Absci Corporation

2025 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 star 1 1 on your telephone. To remove yourself from the queue, you may press star 1 1 again. I would now like to hand the call over to Alex Khan, VP, Finance and Investor Relations. Please go ahead.

Thank you. Earlier today, AdSci released financial and operating results for the quarter ended March 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 investors at AdSci.com. An archived webcast of this call will be available for replay on Abcide's investor relations website at investors.abcide.com for at least 90 days after this call. Joining me today are Sean McLean, Abcide's founder and CEO, and Zach Jonason, Chief Financial Officer and Chief Business Officer. Christian Stegman, Abcide's SVP of Drug Creation, will also join for Q&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 or reports filed by ABSA from time to time with Securities and Exchange Commission. Except as required by law, ATSAI 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, May 13, 2025. With that, I'll turn the call over to Sean.

Good afternoon, everyone. Thank you for joining our Q1 2025 Business Update Call. Today marks a significant milestone for Abcide. We've initiated our first in human clinical trial for ABS 101, officially making Abcide a clinical stage biotech company. It's incredible to see how far we've come in just a short time. About two and a half years ago, Andreas Busch, an experienced drug hunter, joined Abcide as our chief innovation officer. Under Andreas's 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 I clinical trial for ABS-101, our potential best-in-class anti-CL1A antibody. This randomized, double-blind, placebo-controlled trial of single ascending doses of ABS-101 will evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in approximately 40 healthy adult volunteers. The primary focus is safety and tolerability with PK, PD, and immunogenicity as secondary endpoints. We expect interim results later this year from this ongoing study in Australia. As a reminder, BBS101 is a potential best-in-class TL1A antibody demonstrating high affinity, potency, ability to bind both TL1A monomer and trimer, anticipated low immunogenicity, and high bioavailability shown in non-human primates. Additionally, it's formulated for convenient sub-Q administration with an anticipated dosing interval of 8 to 12 weeks. Recent data indicates ADS101 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 confirmed prolonged dose-dependent target engagement with a clear ceiling effect, and ADS101 was well-tolerated in a 13-week GLP study in NHP. Interest from potential partners remains high for this program. Additionally, we are progressing on a bispecific program with a novel arm in conjunction with our PL1A antibody. We'll share more details on this program at a later date for competitive reasons. ABS 101 exemplifies the power of our generative AI platform, demonstrating our capability to rapidly engineer therapeutics with precision. With a growing pipeline of AI-designed antibodies, we're accelerating our mission of bringing better biologics to patients faster. Turning to ABS-201, our potential groundbreaking anti-prolactin receptor antibodies for androgenetic alopecia, commonly known as male and female pattern hair loss. This condition affects approximately 80 million adults in the U.S. alone. and hasn't seen significant therapeutic innovation in nearly 30 years. ABS-201 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. We believe ABS-201 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 have previously shown in preclinical models that ABS-201 outperform minoxidil in hair regrowth. Today, we're pleased to share results from a recent NHP study confirming ABS-201's extended half-life and potential to translate into the dosing interval of every 8 to 12 weeks in humans. The data also indicates excellent subcutaneous bioavailability of greater than 90% in NHPs. The observed PK profile is projected to result in substantial exposure in skin and hair follicles at clinically relevant doses. We believe ABS-201 also supports high concentration formulation potential of greater than 150 mgs per mil, facilitating patient convenience. We're advancing rapidly towards the clinic with guidance from a network of leading hair and dermatology experts. ABS-201 continues IND-enabling studies for the phase one trial expected in early 2026 and interim efficacy data anticipated later that year. Given its potentially promising profile, defined development path, and large market, we plan to develop ABS-201 internally through later stage clinical development and proof of concept to retain maximum value. We're also progressing on two other additional programs. ABS-301. 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. ABS501, a potential best-in-class anti-HER2 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 AbSci success, and we must constantly strive for improvement. Recent initiatives like the National Security Commission on Emerging Biotechnology report support U.S. leadership in biotech, aligning closely with our mission, a topic I spoke passionately about at the 2023 U.S. 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 biosimulation 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. In conclusion, AbbVie remains committed to leading biotech innovation, harnessing AI to deliver life-changing treatments. Thank you to our talented team, the dedicated and limiters 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.