AbCellera Biologics (NASDAQ:ABCL) said it expects to report top-line data “very soon” from its Phase I study of ABCL635, an antibody being evaluated for moderate-to-severe vasomotor symptoms, or hot flashes, associated with menopause.
President and Chief Executive Officer Dr. Carl Hansen said enrollment and initial dosing in the study of post-menopausal women were completed in June, ahead of schedule. The company previously reported interim Phase I data in healthy male volunteers that showed target engagement, which supported advancing the program into the patient study.
ABCL635 Data Expectations and Development Plans
During the question-and-answer session, Hansen said AbCellera is seeking a clean safety profile and efficacy comparable with that of approved small-molecule treatments. On hot-flash frequency, the company is looking for a placebo-adjusted response “on the order of 20% at least,” along with a reduction of at least two hot flashes per day.
The forthcoming top-line release will include four-week data for all patients, Hansen said. It will not include 12-week data for a subset of patients. The Phase I study used a single dose of ABCL635, and the company expects the treatment effect to diminish by 12 weeks as drug levels decline.
AbCellera has emphasized potential safety and convenience differentiation for ABCL635. Hansen said the company has not observed a perceptible increase in liver enzymes in the data reviewed to date. He noted that approved small-molecule treatments have liver-monitoring requirements, while AbCellera believes an antibody should avoid liver effects associated with small-molecule metabolism.
Hansen also said ABCL635 is designed to be specific to the NK3R target and is not expected to produce somnolence associated with binding to NK1R. The company is considering once-monthly dosing as a potential convenience advantage.
Still, Hansen characterized the role of blocking NK3R in the medial preoptic nucleus as a remaining scientific question for the program. He said the company’s earlier Phase I data demonstrated profound and sustained testosterone suppression, indicating target engagement in KNDy neurons believed to be key drivers of vasomotor symptoms. The upcoming patient data will help answer whether activity in other areas of the brain is also needed for clinical efficacy.
AbCellera said it sees an opportunity among women who cannot use hormone therapy, as well as patients experiencing hot flashes related to breast-cancer and prostate-cancer treatment. Hansen estimated that more than 1 million women in the U.S. could benefit from a non-hormonal option, though he said it was too early to discuss the precise design of a potential Phase III program.
Broader Pipeline Progress
Elsewhere in the internal pipeline, Hansen said ABCL688 and ABCL386 continue through investigational-new-drug-enabling activities and are expected to enter Phase I/II studies in 2027. The company plans to disclose additional information when those programs reach the clinic.
AbCellera’s Phase I study of ABCL575 has completed dosing and remains on track for a fourth-quarter readout. The company said it intends to complete Phase I studies for ABCL575 but currently does not plan to advance the program beyond that stage.
Hansen also said the company did not meet its prior goal of moving another program into IND-enabling activities during the first half of 2026, though he said discovery work was making progress.
T-Cell Engager Partnerships Expand
The company highlighted new business-development activity around its T-cell engager, or TCE, platform. Hansen said AbCellera has spent five years building capabilities in TCE discovery, including antibody panels, costimulatory antibodies, protein-engineering workflows, in vitro assays and translational models.
AbCellera recently entered TCE collaborations with Vertex Pharmaceuticals and Jazz Pharmaceuticals, following an earlier TCE collaboration with AbbVie.
- Vertex: The collaboration focuses on TCEs for autoimmune diseases and other conditions. AbCellera will receive $28 million in upfront payments and is eligible for additional milestone payments and tiered royalties on net sales. The agreement also includes a potential option for AbCellera to conduct process development and clinical manufacturing.
- Jazz: The agreement includes three confirmed discovery programs and $84 million in near-term upfront payments. AbCellera has received $56 million for the first two programs and expects another $28 million when the third program begins within 12 months. The company is eligible for more than $2 billion in potential downstream payments and mid-single-digit to low-double-digit tiered royalties. With two possible additional programs, the potential value could exceed $4 billion.
Hansen said AbCellera does not expect a major change in its resource allocation to TCEs, but its work is shifting from building foundational capabilities to executing internal and partner programs. He said the company continues to devote significantly more effort to its GPCR and ion-channel activities than to TCEs.
Second-Quarter Financial Results
Chief Financial Officer Andrew Booth reported approximately $4 million in second-quarter revenue, compared with roughly $17 million in the same quarter of 2025. Revenue during the latest quarter consisted primarily of research fees.
Research and development expenses totaled about $46 million, up approximately $7 million from a year earlier, reflecting investment in internal programs. Sales, general and administrative expenses declined to about $14 million from $22 million, which Booth attributed to the conclusion of intellectual-property litigation and changes to teams following the company’s focus on its internal pipeline.
AbCellera reported a net loss of roughly $55 million, or $0.18 per share, compared with a loss of about $35 million a year earlier.
The company ended the quarter with $567 million in total cash and marketable securities, including approximately CAD$420 million invested in short-term marketable securities. Booth said AbCellera also has roughly $110 million in committed government funding available, resulting in more than CAD$675 million of available liquidity when unused secured government funding is included. The company believes it has sufficient liquidity to fund at least the next three years of pipeline investments.
AbCellera also appointed Dr. Victor Sandor and Dr. Lynn Seely as independent directors. Hansen said the two executives bring development experience spanning oncology, women’s health, immunology and endocrinology.
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.
