AbCellera Biologics Inc. Common Shares Study result

You may proceed. Good morning, good afternoon, and good evening, everyone.

I am Tryn Stimart, AbCellera's Chief Legal and Compliance Officer. We are pleased to welcome you to AbCellera's conference call to discuss our phase II top-line data for ABCL-635. Speaking on the call today are Carl Hansen, AbCellera's President and Chief Executive Officer, Sarah Noonberg, AbCellera's Chief Medical Officer, and Dr. Kelsey Mills, an obstetrician and gynecologist specializing in complex menopause care. During this call, we may make forward-looking statements based on our current expectations and in accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These include statements regarding the therapeutic potential, safety profile, and regulatory pathway for ABCL-635. 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 10-Q filings with the SEC for a more detailed discussion of these risks. AbCellera assumes no obligations to update any forward-looking statements to reflect events or circumstances after today's date. Our presentation today, our press release, and our SEC filings are available on our investor relations website. The information we provide about ABCL-635 is intended for the investment community and is not promotional. As we transition to our prepared remarks, please note that this call is being recorded and will be available for replay on our investor relations website. After our prepared remarks, we will open the lines for questions and answers. With that, I will turn the call over to Carl.

Thanks, Tryn, and good morning, everyone. I have to say that we are more than excited to share our top-line 4-week data for the phase II study of ABCL635 in the treatment of moderate to severe hot flashes. As I said on last week's earnings call, coming into this readout, we were defining success as comparable efficacy to small molecules, improved safety profile that eliminated the need for liver monitoring, and a more convenient once-monthly self-injection dosing regimen. With this product profile, we believed ABCL635 had potential to be a blockbuster product. The top-line results, which were released this morning, exceed our target product profile, and the efficacy data is beyond even the most aggressive upside scenario we had dared to consider.

With this readout, we now view ABCL635 as a potential best-in-class non-hormonal therapy with strong differentiation against approved NK3R competitors across all important dimensions, including efficacy, safety, and dosing convenience. It is exceedingly rare to see phase II data that are so clearly positive and differentiated. Given the large observed effect sizes and the overwhelmingly significant statistics, we believe ABCL635 is now a highly de-risked program. Most importantly, these data present an opportunity to really move the needle on care and to develop a product that offers a profound benefit to patients suffering from VMS. In particular, we believe ABCL635 has potential to capture a large share of two key markets, including the non-hormonal treatment of hot flashes associated with menopause and the treatment of hot flashes arising from hormone deprivation used in cancer therapy.

It is estimated that more than 12 million women in the U.S. experience moderate to severe hot flashes, of which more than half or 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. Therefore, we believe there are approximately 1.2 million women in the U.S. alone who will seek relief from safe and effective non-hormonal treatments. Assuming only price parity with approved small molecule NK3R antagonists, this would correspond to a total addressable U.S. market of at least $6 billion annually. From this base estimate, we see a large upside potential for a highly differentiated product that offers improved efficacy, safety, and convenience.

This upside includes higher pricing, adoption in ex-U.S. markets, and broader use by patients who either choose not to use hormone therapy or who get only partial relief from hormone therapy. In addition to VMS associated with menopause, we believe there is a smaller but comparable opportunity for treatment of VMS in patients undergoing hormone deprivation during cancer therapy. This includes patients being treated with androgen deprivation therapy in prostate cancer and patients treated with tamoxifen or aromatase inhibitors in breast cancer. We estimate there are approximately 500,000 patients being treated for breast and prostate cancers in the U.S. alone. Ultimately, the impact and the commercial success of a product depends on how well it meets the needs of patients and how it fits into the reality of medical practice on the front lines. Today, we are pleased to have Dr. Kelsey Mills on the call.

Dr. Mills is a world-recognized leader in menopause and women's health, a clinical associate professor at the University of British Columbia A board member of the Canadian Menopause Society and a practicing OBGYN with deep expertise and specialization in complex menopause treatment.

She was not an investigator on our trial, but we have invited her to share her expert perspective on the current treatment landscape and the unmet need in VMS.

Dr. Mills? Thank you, Carl, and good morning, everyone.

I think everybody on this call today is aware that menopause is an incredible opportunity in the health space, but that it is not just a moment, but we are seeing this as a movement in women's health. I would argue that menopause is likely one of the most important and urgent aspects in women's health at this time. What we see from a clinical perspective at the current time is that our historical non-hormonal options for treatment of vasomotor symptoms and other menopausal symptoms are now not generally supported by global guidelines. We have the exception of a few small molecules and antidepressants for treatment of patients, and there is a considerable unmet need in my patients who can't, won't, or shouldn't take systemic hormones to treat their symptoms.

Vasomotor symptoms and sleep disruption are the two most ubiquitous symptoms in the midlife, and these can have incredible and far-reaching implications on a woman's mood, ability to maintain her weight, sexual function, metabolic health, cardiovascular disease risk, and more. I have a tremendous number of patients in my practice who have had a breast cancer or other estrogen receptor-positive cancer or other medical complications such as heart disease, stroke, history of blood clot, or simply failure to respond to menopausal hormone therapy. I'm left with these women who are looking for better treatment options. We do have two FDA-approved small molecules, but these come with considerable side effects, very cumbersome monitoring programs, or, as some of my patients have found, lack of effect.

I am truly excited to join this call today as an academic menopause physician, and I am very excited about the opportunity of a novel agent and what it could mean for my patients in my practice who currently have a significant unmet need in their menopause care. I'm really pleased to be here, and I'm happy to answer clinical questions. I'll now turn the call back to Carl.