AbCellera to begin Phase 1 trial for menopause treatment

VANCOUVER, British Columbia - AbCellera Biologics Inc. (NASDAQ:ABCL), a biotechnology company with a market capitalization of $609 million, has announced the upcoming start of a Phase 1 clinical trial for its new investigational drug, ABCL635, following Health Canada’s approval of its Clinical Trial Application (CTA). According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt, positioning it well for clinical development activities. This trial, expected to commence in the third quarter of 2025, will assess the safety, pharmacokinetics, and pharmacodynamics of ABCL635 in healthy participants, as well as postmenopausal women experiencing moderate-to-severe vasomotor symptoms (VMS), commonly referred to as hot flashes.

ABCL635 is a potential first-in-class antibody medicine targeting the neurokinin 3 receptor (NK3R), a G-coupled protein receptor implicated in the regulation of temperature. The treatment is being developed as a non-hormonal option for managing VMS associated with menopause, a condition affecting millions of women globally, impacting their quality of life and daily functioning.

The drug is the first from AbCellera’s GPCR and ion channel platform to advance into clinical development. Natalya Nazarenko, MD, Executive Medical Director at AbCellera, expressed optimism about the potential of ABCL635 to provide a long-acting, non-hormonal therapeutic alternative for women dealing with disruptive menopausal symptoms.

AbCellera, a biotechnology firm specializing in the discovery and development of antibody medicines, focuses on a range of therapeutic areas, including cancer, metabolic and endocrine conditions, and autoimmune disorders. The company combines technology, data science, and interdisciplinary teams to tackle complex antibody discovery challenges.

While the press release from AbCellera includes forward-looking statements regarding the potential of ABCL635 and the company’s future plans, it is important to note that such statements are based on current expectations and are subject to risks and uncertainties that may affect actual results. InvestingPro analysis reveals that the company is currently burning through cash quickly, with analysts anticipating a 14% sales decline in the current year. For deeper insights into AbCellera’s financial health and future prospects, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro.

This news is based on a press release statement from AbCellera Biologics Inc., and it marks a significant step in the company’s efforts to expand its pipeline of innovative treatments. The company’s stock, currently trading near its 52-week low with a 45% decline over the past year, shows mixed signals from analysts who maintain a bullish consensus with significantly higher price targets. Investors and industry observers will be closely monitoring the progress of the Phase 1 trial for ABCL635 as it moves forward. InvestingPro subscribers can access 5 additional ProTips and detailed financial metrics to make more informed investment decisions.

In other recent news, AbCellera Biologics reported its financial results for the fourth quarter of 2024, revealing a revenue of $5.1 million, which fell short of the expected $7.58 million. The company’s annual revenue for 2024 was $28.8 million, down from $38.0 million in 2023, with a net loss of $0.55 per share, slightly wider than the previous year’s $0.51 loss per share. Despite these financial challenges, AbCellera announced a new development partnership with AbbVie focused on a T-cell engager platform, highlighting its strategic shift towards internal program development. Additionally, AbCellera received a favorable ruling from the United States Court of Appeals for the Federal Circuit, which upheld the validity of its patent covering microfluidic devices. The company also shared promising preclinical data on its prostate-specific membrane antigen x CD3 T-cell engagers, showing potential in treating metastatic castration-resistant prostate cancer. Benchmark analysts maintained a Hold rating on AbCellera’s stock, citing the company’s transition to a clinical-stage biotech and recent developments as key factors in their assessment. AbCellera is focused on advancing its internal pipeline and reducing new discovery partnerships, with plans to file CTA applications for two lead programs in 2025.

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