.

Speaker 8: Our first question comes from the line of Evan wing of guggenhamil. Line is open.

Hey, guys. Thanks for taking my question.

Speaker 9: Hi guys, thanks for taking my question.

Speaker 9: Can you toight you know what's remaining before the view ID?

Can you highlight.

Remaining before the <unk> trial start.

Speaker 10: Trial start.

Speaker 10: Spend a little bit more in terms of how you guys are thinking about trial design.

And a little bit more in terms of how you guys are thinking about trial design.

Speaker 9: But you know dosing.

Dosing timelines.

Speaker 9: Timelines, ETC.

Et cetera.

Speaker 11: Yes think Devin, you want to talk a little bit about. What remains is we're getting ready toward the end of this quarter. Yes, as we stated previously, we're still anticipating dosing our first and human study this quarter. We haven't released a lot of details about that study but, as you heard from the call, it's a pretty pretty traditional dose-ranging PK and safety study.

Yes, Thanks, Kevin Pete you want to talk a little bit about what remains as we're getting ready towards the end of this quarter.

As we stated previously we're still anticipating dosing our first in human study. This quarter. We haven't released a lot of details about that study, but as you heard from the call, it's a pretty pretty traditional dose ranging PK and safety study.

Speaker 6: Beyond that, we'll continue to release details as appropriate on our subsequent studies.

Beyond that we'll continue to release details as appropriate on our on our subsequent studies.

Speaker 12: Yes you having a little bit about timing right, and so, as Pete mentioned, we still anticipate the first study starting by the end of the month, just getting clinical trial material to the sitees, getting the recruitment done, et cetera, and then our plan is to continue to have ongoing data releases throughout the year.

John you asked a.

A little bit about timing right and so.

As Pete mentioned, we still anticipate the first study starting by the end of the month just getting kind.

Clinical trial material to the sites getting the recruitment done et cetera, and then our plan is to continue to have.

Ongoing data releases throughout the year.

Speaker 10: Got it, thanks. And then in terms of a Phase 3, and are you guys without the paper low day in terms of correless? How are you guys thinking about primary endpoint?

Got it thanks, and then in terms of the phase III.

But off the paper lower day, Carlos how are you guys thinking about primary endpoint.

Speaker 13: And secondly.

And secondly.

Speaker 9: You know, be I you two to do, you know.

If you do too.

<unk>.

Adapted from ADP 'twenty, how does that kind of.

Speaker 9: Adapted from AV 20. how does that kind of?

Speaker 9: How does that kind of benefit in terms of it? You can provide them maybe.

How does that kind of benefit in terms of.

So maybe a framework in terms of how that may reduce the trial side, what kind of scope of trial are we looking at here.

Speaker 9: A framework in terms of how that may reduce the trial size. What kind of skilled the trial are we looking at here?

Yes, I'll take the first part and then Pete you can take the second so.

Speaker 11: I'll take the first part of them. You can take the second. So, as we've said and shown before, 80 G 20, our original antibody- we went from IND to pivotal clinical data in 16 months and we utilize both treatment and prevention studies, that used event driven clinical and points, and what we continue to look at as a possibility is whether there's an opportunity to use correlate surrogates ammuunno bridging etcetera, and so those discussions continue, as Pete mentioned, as a part of the upfront on the call.

We've said and shown before ADT.

<unk> 'twenty our original.

Antibody, we went from IND to pivotal clinical data in 16 months and we utilize both treatment and prevention studies that used event driven clinical end points and what we continue to look at as a possibility is whether there is an opportunity.

To use correlates surrogates immuno bridging et cetera.

So those discussions continue.

As Pete mentioned as a part of the upfront on the call. This was really articulated during the December 15th joint FDA EMA, meaning.

Speaker 11: This was really articulated during the December fifteenth joint F D a meaning and we, alongside academic and other stakeholders, really commented about the need for these types of approaches, especially given the dynamic environment that we're in, really going against a virus that continues to evolve at such a rapid pace. And so we continue to have those conversation and, as we previously mentioned, as soon as we have outlined and confirmed exactly what those clinical parameters would be for pivotal studies, we plan to share more details about that.

And we alongside academics and other stakeholders really commented about the need for these types of approaches, especially given the dynamic environment that we're in.

Really going against a virus that continues to evolve at such a rapid pace and so we continue to have those conversations and.

As we previously mentioned as soon as we have.

Outlined in confirmed exactly what those clinical parameters would be for pivotal studies.

We plan to share more details.

About that.

Speaker 11: Pete any other comments? A great question about the relationship to adg 20, the molecular relationship and.

Pete any other comments yeah, great question about the relationship to ADT 20 molecular relationship and.

Sure.

Speaker 6: We're still in conversations with global regulators around this, of course, but we do believe that it is an advantage to have a robust safety data set and also efficacy data from our previous Phase three studies in a molecule that was generated on the same manufacturing platform and is so closely structurally related to VID to add twent, I'm sorry.

We're still in conversations with global regulators around this of course, but.

We do believe that.

It is an advantage to have a robust safety data set and also efficacy data from our previous phase III studies in a molecule that was generated on the same manufacturing platform and is so closely structurally related to <unk>.

To ADT, Tony I'm sorry.

Speaker 6: So lots of potential there.

So lots of potential there.

Yes.

Great. Thanks, guys.

Speaker 14: Great texo.

Thank you one moment please.

Speaker 7: Thank you one moment please.

Speaker 8: Our next question comes from the line of C AR.

Our next question comes from the line of Siddhartha <unk>.

Speaker 8: Meta of Jeffrey. jalan is open.

Matter of Jefferies. Your line is open.

Speaker 15: How it sit on for Michael E jeapree.

How does that sit on for Michael Yee of Jefferies.

Speaker 11: So two quick questions first one being you know astrgenic and other big companies while they made a lot of money.

So two quick questions first one being.

Astrazeneca and other big companies, while they made a lot of money in 2022 on antibodies have noted that they see the market going significantly down in 'twenty, three and beyond as we move to an endemic market. So how do you guys think about that as you move your antibody forward.

Speaker 15: 2022 antibodies have noted that they see the market going significantly down in 23 and beyond as you move to an endemic market. So how do you guys think about that as you move your antibody forward? And my second question is: you know, although you've mentioned having these kind of correlates of protection for Phase three studies, has a brainany discussion or definitive answers from the fpon whether not you can use that as a part of your Phase three studies?

My second question is.

Although you've mentioned, having these kind of correlates of protection for Phase III studies has there been any discussion or definitive.

Answers from the FDA on whether or not you can use that as a part of your phase III studies. Thank you.

Speaker 15: Thank you.

Yes, I'll take the first question and so our estimates that in 2022, the sort of overall market across vaccines.

Speaker 11: Think the first question, and so you know our estimates- that in 2022, you know the sort of overall market across vaccines- oral anti virals, monic o antibodies- was almost $1 billion and yes, I think that a lot of folks are predicting that that will come down, but it's still incredibly sizable market. You know moncle antibodies did eight billion about in revenue in 2022 and that was with, you know, predominantly B to Lo, AB and you Shell and, as you se did, you know, 500 and some million dollars in Q3 of last year and what we see is with's a similar indication, really targeting immune compromise vulnerable population.

Oral anti Virals monoclonal antibodies with almost 100 billion.

And yes, I think that.

A lot of folks are predicting that that will come down, but it's still incredibly sizeable market.

Muscle antibodies did 8 billion.

About in revenue in 2022 and that was with.

Predominantly <unk> and have yourself and have yourself did 500 and some million dollars in Q3 of last year and what we see is.

Speaker 11: You know they only touched really a fraction of that population and we continue to work with these groups, talk to patient advocacy groups, speak with these individuals and they still are really clamoring for products. In particular, I spoke to you know position, who works as the male clinic, and said you know he had never been in a position that these types of patients come in and ask for products and there's nothing available and so, based on that, we see the market for mono antibodies continue to be, you know, incredibly significant and a huge unmet need and this patient population.

With a similar.

Indication really targeting immune compromised vulnerable populations.

They only touch really a fraction of that population and we continue to work with these groups talked to patient advocacy groups speak with these individuals and they still are really clamoring for.

Products in particular I spoke to.

Physician.

Who works at the Mayo Clinic and said he had never been in a position that these types of patients come in and ask for our products and there is nothing available.

And so based on that we see the market for monoclonal antibodies continuing to be incredibly significant and a huge unmet need in this patient population.

Speaker 11: As it relates to your other question, in terms of you know where regulators are and you know what the status is. You know will provide updates. You know additional updates when we get them. We continue to be in dialogue with the F D, a and other global regulators and you know, as I said, as soon as we have confirmed what that trial design will look like, we plan to to provide that information.

As it relates to your other question in terms of.

Where regulators are and what the status is and we will provide updates additional updates when we get them. We continue to be in dialogue with the FDA and other global regulators and as I said as soon as we have.

Confirmed what that trial design will look like we plan to provide that information.

Thank you.

Speaker 16: Thank you.

Okay.

Speaker 7: Thank you one moment please.

Thank you.

One moment please.

Speaker 8: Our next question comes from the lot of Matthew Harrison of Morgan famleily. An is open.

Our next question comes from the line of Matthew Harrison of Morgan Stanley . Your line is open.

Okay.

Speaker 17: Hi this is onejhn line for mattheo. Thanks for taking our questions. I have two questions. one is: is there add an update on adding kind of regulatory thresholds for new antibody therapy for COVID-19, given the change of the pandemic stating?

Hi, This is Joe online for Matthew Thanks for taking my questions I have.

Two question one is.

Any update on adding kind of regulatory thresholds for new antibody therapy for Covid.

Given the change of the pandemic setting.

Speaker 17: Could there be adding flexibility in potential approval? The second is: do you have adding updates on your potential progress on flu andbase therapy development?

Would there be any flexibility in potential approval.

The second is do you have any updates on your potential progress through antibodies.

Therapy development.

Sure no. Thank you for the question. So on the first one in terms of regards to thresholds.

Speaker 11: thirnow, Thank you for the question. So on the first one in terms of regards to threshold.

Speaker 12: Jo as you.

As you are likely aware at least in the U S. None of the antibodies have been fully licensed and gone through BLA as they've all been authorized through EUA.

Speaker 11: Likely aware, at least in the? U us, none of the antibodies have been fully licensed and gone through A. they've all been authorized through E ways and there currently are no monl antibodies on the market and so we have not seen any specific changes in thresholds. In particular, what we continue to look at is in vitro data ahead of time and, as what we've seen on, you know, V two 2, two is, you know, consistently strong activity against a variety of variance, including the most recent on dot one 5, and so we see that that is, you know, really important information as it relates to getting the products into clinical trials, ETC.

There currently are no monoclonal antibodies on the market and so we have not seen any specific.

Changes in thresholds in particular, what we continue to look at is in vitro data ahead of time and as what we've seen on <unk> is consistently.

Consistently strong activity against.

A variety of variance including.

The most recent on dot one dot five and so we see that that is.

Really important information as it relates to getting the products into clinical trials et cetera.

Speaker 11: And as I mentioned you know through the presentation, while the public health emergency is ending.

As I mentioned.

Through the presentation, while the public health emergency is ending.

Speaker 11: That does not remove the potential for the FDA to utilize the EAS, and so we still see that as an open possibility for vy 2, two or our additional other candidates that we have in the pipeline.

That does not remove the potential for the FDA to utilize the EUA and so we still see that as a open possibility for <unk> or our additional other candidates that we have in the pipeline.

As it relates to the food component I'll turn it over to Lucas you can provide an update on the status of upwards of what of where we are with the flu program.

Speaker 3: It relates to the flu component. I'll turn it over to Lucas. You can provide an update on the status of what where we are with the flu program.

Speaker 18: Yes Thank you, Dave. So we've identified several interesting molecules in the fllow program already. These molecules are currently being further characterized in nbtraces and other studies and we will be releasing the data as soon as we have them available.

Thank you Dave.

We've identified several interesting molecules in the flu program already.

These molecules are currently being further characterized them <unk> and all of the studies and we will be releasing the data as soon as we have them available.

Okay. Thank you.

Speaker 17: Ok Thank you.

Thank you I'm showing no further questions at this time I will turn the call back over to Dave Henry for any closing remarks.

Speaker 8: Thank you. I'm sureing no further questions of this time. I would turn the call back over to Dave hering for any closing remarks.

Thank you so much so thanks to everyone for joining it was.

Speaker 11: Thank you so much. So thanks to everyone for joining. It was a fantastic quarter and a great 2022, So I'm very excited for where we are and, as I alluded to at the start of this discussion, I'm extremely pleased with our progress in the fourth quarter and our start to this year. We have multiple multiple antibiotic candidates that have shown in vitro utilizing activity against multiple current lineages of ommerron.

Fantastic quarter, and a great 2022, so I'm very excited for where we are and.

As I alluded to at the start of this discussion I'm extremely pleased with our progress in the fourth quarter and our start to this year, we have multiple monoclonal antibody candidates that have shown in vitro neutralizing activity against multiple current lineages of omicron.

Speaker 11: I believe in the company's ability to bring to.

I believe in the company's ability to bring to market a product for COVID-19, as fast and efficiently as possible to meet this continued large unmet need and patients and to capitalize on the significant market opportunity and create value for shareholders.

Speaker 19: Market a product for COVID-19 as fast and efficiently as possible to meet this continued large unmet need in patients and to capitalize on the significant market opportunity and create value for shareholders.

Speaker 3: Given the rapid pace of viral evolution and the ongoing regulatory environment, we are positioning the company to pivot, as necessary to liver, to deliver on that goal time and time again.

Given the rapid pace of viral evolution and the ongoing regulatory environment. We are positioning the company to pivot as necessary deliver to deliver on that goal time and time again.

Speaker 3: So that concludes our memeaning for today and, as always, we'll be happy to follow up with analysts or investors one-on one after the call tonight and tomorrow. Thank you.

So that concludes our meeting for today and as always we'll be happy to follow up with analysts or investors. One on one after the call Tonight and tomorrow.

<unk>.

Speaker 8: Thank you, Ladies and some men. This does conclude today's conference. Thank you all participating. You may now disconnect. Have a great day.

Thank you ladies and gentlemen, this does conclude today's conference. Thank you all participating you may now disconnect have a great day.

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Speaker 8: Thank you for standing by and welcome to the invibit 2022 year and financial results update call.

Thank you for standing by and welcome to the <unk> 2022 year end financial results update call. At this time all participants are in a listen only mode.

Speaker 8: At this time all participants on a listenonly mode. After the speaker's presentation, there will be a question-and-answer session.

After the speaker's presentation, there will be a question and answer session.

Speaker 8: To ask a question at that time. Please first Star one one-on year telephone.

Ask a question at that time, Please press star one on your telephone.

Speaker 8: As remind of today's call is being recorded. I will now turn the comps of you host cure a fair cloth.

As a reminder, today's call is being recorded.

I will now turn the conference host Cara Fair cloth, Vice President advocacy and corporate Communications. Please go ahead.

Speaker 8: Vice President, advocacy and Corporate Communications. Please go ahead.

Speaker 20: Thank you for joining us today. Before we get started, I want to attend to a few housekeeping items. I am by youither to review our press release discussing our full year ended December thirty-first- 2022 financial results, which can be found on the Investors section of the inhivid website.

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

By either of your press release discussing our full year ended December 31, 2022 financial results, which can be found on the investors section of <unk> website.

Speaker 20: I would like to remind you that, during today's discussion, we will be making several forward-looking statements.

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.

Speaker 20: Forward looking statements includde statements concerning, among other things, the future of the COVID-19 landscape, including the expectation of its containing, evolution and emergence of new variants and subvariants. Are ongoing ressearch, clinical development plans, including the timing of these plans, as well as the technology and resources to develop therapeutic or preventative options for COVID-19 and other infectious diseases.

Future of the COVID-19 landscape, including the expectation of continuing resolution.

Margins of new variants in some areas, our ongoing research and clinical development plans, including the timing of these plans as well as the technology and resources to develop therapeutic or preventative options for COVID-19, and other infectious diseases.

Speaker 17: Are regulatory and commercialization plans and opportunities, and our expected cash runway and other statements that are not historical fact. 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 having risk factors, and are filings made with the?

Our regulatory and commercialization plans and opportunities and our expected cash runway and other statements that are not historical fact are 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 10-K filed earlier today.

Speaker 17: U's Securities and Exchange Commission, including our most recent 10-K filed earlier today. It is now my pleasure to introduce the invivid management team to the call. I am joined by Dave hering, she ovivid, DR peachment, Chief Medical Officer, DR Lucas, still under interim, Head of discovery and prequ.

It is now my pleasure to introduce the management team to the call I'm joined by Dave Harry CEO Dr.

Dr. Smith, Chief Medical Officer, Dr. Lucas cylinder interim head of discovery, and preclinical and Fred Driscoll interim Chief Financial Officer with that I will turn the call over to Dave.

Speaker 17: And frederiscoll interim Chief Financial Officer with that I will turn the call over to today's.

Speaker 3: Good afternoon and thanks for joining the call. We are looking forward to sharing with you financial results from this past year, along with highlights of significant progress we made during this past quarter.

Good afternoon, and thanks for joining the call. We are looking forward to sharing with you financial results from this past year, along with highlights of significant progress we made during this past quarter.

Speaker 3: For those who may be muted in the story. We are on a mission to rapidly and perpetually deliver antibody based therapies designed to protect vulnerable people from the devastating consequences of circulating viral threats, beginning with stars coby 2, the foundation of our mission.

For those who may be new to the story, we are on a mission to rapidly and perpetually deliver antibody based therapy designed to protect vulnerable people from the devastating consequences of circulating viral threats beginning with <unk> the.

The foundation of our mission is based on three key factors.

Speaker 15: Is based on three key factors.

Speaker 19: one COVID-19 is here to stay and represents an unacceptable medical burden on humankind. To the medicine cabinet, to protect humanity from COVID-19 is alarmingly limited. And 3- we are uniquely positioned to keep pace with viral evolution and provides therapeutic options to people who urgently need them.

<unk> is here to stay and represents an unacceptable medical burden on humankind.

Two the medicine cabinet to protect humanity from Covid is alarmingly limited and three we are uniquely positioned to keep pace with viral evolution and provide therapeutic options to people, who urgently need them.

Speaker 19: We have reached this stage where SARS co be two is circulating unchecked amongst the broader population, with as many as 85% of people in the? U's having been infected. The vaccination rate for boosters is exceedingly low compared with rates of the primary series. Recent reports highlight that only 28% of the eligible people have now received the most recent COVID-19 booster.

We have reached the stage, where Sars COVID-19 two is circulating unchecked amongst the broader population with as many as 85% of people in the U S having been infected.

<unk> rate for <unk> is exceedingly low compared with rates of the primary series <unk>.

Recent reports highlight that only 28% of the eligible people have now received the most recent COVID-19 booster.

Speaker 15: People are being infected and reinfected while the virus continues to evolve. Every day, 250 to 400 families in the? U's lose a loved one to COVID-19, and COVID-19 remains the third leading cause of death, behind only heart disease in cancer.

People are being infected and reinfected, while the virus continues to evolve every day 250 to 400 families in the U S lose a loved one to COVID-19 and cover it remains the third leading cause of death behind only heart disease and cancer.

Speaker 2: While most of society has accepted this status quo and are trying to live with COVID-19, we would argue that all are not living well, particularly vulnerable population.

While most of society has accepted the status quo and are trying to live with Covid. We would argue that all are not living well, particularly vulnerable populations.

Speaker 15: Although the immediate impacts of COVID-19 on many healthy adults appear mild, the long-term consequences remain unknown. Preliminary data reported by the Mayo clinic showed that COVID-19 infections are linked to long-term complications that impact numerous body systems, including pulmonary renal, neurological and gastrointestinal complication.

Although the immediate impact of COVID-19 on many healthy adult appear mild the long term consequences remain unknown preliminary data reported by the Mayo Clinic show that COVID-19 infections are linked to long term complications that impact numerous body systems, including pulmonary renal neurological.

<unk> and gastrointestinal complications.

Speaker 11: Additionally, vulnerable populations remain at an increased risk of severe disease.

Additionally, vulnerable populations remain at an increased risk of severe disease.

Speaker 15: Resulting in a hospitalization and even death.

The resulting in hospitalization and even death.

Speaker 3: I' mull compromise patients. A level in the? U's represent between eight and two million individuals, depending on how their status is class classified.

<unk> compromised patients alone in the U S represent between eight and 20 million individuals depending on how their status as class classified.

Speaker 21: The threat we are.

Speaker 19: Facing from COVID-19 is.

Speaker 3: Rely changing as viral evolution have continued through omron sublineages. In fact, hundreds of new variants have been identified in the U's in the last five months.

Speaker 3: This continual viral evolution mandates that drug discovery and development must keep pace. However, as of January 2023, there are no longer any monool antibodies for the treatment or prevention of COVID-19 authorized in the U S.

Speaker 3: We consider this market and open opportunity for invivid to target near term. For reference, the last full quarter, with all antibodies authorized in the U's and or approved globally, represented approximately $1.1 billion in revenue. Importantly, we see this category growing because, although many populations have been served by vaccination and treatment with antiviral medication, as we refer to, there are many populations who have not benefited from these approaches and which will require ongoing protection and treatment outside of the major options.

We consider this market and open opportunity for <unk> to target near term for.

For reference the last full quarter with all antibodies authorized in the U S. <unk> approved globally represented approximately $1 $1 billion in revenue.

Speaker 3: marklo antibodies for COVID-19 alone generated almost $8 billion in revenue in 2020 -two.

Monoclonal antibodies for COVID-19 alone generated almost $8 billion in revenue in 2022.

Speaker 22: Yeah.

Speaker 21: While the bad news.

While the bad news is there are no monoclonal antibodies.

Speaker 3: There are no monlo antibodies available for treatment or prevention and an ongoing highbden of disease the good news is we believe in vivid is uniquely positioned to respond to this need having generated a pipeline of multiple next generation engineered antibody candidates per.

Oh for treatment or prevention, and then ongoing high burden of disease. The good news is we believe <unk> is uniquely positioned to respond to this need having generated a pipeline of multiple next generation engineered antibody candidates for COVID-19 designed to keep pace with viral evolution our pipeline assets are engine.

Speaker 19: Over 19, designed to keep.

Speaker 11: Pace with viral evolution. Our pipeline assets are engineered to be broadly neutralizing antibodies affected across multiple members of the coronavirus family to support their prolonged utility.

The year to be broadly neutralizing antibodies effective across multiple members of the Corona virus family to support their prolonged utility.

Speaker 3: Earlier this month we announced plans to advance vy two two 2, our next pipeline candidate, into the clinic for SAR COV two V two two is one of the components of MV two hundred a mAb combination candidate that enviavvid previously elected to advance in development. The company chose to prioritize the clinical development of vy Q2 two monotherapy instead of nvd two hundred combination product because we believe this strategy will enable us to provide patients with a much needed therapeutic option as quickly as possible in a capital efficient way.

Earlier this month, we announced plans to advance <unk>. Our next pipeline candidate into the clinic first arc <unk> <unk>.

<unk> is one of the components of NBD 200, a mab combination candidate that David previously elected to advance in development the.

The company chose to prioritize the clinical development of <unk> monotherapy instead of NBD 200 combination product because we believe this strategy will enable us to provide patients with a much needed therapeutic option as quickly as possible in a capital efficient way.

Speaker 23: Importantly.

Importantly.

Speaker 11: We have selected a combination drug candidate prior to the emergence of potential expedited regulatory pathways which may allow invivid to develop multiple new antibodies, staggered in time, to take advantage of data from new sarsce COV two variants.

Speaker 2: We see vy two two two as a highly attractive candidate for clinical advancements for several reasons. vy two two two targets, despite protein of sarcov 2, a well-understood mechanism with a safety, with a safety profile established by multiple FDA approved antibodies, which we feel reduces clinical risk.

We see <unk> as a highly attractive candidate for clinical advancement for several reasons.

<unk> targets, despite protein of <unk>, a well understood mechanism with the safety.

With a safety profile established by multiple FDA approved antibodies, which we feel reduces clinical risk Adil.

Speaker 15: Additionally, B two two two is an engineered version of our first monoclonal antibody product called inimab, which demonstrated clinically meaningful results across its three primary endpoints and large global Phase three trials. Our strong data package from intrimab has the potential to support accelerated development of uid Q2 two

Our strong data package for <unk> has the potential to support accelerated development of <unk>.

Importantly, and standardized in vitro assays <unk> showed neutralizing activity against multiple currently circulating in Brandon variance of concern, including those that led to the obsolescence of products previously authorized in the U S that has since been pulled from the market we continue to plan.

Speaker 11: Importantly, in standardized in vitro assays, VID 2- two Q showed neutralizing activity against multiple currently circulating variance of concern, including those that led to the obsolescence of products previously authorized in U's. That has since been told from the market.

Speaker 11: We continue to plan to initiate a Phase I clinical trial in Q1 of 2023 and, assuming positive Phase I data, we anticipate rapidly initiating the Phase through pivotal trials that could support regulatory filings globally.

Recently, there have been several positive external developments that indicate momentum for a faster development of next generation COVID-19 treatments, including <unk> we are.

Speaker 11: Recently there have been several positive external developments that indicate momentum for faster development of next-generation COVID-19 treatments, including VID Q Q2. We are often asked about the White House's decision to end the COVID-19 public health emergency and how this could impact the FDA's emergency use authorization for COVID-19 and the development of monoclal antibodies like VID Q Q2.

Speaker 11: We do not see this impacting our development strategy. Soon after the Biden administration announced that the public health emergency will end on May eleventh, the FDA confirmed that existing EAS for vaccines, tests and treatments will not be affected and confirmed that it may continue to issue EAS for new products that meet the required criteria.

We do not see this impacting our development strategy soon after the buy and the administration announced that the public health emergency will end on May 11th the FDA confirmed that existing EUA for vaccines tests and treatments will not be affected and confirms that it may continue to issue EUA for new products that meet the required criteria.

Speaker 15: Additionally the industry.

Speaker 15: Remains hopeful that alternative efficient regulatory strategies to support the development of novel monoclcle antibody therapies will be utilized for this critical unmet need.

Speaker 11: While we are optimistic about V Y D 2, 2- two potential to serve the critical need for therapeutic options for COVID-19, continued viral evolution dictates that we also continue to evolve our assets and further add to our pipeline, leveraging our proprietary discovery platform approach. We are perpetually monitoring emerging viral threats, discovering engineering, avalleing new mono AD bodies for their ability to mutual.alize.

While we are optimistic about <unk> potential to serve the critical need for therapeutic options for COVID-19 continued viral evolution dictates that we also continue to evolve our assets and further add to our pipeline leveraging our proprietary discovery platform approach, we are perpetually monitoring emerging viral threats.

Discovering engineering <unk>, new monoclonal bodies.

Bodies for their ability to neutralize Sars Covid. Two in addition to <unk>, we have three other COVID-19 candidates in our pipeline at the preclinical stage.

Speaker 15: Stars coby two in addition to V Y 2, 2- 2, we have three other COVID-19 candidates in our pipeline at the preclinical stage. The message is clear.

Speaker 24: There remains.

Speaker 21: Large persistent medical and commercial opportunity outside of COVID-19. I am not aware of any other opportunity in biotech that is larger, offers a faster path to authorization and has a higher probability of meaningful clinic ical results. Given our mechanistic understanding of the virus, we believe we are well positioned to capitalize on this opportunity time and time again with our proprietary discovery technology.

<unk> of the virus, we believe we are well positioned to capitalize on this opportunity time and time again with our proprietary discovery technology I will now turn it over to our Chief Medical Officer, Pete Smith to review, our recent pipeline progress in ongoing discovery and development activities.

Speaker 15: I will now turn it over to our Chief Medical Officer peachment, to review our recent pipeline progress and ongoing discovery and development activities.

Speaker 25: Thanks Dave. As Dave mentioned, we recently nominated VID two two two to advance for the clinic as a new monoclonal antibody candidate, or maap, against ourzcoobe two as you know, VID two two two will be our second map candidate to enter clloical testing.

Thanks, Dave as Dave mentioned, we recently nominated BYD to do to to advance to the clinic as a new monoclonal antibody candidate or map against Sars Covid. Two as you know BYD <unk> will be our second half candidate to enter clinical testing.

After a phase one dose ranging trial to evaluate safety and pharmacokinetics or PK, we intend to initiate what we expect to be a larger registrational phase III clinical trial to assess the efficacy of <unk> to prevent COVID-19, specifically in immune compromised individuals.

Speaker 6: vite two to two has demonstrated in vitro neutralizing activity against ourars cobe two variants of concern or bocs, including the current dominant aacroad subidih xtb. One point five.

<unk> has demonstrated in vitro neutralizing activity against Sars Covid, two variance of concern or voc's, including the current dominant omicron sublet inch SPV one five.

Speaker 6: bby two to two is an engineeer version in advada trvamap, our first investigational map.

<unk> is an engineered version of <unk>, our first investigational mab.

Speaker 6: adintrvam has a robust safety data path package and has demonstrated clinically meaningful results in global bhas three clinical trials for both the prevention and treatment of COVID-19 during the Delta and omacron BA one waves of szcoby 2, but subsequently lost invitraa activity against omacron VA two

Subsequently lost in vitro activity against <unk>.

Speaker 6: Utilizing our expertise in protein engineering, we were able to restore in-vitroa utilization activity against B two and other omtheron bocs, while maintaining activity against previous VC.

Utilizing our expertise in protein engineering, we were able to restore in vitro neutralization activity against <unk> and other omicron boc's, while maintaining activity against previous via seats. Our precision engineering resulted in BYD Q2, two different incremented Trevor map by only eight amino acids in the <unk>.

Speaker 6: Our precision engineering resulted in VID Q to 2, different from manattreame by only eight amino acids in the variable region.

<unk> region.

Speaker 6: The regulatory landscape around COVID-19 is ance.

Speaker 6: The agencies are looking for ways to accelerate development of mounts as well. On December fifteenth, twent Y and 22, a joint EMA FDA workshop and title: efficacy of monocoral antibodies in the context of rapidly evolving sarars coobe two variants was held to discuss alternative strategies for the development of novel map therapies, including those based on prototype products that have demonstrated safety and efficacy in clinical trials.

<unk> are looking for ways to accelerate development of mounts as well on December 15, 2022 have joined EMA FDA workshop entitled efficacy of monoclonal antibodies in the context of rapidly evolving Sars Covid. Two variance was held to discuss alternative strategies for the development of <unk>.

<unk> map therapies, including those based on prototype products that have demonstrated safety and efficacy in clinical trials and David with US, 2% alongside Eli Lilly and Regeneron at this workshop to discuss ways of accelerating mass development against COVID-19 as.

Speaker 6: indebbit with us to present alongside eliilum Regeneron at this workshop to discuss ways of accelerating MA development against COVID-19.

Speaker 6: As part of the joint industry presentation and utilizing data from our -and charper map prevention trial debate. Neutralizing antibiotic tiiters were composed as a surrogate marker protection.

As part of the joint industry presentation, and utilizing data from our AD and sharper map prevention trial debate neutralizing antibody titers were proposed as a surrogate marker protection.

Speaker 6: It is our belief that these neutralizing antibody titers, combined with associated PK and safety information.

Speaker 6: Could be used for a streamlined development pathway in the prevention of COVID-19.

Speaker 6: Encouragingly, we have seen other companies in the COVID-19 map space refer to the use of biomarker surrocguit endpoints to expedite their clinical development, which may suggest that the FDA and other major regulatory bodies have agreed in principle to such a trial design for a next-generation map product.

Encouragingly, we have seen other companies in the COVID-19, Mab space referred to the use of biomarker surrogate endpoints to expedite their clinical development, which may suggest that the FDA and other major regulatory bodies have agreed in principle to such a trial design for our next generation map product.

Speaker 6: We see this as an important advancement, not only for vby two to 2, but also for future maps we anticipate generating against sarars COB two to allow us to rapidly shift from one map to another as the virus Mates.

Speaker 6: After demonstrating clinical development success with evintrvoun by generating clinically meaningful results, we are leveraging and applying this expertise to new therapeutic candidates. Furthermore, targeting the sarce coy two receptor binding domain, or RBD, is a well-validated mechanism of action per maps with robust safety and efficacy. Data generated across the class.

IC data generated across the class.

Speaker 6: We expect that these data supporting the broader class of RBD targeted antibodes will also enable regulatory authorities, including the FDA MA, to apply surircuit endpoints as a correlative of protection in future clinical trials.

We expect that these data supporting the broader class of our BD targeted antibodies will also enable regulatory authorities, including the FDA EMA to apply surrogate endpoints as a correlate of protection in future clinical trials.

Speaker 6: I know many of you want more details about our clinical trial design and time lines.

Speaker 6: For viewid two to 2, we are planning a standard Phase one PK and dose raming trial. This trial, which will be conducted in Australia, is on track to dose the first patient this quarter.

Speaker 6: Consistent with the aageheap program, we are planning to initiate Phase three pivotal trial that could support global regulatory filings rapidly on the heels of completing this Phase I trial.

Consistent with the <unk> program, we are planning to initiate a phase III pivotal trial that could support global regulatory filings rapidly on the heels of completing this phase one trial.

Speaker 6: With regards to CMC, to support manufacturing of our clinical materials and commercial drug product, we have the partnership with ouci, which has FDA approved manufacturing facilities and has delivered 100% of our drug substance lots on time.

With regards to CMC to support manufacturing of our clinical materials and commercial drug product we have.

The partnership with Wuxi, which has FDA approved manufacturing facilities and has delivered 100% of our drug substance lots on time.

Speaker 6: Through this relationship we have already manufactured the drug substance needed for clinical trials of VID two two two in support of an EA.

Through this relationship we have already manufactured the drug substance needed for clinical trials of <unk> Q2, two in support of an EUA.

Speaker 6: I am confident in our ability to work with speed, agility and efficiency, to reduce traditional clinical timelines and to get to top line data as quickly as possible.

I am confident in our ability to work with speed agility and efficiency to reduce traditional clinical timelines and to get to top line data as quickly as possible.

Speaker 6: I will now pass the call over to Lucas villinger, hividitss interim Head of discovery preclinical, who will discuss our ongoinging surveillance and antibody discovery, screening and engineering apest.

I will now pass the call over to Lukas Dillinger exhibits interim head of discovery and preclinical who will discuss our ongoing surveillance and antibody discovery screening and engineering.

Speaker 5: thankqupid for that update on our near-term outlook. As they've discussed at the beginning of the call, in vivid approach to RD for COVID-19 is one of perpetual innovation. In vivid was created to continually develop candidates and not rely on any one candidate. The pace of viral evolution demands that our candidates need to keep paid ands have the potential to address emerging viral threats.

Thank you Pete for that update on our near term outlook effective cost at the beginning of the call and visits approach to R&D for COVID-19 is one of perpetual innovation.

And Vivek was created to continually develop candidates and not rely on any one candidate the.

The pace of borrowing their pollution demands that our candidates need to keep pace and have the potential to address emerging viral threats.

Speaker 5: This unique perpetual discovery engine is fueled by cutting edge whileal epigenallogical surveillance, identification of broadly neutralizing monocl antibodies and industry-leading deiesa mining, proteine and antibody engineering, as well as screen capabilities through our internal expertise and collaboration.

This unique perpetual discovery engine is fueled by.

Cutting edge model epidemiological surveillance.

Densification of broadly neutralizing monoclonal antibodies.

<unk> industry, leading detailed mining protein and antibody engineering as well as screening capabilities through our internal expertise and collaboration.

Speaker 5: With regards to monitoring viral e.volution, we continuously maintain and improve our in-house fulanment systems for new and outcoming first covid-two variance, this 4: this become variant of concern.

With regards to multi porting borrowing resolution.

Continuously maintain and improve our in house maintenance system for new and upcoming Sars Covid 2 billion before these become their input.

Furthermore, by pinpointing dominant spike glycoprotein sites targeted by human antibody repertoire, and methane common mutation who escape route.

Speaker 5: Furthermore, by pin points in dominant byike, dryoproteating sites targeted by human antibody at plusass and netting common mutational at CAPE groupps, we aim to predict and target future startge covidto variant.

Aimed to predict and target future Sars Covid two variant.

Speaker 5: We have industry-leading antibody mining engineering, antdevelopabilities screening capabilities, built with our internal expertise and enhanced with our fully operational B abilities that we moved into in December . This is further supported for our partnership with abima, our industrial and academic collaborators and the Council of our world-class scientific advice report comprised of leading researchers and key opinion leaders in immunology biology, epigidemnology and the COVID-19 space.

This is further supported by our partnership with <unk>.

Our industrial and academic collaborators and the council of our World Class Scientific Advisory Board comprised of leading researches and key opinion leaders.

Immunology virology epidemiology, and the COVID-19 space.

Our innovation engine Leverages these are mining capabilities to <unk> growth and neutralizing antibodies.

Speaker 5: Our innovation engine leverages thesea mining capabilities to isset, S broadly neutralizing antibodies, followed by antibody engineering to improve the provenly breadth biophysical properties and developabilities of our candidates. We seek to advance into nonclinical development and IND abing studies.

Followed by antibody engineering to improve the potency breath biophysical properties and develop ability of our candidates we seek to advance into non clinical development.

R&D, enabling studies.

Speaker 5: For example, were applicable. We specifically engineering antibodies to extend the halflives, modified a seiated innate immuniffect dfmptction, or to introduce alternative performanatce, such as single domain of by specific molecules.

For example, very applicable with specifically engineered antibodies to extend the half life modify the few mediated innate immune effector function or to introduce alternative formats.

Such as single domain, a bi specific molecule.

Speaker 5: Our established platform and key learnings from our work without in trmonk helped to accelerate our path to the clinic and beyond.

Our established platform and key learnings from our work with Robin Treasury month helped to accelerate our path to the clinic and beyond.

Speaker 5: Through this approach we are generating not just V by D two to 2, but the robust pipeline of discovery stage canvas with potential for use in both prevention and or treatment of serious viral diseases, starting with COVID-19 and.

This approach we are generating not just <unk>, but the robust pipeline of discovery stage candidates with potential for use in both prevention and treatment of serious viral diseases, starting with COVID-19.

Speaker 5: From there we are expanding discovery efforts into high need indication, including influenza.

From there we are expanding discovery efforts into highly indications, including influenza.

Speaker 5: Beyond vbyd two two 2, we have already initiated new antipo campaigns. The target reengineering and thedefinishcy maturations of our current molecules against the most recent COVID-19 mteen variance of concern, such as XP, point one, point five.

Speaker 5: We are currently evaluating several of these candidates in preclinical studies to support nomination of additional candidates for IND-enabling and clinical development.

We are currently evaluating several of these candidates in preclinical studies to support nomination of additional candidates for IND, enabling in clinical development.

Speaker 5: We envisions further product development opportunities emerging from startars COVID-19 to discovery efforts for the prevention and treatment of COVID-19 and.

The envision further product development opportunities emerging from Sars Covid two discovery efforts for the prevention indoor treatment of COVID-19.

Speaker 5: We believe the discovery of additional broadly neutralizing mono antibodies that target new violed.

We believe the discovery of additional broker neutralizing monoclonal antibody that targets, new viral epitopes, both within and outside the RBC will support durable products.

Speaker 26: Oh.

Speaker 5: Within and outside the RBD will support durable products.

Speaker 5: For COVID-19, as new variance of concern continuue to arise.

For COVID-19, if new variance of confirm continue to arise.

Speaker 5: In conclusion, our strategy is to predict and respond to variants before they become variants of confirm and continuously discover and engineering antibodies with neutralization brandth and potency such that patien in needs may have access to high-quality protection, even in the face of rapid virus evolution.

Speaker 5: We do not rely on a single molecule targeting a single epitop that may experience our escape.

We do not rely on a single molecule targeting a single epitope that may experience long escape.

Speaker 5: We believe our integrated discovery platform, linked to our drug development and manufacturing expertise, offers a unique competitive advantage in this effort and the potential to provide a distinct benefit to patients in need, caregivers and global health authorities searching for durable solutions to the ongoing burden imposed by COVID-19.

<unk> to the ongoing burden imposed by COVID-19.

Speaker 5: With that, I will turn the call over to frred lisco in vibit, interim Chief Financial Officer, who will discuss our financials.

With that I will turn the call over to Fred Driscoll in visit interim Chief Financial Officer, who will discuss our financials.

Speaker 1: Thanks Lucas, and good afternoon everyone. Let me begin by providing an update on our 2022 fiscal year pnl as compared to the comparable 2021 period and an update on cash guidance.

Thanks, Lucas and good afternoon, everyone.

Let me begin by providing an update on our 2022 fiscal year P&L as compared to the comparable 2021 period and an update on cash guidance.

Speaker 2: With respect to operating expenses RND, including in-process RND, was 183.6 million for the year ended December thirty-first twent thousand and thousand, twenty-two, compared to $190.4 million for the comparable period of 2021.

With respect to operating expenses R&D, including in process R&D was $183 6 million for the year ended December 31, 2022, compared to $194 million for the comparable period of 2021.

Speaker 1: This decrease is attributable primarily to wind down of AD and trevaab clinical trials, partially offset by increase in contract manufacturing, including AD andtrevaab commercial supply for a potential EA, and to support our pipeline programs, including void two 2, two

Decrease is attributable primarily to wind down of Adam Trevor Mab clinical trials, partially offset by an increase in contract manufacturing, including Adam Trevor math commercial supply for a potential EUA and to support our pipeline programs, including <unk>.

Speaker 1: This decrease in R was further offset by an increase in personnel-related expenses.

This decrease in R&D was further offset by an increase in personnel related expenses.

Speaker 1: Our SGNA expenses were $47 million for the year ended December thirty-first 2022, compared to $36.5 million for the comparable period of 20 and 21. this increase is attributable to higher personnel-related expenses, professional fees and cost to support our operations as a public company.

Our SG&A expenses were $47 million for the year ended December 31, 2022, compared to $36 5 million for the comparable period of 2021.

This increase was attributable to higher personnel related expenses professional fees and costs to support our operations as a public company.

Speaker 2: The net loss for the year ended December thirty-first twent thousand and 22 was $241.3 million, compared to $226.8 million for the comparable period in 2021.

The net loss for the year ended December 31, 2022 was $241 3 million compared to $226 8 million for the comparable period in 2021.

Speaker 2: Basic and diluted net loss per share was $2 in 23 cents for the year ended December thirty-first 2020 -two, compared to a net loss of $5 in thirtyy-two cents for the comparable period in 2021 . The net loss of two hundred and forty-one point -three million for the year ended December thirty-first 2020 -two included a onetime charge of $17.4 million related to the fair value of the warrants issued to php.

Basic and diluted net loss per share was $2 23 for the year ended December 31, 2022, compared to a net loss of $5 32.

For the comparable period in 2021.

The net loss of $241 3 million for the year ended December 31, 2022 included a onetime charge of $17 $4 million related to the fair value of the warrants issued to PHP.

Speaker 2: We finished 2022 in a strong balance sheet position, with cash, cash equivalents and marketable securities of $372 million.

We finished 2022 and a strong balance sheet position with cash cash equivalents and marketable securities of $372 million.

Speaker 2: Based on our curren operating plans, which reflect the completion of a bottoms up departmental analysis that we highlighted on the Q3 earnings call. Our cash guidance has improved from our previous guidance and we now expect that cash will enable the company to fund its operating expenses. Excluding any potential revenue associated would be right to 2: two into the second half of 2020 -four.

Any potential revenue associated with <unk> into the second half of 2024.

Speaker 2: With that operator. Please open the call for questions.

With that operator, please open the call for questions.

Speaker 7: Thank you again.

Thank you again, ladies and gentlemen, if you'd like to ask a question. Please press star one on your telephone again to ask a question. Please press star one way.

Speaker 8: And gentlemen, if you like to ask a question, please for Star 1: one on your telephone again to askto ask a question, please for Star one one

Speaker 8: one moment please for our first question.

One moment please for our first question.

Our first question comes from the line of Evan Wang of Guggenheim. Your line is open.

Speaker 8: Our first question comes from the line of Evan wing of guggenhamil. Line is open.

Speaker 9: Hi guys, thanks for taking my question.

Hey, guys. Thanks for taking my question.

Speaker 9: Can you toillet? You know what's remaining before the view ID.

Can you highlight.

Remaining before the <unk> trial start.

Speaker 27: Trial start.

Speaker 10: And expend a little bit more in terms of how you guys are thinking about trial design.

And a little bit more in terms of how you guys.

Thinking about trial design.

Speaker 9: But you know dosing.

Dosing timelines.

Speaker 9: Timelines, ETC.

Et cetera.

Speaker 28: Yes think Devin, you want to talk a little bit about. What remains is we're getting readyning towards the end of this quarter. Yes, as we stated previously, we're still anticipating dosing our first and human study this quarter. We haven't released a lot of details about that study but, as you heard from the call, it's a pretty, pretty traditional dose-ranging PK and safety study.

Yes, Thanks, Kevin Pete you want to talk a little bit about what remains as we're getting ready towards the end of this quarter yes.

As stated previously we are we're still anticipating dosing our first in human study. This quarter. We haven't released a lot of details about that study, but as you heard from the call, it's a pretty pretty traditional dose ranging PK and safety study.

Speaker 6: Beyond that, we'll continue to release details as appropriate on our subsequent studies.

Beyond that we'll continue to release details as appropriate on our on our subsequent studies.

John you asked a.

A little bit about timing right and so.

As Pete mentioned, we still anticipate the first study starting by the end of the month just getting kind.

Clinical trial material to the sites getting the recruitment done et cetera, and then our plan is to continue to have.

Ongoing data releases throughout the year.

Speaker 10: Got it, thanks. And then in terms of a Phase 3, and are you guys without the paper low day in terms of correless? How are you guys thinking about primary endpoint?

Got it thanks, and then in terms of the phase III.

But off the paper lower day, Carlos how are you guys thinking about primary endpoint.

Speaker 29: And secondly.

And secondly.

Speaker 10: You know, V I D two to do, you know.

If you do too.

<unk>.

Speaker 10: Adapted from abv 20. how does that kind of?

Adapted bromine into 'twenty, how does that kind of.

Speaker 10: How does that kind of benefit, in terms of it, can provide them maybe?

How does that kind of benefit in terms of.

Maybe a framework in terms of how that may reduce the trial side, what kind of scope of trial or are we looking at here.

Speaker 9: A framework in terms of how that may reduce the trial size. What kind of skilled the trial are we looking at?

Yes, I'll take the first part and then Pete you can take the second so.

Speaker 28: 'lltakethe first part. Them know you can take the second. So you know, as we've said and shown before, you know 80 G 20, our original antibody. We went from I IND D to pivotal clinical data in 16 months and we utilize both treatment and prevention studies that used evvent driven clinical and points. And you know what we continue to look at as a possibility is whether there's an opportunity to use correlate surrogates ammuunno bridging, ETC.

We've said and shown before ADT.

<unk> 'twenty our original.

To use korlym surrogates, immuno bridging et cetera.

Speaker 28: And so those discussions continue, as Pete mentioned, you know, as a part of the upfront on the call, this was really articulated during the December fifteenth joint F a meaning and you know we, alongside academic and you know other stakeholders, really commented about the need for these types of approaches, especially given the dynamic environment that we're in, you really going against a virus that continues to evolve at such a rapid pace.

So those discussions continue.

As Pete mentioned as a part of the upfront on the call. This was really articulated during the December 15th joint FDA EMA, meaning.

And we alongside academic than other stakeholders really commented about the need for these types of approaches, especially given the dynamic environment that we're in.

Really going against a virus that continues to evolve at such a rapid pace and so we continue to have those conversations.

Speaker 28: And so you know we continue to have those congce.

Speaker 28: And you know, as we previously mentioned, as soon as we have outlined and confirmed exactly what those clinical parameters would be for pivotal studies, we plan to share, you know, more details about that.

As we previously mentioned as soon as we have.

Outlined in confirmed exactly what those clinical parameters would be for pivotal studies.

We plan to share more details.

About that.

Speaker 28: Pete any other comments? A great question about the relationship to adg 20, the molecular relationship and.

Pete any other comments yeah, great question about the relationship to ADT 20 molecular relationship.

<unk>.

We're still in conversations with global regulators around this of course, but.

We do believe that.

To ADT 20, I'm sorry.

So lots of potential there.

Yes.

Speaker 14: Great thanks, COEs.

Great. Thanks, guys.

Speaker 7: Thank you one moment please.

Thank you one moment please.

Speaker 8: Our next question comes from the line of Cedar.

Our next.

Comes from the line of Siddhartha <unk>.

Speaker 8: matta of Jeffrey joalan is open.

Matter of Jefferies. Your line is open.

Speaker 4: How it it on for Michael Y jeaprey?

How does that sit on for Michael Yee of Jefferies.

Speaker 28: So two quick questions. First one being, you know, asisgenic and other big companies, while they made a lot of money.

So two quick questions first one being.

Speaker 14: 2022 antibodies have noted that they see the market going significantly down in 23 and beyond as you move to an endemic market. So how do you guys think about that as you move your antibody forward? And my second question is: you know, although you've mentioned having these kind of correlates of protection for Phase three studies, has a brainany discussion or definitive answers from the fpon whether not you can use that as a part of your Phase three studies?

And my second question is.

Although you've mentioned, having these kind of correlates of protection for Phase III studies has there been any discussion or definitive.

Answers from the FDA on whether or not you can use that as a part of your phase III studies. Thank you.

Speaker 14: Thank you.

Yes, I'll take the first question and so our estimates that in 2022, the sort of overall market across vaccines.

Speaker 3: Think the first question, and so you know our estimates- that in 2020 to 2, you know the sort of overall market across vaccin, es- oral anti viralals, monico antibodies- was almost $1 billion and yes, I think that a lot of folks are predicting that that will come down, but it's still a incredibly sizable market. You know moncle antibodies did eight billion about in revenue in 2020. two and that was with, you know, predominantly B to Lo, AB and you Shell and she did, you know, 500 and some million dollars in Q3 of of last year and what we see is, with a similar indication, really targeting immune, compromise vulnerable population.

Oral anti Virals monoclonal antibodies was almost 100 billion.

And yes, I think that.

A lot of folks are predicting that that will come down, but it's still incredibly sizeable market.

Michael antibodies did 8 billion.

About in revenue in 2022.

And that was with.

Predominantly <unk> and have yourself and have yourself did 500 and some million dollars in Q3 of last year and what we see is.

Speaker 28: You know they only touch really a fraction of that population and we continue to work with these groups, talk to patient advocacy groups, speak with these individuals and they still are really clamoring for products. In particular, I spoke to, you know position, who works at the male clinic and said, you know he had never been in a position that these types of patients come in and ask for products and there's nothing available and so, based on that, we see the market for mono antibodies continue to be, you know, incredibly significant and a huge unmet need and this patient population.

With a similar.

Indication really targeting immune compromised vulnerable populations.

They only touch really a fraction of that population and we continue to work with these groups talked to patient advocacy groups speak with these individuals and they still are really clamoring for.

Products in particular I spoke to.

Physician.

Who works at the Mayo Clinic and said he had never been in a position that these types of patients come in and ask for our products and there is nothing available.

And so based on that we see the market for monoclonal antibodies continuing to be incredibly significant and a huge unmet need in this patient population.

Speaker 15: As it relates to your other question, in terms of you know where regulators are and you know what the status is. You know will provide updates. You know additional updates when we get them. We continue to be in dialogue with the F D, a and other global regulators and you know, as I said, as soon as we have confirmed what that trial design will look like, we plan to provide that information.

As it relates to your other question in terms of.

Confirmed what that trial design will look like we plan to provide that information.

Speaker 30: Thank you.

Thank you.

Okay.

Speaker 7: Thank you one moment please.

Thank you one moment please.

Speaker 8: Our next question comes from the lot of Matthew Harrison of mganle. An is open.

Our next question comes from the line of Matthew Harrison of Morgan Stanley . Your line is open.

Okay.

Speaker 14: Hi this is onejn online for mattheo. Thanks for taking our questions. I have two questions. one is: is there having update on adding kind of regulatory thresholds for new anti therapy for COVID-19? Uh, given the change of the pandemic setting?

Hi, This is Joe online format. Thanks.

For taking my questions I have.

Two question one is.

Any update on adding kind of regulatory thresholds for new antibody therapy for Covid.

Given the change of the pandemic setting.

Speaker 14: Could there be adding flexibility in potential proval?

Would there be any flexibility in potential approval.

Speaker 14: The second is: do you have?

The second is do you have any updates on your potential progress through antibodies.

Speaker 14: Updates on your potential progress on flu andase therapy development.

Therapy development.

Sure no. Thank you for the question. So on the first one in terms of regards to thresholds.

Speaker 3: Third no, Thank you for the question. So, on the first: one in terms of regards to thresholds.

Speaker 28: As you're likelyaware, at least in the? U us, none of the antibodies have been fully licensed and gone through be L A. they've all been authorized through E ways and there currently are no monocle antibodies on the market, and so we have not seen any specific changes in thresholds. In particular, what we continue to look at is in vitro data ahead of time and, as what we've seen on, you know, V Y two 2, two is, you know, consistently strong activity against a variety of variance, including the most recent on dot one to 5, and so we see that that is, you know, really important information as it relates to getting the products into clinical trials, ETC.

As you are likely aware at least in the U S. None of the antibodies have been fully licensed and gone through BLA as they've all been authorized through EUA.

There currently are no monoclonal antibodies on the market and so we have not seen any specific.

Changes in thresholds in particular, what we continue to look at is in vitro data ahead of time and as what we've seen on <unk> is consistently.

Consistently strong activity against.

A variety of variance including.

The most recent.

<unk> dot one dot five and so we see that that is.

Really important information as it relates to getting the products into clinical trials et cetera.

Speaker 21: And as I mentioned you know through the presentation, while the public health emergency is ending.

As I mentioned.

Through the presentation, while the public health emergency is ending.

Speaker 15: That does not remove the potential for the FDA to utilize the EAS, and so we still see that as an open possibility for vy 2, two or our additional other candidates that we have in the pipeline.

That does not remove the potential for the FDA to utilize the EUA and so we still see that as a open possibility for <unk> or our additional other candidates that we have in the pipeline.

Speaker 28: It relates to the flu component. I'll turn it over to Lucas. You can provide an update on the status of what where we are with the flu program.

As it relates to the food component I'll turn it over to Lucas you can provide an update on the status of our of what of where we are with the flu program.

Speaker 18: Yes Thank you, Dave. So we've identified several interesting molecules in the fllow program already. These molecules are currently being further characterized in B traces and other studies and we will be releasing the data soon. The weeks have them available.

Thank you Dave.

We've identified several interesting molecules in the flu program already.

These molecules are currently being further characterized <unk> and all of the studies and we will be releasing the data as soon as we have them available.

Speaker 14: Ok Thank you.

Okay. Thank you.

Speaker 8: Thank you. I'm showing no further questions of this time. I would turn the call back over to Dave hering for any closing remarks.

Thank you I'm showing no further questions at this time I will turn the call back over to Dave Henry for any closing remarks.

Thank you so much so thanks to everyone for joining it was.

Speaker 3: Thank you so much So thanks everyone for joining it was a fantastic quarter and a great 2022 So I'm very excited for.

Fantastic quarter, and a great 2022, so I'm very excited for where we are and.

Speaker 15: Where we are, andum.

Speaker 28: As I alluded to you at the start of this discussion, I'm extremely pleased with our progress in the fourth quarter and our start to this year. We have multiple multiple antibiotic candidates that have shown in vutro utilizing activity against multiple current lineages of omacon. I believe in the company's ability to bring to market a product for COVID-19 as fast and efficiently as possible to meet this continued large unmet need and patients and to capitalize on the significant market opportunity and create value for shareholders.

Speaker 15: Given the rapid pace of viral evolution and the ongoing regulatory environment, we are positioning the company to pivot, as necessary to liver deliver on that goal time and time again.

Given the rapid pace of viral evolution and the ongoing regulatory environment. We are positioning the company to pivot as necessary to deliver to deliver on that goal time and time again.

Speaker 28: So that concludes our meeting for today and, as always, we'll be happy to follow up with analysts or investors one on one after the call tonight and tomorrow. Thank you.

So that concludes our meeting for today and as always we'll be happy to follow up with analysts or investors. One on one after the call Tonight and tomorrow.

<unk>.

Speaker 8: Thank you, Ladies and gentmen. This does conclude today's conference. Thank you all participating. You may now disconnect. Have a great day.

Thank you ladies and gentlemen, this does conclude today's conference. Thank you all participating you may now disconnect have a great day.

Q4 2022 Invivyd Earnings Conference Call

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