Announced positive interim Phase 1 data from the HEADLINE™ trial of ABS-201
Completed
Cash, cash equivalents, and marketable securities now sufficient to fund operations into the second half of 2028
“The positive Phase 1 interim data from our HEADLINE trial, combined with our strengthened balance sheet and advancing platform, position us well for what comes next,” said
Recent Highlights
- Reported positive interim Phase 1 data from
Absci's first-in-human trial of ABS-201 (anti-PRLR antibody). Blinded, aggregate interim data suggest study drug was well tolerated and exhibited a favorable safety and tolerability profile. Based on available interim pharmacokinetic (PK) data across all four single ascending dose (SAD) cohorts, half-life for ABS-201 is estimated to be at least 65 days. These results support the potential for dosing two or three times over a six month period, pending confirmation through continued follow-up across all cohorts. - Completed
$100 million underwritten offering, including a$40 million strategic equity investment from Eli Lilly & Company, and participation from leading financial institutions including Adage,BVF Partners ,Columbia Threadneedle ,Invus , Redmile, and a large investment management firm. - Continuing to dose participants with pattern hair loss (PHL) in multiple ascending dose (MAD) portion of the HEADLINE trial.
Absci anticipates reporting interim proof-of-concept data from this study in the second half of 2026 and full proof-of-concept data in early 2027.
Prolactin (PRL) Program Portfolio
- ABS-201 for Pattern Hair Loss: ABS-201, currently undergoing Phase 1/2a studies, is being developed for pattern hair loss (PHL).
Absci believes that ABS-201, if successfully developed and approved, could provide a significant new category of PHL treatment that offers the potential for durable hair growth with a convenient administration profile. In June,Absci announced positive interim Phase 1 data from the HEADLINE trial, demonstrating that the study medication appears well tolerated, with favorable safety data across all blinded single ascending dose (SAD) cohorts. Additionally, the estimated half-life of at least 65 days supports the potential for ABS-201's targeted dosing interval of two or three injections over a six-month period.Absci anticipates reporting interim proof-of-concept data in the second half of 2026 and full proof-of-concept data in early 2027. - ABS-201 for Endometriosis: Endometriosis is a condition that impacts a large, underserved patient population with significant unmet medical need and poor standard of care. Endometriosis is prevalent in up to 10% of women worldwide, including an estimated 9 million women in the
U.S ., and there is currently noFDA -approved disease-modifying therapy. ABS-201 for endometriosis represents a novel non-sex steroid hormone mechanism, with potential to be disease-modifying, act on both pain and lesion growth, and offer an improved safety profile. With the safety, tolerability, and PK data generated in the ongoing HEADLINE trial,Absci anticipates initiation of a Phase 2 clinical trial for endometriosis in the fourth quarter of 2026, with potential proof-of-concept data in the second half of 2027. - ABS-202 for Undisclosed I&I Indication: ABS-202 is an anti-PRLR antibody in preclinical development for an undisclosed I&I indication.
Other Internal Pipeline Programs and Partnerships
Absci’s new partnership with Eli Lilly is tailored around the clinical development strategy for ABS-201, and does not confer any program rights to Eli Lilly. As part of Eli Lilly’s
- mAbs 2026: "Efficient inference of non-polyreactive antibody variants dependent on local fine-tuning"
Accepted Presentations and Abstracts
American Academy of Dermatology Innovation Academy (AAD) 2026: "ABS-201, an AI-designed Antibody, Blocks Prolactin/PRLR Signaling and Presents a Novel Biologic Strategy for the Treatment of Androgenetic Alopecia"- Summer RosettaCon 2026: "Origin-1: A Generative AI Platform for De Novo Antibody Design Against Novel Epitopes"
- Third Barcelona Hair Meeting 2026: "ABS-201-Mediated Prolactin Receptor Inhibition Promotes Hair Growth in Androgen-Sensitive Male Scalp"
European Academy of Dermatology andVenereology Congress (EADV) 2026: "Prolactin Receptor Antagonism by ABS-201 Drives Hair Follicle Growth and Stem/Progenitor Cell Expansion in Human Male Scalp Skin"American Society for Reproductive Medicine (ASRM) 2026: "Prolactin Receptor Blockade With Anti-Prolactin Receptor Antibody (Anti-PRLR Ab) Relieves Pain and Inflammation in a Homologous Transplant Mouse Model of Endometriosis"
Second Quarter 2026 Financial Results
Revenue was
Research and development expenses were
Selling, general, and administrative expenses were
Net loss was
Cash, cash equivalents, and marketable securities as of
Based on the company's current projections,
Webcast Information
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.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding any or all of the following: development and clinical progress of Absci's pipeline programs, including ABS-201, the design, enrollment, conduct, and timelines of our ongoing Phase 1/2a HEADLINE™ trial of ABS-201 for androgenetic alopecia; the anticipated timing of an interim proof-of-concept data readout for ABS-201 in the second half of 2026; the potential advancement of ABS-201 into Phase 3 development; the anticipated initiation of a Phase 2 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 terms, anticipated benefits and strategic rational of our collaboration with Elil Lilly including Eli Lilly's participation in our Endometriosis Advisory Board; 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 in pattern hair loss and endometriosis; projections regarding potential market opportunity 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; the capabilities, development, and anticipated benefits of our ATLAS platform; Absci’s strategy, goals, anticipated financial performance and the sufficiency of its cash, cash equivalents and marketable securities to fund operating plans into the second half of 2028; and expected benefits of its collaborations with partners. Risks that contribute to the uncertain nature of the forward-looking statements include, without limitation, the risks and uncertainties discussed under the heading “Risk Factors” in Absci Corporation’s most recent annual report on Form 10-K and in any other subsequent filings made by Absci Corporation with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. We disclaim any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.
Investor Contact:
Alexander D.H. Khan
Corporate Vice President
Head of Investor Relations
investors@absci.com
Media Contact:
press@absci.com
| Unaudited Condensed Consolidated Statements of Operations | ||||||||||||||||
| For the Three Months Ended | For the Six Months Ended | |||||||||||||||
| (In thousands, except for share and per share data) | 2026 | 2025 | 2026 | 2025 | ||||||||||||
| Revenues | ||||||||||||||||
| Partner program revenue | $ | 318 | $ | 593 | $ | 533 | $ | 1,772 | ||||||||
| Operating expenses | ||||||||||||||||
| Research and development | 22,616 | 20,458 | 41,891 | 36,822 | ||||||||||||
| Selling, general and administrative | 9,164 | 8,528 | 18,222 | 18,000 | ||||||||||||
| Depreciation and amortization | 2,696 | 3,000 | 5,424 | 6,072 | ||||||||||||
| Total operating expenses | 34,476 | 31,986 | 65,537 | 60,894 | ||||||||||||
| Operating loss | (34,158 | ) | (31,393 | ) | (65,004 | ) | (59,122 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Interest expense | (2 | ) | (56 | ) | (20 | ) | (135 | ) | ||||||||
| Other income, net | 990 | 1,011 | 2,273 | 2,469 | ||||||||||||
| Total other income, net | 988 | 955 | 2,253 | 2,334 | ||||||||||||
| Loss before income taxes | (33,170 | ) | (30,438 | ) | (62,751 | ) | (56,788 | ) | ||||||||
| Income tax expense | (40 | ) | (131 | ) | (58 | ) | (127 | ) | ||||||||
| Net loss | $ | (33,210 | ) | $ | (30,569 | ) | $ | (62,809 | ) | $ | (56,915 | ) | ||||
| Net loss per share: Basic and diluted | $ | (0.21 | ) | $ | (0.24 | ) | $ | (0.40 | ) | $ | (0.45 | ) | ||||
| Weighted-average common shares outstanding: Basic and diluted | 157,471,712 | 127,592,948 | 155,217,585 | 126,035,844 | ||||||||||||
| Unaudited Condensed Consolidated Balance Sheets | ||||||||
| (In thousands, except for share and per share data) | 2026 | 2025 | ||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 107,865 | $ | 20,025 | ||||
| Marketable securities | 93,277 | 124,267 | ||||||
| Prepaid expenses and other current assets | 7,124 | 5,281 | ||||||
| Total current assets | 208,266 | 149,573 | ||||||
| Operating lease right-of-use assets | 2,442 | 2,914 | ||||||
| Property and equipment, net | 16,721 | 20,860 | ||||||
| Intangibles, net | 40,051 | 41,514 | ||||||
| Restricted cash, long-term | 1,054 | 1,053 | ||||||
| Other long-term assets | 383 | 383 | ||||||
| TOTAL ASSETS | $ | 268,917 | $ | 216,297 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 16,257 | $ | 19,348 | ||||
| Long-term debt | 150 | 873 | ||||||
| Operating lease obligations | 2,037 | 1,805 | ||||||
| Deferred revenue | 1,154 | 739 | ||||||
| Total current liabilities | 19,598 | 22,765 | ||||||
| Operating lease obligations, net of current portion | 1,642 | 2,624 | ||||||
| Deferred revenue, long-term | 240 | 436 | ||||||
| Other long-term liabilities | 1,306 | 1,023 | ||||||
| TOTAL LIABILITIES | 22,786 | 26,848 | ||||||
| STOCKHOLDERS' EQUITY | ||||||||
| Preferred stock | — | — | ||||||
| Common stock | 17 | 15 | ||||||
| Additional paid-in capital | 933,557 | 813,627 | ||||||
| Accumulated deficit | (687,593 | ) | (624,784 | ) | ||||
| Accumulated other comprehensive income | 150 | 591 | ||||||
| TOTAL STOCKHOLDERS' EQUITY | 246,131 | 189,449 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 268,917 | $ | 216,297 | ||||
