ABSI
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Earnings documents stored for ABSI.
Investor releaseQuarter not tagged2026-05-08Absci Q1 Earnings Call Highlights
MarketBeat
Absci Q1 Earnings Call Highlights
Interested in Absci Corporation? Here are five stocks we like better. ABS-201 is advancing in a Phase I/IIa trial with favorable early safety and PK signals and milestone timing of blinded SAD data in June 2026, an interim 13-week proof-of-concept in H2 2026, and a full 26-week POC in early 2027 as the company positions it as a potential new category for durable hair regrowth with infrequent injections. Absci disclosed a second prolactin-receptor program, ABS-202 for an immunology/inflammation indication while formally deprioritizing oncology programs (ABS-301/ABS-501) to concentrate resources on ABS-201 and I&I opportunities. Financially, Absci reported Q1 cash of $125.7M, increased R&D spend, and expects runway into the first half of 2028 while pursuing non-dilutive deals and AI-driven efficiency gains to extend resources. 2 Reasons Absci Could Be the Future of AI Biotech, and 1 Risk Absci (NASDAQ:ABSI) executives on Wednesday outlined a “data-rich” 2026 anchored by multiple clinical updates for ABS-201, the company’s anti-prolactin receptor antibody being studied in androgenetic alopecia (AGA), and plans to expand a broader prolactin-focused pipeline with a newly disclosed program, ABS-202. Sean McClain, Absci’s founder and CEO, said the company is positioning ABS-201 as a targeted biologic intended to deliver durable hair regrowth “from a few injections,” rather than competing directly with minoxidil. “We’re aiming to create a new category of hair regrowth therapy,” McClain said, adding that if successful, ABS-201 could represent “the first new mechanism of action in androgenetic alopecia in nearly 3 decades.” → Berkshire Hathaway’s Record Cash Hoard: Why and What's Next? Which Healthcare Stock Is the Best Buy Right Now? Ransi Somaratne, chief medical officer, said Absci’s ongoing phase I/IIa “headline” trial of ABS-201 is “progressing well and tracking according to plan.” The randomized, double-blind, placebo-controlled study is designed with a primary endpoint of safety and tolerability and secondary endpoints that include pharmacokinetics (PK), pharmacodynamics, immunogenicity, and multiple hair-related measures such as target area hair count and width, as well as darkening/pigmentation. Patient-reported outcomes are also being collected, Somaratne said. Somaratne said the company has completed dosing in all four planned healthy volunteer single ascen...
Investor releaseQuarter not tagged2026-05-08Absci (ABSI) Q1 2026 Earnings Call Transcript
Motley Fool
Absci (ABSI) Q1 2026 Earnings Call Transcript
Image source: The Motley Fool. May 7, 2026 at 4:30 p.m. ET Founder and Chief Executive Officer — Sean McClain Chief Financial Officer and Chief Business Officer — Zach Jonasson Chief Medical Officer — Ronti Somerotne Vice President, Investor Relations — Alex Khan Alex Khan: Absci Corporation released financial and operating results for the quarter ended 03/31/2026. 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 investorsasci.com. An archived webcast of this call will be available for replay on Absci Corporation's Investor Relations website at investors.avsci.com for at least 90 days after this call. Joining me today are Sean McClain, Absci Corporation's Founder and CEO; Zach Jonasson, Chief Financial Officer and Chief Business Officer; and Ronti Somerotne, Chief Medical Officer. Before we begin, I would like to remind you that management will make statements during the call that are forward-looking within the meaning of the federal securities laws. These statements involve material risks and uncertainties that could cause results or events to materially differ from those anticipated, and you should not place undue reliance on forward-looking statements. These include statements regarding the development and clinical progress of our pipeline programs, including ABS-201; the design, enrollment, product, and timelines of our ongoing Phase 1/2a headline trial of ABS-201 in androgenic alopecia; anticipated timing of interim proof-of-concept data readout for ABS-201 in 2026; the potential advancement of ABS-201 into Phase 3 development; anticipated initiation of a Phase 2 clinical trial of ABS-201 for endometriosis in 2026, and a potential proof-of-concept readout in 2027; the anticipated characteristics and product profile of ABS-201 as a drug product; our target product profile and its attributes; the potential for an expedited development pathway, including the possibility of advancing directly from Phase 1/2a into Phase 3; our plan to engage with the FDA regarding development strategy; and the potential market opportunity and commercial prospects for ABS-201. Certain statements may also include projections regarding potential market opportunity. These estimates are based on various assumptions, including potential regulatory approval, the final approved label, and the evo...
Investor releaseQuarter not tagged2026-05-08Absci Reports Business Updates and First Quarter 2026 Financial and Operating Results
GlobeNewswire
Absci Reports Business Updates and First Quarter 2026 Financial and Operating Results
Successfully dosed all four planned healthy volunteer SAD cohorts of ongoing ABS-201™ HEADLINE trial; well-tolerated with favorable emerging safety data Preliminary pharmacokinetic (PK) modeling from HEADLINE trial supports ABS-201's targeted dosing interval Initiated dosing of first MAD cohort of AGA participants of ongoing ABS-201™ HEADLINE trial Expanding prolactin program portfolio with addition of ABS-202 to internal pipeline VANCOUVER, Wash. and NEW YORK, May 07, 2026 (GLOBE NEWSWIRE) -- Absci Corporation (Nasdaq: ABSI), a clinical-stage biopharmaceutical company advancing breakthrough therapeutics designed with generative AI, today reported financial and operating results for the quarter ended March 31, 2026. “2026 is going to be a data-rich year for Absci with multiple readouts ahead,” said Sean McClain, Founder and CEO. “ABS-201, our AI-designed long-acting antibody against the prolactin receptor, has the potential to be the first new mechanism of action in androgenetic alopecia in nearly three decades, with a targeted dosing interval of just a few times a year. ABS-202, announced today, extends our prolactin work into a third therapeutic area. We're combining Origin with the prolactin biology we've built to go after a target that has been overlooked.” Recent Highlights Successfully dosed all four planned healthy volunteer single ascending dose (SAD) cohorts of ongoing Phase 1/2a HEADLINE trial. To date, ABS-201 continues to be well tolerated, with favorable emerging safety data. Additionally, preliminary PK modeling from the company's ongoing clinical trial supports ABS-201's targeted dosing interval of two or three injections over a six-month period. Absci has also initiated dosing of the first multiple ascending dose (MAD) cohort of AGA participants. Absci anticipates reporting preliminary safety, tolerability, and PK data in the second quarter of 2026. Expanded internal program pipeline with addition of ABS-202, a second novel anti-PRLR antibody currently in preclinical development for an undisclosed indication in inflammation and immunology (I&I). Launched endometriosis clinical advisory board for ABS-201 program, consisting of endometriosis and clinical development experts with backgrounds from renowned institutions including the Yale University School of Medicine, Duke University School of Medicine, UCSF, and the Mayo Clinic. Prolactin (PRL)...
Investor releaseQuarter not tagged2026-05-07Recursion Pharmaceuticals Q1 Earnings Call Highlights
MarketBeat
Recursion Pharmaceuticals Q1 Earnings Call Highlights
Recursion reported clinical proof-of-concept with REC-4881 showing significant, durable reductions in precancerous polyps in familial adenomatous polyposis and has initiated FDA engagement; REC-1245 Phase 1 shows no dose-limiting toxicities so far with predictable PK and target engagement, and REC-4539 has dosed its first patient. The company says its AI-driven platform and partnerships are producing efficiency and cash milestones — partner programs have generated over $500 million and 10 milestones to date, while chemistry/discovery metrics show ~90% fewer compounds synthesized and faster progression to development candidates; Recursion also published transcriptomics models (TxPert, TxFM). Recursion cut cash operating expenses by ~30% year-over-year, ended the quarter with $665 million in cash providing runway through early 2028, and is guiding 2026 cash OpEx at under $390 million. Interested in Recursion Pharmaceuticals, Inc.? Here are five stocks we like better. 2 Reasons Absci Could Be the Future of AI Biotech, and 1 Risk Recursion Pharmaceuticals (NASDAQ:RXRX) leadership used its latest earnings call to emphasize a sharper focus on translating artificial intelligence-enabled discovery into clinical and partnership “proof points,” while maintaining what it described as tighter financial discipline. CEO and President Najat Khan said her priorities since stepping into the role have centered on “signal over noise,” building a “repeatable AI-driven product engine,” and “thoughtful capital allocation.” Khan highlighted what she characterized as early clinical proof-of-concept in familial adenomatous polyposis (FAP) with REC-4881, early Phase 1 safety and pharmacokinetic readouts for REC-1245, and the initiation of a Phase 1 study for REC-4539. She also pointed to partner milestones and platform metrics intended to show improving efficiency and a longer cash runway. → 3 Emerging Markets ETFs to Maximize Exposure to High-Potential Countries These Are the Only 6 Stock Stocks in NVIDIA's 13F Portfolio Khan said Recursion’s first clinical proof of concept came from REC-4881, an allosteric MEK1/2 inhibitor in FAP. She described “significant reduction in the precancerous polyps” and “durability” in data the company has shared, calling the condition “serious” and noting patients “have no medical or therapeutic options to date.” Khan also said Recursion has already “i...
TranscriptFY2026 Q12026-05-07FY2026 Q1 earnings call transcript
Earnings source - 101 paragraphs
FY2026 Q1 earnings call transcript
Ladies and gentlemen, thank you for standing by. My name is Duncan, and I will be your conference operator for today. I would like to welcome you to Absci First Quarter 2026 Business Update. All lines have been placed on mute to prevent any background noise, and after the speaker's remarks, there will be a question and answer session. Now I'd like to turn over the conference over to Alex Khan. Please go ahead.
Thank you. Earlier today, Absci released financial and operating results for the quarter ended 31st March 2026. 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 [email protected]. An archived webcast of this call will be available for replay on 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, Zach Jonasson, Chief Financial Officer and Chief Business Officer, and Ransi Somaratne, Chief Medical Officer. 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. These include statements regarding the development and clinical progress of our pipeline programs, including ABS-201, the design, enrollment, conduct, and timelines of our ongoing phase I/IIa trial of ABS-201 for androgenetic alopecia. The anticipated timing of an interim proof of concept data readout for ABS-201 in second half of 2026. The potential advancement of ABS-201 into phase III development. The anticipated initiation of a phase II clinical trial of ABS-201 for endometriosis in the fourth quarter of 2026, and a potential proof-of-concept readout in the second half of 2027. The anticipated characteristics and product profile of ABS-201 as a drug product. Our target product profile and its attributes.
The potential for an expedited development pathway, including the possibility of advancing directly from phase I-IIA into phase III. Our plan to engage with the FDA regarding development strategy and the potential market opportunity and commercial prospects for ABS-201. Certain statements may also include projections regarding potential market opportunity. These estimates are based on various assumptions, including potential regulatory approval, the final approved label, and the evolving competitive landscape, any of which could cause our actual addressable market to differ materially from these projections. In addition, certain research findings discussed today reflect participant responses to a hypothetical product profile and do not represent clinical results for ABS-201.
Additional information regarding the risks and uncertainties that could affect our forward-looking statements is set forth in the press release Absci issued today, our most recent annual report on Form 10-K, and subsequent documents and reports filed by Absci from time to time with the SEC. 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, 7th May 2026. With that, I'll turn the call over to Sean.
Thanks, Alex. Good afternoon, everyone. Thanks for joining us. Today, I'll cover three things. Where we are on ABS-201, a new addition to our prolactin pipeline, and the strategy driving both. 2026 is going to be a data-rich year for Absci, with multiple readouts in front of us. Ransi will go through the headline files and discuss early PK modeling that supports our targeted dosing frequency. At a high level, the phase I/IIa is on track. We expect to share preliminary safety, tolerability, and PK data next month. Interim 13-week hair regrowth data in the second half of this year and full 26-week proof-of-concept data early next year. ABS-201 is not intended to compete with minoxidil. We're aiming to create a new category of hair regrowth therapy, a targeted biologic against the prolactin receptor that provides durable hair regrowth from a few injections.
If successful, ABS-201 could represent the first new mechanism of action in androgenetic alopecia in nearly three decades and a fundamentally different treatment paradigm for patients. In parallel, we continue to advance towards initiation of a phase II endometriosis trial in the fourth quarter. We recently launched our endometriosis clinical advisory board with leaders from Yale, UCSF, Duke, and Mayo Clinic. They bring deep expertise across reproductive medicine, fertility, and translational research and will help guide the ABS-201 endometriosis program. Endometriosis has the same kind of opportunity as AGA, large, underserved, and underexplored. ABS-201 has the potential to open up a new category of therapy there as well. As Zach will discuss, our top strategic priority is using our platform to create novel, differentiated assets. ABS-201 in AGA and endometriosis is the clearest expression of that.
We go after hard problems, novel biology, and large patient populations where the unmet need is real. Our platform is built for this, our philosophy has always been simple: follow the science and follow the data. One of the places this has taken us is prolactin biology. Prolactin biology is underexplored, underappreciated, and often misunderstood. Even inside the medical community, the name prolactin can read as narrow, and some still think of it as a lactation hormone. It is much more than that. The more mechanistic insight we've generated on prolactin, the prolactin receptor, and the related pathways, the more opportunity we see for this target, well beyond AGA and endometriosis. We have started sharing some of these insights with the medical community as a part of a broader education effort. Today, we're announcing another anti-prolactin receptor antibody, ABS-202, for an undisclosed I&I indication.
ABS-201 in AGA, ABS-201 in endometriosis, and now ABS-202 in I&I are just the start of our prolactin pipeline. The reason we can do this comes back to our people and our platform, OriginOne. We figured out early that having a good platform is not good enough on its own. We need the people who know how to push it. In this industry, you also need the assets, novel and differentiated programs that can make a real difference in patients' lives. The places where unmet need is largest tend to be where biology is most complex and underexplored, and that is exactly where our platform and our people excel. That overlap is also where the potential return on investment is highest, both for patients as well as our shareholders. Our focus remains being an AI-native company dedicated to developing and delivering novel, differentiated therapeutic assets for patients.
As we roll out our agentic AI workflows across Absci, each of our Unlimiters is scaling themselves across research, SG&A, and other functions. We are unlocking real efficiencies and new capabilities. That is the focus, and that is what we are committed to delivering. With that, I'll turn it over to Ramzi, who will walk through the ABS-201 clinical program. Ramzi?
Thanks, Sean, and good afternoon, everyone. As Sean mentioned, we are pleased to share that our ongoing phase I/IIa headline trial for ABS-201 is progressing well and tracking according to plan. As a reminder, this trial is a randomized, double-blind, placebo-controlled study. The primary endpoint for safety and tolerability, while secondary endpoints include PK, PD, immunogenicity, target area hair count, target area hair width, and target area darkening or pigmentation. We will also collect patient-reported outcome data from this study. In the headline trial, we have now finished dosing all four planned healthy volunteer single ascending dose cohorts and initiated dosing in the first multiple ascending dose cohort. To date, emerging safety and tolerability data remain favorable. Additionally, preliminary PK modeling from this clinical trial supports ABS-201's targeted dosing interval of two or three injections over a six-month period.
Next month, we anticipate sharing blinded preliminary safety, tolerability, and PK data from the SAD cohorts. In that update, we plan to share clinical data that support the safety profile and anticipated ABS-201 dosing interval. In the second half of this year, we plan to disclose interim proof-of-concept data, followed by full proof-of-concept data in early 2027. The interim POC readout will include 13-week hair growth data. The 13-week interim is, by design, a directional view. The 26-week time point is the trial's full POC readout. Given the regenerative nature of the mechanism and our targeted dosing interval, the biology may continue to drive hair growth beyond that point, which is consistent with the long-acting profile we are working towards. Zach will speak to how this positions ABS-201 well for commercial success.
We also continue to explore plans to execute our targeted efficient clinical development strategy, which could enable expedited clinical development with the potential of advancing directly to registrational trials following this phase I/IIa study. With that, I'll pass it over to Zach to discuss our business strategy and to provide an update on our financials. Zach?
Thanks, Ramzi. We remain focused on creating and developing therapeutic programs that offer the highest potential return on investment. Our strategic priority is the execution of the ABS-201 headline trial, which supports our future registrational study plan for AGA and our phase II clinical trial plan for endometriosis. As Ramzi mentioned, we plan to share an interim POC readout, including 13-week hair regrowth data, in the second half of this year. Based on the mechanism and our preclinical data, we anticipate the 13-week interim readout will give a directional view of hair growth, with the 26-week full POC providing the trial's primary efficacy readout. Given the regenerative nature of the mechanism, we anticipate hair growth to continue beyond the 26-week time point.
Conversations with the scientific and medical community, as well as patients, continue to affirm our view of the significant ROI potential for ABS-201 in AGA and endometriosis. We estimate that the capital required to advance ABS-201 through registrational AGA trials will be a fraction of the clinical costs required for other large indications such as oncology and IBD. Moreover, we expect to be able to leverage the SAD and MAD portions of the current headline trial to support phase II initiation in endometriosis, thereby saving time and cost. Considering the significant potential market opportunities of AGA and endometriosis in conjunction with our efficient development strategy, we believe that ABS-201 offers a unique and compelling ROI. Our market research supports a significant commercial opportunity for ABS-201.
In our surveys of AGA consumers and dermatologists, we evaluated a target product profile consisting of 2.5 years of hair growth following three injections of ABS-201, with a hair growth effect of approximately 35 hairs per centimeter squared versus baseline, similar to high-dose oral minoxidil. Results from our market research support a potential total available market exceeding $25 billion annually in the U.S., with meaningful potential upside if hair growth exceeds the surveyed threshold. ABS-201 has the potential to significantly expand the overall AGA market as a new premium category of durable regenerative hair growth therapy. Our market research indicates the ABS-201 target product profile would attract not only AGA consumers dissatisfied with current standards of care, but also those who elect to use ABS-201 alongside existing standard of care such as oral minoxidil or new formulations of oral minoxidil.
Similarly, in endometriosis, ABS-201 has the potential to define a new category of therapy that has the potential to address not only pain, but also underlying disease. Endometriosis is prevalent in up to 10% of women worldwide, including an estimated 9 million women in the U.S. We believe ABS-201's differentiated profile could support potential peak sales in excess of $4 billion. As Sean mentioned earlier, our second priority is building and prioritizing an early pipeline of differentiated programs that offer the highest potential return on investment. Accordingly, today, we are pleased to announce the deepening of our pipeline with the addition of a new anti-prolactin receptor antibody, ABS-202. This program, which leverages our prolactin biology expertise and our AI platform, enables us to expand into new indications where we believe prolactin receptor inhibition will offer a novel and efficacious treatment option.
Conversely, we have determined that oncology no longer fits within our strategic scope, and so we will be deprioritizing development of ABS-301 and ABS-501. We will no longer commit internal capital or resources to further development of these programs. Our capital and resources will be directed toward programs that offer the greatest potential ROI within our strategy. In addition to the two previously discussed strategic priorities, we continue to advance partnering discussions associated with our other internal programs, which are at various stages of preclinical and clinical development. Overall, our strategy remains focused on executing the development of ABS-201 in AGA and in endometriosis, and on further building a pipeline of differentiated programs that provide optionality for internal development or partnering. Turning now to our financials. Revenue in the first quarter was $200,000 as we continue to progress our partnered programs.
Research and development expenses were $19.3 million for the three months ending 31st March 2026, as compared to $16.4 million for the prior year period. This increase was primarily driven by advancement of Absci's internal programs, including direct costs associated with external preclinical and clinical development of ABS-201. Selling, General, and Administrative expenses were $9.1 million for the three months ending 31st March 2026, as compared to $9.5 million for the prior year period. This decrease was primarily due to a reduction in personnel-related costs. Cash, cash equivalents, and marketable securities as of 31st March 2026, were $125.7 million as compared to $144.3 million as of 31st December 2025.
Based on our current projections, we believe our cash equivalents, and marketable securities will be sufficient to fund our operating plans into the first half of 2028. Our current balance sheet supports our execution of key upcoming catalysts, including potential proof-of-concept readouts for both AGA and endometriosis, and continued progress of our early-stage pipeline. We also remain focused on opportunities to generate additional non-dilutive cash inflows that could come from early-stage asset transactions and/or new platform collaborations with large pharma. In particular, we believe our early pipeline programs may offer attractive partnering opportunities. At the same time, we are aggressively implementing agentic AI workflows across our organization, including in business and scientific functions. These implementations are already creating meaningful efficiency gains as well as capability gains. Going forward, we expect to continue to realize cost savings and productivity gains from advancement of our agentic workflows.
With that, I'll now turn it back to Sean.
Thanks, Zach. Before we open up for questions, I want to thank the team at Absci, our Unlimiters, for the work they put in each and every day. The catalysts ahead this year are: one, preliminary safety and PK data for ABS-201 next month. two, interim 13-week proof-of-concept hair regrowth data in the second half of this year. three, initiation of phase II endometriosis trial in Q4, subject to data and regulatory review. Last, continued progress on our early-stage pipeline, including our newest prolactin program, ABS-202. Looking into early 2027, we expect full 26-week proof-of-concept data for ABS-201 in AGA. Thank you all for your continued support. Operator, let's open the line for questions.
Thank you. Your first question comes from the line of Brendan Smith from TD Cowen. Your line is now open. Please go ahead.
Brendan, are you there?
Brendan, you may be muted. Just to double-check.
Hey, guys. Hi, guys. Apologies. Can you hear me now?
Yes.
Yes. Sorry about that. Guess I wasn't good. Yeah, thanks for taking the questions, guys. Congrats on everything going on here. I guess maybe just a kind of a quick follow-up on the ABS-202 conversation. Can you maybe just help us understand a little bit more, even on a mechanistic level here, what kind of the most important distinctions versus ABS-201 are in terms of why it would make sense for some indications versus others and, you know, I guess versus the first two you're pursuing there? And is there kind of a difference of product profile or something about actual mechanism that makes sense for that distinction? Thanks.
Yeah, absolutely. With ABS-202, we are creating a differentiated profile with this. Additionally, we do want to be able to have this outside of AGA and endometriosis for other indications where there may be, you know, pricing differences. You know, with regards to the prolactin biology, some of the things that we're really interested in is how prolactin is driving some of these autoimmune diseases. It looks to be sitting on this stress inflammatory axis and is also driving some interesting B cell biology as well. You just see it expressed at least in prolactin receptor all throughout the body.
I mean, it's sitting in bones, immune system, endothelial cells, the synovium. So, we're continuing to expand out the biology there, as well as going into other indications with ABS-202. Additionally, looking at, you know, bispecifics as well, that could be synergistic with this particular mechanism.
Got it. Okay. That's super helpful. Then maybe just quickly on the upcoming MAD efficacy readout with ABS-201. Appreciate the color on some of the how you're thinking about some of this data. I guess just given how the space has evolved in recent months there, are you kind of ultimately thinking, you know, comparable efficacy but with clean safety and maybe differentiated dosing is kind of enough to win given how big the market is? Are you expecting, kind of based on how things have evolved now that you would potentially need to show superior efficacy? Just help us understand some of those dynamics.
Yeah, absolutely. Zach can touch on this more from the consumer quant study we did. We believe having a comparable efficacy to oral minoxidil with the infrequent dosing will be really a home run product. That convenience factor with equivalent efficacy, we do see that being a home run product. Any efficacy above that, we see that as just increasing the overall TAM of the opportunity here. Zach, maybe you want to speak a little bit more to the consumer quant study that we did.
I'd be happy to comment. Brendan, as you know, we've conducted a sizable consumer survey. We've also conducted surveys with dermatologists. I think the takeaway from those surveys is that the profile of ABS-201 would really establish a brand new category of therapy. That's based on its durable, the durability of the profile, infrequent dosing, and the truly regenerative mechanism. When we test a profile with consumers, dermatologists that has efficacy that's consistent with at least some reports of high-dose oral minoxidil, think about that sort of 35 hairs per sq cm growth in target area hair count, we see the massive potential for adoption. That's how we get to a potential $25 billion TAM just on a TPP that looks like that, because it's a compilation of all those factors that really define this as a new category.
I think we're quite excited about that. We think ultimately this product would expand the overall AGA market, and we saw that in our consumer research as well. It looks to us like there are a lot of patients out there who are dissatisfied with current standard of care who would come to ABS-201 as a therapeutic option. There are also lots of patients that would just come first line, so before they try anything else. We saw over a third of males and females we surveyed said they would come first line, and that's before trying even like a nutraceutical or something very inexpensive. We also saw in the data there are lots of patients that would elect to use both. They might use an oral minoxidil in combination with ABS-201.
I think as a brand new category of therapy, and a premium category, I think ABS-201 has the potential to be really well-positioned.
Awesome. Super helpful, guys. Thank you.
Your next questions come from the line of Gil Blum from Needham & Company. Your line is now open. Please go ahead.
Good afternoon, and thanks for taking our questions. A little bit of a similar question as it relates to the, you know, ABS-201 and ABS-202. Is the difference there, pharmacokinetics, binding? Is there anything you can tell us about, you know, the upgrades in ABS-202? I have a follow-up on the ABS-201 program after this. Thanks.
At this point in time, we are not disclosing the profile that we're looking to achieve for this, other than the fact that we are planning to take this into a different indication.
Okay. Fair enough. As it relates to the 13-week readout, you know, Verderax in their own call noted, quote unquote, "appreciable improvement at two months." It's a very qualitative measure, as it relates to early data, you know, an early time point. Is this what we should be expecting at 13 weeks, or should we be expecting something more methodical? Thank you.
The 13 weeks is really a directional readout. We want to see hair growth, and the 26 week is where we expect to see the oral minoxidil hairs per square centimeter. That's what we're utilizing as the final readout. The 13-week again is just directional from there. Given the differences in hair growth and the mechanism, we want to reserve the 26 week as the final definitive readout.
All right. I appreciate that. Thank you.
Your next question comes from the line of Vamil Divan from Guggenheim.
Hi, this is Arseny, on for Vamil. Thanks for taking our questions and congrats on all the progress. You've previously talked about 90% receptor occupancy being necessary to achieve the full therapeutic effect with the prolactin mechanism. Do you think it's ultimately achievable with that dosing schedule that you need?
Yeah. So far what we're seeing, we definitely see that as achievable. Ransi, maybe you wanna speak a little bit more to that.
Yeah. We're not looking at anything like hair growth in the SAD study. The way we've designed the dosing paradigm, we've been very conservative in our scaling, we're confident we can hit that 90% receptor occupancy. This is certainly something that is something to look forward to with the MAD data the hair growth data.
One more follow-up. Do you expect variability in therapeutic response, among the patients that you enroll, whether that's because of their biomarker profile, because of their age, or there is something about this mechanism where you think, essentially every patient will respond at least to some degree?
I mean, at this point, we seem to have a balanced enrollment of the various stages of the Norwood classification. There's nothing that from a biomarkers perspective that I would expect to see or be able to predict a variation in response in the AGA population. I don't have a great answer to that question, but it's a reasonably sized study, and it's randomized. In terms of the baseline hair characteristics, we're pleased with how patients are distributing amongst the arms. At this point, I'm not worried about something else causing inter-subject variability in the mechanism of action itself.
Thank you. Yeah, we've seen any of that as well in the in vivo or ex vivo experiments that we've run to date.
Understood.
Your next question comes from the line of Kripa Devarakonda from Truist. Your line is now open. Please go ahead.
Hi, how's it going? This is Alex Khan on for Kripa Devarakonda. Really exciting time at Absci. Two questions from us. When can we expect to learn more about the mechanism and the properties and indication for ABS-202? Also in your consumer survey, did you specifically test for patient preference and desire for combination therapy for ABS-201 and other currently approved products? Thanks.
Yeah, at the current moment, we are not planning on disclosing any more than we have on ABS-202 and the mechanism of action. Though I will say we are very excited about the overall opportunities and, you know, as we get closer to the clinic, we'll definitely be disclosing more on that, but just from a, you know, competitive standpoint, we're not disclosing at this point in time. Zach, do you wanna take the second question?
Yeah, absolutely. In the survey itself, we did not specifically ask that question, but we have asked that question in our patient interview segments. In the survey, what we did see, which I think was really, you know, really exciting for us, is when we talked to surveyed men and women, we saw a very high response rate in terms of those who said they would be extremely likely or very likely to go seek out the product today if it were available. That was 87% of men, 69% of women. When we zeroed in on subgroups who are on existing standard of care, for example, oral minoxidil, those numbers went up dramatically. For men, they went from 87% to 92%, and for women, they went from 69% to 89%.
We clearly see a strong level or a stronger level of interest in the product if you're already using a standard of care in those subgroups. We think that the survey really supports the new category definition here, where patients are really gonna be looking for this as a new category, either to replace standard of care that they're dissatisfied with or to use on top of standard of care.
All right. That's great color. Thanks. Very excited over here. Congrats on all the progress.
Thanks, Alex.
Your next question comes from the line of Debanjana Chatterjee from Jones. Please go ahead.
Hi. Thanks for taking my question. I have a question on the endometriosis program. I know pain is a very common endpoint for these trials. Historically, the high placebo response has been an issue with pain studies. What kind of structural elements would you implement in this trial to prevent, like, or control placebo response? I have a follow-up.
Yeah, Ramzi, you wanna take that?
Yeah, no, thanks for the question. I learned a lot in my time at Vertex overseeing the pain program there. Yeah, I'm glad you appreciate that. The pain aspect of these studies is ultra important. You know, the crux, I think, is how you execute the trial. We will spend a lot of time making sure the sites are carefully chosen, the investigators are carefully chosen, all the partners that we're working with understand how to mitigate placebo response. Placebo training is really important. We will be surveilling the blinded data for evidence of placebo response.
There is a lot of operational stuff that's not put into the protocol because these are really things that you have to do in execution, and we've also engaged the FDA in how we're approaching mitigation of placebo response. It's really, really important, not something that you always see in the protocols, but heavily operational and done behind the scenes.
Okay, that's helpful. For 202, I know for competitive reasons you can't share much details, but just wanted to know if that is something for internal development or is that something you would partner off, given that, you know, the pricing would be very different for I&I indications.
Yeah, we are definitely open to both options on ABS-201. The current option at the moment is pursuing this ourselves. Given the opportunity here in the market size, we are considering both internal development as well as partnering.
That's helpful. Thank you.
Sorry, and that is for ABS-202. Sorry.
You did. Mm-hmm.
Your next question comes from the line of Brian Cheng from J.P. Morgan. Your line is now open. Please go ahead.
Hey, guys. Can you hear me?
Yep.
Hey, guys. Can you hear me?
Yeah, Brian, we can.
Oh, hey, sorry. Thanks for taking our question this afternoon. When you talk about the 20 hair growth as the benchmark for success, I think, you know, that's what you have been guiding for some time now for your AGA MAD portion. Can you clarify whether that's the benchmark that you expect for the end of the MAD portion, meaning the end of the 26-week? If it is, just curious if you can also help us think about what you would want to see or what you expect to see at the 13-week mark, based on the preclinical work that you have done.
Yeah, it's a great question, Brian, where we wanna be at the 26 weeks is definitely where oral minoxidil sits. At the 13-week, we are not putting an official guide on that. We wanna see directional hair growth. Just given the biology and the new mechanism here, we don't wanna set any sort of unrealistic expectations. I think the best way to look at this is through the lens of the 26-week readout, which again is where we wanna be right around oral minoxidil with infrequent dosing.
Got it.
Brian, if I could add to that.
What we showed in the survey is if we have the TPP that includes that sort of effect size that's similar to the high-dose oral minoxidil, so think in the 30s, with that convenient profile and durability, that's a really a home run product. There's a product at efficacy below that as well, but the consumer research we've done with KOLs and with AGA consumers would suggest that that is a very fantastic product, category defining at that threshold.
Got it. Maybe just going back to the PK data that you have seen so far, you know, I think you said in your prepared remarks that the modeling work that you have seen from the trial, it truly supports a few times a year type of dosing regimen. Can you give us a little bit more color, you know, you know, a little bit of glance of, you know, how we should think about the key parameters that are driving the conclusions? Thank you.
Yeah, Ramzi, do you wanna speak on the PK?
Yeah. I mean, we're assessing PK from all of the SAD cohorts. We just started dosing the MAD cohorts, so we don't have MAD PK, but the SAD cohorts are developing nicely. We feel pretty good about being able to dose at least every 8 weeks subcutaneously. We'll have more color on this and a more refined estimation of dosing frequency when we have the data that we talked about in a few weeks.
Yeah. I would say from the preliminary, you know, half-life and PK, we feel very, we're feeling very optimistic and looking forward to sharing the full data on that in June.
Your next question comes from the line of Swayampakula Ramakanth from H.C. Wainwright & Co. Your line is now open. Please go ahead.
Thank you. Good afternoon, Sean and Zach. Thanks for taking my questions. I apologize that I'm going to disappoint you by not asking a question on ABS-201 or ABS-202. However, I have a couple other questions. One is, you stated that you're de-emphasizing oncology products. I'm just trying to understand what's some of the reasonings behind it and also, you know, what sort of an interest are you seeing from outside, especially, you know, for these novel drugs?
Yeah. From a strategy standpoint, you know, if you look at, you know, ABS-201 in particular, going after AGA, I mean, this is gonna be a, you know, direct to consumer type of product. We really wanna be building out products that would support this, and in particular, you know, in I&I, makes a lot of sense. Oncology just doesn't, you know, support that particular go-to-market strategy that we wanna have with AGA. So, we have deprioritized these and no longer going to fund any of these internally and again, put all the focus into assets that are gonna be supporting the lead asset, ABS-201 in AGA and in endometriosis.
Okay. In terms of bringing in partners, right? Because, you know, you've been talking about generating partnerships, including a large cap pharma for a while now, and that cadence has been slower than what we had seen in the previous years. I'm just trying to understand the some of the factors that are going into it. Is it more because some of these large cap pharma or large cap biotech, they are generating their own tools that they feel sufficient enough? Is it because the economics of that they bring to the table?
Doesn't seem viable, for you to enter into a relationship.
So our focus is driving the clinical development of ABS-201. We are continuing to look for pharma partnerships around our pipeline, but they have to make sense for us. We're a limited, you know, team here, and we wanted to synergize, so we are being, you know, very selective of who we partner with and how they, you know, synergize in building out the overall portfolio that we wanna build out and supports, you know, the go-to-market strategy as well with ABS-201. It is definitely an area that we are focused in on, but it has to make sense strategically for us. Zach, do you have anything else to add to that?
Yeah. I mean, Sean is exactly right. RK, I'll just add one thing, and that's internally, we have the capability to generate assets, and we believe we have a leading platform that's very focused on challenging targets, as well as a leadership in certain areas of biology, foremost prolactin biology. We believe, we've done a full-blown analysis internally, that we can generate better economic terms on partnerships that are focused on an asset, even at a preclinical stage, versus tying up our resources and capacity for target-based platform partnerships. We've got a number of assets that are coming towards DC this year, and several of those we think would be earmarked towards partnering to generate non-dilutive cash flow.
When we run the analysis internally, the risk-adjusted NPV from focusing on creating assets and partnering those is a multiple of what it would be relative to a platform target-based deal when you look at it on a target-by-target or program-by-program basis. For us, the economics also point us in that direction.
Great. Thanks. Thanks for taking my questions, gentlemen.
Your next question comes from the line of Steve Bashir from KeyBanc Capital Markets. Your line is now open. Please go ahead.
Hey, guys. You mentioned adopting more agentic AI into your business. I guess just how is this impacting your drug discovery process as well as your business operations and any kind of cost savings near term that you can point to? Thanks.
Zach, you wanna take that?
Happy to. We are very aggressively implementing agentic workflows throughout Absci, and that includes not just in science and R&D, but also across SG&A. We're in a period where we're rolling that out. We're already seeing significant efficiency gains, and we expect to realize those in terms of cost reduction as well as capability gains on a go-forward basis. You can think of it even over the next few months, we should start realizing some of those gains.
All right. Thank you.
Your next question comes from the line of Vamil Divan from Guggenheim.
It's Arseny on for Vamil. I had one more follow-up on the hair repigmentation opportunity. My question is, what do you expect to see there? What readout do you think would be clinically meaningful? Would you consider pursuing it as a separate indication down the line with additional studies or would it be sort of an extra claim in the label in addition to the AGA indication? Just any color on that would be helpful.
Yeah. Look, we're really excited about the potentials for repigmentation. We do see it as creating even a bigger market opportunity than what we currently have. Right now it's an exploratory endpoint, and we're gonna see how the readouts go at the 13 and 26 week and then determine, you know, how we wanna proceed forward from there. Ransi, I don't know if you have any other color you wanna add to that.
Yeah. I think you summed it up well, Zach. The cinacalcet data from that other program are really interesting and exciting and at this point, we're looking to see what we can see. Mechanistically it does make sense that it's a potential finding.
Very helpful. Thank you.
Thank you. We have reached the end of the question and answer session. This also concludes our call for today. Thank you everyone for attending this call. You may now disconnect. Goodbye.
Investor releaseQuarter not tagged2026-05-06Absci Corp (ABSI) Q1 2026 Earnings Report Preview: What To Look For
GuruFocus.com
Absci Corp (ABSI) Q1 2026 Earnings Report Preview: What To Look For
This article first appeared on GuruFocus. Absci Corp (NASDAQ:ABSI) is set to release its Q1 2026 earnings on May 7, 2026. The consensus estimate for Q1 2026 revenue is $1.55 million, and the earnings are expected to come in at -$0.23 per share. The full year 2026 revenue is expected to be $8.70 million, and the earnings are expected to be -$0.88 per share. More detailed estimate data can be found on the Forecast page. Warning! GuruFocus has detected 7 Warning Signs with ABSI. Is ABSI fairly valued? Test your thesis with our free DCF calculator. Over the past 90 days, revenue estimates for Absci Corp (NASDAQ:ABSI) have declined from $20.33 million to $8.70 million for the full year 2026 and from $34.81 million to $32.33 million for 2027. Earnings estimates have decreased from -$0.71 per share to -$0.88 per share for the full year 2026 but have improved slightly from -$0.57 per share to -$0.56 per share for 2027. In the previous quarter ending on December 31, 2025, Absci Corp's (NASDAQ:ABSI) actual revenue was $0.65 million, which missed analysts' revenue expectations of $1.10 million by -40.91%. Absci Corp's (NASDAQ:ABSI) actual earnings were -$0.20 per share, which met analysts' earnings expectations. After releasing the results, Absci Corp (NASDAQ:ABSI) was down by -2.99% in one day. Based on the one-year price targets offered by 7 analysts, the average target price for Absci Corp (NASDAQ:ABSI) is $8.03, with a high estimate of $10.00 and a low estimate of $4.20. The average target implies an upside of 47.04% from the current price of $5.46. Based on GuruFocus estimates, the estimated GF Value for Absci Corp (NASDAQ:ABSI) in one year is $1.11, suggesting a downside of -79.67% from the current price of $5.46. Based on the consensus recommendation from 9 brokerage firms, Absci Corp's (NASDAQ:ABSI) average brokerage recommendation is currently 2.0, indicating an "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.
Investor releaseQuarter not tagged2026-04-24Absci to Report Business Updates and First Quarter 2026 Financial and Operating Results on May 7, 2026
GlobeNewswire
Absci to Report Business Updates and First Quarter 2026 Financial and Operating Results on May 7, 2026
VANCOUVER, Wash. and NEW YORK, April 23, 2026 (GLOBE NEWSWIRE) -- Absci Corporation (Nasdaq: ABSI), a clinical-stage biopharmaceutical company advancing breakthrough therapeutics designed with generative AI, today announced the company will report business updates and financial and operating results for the first quarter 2026 after market close on Thursday, May 7, 2026. Absci management will webcast a corresponding conference call beginning at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss its business developments, financial and operating results, and outlook. Live audio of the webcast will be available on the company’s investor relations website at: investors.absci.com. The webcast will be archived and available for replay after the event. About Absci Absci is advancing the future of drug discovery with generative design to create better biologics for patients, faster. Our Integrated Drug Creation™ platform combines cutting-edge AI models with a synthetic biology data engine, enabling the rapid design of innovative therapeutics that address challenging therapeutic targets. Absci’s approach leverages a continuous feedback loop between advanced AI algorithms and wet lab validation. Each cycle refines our data and strengthens our models, facilitating rapid innovation and enhancing the precision of our therapeutic designs. Alongside collaborations with top pharmaceutical, biotech, tech, and academic leaders, Absci is advancing its own pipeline of AI designed therapeutics including ABS-201™, a groundbreaking innovation in hair regrowth with the potential to redefine treatment possibilities for androgenetic alopecia, commonly known as male and female pattern hair-loss. ABS-201 is also being investigated as a potential “best-in-class” therapeutic for endometriosis, a condition with significant unmet medical need and market potential. Absci is headquartered in Vancouver, WA, with AI Research Labs in New York City and Serbia, and an Innovation Center in Switzerland. Learn more at www.absci.com or follow us on LinkedIn (@absci), X (@Abscibio) and YouTube. Absci® standard character mark, ABS-201™, and Integrated Drug Creation™ are trademarks and registered trademarks of Absci Corporation. Investor Contact Alexander D.H. Khan Corporate Vice President, Head of Investor Relations [email protected] Media Contact [email protected]
Investor releaseQuarter not tagged2026-03-25Absci (ABSI) Q4 2025 Earnings Call Transcript
Motley Fool
Absci (ABSI) Q4 2025 Earnings Call Transcript
Image source: The Motley Fool. Tuesday, March 24, 2026 at 4:30 p.m. ET Founder and Chief Executive Officer — Sean McClain Chief Financial Officer and Chief Business Officer — Zach Jonasson Chief Medical Officer — Ronti Somerotne Need a quote from a Motley Fool analyst? Email [email protected] Alex Khan: Thank you. Earlier today, Absci Corporation released financial and operating results for the quarter and full year ended December 31, 2025. 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 on Absci Corporation’s Investor Relations website at investors.absci.com for at least 90 days after this call. Joining me today are Sean McClain, Absci Corporation’s Founder and CEO; Zach Jonasson, Chief Financial Officer and Chief Business Officer; and Ronti Somerotne, Absci Corporation’s new Chief Medical Officer. Before we begin, I would like to remind you that management will make statements during the 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 differ materially from those anticipated and you should not place undue reliance on forward-looking statements. These include statements regarding the development and clinical progress of ABS-201, anticipated clinical trial design, enrollment, and timelines; expected clinical data and their timing; anticipated characteristics and product profile of ABS-201 as a drug product; our target product profile and attributes; the potential for an expedited development pathway, including the possibility of advancing directly from Phase 1/2a into Phase 3; our planned engagement with the FDA regarding development strategy; and potential market opportunity and commercial prospects for ABS-201. Certain statements may also include projections regarding potential market opportunity. These estimates are based on various assumptions, including potential regulatory approval, the final approved label, and the evolving competitive landscape, any of which could cause our actual addressable market to differ materially from these projections. In addition, certain research findings discussed today reflect participant responses to a hypothetical product pr...
Investor releaseQuarter not tagged2026-03-25Absci Corp (ABSI) Q4 2025 Earnings Call Highlights: Strategic Advances and Financial Resilience
GuruFocus.com
Absci Corp (ABSI) Q4 2025 Earnings Call Highlights: Strategic Advances and Financial Resilience
This article first appeared on GuruFocus. Revenue: $700,000 for the fourth quarter. Research and Development Expenses: $25.3 million for the three months ending December 31, 2025, up from $18.4 million in the prior year period. Selling, General and Administrative Expenses: $8.6 million for the three months ending December 31, 2025, compared to $8.8 million in the prior year period. Gain on Settlement: $5.1 million gain on the settlement of the company's contingent consideration in Q4 2025. Net Proceeds: $8.7 million of unrestricted cash from the settlement. Cash, Cash Equivalents, and Marketable Securities: $144.3 million as of December 31, 2025, compared to $152.5 million as of September 30, 2025. Cash Runway: Sufficient to fund operations into the first half of 2028. Warning! GuruFocus has detected 4 Warning Signs with ABSI. Is ABSI fairly valued? Test your thesis with our free DCF calculator. Release Date: March 24, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. ABS-201 is progressing well in clinical trials, with favorable emerging safety data and potential for expedited development. The company has expanded ABS-201 into endometriosis, a second multibillion-dollar indication, highlighting its market potential. Absci Corp (NASDAQ:ABSI) has demonstrated the first de novo full-length antibody design to zero prior epitopes, showcasing its innovative capabilities. The company has a strong financial position with $144.3 million in cash, cash equivalents, and marketable securities, sufficient to fund operations into the first half of 2028. Absci Corp (NASDAQ:ABSI) is leveraging its AI platform to rapidly advance drug development, reducing time and cost compared to industry standards. ABS-201's success is contingent on achieving efficacy comparable to or exceeding high-dose oral minoxidil, which remains uncertain. The company faces significant competition in the androgenetic alopecia (AGA) market, with other treatments gaining traction. There are risks associated with the clinical development of ABS-201, including potential safety concerns and regulatory hurdles. Absci Corp (NASDAQ:ABSI) is heavily reliant on partnerships for its oncology programs, which may impact its strategic focus and resource allocation. The company's projections for market opportunities are based on assumptions that may not materia...
Investor releaseQuarter not tagged2026-03-25Absci Reports Business Updates and Fourth Quarter and Full Year 2025 Financial and Operating Results
GlobeNewswire
Absci Reports Business Updates and Fourth Quarter and Full Year 2025 Financial and Operating Results
Successfully dosed first three cohorts in SAD portion of ongoing ABS-201™ HEADLINE trial; well-tolerated with favorable emerging safety data Unveiled human ex vivo data demonstrating that ABS-201 stimulates hair growth and regenerates follicle stem cell niche Appointed seasoned biopharmaceutical executive Ransi Somaratne, M.D., FACC, MBA as Chief Medical Officer Cash, cash equivalents, and marketable securities sufficient to fund operations into the first half of 2028 VANCOUVER, Wash. and NEW YORK, March 24, 2026 (GLOBE NEWSWIRE) -- Absci Corporation (Nasdaq: ABSI), a clinical-stage biopharmaceutical company advancing breakthrough therapeutics designed with generative AI, today reported financial and operating results for the quarter and full year ended December 31, 2025. “Over the past year, we advanced ABS-201 from preclinical to three dosed cohorts in our HEADLINE trial with favorable emerging safety data, extending our track record of moving from AI design to clinic in approximately two years at a fraction of industry cost,” said Sean McClain, Founder and CEO. “Dr. Ransi Somaratne has joined as our first Chief Medical Officer to lead clinical execution and strategy. We are focused on delivering interim proof-of-concept data in the second half of 2026 and initiating our endometriosis Phase 2 by year-end. In AGA and endometriosis, there is a significant unmet need, as no approved disease-modifying therapeutic options exist for these patients. This is the kind of whitespace where we believe our AI-native drug creation strategy can generate the most value.” Recent Highlights Successfully dosed first three cohorts in single ascending dose (SAD) portion of ongoing Phase 1/2a HEADLINE trial. ABS-201 has been well tolerated to date, with favorable emerging safety data. Unveiled human ex vivo data demonstrating that ABS-201 effectively stimulates hair growth by regenerating the stem cell niche as well as promoting additional key growth modulators. In these studies, ABS-201 treatment significantly inhibited the PRLR signaling pathway (STAT5 phosphorylation), which correlated with prolongation of anagen and restoration of growth signaling, preservation and expansion of the stem cell niche, and potential for follicle reconversion. Released manuscript on Origin-1: a generative AI platform that designs full-length monoclonal antibodies (mAbs) against "zero-prior" epit...
Investor releaseQuarter not tagged2026-03-25Absci Q4 Earnings Call Highlights
MarketBeat
Absci Q4 Earnings Call Highlights
ABS-201 has shown favorable early safety and PK in the Phase I/IIa HEADLINE trial with SAD cohorts dosed and the first MAD cohort starting, and Absci expects preliminary safety/PK data in H1 2026, a 13-week interim proof-of-concept readout in H2 2026, and full 26-week data in early 2027. Absci added endometriosis as a second indication for ABS-201, targeting a non-hormonal pathway and planning a Phase II start in Q4 2026 (interim POC expected in H2 2027), subject to HEADLINE data and regulatory review. R&D spending increased to $25.3M in Q4, cash totaled $144.3M at year-end, and management says current resources should fund operations into the first half of 2028 while pursuing non-dilutive financing and collaborations. Interested in Absci Corporation? Here are five stocks we like better. 2 Reasons Absci Could Be the Future of AI Biotech, and 1 Risk Absci (NASDAQ:ABSI) provided a fourth-quarter and full-year 2025 business update on Monday, highlighting early progress for lead candidate ABS-201, expansion into a second indication, and continued investment in its AI-enabled drug creation platform. Founder and CEO Sean McClain said Absci “had a strong fourth quarter,” led by the clinical advancement of ABS-201. The company’s ongoing Phase I/IIa HEADLINE trial has now dosed the first three cohorts in the single-ascending dose (SAD) portion, with what management described as “favorable emerging safety data.” → Active ETFs Surge Past Passive, and These Are in the Lead Which Healthcare Stock Is the Best Buy Right Now? Chief Medical Officer Ransi Somaratne, who recently joined Absci after clinical development roles at Amgen, BioMarin, and Vertex, outlined the HEADLINE study design and objectives. The randomized, double-blind, placebo-controlled trial is intended to serve as a first-in-human study while also providing preliminary proof-of-concept (POC) data in androgenetic alopecia (AGA) through its multiple-ascending dose (MAD) portion. Somaratne said primary endpoints are safety and tolerability, while secondary endpoints include pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and several hair-related measures such as target area hair count and hair width. The trial is enrolling up to 227 healthy volunteers with or without AGA, with four intravenous SAD dose groups followed by three subcutaneous MAD dose groups in participants with AGA. → Macy’s Beats...
Investor releaseQuarter not tagged2026-03-25Absci Corporation Q4 2025 Earnings Call Summary
Moby
Absci Corporation Q4 2025 Earnings Call Summary
Successfully transitioned to a clinical-stage company with ABS-201 entering Phase 1/2a trials, demonstrating the platform's ability to move from AI design to IND in approximately two years. Prioritized ABS-201 for androgenetic alopecia (AGA) and endometriosis due to high unmet need, low competition, and the potential for significant return on investment in large markets. Validated the 'lab-in-the-loop' AI strategy by publishing the first demonstration of de novo, full-length antibody design against targets with zero prior reported complex structures. Adopted a capital-efficient R&D model, reporting a cost of roughly $15 million per program compared to the industry standard of $50 million or more. Strategically pivoted internal oncology programs (ABS-301, ABS-501) toward partnering to focus resources on the high-value Immunology and Inflammation (I&I) pipeline. Strengthened the leadership team with the appointment of Dr. Ronti Somerotne as CMO to leverage his experience in leading novel mechanisms through FDA approval. Anticipates preliminary safety and PK data for ABS-201 in the first half of 2026, followed by interim 13-week proof-of-concept hair regrowth data in the second half. Plans to initiate a Phase 2 trial in endometriosis in Q4 2026, utilizing safety and PK data from the ongoing headline trial to accelerate development timelines. Engaging with the FDA to explore an expedited development pathway that could allow ABS-201 to advance directly from Phase 1/2a into Phase 3 registrational trials. Targeting a 2030 FDA approval timeframe for ABS-201, with a commercial strategy focused on the $25 billion U.S. AGA market via dermatologists and med spas. Projecting a cash runway into 2028, which supports reaching major value inflection points for both lead indications without immediate need for dilutive financing. Recorded a $5.1 million gain on the settlement of contingent consideration, contributing to a total of $8.7 million in unrestricted cash proceeds. Acknowledged the retirement of Andreas Boesch, a key architect of the drug creation organization, who will transition to co-chair of the scientific advisory board. Identified potential risks including the variability of clinical outcomes, regulatory approval hurdles, and the evolving competitive landscape for AGA treatments. Emphasized that while market research shows high consumer interest, actual capture...

