AbCellera Biologics NASDAQ: ABCL said its first quarter of 2026 was marked by progress in its internal drug pipeline, including interim Phase 1 data for its lead program, ABCL635, and continued preparation for multiple clinical catalysts expected over the next two years.
President and CEO Dr. Carl Hansen said the company entered 2026 in a “strong financial position,” with major platform and infrastructure projects “substantially complete” and its internal pipeline positioned for several upcoming readouts. The company’s priorities for the year include top-line data for ABCL635 and ABCL575, advancing ABCL688 and ABCL386 through IND-enabling activities, and adding at least one new development candidate.
The most closely watched milestone is the Phase 2 readout for ABCL635, which Hansen said remains expected in the third quarter of 2026. The program is being developed as a potential first-in-class antibody medicine for the non-hormonal treatment of moderate to severe vasomotor symptoms, or hot flashes, associated with menopause.
ABCL635 Moves Forward After Interim Phase 1 Data
Chief Medical Officer Dr. Sarah Noonberg presented interim Phase 1 data for ABCL635, an antibody targeting NK3R, a GPCR target that has been clinically validated in hot flashes. The Phase 1 trial was a randomized, double-blind, placebo-controlled study in healthy volunteers, including a single ascending dose portion and a multiple ascending dose portion.
Noonberg said unblinded data from the single ascending dose portion showed that ABCL635 was “generally well-tolerated.” Across cohorts, there were no reports of serious adverse events, severe adverse events, adverse events leading to discontinuation, or liver toxicity. She said the absence of liver-related adverse events was “an important differentiator” for the program.
The overall incidence of any adverse event was 50% in both the ABCL635 treatment group and the pooled placebo group. Most reported adverse events were grade 1. Noonberg said the only potential signal was self-limiting headache clustered in the 900 mg cohort, generally mild and resolving without complication. No headache adverse events were reported in the 600 mg cohort.
ABCL635 also showed pharmacokinetic characteristics that the company believes support monthly subcutaneous dosing. Noonberg said the drug exhibited “favorable linear pharmacokinetics” across doses, with low variability and an estimated half-life of about 24 days.
Company Highlights Target Engagement Data
A key question for the program was whether an antibody could access NK3R in the hypothalamus. Noonberg said testosterone levels in men were used as a surrogate biomarker for NK3R target engagement, based on prior validation in the early development of the small molecule fezolinetant.
According to Noonberg, a single dose of ABCL635 produced sustained, dose-dependent testosterone suppression in men over a four-week period, with recovery to baseline by eight to 12 weeks. She said doses of 300 mg, 600 mg and 900 mg were associated with sustained testosterone reductions of 50% to more than 75% for several weeks. The company also observed dose-dependent suppression of FSH and LH at those doses.
“Based on these pharmacodynamic data, we feel confident that ABCL635 is able to reach the KNDy neurons in the infundibular nucleus, and we have addressed an important scientific risk for this program,” Noonberg said.
The ongoing Phase 2 portion is a randomized, double-blind, placebo-controlled, multicenter study of approximately 80 patients with moderate to severe vasomotor symptoms. Participants receive a single 600 mg dose of ABCL635 or placebo. The primary efficacy endpoint is at four weeks, with patients followed for an additional eight weeks to evaluate drug concentration and efficacy relationships.
Noonberg said the Phase 2 study is enrolling well and remains on track for top-line efficacy and safety data in the third quarter. If successful, the company plans to discuss a late-stage development program for menopause-associated vasomotor symptoms and evaluate potential use in hot flashes associated with breast and prostate cancer treatments.
Additional Pipeline Readouts Expected
Hansen said AbCellera expects a top-line Phase 1 readout for ABCL575 in the fourth quarter of 2026. The company describes ABCL575 as a potential best-in-class OX40L antagonist. Hansen reiterated that AbCellera’s plan is to complete Phase 1 studies before seeking a partner and that the company does not currently intend to develop the program beyond Phase 1 on its own.
Beyond ABCL635 and ABCL575, Hansen said the company is on track to have up to three additional clinical-stage programs by the end of 2027. That includes undisclosed programs ABCL688 and ABCL386, which he said are expected to begin clinical development in Phase 1/2 studies with a path to early proof of concept in patients. The company also aims to select a fifth development candidate in the first half of 2026.
First-Quarter Financial Results
Chief Financial Officer Andrew Booth said AbCellera ended the quarter with approximately CAD 531 million in cash equivalents and marketable securities, down CAD 30 million from the prior quarter. He said the company has roughly CAD 125 million in available committed government funding, bringing available liquidity to approximately CAD 655 million.
Revenue for the quarter was about CAD 8 million, compared with approximately CAD 4 million in the same quarter of 2025, consisting mostly of research fees. Booth said research fee revenue is expected to trend lower as the company focuses on its internal pipeline.
Research and development expenses were approximately $47 million, about $4 million higher than a year earlier, reflecting investment in internal programs. Sales, general and administrative expenses were about $12 million, compared with roughly $19 million last year. Booth said the more than 35% decrease was related to the conclusion of intellectual property litigation and team changes tied to the internal pipeline focus.
AbCellera reported a net loss of roughly $43 million for the first quarter, compared with a loss of about $46 million a year earlier. The loss was $0.14 per share on a basic and diluted basis. Booth said the company continues to believe it has sufficient liquidity to fund at least the next three years of pipeline investments.
Management Addresses Development Questions
During the question-and-answer session, analysts focused heavily on the interpretation of ABCL635’s testosterone suppression data and how it may translate into efficacy for patients with hot flashes. Hansen cautioned that the biomarker is not a direct measure of efficacy, saying the Phase 2 trial is designed to answer that question.
Hansen said the company’s base commercial profile for ABCL635 would be a product with efficacy comparable to small molecules, a cleaner safety profile without liver monitoring and once-monthly subcutaneous dosing. Noonberg added that the 12-week follow-up in Phase 2 should help the company build a pharmacokinetic and pharmacodynamic model to support discussions with regulators about late-stage development.
About AbCellera Biologics NASDAQ: ABCL
AbCellera Biologics Inc NASDAQ: ABCL is a biotechnology company specializing in the discovery and development of therapeutic antibodies. The company's technology platform integrates single-cell screening, microfluidics, high-throughput sequencing and artificial intelligence to rapidly identify and optimize antibody candidates against a wide range of disease targets. By combining experimental data with machine learning, AbCellera accelerates early-stage drug discovery and improves the efficiency of lead candidate selection.
AbCellera primarily operates through partnerships with pharmaceutical and biotechnology firms, offering its antibody discovery services on a fee-for-service and milestone-driven basis.
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