Syntara’s SNT-5505 Shows Promising Phase 2 Results, Secures A$15M Funding Boost
Syntara Limited has reported encouraging interim Phase 2 trial results for its lead drug candidate SNT-5505 in myelofibrosis, alongside a successful A$15 million capital raise to advance multiple clinical programs.
- Positive interim Phase 2 data for SNT-5505 in myelofibrosis with symptom and spleen volume improvements
- No treatment-related serious adverse events reported in combination with JAK inhibitor ruxolitinib
- A$15 million capital raising completed via two-tranche placement to fund clinical trials and operations
- Strong cash position of A$18.1 million at December quarter end, pro forma A$20.7 million including tranche 2
- Plans to engage FDA for pivotal Phase 2c/3 trial design and explore partnerships in 2025
Positive Phase 2 Data Highlights SNT-5505’s Potential
Clinical-stage drug developer Syntara Limited (ASX: SNT) has delivered a significant update for investors with the release of positive interim results from its Phase 2 trial of SNT-5505, a pan-LOX inhibitor targeting myelofibrosis (MF). Presented at the prestigious American Society of Hematology (ASH) conference in December 2024, the data demonstrated meaningful improvements in symptom relief and spleen volume reduction in patients with intermediate-2 or high-risk MF, many of whom had been on the standard JAK inhibitor ruxolitinib for over three years.
At 12 weeks, nearly half of evaluable patients achieved a 50% or greater reduction in total symptom score, a figure that rose to 80% by 38 weeks, indicating sustained and increasing benefit. Spleen volume reductions were also notable, with 30% and 20% of patients achieving 25% and 35% reductions respectively at 38 weeks. Importantly, the treatment was well tolerated with no serious adverse events linked to SNT-5505, and haematological parameters remained stable.
Capital Raise Strengthens Financial Position
Coinciding with the clinical update, Syntara successfully raised approximately A$15 million through a two-tranche placement priced at A$0.06 per share. The first tranche raised A$12.4 million under the company’s placement capacity, while the second tranche of A$2.6 million awaits shareholder approval in February 2025. This capital injection bolsters Syntara’s balance sheet, with a closing cash position of A$18.1 million at the end of December 2024, rising to a pro forma A$20.7 million including the second tranche.
Funds will be allocated to advancing clinical trials not only for myelofibrosis but also for myelodysplastic syndrome (MDS), idiopathic REM sleep behaviour disorder (iRBD)/Parkinson’s disease, scar therapies, and general operational costs. The company also benefited from a A$4.56 million R&D tax incentive refund and proceeds from the sale of its mannitol respiratory business unit, further supporting its financial flexibility.
Looking Ahead: Regulatory Engagement and Pipeline Progress
CEO Gary Phillips emphasised the strategic importance of the ASH presentation, noting the opportunity to engage with leading clinicians and industry players. Syntara plans to continue data collection and analysis from the ongoing MF study, aiming to seek FDA feedback on the design of a pivotal Phase 2c/3 trial in the second quarter of 2025 once 12-month patient data is available.
Beyond myelofibrosis, the company is progressing clinical programs in MDS and scar prevention/modification, with recruitment for additional Phase 1c/2 studies expected to commence in the first half of 2025. Syntara is also exploring global and regional partnerships to support the next stages of development, signalling a busy and potentially transformative year ahead.
While the company navigates some uncertainty regarding outstanding payments from the sale of its respiratory business, its strengthened financial position and promising clinical data position Syntara well to advance its pipeline and deliver shareholder value.
Bottom Line?
Syntara’s robust Phase 2 data and fresh capital set the stage for pivotal trials and strategic partnerships in 2025.
Questions in the middle?
- How will the FDA respond to Syntara’s planned pivotal Phase 2c/3 trial design?
- What timelines and milestones can investors expect for the MDS and iRBD clinical programs?
- What is the potential impact of unresolved payments from the respiratory business sale on cash flow?