Athira Pharma, Inc., a clinical-stage biopharmaceutical company, has acquired an exclusive global license (excluding Asia and select Middle Eastern countries) from Sermonix Pharmaceuticals for the development and commercialization of laofoxifene, a selective estrogen receptor modulator (SERM) being evaluated in the Phase 3 ELAINE‑3 trial for ER+, HER2-negative, ESR1-mutated metastatic breast cancer.
The trial is more than 50 per cent enrolled, with topline data expected in mid-2027, aiming to establish lasofoxifene in combination with the CDK4/6 inhibitor abemaciclib as a new standard of care for patients with limited treatment options.
In conjunction with the license, Athira announced financing of up to $236 million, including an upfront $90 million private placement of common stock and warrants, with potential additional proceeds of $146 million if warrants are exercised.
The financing, co-led by Commodore Capital, Perceptive Advisors, and TCGX, with participation from ADAR1, Blackstone Multi‑Asset Investing, Kalehua Capital, Ligand Pharmaceuticals, NEA, Spruce Street Capital, and 9vc, will support lasofoxifene development through key clinical and regulatory milestones, providing a capital runway into 2028.
Under the license terms, Athira will issue pre-funded warrants to purchase 5.5 million shares to Sermonix and is obligated to make up to $100 million in milestone payments and low single-digit royalties on net sales of lasofoxifene.
Lasofoxifene has demonstrated efficacy in Phase 2 ELAINE-1 and ELAINE-2 trials, showing prolonged progression-free survival, higher objective response rates, and quality-of-life benefits in heavily pretreated patients. Athira also intends to use proceeds to advance other clinical assets, including ATH‑1105, a next-generation small molecule candidate for neurodegenerative diseases such as ALS.
The Phase 3 program represents a multi-billion-dollar market opportunity, addressing a patient population with limited endocrine therapy options following progression on aromatase inhibitors and CDK4/6 inhibitors. The ELAINE-3 trial is designed to provide pivotal data for potential regulatory submission, reinforcing Athira’s commitment to developing therapies with significant clinical impact.
