Highlights

  • Acrux received FDA feedback outlining a pathway toward Phase III trials for its female testosterone spray targeting Hypoactive Sexual Desire Disorder (HSDD).
  • FY26 customer receipts increased to $5.002 million from $0.521 million in FY25, primarily due to licensing income.
  • A $1.35 million upfront payment from Gedeon Richter contributed to FY26 receipts growth under the amended Lenzetto licensing agreement.
  • Acrux ended FY26 with cash of $1.705 million after completing a $1.6 million share placement.

Acrux (ASX:ACR) has told the market the FDA has clarified the regulatory pathway for its female testosterone spray, giving the company a clearer route toward Phase III trials for a hormone therapy aimed at Hypoactive Sexual Desire Disorder (HSDD). The update, released with the company's June-quarter and full-year Cash Flow report on 31 July 2026, landed alongside a rise in customer receipts — up roughly 960% to $5.002 million for FY26, from $0.521 million in the prior year.

Both developments have different implications. The receipts increase was driven substantially by a single licensing payment rather than Organic Sales growth, so it should not be interpreted as a change in underlying trading performance. The FDA feedback on the female testosterone program, combined with completed Phase I and II data, provides further clarity for future development, although Phase III has not started and no development partner has been signed.

What Was Announced?

Acrux, known for its transdermal "Patchless Patch" spray-on drug delivery technology, said the FDA has provided a pathway toward Phase III trials for its female testosterone product, aimed at treating HSDD. The regulator provided feedback on preclinical safety data, toxicology and Manufacturing plans. Phase I and II trials are complete, and Acrux said the available results provide a basis to progress toward late-stage development with a potential global pharmaceutical partner.

Acrux is targeting a potential US market launch window of FY28 to FY29, subject to securing a partner and progressing through Phase III development.

On the financial side, FY26 customer receipts totalled $5.002 million, compared with $0.521 million in FY25. The largest contributor was a $1.35 million upfront payment received in June 2026 from Gedeon Richter, as part of an amended licensing agreement extending Acrux's existing Lenzetto® estradiol spray into Australia. The agreement includes potential milestone payments of up to $4.05 million, subject to Therapeutic Goods Administration (TGA) Marketing approval and cumulative sales targets after launch.

June-quarter receipts were $1.780 million, including $0.430 million in profit-share and Royalty income. Full-year Revenue from Acrux's generic product portfolio and laboratory services totalled $3.652 million.

Acrux ended the June quarter with cash of $1.705 million, compared with $0.587 million three months earlier, following a $1.6 million share Placement completed across May and July 2026.

Why This Matters

HSDD remains an area of unmet need in women's health, with Acrux highlighting existing off-label testosterone use among women despite no FDA-approved testosterone product for this indication in the US. The FDA feedback reduces uncertainty around the development pathway and may support discussions with potential pharmaceutical partners.

The Gedeon Richter Lenzetto agreement also demonstrates Acrux's approach of using existing commercial products to generate funding for pipeline development. The FY26 receipts increase reflects licensing Economics from an existing product agreement rather than Recurring Revenue growth from new drug sales.

Company Background

Acrux is a Melbourne-based specialty pharmaceutical company focused on its proprietary Patchless Patch transdermal spray technology, developed at Monash University, which enables drug delivery through the skin without a physical patch. Its commercial activities include generic pharmaceutical products, laboratory services and out-licensed branded products including Lenzetto, an estradiol spray used in menopausal hormone therapy.

The company's pipeline focus includes a female testosterone spray for HSDD, which has completed Phase I and II trials and is being considered for further development through a potential co-development partnership.

Financial Position

Acrux finished FY26 with cash of $1.705 million, compared with $0.587 million in the prior quarter. Total available funding, including unused facilities, was $2.106 million, representing an estimated funding runway of approximately nine quarters based on company disclosure.

Research and development expenditure for the June quarter was $205,000 and $1.055 million for FY26, compared with $8.825 million in operating expenditure disclosed for the prior year. The company also completed a $1.6 million share placement across May and July 2026.

What Comes Next?

The company is pursuing discussions with global pharmaceutical partners to advance the female testosterone program into Phase III trials, with a potential US launch window of FY28 to FY29. This timeline remains dependent on securing a partner and successful Phase III execution.

For the Lenzetto Australian agreement, further milestones depend on TGA marketing authorisation and commercial sales performance by Gedeon Richter, which could result in additional payments of up to $4.05 million.

Risks

The female testosterone program's FY28-29 launch target depends on securing a co-development partner and completing a Phase III trial, neither of which has been confirmed. Clinical development for hormone therapies can require substantial time and funding, and earlier-stage results may not translate into later-stage outcomes. The FY26 receipts increase was materially influenced by a one-off upfront licensing payment, limiting visibility on recurring cash generation. Additional milestone payments under the Gedeon Richter agreement remain dependent on regulatory approval and sales performance. Manufacturing, reimbursement and market adoption also remain relevant execution considerations.

Investor Takeaway

The FDA pathway clarification provides additional visibility around Acrux's female testosterone program, while the Gedeon Richter agreement has contributed licensing income from the Lenzetto franchise. However, FY26 receipts were affected by a one-time upfront payment, and the female testosterone program still requires a development partner and completion of Phase III trials before any potential commercial launch.

Future developments to monitor include potential co-development partnerships, TGA progress for the Lenzetto Australian registration, and further details around Phase III trial design and timing.