Syntara (ASX:SNT) management outlined a busy 2026 agenda and fielded shareholder questions during a company webinar focused on upcoming clinical milestones, partnering strategy, and market conditions for biotech dealmaking.
Management highlights: multiple readouts expected in 2026
CEO Gary Phillips said the company expects a “near-constant flow of news” during 2026, pointing to five clinical trials expected to deliver efficacy and safety data over a 12-month period. Phillips described Syntara as a clinical-stage drug developer with 43% institutional backing and said its pipeline has been built through internal discovery efforts supported in part by Australia’s R&D tax credit program.
Non-Executive Director Hashan De Silva, whose fund KPRX is among Syntara’s largest shareholders, joined Phillips for the Q&A. Phillips also cited analyst coverage from Canaccord Genuity, Bell Potter Securities, Euroz Hartleys, and Evolution Capital.
Samalastat: FDA discussions and hematology trial plans
Phillips described Samalastat as the company’s lead asset and said it gained momentum following a presentation at the American Society of Hematology (ASH) meeting in December. He added that Syntara broadened regulatory engagement beyond the FDA to the European Medicines Agency, which granted orphan drug designation; Phillips said the EMA process is “very rigorous” and requires evidence the drug may add value in the proposed indication.
Looking ahead, Phillips said Syntara is in ongoing discussions with the FDA to approve its development plan in myelofibrosis. He characterized that FDA feedback as a key “trigger point” expected in the first half of 2026, both for the program’s next development steps and for potential partnering engagement.
In myelodysplastic syndromes (MDS), Phillips said two studies are recruiting:
- Azilock Study (Germany): high-risk MDS; interim safety and efficacy data expected around mid-year, followed by phase 2 initiation in the second half of 2026.
- Message Study (Australia): low-risk MDS; interim safety and efficacy data expected in the second half of 2026.
Phillips added that Syntara expects to initiate a pancreatic cancer study in the second half of 2026, and said both MDS studies and the pancreatic cancer study are funded by non-dilutive cash at their current stage.
What the company says it has learned from myelofibrosis work
Responding to questions about Samalastat’s “clinical sweet spot,” Phillips said the company has run multiple myelofibrosis studies in patients who were either not responsive to standard-of-care JAK inhibitors or were still taking JAK inhibitors but were not well controlled. He said the safety profile has appeared robust across a wide range of patients, ranging from those described as near end-stage to those earlier in treatment.
Phillips also said the company observed symptom responses “inside 3 months” in a study where it had expected a longer time to efficacy, based on the drug’s mechanism. He suggested earlier symptomatic benefit could support patient adherence. In MDS, he said it is too early to determine the optimal setting, though he referenced preclinical work in high-risk disease as a reason the company expects to see a relatively rapid response in red blood cell counts if the preclinical findings translate clinically.
De Silva argued the market may be missing the importance of evaluating efficacy outcomes alongside safety, and said investor confusion about FDA guidance to run a phase 2 before a phase 3 was misplaced, describing that as normal drug development. He also discussed Syntara’s work related to fibrosis and said the company has seen evidence of a link between target inhibition and reductions in fibrosis in topical scarring studies, while framing the remaining question for myelofibrosis as whether this translates into disease modification.
Partnering and capital strategy: “open and flexible”
Phillips said Syntara is seeking optionality around financing the next myelofibrosis study and potential partnering, and that the board wants the company to explore both partnering structures and capital raising alternatives. He said the company remains open to multiple deal formats, including regional transactions that trade territory rights for cash, as well as global licensing agreements. Phillips added that, in his view, partnering after a phase 2b study can be “almost the same” as partnering after a phase 3 if the trial provides controlled safety and efficacy data.
De Silva described broader biotech market trends, saying deal focus has shifted away from early platform plays common in 2020–2021 and toward de-risked, later-stage assets. He linked increased urgency to the “patent cliff” and said big pharma is looking for assets that can generate revenue within two to three years. Phillips added that ruxolitinib, which he described as a $4.5 billion drug with roughly $1.5 billion in myelofibrosis sales, goes off patent in 2028, which he said could significantly reshape the market.
Other pipeline programs: scarring and Parkinson’s-related iRBD
Phillips said Syntara’s skin scarring program includes two studies using SNT-6302:
- Keloid scarring (UWA/Fiona Wood): interim safety and efficacy data expected around mid-year.
- Hypertrophic scarring: top-line safety and efficacy data expected in the second half of 2026.
Phillips said the hypertrophic scarring study is designed to produce clinical proof of concept and could enable program acceleration and potential partnering interest. He described the trial design as using patients as their own control, including placebo versus active treatment on scars, tissue sampling, measurements of scar flexibility and volume, and high-quality photography with independent, blinded ranking.
For SNT-4728 in Parkinson’s-related isolated REM sleep behavior disorder (iRBD), Phillips said recruitment is complete and top-line phase 2 data is expected in the second quarter of 2026. He noted the program is funded by Parkinson’s UK, and said Syntara expects an AUD 1.8 million payment from Parkinson’s UK in the current quarter. Management said potential next steps, if data are positive, could include interest from sleep-focused companies and neurodegeneration-focused companies, and Phillips referenced philanthropic organizations such as Parkinson’s UK and the Michael J. Fox Foundation as engaged stakeholders. De Silva added that prior development work supports confidence in safety and said the company knows the compound crosses the blood-brain barrier, with the current question centered on downstream biological effects.
Closing the webinar, Phillips reiterated that Syntara has advanced multiple programs that are either recruiting or completed recruitment, and said the team is focused on the year’s upcoming milestones.
About Syntara (ASX:SNT)
Syntara Limited operates as a clinical stage drug development company that focuses on blood-related cancers. Its lead product candidate is PXS-5505, which is in phase 2 trial for the bone marrow cancer myelofibrosis, which causes a build-up of scar tissue leading to loss of red and white blood cells and platelets. The company was formerly known as Pharmaxis Ltd and changed its name to Syntara Limited in December 2023. Syntara Limited was incorporated in 1998 and is headquartered in Frenchs Forest, Australia.
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