8/5/2026

speaker
Jonathan
Conference Call Operator

Good afternoon, and welcome to Accelera's Q2 2026 Business Update Conference Call. My name is Jonathan, and I will facilitate the audio portion of today's interactive broadcast. After the prepared remarks, we will host a question and answer session. If you would like to ask a question, please press star 1 to raise your hand. To withdraw your question, press star 1 again. At this time, I would like to turn the call over to Tryn Stimart, Accelera's Chief Legal and Compliance Officer. You may proceed.

speaker
Tryn Stimart
Chief Legal and Compliance Officer

Thank you. Hello, everyone. Thank you for joining us for Accelera's second quarter 2026 earnings call. I'm Tryn Stimart, Accelera's chief legal and compliance officer. Dr. Carl Hansen, Accelera's president and CEO, and Andrew Booth, Accelera'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 10-Q filings with the SEC for a more detailed discussion of these risks. Cellera assumes no obligation to update any forward-looking statements to reflect events or circumstances after today's date. Thank you for joining us. I'll turn the call over to Carl.

speaker
Dr. Carl Hansen
President and Chief Executive Officer

Thanks Tryn, and thank you everyone for joining us today. The most important data readout this year is the top line results for ABCL635 in the treatment of moderate to severe hot flashes associated with menopause. Last quarter we shared our interim Phase 1 data that showed robust and sustained target engagement in healthy male volunteers and supported quickly advancing into a Phase 2 study in postmenopausal women experiencing moderate to severe hot flashes. Recruitment in this study accelerated through H1, and we completed enrollment and initial dosing of patients in June, well ahead of schedule. Based on this, we expect a top-line data readout very soon. If the data is positive, we believe ABCL635 will be highly de-risked. As noted in our last call, We've been preparing for next steps, which would include late-stage clinical development in moderate to severe VMS associated with menopause, and clinical studies to evaluate ABCL635 in treating VMS associated with cancer treatment. Turning to our broader portfolio, ABCL688 and ABCL386 continue to progress through IND enabling activities, and we expect both to enter Phase 1-2 studies in 2027. We will disclose more information on these programs when they enter clinical studies. Our Phase 1 trial for ABCL575 completed dosing and is on track for a readout in Q4. As previously discussed, we intend to complete Phase 1 studies and we currently have no plans to develop it past Phase 1.

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