Key Highlights

  • A non-binding term sheet was signed with FlashDx Shenzhen for a proposed 50:50 joint venture on an enhanced molecular GBS diagnostic, with no financial terms disclosed.
  • Enrolment in a StrepSure study at Northern Health was suspended after an interim data review, and the US FDA submission is now expected in early 2027.
  • Closing cash was A$3.561 million with no debt, and about four quarters of funding estimated.

Proposed joint venture

Nexsen Limited (ASX:NXN) said in its quarterly report on 28 October 2026 that it has signed a non-binding term sheet with FlashDx Shenzhen Inc. for a proposed 50:50 joint venture to develop and commercialise an enhanced molecular diagnostic for Group B Strep, or GBS. The venture would build on FlashDx's existing CE-marked, laboratory-grade DNA test, which the company said delivers a result in under an hour, and add a sample preparation step intended to improve sensitivity when GBS levels are low.

Nexsen said the joint venture device targets hospitals and labour wards, while its own StrepSure product targets antenatal screening and clinics with limited laboratory access, so the two would serve different settings and price points. Nexsen would lead Asia-Pacific sales outside China and would lead and fund the planned US FDA 510(k) and European CE-IVDR programs, with three US clinical sites already engaged. The company said the initial focus is Asia-Pacific, with India a significant target subject to its regulatory pathway. The arrangement remains subject to definitive binding agreements, which the parties are progressing, and no financial terms were disclosed.

StrepSure study and revised timing

The company said a study of StrepSure in women in labour at Northern Health in Melbourne had enrolment suspended after an interim data review, in line with the study protocol. It said assessment of StrepSure in its current form has ceased and reported no adverse safety signal or event. Planned enhancements include collecting more GBS from each sample, reading results electronically rather than by eye, and confirming results in two independent ways. Nexsen said these build on the existing test and are not expected to need material additional development expenditure.

As a result, the company changed its guidance on timing: the US FDA submission, previously targeted for an earlier date, is now expected in early 2027. This applies only to the US pathway. StrepSure continues for antenatal screening and clinics across Asia-Pacific, with clinical validation work at the University of Hong Kong.

Hong Kong base and other programs

Nexsen said it has established a Hong Kong research and development facility as its principal base in Asia, supported by a HK$6 million Ignite grant, which is non-dilutive. University partners include the University of Hong Kong for GBS validation, the Chinese University of Hong Kong for neonatal care and sepsis, City University of Hong Kong for biosensor development and Hong Kong Metropolitan University for translational research.

On the corporate side, the KIDNEYSURE and RENALSURE trade marks were registered in Australia on 25 September 2026. Professor Shekhar Kumta became an executive director on 1 October 2026, having previously been a non-executive director, and will lead technical execution including the Hong Kong team.

Cash and use of funds

The Appendix 4C shows no customer receipts. Net operating cash outflow was A$851,000, including A$830,000 on research and development, A$223,000 on staff and A$299,000 on administration, offset by A$134,000 of grants and a A$336,000 repayment from Universiti Malaya. Closing cash was A$3.561 million, down from A$4.49 million, with no debt. The company estimated about four quarters of funding at the current rate of spending and described itself as well funded.

Against its 2025 prospectus, the company reported spending of A$6.16 million to 30 September 2026 versus an allocation of A$8.2 million over two years. Spending on GBS product development, validation and regulatory work was A$1.93 million against A$1.35 million allocated, which the company said reflects accelerated spending, while kidney disease diagnostic spending was A$780,000 against A$1.8 million.

Points to note

The joint venture is a proposal only. The report also lists an ISO 27001 certification dated 30 October 2026, two days after the report's own date, and the net cash movement line in the Appendix 4C does not show the change in cash, although the closing balance reconciles.