Amplia Therapeutics Limited (ASX:ATX), Paradigm Biopharmaceuticals Limited (ASX:PAR) and Starpharma Holdings Limited (ASX:SPL) represent three different drug-development models. Amplia is advancing the focal adhesion kinase inhibitor narmafotinib across oncology programmes, Paradigm has completed enrolment in a pivotal Phase 3 knee osteoarthritis study, while Starpharma is developing and licensing its DEP dendrimer drug-delivery platform across oncology and radiopharmaceutical applications.

Their 2026 updates show how clinical-stage companies depend on trial execution, regulatory interaction, partnerships and access to funding. Amplia is preparing further dose-selection work while adding a new combination study, Paradigm is approaching a major Phase 3 data period, and Starpharma is moving a radiopharmaceutical programme toward first-in-human development while generating Revenue from licensing arrangements.

2026 Drug Development Context

Clinical-stage biotechnology companies typically operate for extended periods before product revenue becomes meaningful. Research and Development incentives, grants, Equity raisings and partnerships therefore remain important sources of funding while clinical programmes progress.

Trial design is also becoming increasingly important, particularly in oncology. Regulators are placing greater emphasis on selecting appropriate doses before pivotal studies, which can require additional controlled development work even where earlier clinical signals appear encouraging.

Late-stage programmes face different pressures. A fully enrolled Phase 3 study may substantially reduce recruitment uncertainty, but clinical outcome risk remains until the trial's endpoints are assessed.

Platform companies can follow another path by licensing technology to larger partners. This can provide upfront revenue and potential milestone payments while reducing the need to commercialise every programme independently.

Amplia Therapeutics Limited (ASX:ATX)

Business Profile

Amplia Therapeutics develops focal adhesion kinase, or FAK, inhibitors for cancer treatment.

Its lead candidate, narmafotinib, is being evaluated in cancers where tumour biology and fibrotic tissue can make treatment difficult. FAK is involved in tumour signalling and the surrounding microenvironment, making it a potential target in diseases such as pancreatic, ovarian and lung cancer.

Amplia reports on a financial year ending 31 March.

Pancreatic Cancer Programme

Narmafotinib has generated early clinical data through the ACCENT study in advanced pancreatic cancer.

The Phase 1b/2a programme evaluated narmafotinib in combination with gemcitabine and nab-paclitaxel. Amplia reported a complete response rate of 7.8%, an overall response rate of 36%, disease control of 70% and median overall survival of 11.1 months.

Financial Position

For FY2026, covering the year ended 31 March 2026, Amplia reported revenue of approximately AUD 4.79 million. The amount largely reflected research and development incentives and other income rather than commercial product sales.

Net loss for the year was approximately AUD 7.71 million.

Amplia reported cash of approximately AUD 24.0 million at 30 June 2026.

The cash position provides funding for current development activities but is not expected to be sufficient for an entire pivotal Phase 3 programme. Additional capital, a licensing arrangement or another strategic Partnership may therefore become necessary as narmafotinib advances.

Risks

Clinical evidence remains the main risk because the pancreatic cancer results come from a relatively small uncontrolled study.

The planned randomised programme will provide a more rigorous test of efficacy.

Funding is another consideration because later-stage oncology trials require substantially greater Investment than early clinical studies.

Amplia is also developing narmafotinib across multiple cancer settings, creating execution and prioritisation risks as resources are allocated among programmes.

What Investors May Monitor Through the Rest of 2026

Initial dosing in ACCENT-mini and commencement of the Lilly-supported lung cancer study will be important clinical milestones.

Investors may also monitor whether Amplia provides additional detail on the planned Phase 2b programme and how the company intends to finance later-stage development.

Further data from existing oncology programmes could also influence the development strategy.

Paradigm Biopharmaceuticals Limited (ASX:PAR)

Business Profile

Paradigm Biopharmaceuticals is developing injectable pentosan polysulfate sodium, branded Zilosul, for knee osteoarthritis.

The programme aims to provide a non-opioid treatment option for a large patient population experiencing pain and functional limitation.

Paradigm is also exploring whether Zilosul can provide benefits beyond symptom management, although confirmation of any disease-modifying effect requires clinical evidence.

Phase 3 Enrolment

Paradigm's key programme is the Phase 3 PARA_OA_012 trial.

In September 2026, the company confirmed that 538 participants had been enrolled, exceeding the original target of 466.

The study includes sites across the United States, Australia, Hong Kong and Moldova.

Completion of recruitment reduces one of the operational uncertainties associated with the trial, although participants still need to complete follow-up and the dataset must undergo analysis before conclusions can be drawn.

The programme has already passed an independent safety review that supported continued study conduct.

FY2026 Financial Position

For the year ended 30 June 2026, Paradigm reported revenue from ordinary activities of approximately AUD 8.1 million. This reflected tax incentives and other income rather than commercial drug revenue.

Net loss for FY2026 was approximately AUD 56.3 million.

Operating cash outflow during the year was around AUD 43.7 million, reflecting the significant cost of running the Phase 3 programme.

The company therefore remains dependent on financing arrangements and other funding sources until it can complete its clinical and regulatory programme.

Risks

Paradigm's development profile is concentrated heavily around Zilosul and the PARA_OA_012 outcome.

This creates binary clinical risk because failure to meet the study's endpoints would materially affect the company's primary development programme.

Funding is also significant. Despite the company stating that the current programme is funded through top-line data, further development and commercialisation would require additional Capital following a successful result.

Convertible funding also creates potential dilution through future securities issuance.

What Investors May Monitor Through the Rest of 2026

Completion of follow-up within PARA_OA_012 will remain the principal clinical focus.

Any additional detail on timing of the interim analysis and top-line readout could clarify the next major milestones.

Investors may also monitor further use of the convertible facility, research and development incentive receipts and future capital-management decisions.

Starpharma Holdings Limited (ASX:SPL)

Business Profile

Starpharma develops and licenses its DEP dendrimer drug-delivery technology.

Dendrimers are highly structured synthetic polymers that can carry therapeutic or radioactive payloads. Starpharma is using the platform to investigate whether drug distribution can be improved while reducing exposure to healthy tissue.

The company also generates revenue through selected existing products and licensing agreements.

Its development strategy is increasingly focused on targeted oncology and radiopharmaceutical applications.

FY2026 Performance

For the year ended 30 June 2026, Starpharma reported revenue from contracts with customers of approximately AUD 12.05 million.

The figure included approximately AUD 8.34 million recognised from its collaboration and licence arrangement with Genentech.

Net loss for FY2026 was approximately AUD 7.47 million.

Research and development expenditure, net of research incentive income, reached approximately AUD 11.15 million as the company expanded its development activities.

Licensing revenue can be uneven between reporting periods because upfront and milestone payments depend on specific contractual events rather than recurring product sales.

Genentech Collaboration

The Genentech collaboration provides Starpharma with a significant third-party validation of its DEP technology.

The arrangement includes potential development and commercial milestones of up to USD 564 million as well as tiered royalties if partnered products advance successfully.

Those potential milestone amounts are contingent and should not be treated as current revenue.

Future payments depend on the progress of programmes being developed under the agreement.

FY2027 Priorities

Starpharma's stated priorities include advancing DEP HER2-Lu into clinical development, progressing existing partnerships and expanding the radiopharmaceutical pipeline.

The company also continues to pursue licensing opportunities for other DEP clinical assets.

Partnering remains central to the model because it can shift part of the cost and commercialisation burden to larger organisations while preserving milestone and Royalty economics.

Risks

Revenue remains dependent on licensing events and can therefore vary materially between periods.

The Genentech arrangement provides substantial potential economics, but most milestone payments remain dependent on future programme progression.

Starpharma's internal radiopharmaceutical programmes are also still at an early clinical stage and face normal development and regulatory risk.

Manufacturing radioactive products introduces additional technical and logistical requirements.

The company also continues to seek partners for other DEP assets, and the timing of such agreements cannot be assured.

What Investors May Monitor Through the Rest of 2026

First-in-human dosing for DEP HER2-Lu will be one of the most important development milestones.

Investors may also monitor whether the Radiopharm option converts into a licence and whether existing partners trigger additional payments.

Further progress across the broader radiopharmaceutical pipeline and updates on licensing discussions for existing DEP Assets could also influence the FY2027 outlook.

Risks to Watch

Amplia faces clinical-validation and funding risk as it moves from an early uncontrolled pancreatic cancer dataset toward dose-selection and randomised studies.

Paradigm faces concentrated Phase 3 risk around Zilosul alongside substantial funding requirements. The trial is fully enrolled, but the clinical outcome remains unresolved.

Starpharma faces partner-dependence and early clinical-development risk. Its platform has generated licensing revenue, although much of its potential Economics remains contingent on future partner and clinical progress.

Across all three companies, regulatory designations and partnerships can support development but do not remove the possibility of clinical failure.

Outlook Through the Rest of 2026

Amplia enters the next phase with narmafotinib progressing through several oncology programmes and approximately AUD 24 million of reported cash at 30 June 2026. ACCENT-mini and the Lilly combination study will provide the next development checkpoints.

Paradigm enters the remainder of 2026 with its pivotal knee osteoarthritis trial fully enrolled. Follow-up, interim analysis and eventual top-line data now become the central drivers.

Starpharma enters FY2027 with additional funding from its AUD 32 million entitlement offer, an established licensing relationship and plans to move DEP HER2-Lu into first-in-human development.

The three companies therefore face different priorities: Amplia is focused on validating its oncology signal in more rigorous studies, Paradigm on delivering a pivotal Phase 3 result, and Starpharma on advancing radiopharmaceutical development while monetising its DEP platform.