Absci - Earnings Call - Q4 2024

Executive Summary

• Absci’s Q4 2024 delivered modest partner revenue growth with a wider YoY operating loss as the company accelerated pipeline spend; cash/short-term investments ended at $112.4M with runway into 1H 2027. The quarter’s operational focus: preparing ABS-101 (anti‑TL1A) for Phase 1 in 1H 2025 and advancing ABS-201 (anti‑PRLR for androgenic alopecia) toward Phase 1 in early 2026.
• Strategic developments included a new AMD collaboration with a $20M equity investment; combined with ~$20M raised via ATM in early 2025, this adds ~$40M incremental capital to fund internal programs and speeds AI compute throughput for drug design.
• Management shifted disclosure: it will no longer guide to a target count of new partnerships and will instead provide material program updates; it still anticipates one or more new partnerships in 2025 including a Large Pharma platform deal.
• Key potential stock reaction catalysts near term: ABS-101 Phase 1 initiation and 2H 2025 interim readout; ABS-201 clinical initiation (early 2026) in a large, consumer-driven market; and a prospective Large Pharma platform agreement.

What Went Well and What Went Wrong

What Went Well

• AMD strategic collaboration and $20M equity investment bolstered compute capacity and provided nondilutive-like capital at a premium; management emphasized training resolution, accelerated throughput, and cost efficiency from the partnership.
• Pipeline momentum: ABS-101 on track for Phase 1 in 1H 2025 with interim data in 2H 2025; ABS‑201 development candidate nominated (anti‑PRLR) targeting androgenic alopecia with Phase 1 planned for early 2026.
• Cash discipline: FY2024 gross cash use (~$72M) came in better than the latest ~$75M outlook, and runway remains into 1H 2027, reducing near-term financing risk.

What Went Wrong

• Revenue base remains very small, underscoring reliance on external milestones and future partnership economics (Q4 revenue $0.665M).
• Operating losses widened YoY as R&D investment ramped for internal programs (Q4 R&D $18.4M vs. $12.3M YoY; Q4 net loss $29.0M vs. $23.5M YoY).
• Management moved away from partner-count guidance; while strategically sound, it reduces near-term visibility on external deal flow cadence, a prior focus for investors.

Transcript

Operator (participant)

Thank you for standing by, and welcome to Absci's fourth quarter and full year 2024 business update and financial operating results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during this session, you'll need to press star 11 on your telephone. If your question has been answered and you'd like to remove yourself from the queue, simply press star 11 again. As a reminder, today's program is being recorded. Now I'd like to introduce your host for today's program, Alex Khan, Vice President of Finance and Investor Relations.

Alex Khan (VP of Finance and Investor Relations)

Thank you. Earlier today, Absci released financial and operating results for the quarter and year ended December 31, 2024. If you have not received this news release, or if you would like to be added to the company's distribution list, please send an email to [email protected]. An archived webcast of this call will be available for replay at Absci's Investor Relations website at investors.absci.com for at least 90 days after this call. Joining me today are Sean McClain, Absci's founder and CEO, and Zach Jonasson, Chief Financial Officer and Chief Business Officer. Christian Stegmann, Absci's SVP of Drug Creation, will also join for Q&A following prepared remarks. Before we begin, I would 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 in 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. This conference call contains time-sensitive information and is accurate only as of the live broadcast, March 18, 2025. With that, I'll turn the call over to Sean.

Sean McClain (Founder and CEO)

Thanks, 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. We capped the year off with our 2024 R&D Day in December, where we unveiled our potentially category-defining ABS-201 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-101, our anti-TL1A program, and preclinical data for ABS-301 and ABS-501 programs. Additionally, we showcased new breakthroughs in de novo antibody design from our leading AI platform and hosted distinguished guest presenters, including our KOLs.

And partners such as Dr. Dennis Slamon from UCLA and Dr. Luis Diaz from Memorial Sloan Kettering. For those who did not view the webcast, I encourage you to access the replay on our website. ABS-201, in particular, is an asset we are extremely excited about. We see the opportunity for ABS-201 to become a potential flagship asset for Absci. 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. Similar 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 preprint.

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. At 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 million strategic investment in Absci. This collaboration supports our mission of creating better biologics faster by offering optimized compute solutions for complex biological modeling.

These 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 silico antibody design and evaluation, and ultimately reducing R&D timelines and costs. Stepping back, what's the broader purpose of harnessing generative AI for antibody design? It'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 Caldera region, potentially facilitating the development of a universal neutralizing HIV antibody. The Caldera region, uniquely accessible only in the gp120 open conformation, 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. We're also actively applying our generative AI drug creation capabilities to our proprietary internal pipeline. In December, we unveiled ABS-201, a potential best-in-class antiprolactin receptor antibody for androgenic alopecia. This is an indication with significant unmet need and a large patient population, approximately 80 million people in the U.S. alone. Androgenic alopecia, also known as male and female pattern hair loss, affects 50% of men and 40% of women by the age of 50.

There's been no real innovation in nearly 30 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-201, supported by preclinical data suggesting high affinity 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. As we advance ABS-201, we envision a straightforward path to clinical development and have assembled a robust network of renowned hair and dermatology KOLs advising our progress. ABS-201 is currently in IND-enabling studies, with phase I trials anticipated to begin in early 2026. Since unveiling ABS-201 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-201 internally through later-stage clinical development and proof of concept, retaining maximum value for Absci. Turning now to ABS-101, our potential best-in-class anti-TL1A antibody. At December's R&D Day, we shared new data indicating ABS-101 shows reduced internalization of TL1A complexes in in vitro THP1 immunogenicity tests compared to competitor molecules that had high clinical ADA rates. These data suggest ABS-101 may have lower ADA development risk in clinical settings. Additionally, in January, we shared new ABS-101 NHP PK/PD 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 I clinical studies for ABS-101 in the first half of 2025, 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. Additional data will be provided later. We recently shared data on ABS-301 and ABS-501 programs as well. ABS-301, 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 ABS-501, 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. Earlier, 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 Zach to walk through our new partnerships, our outlook, and financial updates. Zach.

Zach Jonasson (CFO and Chief Business Officer)

Thanks, 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 Owkin and Invetx in December. Our collaboration with Owkin combines Owkin'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 Owkin plan to co-develop therapeutic candidates addressing novel targets in immuno-oncology and other indications, such as immunology and inflammation. The partnership will leverage Owkin's predictive AI models and its biomedical data sets 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 Invetx 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. Invetx will have rights to use the HLE sequences across its product portfolio to enhance duration of therapeutic effect and customer convenience, both significant potential differentiators in the animal health market. This partnership includes R&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. Moreover, 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.

Hence, 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 partnered programs as they advance through development. We will also very soon be a clinical stage biotech company, with ABS-101 expected to enter the clinic shortly and ABS-201 accelerating toward first-in-human clinical trials potentially early next year.

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. Turning now to our financials, revenue in the fourth quarter was $0.7 million as we continue to progress our partner programs. Research and development expenses were $18.4 million for the three months ended December 31, 2024, as compared to $12.3 million 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-101 and the increase in stock compensation expense. Selling, general and administrative expenses were $8.8 million for the three months ending December 31st, 2024, as compared to $9.3 million for the prior year period.

This 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 million, below our outlook of $75 million on a gross basis. Turning to our balance sheet, we ended the year with $112.4 million in cash, cash equivalents, and short-term investments, as compared to $127.1 million as of September 30, 2024. In January of this year, we announced a new strategic collaboration with AMD. As part of that collaboration, AMD made a $20 million equity spend in Absci, purchasing Absci Common Shares at a price representing an approximate 14% premium to Absci's share price based on the prior day's market closing price.

Further, this year, we have also raised an additional approximately $20 million by utilizing our at-the-market facility, the vast majority of which was raised from two premier mutual funds. This additional approximately $40 million raised since the end of 2024 enables us to continue investing in our internal programs, including accelerating the development of ABS-201, 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 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 2027.

In 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.

Sean McClain (Founder and CEO)

Thanks, Zach. In closing, we've made tremendous recent progress across our platform and internal pipelines. New data for ABS-101 reinforces its best-in-class potential, and ABS-201 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-101 enters the clinic. As we also advance ABS-201 towards the clinic, we're energized by the potential to bring this innovative product to roughly 80 million people affected in the U.S.. 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 innovators at Absci, who advance our mission each and every day. Thank you all. I'll now turn the call back to the operator for Q&A.

Operator?

Operator (participant)

Certainly. Our first question for today comes from the line of Kripa Devarakonda from Truist Securities. Your question, please.

Hi, this is Alex on for Kripa. Congrats on all the progress. Looking forward to another exciting year with Absci. We had a couple of questions on our end. One, for ABS-101, we saw compelling preclinical data last year at your R&D Day. We know as we wait for the clinical trial to get underway now and the phase one data later this year, does Absci plan to conduct additional preclinical studies with ABS-101, and would investors get to see that, and maybe also with ABS-201 as well, if there are preclinical studies underway and plans to present that in a 2025 timeframe? Thanks.

Sean McClain (Founder and CEO)

Yeah, great question, Alex. Christian, do you want to take that?

Christian Stegmann (SVP of Drug Creation)

Sure, happy to. Regarding ABS-101, we have disclosed at R&D Day a novel preclinical data. At JPMorgan, we have also disclosed target engagement data in non-human primates for ABS-101, and we are essentially wrapping up our IND-enabling work currently. We will disclose at a scientific conference the full toxicology data, but we are proceeding towards clinical development, as mentioned. For ABS-201, we are in the IND-enabling phase, and we will disclose data in the course of this work, also preferably at a scientific conference that's upcoming.

Sean McClain (Founder and CEO)

Yeah, no, I think.

Okay, great.

I was just going to say, on ABS-201, we have accelerated our timeline on that. We do plan to be in the clinic in early 2026 with a potential interim efficacy readout next year on ABS-201. We will have 101 in the clinic later this year, followed by 201.

Oh, that's great. 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 partnered programs. Any additional color you can provide on the partnered program updates, what that might look like, given that other people might be taking the lead as part of your contracts over there. Obviously, very interested in all that development for investors and for us.

Yeah, absolutely. We're really focused on the large pharma partnership. We plan to execute one new large pharma platform deal this year. Additionally, we are in discussions on ABS-101 on potentially out-licensing that asset. 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. 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. Zach, is there anything else you would like to add there?

Zach Jonasson (CFO and Chief Business Officer)

Yeah, 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 co-dev 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. 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 co-devs in there as well, I think gives us quite a bit of guidance to provide around those. That'll be our focus going forward.

Fantastic. Thank you all.

Operator (participant)

Thank you. Our next question comes from the line of Arseniy Shabashvili. Your question, please, from Guggenheim.

Arseniy Shabashvili (Analyst)

Hi, Arseniy, [inaudible]. Congrats on all the progress in 2024. We had a question on 201. Given the data that you've seen preclinically, how are you thinking about the design and endpoints for the planned phase one study?

Sean McClain (Founder and CEO)

Yeah, that's a great question. I can speak a little bit to the design and hand it over to Christian for the endpoints. 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. All that will be beginning next year. Christian, do you want to speak to the endpoints that we're going to be looking at?

Christian Stegmann (SVP of Drug Creation)

Yeah, absolutely. Great question. When it comes to androgenic alopecia, there is a number of well-accepted endpoints described. Importantly, they can all be measured with a very well-established device, the TrichoScan device. These endpoints have also been accepted by regulators. This is a non-invasive computer-assisted optical measurement of hair density, terminal hair count. It allows us essentially to progress this program very effectively through clinical development.

Arseniy Shabashvili (Analyst)

Thank you. Very helpful. Maybe one more on the large pharma partnership that you're hoping to secure in 2025. Can you share maybe just at a high level which therapeutic areas and modalities these discussions are focusing on, maybe what companies are interested in, and maybe where they recognize your capabilities and your expertise?

Sean McClain (Founder and CEO)

Yeah. I would say that the focus is pretty broad in terms of overall indication. I think some of the focuses are definitely on I&I and oncology. I would say more generally, where the focus lies and what's really driving these platform partnerships is the de novo model's 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. I think what we're seeing is that there's a lot of interest in ion channels, like the ones that we're working on with Almirall or various GPCRs, where there's been difficulty drugging these. The indications have been pretty broad in terms of overall interest. Zach, did I miss anything there? Do you want to add?

No, I mean, the only one thing I would add, Arseniy, is you can think of the partnerships we're working on or working towards with large pharmas being multi-target. To Sean's point, they could span multiple indications.

Arseniy Shabashvili (Analyst)

Thank you.

Operator (participant)

Thank you. Our next question comes from the line of Vikram Purohit from Morgan Stanley. Your question, please.

Vikram Purohit (Analyst)

Hi. 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. I was just curious to see any updated thoughts you might have around the size of the dataset, the scope of the dataset we'll be receiving, and just your current view on what you would consider a really strong outcome here. 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 101, or would that be a separate effort you want to hold on to for a longer time point. Thanks.

Sean McClain (Founder and CEO)

Yeah, thanks, Vikram. I can answer your second one and hand the first question over to Christian. 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. We see this as an exciting potential first-in-class TL1A bispecific, but additionally developing it out as a monotherapy as well. We plan to have a lead on that this year and then a DC to follow shortly thereafter. We do see this as, I think, an exciting evolution of the I&I pipeline that we're building out. 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.

Operator (participant)

Thank you. Our next question comes from the line.

Sean McClain (Founder and CEO)

Sorry.

Operator (participant)

Oh, sorry.

Sean McClain (Founder and CEO)

Sorry, Christian. Christian, are you there? Alex, did we lose Christian?

Alex Khan (VP of Finance and Investor Relations)

His line is getting...

Christian Stegmann (SVP of Drug Creation)

Hello.

Alex Khan (VP of Finance and Investor Relations)

Yes, we can hear you, Christian.

Sean McClain (Founder and CEO)

Christian, are you still there?

Christian Stegmann (SVP of Drug Creation)

Can you hear me?

Sean McClain (Founder and CEO)

Yeah, we can hear you now.

Christian Stegmann (SVP of Drug Creation)

All right. I'm not sure what's going on. I'll try again. With regard to the interim readout in the second half of this year for ABS-101, what you can expect to see is something quite similar to what we have disclosed for non-human primates at JPMorgan earlier this year. Essentially, what we'd like to see is a demonstration of sustained elevation of soluble TL1A in serum in humans after a single dose. We'd like to see that in one cohort after a single dose administration. That's an important de-risking point. 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 non-human primates, but also in humans.

Operator (participant)

Thank you. Our next question comes from the line of Gil Blum from Needham & Company. Your question, please.

Gil Blum (Analyst)

Good afternoon, and thanks for taking our questions. One relating to the planned pharma partnership. Did some of the achievements that you guys demonstrated binding to the Caldera region of HIV, did that play into your pharma discussions? I have a follow-up.

Sean McClain (Founder and CEO)

Yes, that case study has been a big driver in the discussions we're having with large pharma right now. I think it's a really strong illustration of how we can go after these difficult targets that still exist. 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.

Zach Jonasson (CFO and Chief Business Officer)

Thank you. This is Zach. 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 Caldera epitope, for example.

Gil Blum (Analyst)

Okay. That's very helpful. As it relates to this bispecific lead you mentioned for IBD, what kind of dynamic should we imagine here with ABS-101? 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? Thank you.

Sean McClain (Founder and CEO)

Yeah. Thanks, Gil. We do see this as different. Christian, do you want to maybe talk a little bit about the biology and what we're trying to achieve with this particular bispecific?

Christian Stegmann (SVP of Drug Creation)

Yeah, absolutely. Yeah, you're of course correct. 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. We haven't disclosed the target we're looking at specifically, but we do think there is potentially a strong synergy between TL1A and the other mechanism.

Sean McClain (Founder and CEO)

Yeah. I will note this is not an IL-23 or an alpha4beta7. This is a novel target. Again, that's been difficult to drug. As a monotherapy, it definitely would be a first-in-class, both as a monotherapy and as a bispecific.

Gil Blum (Analyst)

Great. Very helpful. Thanks for taking our questions.

Operator (participant)

Thank you. Our next question comes from the line of Brendan Smith from TD Cowen. Your question, please.

Hi, this is Jacky, 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? Do you have any additional color on when we might see updates on the progress regarding that program?

Sean McClain (Founder and CEO)

Yeah. This is a collaboration that we have with Caltech, and it's being funded by the Gates Foundation. 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. 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. Stay tuned.

That's great. 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 in spend from the study initiations and maybe anticipated cash burn rate?

Yeah, Zach, I'll let you take that.

Zach Jonasson (CFO and Chief Business Officer)

Yeah, sure. I think to start off, just to note that we've reiterated our guidance that we have a balance sheet that'll fund our strategy and operations into the first half of 2027. I think we're very well positioned to advance our phase I studies for ABS-101. As we mentioned earlier, we'll have an interim readout on that trial in the second half of this year. I think the other point, which Sean mentioned earlier, is we'll be accelerating the development plan for ABS-201, and that is within our budget. The plan there is to be able to initiate first-in-human studies early next year with the potential for an interim efficacy readout in 2026. That's all part of our core strategic plan. I think we're capitalized to achieve that as well as advance some earlier stage programs that we're working on today.

Great. Thank you.

Operator (participant)

Thank you. As a reminder, ladies and gentlemen, if you do have a question at this time, please press star one one on your telephone. Our next question comes from the line of Devanjana Chatterjee from Jones. Your question, please.

Debanjana Chatterjee (Senior Analyst)

Thanks for taking my question. Given the recent positive data from Sanofi and Pfizer's duvakitug in ulcerative colitis, particularly the strong efficacy and low ADA rates in patients, how is Absci positioning its anti-TL1A asset to compete? To what extent does this raise the bar in terms of clinical performance or commercial potential?

Sean McClain (Founder and CEO)

Great question. Christian, do you want to take that?

Christian Stegmann (SVP of Drug Creation)

Yes. Great question. 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. In particular, there was a significant share of patients in the study. That raises the question, to what extent can we expect similar data from other antibodies? The other interesting thing, we believe with ABS-101, there may be a potential to potentially dose higher than what we've seen with competitors. This is an avenue we are exploring as well. 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.

Debanjana Chatterjee (Senior Analyst)

Okay. Thanks for that.

Operator (participant)

Thank you. Our next question comes from the line of Swayampakula Ramakanth from HCW. Your question, please.

Thank you. This is RK from HC Wainwright. Good afternoon, Sean and Zach and Alex. A lot of the questions on the pipeline have been already asked. In the time that you have spent generating this pipeline, how much of the data that has allowed you to expand the pipeline are you able to take back into your model, into your AI models, and are able to strengthen it? What sort of benefits are you seeing by developing this kind of a vast pipeline? The second part of the question is, from your initial conversations with Merck way back in 2021, what sort of conversations happen now when you start working with potential partners? What is the evolution there?

Sean McClain (Founder and CEO)

Yeah, great question. To answer the first one, RK, we have a lab-in-the-loop process. We are in a six-week time period. We can go from data in our wet lab to training our models to validating that. That occurs both on, as you mentioned, our own internal pipeline, but also in our partner programs. That lab-in-the-loop 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.

We have made, even since two and a half years ago, 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 Caldera region or ion channels. 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. That is really the reason why we have been able to achieve what we have today. Zach, do you want to answer that second question?

Zach Jonasson (CFO and Chief Business Officer)

Yeah, 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. 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. That is a real central value proposition that we're actively exploring with pharma right now. There 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&D Day you can refer to.

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.

Thank you. Thank you both for taking the questions.

Operator (participant)

Thank you.