AbCellera Biologics NASDAQ: ABCL is emphasizing its transition from a partner-based antibody discovery business to a proprietary drug development company, Chief Financial Officer Andrew Booth said during a company presentation focused on the biotech’s pipeline and lead clinical program.
Booth said the Vancouver-based company, which also has offices in Montreal and Sydney, was founded in 2012 out of CEO Carl Hansen’s lab at the University of British Columbia. AbCellera initially built its business around partnerships, working on more than 100 therapeutic antibody programs and accumulating royalties over roughly a decade.
The company became widely known during the COVID-19 pandemic as the discovery engine behind Eli Lilly’s COVID antibodies. Booth said royalties from those molecules brought in close to $1 billion in non-dilutive funding. AbCellera also partnered with the Canadian government, receiving approximately CAD 400 million to support infrastructure, capabilities and pipeline development.
Company Shifts Toward Proprietary Pipeline
Since 2023, Booth said AbCellera has shifted away from the partnership model and toward its own proprietary pipeline. The company currently has two molecules in the clinic and two more in IND-enabling activities that are expected to enter the clinic in 2027.
Booth said AbCellera remains in a strong liquidity position, with approximately CAD 655 million in total liquidity. He said that funding is expected to support at least the next three years of pipeline advancement, investment and early discovery work.
The company’s historical work with partners helped validate its antibody discovery capabilities, Booth said, particularly for difficult targets such as complex membrane proteins, ion channels and GPCRs. He said AbCellera is also working on novel modalities, including multispecific antibodies and what it describes as next-generation antibody-drug conjugates.
Lead Program Targets Menopause-Related Hot Flashes
AbCellera’s lead molecule is ABCL635, an antibody antagonist targeting the neurokinin 3 receptor, or NK3R. Booth described it as a potential first-in-class antibody for vasomotor symptoms, also known as hot flashes, associated with menopause.
Booth said the company estimates approximately 12 million women in the United States experience moderate to severe hot flashes at any given time, with about 6 million seeking treatment. AbCellera is focusing on patients for whom hormone replacement therapy is not appropriate, including those with contraindications or intolerance. Booth estimated that group represents about 1.2 million women.
He said two small-molecule drugs targeting the pathway have recently been approved: Astellas’ fezolinetant, marketed as VEOZAH, and Bayer’s elinzanetant, marketed as Lynkuet. Booth said Astellas generated about $300 million in second-year sales despite drawbacks including required liver monitoring and a boxed warning. He said Bayer’s drug also requires liver monitoring and carries a warning related to somnolence.
Booth said both drugs are priced at roughly $5,000 annually, implying a potential $6 billion total addressable market for non-hormonal therapies in the patient group AbCellera is targeting.
Phase 1 Data Supports Target Engagement
Booth said AbCellera disclosed Phase 1 data for ABCL635 during its May 11 earnings call. The study included single ascending dose and multiple ascending dose portions and showed what Booth described as a favorable tolerability profile.
He noted that headaches were observed in the 900 mg cohort, but said participants were housed together and were restricted from regular daily activities such as drinking coffee, which the company believes may have contributed. Booth said the company did not observe comparable effects in the 600 mg cohort.
Booth highlighted the absence of a liver signal in the Phase 1 data, saying AbCellera’s results were within or below the upper range of normal across liver-related measurements. He said this supported the company’s view that an antibody, which is not metabolized in the liver, could have a clean safety profile in the indication.
The company is targeting a once-monthly subcutaneous injection. Booth said Phase 1 pharmacokinetic data closely matched AbCellera’s modeling and showed a half-life of about 25 days, supporting the monthly dosing profile.
To assess target engagement, AbCellera measured testosterone suppression in healthy males, a biomarker also used in the development of fezolinetant. Booth said the 600 mg dose, which AbCellera is advancing into Phase 2, produced a stable 60% reduction in testosterone, giving the company confidence that ABCL635 reaches and engages the target.
Phase 2 Readout Expected in Q3
AbCellera is now advancing ABCL635 in a double-blind, placebo-controlled Phase 2 trial involving 80 patients, with 40 in the placebo arm and 40 in the treatment arm. The study will evaluate frequency and severity of hot flashes at four weeks, with 12 weeks of follow-up.
Booth said the remaining biological question is whether suppressing NK3R in the infundibular nucleus is sufficient to reduce hot flashes, or whether engagement inside the preoptic nucleus, which is behind the blood-brain barrier, is also necessary. He said the Phase 2 study is designed to address that question.
The company is using a 600 mg dose in Phase 2, with a target product profile of a 300 mg monthly maintenance dose. Booth said the company’s formulation could support delivery of 300 mg in a single monthly subcutaneous dose using a standard auto-injector.
For the Phase 2 readout, Booth said AbCellera is looking for a statistically significant and clinically meaningful reduction in hot flash frequency and severity at four weeks. He said a reduction of at least two moderate to severe hot flashes per day would be comparable to the efficacy seen with approved small molecules.
Other Pipeline Updates
AbCellera’s second clinical molecule, ABCL575, targets OX40 ligand. Booth said it was originally developed in partnership with EQRx and reverted to AbCellera after EQRx’s business challenges and acquisition by Revolution Medicines. AbCellera has taken the molecule through Phase 1, but Booth said the company does not plan to allocate additional capital beyond completing that stage. It may seek partnering opportunities.
Booth also discussed ABCL688, an autoimmune program, and ABCL386, an oncology program. He said both remain in IND-enabling activities and are on track to enter the clinic in 2027, though the company has not disclosed many details for competitive reasons.
If ABCL635 produces positive Phase 2 data, Booth said AbCellera would look to advance the program into a Phase 3 pivotal trial in 2027. The company also plans to study ABCL635 for vasomotor symptoms in oncology-related settings, including breast cancer patients on tamoxifen and prostate cancer patients experiencing treatment-related hot flashes.
Booth said AbCellera’s broader goal remains to move one to two molecules per year into IND-enabling activities and then into the clinic, supported by its current capital position.
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.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.
Before you consider AbCellera Biologics, you'll want to hear this.
MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and AbCellera Biologics wasn't on the list.
While AbCellera Biologics currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys.
View The Five Stocks Here
Learn the basics of options trading and how to use them to boost returns and manage risk with this free report from MarketBeat. Click the link below to get your free copy.
Get This Free Report
