How Syntara’s Amsulostat Fast Track Could Transform Myelofibrosis Treatment
Syntara Limited reported a significantly reduced loss for FY2025, driven by clinical progress and capital raises, while advancing its lead drug amsulostat with FDA Fast Track designation. The company also navigates ongoing payment disputes following the sale of its mannitol respiratory business.
- Loss narrowed to $7.9 million from $15.1 million in prior year
- Amsulostat granted FDA Fast Track and WHO International Non-Proprietary Name
- Completed $20 million capital raising in 2024-25 to fund clinical programs
- Sale of mannitol respiratory business classified as discontinued operations
- Robust cash position of $15.1 million supports ongoing R&D and trials
Financial Performance and Capital Strength
Syntara Limited has reported a loss of $7.9 million for the year ended 30 June 2025, a marked improvement from the $15.1 million loss recorded in the previous year. This progress reflects increased revenues, reduced expenses, and the impact of the sale of its mannitol respiratory business unit (MBU) in October 2023, now classified as discontinued operations. The company strengthened its balance sheet through two institutional placements in 2024, raising a total of $20 million before costs, and ended the year with $15.1 million in cash and cash equivalents, positioning it well to fund ongoing clinical development.
Clinical Advances with Amsulostat
Syntara’s lead drug candidate, amsulostat (SNT-5505), an oral pan-Lysyl Oxidase inhibitor, continues to make significant strides in clinical development for myelofibrosis (MF) and myelodysplastic syndrome (MDS). The drug received Fast Track designation from the US Food and Drug Administration (FDA) in June 2025, accelerating its regulatory pathway based on promising Phase 2 trial results demonstrating symptom relief and spleen volume reduction in MF patients, particularly those with suboptimal responses to existing therapies.
Further validation came with the World Health Organization granting an International Non-Proprietary Name (INN) to amsulostat in July 2025, a key milestone for global recognition. The company is also advancing Phase 1c/2 trials in MDS, supported by collaborations with the University of Heidelberg and the Australasian Leukaemia and Lymphoma Group, with initial results expected in the first half of 2026.
Pipeline Diversification and Collaborations
Beyond amsulostat, Syntara is progressing topical pan-LOX inhibitors targeting scar revision and prevention, with Phase 1 trials underway for SNT-6302 and SNT-9465. Additionally, the SSAO/MAO-B inhibitor SNT-4728 is in a Phase 2 study for sleep disorders linked to Parkinson’s disease, funded substantially by Parkinson’s UK. These programs underscore Syntara’s diversified approach to addressing fibrosis, inflammation, and neurodegenerative conditions.
Operational and Governance Highlights
The company completed the sale of its mannitol respiratory business to Arna Pharma Pty Ltd, with ongoing disputes over payment obligations. Syntara has conservatively provided for doubtful debts related to this sale but continues to pursue outstanding amounts. Governance remains robust, with a board comprising experienced pharmaceutical and biotech executives, and remuneration aligned with performance through equity incentives and options.
Research and development tax incentives contributed $5.6 million in receivables, supporting the company’s clinical programs without diluting shareholder value. The company also maintains prudent financial risk management, with no significant environmental liabilities and a clear focus on advancing its clinical pipeline.
Bottom Line?
Syntara’s improved financial footing and regulatory progress with amsulostat set the stage for pivotal clinical milestones and potential partnerships in the coming year.
Questions in the middle?
- How will Syntara navigate the timing and quantum uncertainties of disputed payments from Arna Pharma?
- What are the next regulatory and clinical milestones for amsulostat following FDA feedback?
- How might upcoming Phase 2 trial results in MDS and other indications impact Syntara’s valuation and partnership prospects?
