AbCellera Biologics (NASDAQ:ABCL) plans to advance its experimental hot flash treatment ABCL635 into late-stage development in 2027 after reporting positive mid-stage results, while shelving further development of a separate antibody candidate for now.
On its third-quarter earnings call, the company also reported a narrower net loss and said it had more than $890 million in available liquidity, including committed government funding.
Hot Flash Treatment Moves Toward Late-Stage Studies
ABCL635 is an investigational non-hormonal antibody for moderate to severe vasomotor symptoms, or hot flashes. The Phase II trial evaluated efficacy and safety four weeks after a single 600-milligram injection.
At four weeks, patients receiving ABCL635 had an average reduction of 8.8 moderate or severe hot flashes per day, compared with a reduction of 3.5 per day in the placebo group, President and CEO Carl Hansen said. That represented an 83% reduction from baseline for the treatment group, compared with 33% for placebo.
Mean severity scores fell 1.4 points in the treatment group and 0.3 points in the placebo group. Hansen said 37% of treated participants reported complete resolution of moderate or severe events at four weeks, compared with 2.2% of those receiving placebo.
Hansen said the observed treatment effect compared favorably with results from separate studies of approved non-hormonal therapies fezolinetant and elinzanetant, while acknowledging the limitations of cross-trial comparisons.
More patients receiving ABCL635 reported at least one adverse event than those on placebo, but there were no serious or severe adverse events in the treatment group during the first four weeks, Hansen said. Headache and fatigue were reported more frequently among treated patients. He said the study showed no evidence of gastrointestinal toxicity or a clear signal of liver toxicity.
AbCellera expects to release 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; the later observations are intended to help model the relationship between drug exposure and response for 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. It also plans trials next year in patients experiencing hot flashes associated with breast and prostate cancer treatments.
New Pipeline Programs and ABCL575 Decision
AbCellera introduced ABCL992, a longer-acting version of ABCL635 that entered activities required to support an investigational new drug application in the third quarter. Hansen said the company is not yet ready to disclose how it will position the two products, but emphasized that it remains committed to ABCL635.
Hansen said ABCL992 is not expected to enter clinical trials in 2027 and could do so in 2028. Two other candidates, ABCL688 and ABCL386, are on timelines that would bring them into the clinic in 2027, he said.
The company also announced ABCL385, an oncology program for an undisclosed indication, and ABCL646, an antibody antagonist against an undisclosed ion channel target. AbCellera does not expect to provide further details on those programs until they enter clinical development.
Separately, AbCellera said it does not currently plan to develop ABCL575 beyond Phase I. Hansen attributed the 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 participants receiving the antibody reported at least one adverse event, compared with 60% on placebo. The observed mean half-life was approximately 55 days, supporting potential dosing once a quarter or less frequently, she said.
Loss Narrows as Liquidity Tops $890 Million
Third-quarter revenue was more than $10 million, compared with approximately $9 million a year earlier, and consisted mostly of research fees, Chief Financial Officer Andrew Booth said. Research and development expenses were approximately $44 million, while sales, general and administrative expenses were approximately $14 million.
AbCellera reported a net loss of roughly $41 million, or $0.13 per share, compared with a loss of about $57 million in the prior-year quarter. Booth attributed the decline in administrative expenses in part to the conclusion of intellectual property litigation and team changes associated with the company’s focus on its internal pipeline.
The company ended the quarter with more than $790 million in cash and marketable securities after completing a $200 million equity raise. Including more than $100 million in available committed government funding, AbCellera had over $890 million in available liquidity, Booth said. He said the company believes it has sufficient liquidity to fund at least the next three years of pipeline investments.
About AbCellera Biologics (NASDAQ:ABCL)
AbCellera Biologics Inc is a biotechnology company headquartered in Vancouver, Canada. It discovers and develops antibody-based medicines, using laboratory and computational tools to identify and optimize antibodies that may be developed into treatments for disease.
The company works with pharmaceutical and biotechnology partners on antibody discovery and drug development, while also advancing a portfolio of its own therapeutic candidates. Its work spans early-stage research through preclinical and clinical development, with programs focused on areas including cancer and immune-related diseases.
Founded in 2012, AbCellera has collaborated with global partners, including Eli Lilly, on antibody treatments for COVID-19.
