Athira Pharma, Inc. (ATHA) has acquired exclusive global rights to Lasofoxifene, a selective estrogen receptor modulator now in pivotal Phase 3 trial for ESR1-mutant metastatic breast cancer.
Metastatic breast cancer remains difficult to treat, particularly for patients who progress after aromatase inhibitors and prior CDK4/6 inhibitors. Lasofoxifene's tissue-selective profile is designed to preserve estrogen function in non-breast tissue, potentially improving tolerability and bone health.
Lasofoxifene is a selective estrogen receptor modulator (SERM) being developed as a targeted therapy for estrogen receptor-positive, HER2-negative metastatic breast cancer with ESR1 mutations. These mutations often drive resistance to endocrine treatments. The drug's tissue-selective profile is designed to maintain estrogen function outside the breast tissue, offering potential tolerability and bone health benefits.
Earlier Phase 2 studies with Lasofoxifene demonstrated encouraging results, including a median progression-free survival of 13 months in heavily pretreated patients and a 56% objective response rate when combined with Eli Lilly's blockbuster drug, Verzenio (abemaciclib).
The ongoing Phase 3 trial, dubbed ELAINE-3, is evaluating Lasofoxifene with abemaciclib, aiming to establish a new standard of care for this patient group. Progression-free survival is the primary endpoint, supported by secondary measures of clinical benefit.
To fund development, Athira announced $90 million in upfront financing through a private placement of common stock and warrants, with the potential to raise an additional $146 million if warrants are exercised.
The financing was co-led by Commodore Capital, Perceptive Advisors and TCGX, alongside other investors. The capital is expected to support Lasofoxifene through topline readouts and regulatory milestones, extending Athira's runway into 2028.
The pivotal ELAINE-3 trial is more than halfway enrolled, with topline data expected in mid-2027.
Athira is also advancing ATH-1105, its next-generation small molecule for Amyotrophic lateral sclerosis (ALS), with Phase 2 trials planned for early 2026.
The company has traded between $2.20 and $6.08 over the past year. Shares of ATHA surged 86.28% today to $7.72, marking a new 52-week high.
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