AbCellera Advances ABCL635 as Quarterly Loss Narrows

By Tom Whitfield

AbCellera Biologics reported a third-quarter net loss of roughly $41 million, or $0.13 per share, against $57 million a year earlier, with available liquidity above $890 million. It plans 2027 late-stage studies for hot-flash antibody ABCL635, but its chief medical officer does not expect one-dose efficacy to last through 12 weeks.

What does the ABCL635 data show?

ABCL635 is an investigational, non-hormonal antibody targeting moderate to severe vasomotor symptoms, commonly called hot flashes. Its Phase II trial assessed efficacy and safety four weeks after a single 600-milligram injection.

Patients taking ABCL635 reduced their average number of moderate or severe hot flashes by 8.8 per day, compared with 3.5 per day among placebo recipients. The treatment group delivered an 83% reduction from baseline, against 33% for placebo.

Mean severity scores fell 1.4 points for treated patients and 0.3 points for placebo patients. At four weeks, 37% of treated participants reported complete resolution of moderate or severe events, compared with 2.2% on placebo.

President and CEO Carl Hansen said: “The observed treatment effect compared favorably with results from separate studies of approved non-hormonal therapies fezolinetant and elinzanetant.” He also acknowledged the limits of cross-trial comparisons, so the comparison does not establish a head-to-head advantage.

More treated patients reported at least one adverse event than placebo patients, although Hansen reported no serious or severe adverse events in the treatment group during the first four weeks. Headache and fatigue were more frequent among treated patients. The study found no evidence of gastrointestinal toxicity or a clear signal of liver toxicity.

The data support further testing, not conclusions on duration or comparative benefit.

What must happen before the 2027 late-stage plan?

AbCellera expects to publish additional 12-week and open-label extension data in early 2027. Chief Medical Officer Sarah Noonberg said the company “does not expect efficacy from the single dose to be maintained throughout the full 12 weeks.”

Those later observations are intended to map drug exposure against response and guide dose selection. The company is working with the Food and Drug Administration through its Model-Informed Drug Development program and expects to begin late-stage studies in 2027.

The company also plans trials next year in patients experiencing hot flashes associated with breast and prostate cancer treatments.

The 2027 target remains contingent on dose selection and longer follow-up.

How has the pipeline changed?

ABCL992, a longer-acting version of ABCL635, entered activities required to support an investigational new drug application during the third quarter. Hansen said AbCellera is not ready to disclose how it will position the two products, though it remains committed to ABCL635.

ABCL992 is not expected to enter clinical trials in 2027 and could reach the clinic in 2028. ABCL688 and ABCL386 are on timelines that would bring them into the clinic in 2027.

AbCellera also introduced ABCL385, an oncology program for an undisclosed indication, and ABCL646, an antibody antagonist against an undisclosed ion-channel target. The company does not expect to disclose more on either program until clinical development.

AbCellera does not currently plan to develop the antibody ABCL575 beyond Phase I. Hansen attributed that decision to disappointing results for other therapies targeting the OX40 pathway in atopic dermatitis.

Noonberg said ABCL575 showed favorable tolerability and pharmacokinetics in a study of 40 healthy volunteers. About 57% of antibody recipients reported at least one adverse event, compared with 60% on placebo. Its observed mean half-life was approximately 55 days, which could support dosing once a quarter or less frequently.

The pipeline is narrower, with ABCL635 remaining the stated priority.

How did the financial position change?

Third-quarter revenue exceeded $10 million, compared with approximately $9 million a year earlier, and consisted mostly of research fees, CFO Andrew Booth said. Research and development expense was approximately $44 million, while sales, general and administrative expense was about $14 million.

Booth attributed part of the lower administrative expense to the conclusion of intellectual-property litigation and team changes tied to AbCellera’s focus on its internal pipeline. Without a prior-period R&D figure, the full expense bridge behind the narrower loss remains unclear.

AbCellera ended the quarter with more than $790 million in cash and marketable securities after completing a $200 million equity raise. It also had more than $100 million in available committed government funding, taking total available liquidity above $890 million.

Booth said the company believes it has sufficient liquidity to fund at least the next three years of pipeline investments. The three-year funding horizon reduces near-term financing pressure, although it does not settle whether the clinical targets will be met.

Funding buys time; trials must still deliver.

What does AbCellera do?

Founded in 2012 and headquartered in Vancouver, AbCellera develops antibody-based medicines using laboratory and computational tools to identify and optimize antibodies.

The company works with pharmaceutical and biotechnology partners across discovery and development while advancing its own therapeutic candidates from early research through preclinical and clinical stages. Its programs focus on cancer and immune-related diseases. The company has collaborated with global partners, including Eli Lilly, on antibody treatments for COVID-19.

Partnerships support the platform; clinical results will test the pipeline.