Invivyd Inc. Q1 2023 Earnings Call
Speaker 1: bass guitar plays
Speaker 2: Welcome to the Invivid first quarter 2023 financial results update call. I will now turn the call over to Gabriella Linville-Angler, Director of External Communications.
Speaker 3: Thank you for joining us today. Before we get started, I want to tend to a few housekeeping items. I invite you to review our press release discussing our first quarter 2023 financial results, which can be found on the investor section of the Invivid website.
Speaker 3: I would like to remind you that during today's discussion, we will be making several forward-looking statements.
Speaker 3: Forward-looking statements include statements concerning, among other things, the future of the COVID-19 landscape, our ongoing research and clinical development plans, including the timing of these plans.
Speaker 3: our regulatory and commercialization plan, strategies and opportunities, our expected cash runway, and other statements that are not historical fact.
Speaker 3: 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 statement, including those described under the heading risk factors in our filings made with the U.S. Securities and Exchange Commission's report.
Speaker 3: including our most recent form, 10K. It is now my pleasure to introduce the Invisit Management Team to the call. I am joined by Dave Herring, CEO of Invisit, Dr. Pete Schmidt, Chief Medical Officer, and Fred Driscoll, Inherent Chief Financial Officer.
Speaker 4: With that, I will turn the call over to Dave. Welcome. Thank you for joining us today on our quarterly update call, and thank you for your continued support of Envivid. Thank you. Thank you.
Speaker 4: Since our last update call, we've made significant progress on the development of our lead candidate BYD222, as well as great strides advancing our early pipeline and discovery capabilities and our overall mission to rapidly and perpetually deliver antibody-based therapies for patients with B.
Speaker 4: designed to protect the vulnerable from the devastating consequences of circulating viral threats.
Speaker 4: immunocompromised people. At the end of March, we announced the dosing of the first participants in our Phase 1 BYD-222 clinical trial being conducted in Australia. Now, roughly a month and a half later, we are pleased to share that we have finished dosing all 30 participants in the trial.
Speaker 4: We remain on track for initial data readouts from that Phase 1 trial in the second quarter, with additional clinical readouts from the BYD222 program anticipated in 2023.
Speaker 4: We also recently announced that the US FDA has cleared our investigational new drug, IND, application for VYD222, an important step in our efforts to rapidly develop a therapeutic to protect the millions of immunocompromised people in the US who are still under threat from COVID-19.
Speaker 4: Before I hand the call over to Pete to provide an overview of our VYD 222 program and our regulatory strategy, I will provide a brief overview of the patient population we are focused on and cover recent developments in the field that speak to the strong unmet need for new therapeutics for COVID-19.
Speaker 4: As you are aware, we are primarily focused on COVID-19 as it continues to remain a serious problem and a significant unmet medical need, particularly for immunocompromised people who remain vulnerable to the virus.
Speaker 4: People with dysfunctional or suppressed immune systems may not be able to mount an adequate response to vaccination and generate protective immunity.
Speaker 4: Therefore, immunocompromised people, which are estimated to number between 8 and 18 million people in the US and 14 million people in the EU require a different approach to COVID-19 prevention that does not rely on a healthy and functioning immune system.
Speaker 4: This population includes, for example, people who take immunosuppressive drugs, including organ transplant recipients, and people with autoimmune diseases such as multiple sclerosis, rheumatoid arthritis, or inflammatory bowel disease.
Speaker 4: This population also includes patients with hematological cancers that affect immune system like leukemia or lymphoma, as well as patients with forms of cancer that require treatments that weaken the immune system such as chemotherapy.
Speaker 4: I mean, you'll compromise people are at increased risk for severe COVID-19 outcomes such as hospitalization and death and are an urgent need of new therapeutic options.
Speaker 4: As SARS-CoV-2 has continued to circulate and mutate, what clinicians have to offer these individuals and the global medicine cabinet has become extremely limited at present.
Speaker 4: For instance, there is increasing real-world evidence that suggests the bivalent mRNA boosters offer marginal protection against symptomatic disease caused by emerging variants of concern, even in people with normal immune systems.
Speaker 4: Now more than ever, immunocompromised people need the rapid protection provided by monoclonal antibodies. With the previously authorized anti-SARS COVID-19-2 MABs losing activity against variants of concern and being removed from the market in the U.S., there remains a significant unmet need.
Speaker 4: With COVID-19 still threatening millions of people, we are pleased to see that COVID-19 is still a priority for the US government. The recently announced project next gen and $5 billion of associated funding is evidence of the government's continued commitment to supporting the advancement of vaccine.
Speaker 4: and therapeutics that provide more durable protection and address future variants, with new monoclonal antibodies identified as one of three priorities for the initiative.
Speaker 4: We are encouraged by the government's recognition that there remains a need to advance improved tools that provide better, broader, and more long lasting protection.
Speaker 4: And we agree that multiple approaches beyond vaccines are needed to address the prevention and treatment of COVID-19.
Speaker 4: Filling this gap in the product landscape represents a significant market opportunity for in vivid. Consider that Ebu Shield captured $2.2 billion in total revenue in 2022 with strong growth prior to its removal from the market when it lost activity against emerging variants of concern.
Speaker 4: Additionally, the first quarter of 2023 in the biopharmaceutical industry has featured stronger than anticipated utilization of vaccines and drugs, which while counter to some who think COVID-19 is over, aligns with the vast unmet need that still exists.
Speaker 4: We believe that among all of the choices of vulnerable person and their healthcare professional can make relative to COVID-19, reducing the probability of having symptomatic COVID-19 that is not getting sick remains the strategy that is likely to lead to the over lowest overall burden of disease and lowest negative health outcome.
Speaker 4: While vaccines have done incredible work to keep us alive, it remains substantial work to keep vulnerable populations well. Monoclonal antibodies are well-suited to meet this gap by augmenting the human immune system and helping to protect vulnerable populations from COVID-19. While COVID-19 is transitioning into an ongoing endemic disease, it remains a massive disease category.
Speaker 4: Immunocompromised people who will continue to be at high risk could benefit significantly from monoclonal antibodies. Given the enduring need for these patients and the unique value proposition for MAMS, we believe this market has the potential to become a high growth, multi-billion dollar opportunity in the space for many years to come. Among the companies developing antibody-based therapeutics, we believe we are...
Speaker 4: perpetual innovation has to keep pillars. The first pillar is the cutting edge viral and epidemiological surveillance. With these capabilities we aim to predictably model and target future SARS-CoV-2 variant.
Speaker 4: We have generated multiple monocle antibody candidates for COVID-19. The first candidate from our engine, Aiden Trevimab, we advanced from IND to Pivotal Clinical Trial Data in 16 months. Our second candidate, VYD222, is in clinical development now.
Speaker 4: Q2 is unique because it is engineered from our previous candidate Ayn Trevimab, which demonstrated clinically meaningful results in global phase 3 clinical trials and has a robust safety data package. As people discuss shortly,
Speaker 4: We aim to leverage insights from our experience of the A&TREVA map, including our recently published landmark research on monoclonal antibody coral is a protection to move much faster with the development of VYD-222. Beyond VYD-222, we have multiple anti-SARS COVID-2 monoclonal antibodies in discovery and recently nominated an additional monoclonal antibody candidate for further preclinical characterization. This robust discovery pipeline reflects our strategy to predict and respond to variants before they become variants of concern and continuously discover and engineer new antibody candidates that can be leveraged to keep pace with viral evolution.
Speaker 4: I am proud of the tremendous progress we have made to advance our work in the recent months, and I look forward to continuing to drive our mission forward with the urgency and speed that these vulnerable populations deserve. I will now pass the call to Peach Smith, Chief Medical Officer, who will provide an update on our BYD-222 clinical program. Thanks Dave.
Speaker 5: As they mentioned, we are pleased to report that we have completed dosing all 30 participants in our Phase 1 clinical trial of the UID-222.
Speaker 5: BYD-222 has demonstrated in vitro neutralizing activity against variants of concern, including Omicron sublimine, sub-linearges up to and through XBB 1.5. We continue to actively monitor emerging variants of concern and BYD-222's in vitro neutralizing activity against these variants. BYD-222 was engineered from Edm Shabbimab, our first investigational monoclonal antibody, which demonstrated clinically meaningful results in global phase 3 clinical trials and has a robust safety data package. Our precision engineering resulted in only eight amino acids that differ in the various...
Speaker 5: to provide durability in the face of viral evolution and flexibility at the time of regulatory submission.
Speaker 5: We are on track for initial readouts from the Phase 1 clinical trial in the second quarter, including initial insights into VID-222's serum virus neutralizing activity.
Speaker 5: which may provide an early look at anticipated clinical efficacy. Based on research, we and our collaborators published in March 2023 in the peer-reviewed journal Science Translational Medicine, which relied heavily on data from our Atten-Trevimab clinical trial. We believe that serum virus-neutralizing activity is the optimal biomarker.
Speaker 5: for predicting clinical efficacy and potentially accelerating the clinical development path for VYD222 when combined with associated pharmacokinetic safety data pending input from regulators. Our recently published paper establishes a quantitative relationship that defines a correlative protection.
Speaker 5: from monoclonal antibodies, demonstrating protection from symptomatic infection, even at relatively modest antibody titers, which speaks to the potential to have an extended period of time before needing to redo-smapped therapies with extended half-life. Additionally, the research indicates that antibodies, whether polyclonal or monoclonal,
Speaker 5: are mechanistic for protection against symptomatic disease. This groundbreaking work suggests that clinical efficacy of monoclonal antibodies against the SARS-CoV-2 spike protein is a predictable phenomenon that can be modeled.
Speaker 5: We see this publication as transformational towards accelerating the clinical development of monoclonal antibodies for the prevention of symptomatic COVID-19.
Speaker 5: On the regulatory front, we continue to be encouraged by the evolving regulatory landscape following the Joint FDA EMA workshop in December of 2020-2022, where alternative, surrogate market-based strategies for development of novel and monoclonal antibody therapies for COVID-19 were discussed.
Speaker 5: including a presentation by Invid about the potential use of SVNA titers as a surrogate marker for protection against symptomatic COVID-19.
Speaker 5: Since that meeting, we have seen other companies in the COVID-19 MAP space refer to rapid development plans and the use of SVNA titers as surrogate endpoints in their clinical trials, which may suggest that the FDA and other major regulatory bodies have agreed in principle to such a trial designed for next-generation MAP candidates. We intend to work closely with global regulators to ensure our clinical trials are designed to provide the data they require
Speaker 5: as they establish regulatory frameworks that reflect the pace of SARS-CoV-2 viral evolution.
Speaker 5: We have had constructive interactions with the FDA and EMA, regarding our VYD-222 development program and pending feedback from regulators. We plan to share an update once the design of our pivotal VYD-222 clinical trial is finalized.
Speaker 5: Like we did with adenrevamab, our intention is to initiate the pivotal trial of BYD222 as quickly as possible on the heels of early positive data from our Phase 1 trial, including sDNA titers.
Speaker 5: to help ensure that we are well positioned to support rapid recruitment into our Plan Faze 3 trials, we have established a database of recruitment-ready immunocompromised individuals for potential enrollment into the pivotal clinical trial. As the regulatory landscape evolves, one thing that remains the same is our belief that emergency used authorization.
Speaker 5: The FDA has confirmed that existing EUAs for vaccines, tests, and treatments will not be affected and has further confirmed that it may continue to issue EUAs for new products that need to require criteria. In fact, just last month, a host directed monoclonal antibody received emergency use authorization for the treatment of COVID-19 in hospitalized adults receiving mechanical ventilation or artificial life support. As we look ahead, we look forward to constructing in partnership with global regulators, a future paradigm where viral directed monoclonal antibodies.
Speaker 5: have a standard rapid development pathway that is similar to the platform-based approach used for the periodic modification and approval of flu and SARS-CoV-2 vaccines. We are optimistic about our path forward from here and our ability to address the significant need for novel therapeutic approaches.
Speaker 5: for the prevention of COVID-19, particularly for immune compromised individuals. With that, I will turn the call over to Fred Dreskel, and vivid interim chief financial officer, who will discuss our financials. Thanks, Pete, and good afternoon, everyone. With respect to operating expenses.
Speaker 5: R&D expenses, including in-process R&D, were $28 million for the first quarter of 2023.
Speaker 5: compared to $92 million for the comparable period of 2022. This decrease is attributable to lower contract manufacturing costs driven by Adintrevimab commercial manufacturing in 2022, with no comparable commercial manufacturing costs.
Speaker 4: in 2023 and lower clinical trial costs due to the windout of adentruver map clinical trials. Our SGNA expenses were $11 million for the first quarter of 2023 compared to $8.7 million for the comparable period of 2022.
Speaker 5: This increases attributable to low-estock base compensation expense in 2022, partially offset by reduced consulting costs, professional fees, and public company costs in 2023. The net loss of the first quarter of 2023 was 35.3 million compared to 100.7 million.
Speaker 5: for the comparable period in 2022.
Speaker 4: Basic and deluded net loss for Shia was 32 cents for the first quarter of 2023 Compared to 93 cents for the comparable period in 2022 We exited the first quarter well capitalized with cash cash equivalents and marketable securities of 333 million dollars
Speaker 4: Based on our current operating plans, we expect our cash will enable the company to fund its operating expenses excluding any potential revenue associated with VID222 into the second half of 2024. With that operator, please open the call for questions.
Speaker 2: If you'd like to ask a question at this time, please press star 1 1 on your telephone and wait for your name to be announced.
Speaker 2: To withdraw your question, please press star 1-1 again.
Speaker 2: with your gun I'm securities.
Speaker 6: in terms of recent interactions with regulatory agencies, how is that progressing? Have you proposed a phase three design? And I guess...
Speaker 6: How quickly can you approach them with Phase 1 data? And I know you highlighted some aspects of potential phase 3 preparation that's currently ongoing, but how quickly can you...
Speaker 6: moving to phase three once the design is finalized. Thanks.
Speaker 4: Yeah, thanks Evan, great to hear from you. Yeah, we're really excited about the quarter and the news that we have finished dosing all the Phase I cohort participants. A little bit more right, so as a part of the IND, we submitted our design for the Phase Phase III Pivotal Study.
Speaker 4: So we're certainly excited about that and waiting for that. As I've mentioned previously, we've done a considerable amount of work to be ready and prepared for that clinical trial. As Pete mentioned in the call, we've even got this database of immunocompromised individuals that we're looking to utilize for that potential trial.
Speaker 4: which is to do this as quickly as possible.
Speaker 4: seeing the need that still remains in vulnerable populations and the EUA pathway that continues to be open. And so that's all supportive of our desire to do this as quickly as possible and to be smart about these different preparations and be at the ready.
Speaker 5: so that really, once everything is completed and all the I's are dotted and T's are crossed, we can start. Pete, anything more from your side on the clinical preparation? Yeah, I think completing dosing is a big milestone here because, of course, we will have to provide some data from the Phase 1 to initiate the Phase 3, but we have no concerns about that happening quickly as well, as Dave said. And I had one follow-up. I guess how quickly.
Speaker 5: that you'll see later this quarter. But there's also the concept of having dose flexibility at the time of submission. So that's why we studied this dose range. Because as we know, the viruses evolving, the potency of the antibodies against the virus changes over time. And so we may be able to go.
Speaker 4: one is the S-V-N-A data, which gives us a view based on the paper that we published to get an early read-up where we would fall on that curve, which, as you know, would give us this correlative protection and these tighter levels related to predicted efficacy of what they would be. And so that will also...
Speaker 4: greatly influence us, as well as looking at whatever new variants of concern are circulating throughout this period of time, we can apply those back into the model and make some determinations and assessment of which is the most appropriate dose. Thanks. We'll go back to you.
Speaker 7: comparable data from earlier programs that would be good for us to look to? Or is this third, you know, would that earlier data be less relevant given the new variants and a new antibody?
Speaker 5: Yeah, that's a great question. We anticipate the data will be against contemporary variants of concern. So looking back at previous variants or previous programs is probably not as valuable.
Speaker 7: And just assuming that, you know, the Phase III program kind of progresses as you would expect, I'm wondering if you can clarify for us the use of the emergency use authorization. Specifically, what would that submission process look like, you know, from the time of submission to a potential authorization?
Speaker 4: and if or when a DLA would be needed to ensure continued access? So the first part, right, so we continued to see timelines. We don't have...
Speaker 4: information on exactly when other companies have filed e-ways, but certainly we've seen that that
Speaker 4: review period from the FDA. It doesn't fall under any specific clock, but that it is done in the past quite quickly. That's a part of being in the emergency use piece. So, unlike the pedophidates and VLA timelines, which have a very set clock, the of course good news bad news about the EUA is that doesn't exist. And so we've seen it in months.
Speaker 4: in the past and certainly the idea is to be and continue conversations with regulatory authorities and providing them data along the way. And so they would have an understanding of what's coming in that package.
Speaker 4: I don't know, Pete, any other insights? I mean, there's certainly no...
Speaker 4: you know, hard and fast pieces from them, but with no antibodies on the market, it certainly is not lost on them or others the need for products like this. And so that to us is certainly.
Speaker 5: indicative of why there would be a quick review. Yeah, I completely agree with Dave and in terms of the BLA, as the EURI criteria are currently written, you need to intend as a sponsor to continue to develop towards BLA.
Speaker 5: And our trials are designed, as you know, we have a long-term safety follow-up. Our trials are designed to potentially support a BLA as well.
Speaker 7: Yeah, that's helpful. And then just one last one, if I may. What additional data, you know, I appreciate the earlier comments about the openness of regulators on the approach with the surrogate endpoints, you know, but what additional data might they ask for, might the FDA or MA ask for, or what would they want to see maybe from trials that are already running to give further confidence and expertise.
Speaker 5: But I do anticipate that we and others will continue to generate secondary endpoint supportive clinical data to confirm our primary endpoint surrogate markers.
Speaker 5: But I do anticipate that we and others will continue to generate secondary endpoint supportive clinical data to confirm our primary endpoint surrogate markers. Yep. Terrific. Thank you so much.
Speaker 8: Thanks Patrick. Thank you.
Speaker 3: Our next question comes from Michael Ye with Jefferies. Hi, good afternoon. Thanks for taking our question. This is Jenna on for Mike. We wanted to follow up on the S-VNA biomarker and could you talk about what are your expectations on the biomarker? What level of reduction would you want to see in the biomarker?
Speaker 4: for a different dose. Thank you. Yeah, so what we've talked about in the past is really right from a target product profile on our goal is to provide at least six months of protection. Now these are highly vulnerable groups who are currently receiving infusions and are in.
Speaker 4: a variety of outpatient and inpatient care.
Speaker 4: of outpatient and inpatient care. And so with what I said earlier as well,
Speaker 4: I mean, the five-alien vaccines in terms of emerging data are showing limited protective properties against symptomatic disease, and that's in folks who have fully functioning immune systems. In these vulnerable populations, they're really...
Speaker 4: looking for anything that can help them with prevention. And we speak with the patient populations frequently. And so what we really see here is getting a look at where we would be providing, and you can make some trade-offs between dose in terms of higher or lower and...
Speaker 4: predicted duration of protection. And so those are the types of things that we're looking at. And then again, in the publication, we've specifically linked and shown that this correlate between these FNATiders and efficacy from previous clinical studies.
Speaker 4: is what has made that curve. And so you can see where you are on that curve, and that's really what we're comparing those against and looking to provide, again, very usable products to people who currently have none. Got it. Thanks so much. Thank you. Showing no further questions in queue at this time, I'd like to turn the call back to Dave Haring for closing remarks. Thank you all for joining the call today.
Speaker 4: We are entering a transformational period that we believe has the potential to establish near-term and long-term success and value creation by realizing the potential of our strategy and technology. We thank you for your continued support and interest in Invinid and we look forward to catching up with any of you individually over the coming days. Thank you so much.
Speaker 2: This concludes today's conference call. Thank you for participating. You may now disconnect.
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