Vectus clears FDA pre-IND step for VB0004 fibrosis drug

FDA feedback becomes the next VB0004 catalyst

Vectus Biosystems Limited (ASX:VBS) has cleared an important procedural hurdle for VB0004, with the US Food and Drug Administration granting its request for a pre-IND Type B meeting on the drug candidate’s proposed development programme in idiopathic pulmonary fibrosis.

The meeting will be conducted through written FDA responses, which Vectus expects by mid-November 2026. Those responses are intended to provide formal guidance on the proposed clinical and regulatory pathway, but they do not themselves authorise a clinical trial or establish a development timetable. The company has begun finalising its meeting package.

The milestone confirms the same regulatory thread outlined in the FDA pre-IND meeting pathway, where the company said FDA feedback could clarify VB0004’s next US development steps. Vectus describes VB0004 as a first-in-class oral vasoactive intestinal peptide-mimetic and natriuretic peptide receptor C-agonist targeting IPF, a progressive and often fatal lung disease.

Cardinal Health takes on FDA-facing work

Vectus has appointed Cardinal Health Regulatory Services as its US regulatory agent, giving the company an external regulatory affairs partner for FDA communications, interactions and submissions. The mandate covers the proposed Orphan Drug Designation Request, pre-IND work and a future Investigational New Drug application for VB0004 in IPF.

Cardinal’s appointment, first disclosed in July, gives practical support to the US pathway as Vectus moves beyond its completed Phase Ia study in healthy volunteers. That study established what the company described as a favourable safety and pharmacokinetic profile, but the quarterly report contains no new efficacy data or clinical trial results.

Cash position leaves little room for delay

The regulatory progress comes alongside a tight funding position. Vectus used $309,000 in operating cash during the September quarter and ended it with $410,000 on hand. The Appendix 4C calculates available funding at 1.33 quarters based on the reported cash balance and operating cash use, with no unused financing facilities at quarter end.

A $450,000 loan facility from non-executive director Maurie Stang was fully drawn. Vectus says the facility can be repaid without penalty if alternative funding is secured, while repayment is expected from future Australian Taxation Office research and development cash-back or other funds received. The company subsequently received a $208,000 R&D cash refund in October, but that payment was not part of the 30 September cash balance.

Vectus says spending has fallen after the Phase Ia trial, with reduced staff and consultant numbers, lower-cost premises and no trial currently running. It is evaluating licensing opportunities and may sell some of its XORTX shares to improve liquidity. Neither option is described as a committed transaction, leaving the timing and funding of the next clinical stage dependent on decisions still to come.