Q1 2025 Invivyd Inc Earnings Call
Thank you for standing by and welcome to inhibits first quarter 2025 earnings Conference call. At this time, all participants are in a listen only mode.
Speaker Change: After the speaker presentation, there will be a question and answer session to ask a question. During the session you will need to press star one one on your telephone to remove yourself from the queue. You May Press Star one one again I would now like to hand, the call over to Katie <unk> Zani SVP Finance. Please go ahead.
Speaker Change: Thank you operator, a short while ago, we issued a press release announcing our Q1 2025 financial results and business highlights.
Speaker Change: Our press release and the slides that are being used on today's webcast can be found in the investors section of the <unk> website under the press release and events and presentations section respectively.
Marc: Today's discussion will be led by Marc <unk> Chairman of the board of Directors. He is joined by Ken Lee Chief Commercial Officer, El Duque, Chief Financial Officer, Dr. Robert Allen, Chief Scientific Officer, and Dr. Mark <unk> Senior Vice President of clinical development.
Marc: During today's discussion, we will be making forward looking statements concerning among other things, our corporate and commercial strategy, our research and development activities.
Marc: A regulatory plan certain financial expectations, our future prospects and other statements that are not historical facts.
Marc: These forward looking statements are covered within the meaning of the private Securities Litigation Reform Act and are subject to various risks assumptions and uncertainties that may change over time and cause our actual results to differ materially from those expressed or implied today.
Marc: These forward looking statements speak only as of the date of this call and inhibit assumes no duty to update such statements.
Marc: Additional information on the risk factors that could affect this business can be found in our filings made with the U S Securities and Exchange Commission, including our most recent Form 10-K, and 10-Q, which are also available on our website.
Mark: I will now turn the call over to Mark.
Mark: Good morning, and thank you all for joining us.
Speaker Change: Turning to slide four.
Speaker Change: The first quarter and our early second quarter, it's been a very busy and productive time marked by transition.
Speaker Change: Our commercial organization is now fully internalized new in the field. It reflects an intentional bet by this management team that our new internal team will drive broader adoption of Perm Gardner with associated commercial results. While it is early our leading indicators are promising and we remain targeting near term breakeven with continued revenue growth.
Speaker Change: And operating expense management.
Speaker Change: Scientifically we're very pleased with what we see in the evolutionary journey of Sars Covid two relative to the epitope, we're exploring with <unk> and is now we see no obstacle to long term growth in our commercial <unk> business, we have secured access to additional non dilutive capital to grow if certain conditions and milestones are met and we are.
Speaker Change: Spending our pipeline to multiple disease areas in which we believe our scientific approach can add value to patients in need.
Speaker Change: Specifically.
Speaker Change: We have added discovery programs against new viral targets with the potential for identifying best in class medicines for diseases outside of COVID-19.
Speaker Change: Our previous work in influenza continues at a low intensity, but bird flu with pandemic potential has not meaningfully emerged and in the very recent short ton, we've actually seen more U S deaths from measles outbreaks than we've seen from avian influenza over the past year or so at this point it is reasonable to expect that trend to continue and our folk.
Speaker Change: This shifted accordingly towards early measles discovery.
Speaker Change: Last year, we initiated a new discovery program print of RSV monoclonal antibody that Ravi Ellen our CSO will describe in a bit more detail.
Speaker Change: <unk> presents a very clear high value competitive landscape.
Speaker Change: And some molecular properties, we believe we can target to generate a potential best in class monoclonal antibody with blockbuster commercial potential.
Speaker Change: As we grow and expand our covered franchise, we will accordingly want to make targeted financially responsible investments in discovery that can yield drugs, we can capitalize for development either in concert with the equity markets or with potential strategic partners. There has been no shortage of interest in our work from potential partners, particularly those with a vaccine.
Speaker Change: Footprint.
Speaker Change: It is important to note that our corporate goals, including targeting near term near term breakeven, our audacious by design and reflective of our integrated strategic and operational choices in the Big picture, we want to create as much medical value for patients and society as fast as possible and then we want to translate that value into per share.
Speaker Change: <unk> shareholder value as efficiently as possible.
Speaker Change: In an easy biotech financing environment characterized by low interest rates and long return horizons with blue skies for investors. It is much easier for companies to Rachel to raise large quantities of dilutive equity. They may enable a mediocre farfetched biological premise to survive to the next catalyst, but such a business strategy rarely translates into long.
Speaker Change: <unk> per share.
Speaker Change: <unk> of shareholder value, we are taking the opposite approach and trying to be highly disciplined with our expenditures and capital base to the maximum extent and not just because these days the biotech investing backdrop and equity cost of capital has been tougher we've been taking our approach because we see full operational proof of concept and our ability to make met.
Speaker Change: <unk> rapidly and efficiently and we wish to exploit that advantage, which we see as unique in the industry as we grow our business so that our shareholders can benefit accordingly.
Speaker Change: Turning to slide five in the bigger social picture. It is important to note that our fundamental corporate strategy reflects a great. Many macro level reality instead of also undergone transition specifically a U S election results and new public health leadership focused on chronic disease, who are moving and directions on multiple fronts that <unk>.
Speaker Change: Well with our business strategy.
Speaker Change: A quick reminder, in vivid was started based on the simple reality that Sars Covid two was a unique virus designed to pray on a distinctly vulnerable human population. It was clear early the vaccines for COVID-19 disease would work over the short term, but did waning responses would be problematic for every person, especially for immuno.
Speaker Change: <unk> persons and on top of that immune invasive omicron viruses event is another headwind as has the growing underlying burden of long COVID-19.
Speaker Change: More given the handling of COVID-19 vaccine policies. There is a regrettable secular shift underway with respect to American attitudes towards vaccination as a whole reviewing the last year's events with respect to COVID-19 vaccines, such as shift is indeed, regrettable, but perhaps not surprising.
Speaker Change: Monoclonal antibodies can be designed to overcome challenges with vaccination after.
Speaker Change: We're all we are all born immuno compromised and preloaded with a suite of Nonself monoclonal antibodies from our mothers and yet in the pursuit of freedom from the burden of Sars koby to our regulatory and public health complex for four years with single Mindedly focused unexposed humans, serially and broadly to spike protein.
Speaker Change: Largely in mrna form in an effort to get us our protective antibodies to hardwood rather than as mom and mother nature might suggest providing mechanisms for humans to access additional antibody support so that humans don't need to choose between dangerous infections and increasingly debatably effective vaccination.
Speaker Change: Unique in the industry and vivid has now fully developed through multiple placebo controlled RCT two monoclonal antibodies against Sars Cov, two Adam Trevor map against ancestral viruses like Delta and now <unk> against contemporary immune invasive omicron viruses more in our recent canopy phase III clinical.
Speaker Change: Study assessing safety immuno bridging and exploratory clinical efficacy analyses, we are reporting clinical results from a modern American population, specifically a population that has preexisting immune experience or cero positivity in both study and the placebo arms to some observers of the vaccine industry.
Speaker Change: Conducting such studies is unknowable or unthinkable and yet to us and others in the monoclonal antibody business. Those studies are business as usual you.
Speaker Change: You will see elements of our recent citizen petition to the U S. FDA that focuses in on these issues because to US there is clearly within reach of mechanism to scale access to monoclonal antibodies, if and when regulators. So choose as you will see later in this mornings call. We have multiple parallel conversations with public health authorities.
Speaker Change: Designed to extend the consequences of our discovery and development work.
Speaker Change: With that I'll turn the call over to Tim Lee to discuss our commercial progress in the quarter.
Tim Lee: Thank you Mark and good morning all.
Speaker Change: Turning to slide six.
Speaker Change: The first quarter cemented our transition from a contracted largely outsourced model designed to hit a short seasonal window.
Speaker Change: Two a best in class commercial footprint to drive consistent growth via an in house team.
Speaker Change: We did not have a fourth quarter call. So it's been six months since I've had the opportunity to speak with the broad investor community is worth sharing a few general observations from the fall in winter before we walk through key indicators.
Speaker Change: Mark and the team asked me to create a best in class commercial effort to put behind <unk> and our future molecules, but I'm pleased with what we've done so far but in many ways. We're just getting started.
Speaker Change: First we spent an enormous amount of time with health care providers and health systems simply re educating on the existence of monoclonal antibodies as an alternative therapy available today.
Speaker Change: What began as a commercial interest largely driven by those who knew and anticipated Pip Garda. We're now beginning to see institutional orders that are just beginning to reflect the underlying medical need.
Speaker Change: Protocols pathways real world experience and word of mouth and the clinical community are still in the early innings, and we expect real growth to follow as this familiarity rises.
Speaker Change: Second health care providers begin with real skepticism on the ability of from garden to navigate virus evolution.
Speaker Change: Particularly following the Fda's misguided and harmful insertion of inaccurate third party virology data into the pet and garden Factsheet last fall.
Speaker Change: The combination of our communication of the underlying science and long along with the empirical reality of the attractive continuing activity is now gaining notice and beliefs.
Speaker Change: Third.
Speaker Change: The understanding of COVID-19 O. The community has undergone a notable evolution.
Speaker Change: Most health care providers are now moving beyond the pandemic era concept of an acute respiratory syndrome, the Sars protostar as koby too.
Speaker Change: And now see acute infection and corresponding respiratory disease as part of a much broader more insidious long term health challenge.
Speaker Change: We are and we believe now on the forefront of educating these clinicians on why patients who are battling cancer <unk>.
Speaker Change: <unk> transplant, where who lack sufficient immune cells to Mount a responsive vaccination need a protective option.
Speaker Change: The untapped market potential ahead of us remains numerically best.
As we execute on our new posture, we expect to see a meaningful acceleration in product growth.
Speaker Change: Now I can get into the specifics of execution.
On slide seven.
Speaker Change: You see here the top level metrics accompanied by three of the structural elements, we have installed and vivid.
Speaker Change: We have moved to a focus trained in house team.
Speaker Change: Ending our relationship with contract Representatives.
Speaker Change: We have established and built a culture of accountability and measurement.
Speaker Change: We have substantial re refined our messaging and believe that we are recognized as leaders in the COVID-19 fields.
Speaker Change: Health care providers.
Institutions broadly.
Speaker Change: All of these elements are the keys to each successful launch in pharmaceutical growth initiator nation over my career.
Speaker Change: We're also beginning to make some progress around numerous fronts, including contracted.
Speaker Change: We will not contemplated in the very early launch.
Speaker Change: We are receiving scaled interest from organizations.
Speaker Change: Who wished to derive value from commitments to our large ordering and are pleased to be working with them.
Speaker Change: We're seeing ourselves placed in <unk> protocols and guidelines nationally.
Leading to a deeper understanding of converted.
Speaker Change: Turning to slide eight.
Speaker Change: Slide eight shows the continued steady growth in our commercial reach.
Speaker Change: While Q1 revenues dipped from Q4.
Speaker Change: We believe much of that is attributable to the lack of feet on the street.
Speaker Change: In January and February as we trained up and deployed hired our new sales team.
Speaker Change: Encouragingly, we've seen strong revenues, thus far in Q2.
Speaker Change: Including for example, our biggest ever commercial day.
Speaker Change: And biggest ever commercial week.
Speaker Change: Day by day, the highs are getting higher and the lows are getting higher as well.
Speaker Change: This is the hallmark of ongoing growth.
Speaker Change: Okay.
Speaker Change: Turning to slide nine.
Speaker Change: We would note that professional societies and guideline writers are taking notice of our work.
Speaker Change: In addition to the idea of say guidelines.
Speaker Change: We now have some garda.
Speaker Change: In the end CCN guidelines for B cell lymphomas, which is a substantial U S population.
Speaker Change: Which deserves high quality protection.
Speaker Change: We routinely see from Kols at medical conferences and awareness of non relapse death for example, among patients who undergo car T therapy.
Speaker Change: Deep immune ablation to manage lymphomas and infectious disease deaths is a major contributor to that.
Speaker Change: Within infectious disease, COVID-19 is again, a dominating contributor to that.
Speaker Change: Moving to slide 10.
Speaker Change: Of course in contrast, other infectious diseases COVID-19 is ever present in.
Speaker Change: And characterized by periodic waves.
Speaker Change: While the sales of COVID-19 treatments are highly influenced by surges in disease.
Speaker Change: And we saw that clearly amongst certain bigger pharmaceutical companies in their Q1 earnings calls.
Speaker Change: Prevention via monoclonal antibody may be a bit more predictable.
Speaker Change: And steady.
Speaker Change: Covid is always a threat for these populations.
Speaker Change: As we go into the warmer months.
Speaker Change: We tend in the U S to see waves of COVID-19, among the southern states it.
Speaker Change: It will be launching a targeted digital campaign regarding the likely summer surge accordingly.
Speaker Change: Finally on slide 11.
Speaker Change: On pricing.
Speaker Change: We took in March the modest price increase and still come Garter remains one of the lowest priced anybody's ever launched.
Speaker Change: Obviously, the original pricing analysis contemplated larger volumes and potentially lower risk and lower acuity patients.
Speaker Change: Especially consider the potential for COVID-19 treatment.
Speaker Change: With treatment off the table for the moment we.
Speaker Change: We took a small price increase to better reflect the value of this medicine brings to populations in need.
Speaker Change: Note the price increase only took effect in March and will be updated by CMS beginning in July.
Speaker Change: Next slide please.
Speaker Change: Okay.
Speaker Change: We're pleased that <unk> continues to be available through EUA.
Speaker Change: And maintained focused commitment on serving the immunocompromised community.
Speaker Change: I'll now turn the call over to Ravi to discuss some of our progress in research and development Ravi.
Ravi Ellen: Thanks, Tim.
Ravi Ellen: This is an exciting time to be an infectious disease prevention and treatment as the central authorities in the United States reconsider the state of the World for COVID-19 and beyond I'll.
Ravi Ellen: I'll begin on slide four.
Ravi Ellen: By commenting on our now multi year work with antibodies directed against the receptor binding domain or RVP off as far as youll be two spike protein.
Ravi Ellen: This is obviously a validated target and has been targeted repeatedly by our colleagues and competitors and other companies who would like to produce highly effective treatments on preventatives for COVID-19.
Ravi Ellen: The challenge, we faced and that we believe we are overcoming as evolutionary.
Ravi Ellen: <unk> proprietary technologies are designed to yield antibiotic medicines that target structural real estate.
Ravi Ellen: A biological targeted motions such as far as <unk>. So.
Speaker Change: So far remember Barth who's been a total success on that front when we back of the envelope calculate the shared number of mammalian CRC will be two infections and consider the quantitative by Merrimack co infections, the fidelity of the Saar COPD to glamorize et cetera.
Speaker Change: We begin to estimate that the virus has explored petroleum's, but molecular variance over the past years throughout the epitope.
Speaker Change: All lines of the <unk> binding site. It has remained structurally intact.
Speaker Change: <unk> the product potency as a SaaS and best in class industrial systems.
Speaker Change: It remained accordingly staple.
Speaker Change: Reassuringly of course for our pipeline molecule 2311, <unk> 311. The same is true only easy Buck 50 values are holding more stable and much more potent levels.
Speaker Change: Fact, neither the measure potency nor any change for <unk> hundred 311 would be visible replaced hard neutralization data onto the chart at the bottom of slide 14.
Speaker Change: Why.
Speaker Change: Slide 15 shows a graphical depiction of sorry of the pharmacy will be two spike protein with a blue areas shaded, indicating the <unk> epitope.
Speaker Change: <unk> structural change observed over time, but each amino acid residue in the spike is represented by intensity yellow for minor orange for moderate and readiness for substantial change you will note some yellow in a few spots or epitope, but that changed resolved in the a more prolonged transition ever since then three years, which can.
Speaker Change: B in some ways considered a new phase of the pandemic or a very different endemic phase our binding sites.
Speaker Change: Remained quiescent.
Speaker Change: More as vaccination rates have dropped pressure applied to the R&D at the population level has also dropped.
Speaker Change: Even more intriguing data out of the Bloom Rabbit Fred Hutchinson.
Speaker Change: Demonstrates that children, who are not.
Speaker Change: Not been vaccinated, but who have been primarily impacted by the <unk> virus variants.
Speaker Change: Appeared to generate antibodies suites directed more towards the <unk> terminal bromine and away from RBC.
Speaker Change: While these MTBE mutations are in keeping with a known immuno base of properties Homochrome variance there appears to be less evidence of selective pressure, but those classic lead historically antigenic sites on R&D near the Premier Global regarding site and borrowers as isolated from these more recent trials with injections in short we feel very good.
Speaker Change: Continued.
Speaker Change: Activity over the long term based on the observed stability Acapu Bart epitope.
Speaker Change: Slide 16 provides a little more color on a discovery program. We are moving through now related to RSV respiratory syncytial virus is a major medical burden and there is a well developed commercial category devoted to the use of monoclonal antibodies to prevent infection in neonates in children under two years.
Speaker Change: Or is at risk from seasonal RSV.
Speaker Change: Or some amount of Fortis is the class leading antibody, although parallelism Bob is still used in merck's has broken them out as a near term Paducah date.
Speaker Change: The two more contemporary antibodies have certain strengths in liabilities and variation of the targeted protein makes the RSV landscape, an excellent opportunity to see of our platform and generating attractive medicine to compete with the class leaders and.
Speaker Change: And our screening and engineering, we can establish certain parameters designed to yield best in class properties, and we will look forward to updating on our progress later this year.
Speaker Change: Slide 17 provides further detail on our recently announced measles discovery program by degree.
Speaker Change: We'll share some of the same features as COVID-19 in RSV in terms of multiple circulating variance that require an engineered broadly neutralizing monoclonal antibody, but which also prevents a highly validated antibody target considering the generally understood efficacy of for example, both MMR vaccine and <unk>.
Speaker Change: And the post exposure prophylaxis study.
Speaker Change: We have begun our work and our goal would be a tool useful for the treatment of acute infection and also useful in post exposure or even pre exposure prophylaxis use cases.
Speaker Change: We will look forward to reporting on our progress before the end of this year.
Speaker Change: Now I'll turn the call over to Mark Wingard song and market leader to discuss clinical and regulatory.
Mark Wingard: Thanks, Robbie and good morning, everyone.
Mark Wingard: In early February we reported our initial progress with the wind <unk> 2311, our next generation antibody designed to improve upon the middle bar.
Mark Wingard: As a reminder, on slide 19, all and vivid COVID-19 antibody sure identical scaffolding and generally our discovery product process works such that each successive monoclonal antibody as a minor but essential tweak from the labs.
Mark Wingard: This process results in molecules that are near identical in terms of amino acid sequence. In fact generally changed about two a similar even lesser extent than let's say mrna COVID-19 vaccines from one generation to the next.
Mark Wingard: With <unk> 311, we are not trying to solve a problem related to variation or some threats at the middle bar activity, rather we're trying to engineer more medically and commercially attractive features into our medicines.
Mark Wingard: Slide 20 quickly outlines our first in human dose and route of administration, ranging clinical trial designed to provide maximum forward flexibility for our go to market.
Mark Wingard: And regulatory conversations.
Mark Wingard: You can see the cohorts on the slide and the concepts behind assessing them initially.
Mark Wingard: We will be wrapping up the study soon and we'll be pleased to provide an update next weeks on our progress.
Mark Wingard: Turning to slide 21, it reminds us very quickly the properties of <unk> 311 relative to the milk Bart and what we think those properties allow Florida.
Mark Wingard: It is our belief that 2311 can be a major step forward for people sick with COVID-19, and people highly vulnerable to COVID-19, whether immuno compromised or not.
Mark Wingard: <unk> 311 represents a potential step change and accessibility and scalability for protection compared to Tim Garda and May present, the opportunity to also create a highly efficient and effective treatment.
Mark Wingard: With that I'd like to turn the call back to Mark <unk>, who will discuss our regulatory experience with our COVID-19 treatment EUA request and some next steps Mark.
Mark Wingard: As previously mentioned, we've been watching evolution of HHS and FDA with great interest one of the key messages new HHS FDA leadership percentage has been a desire for greater transparency, especially as it relates to communication between FDA and industrial sponsors.
Mark Wingard: At this time, we have not seen any convention emerge on this front among our colleagues in the industry nor do we have any guidance on this topic from the agency. However, we are aligned with the notion that transparency is a generally good thing for regulators patients sponsors and citizens with that in mind and given the sheer volume of correspondence.
Mark Wingard: Companies like ours have with FDA, we are today, beginning by providing direct experts in data from one recent correspondence back in February specifically, the declination by the legacy bite and FDA of our application for expansion of our EUA to include treatment of active mild to moderate COVID-19 in immunocompromised persons with no.
Mark Wingard: Treatment options.
Mark Wingard: This action generated many questions to our company from Hcp's and patients and we hope to todays presentation provide some answers.
Mark Wingard: Importantly, we believe our presentation today reflects both the core of the scientific review by the agency and the bulk of their communication to us on the topic and would resemble in some ways. The major points. The agency might render too for example, an advisory committee if that were an operative form we are including our rebuttals to those points, which ultimately will build to our intended.
Mark Wingard: Next steps.
Speaker Change: Importantly, it and vivid we are Americans taxpayers and some of US are patients too. In addition to industrial sponsors and so we view our partnership with FDA as fundamentally collaborative on behalf of patients in need.
Speaker Change: Slide 22 describes the operative background immuno bridging of antibodies for COVID-19 has its roots in the December 2022 joint EMA FDA webinar attended by regulators in academic and industrial experts, including and vivid and was devoted to accelerated COVID-19 monoclonal antibody development.
Speaker Change: In our case, our immuno bridging prototype molecule at Intrepid lab went through full phase III Registrational rct's for both prep and treatment of COVID-19, and as such adding traveling bad breath presents a biophysical profile well associated with demonstrated placebo controlled clinical efficacy Indus.
Speaker Change: Industry academic and regulatory confidence in SPN, a tighter or clinical antibody anti viral activity is sufficiently high to use that surrogate is a way to bridge from one clinical dataset to a new molecule without the need for full Preauthorization clinical studies, just as we did for our prep authorization.
Speaker Change: From a regulatory perspective, it was clear in 2022 and has been clear for the last three years that UA was the pathway FDA preferred or believed was the best fit with what was understood to be a short useful life of all COVID-19 monoclonal. This is of course, a contrast to vaccines, which enjoy full approval and S. P.
Speaker Change: L. A updates on the basis of similar comparative titers either way in the spring of 2020 for a bridging UA for treatment seemed to be a structure that might suit both our in fda's interest sets depending on the nature of the tighter bridge just as was the case for a prep authorization the clear desire from the agency.
Speaker Change: <unk> has been for what they would consider quote conservatism unquote or the highest possible anti viral titers and therefore antibody dose to satisfy some of the a pissed him a logical limitations of immuno Bridget.
Speaker Change: This is an understandable desire if you remember that the first job of the agency is assurance or confidence and likely clinical benefit rather than stewardship of our medicines. Overall profile. There are of course consequences to the degree of insurance required by the agency that take some careful thought and unpacking, which is where we'll spend some time today.
Speaker Change: It is an important exercise in part for reasons embedded into our citizen petition there is a wide gap between the assumptions and habits of seeber in cedar respectively. As between assurances traditionally required a COVID-19 vaccine versus assurances traditionally required for Covid monoclonal antibodies and we believe regulatory evolution is required for the <unk>.
<unk> of patients in need.
Speaker Change: A few more background points first <unk> and Adam Trevor Mab. Despite the near identical Molecularly has very different potencies, and hence different routes of administration of doses, which means their PK and PD profiles cannot overlap, but can be easily compared to one another visually and quantitatively second the proposal for EUA expansion.
Speaker Change: As for immuno compromised persons for whom alternative therapies are inaccessible or not clinically appropriate. So the choice here is between <unk> or nothing.
Speaker Change: Third we will not touch much on the <unk> safety profile in this overview, both because <unk> was and remains authorized for use by people, who are well, which would seem to create a safety pathway for use by people who are sick and because the bulk of FDA feedback relates to the science of assurance of efficacy benefit in immuno bridge.
Speaker Change: Slide 23, the major F D. A finding on the application for treatment presented in terms that are drawn straight from the <unk> statute is that they are unable to reasonably conclude that the known and potential benefits of some of the burden treatment outweigh the known and potential risks. They offered for specific scientific conclusions related to assurance of clinical benefit.
Speaker Change: A fit in the immediate in the immuno bridging exercise, which we have paraphrased here and will present in more detail on the next slide.
Speaker Change: Slide 24 depicts curves and comparison between Adam Trevor Mervyn pillar of our PK and PD expressed as SPN, a tighter or clinical anti viral activity the primary basis for immuno bridge on.
Speaker Change: On the Upper left chart, you can see that that interest on that being administered intramuscularly starts with very low circulating titers and rises slowly over five to seven days toward its peak.
Speaker Change: By contrast permit Novartis dosed intravenously, and so begins instantly very high and then settles over time, you can read below the FDA interpretation of the comparative curves, which they described as quote similar to or higher than unquote, Adam tripling that for only three days after which it is less than and you can see a tail.
Speaker Change: In the upper right expressing the ratio of those two curves over various increasingly longer time periods. The agency here is justifiably focused on weather permit a bark delivers comparative titers to Ed and trip them that for the longest possible time.
Speaker Change: Next slide 25 conveys our perspective on this primary immuno bridging in contrast to FDA description, we see <unk> titers is much higher than where comparable to at entrust them out for four days then modestly below for day five.
Speaker Change: After which the Pilbara titers settled below editor of them out but are of course still quite high compared to nothing for many days and then weeks given the half life of the molecule wire weird and vivid so interested in five days three reasons first over five days, Adam Trevor Mab conferred the majority of its measured virological benefit compare.
Speaker Change: To placebo, even starting at very low titers.
Speaker Change: Treatment alternatives packs love it and look embryo, our five day regimens themselves after which of course, they stop and confirm zero antiviral activity.
Speaker Change: And third as a general statement treating early in the course of an infection of COVID-19 is associated with improved outcomes. So to US. That's five day duration comparison is rather interesting and the seven day comparison as attractive although we agree that conferring long term antiviral activity to help with persistent shedding or viral.
Speaker Change: <unk> is a wonderful potential benefit of using a long acting antibodies in treatment setting.
Speaker Change: Finally to us while in immuno bridging analysis like this one compares a predicate antibody to a new antibody of course for patients in need today. The actual choice in front of FDA is between the new antibody and nothing at all to which we will return in a moment.
Speaker Change: Slide 26 next slide depicts one of two conceptually and substantively similar meta analyses presented to the agency. In this case you can see that permit the Bart is not among the most potent antibodies ever developed for Covid, 19, which we understand and agree with.
Speaker Change: It is however, well within the range of effective Nab titers and would provide antiviral activity a good bit above so trove of mab used to treat COVID-19 to great effect in the pandemic phase of COVID-19 also on this chart on the right side. So excuse me the electric side of the curve you will see convalescent plasma titers comp.
Speaker Change: The lesson plasma interestingly enough retains a treatment to U S.
Speaker Change: And you can see that the range of antiviral activity conferred by convalescent plasma is far below both so drove him out and pull them apart.
Speaker Change: Nonetheless, the FDA notes here that they would wish to live a bar to be nudged more to the right to sit among other maps irrespective of the fact that moving right where it appears to have a de minimis predictive effect unexpected clinical outcomes.
Speaker Change: Slide 27 presents our view on this point moving right word may confer some benefit to patients and we may be able to deal with with newer molecules, but will last we are once again not picking between all of these molecules is if any of the competitors currently exist. The only active molecules depicted on this chart or <unk> and the components of convalescent plasma well.
Speaker Change: To the left.
Speaker Change: Further agency leadership was well aware and communicated to us in the past that antibodies have been consistently overdose, which seems like a minor maybe even academic problem until now when a decision has to be made about an antibody like <unk>. We look at the activity conferred by some error bars and see it as well in an antiviral range validated.
Speaker Change: RCT is having an attractive treatment effect.
Speaker Change: Slide 28 is the FDA language, describing the residual clinical uncertainty of what permit Bart dose may be optimal for those severely immune compromised patients who are fighting an active infection without adequate immunologic response.
Speaker Change: On slide 29, we simply note on this point there is a peculiar and deeply unfortunate consequence to the fda's perspective for patients in such a clear need.
Speaker Change: Slide 30 relates to the fact that indeed comparator antibodies are different and may have subtle differences and mechanism of action and those differences may be difficult to measure, but way on regulatory consideration.
Speaker Change: Slide 31 next notes our views it indeed other than neutralization activity, we assessed and found effector function essentially identical between per live apart and Adam Trevor Mat, which should not be a surprise given the identical backbones as for antibody non neutralization noneffective activities that are undiscovered and unmeasured bye.
Speaker Change: Both industry and FDA.
Speaker Change: Those are a little hard for us to assess and respond to we would humbly submit that these ambiguities are ever present in medicines, new and old and indeed, we would welcome guidance on what unknown and undiscovered thing we might measure going forward.
Speaker Change: So slide 32.
Speaker Change: Well, we have a new leadership team at the FDA changing agency and as described changing priorities at FDA and HHS, we intend to continue engagement with FDA both on <unk>.
Speaker Change: Which is here today and on our new molecule <unk> 23, 11, which we had accelerated rapidly through early clinical development.
Speaker Change: As a final point on the matter Slide 33 depicts the result of a similar analysis for bridging to treatment.
Speaker Change: For <unk> 'twenty 311.
Speaker Change: Using arithmetic from currently circulating variance you can see on the Y axis that both proposed doses of <unk> 23, 11 provide SG&A tighter well in excess of that and Trevor that and indeed can either approach from below or well exceed the titers delivered by Virgin Cove, which set towards the top of the old antibody.
The leader Board, if you're keeping score at home with data like these for <unk> 'twenty 311, we see the majority of the agency's permit Bart concerns well addressed we hope that this comparison and recitation of the permit labar treatment declination logic answers outstanding questions in the field, we will be working up a manuscript to describe this.
Speaker Change: Situation for a scientific journal in the next weeks.
Speaker Change: In the biggest picture, we're thrilled with the medical potential we see in our medicines. We appreciate the fda's alignment with our desire for greater public transparency and we look forward to re engaging with the new F. D. A to discuss <unk> <unk> 23, 11, and this field of medicine generally.
Speaker Change: Needless to say it is our overarching goal as a company to bring important high value medicines to patients in need as rapidly as possible.
Speaker Change: Now I'll turn the call over to Bill due to talk about the financials before we move to Q&A Bill.
Bill: Thank you Mark.
Bill: Turning to slide 35.
Speaker Change: Prior to today's call, we released our Q1 2025 results, including some guarded net product revenue of $11 3 million in March ending cash and cash equivalents of approximately $48 million.
Bill: As previously mentioned to drive long term top line growth, we made a strategic decision to internalize our sales force at the beginning of 2025.
Bill: Although the shift created a short term headwind reflected in Pentagon net product revenue during Q1.
Bill: We are now seeing positive momentum with a return to growth and early signs of acceleration in Q2.
Bill: We are pleased with the continued execution of financial discipline reporting a continued reduction of operating expenses.
Bill: We recorded $27 4 million in operating expenses in Q1, 2025 compared to $32 3 million in Q4 2024.
Bill: A 15% reduction quarter over quarter.
Bill: This was after a decrease from Q3 to Q4 of over 50%.
Bill: We anticipating we anticipate operating expenses will continue to decrease in the second quarter as we have manufactured sufficient.
Bill: Supply.
<unk> <unk> 2011.
And develop plans for significant further manufacturing expense in the near term.
Bill: Backed by a strong cash position and potential to access up to $30 million in non dilutive funding through our term loan facility with SBB secured in April.
Bill: We remain focused on growing <unk> to topline revenue.
Bill: Continued financial discipline and.
Bill: And continue to target profitability by the end of the first half of 2025.
Speaker Change: I'll now turn the call over to the operator to open the call for questions.
Speaker Change: Thank you as a reminder to ask a question you will need to press star one one on your telephone.
Speaker Change: To remove yourself from the queue you May press Star one one again.
Speaker Change: These standby, while we compile the Q&A roster.
Speaker Change: Our first question comes from the line of Michael Yang of Jefferies. Please go ahead Michael.
Speaker Change: Hey, good morning, guys. Thanks for taking our questions. This is Carl Yeung for Michael Yee.
Speaker Change: Just a few from US the first one is could you. Please characterize your recent interaction and or experience with a new agency, particularly on.
Speaker Change: U E and cooling maintaining your U a.
Speaker Change: For Kobe prevention, and the use of UA for.
Speaker Change: Future applications, including <unk>.
Speaker Change: For treatment.
Speaker Change: I'd also use of surrogate endpoints such as.
Speaker Change: The virus titers for approval.
Speaker Change: The second one real quick is on Q1 sales could you. Please characterize your.
Speaker Change: The headwinds that you encountered.
Speaker Change: In Q1.
Speaker Change: I understand team briefly discussed it could you please.
Speaker Change: Expand on that and.
Speaker Change: Tell us how you addressed.
Speaker Change: You know these areas.
Speaker Change:
Speaker Change: The improvements in the second quarter.
Speaker Change: And I'm just.
Speaker Change: Just help us think about your sales in Q2 and how do you.
Speaker Change: And your confidence.
Speaker Change: What gives you confidence that you're going to see.
Speaker Change: See the momentum continue.
Speaker Change: In the second quarter. Thank you.
Speaker Change: Great. Thanks, So much look let me start and then I'll ask Tim to answer the second part so so regarding the EUA.
Speaker Change: You asked a couple different things, but with respect to maintenance of the U a E.
Speaker Change: It is actually our preference to move with the FTA beyond that construct indeed.
Speaker Change: Its generally understood that he weighs are designed to effectively convert at some pace and subject to some mechanism. We have not actually had that conversation with the new FDA, which as you may or may not know is effectively recently seeded but we're looking forward to it very much critically our current your way for.
Speaker Change: The prevention of COVID-19 in certain immunocompromised persons.
Speaker Change: Yes was generated on the basis of immuno bridging but of course carries with it.
Speaker Change: The results of a randomized clinical study interrogating, both safety and exploratory clinical efficacy so in our minds.
Speaker Change: Those data are unique in the field.
Speaker Change: This is the point we've raised in a few different domains, particularly our recent citizen petition so.
Speaker Change: Unlike any other company. We're aware of that has an authorized preventative or approved preventative we actually have contemporary efficacy data and so would seek to leverage that in one form or another subject to discussion with the FDA of moving towards BLA that would be our preference and it would certainly be our preference going forward. So I don't think.
Speaker Change: Any of that is either of.
Speaker Change: Nerve wracking, nor surprising it's in fact embedded into the very nature of a grant to the U N. We are really looking forward to talking with them about that on a go forward basis I think what we what we see is a pretty clear scientific and I mean sort of academic and clinical understanding.
Speaker Change: S. PMA titers are a highly useful validated surrogate endpoint and you can see that embedded into of course, the work that we've done with FDA to date.
Speaker Change: And in fact, the evolution of our of our product factory, which alludes to some of the meta analytics describing these relationships. So.
Speaker Change: You know we see the endemic virus situation as an opportunity to normalize all of this away from UA into a landscape akin to an accelerated approval with a post market conversion study, which I think not coincidentally, perhaps appears to be the direction of travel for COVID-19 vaccines all of that is to us.
Speaker Change: US highly welcome and embedded into all of our plans for both <unk> and our molecules going forward you have to remember that an EUA does not carry an express obligation to generate randomized clinical data on the other side of it but of course accelerated approvals do so we would look forward to that.
Speaker Change: And.
Speaker Change: It's going to be a major feature of what we believe will be our upcoming discussions with the agency.
Speaker Change: So I hope that's clear if it's not please please get back into the tier, but Meanwhile, I'll ask Tim to expand on our Q1 changes and our confidence going forward. Yes of course, thank you Brian.
Speaker Change: I think we I brushed over pretty quickly, but when I look back at what we were able to do in Q1.
Tim: It was pretty remarkable.
Tim: We decoupled from the contract sales organization.
Tim: And builds our own best in class sales team trained them and deployed them.
Tim: By partnering with our human resources team.
Tim: To make all this happen in weeks and so we did see a disruption in field activity.
Tim: But with that we were really thoughtful in how we made that approach.
Tim: In.
Tim: Amplified some of our some of the air cover that we can do with digital marketing.
Tim: In others to fill a little bit of that void.
Tim: What we're pleased with seeing right now and I shared it on the key launch metrics.
Tim: Slide is that when you look from January one through the end of April 30th.
Tim: We're seeing a really nice increase in breadth depth.
Tim: As well as unique accounts that.
Tim: That the team is calling on so we've really refocused around.
Tim: What we're calling a core for specialists.
Tim: Including rheumatology, where we've seen.
Tim: A high degree of acceptance and adoption.
Tim: And it's.
Tim: Been a really good area of focus for us.
Tim: So look at where <unk> is available.
Tim: I had my first call about a year ago with you. We had about 120 sites right. Now if you go to infusion finder, we have over 880 sites. So we continue to drive access to them guard, a really broadly through multiple channels.
Tim: And are starting to see that and I alluded to we're seeing some of our.
Tim: We're seeing some really strong numbers into Q1 right now.
Tim: And are excited about that.
Tim: Thanks, so much.
Tim: Thank you.
Speaker Change: Our next question comes from the line of Patrick <unk> of H C. Wainwright.
Speaker Change: Go ahead Patrick.
Speaker Change: Patrick Your line is open please make sure your line isn't muted maybe on a speaker phone lift your handset.
Luis: Hi, Good morning, I'm, sorry, I was on mute. This is luis into Patrick. Thank you for taking my questions and again, we understand that there are John These are challenging times with me appreciates all of the teams work and progress so far so on the on the on a follow up.
Luis: And a little bit to what was discussed earlier can you discuss a little bit more.
Luis: More in detail the music program.
Luis: Is it.
Luis: Mutuals.
Luis: We should.
Speaker Change: Every details you can share on the expected clinical trial development paths and potential market size.
Luis: Oh and in the context of your current cash position and the.
Luis: The non dilutive loan facility, how you're planning to prioritize.
Luis: Thank you.
Luis: Yeah, Let me, let me start and this is mark and I'll see maybe Ravi can add some color but.
Luis: When we're discussing our discovery programs that is spending that is essentially.
Speaker Change: In all of our standing budgets and it doesn't represent a particularly incremental draw from our forecasted cash balances. It is a matter of priority. So yes, we're adding a program for example in measles, but I want to say you might have used the word pivot, which is not something that I would agree with we're not pivoting anymore.
Speaker Change: We leave English class and go to math class, we're pivoting and deciding to just focus on math, we're adding something that we think could be potentially important and that could create a lot of value for patients in need and shareholders overtime. So doing these early discovery programs provides us with a basis.
Speaker Change: For considering clinical development under the right circumstances, and again as stewards of capital we are always going to try to be disciplined about spending shareholder money.
Speaker Change: Only on those projects that we see having a very very attractive near term return profile now in the case of measles, there may well be some interest in the even the national level and we will look forward to exploring that potential, but but I don't think you can consider any of it as a.
Speaker Change: Change or.
Speaker Change: A particular drop.
Speaker Change: Draw on our capabilities or interests elsewhere. It is all about adding optionality and setting into place the ability to grow over the long term both in terms of our the scale of our business, but more importantly, growing the scale of our anticipated medical impact is that is that clear.
Speaker Change: Yes, that's helpful. Thank you so much.
Speaker Change: Thank you I would now like to turn the conference back over to the company for any closing remarks.
Speaker Change: Okay, well. Thank you very much all for joining us this morning, and we will look forward to any further questions in follow up later today. Thanks, all bye bye.
Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect.
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Speaker Change: Yeah.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: But at the moment.
Speaker Change: Okay.