AbCellera Biologics Pivots to In-House Pipeline, Teases Q3 Phase II Data for ABCL635 Hot Flashes

Key Points

• AbCellera is shifting from a partnership-driven discovery model to advancing an internal clinical pipeline, having built end-to-end capabilities including an on-site GMP facility and reporting about $700 million in available liquidity to fund programs.
• Lead candidate ABCL635 is a first-in-class anti-NK3R antibody for menopausal hot flashes with a once-monthly autoinjector profile, and management expects a Phase II readout in Q3 while estimating a U.S. addressable market near $6 billion.
• Key risks and next steps: the Phase II (~80 patients) will determine if an antibody can engage the relevant brain region (potential safety advantages over small molecules were noted), and if successful AbCellera plans a registrational trial in 2027 and expansion into related indications.

AbCellera Biologics NASDAQ: ABCL is shifting from a partnership-driven discovery business toward advancing its own internally developed clinical pipeline, Chief Financial Officer Andrew Booth said during a company presentation. Booth highlighted the company’s cash position, expanded end-to-end capabilities—including GMP manufacturing—and the near-term focus on a Phase II readout for its lead program ABCL635 in menopausal hot flashes.

From partnership model to internal pipeline

Booth said AbCellera was spun out of University of British Columbia professor Carl Hansen’s lab, with Hansen serving as founding CEO. In its first eight years, the company focused on “rebuilding the front end of drug discovery” for therapeutic antibodies using newer technologies. AbCellera then took those capabilities to market in a partnership model, working with large pharmaceutical companies and biotechs on partner-chosen targets, while retaining downstream economics through milestones and royalties.

Booth described the approach as capital efficient, noting the company “managed to not raise very much money at all” during that period. He added that partners typically brought AbCellera “very, very hard stuff,” citing major pharmaceutical companies that relied on AbCellera’s technical angles for difficult discovery problems.

COVID antibodies, cash position, and expanded capabilities

Booth said that around 2020 the company completed its first significant private raise and served as the discovery engine behind Eli Lilly’s COVID-19 antibodies, which he said went to about 2.5 million patients and were estimated to have saved “tens of thousands of lives.” He said AbCellera’s royalty on those products “filled up our balance sheet with probably about $1 billion worth of cash,” alongside proceeds from the company’s IPO and Canadian government support.

According to Booth, that funding helped AbCellera build capabilities across the development chain, including target work, discovery, development, translational sciences, process development, cell line development, and GMP manufacturing. He said the company now has its own GMP facility and expects to manufacture its therapeutic antibodies internally going forward.

While the partnership business has included more than 100 antibody programs, Booth said the company’s downstream participation portfolio remains difficult for the market to value because it is still early-stage. He noted there are “16 or 17 molecules” in the clinic where AbCellera has downstream participation, but said he believes the market assigns “precisely zero value” to that portfolio today because few partnered programs have reached late-stage development.

Pipeline focus: difficult targets and clinical cadence

Booth said AbCellera is focused on difficult-to-drug targets such as ion channels and GPCRs, arguing these complex membrane proteins represent a competitive differentiation because it can be challenging to find antibodies that bind them. He also cited multi-specific capabilities and “next generation ADCs,” and emphasized the company is “indication agnostic,” selecting targets where its technology can address the underlying problem rather than limiting itself to a single therapeutic area.

He said AbCellera has more than 20 programs in discovery and sizes its portfolio to advance “about one-two programs a year” into the clinic, depending on scientific conviction. Booth added that the company now has two clinical programs in the clinic and two more expected to enter the clinic “sometime in next year or about a year from now.” He also referenced “about $700 million in available liquidity,” which he said provides capital to continue advancing the pipeline.

Lead program ABCL635: Phase II data expected in Q3

Booth spent much of the presentation on ABCL635, which he described as a first-in-class antibody targeting the neurokinin 3 receptor (NK3R), a GPCR implicated in menopausal hot flashes. He said the target has been validated by two approved small-molecule drugs: Astellas’ fezolinetant and Bayer’s elinzanetant. However, he framed a key scientific question for ABCL635 as whether an antibody can effectively engage the target in the relevant brain region.

Booth outlined AbCellera’s commercial rationale, stating the company estimates about 12 million U.S. women experience moderate-to-severe hot flashes at any point in time, with symptoms lasting seven to 10 years. He said about half seek treatment, and that contraindications or tolerability issues for hormone replacement therapy encompass roughly 20% of those patients—about 1.2 million women. Using an estimated $5,000 annual net price for non-hormonal options, he pegged the total addressable market at roughly $6 billion.

He also pointed to safety considerations with existing small molecules, including liver monitoring requirements and, in the case of fezolinetant, a boxed warning. Booth said Astellas reached about $300 million in its second year of sales despite those requirements, and he cited the company’s peak sales expectations of $1 billion to $1.7 billion, with similar expectations referenced for Bayer’s product.

AbCellera’s target product profile for ABCL635 includes a once-monthly subcutaneous injection delivered by autoinjector, with a “clean safety signal” and no somnolence. Booth said elinzanetant’s dual NK1R/NK3R activity is associated with somnolence and that the company does not expect either liver toxicity or somnolence with a monoclonal antibody. He also cited a patient survey in which more than half of respondents preferred a monthly self-administered injection over a daily oral option if efficacy and safety were the same; among those with autoinjector experience, the preference rose above 75%.

Booth said AbCellera plans to disclose ABCL635 preclinical and Phase I data—including safety and PK/PD—at its May 11 earnings call, after previously intending to release preclinical, Phase I, and Phase II data together. He described the Phase II trial as a double-blind, placebo-controlled study in about 80 patients with moderate-to-severe hot flashes, measuring frequency and severity endpoints that he said are registrational. Booth said the Phase I and Phase II trials are being run exclusively in Canada, which he described as a first, and tied the effort to work with the governments of Canada and British Columbia.

During Q&A, Booth said the mechanism behind liver toxicity observed with the small molecules is believed to be related to hepatic metabolism and “not believed to be an on-target effect.” He said AbCellera will closely monitor potential liver toxicity and that the company “feel[s] very good about the safety signal” seen in Phase I, with data to be provided May 11.

Other programs and next steps

Booth briefly discussed ABCL575, an OX40 ligand program he said is similar to Sanofi’s amlitelimab. He noted Sanofi has had a “somewhat disappointing readout” with safety signals and said AbCellera’s intent is to complete Phase I and evaluate partnering opportunities, but the company does not currently intend to advance ABCL575 into Phase II.

Looking ahead, Booth said that if ABCL635 is successful, AbCellera would pursue additional hot flash indications related to cancer treatment, including breast and prostate cancer patients receiving androgen deprivation therapy. He also cited ABCL688 (autoimmunity) and ABCL386 (oncology) as in IND-enabling studies, with an intent to bring them into the clinic in 2027, along with another program as a “stretch goal.” Booth added that if ABCL635 performs well, AbCellera would aim to move quickly into a registrational trial starting in 2027.

Asked about the possibility of a head-to-head pivotal trial versus competitors, Booth said the company has considered it but has not made decisions, and will wait for Phase II efficacy results and biomarker data. He described biomarker work from Phase I—testosterone reduction in males as a measure of pathway inhibition—as supportive of target engagement, while emphasizing that the remaining unknown is whether that translates into reduced hot flash frequency and severity. Booth also noted a remaining scientific risk: NK3R is expressed in the preoptic nucleus, which small molecules may reach, but the antibody is not expected to reach—something he said the Phase II trial should help address.

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.

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