AbCellera Biologics (NASDAQ:ABCL) is working to evolve from a technology-enabled drug discovery partner into what the company described as an integrated biotech with internal programs advancing through mid- to late-stage development, according to comments from Senior Director of Strategic Finance and Investor Relations Martin Hogan during a KeyBanc Virtual Healthcare Forum fireside chat.
Building an integrated antibody discovery and development platform
Hogan said AbCellera’s journey spans roughly 13 years, with significant technology investment during its first decade to build capabilities ranging from target nomination through manufacturing drug product for antibody-based therapeutics. He said experience across more than 100 drug discovery programs has helped AbCellera assemble an integrated capability intended to pursue difficult antibody targets. That platform, he said, has supported partner programs that can generate downstream stakes, while also enabling a growing pipeline of internal programs.
How AbCellera prioritizes programs
In discussing how the company allocates resources across its portfolio, Hogan outlined four criteria AbCellera applies to evaluate and prioritize target ideas and pipeline programs:
- Scientific de-risking: a focus on targets where AbCellera believes biology risk is reduced and the remaining challenge is primarily identifying the right antibody or construct to achieve the desired therapeutic effect.
- Unmet need and commercial opportunity: including whether payers are likely to cover a potential therapy adequately.
- Competitive advantage: the potential to differentiate versus current and emerging therapies, with an emphasis on first-in-class opportunities and maintaining an advantage.
- Development path: whether clinical trials can be designed to de-risk (or fail) early, and whether AbCellera has the capabilities and resources to advance a program through meaningful inflection points.
He said the approach has helped shape the company’s pipeline, including its lead program ABCL635, ABCL575, two programs in IND-enabling activities, and roughly 20 earlier-stage programs.
ABCL635: Phase II readout expected in Q3
Hogan said ABCL635 is a first-in-class, non-hormonal treatment being developed for vasomotor symptoms (hot flashes), with an initial focus on menopause-associated hot flashes. He described the drug’s intended mechanism as rebalancing signaling to the body’s thermoregulatory core, which can become disrupted when estrogen drops during menopause.
He noted that menopausal hormone therapy can be a strong first-line option for patients who can use it, but some patients are contraindicated or unable to tolerate it. Hogan characterized moderate to severe hot flashes as debilitating and said that, until just over a year ago, patients without access to hormone therapy had limited effective options. He added that in the past 1.5 years, two small-molecule therapies have entered the market that reduce hot flash frequency and severity, but he highlighted safety and tolerability trade-offs, including liver toxicity (to varying degrees) and, for one drug, somnolence that effectively limits dosing to nighttime.
Hogan said AbCellera’s target product profile for ABCL635 is comparable efficacy with a cleaner safety and tolerability profile, as well as greater convenience through a once-monthly, single auto-injector approach compared with daily oral dosing. He also pointed to an aim to avoid baseline and follow-up liver testing that may be required for some existing therapies.
On clinical progress, Hogan said phase II de-risking began at the end of last year and that AbCellera expects a phase II readout at the end of the third quarter this year. He said AbCellera remains blinded to phase I results, but indicated there had been no safety signals causing concern and that pharmacodynamic information known so far is consistent with a half-life that could support monthly dosing. He emphasized that the phase II portion is designed to provide a clear signal on whether ABCL635 is on track to deliver at least comparable efficacy to available small molecules.
Hogan also discussed potential expansion beyond menopause-associated hot flashes, citing hot flashes experienced by men and women undergoing certain cancer therapies that suppress hormones, including breast cancer and prostate cancer treatments. He said the mechanism is similar and that there is reason to believe efficacy could translate to these settings; he also noted that at least one small molecule is already in clinical trials in this area.
ABCL575: Phase I readout expected in Q4 and partnership focus
Hogan described ABCL575 as an OX40 ligand blocking antibody program positioned as a fast follower to Sanofi’s amlitelimab. He said the program was initiated as a co-development effort with an explicit goal of fast-following amlitelimab, which targets an upstream immune pathway implicated in multiple conditions, including atopic dermatitis, and has shown promising efficacy in certain types of asthma, among other potential indications.
He said ABCL575 scores highly on scientific de-risking, unmet need, and development path, but less so on differentiation due to its fast-follower nature. The company’s aim, he said, is to achieve comparable efficacy and safety, with possible differentiation via a longer dosing profile enabled by a longer half-life that could translate into an extended dosing interval. Hogan said AbCellera remains blinded in the ongoing phase I study, but that information to date is consistent with those goals. He said a phase I readout is expected in the fourth quarter.
Hogan added that ABCL575’s future will depend heavily on the outcome for the class, including whether amlitelimab is approved (which he said is expected at the end of this year), and how it is ultimately used. He also said developing in atopic dermatitis and related conditions can be complex and expensive, and may benefit from prior experience, a strong balance sheet, and combination testing. As a result, he said AbCellera’s plan is to complete phase I, conduct additional work to make ABCL575 phase II-ready, and seek a partner.
Manufacturing, funding, and balance sheet
Hogan said AbCellera has built its own clinical manufacturing capability in the Vancouver area, which he described as uncommon for biotech companies. He attributed the ability to make the investment in part to support from the governments of Canada and British Columbia, saying AbCellera likely would not have made the investment without that support. He said the facility is now manufacturing antibodies.
He outlined several benefits of in-house manufacturing, including speed by avoiding external technology transfer and greater flexibility to address manufacturing hiccups without waiting for a contract development and manufacturing organization’s next available slot. He also said in-house capacity enables parallel work on multiple candidates at lower marginal cost, potentially improving the odds of selecting the best molecule for clinical trials. Hogan further argued that retaining sequences in-house can allow AbCellera to delay patent filing until clinical trial initiation, which he said could effectively provide more than two additional years of patent protection compared with transferring sequences to a CDMO earlier.
On financial resources, Hogan said that at the end of last year AbCellera had about $700 million in cash equivalents, marketable securities, and committed government funding. With major platform and facility investments largely completed last year, he said operating cash usage is “somewhere around $120–$130 million” per year, including preclinical and, to a degree, phase I studies. He said the company describes itself as funded for “3+ years” to advance its strategy and noted that government funding is intended to support building domestic drug discovery and development capabilities, including support for advancing up to 17 programs through phase I clinical trials. He added that if programs advance successfully into pivotal trials, the company could consider bringing in additional investors following positive data.
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.
