Q126 Update: ABCL635 P1 Data Supports P2 POC Advancement

研报英文原文证据摘录

Q126 Update: ABCL635 P1 Data Supports P2 POC Advancement

.1M) and SG&A expense of $12.3M (vs. consensus $19.2M; PSC $18.9M).

FY27E Rev (mil) US$37.7 US$42.6

Total available liquidity at quarter-end was $655M, which included $531M in cash, cash

FY26E EPS US$(0.82) US$(0.67)

equivalents, and marketable securities, and $124M in available non-dilutive government FY27E EPS US$(0.94) US$(0.78)

funding. We are updating our model for Q126 actuals, maintaining our $12 PT.

52-Week High / Low US$6.51 / US$1.94

Shares Out (mil) 303.1

• Encouraging interim P1 ABCL635 data. ABCL635 is a potential first-in-class antibody Market Cap. (mil) US$1,591.1

targeting the NK3R for the non-hormonal treatment of moderate-to-severe vasomotor Avg Daily Vol (000) 4,497

symptoms (VMS) associated with menopause. Recall, ABCL previously announced Div Yield 0.00%

advancement of ‘635 into P2 based on confidence from early biomarker, data and today’s Fiscal Year End Dec

interim P1 results confirm that decision was well-founded. Importantly, ‘635 was well-

Price Performance - 1 Year tolerated, with no SAEs, discontinuations, or liver toxicity, an important differentiator

given the hepatotoxicity concerns with the small-molecule NK3R class. PK data showed USD

dose-proportional exposure with a 24-day half-life, supporting a QM subQ dosing 7

regimen. PD data in male volunteers, using testosterone as a validated surrogate for 6

NK3R target engagement in hypothalamic KNDy neurons, showed sustained, dose- 5

dependent suppression (50% to >75%) over 4 weeks, outperforming the transient, 4

hours-long suppression (~50% reduction) reported for the approved small-molecule

fezolinetant. Consistent with these findings, ‘635 also demonstrated dose-dependent 3

suppression of the pituitary hormones FSH and LH.