Absci Q1 2025 Earnings Call Transcript

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Provided by Quartr
May 13, 2025

There are 13 speakers on the call.

Operator

Thank you for standing by and welcome to AbSci's First Quarter twenty twenty five Business Update and Financial and Operating Results Conference Call. At this time, all participants are in a listen only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. To remove yourself from the queue, you may press 11 again.

Operator

I would now like to hand the call over to Alex Kahn, VP, Finance, Investor Relations. Please go ahead.

Speaker 1

Thank you. Earlier today, ADSA released financial and operating results for the quarter ended 03/31/2025. If you haven't received this news release, or if you would 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 on Abseye's Investor Relations website at investors.abseye.com for at least ninety days after this call. Joining me today are Sean McLean, Abseye's Founder and CEO and Zach Jonasen, Chief Financial Officer and Chief Business Officer.

Speaker 1

Christian Stegman, Abseye's SVP 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 in the press release, Absa issued today and the documents and reports filed by Absa from time to time with Securities and Exchange Commission. Except as required by law, Absa 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 1

This conference call contains time sensitive information and is accurate only as of the live broadcast, 05/13/2025. With that, I'll turn the call over to Sean.

Speaker 2

Good afternoon, everyone. Thank you for joining our Q1 twenty twenty five business update call. Today marks a significant milestone for Abstai. We've initiated our first in human clinical trial for ABS one hundred one, officially making AbSci a clinical stage biotech company. It's incredible to see how far we've come in just a short time.

Speaker 2

About two and a half years ago, Andreas Busch, an experienced drug hunter, joined AbSci as our chief innovation officer. Under Andreas' leadership and with the talented team he assembled, we quickly leveraged our AI platform to create a robust pipeline of potential best in class and first in class therapeutics. Today, I'm proud to announce the start of our phase one clinical trial for ABS one hundred one, our potential best in class anti CL1A antibody. This randomized, double blind, placebo controlled trial of single ascending doses of ABS one hundred one will evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in approximately 40 healthy adult volunteers. The primary focus is safety and tolerability with PKPD and immunogenicity as secondary endpoints.

Speaker 2

We expect interim results later this year from this ongoing study in Australia. As a reminder, AVS one zero one is a potential best in class t l one a antibody demonstrating high affinity, potency, ability to bind both t l one a monomer and trimer, anticipated low mutagenicity, and high bioavailability shown in nonhuman primates. Additionally, it's formulated for convenient sub q administration with an anticipated dosing interval of eight to twelve weeks. Recent data indicates ADS-one hundred one may have a lower chance of developing anti drug antibodies in clinical settings compared to a competitor molecule with high clinical ADA rates. Our recent NHP studies confirm prolonged dose dependent target engagement with a clear ceiling effect.

Speaker 2

And ADS one hundred and one was well tolerated in a thirteen week GLP study in NHP. Interest from potential partners remained high for this program. Additionally, we are progressing on a bispecific program with a novel arm in conjunction with our p l one a antibody. We'll share more details on this program at a later date for competitive reasons. ABS one zero one exemplifies the power of our generative AI platform, demonstrating our capability to rapidly engineer therapeutics with precision.

Speaker 2

With a growing pipeline of AI designed antibodies, we're accelerating our mission of bringing better biologics to patients faster. Turning to ABS two zero one, our potential groundbreaking anti prolactin receptor antibody for androgenetic alopecia, commonly known as male and female pattern hair loss. This condition affects approximately eighty million adults in The US alone and hasn't seen significant therapeutic innovation in nearly thirty years. ABO-two zero one represents a potential new category of therapy offering durable, effective hair regrowth. We recently nominated a development candidate with strong preclinical evidence that we believe supports high potency, favorable safety, low immunogenicity, extended half life, and manufacturability.

Speaker 2

We believe ABS two zero one could offer significant improvements over current standard of care treatments like finasteride and minoxidil, known for their side effects and variable or limited efficacy. We've previously shown in preclinical models that ABF-two zero one outperformed minoxidil in hair regrowth. Today, we're pleased to share results from our recent NHP study confirming AVS-two zero one's extended half life and potential to translate into the dosing interval of every eight to twelve weeks in humans. The data also indicates excellent subcutaneous bioavailability of greater than ninety percent in NHPs. The observed PK profile is projected to result in substantial exposure in skin and hair follicles at clinically relevant doses.

Speaker 2

We believe ABS two zero one also supports high concentration formulation potential of greater than one hundred and fifty mgs per mil, facilitating patient convenience. We're advancing rapidly towards the clinic with guidance from a network of leading hair and dermatology experts. ABS201 continues IND enabling studies for the phase one trial expected in early twenty twenty six and interim efficacy data anticipated later that year. Given its potentially promising profile, defined development path, and large market, we plan to develop ABS two zero one internally through later stage clinical development and proof of concept to retain maximum value. We're also progressing on two other additional programs.

Speaker 2

AVS-three zero one, a potential first in class antibody targeting an undisclosed immune oncology target identified through our reverse immunology platform. Early data indicate potential broad applicability to squamous cell carcinomas and other indications. AVS five zero one, a potential best in class anti HER two antibody identified using our zero shot de novo AI models. These AI designed leads display novel epitope interactions, increased or equivalent affinity to trastuzumab in preclinical settings, efficacy against trastuzumab resistant xenograft tumor expressing wild type HER2, and good developability. Innovation is at the core of outside success, and we must constantly strive for improvement.

Speaker 2

Recent initiatives like the National Security Commission on Emerging Biotechnology Report support US leadership in biotech, aligning closely with our mission, a topic I spoke passionately about at the twenty twenty three US Senate AI Forum on Innovation. We were also encouraged by the FDA's recent proposal to reduce or eliminate certain animal tests for monoclonal antibodies, favoring advanced technologies like AI and bio simulation models. This roadmap fits squarely with our approach of using AI models to design and optimize antibodies for safety, specificity, and efficacy. For example, our AI models for naturalness introduced in our 2022 manuscript evaluate how closely an antibody resembles the natural immune repertoire and mitigates potential downstream developability and immunogenicity issues by prioritizing more natural antibody variants. As a leader in AI drug discovery, we are encouraged by this recent announcement from the FDA and look forward to next steps.

Speaker 2

In conclusion, AbFi remains committed to leading biotech innovation, harnessing AI to deliver life changing treatments. Thank you to our talented team, the dedicated unlimited at AppSci, whose hard work and dedication drive our mission each and every day. With that, I'll now turn the call over to Zach to walk through our partnerships, our outlook, and provide an update on our financials. Zach?

Speaker 3

Thanks. Thanks, Sean. As Sean mentioned, we continue to execute across all aspects of our business. This includes progressing our internal and partner programs, as well as advancing discussions with prospective new high quality partners. As our business development discussions remain robust, we continue to anticipate signing one or more drug creation partnerships, including with a large pharma company this year.

Speaker 3

We also plan to continue providing material updates when possible about ongoing internal and partner programs as they advance through development. As we think about the growing capabilities of our AI platform, we believe our greatest value proposition is designing novel and differentiated therapeutic assets that address unmet medical needs. Accordingly, in addition to leveraging our platform to reduce drug design timelines and costs, we are increasingly focused on applying the platform design therapeutics addressing disease targets for which legacy drug discovery approaches have been unsuccessful. The HIV Caldera case study, which we have shared previously, as well as recent successes in several of our partnerships, give us confidence in our ability to design therapeutics addressing challenging target classes, both in our own internal programs and in our partnerships. We are pleased to note a growing number of discussions with industry participants who recognize the potential unique value we can bring to drug creation collaborations.

Speaker 3

As Sean discussed earlier, we recently achieved a key milestone in our evolution as we officially became a clinical stage biotech with ABS one hundred one entering the clinic. We are also excited to see ABS two zero one, our hair regrowth program accelerating toward the clinic as we anticipate initiation of a first in human trial in early twenty twenty six. As a reminder, our business model is focused on out licensing or selling our internal programs and co developed programs following value inflection proof points. These potential transactions could occur as early as preclinical proof of concept or at much later stages. Along those lines, we continue to be engaged with multiple interested parties regarding a potential transaction for our ABS 101 PL1A program.

Speaker 3

Meanwhile, as Sean mentioned earlier, we see strong rationale to retain and develop our ABS201 androgenetic alopecia program through much later stages of development. This program offers a straightforward clinical development pathway, which includes objective endpoints and the potential for rapid clinical trial recruitment, as well as the potential to achieve a proof of concept in our phase one trial design. Turning now to our financials. Revenue in the first quarter was $1,200,000 as we continue to progress our partner programs. Research and development expenses were $16,400,000 for the three months ended 03/31/2025, as compared to $12,200,000 for the prior year period.

Speaker 3

This increase was primarily driven by advancement of our internal programs, including direct costs associated with external preclinical development and an increase in personnel and stock compensation expense. Selling, general and administrative expenses were $9,500,000 for the three months ended 03/31/2025, as compared to $8,700,000 for the prior year period. This increase was due to an increase in stock compensation expense. Turning to our balance sheet. We ended the quarter with $134,000,000 in cash, cash equivalents and short term investments as compared to $112,400,000 as of 12/31/2024.

Speaker 3

With this strong balance sheet and line of sight to multiple potential catalysts in the near term, we will continue to invest in our internal program portfolio, including supporting the acceleration of development for ABS201 androgenetic alopecia program and ensure that we maintain a strong healthy capital position while executing on the strategy. Overall, we continue to deepen our focus on high value proprietary internal programs by also seeking high quality co development and drug creation partnerships with industry leaders who bring synergistic expertise and technology. We believe that this strategy and balanced approach will provide the best return for our 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. And as a reminder, we see additional upside to this forecast through non dilutive cash inflows, which could come from potential new platform collaborations with large pharma and or an asset transaction around any of our wholly owned programs such as our ABS one hundred one TL1A asset.

Speaker 3

In sum, we are very pleased with our recent progress and are confident in our ability to execute across our portfolio of programs this year and beyond. With that, I'll turn

Speaker 4

it back to Sean.

Speaker 2

Thanks, Zach. Today is a deeply gratifying day, not just for me as a founder, but for all of Abzai and the dedicated limiters who bring our mission to life. Fourteen years ago, when we started this journey, we knew nothing would come easy. From the beginning, we relied on drive, tenacity, innovation, and perseverance, not just to survive, but to thrive in the space of uncertainty. As we complete our transition to a clinical stage company, I think back to those early days in the basement lab.

Speaker 2

Our mission hasn't changed to harness technology and science to improve the lives of patients everywhere. And today, I'm proud to see our continued execution bring us closer to that goal. Looking ahead, AVS-one hundred one is now in the clinic, and we expect to share interim data in the second half of this year. AVS-two zero one, our hair regrowth program, is also gaining momentum as it moves towards the clinic. We plan to begin first in human studies in early twenty twenty six with an interim efficacy readout expected later that year.

Speaker 2

Beyond our internal programs, and as Zach mentioned, we have a clear line of sight to bring one or more new large pharma partners into our growing ecosystem of collaborators this year. None of this would be possible without the incredible work of our end limiters. To everyone at AdSci, thank you for your continued dedication to our mission. With that, I'll turn the call back over to our operator to begin q and a. Operator?

Operator

Thank you. Our first question comes from the line of Arseny Sabasili of Guggenheim Securities. Please go ahead, Arseny.

Speaker 4

Hi. This is Arseny on for Vamil. Thank you for taking our questions, and congrats on all your progress. Regarding ABS 101, what are you hoping to see in the phase one top line in the second half of the year in terms of decay and immunogenicity endpoints, as well as any other metrics you may be looking at?

Speaker 2

Yeah, thanks, Arseni. First off, we're looking to see a really nice safety profile looking at immunogenicity. The second is looking at target engagement. We're hoping to see similar target engagement data as what we saw and presented at the JPMorgan Healthcare Conference earlier this year. And, Christian, is there anything else that you'd like to add in terms of what we'd like to see for ABS 101?

Speaker 5

Yeah, absolutely. We would like to, in addition to what Sean mentioned, we would like to validate the extended half life to really demonstrate that in humans we can potentially support dosing of every two months to every twelve weeks. And then as Sean mentioned, we will continue to observe and hopefully validate expected low immunogenicity, an overall good tolerability and safety profile, and then demonstrate target engagement as measured by the elevation of total soluble TLT1A. And note that the elevation of total soluble TLT1A will also be measured over an extended period of time, really then demonstrating not only extended half life in terms of the PK of the antibody, but also the pharmacodynamics, meaning we see an elevation of total soluble T1A over an extended period of time, really demonstrating target engagement and confirming the overall target product profile.

Speaker 4

Thank you. And one more, if I may, regarding two zero one. Obviously, it is the early days, but based on what you now know, do you think this product can potentially be self administered in the future?

Speaker 2

Yes. We do believe this can be self administered. Right now, though, we are working we we want to work with, dermatologists on being able to, make sure that this is effectively, administered. And so we we do think, over time, it could be self administered, but we do think working with the providers initially is likely the best route to go.

Speaker 4

Thank you.

Operator

Thank you. Our next question comes from the line of Brendan Smith of TD Cohen. Please go ahead, Brendan.

Speaker 6

Great. Thanks for taking the questions, guys. Congrats on all the progress. Maybe just a quick one from us on 02/2001. As you look at the data today and think about a potential clinical trial ahead, I guess, how are you thinking about potential market segmentation here?

Speaker 6

And I guess, maybe just among that 80,000,000 to 90,000,000 patient figure that I think you flagged in the past, I guess who among them do you think would maybe be lowest hanging fruit to target first and just kind of how you're thinking about that rollout?

Speaker 2

Zach and Christian, do you want to take that?

Speaker 3

Yeah, this is Zach. I'd be happy to. It's a great question, Brendan. We've spent a lot of time with our KOL network evaluating that. At this point, we think this mechanism could be efficacious in almost all of those segments for angiogenetic alopecia.

Speaker 3

So we are looking at a phase one trial design where we'll see some breadth in terms of age, both male and female. We'll put out more data around that trial design later this year. But as of today, just looking at the mechanism and the strong translational data, and including the human genetics that support safety, we don't see any particular segment of that population that could not be treated. But it's certainly something we're going to have to evaluate in the human clinical trial setting. Christian, don't know if you want to add anything.

Speaker 5

Yeah, great point, Zach. Not much to add. As you correctly pointed out, we will observe as we go into clinical development, how this product is best administered, how it is best served in different populations, and I think this will inform our commercialization strategy. I will flag that beyond androgenic alopecia, there is potential for this mechanism as well. So beyond the market segmentation in androgenic alopecia, it'll also be interesting to look in indications such as endometriosis where this mechanism has a potential, and we are actively exploring that as well.

Speaker 6

Got it, okay, great, thanks guys.

Operator

Thank you. Our next question comes from the line of Gil Blum of Needham and Company. Please go ahead,

Speaker 7

Good afternoon, everyone. And allow me to add my congrats to the progress here. So maybe a couple of questions on two zero one. Now that we have some, you know, pharmacokinetics from the nonhuman primate model, maybe kind of initial thoughts on the type of dosing you're going to first look at in humans and kind of as a follow on. So I remember the idea was to inject the compound to the target site.

Speaker 7

How much systemic exposure did you observe in the NHP model? Thank you.

Speaker 2

Christian, you want to take that?

Speaker 5

Yeah, so we will disclose the full pharmacokinetic data set at a later point in time at a scientific venue. I will say that we have, as we've shown, a very attractive pharmacokinetic profile in nonhuman primates. We think it is conducive based on the pharmacokineticpharmacodynamic modeling we've done to a dosing of every eight to twelve weeks, as Sean mentioned earlier. We think this is overall a very attractive profile, in particular for an aesthetic indication as androgenic alopecia, and we anticipate that this product will be dosed over a six month treatment period, so you could imagine that we can achieve this treatment regimen in just two or three doses. So we think that's attractive, and with regards to the total exposure, stay tuned, we will disclose the full data at a scientific venue at a later point in time.

Speaker 2

Thanks.

Speaker 5

Does that answer your question?

Operator

Yep. Thank you. Our next question comes from the line of Vikram Purahit of Morgan Stanley. Please go ahead, Vikram.

Speaker 8

Hi, everyone. This is Morgan on from Vikram. Thanks for taking our question. And, again, wanted to extend our congratulations on all the progress this quarter. Wanted to ask a quick question on ABS three zero one and when we can expect that development candidate to be shared.

Speaker 8

Thank you so much.

Speaker 2

Thanks, Morgan. We are continuing to advance it. We recently showed some recent target validation data last quarter, and we are still progressing towards a DC. We have not disclosed at this point in time when that DC will be ready, but we are doing in vivo validation or in vivo studies currently, and after that, be ready to nominate a drug candidate.

Speaker 8

Okay. Appreciate it. And then one last question on ABS two zero one, for that interim data readout, I know it's still very early days, but do you have a sense of what kind of data will be shared there and what could be expected based on what you're seeing right now?

Speaker 2

Yes. We are looking to have that be a interim proof of concept readout from both, potentially both from the SAD portion as well as the MAD portion of that study, which would be in the second half of this year. And as we get closer to that study, we will be disclosing more of the study design of that. But again, we do expect a potential efficacy readout in the second half of next year on that trial.

Speaker 8

Excellent. Thank you very much.

Operator

Thank you. Our next question comes from the line of George Farmer of Scotiabank. Your question please George.

Speaker 9

Hi, good afternoon. Thanks for taking my question. Sean, can you elaborate a little bit more on this combo strategy that you have with 101? That sounds pretty intriguing. And regarding the partnership that you have with AstraZeneca, I recall that there was a big milestone that you guys had hit with them.

Speaker 9

Can you give us an indication of like whether you might be getting any milestones in the near future, maybe just on a qualitative basis, how substantial those could be? And then number three, regarding five zero one, how do you see this drug fitting into the competitive landscape? It's pretty crowded area and how does this really differentiate? Thanks.

Speaker 2

Yeah. So first off on the combo, what we're seeing especially as we're engaging with large pharma on this, there is a push into combo based approaches. You're you're seeing J and J really lead the way on this. And and you're starting to just see also combo based approaches coming from AbbVie as well. And so we do think that t l one a combo based strategy is likely to help increase overall efficacy and durability.

Speaker 2

And that's a direction that potential partners are thinking of with regards to ABS 101. And then we also have a bispecific strategy with a novel arm. So it'd be TL1A with a novel arm. And this is not the typical IL-twenty three or alpha-four beta-seven arm. This is a novel target we are pursuing with that bispecific strategy.

Speaker 2

And I'll let Zach take the AZ question, and then Christian can take 501.

Speaker 3

Hi, George, it's Zach. Unfortunately, we can't give any specific commentary around any of those partnerships as you'll appreciate they're all under NDA provisions. I can share like more generally, I think we've mentioned publicly about some more recent successes in some of our other partnerships, including applying our platform to develop antibodies that actually effectively block an ion channel. That's been one of these targets that's been very challenging to address. So I can make some general comments like that, but I can't give you anything specific.

Speaker 5

This is Christian answering your question on ABS501. Yes, obviously you're correct. The HER2 space is indeed a very competitive space. We have currently ongoing a number of preclinical studies that would help us to position ABS five zero one in this space. Among them could also be combination approaches, and we are exploring actively where that potential niche is.

Speaker 5

These studies are currently ongoing, we may have a drug candidate this year, but potentially also next year, depending on the timing of the studies and the data as they emerge.

Speaker 9

Okay, thanks. And Sean, again, back to the combo approach, this bispecific that you're referring to, is this one of an in house bispecific that you're making, or is it somebody else's?

Speaker 2

This is an in house bispecific that we have developed. And so we're, in addition to that bispecific, we're also developing the other arm of this novel target, as well as a mono based therapy. But this is all developed in app side.

Speaker 9

Okay. Thanks.

Operator

Thank you. Our next question comes from the line of Kripa Devarakonda of Truist Securities. Please go ahead, Kripa.

Speaker 10

Hello, this is Alex on for Kripa. First, congrats on the progress on becoming commercial stage. That's fantastic. And question from our side, as the assets continue in development, ABS 101 and ABS two zero two, as they progress, is there also an updated sentiment on how you think about future partnerships? Namely, do you think you can command improved economics?

Speaker 10

Is there any change to that? Or any key differences that you see how your business might evolve given the success in the clinic? And then another one from us on your cost structure, could you speak to how flexible it is with fixed and variable costs and namely as many people are concerned about the state of the markets, biotech markets specifically at the moment, are you able to run any more leanly if you need to? Thanks.

Speaker 2

Yeah, thanks Alex. I'll let Zach take both those questions.

Speaker 3

Hey, Alex. Great questions. In terms of the platform and the kind of deal terms that we think we'll see in the future and going forward, I would answer your question by saying yes, but due to two reasons. I mean, we do hope to see enhanced deal terms certainly with some success with ABS 101 and that interim data readout. I think that's an important milestone for the company and helps provide additional validation of the platform.

Speaker 3

But the other really exciting developments on the platform is that now that we're in version three of our models moving into version four, we've shown an ability to address these very challenging target classes. And as an example, that is the HIV caldera case study that we've put out publicly at the end of last year, but also more recently some successes in various partnerships that we have ongoing. And so we feel like that is a really significant value proposition that differentiates us from many other players really in the field. And so we're seeing a lot of engagement from pharma around how they can potentially leverage our platform to address some of these targets that they've struggled with. So we're looking forward to advancing these discussions and negotiations over the next year to see what kind of terms we can reach on drug creation partnerships.

Speaker 3

But we do expect to see them increase materially versus what we've done in prior years. And then on your question pertaining to cost structure, I would say, you know, we continually look for ways to leverage more efficiencies out of the AI platform. And I just mentioned we've made some advances there and we continue to make advances year on year really on a quarterly basis with the platform. So we do see opportunities to reallocate resourcing and also to reduce certain areas of resourcing as we leverage more and more of our AI capability. And that's an ongoing process that we evaluate each and every quarter.

Speaker 2

Thank you.

Operator

Thank you. Our next question comes from the line of Chatterjee of Jones. Your question please, Dibhanjana.

Speaker 11

Hi. Thanks for taking my question. So I have two. The first one is that assuming that you see optimal results as you expect in the phase one readout for ABS 101. As you think about the phase two, will the study include both open level and randomized arms similar to the design in one of the competitor trials?

Speaker 2

Thanks. That's a great question. At this time, we have not disclosed what the Phase 1b2a is going to look like. As the interim data comes out, we'll be sharing more information on what those studies are gonna be looking like in the future.

Speaker 11

Okay. Great. And one follow-up. So this is broader. As the FDA shifts towards minimizing animal use for safety testing and emphasizes AI based safety predictions, can you leverage Upside's Data First AI driven platform to model toxicity and predict safety?

Speaker 11

And is AppSight better positioned than its non AI driven peers to navigate this shift?

Speaker 2

Yes. Absolutely. We're really excited to see the FDA wanting to leverage AI models to help reduce toxicity and immunogenicity. And as we mentioned on the call, one of the models that we've developed that we released in 2022 was our naturalness model, being able to ensure that antibodies are as human like as possible. And we see this as a big advantage for us moving forward, in particular, and being able to reduce overall immunogenicity and ensure favorable developability and manufacturability, but also helping to align with the FDA on where they're going.

Speaker 2

And so we see this definitely as a big advantage for us moving forward. And Christian, please add anything else.

Speaker 5

Yeah, very well said, Sean. Indeed, I think the developments at administration are very exciting for us. We will continue to engage and continue to follow the FDA's process and advisory relationships to observe what the next steps are. These things will usually also result in revised global, globally harmonized guidelines, and this is indeed a very exciting opportunity as these efforts towards reducing usage of animals are taking, these measures are taking place, we will see a much more broad adoption of AI models, and clearly this is a very interesting opportunity for AppSci.

Speaker 11

Okay, that's very helpful, thank you.

Operator

Thank you. Our next question comes from the line of Lee Chen of H. C. Wainwright. Your question, please, Lee.

Speaker 12

Hello. Hello, everyone. Congratulations on the quarter. So to extend the t l one a questions a little bit, so can you give us some understanding of the strategy behind going after the novel target of the bispecific instead of your competitor strategy of going for the clinical approved targets? So, what's the advantage of this novel target?

Speaker 2

Yeah, thank you, Li Chen. So this is a known target with known biology. It's been difficult to drug both from an antibody standpoint as well as a small molecule. And we have figured out a way to drug it with an antibody. And we do think that it has really strong synergy with our TL1A asset, and I'll hand it over to Christian to maybe go in a little bit more depth on some of the biology.

Speaker 5

Yes, 100%. So this target, as Sean mentioned, have not disclosed this target, so we have to tread a little bit lightly in terms of what I can tell you in terms of the details here, but what I can say that just like tier 1A, the mechanism is a pro inflammatory mechanism that is clinically highly relevant in autoimmune diseases, hence we believe there's a very good rationale for combining it with an anti TIAA antibody. As Jean mentioned, we are actively working on a bispecific on this combination, and we think this particular combination could indeed be very differentiating from other combinations that others are pursuing, for example, what is already out there, tier one A alpha four beta seven or tier one A IL-twenty three, we thought rather than following these paths that others have already taken, we're exploring a novel combination here with a difficult to drug target, at least historically, and thereby potentially really have a very differentiated and potentially highly efficacious bispecific antibody in our hands.

Speaker 12

Got it, thanks for the color. And if I may, a quick follow-up. So based, for example, when should we expect to see some gono go decision about prioritizing the monomeric TR1A versus the bispecific?

Speaker 2

So at this point in time, we are planning on pursuing both of these assets. In terms of partners, partners are both interested in the TL1A monotherapy as well as the bispecific. And so we, again, continue to develop both of these in parallel and see value in both of those. I think it's important to have both of these from a partnering perspective as well.

Speaker 12

Okay. Thanks for taking my questions.

Operator

Thank you. That does end our Q and A session and concludes today's conference call. Thank you for participating. You may now disconnect.

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Key Takeaways

  • AbSci has become a clinical-stage biotech by initiating its first-in-human Phase 1 trial of ABS-101, a potential best-in-class anti-TL1A antibody in ~40 healthy volunteers, with safety, tolerability, PK/PD and immunogenicity readouts and interim data expected later this year.
  • ABS-201, an anti-prolactin receptor antibody for androgenetic alopecia, has a nominated development candidate with preclinical data showing high potency, extended half-life, >90% subcutaneous bioavailability and an anticipated 8–12-week dosing interval; IND-enabling studies are under way with Phase 1 planned for early 2026 and interim efficacy data in late 2026.
  • The company’s AI platform has also generated additional pipeline assets including ABS-301 (a first-in-class immuno-oncology antibody) and ABS-501 (an anti-HER2 antibody active in trastuzumab-resistant models), highlighting its ability to tackle challenging targets and attract potential partnerships.
  • Business development discussions remain robust, with expectations to sign at least one large-pharma drug creation partnership this year; AbSci plans to out-license most assets at key proof-of-concept milestones while retaining ABS-201 through later clinical stages to maximize value.
  • In Q1 2025, AbSci reported $1.2 million in revenue, $16.4 million in R&D expenses and ended the quarter with $134 million in cash and investments, providing a runway into H1 2027 and potential non-dilutive inflows from collaborations or asset transactions.
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Earnings Conference Call
Absci Q1 2025
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