NASDAQ:ABSI Absci Q4 2024 Earnings Report $3.09 +0.04 (+1.31%) Closing price 04:00 PM EasternExtended Trading$3.05 -0.04 (-1.29%) As of 05:48 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Absci EPS ResultsActual EPS-$0.25Consensus EPS -$0.22Beat/MissMissed by -$0.03One Year Ago EPSN/AAbsci Revenue ResultsActual Revenue$0.67 millionExpected Revenue$1.77 millionBeat/MissMissed by -$1.10 millionYoY Revenue GrowthN/AAbsci Announcement DetailsQuarterQ4 2024Date3/18/2025TimeAfter Market ClosesConference Call DateTuesday, March 18, 2025Conference Call Time4:30PM ETUpcoming EarningsAbsci's Q1 2025 earnings is scheduled for Tuesday, May 13, 2025, with a conference call scheduled at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Annual Report (10-K)Earnings HistoryCompany ProfilePowered by Absci Q4 2024 Earnings Call TranscriptProvided by QuartrMarch 18, 2025 ShareLink copied to clipboard.There are 11 speakers on the call. Operator00:00:00Thank you for standing by and welcome to Absa's Fourth Quarter and Full Year twenty twenty four Business Update and Financial Operating Results Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. As a reminder, today's program is being recorded. And now I'd like to introduce your host for today's program, Alex Khan, Vice President of Finance and Investor Relations. Speaker 100:00:35Thank you. Earlier today, Absci released financial and operating results for the quarter and year ended 12/31/2024. If you haven't received this news release or if you'd like to be added to the company's distribution list, please send an email to investorsabsci dot com. An archived webcast of this call will be available for replay at Absci's Investor Relations website at investors.avsai.com for at least ninety days after this call. Joining me today are Shawn MacLean, Absci's Founder and CEO and Zach Jonason, Chief Financial Officer and Chief Business Officer. Speaker 100:01:08Christian Stegman, Absci's FCP of Drug Creation will also join for Q and A following prepared remarks. Before we begin, I'd like to remind you that management will make statements during this call that are forward looking within the meaning of the federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated, and you should not place undue reliance on forward looking statements. Additional information regarding these risks, uncertainties and factors that could cause results to differ appears in the section titled Forward Looking Statements and the press release Absci issued today and the documents or reports filed by Absci from time to time with the Securities and Exchange Commission. Except as required by law, Absci disclaims any intention or obligation to update or revise any financial or product pipeline projections or other forward looking statements either because of new information, future events or otherwise. Speaker 100:01:55This conference call contains time sensitive information and is accurate only as of the live broadcast, 03/18/2025. With that, I'll turn the call over to Sean. Speaker 200:02:05Thanks, Alex. Good morning, everyone. Thank you for joining us for our fourth quarter and full year 2024 business update call. 2024 was a successful year for Absci. I'm proud to say we executed across all aspects of our business, including advancing our proprietary internal programs, delivering on partner programs and adding four new partners to our ecosystem of collaborators. Speaker 200:02:31We capped the year off with our twenty twenty four R and D Day in December, where we unveiled our potentially category defining ABS-two zero one program, targeting the prolactin receptor for the treatment of androgenic alopecia. At this event, we shared new data supporting a potential best in class profile for ABS-one hundred and one, our anti T01A program and preclinical data for ABS-three zero one and ABS-five zero one programs. Additionally, we showcased new breakthroughs in de novo antibody designs from our leading AI platform and hosted distinguished guest presenters, including our KOLs and partners such as Doctor. Dennis Sleiman from UCLA and Doctor. Luis Diaz from Memorial Sloan Kettering. Speaker 200:03:21For those who did not view the webcast, I encourage you to access the replay on our website. ABS-two zero one in particular is an asset we are extremely excited about. We see the opportunity for ABS-two 01 to become a potential flagship asset for Absci. But first, I'd like to reflect on the capabilities that enabled us to generate these differentiated antibody assets. Looking back on 2024, we're encouraged by the significant advancements in our AI integrated drug creation platform. Speaker 200:03:52Similar to how the broader tech industry is experiencing successive breakthroughs in generative AI, we view the progress of our model and platform in a similar light. Just two years ago in January 2023, we released our first AI de novo proof current. Since then, we have demonstrated notable platform improvements progressing from single CDR design to designing antibodies to targets with no known binders. These capabilities were clearly showcased in December, particularly through our collaboration with Caltech, which focused on designing a universally neutralizing HIV antibody. Before discussing that collaboration further, I'd like to highlight the key factors behind our success. Speaker 200:04:37At Absci, we see four key ingredients for success: our data advantage, our leading AI models, access to scalable compute and fostering a team with multilingual expertise. While we've spoken extensively about each of these in the past, I'd specifically like to focus on compute. In January, we announced a collaboration with AMD, a leader in high performance computing. As part of this partnership, AMD made a $20,000,000 strategic investment in Absci. This collaboration supports our mission of creating better biologics faster by offering optimized compute solutions for complex biological modeling. Speaker 200:05:19These solutions provided exceptional performance, reduced infrastructure costs and accelerated cycle times. At the JPMorgan Healthcare Conference in January, I outlined several key reasons we chose to partner with AMD. AMD's chips gave us unmatched training resolution, allowing us to model large protein complexes without the need to crop, preserving biological context and enhancing model accuracy. Furthermore, this collaboration significantly accelerates throughput, scaling in silicone antibody design and evaluation and ultimately reducing R and D timelines and costs. Stepping back, what's the broader purpose of harnessing generative AI for antibody design? Speaker 200:06:04It's not just about designing faster or cheaper, it's about creating truly differentiated candidates and unlocking novel biology for the benefit of patients. In December, we shared a case study illustrating breakthroughs in AI de novo design through our collaboration with Caltech. Using our proprietary de novo design model, we created antibodies targeting a difficult to drug epitope in the HIV Coldera region, potentially facilitating the development of a universal neutralizing HIV antibody. The Colvera region uniquely accessible only in the GP120 open confirmation has remained untargeted by previously neutralizing antibodies. Successfully creating these antibodies marks a potential pivotal milestone in HIV vaccine research and underscores the capability of our de novo design model to target previously undruggable epitopes. Speaker 200:07:02We're also actively applying our generative AI drug creation capabilities to our proprietary internal pipeline. In December, we unveiled ABS-two zero one, a potential best in class anti prolactin receptor antibody for angiogenic alopecia. This is an indication with significant unmet need in a large patient population, approximately eighty million people in The U. S. Alone. Speaker 200:07:28Androgenic alopecia, also known as male and female pattern hair loss, affects fifty percent of men and forty percent of women by the age of 50. There's been no real innovation in nearly thirty years, creating a large market potential. Our approach aims to not just slow hair loss, but to unlock an entirely new category focused on hair regrowth. We've nominated a development candidate for ABS-two zero one supported by preclinical data suggesting high acidity and potency, favorable safety and immunogenicity, extended half life enabling convenient infrequent dosing and excellent developability and manufacturability. Preclinical models demonstrated improved hair growth compared to minoxidil. Speaker 200:08:17As we advanced ABS-two zero one, we envision a straightforward path to clinical development and have assembled a robust network of renowned hair and dermatology KOLs advising our progress. ABS-two 01 is currently an IND enabling site with Phase one trials anticipated to begin in early twenty twenty six. Since unveiling ABS-two zero one three months ago, we've received very positive responses from industry experts and the financial community. Given the compelling data, clear development path and significant market opportunity, our strategy is to develop ABS-two zero one internally through later stage clinical development and proof of concept, retaining maximum value for Absci. Turning now to ABS-one hundred and one, our potential best in class anti TL1A antibody. Speaker 200:09:12At December's R and D day, we shared new data indicating ABS-one hundred and one does reduce internalization of TL1a complexes in in vitro THP1 immunogenicity tests compared to competitive molecules that had high clinical ADA rates. These data suggest ABS-one hundred and one may have lower ADA development risk in clinical settings. Additionally, in January, we shared new ABS-one hundred and one NHP PKPD data confirming prolonged target engagement, demonstrating dose dependent engagement, including a ceiling effect and significantly improved target engagement compared to competitor molecules at comparable dosing regimes. We plan to initiate Phase one clinical studies for ABS-one hundred and one in the first half of twenty twenty five with an interim readout expected in the second half of this year. We continue to see active partner interest and have begun developing a potential first in class bispecific antibody incorporating our TL1A antibody as one arm. Speaker 200:10:17Additional data will be provided later. We recently shared data on ADS-three zero one and ADS-five zero one programs as well. ADS-three zero one targeting an undisclosed immuno oncology target discovered through Absci's reverse immunology platform showed expression across squamous cell carcinomas. Our first in vivo target validation study demonstrated potent anti tumor response, strongly supporting further development. For AVS-five zero one, our potential best in class AI designed anti HER2 antibody, preclinical data confirms novel epitope interactions, affinity comparable or superior to trastuzumab, efficacy against trastuzumab resistant xenograft tumors expressing wild type HER2 and good developability. Speaker 200:11:10Earlier, I mentioned that our team was a key ingredient to Absci's success. This is evident in our achievements in 2024. As always, I'd like to thank our dedicated team at Absci for their unwavering commitment and effort towards our mission. With that, I'll turn the call over to Zack to walk through our new partnerships, our outlook and financial updates. Zack? Speaker 300:11:35Thanks, Sean. As Sean mentioned, we added two new partners toward the end of 2024 and achieved our partnership guidance for the year. In addition to our partnerships with Memorial Sloan Kettering Cancer Center and Twist Bioscience, which were announced earlier in 2024, we entered into new partnerships with Alcon and in FedEx in December. Our collaboration with Alcon combines Alcon's novel AI target discovery and Agentic AI expertise with our leading AI de novo design models with the aim of designing and co developing potential first in class therapeutics. Together, Absci and Alcon plan to co develop therapeutic candidates addressing novel targets in the immuno oncology and other indications such as immunology and inflammation. Speaker 300:12:21The partnership will leverage Alcon's predictive AI models and its biomedical datasets and patient derived organoids for target selection and validation. Absci's generative AI drug creation platform, including our de novo antibody design models, will be used to design novel therapeutic candidates against these targets. Together, we aim to streamline and accelerate the development of novel therapeutics targeting novel disease targets. Our partnership with INVID X will leverage our leading generative AI drug creation models to create novel antibody half life extension or HLE capabilities for animal health applications. Through this partnership, Absci will utilize its AI models to design novel modular antibody sequences that confer half life extension in specific animal species. Speaker 300:13:11InVIDX will have rights to use the HLE sequences across its product portfolio to enhance duration of therapeutic effects and customer convenience, both significant potential differentiators in the animal health market. This partnership includes R and D funding as well as election fees, milestone payments and royalties on a product by product basis. We believe this collaboration has the potential to address significant unmet needs in animal health, starting with initial applications for large market indications in canine medicine. Since our IPO nearly four years ago, we have continued to evolve our business model as our capabilities have grown. Today, we are focused on building and advancing a balanced portfolio of high quality, high value therapeutic programs, including a growing number of proprietary internal wholly owned programs. Speaker 300:14:07Moreover, while we continue to collaborate with partners to create therapeutic programs for their targets under traditional deal structures, We have also more recently initiated creative co development partnerships to leverage risk sharing and cost reduction synergies for the creation and development of first in class therapeutic programs. Based on our business model today, including expansion and advancement of our wholly owned programs, we believe that the legacy metric of number of external partnered programs simply on a gross volume basis has become outdated and is now a less meaningful approach to understanding and valuing our business. Our strategy is based on leveraging our platform and resources to create a portfolio of novel and differentiated therapeutic programs that offer the most promising return. Accordingly, we invest our resources in internal programs as well as a variety of partnership programs that we believe offer the best risk return profile rather than simply seeking a potential gross number of partnership programs. We, of course, continue to see value in adding partner programs with high quality collaborators and will continue to do so on a selective basis. Speaker 300:15:22Hence, going forward, we do not plan to provide an exact number of expected new partners or partnered programs as a business outlook as we have in prior years, but rather plan to provide material updates and guidance on our internal and or partnered therapeutic programs when possible. This year, we plan to advance our proprietary internal asset programs as described by Sean earlier. We also anticipate signing one or more partnerships, including with a large pharma company for a drug creation collaboration and continue to plan to provide material updates on ongoing partner programs as they advance through development. We will also very soon be a clinical stage biotech company with ABS-one hundred and one expected to enter the clinic shortly and ABS-two zero one accelerating toward first in human clinical trials potentially early next year. And as a reminder, our business model is focused on out licensing or selling our internal programs and co develop programs following value inflection proof points as early as preclinical proof of concept or much later stages. Speaker 300:16:32Turning now to our financials. Revenue in the fourth quarter was $700,000 as we continue to progress our partner programs. Research and development expenses were $18,400,000 for the three months ended 12/31/2024, as compared to $12,300,000 for the prior year period. This increase was primarily driven by advancement of our internal programs, including direct costs associated with IND enabling studies for ABS-one hundred and one and the increase in stock compensation expense. Selling, general and administrative expenses were $8,800,000 for the three months ending 12/31/2024, as compared to $9,300,000 for the prior year period. Speaker 300:17:18This decrease was due to lower personnel and other costs, offset by an increase in stock compensation expense. For the full year 2024, our gross use of cash, cash equivalents and short term investments, exclusive of partnered program payments was approximately $72,000,000 below our outlook of $75,000,000 on a gross basis. Turning to our balance sheet, we ended the year with $112,400,000 in cash, cash equivalents and short term investments as compared to $127,100,000 as of 09/30/2024. In January of this year, we announced a new strategic collaboration with AMD. As part of that collaboration, AMD made a $20,000,000 equity spend in Absci, purchasing Absci common shares at a price representing an approximate 14% premium to Absaize share price based on the prior day's market closing price. Speaker 300:18:19Further, this year, we have also raised an additional approximately $20,000,000 by utilizing our aftermarket facility, the vast majority of which was raised from two premier mutual funds. This additional approximately $40,000,000 raised since the end of twenty twenty four enables us to continue investing in our internal programs, including accelerating the development of ABS-two zero one, our anti PRLR program for the treatment of androgenic alopecia as well as our co development programs. In sum, we continue to deepen our focus on the high value proprietary internal programs as well as high quality co development and drug creation partnerships with industry leaders who bring synergistic capabilities. We believe that this strategic balanced approach will provide us with the best return for shareholders. Based on our current plan, we believe our existing cash, cash equivalents and short term investments will be sufficient to fund our operations into the first half of twenty twenty seven. Speaker 300:19:23In all, we are very pleased with the progress we have made over the past year and are confident in our ability to execute across our portfolio of programs this year and beyond. With that, I'll turn it back to Sean. Speaker 200:19:36Thanks, Zack. In closing, we've made tremendous recent progress across our platform and internal pipeline. New data for ABS-one hundred and one reinforces its best in class potential and ABS-two zero one presents an exciting opportunity to create an entirely new category addressing a significant market and patient need. In coming months, we'll reach the milestone of becoming a clinical stage biotech company as ABS-one hundred and one enters the clinic. As we also advance ABS-two zero one towards the clinic, we're energized by the potential to bring this innovative product to roughly eighty million people affected in The U. Speaker 200:20:19S. Alongside progress on our internal programs, as Zach mentioned, we anticipate adding one or more new partners, including a large pharma partnership. Again, these achievements are possible because of our dedicated team of eliminators and Absci who would advance our mission each and every day. Thank you all. I'll now turn the call back to the operator for Q and A. Speaker 200:20:46Operator? Operator00:20:48Certainly. And our first question for today comes from the line of Kripa Devarkanda from True Securities. Your question please. Speaker 400:20:59Hi, this is Alex on for Kripa. Congrats on all the progress. Looking forward to another exciting year with Absaime. We had a couple of questions on our end. One for Absahe one hundred and one, we saw compelling preclinical data last year at your R and D Day. Speaker 400:21:14We know as we wait for the clinical trial to get underway now and the Phase one data later this year, does Absahe plan to conduct additional preclinical studies with ABS-one hundred and one and would investors get to see that? And maybe also with ABS-two zero one as well if there are preclinical studies underway and plans to present that in the 2025 timeframe? Thanks. Speaker 200:21:39Yes. Great question, Alex. Christian, do you want to take that? Speaker 500:21:46Sure. Happy to. So regarding ADS101, we have disclosed at R and D Day, a novel preclinical data. At JPMorgan, we have also disclosed target engagement data in non human primates for ADS101. And we are essentially wrapping up our IND enabling work currently. Speaker 500:22:10So we will disclose at a scientific conference the full toxicology data, but we are proceeding towards clinical development as mentioned. And then for ADS-two zero one, we are in the IND enabling phase and we will disclose data in the course of this work, also preferably at Speaker 600:22:32a scientific conference that's upcoming. Yes. Speaker 700:22:36Okay. Great. Speaker 200:22:38I was just going to say, on ABS-two zero one, we have accelerated our timeline on that. We do plan to be in the clinic in early twenty twenty six with a potential interim efficacy readout next year on ABS-two zero one. So we'll have 101 in the clinic later this year followed by two zero one. Speaker 400:23:04That's great. And one more if I may. I think you said that you're not going to provide the number of new partners going forward as some standard practice for the firm, but more material guidance on internal assets and also the partner programs. And any additional color you can provide on the part and program updates, what that might look like given that other people might be taking the lead as part of your contracts over there, but obviously very interested in all that development for investors and for us? Speaker 200:23:37Yes, absolutely. We're really focused on the large pharma partnership. We plan to execute one new large pharma platform deal this year. And then additionally, we are in discussions on AGS-one hundred and one on potentially out licensing that asset. And so there definitely are going to continue to be transactions, but we really want to be focused in on transactions that can bring in significant upfront payments that can in a non dilutive way extend cash runway. Speaker 200:24:16And it also provides really nice validation for the platform and additionally allows us to go into other indications that we would not pursue on our own and really having us to have a diversified portfolio. Zack, is there anything else you would like to add there? Speaker 300:24:34Yes. I mean, I'll just add that going forward there'll be a much greater focus on providing guidance around our internal programs and the CODET programs, particularly once they're at a DC stage. As you would imagine in our drug creation partnerships, disclosure of information on those programs is sometimes not as easy because that partner would have to agree to that. But certainly for the programs that we're advancing and as you've seen, we've evolved our business model to have a greater focus on internal programs and now adding CODEVs in there as well, I think gives us quite a bit of guidance to provide around those. And so that will be our focus going forward. Speaker 400:25:18Fantastic. Thank you all. Operator00:25:23Thank you. And our next question comes from the line of Arseniy Shappashvili. Your question please from Guggenheim. Speaker 600:25:32Hi, it's Arseniy on for Vamil. Congrats on all the progress in 2024. We had a question on two zero one. Given that due to data that you've seen pre clinically, how are you thinking about the design and endpoint for the planned Phase one study? Speaker 200:25:52Yes, that's a great question. I can speak a little bit to the design and hand it over to Christian for the endpoint. So the way we're thinking about this right now is that we will start with a SAD study that would begin sometime early next year, followed by a MAD study where we do plan to power that study appropriately to be able to achieve a proof of concept and all that will be beginning next year. Christian, do you want to speak to the endpoints that we're going to be looking at? Speaker 500:26:32Yeah, absolutely. Great question. So when it comes to allogeneic alopecia, there is a number of well accepted endpoints described. And importantly, they can all be measured with a very well established device, the TrickelScan device. These endpoints have also been accepted by regulators. Speaker 500:26:56So this is a non invasive computer assisted optical measurement of hair density, terminal hair count. And it allows us essentially to progress this program very effectively through clinical development. Speaker 600:27:15Thank you. Very helpful. And maybe one more on the large pharma partnership that you're hoping to secure in 2025. Can you share maybe just on the high level which therapeutic areas or modalities discussions are focusing on? Maybe what the companies are interested in and maybe where they recognize your capabilities and your expertise? Speaker 200:27:42Yes. So I would say that the focus is pretty broad in terms of overall indication. I think some of the focuses are definitely on INI and oncology. But I would say more generally where the focus lies and what's really driving these platform partnerships is the de novo models capability that we've been able to show where we can go after epitopes that have no known binders that have been difficult to drug in the past and being able to ultimately drug those particular epitopes or targets with our platform. And I think what we're seeing is that there's a lot of interest in ion channels like the ones what we're working on with Almirall or various GPCRs where there's been difficulty drugging these. Speaker 200:28:38And the indications have been pretty broad in terms of overall interest. Zach, did I miss anything there or do you want to add? Speaker 300:28:51No. The only one thing I would add, Arseniy, is you can think of the partnerships we're working on or working towards with large pharma as being multi target and to Sean's point, they could span multiple indications. Speaker 600:29:06Thank you. Operator00:29:09Thank you. And our next question comes from the line of Vikram Purehit from Morgan Stanley. Your question please. Speaker 800:29:21Hi, good afternoon. Thanks for taking our questions. We had two. First on 101, we just wanted to revisit expectations for the readout in the second half of the year. Was curious to see any updated thoughts you might have around the size of the data set, the scope of the data set we'll be receiving and just your current view on what you would consider a really strong outcome here? Speaker 800:29:44And then secondly, I think you mentioned that you're working on a bispecific that addresses TL1A in part. I was just curious on what the next steps there might be and what you think the future for that program could be, whether that could be something that's eventually partnered alongside one hundred and one or would that be a separate effort you want to hold on to for a longer time point? Thanks. Speaker 200:30:08Yes. Thanks Vikram. So I can answer your second one and hand the first question over to Christian. So regarding the bispecific, we are planning on developing a potential first in class TL1A bispecific with TL1A on one arm and then a target that has been known, but has been difficult to drug in the past. And we see this as an exciting potential first in class TL18 bispecific, but additionally developing it out as a monotherapy as well. Speaker 200:30:48And we plan to have a lead on that this year and then DC to follow shortly thereafter. But we do see this as, I think, exciting evolution of the INI pipeline that we're building out. And we do see combo based therapy or being able to hit multiple pathways with the bispecific as a way to really meet some of the unmet needs within the IBD and UC space. Christian, I'll hand it over to you for anything I missed there and then answering the first question. Speaker 600:31:34Thanks. Operator00:31:40Thank you. Our next question comes Speaker 200:31:42from Operator00:31:42the line. Speaker 200:31:43Sorry. Christian. Christian, are you there? Alex, did we lose Christian? Speaker 700:31:58His line is still muted. Operator00:31:59Yes, we can hear you, Christian. Speaker 200:32:06Christian, are you still there? Speaker 500:32:14Can you hear me? Speaker 200:32:16Yes. We can hear you now. Speaker 500:32:18All right. I'm not sure what's going on. I'll try again. So with regard to the interim readout in the second half of this year for ADAS 101, What you can expect to see is something quite similar, what we have disclosed for non human primates at JPMorgan earlier this year. So essentially what we'd like to see is a demonstration of sustained elevation of soluble TiVo1a in serum in humans after a single dose. Speaker 500:32:49And we'd like to see that in one cohort after a single dose administration. So that's an important de risking point. And I will just remind you that the competitor molecules that have claimed prolonged half life have to our knowledge not disclosed target engagement in non human primates. Hence, we think we are very well positioned to demonstrate that not only in human primates, but also in humans. Operator00:33:23Thank you. And our next question comes from the line of Gil Blum from Needham and Company. Your question please. Speaker 700:33:30Good afternoon and thanks for taking our questions. So one relating to the Plant Pharma partnership. So did some of the achievements you guys demonstrated binding to the Caldara region of HIV, did that play into your pharma discussions? And I have a follow-up. Speaker 200:33:54Yes. That case study was a has been a big driver in the discussions we're having with large pharma right now. And I think it's a really strong illustration of how we can go after these difficult targets that still exist. And we do believe that that case study is an important piece to the value prop and ultimately driving these large pharma partnerships across the finish line. Speaker 300:34:31Hey, Gil, this is Zach. If I might add to that too just to contextualize it. I think the other thing that we're excited about and we've seen resonate with the pharma companies we're dialoguing with is not only the results there, but if you look over the history of the versioning of our models, you can see the kind of dramatic performance and capability gains as we go from early versions back in 2022 to where we are today with the models that can address the Caldara epitope, for example. Speaker 700:35:03Okay. That's very helpful. And as it relates to this bispecific lead you mentioned for IVD, how what kind of dynamic should we imagine here with ABS-one hundred and one? I mean, there are other companies in the space that are really taking lead on this kind of combo approach. Is this what we're thinking of here or is this something really completely different? Speaker 700:35:34Thank you. Speaker 200:35:38Yes. Thanks, Gail. We do see this as different. But Christian, do you want to maybe talk a little bit about the biology and what we're trying to achieve with this particular bispecific? Speaker 500:35:51Yes, absolutely. So, yes, you're of course correct that there is competition that has announced to run combination studies. We think obviously this is quite interesting. We do think a bispecific can potentially provide additional value that will be more difficult to realize in the clinic in combination studies. So we haven't disclosed the target we're looking at specifically, but we do think there is potentially a strong synergy between Tier 1a and the other mechanism. Speaker 200:36:30Yes. And I will note this is not an IL-twenty three or an alpha-four beta-seven. This is a novel target. Again, that's been difficult to drug. And as a monotherapy, it definitely would be a first in class both as a monotherapy and as a bispecific. Speaker 700:36:53Great, very helpful. Thanks for taking our questions. Operator00:36:59Thank you. And our next question comes from the line of Brendan Smith from T. B. Cowen. Your question please. Speaker 900:37:07Hi. This is Jackie on for Brendan. Thanks for taking the questions. Maybe just touching back on your HIV program, could you remind us on how you plan on progressing that program and kind of how that works under the current partnership structure? And give me any additional color on when we might see updates on the progress regarding that program? Speaker 200:37:27Yes. So this is a collaboration that we have with Caltech and it's being funded by the Gates Foundation. And so we're going to continue to develop this molecule and at the appropriate time work with the Gates Foundation on taking this into the clinic, assuming the preclinical data looks good. And at that point in time, once we start to see some in vivo results, we should be able to come out with a plan on how we plan to develop this in collaboration with Caltech and the Gates Foundation. So stay tuned. Speaker 900:38:14That's great. And maybe just swinging over to more of the business side. Can you give us any update on how to kind of look at 2025, particularly around the expected ramp and spend from the study initiations and maybe anticipated cash burn rate? Speaker 200:38:30Yes, Zach, I'll let you take that. Speaker 300:38:33Yes, sure. So I think we to start off, just to note that we've reiterated our guidance that we have a balance sheet that will fund our strategy and operations into the first half of twenty twenty seven. So I think we're very well positioned to advance our Phase one studies for ABS-one hundred and one. And as we mentioned earlier, we'll have an interim readout on that trial in the second half of this year. And I think the other point which Sean mentioned earlier is we'll be accelerating the development plan for ABS-two zero one and that is within our budget. Speaker 300:39:08The plan there is to be able to initiate first and human studies early next year with the potential for an interim efficacy readout in 2026. So that's all part of our core strategic plan and I think we're capitalized to achieve that as well as advance some earlier stage programs that we're working on today. Speaker 900:39:30Great. Thank you. Speaker 500:39:32Thank Operator00:39:39you. Our next question comes from the line of Devan Chatterjee from Jones. Your question please. Speaker 1000:39:47Thanks for taking my question. So given the recent positive data from Sanofi and Piva's duvetic coding ulcerative colitis, like particularly the strong efficacy and low ADA rates in patients, how is Absahe positioning its anti TL1A assay to compete? To what extent does this raise the bar in terms of like clinical performance or commercial potential? Speaker 200:40:14Great question. Christian, do you want to take that? Speaker 500:40:18Yes. Great question. So we have obviously seen the Sanofi Teva data. It is indeed impressive data. However, it was interesting to observe that the inclusion exclusion criteria in that study was perhaps an aspect that makes it a little bit more difficult to compare this study with other data that's out there. Speaker 500:40:46In particular, there was a significant share of patients in the study. So that raises the question, to what extent can we expect similar data from other antibodies? The other interesting thing we believe with AGS-one hundred and one, there may be a potential to potentially dose higher than what we've seen with competitors. So this is an avenue we are exploring as well. So it remains to be seen whether in terms of the efficacy there is a ceiling effect or whether dosing higher can potentially lead to additional efficacy. Speaker 1000:41:29Okay. Thanks for that. Operator00:41:36Thank you. And our next question comes from the line of Shyamakanth from HCW. Your question please. Speaker 600:41:48Thank you. This is RK from H. C. Wainwright. Good afternoon, Sean and Zach and Alex. Speaker 600:41:56So a lot of my questions on the pipeline have been already asked. But in the time that you have spent generating this pipeline, how much of that the data that has allowed you to expand the pipeline, are you able to take it back into your model into your AI models and are able to strengthen it? And what sort of benefits are you seeing by developing this kind of a vast pipeline? And the second part of the question is, from your initial conversations with Mark way back in 2021, what sort of conversations happen now when you start working with potential partners? What's the evolution there? Speaker 200:42:58Yes. Great question. So to answer the first one, RK, we have a lab in the loop process. We're in a six week time period. We can go from data in our wet lab to training our models to validating that. Speaker 200:43:15And that occurs both on, as you mentioned, our own internal pipeline, but also in our partner programs. And so that lab in the blue process allows us to rapidly iterate on the design and the architectures of our models to continually improve them as well as being able to feed in new data for training, which is obviously helping us increase the overall accuracy and generalizability of these models. And we've made even since two, two point five years ago, we've made tremendous progress from being able to design the hcdr3 of an antibody to now being able to design an antibody where there was no known binder to difficult and challenging targets like the cold air region or ion channels. And we see again that lab in the loop process as really key to unlocking our ability to increase the generalizability and accuracy of our models. And that's really the reason why we've been able to achieve what we have today. Speaker 200:44:36And Zach, do you want to answer that second question? Speaker 300:44:40Yes, sure. I mean, it bridges up exactly what you were describing, Sean. RK, our discussions with pharma right now are really highly centered on the de novo design models that we have and the capabilities that we've advanced over the last year to two years. And so it's I think the big value proposition to Sean's point is sort of unlocking these targets that haven't been addressable with traditional antibody discovery technologies. And so that's a real central value proposition that we're actively exploring with pharma right now. Speaker 300:45:18There are some other interest points too around the ability to create novel pharmacology profiles, for example, pH dependent binding. There's definitely some interest in that aspect of what we're doing and some of the data we've put out at R and D Day, you can refer to. But back to Sean's point, I mean, the biggest emphasis here and I think the biggest value proposition is being able to use those de novo design models to address these targets where there's really known biology, but they just have not been addressable by traditional techniques. Speaker 600:45:55Thank you. Thank you both for taking the questions. Operator00:46:00Thank you.Read moreRemove AdsPowered by Conference Call Audio Live Call not available Earnings Conference CallAbsci Q4 202400:00 / 00:00Speed:1x1.25x1.5x2xRemove Ads Earnings DocumentsPress Release(8-K)Annual report(10-K) Absci Earnings HeadlinesKeyBanc Reaffirms Their Buy Rating on AbSci (ABSI)April 16 at 3:48 PM | markets.businessinsider.comAbsci price target raised to $9 from $5 at KeyBancApril 16 at 3:48 PM | markets.businessinsider.comThe Trump Dump is starting; Get out of stocks now?The first 365 days of the Trump presidency… Will be the best time to get rich in American history.April 17, 2025 | Paradigm Press (Ad)Absci to Report Business Updates and First Quarter 2025 Financial and Operating Results on May 13, 2025April 14 at 4:05 PM | globenewswire.comAbsci's (ABSI) "Buy" Rating Reiterated at Needham & Company LLCApril 12, 2025 | americanbankingnews.com3ABSI : Absci Stock: A Deep Dive Into Analyst Perspectives (7 Ratings)April 9, 2025 | benzinga.comSee More Absci Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Absci? 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There are 11 speakers on the call. Operator00:00:00Thank you for standing by and welcome to Absa's Fourth Quarter and Full Year twenty twenty four Business Update and Financial Operating Results Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. As a reminder, today's program is being recorded. And now I'd like to introduce your host for today's program, Alex Khan, Vice President of Finance and Investor Relations. Speaker 100:00:35Thank you. Earlier today, Absci released financial and operating results for the quarter and year ended 12/31/2024. If you haven't received this news release or if you'd like to be added to the company's distribution list, please send an email to investorsabsci dot com. An archived webcast of this call will be available for replay at Absci's Investor Relations website at investors.avsai.com for at least ninety days after this call. Joining me today are Shawn MacLean, Absci's Founder and CEO and Zach Jonason, Chief Financial Officer and Chief Business Officer. Speaker 100:01:08Christian Stegman, Absci's FCP of Drug Creation will also join for Q and A following prepared remarks. Before we begin, I'd like to remind you that management will make statements during this call that are forward looking within the meaning of the federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated, and you should not place undue reliance on forward looking statements. Additional information regarding these risks, uncertainties and factors that could cause results to differ appears in the section titled Forward Looking Statements and the press release Absci issued today and the documents or reports filed by Absci from time to time with the Securities and Exchange Commission. Except as required by law, Absci disclaims any intention or obligation to update or revise any financial or product pipeline projections or other forward looking statements either because of new information, future events or otherwise. Speaker 100:01:55This conference call contains time sensitive information and is accurate only as of the live broadcast, 03/18/2025. With that, I'll turn the call over to Sean. Speaker 200:02:05Thanks, Alex. Good morning, everyone. Thank you for joining us for our fourth quarter and full year 2024 business update call. 2024 was a successful year for Absci. I'm proud to say we executed across all aspects of our business, including advancing our proprietary internal programs, delivering on partner programs and adding four new partners to our ecosystem of collaborators. Speaker 200:02:31We capped the year off with our twenty twenty four R and D Day in December, where we unveiled our potentially category defining ABS-two zero one program, targeting the prolactin receptor for the treatment of androgenic alopecia. At this event, we shared new data supporting a potential best in class profile for ABS-one hundred and one, our anti T01A program and preclinical data for ABS-three zero one and ABS-five zero one programs. Additionally, we showcased new breakthroughs in de novo antibody designs from our leading AI platform and hosted distinguished guest presenters, including our KOLs and partners such as Doctor. Dennis Sleiman from UCLA and Doctor. Luis Diaz from Memorial Sloan Kettering. Speaker 200:03:21For those who did not view the webcast, I encourage you to access the replay on our website. ABS-two zero one in particular is an asset we are extremely excited about. We see the opportunity for ABS-two 01 to become a potential flagship asset for Absci. But first, I'd like to reflect on the capabilities that enabled us to generate these differentiated antibody assets. Looking back on 2024, we're encouraged by the significant advancements in our AI integrated drug creation platform. Speaker 200:03:52Similar to how the broader tech industry is experiencing successive breakthroughs in generative AI, we view the progress of our model and platform in a similar light. Just two years ago in January 2023, we released our first AI de novo proof current. Since then, we have demonstrated notable platform improvements progressing from single CDR design to designing antibodies to targets with no known binders. These capabilities were clearly showcased in December, particularly through our collaboration with Caltech, which focused on designing a universally neutralizing HIV antibody. Before discussing that collaboration further, I'd like to highlight the key factors behind our success. Speaker 200:04:37At Absci, we see four key ingredients for success: our data advantage, our leading AI models, access to scalable compute and fostering a team with multilingual expertise. While we've spoken extensively about each of these in the past, I'd specifically like to focus on compute. In January, we announced a collaboration with AMD, a leader in high performance computing. As part of this partnership, AMD made a $20,000,000 strategic investment in Absci. This collaboration supports our mission of creating better biologics faster by offering optimized compute solutions for complex biological modeling. Speaker 200:05:19These solutions provided exceptional performance, reduced infrastructure costs and accelerated cycle times. At the JPMorgan Healthcare Conference in January, I outlined several key reasons we chose to partner with AMD. AMD's chips gave us unmatched training resolution, allowing us to model large protein complexes without the need to crop, preserving biological context and enhancing model accuracy. Furthermore, this collaboration significantly accelerates throughput, scaling in silicone antibody design and evaluation and ultimately reducing R and D timelines and costs. Stepping back, what's the broader purpose of harnessing generative AI for antibody design? Speaker 200:06:04It's not just about designing faster or cheaper, it's about creating truly differentiated candidates and unlocking novel biology for the benefit of patients. In December, we shared a case study illustrating breakthroughs in AI de novo design through our collaboration with Caltech. Using our proprietary de novo design model, we created antibodies targeting a difficult to drug epitope in the HIV Coldera region, potentially facilitating the development of a universal neutralizing HIV antibody. The Colvera region uniquely accessible only in the GP120 open confirmation has remained untargeted by previously neutralizing antibodies. Successfully creating these antibodies marks a potential pivotal milestone in HIV vaccine research and underscores the capability of our de novo design model to target previously undruggable epitopes. Speaker 200:07:02We're also actively applying our generative AI drug creation capabilities to our proprietary internal pipeline. In December, we unveiled ABS-two zero one, a potential best in class anti prolactin receptor antibody for angiogenic alopecia. This is an indication with significant unmet need in a large patient population, approximately eighty million people in The U. S. Alone. Speaker 200:07:28Androgenic alopecia, also known as male and female pattern hair loss, affects fifty percent of men and forty percent of women by the age of 50. There's been no real innovation in nearly thirty years, creating a large market potential. Our approach aims to not just slow hair loss, but to unlock an entirely new category focused on hair regrowth. We've nominated a development candidate for ABS-two zero one supported by preclinical data suggesting high acidity and potency, favorable safety and immunogenicity, extended half life enabling convenient infrequent dosing and excellent developability and manufacturability. Preclinical models demonstrated improved hair growth compared to minoxidil. Speaker 200:08:17As we advanced ABS-two zero one, we envision a straightforward path to clinical development and have assembled a robust network of renowned hair and dermatology KOLs advising our progress. ABS-two 01 is currently an IND enabling site with Phase one trials anticipated to begin in early twenty twenty six. Since unveiling ABS-two zero one three months ago, we've received very positive responses from industry experts and the financial community. Given the compelling data, clear development path and significant market opportunity, our strategy is to develop ABS-two zero one internally through later stage clinical development and proof of concept, retaining maximum value for Absci. Turning now to ABS-one hundred and one, our potential best in class anti TL1A antibody. Speaker 200:09:12At December's R and D day, we shared new data indicating ABS-one hundred and one does reduce internalization of TL1a complexes in in vitro THP1 immunogenicity tests compared to competitive molecules that had high clinical ADA rates. These data suggest ABS-one hundred and one may have lower ADA development risk in clinical settings. Additionally, in January, we shared new ABS-one hundred and one NHP PKPD data confirming prolonged target engagement, demonstrating dose dependent engagement, including a ceiling effect and significantly improved target engagement compared to competitor molecules at comparable dosing regimes. We plan to initiate Phase one clinical studies for ABS-one hundred and one in the first half of twenty twenty five with an interim readout expected in the second half of this year. We continue to see active partner interest and have begun developing a potential first in class bispecific antibody incorporating our TL1A antibody as one arm. Speaker 200:10:17Additional data will be provided later. We recently shared data on ADS-three zero one and ADS-five zero one programs as well. ADS-three zero one targeting an undisclosed immuno oncology target discovered through Absci's reverse immunology platform showed expression across squamous cell carcinomas. Our first in vivo target validation study demonstrated potent anti tumor response, strongly supporting further development. For AVS-five zero one, our potential best in class AI designed anti HER2 antibody, preclinical data confirms novel epitope interactions, affinity comparable or superior to trastuzumab, efficacy against trastuzumab resistant xenograft tumors expressing wild type HER2 and good developability. Speaker 200:11:10Earlier, I mentioned that our team was a key ingredient to Absci's success. This is evident in our achievements in 2024. As always, I'd like to thank our dedicated team at Absci for their unwavering commitment and effort towards our mission. With that, I'll turn the call over to Zack to walk through our new partnerships, our outlook and financial updates. Zack? Speaker 300:11:35Thanks, Sean. As Sean mentioned, we added two new partners toward the end of 2024 and achieved our partnership guidance for the year. In addition to our partnerships with Memorial Sloan Kettering Cancer Center and Twist Bioscience, which were announced earlier in 2024, we entered into new partnerships with Alcon and in FedEx in December. Our collaboration with Alcon combines Alcon's novel AI target discovery and Agentic AI expertise with our leading AI de novo design models with the aim of designing and co developing potential first in class therapeutics. Together, Absci and Alcon plan to co develop therapeutic candidates addressing novel targets in the immuno oncology and other indications such as immunology and inflammation. Speaker 300:12:21The partnership will leverage Alcon's predictive AI models and its biomedical datasets and patient derived organoids for target selection and validation. Absci's generative AI drug creation platform, including our de novo antibody design models, will be used to design novel therapeutic candidates against these targets. Together, we aim to streamline and accelerate the development of novel therapeutics targeting novel disease targets. Our partnership with INVID X will leverage our leading generative AI drug creation models to create novel antibody half life extension or HLE capabilities for animal health applications. Through this partnership, Absci will utilize its AI models to design novel modular antibody sequences that confer half life extension in specific animal species. Speaker 300:13:11InVIDX will have rights to use the HLE sequences across its product portfolio to enhance duration of therapeutic effects and customer convenience, both significant potential differentiators in the animal health market. This partnership includes R and D funding as well as election fees, milestone payments and royalties on a product by product basis. We believe this collaboration has the potential to address significant unmet needs in animal health, starting with initial applications for large market indications in canine medicine. Since our IPO nearly four years ago, we have continued to evolve our business model as our capabilities have grown. Today, we are focused on building and advancing a balanced portfolio of high quality, high value therapeutic programs, including a growing number of proprietary internal wholly owned programs. Speaker 300:14:07Moreover, while we continue to collaborate with partners to create therapeutic programs for their targets under traditional deal structures, We have also more recently initiated creative co development partnerships to leverage risk sharing and cost reduction synergies for the creation and development of first in class therapeutic programs. Based on our business model today, including expansion and advancement of our wholly owned programs, we believe that the legacy metric of number of external partnered programs simply on a gross volume basis has become outdated and is now a less meaningful approach to understanding and valuing our business. Our strategy is based on leveraging our platform and resources to create a portfolio of novel and differentiated therapeutic programs that offer the most promising return. Accordingly, we invest our resources in internal programs as well as a variety of partnership programs that we believe offer the best risk return profile rather than simply seeking a potential gross number of partnership programs. We, of course, continue to see value in adding partner programs with high quality collaborators and will continue to do so on a selective basis. Speaker 300:15:22Hence, going forward, we do not plan to provide an exact number of expected new partners or partnered programs as a business outlook as we have in prior years, but rather plan to provide material updates and guidance on our internal and or partnered therapeutic programs when possible. This year, we plan to advance our proprietary internal asset programs as described by Sean earlier. We also anticipate signing one or more partnerships, including with a large pharma company for a drug creation collaboration and continue to plan to provide material updates on ongoing partner programs as they advance through development. We will also very soon be a clinical stage biotech company with ABS-one hundred and one expected to enter the clinic shortly and ABS-two zero one accelerating toward first in human clinical trials potentially early next year. And as a reminder, our business model is focused on out licensing or selling our internal programs and co develop programs following value inflection proof points as early as preclinical proof of concept or much later stages. Speaker 300:16:32Turning now to our financials. Revenue in the fourth quarter was $700,000 as we continue to progress our partner programs. Research and development expenses were $18,400,000 for the three months ended 12/31/2024, as compared to $12,300,000 for the prior year period. This increase was primarily driven by advancement of our internal programs, including direct costs associated with IND enabling studies for ABS-one hundred and one and the increase in stock compensation expense. Selling, general and administrative expenses were $8,800,000 for the three months ending 12/31/2024, as compared to $9,300,000 for the prior year period. Speaker 300:17:18This decrease was due to lower personnel and other costs, offset by an increase in stock compensation expense. For the full year 2024, our gross use of cash, cash equivalents and short term investments, exclusive of partnered program payments was approximately $72,000,000 below our outlook of $75,000,000 on a gross basis. Turning to our balance sheet, we ended the year with $112,400,000 in cash, cash equivalents and short term investments as compared to $127,100,000 as of 09/30/2024. In January of this year, we announced a new strategic collaboration with AMD. As part of that collaboration, AMD made a $20,000,000 equity spend in Absci, purchasing Absci common shares at a price representing an approximate 14% premium to Absaize share price based on the prior day's market closing price. Speaker 300:18:19Further, this year, we have also raised an additional approximately $20,000,000 by utilizing our aftermarket facility, the vast majority of which was raised from two premier mutual funds. This additional approximately $40,000,000 raised since the end of twenty twenty four enables us to continue investing in our internal programs, including accelerating the development of ABS-two zero one, our anti PRLR program for the treatment of androgenic alopecia as well as our co development programs. In sum, we continue to deepen our focus on the high value proprietary internal programs as well as high quality co development and drug creation partnerships with industry leaders who bring synergistic capabilities. We believe that this strategic balanced approach will provide us with the best return for shareholders. Based on our current plan, we believe our existing cash, cash equivalents and short term investments will be sufficient to fund our operations into the first half of twenty twenty seven. Speaker 300:19:23In all, we are very pleased with the progress we have made over the past year and are confident in our ability to execute across our portfolio of programs this year and beyond. With that, I'll turn it back to Sean. Speaker 200:19:36Thanks, Zack. In closing, we've made tremendous recent progress across our platform and internal pipeline. New data for ABS-one hundred and one reinforces its best in class potential and ABS-two zero one presents an exciting opportunity to create an entirely new category addressing a significant market and patient need. In coming months, we'll reach the milestone of becoming a clinical stage biotech company as ABS-one hundred and one enters the clinic. As we also advance ABS-two zero one towards the clinic, we're energized by the potential to bring this innovative product to roughly eighty million people affected in The U. Speaker 200:20:19S. Alongside progress on our internal programs, as Zach mentioned, we anticipate adding one or more new partners, including a large pharma partnership. Again, these achievements are possible because of our dedicated team of eliminators and Absci who would advance our mission each and every day. Thank you all. I'll now turn the call back to the operator for Q and A. Speaker 200:20:46Operator? Operator00:20:48Certainly. And our first question for today comes from the line of Kripa Devarkanda from True Securities. Your question please. Speaker 400:20:59Hi, this is Alex on for Kripa. Congrats on all the progress. Looking forward to another exciting year with Absaime. We had a couple of questions on our end. One for Absahe one hundred and one, we saw compelling preclinical data last year at your R and D Day. Speaker 400:21:14We know as we wait for the clinical trial to get underway now and the Phase one data later this year, does Absahe plan to conduct additional preclinical studies with ABS-one hundred and one and would investors get to see that? And maybe also with ABS-two zero one as well if there are preclinical studies underway and plans to present that in the 2025 timeframe? Thanks. Speaker 200:21:39Yes. Great question, Alex. Christian, do you want to take that? Speaker 500:21:46Sure. Happy to. So regarding ADS101, we have disclosed at R and D Day, a novel preclinical data. At JPMorgan, we have also disclosed target engagement data in non human primates for ADS101. And we are essentially wrapping up our IND enabling work currently. Speaker 500:22:10So we will disclose at a scientific conference the full toxicology data, but we are proceeding towards clinical development as mentioned. And then for ADS-two zero one, we are in the IND enabling phase and we will disclose data in the course of this work, also preferably at Speaker 600:22:32a scientific conference that's upcoming. Yes. Speaker 700:22:36Okay. Great. Speaker 200:22:38I was just going to say, on ABS-two zero one, we have accelerated our timeline on that. We do plan to be in the clinic in early twenty twenty six with a potential interim efficacy readout next year on ABS-two zero one. So we'll have 101 in the clinic later this year followed by two zero one. Speaker 400:23:04That's great. And one more if I may. I think you said that you're not going to provide the number of new partners going forward as some standard practice for the firm, but more material guidance on internal assets and also the partner programs. And any additional color you can provide on the part and program updates, what that might look like given that other people might be taking the lead as part of your contracts over there, but obviously very interested in all that development for investors and for us? Speaker 200:23:37Yes, absolutely. We're really focused on the large pharma partnership. We plan to execute one new large pharma platform deal this year. And then additionally, we are in discussions on AGS-one hundred and one on potentially out licensing that asset. And so there definitely are going to continue to be transactions, but we really want to be focused in on transactions that can bring in significant upfront payments that can in a non dilutive way extend cash runway. Speaker 200:24:16And it also provides really nice validation for the platform and additionally allows us to go into other indications that we would not pursue on our own and really having us to have a diversified portfolio. Zack, is there anything else you would like to add there? Speaker 300:24:34Yes. I mean, I'll just add that going forward there'll be a much greater focus on providing guidance around our internal programs and the CODET programs, particularly once they're at a DC stage. As you would imagine in our drug creation partnerships, disclosure of information on those programs is sometimes not as easy because that partner would have to agree to that. But certainly for the programs that we're advancing and as you've seen, we've evolved our business model to have a greater focus on internal programs and now adding CODEVs in there as well, I think gives us quite a bit of guidance to provide around those. And so that will be our focus going forward. Speaker 400:25:18Fantastic. Thank you all. Operator00:25:23Thank you. And our next question comes from the line of Arseniy Shappashvili. Your question please from Guggenheim. Speaker 600:25:32Hi, it's Arseniy on for Vamil. Congrats on all the progress in 2024. We had a question on two zero one. Given that due to data that you've seen pre clinically, how are you thinking about the design and endpoint for the planned Phase one study? Speaker 200:25:52Yes, that's a great question. I can speak a little bit to the design and hand it over to Christian for the endpoint. So the way we're thinking about this right now is that we will start with a SAD study that would begin sometime early next year, followed by a MAD study where we do plan to power that study appropriately to be able to achieve a proof of concept and all that will be beginning next year. Christian, do you want to speak to the endpoints that we're going to be looking at? Speaker 500:26:32Yeah, absolutely. Great question. So when it comes to allogeneic alopecia, there is a number of well accepted endpoints described. And importantly, they can all be measured with a very well established device, the TrickelScan device. These endpoints have also been accepted by regulators. Speaker 500:26:56So this is a non invasive computer assisted optical measurement of hair density, terminal hair count. And it allows us essentially to progress this program very effectively through clinical development. Speaker 600:27:15Thank you. Very helpful. And maybe one more on the large pharma partnership that you're hoping to secure in 2025. Can you share maybe just on the high level which therapeutic areas or modalities discussions are focusing on? Maybe what the companies are interested in and maybe where they recognize your capabilities and your expertise? Speaker 200:27:42Yes. So I would say that the focus is pretty broad in terms of overall indication. I think some of the focuses are definitely on INI and oncology. But I would say more generally where the focus lies and what's really driving these platform partnerships is the de novo models capability that we've been able to show where we can go after epitopes that have no known binders that have been difficult to drug in the past and being able to ultimately drug those particular epitopes or targets with our platform. And I think what we're seeing is that there's a lot of interest in ion channels like the ones what we're working on with Almirall or various GPCRs where there's been difficulty drugging these. Speaker 200:28:38And the indications have been pretty broad in terms of overall interest. Zach, did I miss anything there or do you want to add? Speaker 300:28:51No. The only one thing I would add, Arseniy, is you can think of the partnerships we're working on or working towards with large pharma as being multi target and to Sean's point, they could span multiple indications. Speaker 600:29:06Thank you. Operator00:29:09Thank you. And our next question comes from the line of Vikram Purehit from Morgan Stanley. Your question please. Speaker 800:29:21Hi, good afternoon. Thanks for taking our questions. We had two. First on 101, we just wanted to revisit expectations for the readout in the second half of the year. Was curious to see any updated thoughts you might have around the size of the data set, the scope of the data set we'll be receiving and just your current view on what you would consider a really strong outcome here? Speaker 800:29:44And then secondly, I think you mentioned that you're working on a bispecific that addresses TL1A in part. I was just curious on what the next steps there might be and what you think the future for that program could be, whether that could be something that's eventually partnered alongside one hundred and one or would that be a separate effort you want to hold on to for a longer time point? Thanks. Speaker 200:30:08Yes. Thanks Vikram. So I can answer your second one and hand the first question over to Christian. So regarding the bispecific, we are planning on developing a potential first in class TL1A bispecific with TL1A on one arm and then a target that has been known, but has been difficult to drug in the past. And we see this as an exciting potential first in class TL18 bispecific, but additionally developing it out as a monotherapy as well. Speaker 200:30:48And we plan to have a lead on that this year and then DC to follow shortly thereafter. But we do see this as, I think, exciting evolution of the INI pipeline that we're building out. And we do see combo based therapy or being able to hit multiple pathways with the bispecific as a way to really meet some of the unmet needs within the IBD and UC space. Christian, I'll hand it over to you for anything I missed there and then answering the first question. Speaker 600:31:34Thanks. Operator00:31:40Thank you. Our next question comes Speaker 200:31:42from Operator00:31:42the line. Speaker 200:31:43Sorry. Christian. Christian, are you there? Alex, did we lose Christian? Speaker 700:31:58His line is still muted. Operator00:31:59Yes, we can hear you, Christian. Speaker 200:32:06Christian, are you still there? Speaker 500:32:14Can you hear me? Speaker 200:32:16Yes. We can hear you now. Speaker 500:32:18All right. I'm not sure what's going on. I'll try again. So with regard to the interim readout in the second half of this year for ADAS 101, What you can expect to see is something quite similar, what we have disclosed for non human primates at JPMorgan earlier this year. So essentially what we'd like to see is a demonstration of sustained elevation of soluble TiVo1a in serum in humans after a single dose. Speaker 500:32:49And we'd like to see that in one cohort after a single dose administration. So that's an important de risking point. And I will just remind you that the competitor molecules that have claimed prolonged half life have to our knowledge not disclosed target engagement in non human primates. Hence, we think we are very well positioned to demonstrate that not only in human primates, but also in humans. Operator00:33:23Thank you. And our next question comes from the line of Gil Blum from Needham and Company. Your question please. Speaker 700:33:30Good afternoon and thanks for taking our questions. So one relating to the Plant Pharma partnership. So did some of the achievements you guys demonstrated binding to the Caldara region of HIV, did that play into your pharma discussions? And I have a follow-up. Speaker 200:33:54Yes. That case study was a has been a big driver in the discussions we're having with large pharma right now. And I think it's a really strong illustration of how we can go after these difficult targets that still exist. And we do believe that that case study is an important piece to the value prop and ultimately driving these large pharma partnerships across the finish line. Speaker 300:34:31Hey, Gil, this is Zach. If I might add to that too just to contextualize it. I think the other thing that we're excited about and we've seen resonate with the pharma companies we're dialoguing with is not only the results there, but if you look over the history of the versioning of our models, you can see the kind of dramatic performance and capability gains as we go from early versions back in 2022 to where we are today with the models that can address the Caldara epitope, for example. Speaker 700:35:03Okay. That's very helpful. And as it relates to this bispecific lead you mentioned for IVD, how what kind of dynamic should we imagine here with ABS-one hundred and one? I mean, there are other companies in the space that are really taking lead on this kind of combo approach. Is this what we're thinking of here or is this something really completely different? Speaker 700:35:34Thank you. Speaker 200:35:38Yes. Thanks, Gail. We do see this as different. But Christian, do you want to maybe talk a little bit about the biology and what we're trying to achieve with this particular bispecific? Speaker 500:35:51Yes, absolutely. So, yes, you're of course correct that there is competition that has announced to run combination studies. We think obviously this is quite interesting. We do think a bispecific can potentially provide additional value that will be more difficult to realize in the clinic in combination studies. So we haven't disclosed the target we're looking at specifically, but we do think there is potentially a strong synergy between Tier 1a and the other mechanism. Speaker 200:36:30Yes. And I will note this is not an IL-twenty three or an alpha-four beta-seven. This is a novel target. Again, that's been difficult to drug. And as a monotherapy, it definitely would be a first in class both as a monotherapy and as a bispecific. Speaker 700:36:53Great, very helpful. Thanks for taking our questions. Operator00:36:59Thank you. And our next question comes from the line of Brendan Smith from T. B. Cowen. Your question please. Speaker 900:37:07Hi. This is Jackie on for Brendan. Thanks for taking the questions. Maybe just touching back on your HIV program, could you remind us on how you plan on progressing that program and kind of how that works under the current partnership structure? And give me any additional color on when we might see updates on the progress regarding that program? Speaker 200:37:27Yes. So this is a collaboration that we have with Caltech and it's being funded by the Gates Foundation. And so we're going to continue to develop this molecule and at the appropriate time work with the Gates Foundation on taking this into the clinic, assuming the preclinical data looks good. And at that point in time, once we start to see some in vivo results, we should be able to come out with a plan on how we plan to develop this in collaboration with Caltech and the Gates Foundation. So stay tuned. Speaker 900:38:14That's great. And maybe just swinging over to more of the business side. Can you give us any update on how to kind of look at 2025, particularly around the expected ramp and spend from the study initiations and maybe anticipated cash burn rate? Speaker 200:38:30Yes, Zach, I'll let you take that. Speaker 300:38:33Yes, sure. So I think we to start off, just to note that we've reiterated our guidance that we have a balance sheet that will fund our strategy and operations into the first half of twenty twenty seven. So I think we're very well positioned to advance our Phase one studies for ABS-one hundred and one. And as we mentioned earlier, we'll have an interim readout on that trial in the second half of this year. And I think the other point which Sean mentioned earlier is we'll be accelerating the development plan for ABS-two zero one and that is within our budget. Speaker 300:39:08The plan there is to be able to initiate first and human studies early next year with the potential for an interim efficacy readout in 2026. So that's all part of our core strategic plan and I think we're capitalized to achieve that as well as advance some earlier stage programs that we're working on today. Speaker 900:39:30Great. Thank you. Speaker 500:39:32Thank Operator00:39:39you. Our next question comes from the line of Devan Chatterjee from Jones. Your question please. Speaker 1000:39:47Thanks for taking my question. So given the recent positive data from Sanofi and Piva's duvetic coding ulcerative colitis, like particularly the strong efficacy and low ADA rates in patients, how is Absahe positioning its anti TL1A assay to compete? To what extent does this raise the bar in terms of like clinical performance or commercial potential? Speaker 200:40:14Great question. Christian, do you want to take that? Speaker 500:40:18Yes. Great question. So we have obviously seen the Sanofi Teva data. It is indeed impressive data. However, it was interesting to observe that the inclusion exclusion criteria in that study was perhaps an aspect that makes it a little bit more difficult to compare this study with other data that's out there. Speaker 500:40:46In particular, there was a significant share of patients in the study. So that raises the question, to what extent can we expect similar data from other antibodies? The other interesting thing we believe with AGS-one hundred and one, there may be a potential to potentially dose higher than what we've seen with competitors. So this is an avenue we are exploring as well. So it remains to be seen whether in terms of the efficacy there is a ceiling effect or whether dosing higher can potentially lead to additional efficacy. Speaker 1000:41:29Okay. Thanks for that. Operator00:41:36Thank you. And our next question comes from the line of Shyamakanth from HCW. Your question please. Speaker 600:41:48Thank you. This is RK from H. C. Wainwright. Good afternoon, Sean and Zach and Alex. Speaker 600:41:56So a lot of my questions on the pipeline have been already asked. But in the time that you have spent generating this pipeline, how much of that the data that has allowed you to expand the pipeline, are you able to take it back into your model into your AI models and are able to strengthen it? And what sort of benefits are you seeing by developing this kind of a vast pipeline? And the second part of the question is, from your initial conversations with Mark way back in 2021, what sort of conversations happen now when you start working with potential partners? What's the evolution there? Speaker 200:42:58Yes. Great question. So to answer the first one, RK, we have a lab in the loop process. We're in a six week time period. We can go from data in our wet lab to training our models to validating that. Speaker 200:43:15And that occurs both on, as you mentioned, our own internal pipeline, but also in our partner programs. And so that lab in the blue process allows us to rapidly iterate on the design and the architectures of our models to continually improve them as well as being able to feed in new data for training, which is obviously helping us increase the overall accuracy and generalizability of these models. And we've made even since two, two point five years ago, we've made tremendous progress from being able to design the hcdr3 of an antibody to now being able to design an antibody where there was no known binder to difficult and challenging targets like the cold air region or ion channels. And we see again that lab in the loop process as really key to unlocking our ability to increase the generalizability and accuracy of our models. And that's really the reason why we've been able to achieve what we have today. Speaker 200:44:36And Zach, do you want to answer that second question? Speaker 300:44:40Yes, sure. I mean, it bridges up exactly what you were describing, Sean. RK, our discussions with pharma right now are really highly centered on the de novo design models that we have and the capabilities that we've advanced over the last year to two years. And so it's I think the big value proposition to Sean's point is sort of unlocking these targets that haven't been addressable with traditional antibody discovery technologies. And so that's a real central value proposition that we're actively exploring with pharma right now. Speaker 300:45:18There are some other interest points too around the ability to create novel pharmacology profiles, for example, pH dependent binding. There's definitely some interest in that aspect of what we're doing and some of the data we've put out at R and D Day, you can refer to. But back to Sean's point, I mean, the biggest emphasis here and I think the biggest value proposition is being able to use those de novo design models to address these targets where there's really known biology, but they just have not been addressable by traditional techniques. Speaker 600:45:55Thank you. Thank you both for taking the questions. Operator00:46:00Thank you.Read moreRemove AdsPowered by