AbCellera Biologics Pivots to Pipeline as ABCL635 Phase II Hot Flash Data Nears, Exec Says

AbCellera Biologics (NASDAQ:ABCL) is positioning itself as a more pipeline-driven biotechnology company after more than a decade of platform investment, according to comments from Senior Director of Strategic Finance and Investor Relations Martin Hogan at TD Cowen’s 46th Annual Health Care Conference.

Hogan said AbCellera has spent “something like $1 billion” over roughly 13 years to build an end-to-end capability to discover and develop—and now also manufacture drug product—antibody-based therapeutics. He emphasized the company’s focus on difficult target classes, including complex membrane proteins, ion channels, GPCRs, T-cell engagers, and multispecific antibodies. While AbCellera has run more than 100 discovery programs for large biopharma partners—earning research fees and downstream economics such as milestones and royalties—Hogan said the most valuable output has been the platform capability itself, which the company is increasingly applying to internally selected targets.

ABCL635: lead program in menopausal vasomotor symptoms

Hogan highlighted ABCL635 as AbCellera’s lead internal program, with a Phase II readout expected in the third quarter, “probably sometime after Labor Day.” The initial lead indication is vasomotor symptoms (VMS), or hot flashes, associated with menopause. He estimated there are about 12 million women in the U.S. with moderate-to-severe symptoms, describing the condition as meaningfully disruptive.

Menopause hormone therapy (MHT) is an effective first-line treatment for many patients, Hogan said, but he noted that about 12% of women are contraindicated for MHT and about 8% start treatment but cannot tolerate it—leaving roughly one in five women seeking a non-hormonal alternative. He pointed to recently launched small-molecule NK3R inhibitors, including Astellas’ NK3R inhibitor and a Bayer dual NK3R/NK1R inhibitor, but argued there remains unmet need related to safety and tolerability, as well as the burden of liver enzyme monitoring.

AbCellera’s target product profile for ABCL635 is an antibody therapy that is specific to NK3R, which Hogan said could support a “very clean safety and tolerability profile” and a more convenient dosing regimen. He cited market research indicating that about half of women would prefer a monthly auto-injection over a daily oral therapy if safety and efficacy were comparable; among survey respondents with auto-injector experience, preference for auto-injectors rose to 70%.

Early Phase I signals and Phase II study design

ABCL635 is being studied in a combined Phase I/II trial. Hogan said safety data to date look “as clean as we had expected,” and that pharmacokinetic modeling has aligned with observations in humans. He also described a biomarker readout suggesting the drug is engaging its target in humans in a manner consistent with expectations from non-human primate work and with the biomarker behavior seen with a small-molecule comparator. However, he cautioned that Phase II will be needed to confirm clinical impact.

In Phase II, AbCellera plans to enroll 80 women with moderate-to-severe hot flashes in a triple-blinded, randomized, placebo-controlled study with an approximately 2:1 drug-to-placebo allocation, according to Hogan. The Phase I SAD/MAD portion was used to select a Phase II dose, and the Phase II study is intended to deliver an efficacy signal. Hogan said the company’s baseline efficacy goal is to be at least comparable to existing small molecules, with improved safety/tolerability and preferred dosing as key differentiators.

Potential oncology-related expansion for ABCL635

Hogan also discussed plans to expand ABCL635 into VMS associated with cancer therapies, including breast and prostate cancer, based on shared underlying biology. He described the drug’s mechanism as binding NK3R on KNDy neurons, addressing imbalanced signaling that can occur when sex hormone signaling is reduced. He said endocrine therapy in breast cancer and androgen deprivation therapy in prostate cancer can remove hormone signaling in a way that creates a similar imbalance to menopause, suggesting the antibody could work through the same mechanism in those settings.

On timing, Hogan said that following a positive Phase II readout in menopausal VMS, AbCellera would move “quickly” into Phase II trials for cancer-associated or cancer treatment-associated VMS, and would move “at maximum speed” toward registrational trials in menopausal VMS. He said the company would not need to “reinvent the wheel” for Phase III design given precedent from other approved therapies, and suggested 2027 could be a year of rapid execution if the data support it. AbCellera’s goal remains a subcutaneous auto-injector pen for menopausal VMS, while dosing considerations for oncology-related indications may evolve.

ABCL575 and the broader internal pipeline

AbCellera’s second clinical program, ABCL575, targets OX40 ligand. Hogan characterized it as “off strategy” and a “fast follower” approach that originated in collaboration with EQRx, with limited differentiation potential beyond dosing. He said the company remains encouraged by the broader OX40L profile in atopic dermatitis and other immune conditions, citing a “clean safety profile” and efficacy that “doesn’t seem to be tailing off yet at 26 weeks” for a leading molecule in the class. For ABCL575 specifically, Hogan said AbCellera sees potential to improve dosing frequency—depending on what is ultimately approved for the class—through half-life extension.

Hogan said AbCellera expects a data update for ABCL575 by year-end 2026 and indicated the company is considering partnering the asset after Phase I “box-checking,” noting that fully developing and commercializing a drug in the space would require scale and capabilities beyond AbCellera’s current scope.

Beyond the two clinical-stage programs, Hogan said AbCellera has additional assets approaching the clinic, including ABCL688 (autoimmune) and ABCL386 (oncology), both with potential to be first in class. However, he said the company is not yet disclosing targets and indications and intends to “unveil the target and the indication around the time of initiating clinical trials” in order to preserve competitive advantage.

Capital position and manufacturing strategy

Hogan said AbCellera’s new GMP facility completes its major platform investments and supports supply chain control, faster CMC and manufacturing work, and increased flexibility versus relying solely on CDMOs. He also argued in-house manufacturing could extend patent runway by allowing the company to delay filing and sequence disclosure that can be required earlier when working with external manufacturers.

He said AbCellera has $700 million of “cash equivalents and committed government funding,” and estimated the company’s annual run rate is coming down to “somewhere just north of $100 million,” suggesting approximately $120 million per year.

Looking further out, Hogan said AbCellera’s strategy is to continue building a clinical pipeline—potentially with five programs in the clinic within a couple of years—supported by more than 20 programs in discovery and early preclinical development. He added that the company expects to designate a fifth development candidate later this year and emphasized that program selection is guided by internal criteria, with roughly half of programs focused on ion channel and GPCR targets and the remainder leveraging other advanced antibody modalities such as T-cell engagers and multispecifics. Hogan said AbCellera plans to remain flexible on whether to advance programs internally or partner them, depending on value and the presence of a “better owner” for certain assets.

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.