5/11/2026

speaker
Ben
Conference Call Operator

Good afternoon, and welcome to Abcelera's Q1 2026 Business Update Conference Call. My name is Ben, and I will facilitate the audio portion of today's interactive broadcast. After today's prepared remarks, there will be a question and answer session. If you would like to ask a question, please press star 1 to raise your hand. If you would like to withdraw your question, please press star 1 again. At this time, I would like to turn the call over to Trin Steinmart, Abcelera's Chief Legal and Compliance Officer. You may proceed.

speaker
Trinh Steimart
Chief Legal and Compliance Officer

Thank you. Hello, everyone. Thank you for joining us for Abcelera's first quarter 2026 earnings call. I'm Trinh Steimart, Abcelera's chief legal and compliance officer. Dr. Carl Hansen, Abcelera's president and CEO. Dr. Sarah Neuenberg, Abcelera's chief medical officer. And Andrew Booth, Abcelera's chief financial officer, are speaking on today's call. During this call, we may make statements about our strategic priorities and financial outlook based on our current expectations and in accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Our statements are subject to a number of risks, uncertainties, and other factors that could cause actual results to differ materially from those described. Please review the risk factors section of our most recent Form 10-K and subsequent 10Q filings with the SEC for a more detailed discussion of these risks. Abcelera assumes no obligation to update any forward-looking statements to reflect events or circumstances after today's date. Our presentation today, our earnings press release, and our SEC filings are available on our investor relations website. The information we provide about our pipeline is intended for the investment community and is not promotional. Transition to our prepared remarks, please note that this call is being recorded and will be available for replay on our investor relations website, and that all dollars referred to during the call are US dollars. After our prepared remarks, we will open the lines for question and answers. Now, I turn the call over to Carl.

speaker
Dr. Carl Hansen
President and Chief Executive Officer

Thanks, Trent, and thank you everyone for joining us today. 2026 has the potential to be a big year for Accelera. We started the year in a strong financial position with our platform and large infrastructure projects substantially complete, and with our internal pipeline set up for multiple catalysts over the next 24 months. Our key priorities for the year include delivering top line data readouts for ABCL 635 and ABCL 575, advancing ABCL 688 and ABCL 386 through IND enabling activities, and adding at least one new development candidate to our pipeline. In January, on the strength of early biomarker data and safety data, we announced that our lead program, ABCL635, had moved into phase two testing. By far the most important data readout in 2026 will be the top line readout of this study, which is anticipated in Q3. On today's call, we are excited to present interim phase one data for this program. As a reminder, ABCL635 is a potent antagonist of NK3R, a GPCR target that has been clinically validated for the treatment of vasomotor symptoms, also known as hot flashes. It is the first GPCR-targeting antibody from our platform to advance into clinical testing and is being developed as a potential first-in-class antibody medicine for the non-hormonal treatment of moderate to severe hot flashes associated with menopause. We believe ABCL635 has potential to address a large need and market opportunity in women's health. For most women, hot flashes are the most problematic symptoms of menopause. They can be highly disruptive to sleep, to work, and to family life and present a significant burden that persists for a median of over four years. At any given time, it is estimated that more than 12 million women in the U.S. experience moderate to severe VMS, of which more than 6 million will seek treatment. Menopause hormone therapy, which is an effective treatment and currently the standard of care, is unsuitable for at least an estimated 20% of these women because of contraindications, tolerability, and other factors. As a result, we believe there are over 1 million women in the U.S. who could benefit from safe and effective non-hormonal treatments. Assuming only price parity with approved small molecule NK3R antagonists, we estimate the total addressable U.S. market for non-hormonal VMS treatments to be at least $6 billion annually. From this, we believe there is upside potential in pricing as well as in broader use by patients who experience VMS caused by cancer treatments that reduce hormone levels. This includes patient populations in breast, ovarian, and prostate cancers. ABCL635 aims to provide a treatment option that has efficacy comparable to small molecules, a differentiated safety profile without the need for liver enzyme monitoring, and an advantage in dosing convenience with once-monthly subcutaneous self-injection. And now, I'll ask Sarah to present details about the program and our interim Phase I results. Sarah?

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