Acrux strategy focuses on Female Testosterone for low libido
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Released
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ASX Release
Acrux strategy focuses on Female Testosterone for low libido
Melbourne, Australia; 28 April 2026: Acrux Limited (ASX:ACR, “Acrux” or the “Company”) is
pleased to announce the release of its new strategy that focuses on high value, innovative,
transdermal IP. This follows a thorough review of the business by the new Chief Executive Officer
and the Executive Team.
The review considered:
1. the performance of the company’s existing, commercialised Topical Generic drugs in the US
and the potential for geographic expansion;
2. the potential for Topical Generic drugs currently under development;
3. changes in the clinical and regulatory environment for Hormone Replacement Therapy,
particularly in Women’s Health;
4. the potential for leveraging existing Acrux know how and R&D;
5. FDA feedback on Phase I & II clinical trials for Female Testosterone already completed by
Acrux and a viable pathway to proceed to Phase III; and
6. commercialisation strategies for Female Testosterone and, specifically, co-development.
Based on the team’s analysis and assessment of Acrux’s options, the new strategy has moved from
purely focusing on Topical Generics to bringing Acrux’s Female Testosterone product to market for
the treatment of Hypoactive Sexual Desire Dysfunction or HSDD (currently an area of high unmet
need). The strategy is presented in the company’s new Strategic Update deck released today.
Chief Executive Officer and Managing Director, John Warmbrunn, commented:
“Female Testosterone is a great opportunity that Acrux is incredibly well positioned to exploit.
The core revenue we are generating from our Topical Generics portfolio underpins and
supports our capacity to bring this product to market. Our proven capability in registering and
commercialising products gives us great confidence that we can gain an early mover
advantage. The direction provided by the FDA, and our long-term existing relationships with
potential partners, means that a co-development pathway is clearly the best option to
commercialise the product.
With a huge unmet need for women with Hypoactive Sexual Desire Dysfunction (HSDD), Acrux
is looking forward to making a significant contribution to women’s health globally.
In joining Acrux, it has been wonderful to find that there are significant new opportunities to
apply the extraordinary skills and talents that our scientists have acquired over 25 years.”
ENDS
Approved for release by the Board of Acrux Ltd
For more information, please contact:
About Acrux
Acrux is a dynamic Australian drug delivery specialist with unique expertise in developing and
commercialising patient preferred healthcare products for global markets.
Acrux talent create value through the development and commercialisation of healthcare products
using owned or acquired technologies. Acrux’s products are patient preferred, protected by patent
or other means, using innovative drug delivery.
For further information on Acrux, visit www.acrux.com.au
John Warmbrunn
Acrux Limited
CEO & Managing Director
P: + 61 3 8379 0100
E: john.warmbrunn@acrux.com.au
Strategic Update
April 2026
Disclaimer
Acrux Ltd (ASX:ACR) | Strategic Update | April 2026 2
This presentation contains forward-looking statements which are identified by words such as ‘may’, ‘could’, ‘believes’, ‘estimates’, ‘expects’, or ‘intends’ and other
similar words that involve risks and uncertainties.
These statements are based on an assessment of present economic and operating conditions, and on a number of assumptions regarding future events and
actions that, as at the date of this presentation, are reasonablyexpected to take place.
Actual results could differ materially depending on factors such as the availability of resources, the results of non-clinical and clinical studies, the timing and
effects of regulatory actions, the strength of competition, the outcome of legal proceedings and the effectiveness of patent protection.
Such forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties, assumptions and other important
factors, many of which are beyond the control of our Company, the Directors and our management.
We cannot and do not give any assurance that the results, performance or achievements expressed or implied by the forward-looking statements contained in this
presentation will actually occur and investors are cautioned not to place undue reliance on these forward-looking statements.
We have no intention to update or revise forward-looking statements, or to publish prospective financial information in the future, regardless of whether new
information, future events or any other factors affect the information contained in this presentation, except where required by law and under our continuous
disclosure obligations.
These forward-looking statements are subject to various risk factors that could cause our actual results to differ materially from the results expressed or
anticipated in these statements.
3
Female
Testosterone
Helping millions of women
with Hypoactive Sexual
Desire Dysfunction (HSDD)
4
“Testosterone is not simply a male hormone but is also an
important hormone in women. Low sexual desire is the
most prevalent sexual concern amongst women. When
sufficient to cause personal distress women are
considered as having hypoactive sexual desire dysfunction
or HSDD.
There is irrefutable evidence that testosterone therapy in
doses that result in blood levels within the physiological
range for premenopausal women improves sexual desire,
arousal, orgasm and sexual self-image and reduces
personal distress in postmenopausal women with HSDD.
The Acrux’s Testosterone* MDTS# has the advantages of
acting as a "patchless" patch with good
pharmacokinetic evidence of absorption”
Professor Susan R Davis
AO, MBBS FRACP PhD
FAHMS
*Acrux Testosterone is not yet registered for this indication
#MDTS – Metered Dose Transdermal System
• Head of the Monash Women’s Health
Research program.
• Fellow and council member of the
Australian Academy of Health and
Medical Sciences.
• Advisor to the NHS Menopause
Improvement Program Steering
Committee.
• Author of the 2019 Global Consensus
Position Statement on the Use of
Testosterone Therapy for Women. ^
References:
^ Davis, SR, Baber, R, Panay, N, Bitzer, J, Perez, SC, Islam, RM, Kaunitz, AM, Kingsberg SA, Lambrinoudaki I, Liu J, Parish SJ, Pinkerton J, Rymer J, Simon JA, Vignozzi, L, Wierman ME,
(2019). Global Consensus Position Statement on the Use of Testosterone Therapy for Women. The Journal of Clinical Endocrinology & Metabolism. Vol 104(10), pp. 4660-4666.
Female Testosterone catalyses investment proposition
Phase III Ready Asset Significant, Fast-Growing Market Early Mover Advantage
Phase I & Phase II Clinical Trials have
demonstrated astrong efficacy and safety profile.
No material adverse events recorded.
~4.9m US menopausal women suffer from
Hypoactive Sexual Desire Disorder (HSDD) with a
total addressable US population of ~12m
sufferers. By 2030, ~130,000 women willenter
menopause globally each day.
There is no existing Female Testosterone treatment
approved for HSDD in the US despite ~2.0m women
using off-label treatments. Acrux has aunique
opportunity to be early to market with an approved
formulation.
Co-Development Pathway Existing commercial portfolio IP & Know-How
Acrux will de-risk and expedite the regulatory and
market entry process with a major global partner.
Acrux has significant, long-term existing
relationships potential co-developers.
Acrux stands apart from clinical-stage developers
with an existing portfolio of in-market, approved
products that generate revenue to subsidise and
support further R&D into high-value products and
technology.
Acrux has a significant and successful corporate
history of commercialising transdermal
solutions and applications. Acrux is uniquely
placed to leverage its 505 (b)(2) pathway IP for the
Female Testosterone market.
Acrux Ltd (ASX:ACR) | Strategic Update | April 2026 5
HSDD: Problem and Solution
Acrux Ltd (ASX:ACR) | Strategic Update | April 2026 6
• HSDD affects ~4.9m menopausal women
in the US.
• HSDD impacts ~10% of all adult women,
most commonly as low or absent sexual
desire and/or response to stimulation.
• Other symptoms include low self-
esteem, reduced energy, depression,
anxiety and interpersonal conflict.
What is Hypoactive Sexual Desire Disorder?
• HSDD efficacy in postmenopausal women
demonstrated in 36 randomised clinical
trials.
• ~52% noted improved sexual function
6 – 8 weeks after treatment initiation.
• Anecdotal benefits included improved
mood, energy and cognitive function.
References:
• Islam, RM, Bell, RJ, Green, S, Page, MJ, Davis, SR, (2019). Safety and efficacy of testosterone for women: a systematic review and meta-analysis of randomised controlled trial data. The Lancet Diabetes & Endocrinology. Vol. 7(10), 754–766.
• Ronghe V, Pannase K, Gomase KP, Mahakalkar MG, (2023) Understanding Hypoactive Sexual Desire Disorder (HSDD) in Women: Etiology, Diagnosis, and Treatment. Cureus. Vol. 15(11)
• Parish, SJ, Kling, JM, (2023). Testosterone use for hypoactive sexual desire disorder in postmenopausal women. Menopause. Vol. 30(7) 781-783
• Shifren, JL, Monz, BU, Russo, PA, Segreti, A, & Johannes, CB. (2008). Sexual problems and distress in United States women: prevalence and correlates. Obstetrics and gynecology, 112(5), 970–978
• Statista for USA population information
Benefits of treating HSDD with Testosterone
7
Significant Global Market Opportunity
References:
• Hill K., (1996) The demography of menopause, Maturitas 23:113-127.
• Parish SJ et al, (2021) International Society for the Study of Women’s Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women J Sex Med 18:849-867
Approximately 60 million women in the US are affected by menopause with an estimated 4.9 million menopausal women suffering from HSDD.
Acrux estimates the US menopausal market for HSDD alone could deliver a commercial value of ~US$2.88 billion per annum. Already 2 million
US women are estimated to use off-label testosterone products for HSDD. Globally, approximately 120 million women are estimated to
have HSDD by 2030.
Assumptions:
• 12.3% 45-65y, 8.9% 18-44 y and 7.4% >65 y have HSDD
• Cost of annual treatment = $USD 300 per month.
• 40% may women respond to treatment/clinically meaningful improvements
• 75% women would speak to doctor & 82% of these initiate discussion with healthcare provider.
• No rebates assumed.
Estimated US HSDD Market Potential p.a. (US$Bn)
HSDD -
Postmenopausal
women (natural +
surgical)
45%
HSDD – Premenopausal Women 9%
Post-cancer (chemo /
radiotherapy) sexual dysfunction…
Premature
menopause / POI
6%
IVF / ovarian
priming
4%
Alzheimer’s
disease /
cognitive decline
28%
Global population potential indications* for
Female Testosterone
*There is no known published market report that segments the testosterone market exclusively for women by
indication/population. The percentages shown are derived estimates constructed from information, real-world prescribing
patterns, epidemiology, and other therapy information. Estimates are intended for strategic and illustrative purposes and are not
sourced from a single proprietary market report."
Female Testosterone Awareness
Acrux Ltd (ASX:ACR) | Strategic Update | April 2026 8
Female Testosterone is gaining significant mainstream patient population awareness and traction
across key global markets.
Female Testosterone: A New Global Market for Acrux
Acrux Ltd (ASX:ACR) | Strategic Update | April 2026 9
• In the early 2000s, the World Health Initiative
found the overall risks exceeded benefits from
certain hormone products, not including
testosterone, but creating a misconception.
• July 2025: The unmet clinical need of HSDD
in post-menopausal women was a key
aspect of the FDA Expert Panel on Menopause
and Hormone Replacement Therapy for
Women.
• In 2025, the landscape shifted, with recent
approvals in the UK, Australia, New Zealand
and South Africa of products treating HSDD in
post-menopausal women.
Acrux has significant IP in testosterone products, regulatory engagement and transdermal spray application technology and is uniquely positioned
to exploit global demand for female testosterone products.
Acrux has had positive engagement with the US FDA regarding the clinical pathway required to register our Female Testosterone treatment.
• 2002: Pre-IND* meeting held with FDA to discuss
potential populations and Phase II protocol
design, IND application lodged.
• 2005: Pre-IND meeting held with FDA to
discuss safety requirements, end of Phase II
meeting to discuss Phase III program planned,
program ceased.
• October 2025: Acrux submitted a Pre-IND
package to the FDA.
• November 2025: US Department of Health &
Human Services removes US FDA Black Box
warnings from female hormone replacement
therapy products.
• January 2026: Acrux’s registration pathway
clarified by the FDA.
Head start with strong US
FDA Regulatory Engagement
Clinical spotlight on HSDD
• Acrux has a strong history of pioneering transdermal
drug delivery systems, turning opportunities into
marketed products.
• Our R&D has led to multiple first-in-class, hormone
formulations such as Axiron®, Evamist® and
Lenzetto®.
• Our clinical journey began with addressing an unmet
need in women for HSDD.
• Acrux’s Phase II trials demonstrated significant
improvement, confirming efficacy and safety.
• The Female Testosterone MDTS spray was
developed for women using Acrux’s applicator and
Patchless Patch technologies.
• 505 (b)(2) exclusivity
• Decades of research, proven know-how and
expertise in regulatory pathways underpin Acrux’s
commitment to advancing patient care.
Core Acrux expertise & IP
* Pre-investigational New Drug
+ +
Acrux Proven MDTS Technology
2. ACROSS Enhancers
1. MDTS or MD-Lotion Applicator 3. Patchless Patch Reservoir
Acrux’s proven Meter Dose Transdermal System (MDTS) technology is an ideal mode of administration for Female Testosterone.
The spray is applied to the abdomen, reducing the risk of incidental contact and transfer on other parts of the body.
Utilising the same delivery technology as Lenzetto and Evamist ensures high scalability once in market.
Acrux Ltd (ASX:ACR) | Strategic Update | April 2026 10
Used for simple, accurate &
flexible dosing. Appliedto the
abdomen.
Allow drugs to pass through
skin more rapidly.
Forms an invisible reservoir
within the skin.
Female Testosterone Strategy
Acrux will seek to co-develop the Female Testosterone solution to enable an expedited pathway through the proposed Phase III trial and ensure a
fast market entry. Given no product is currently registered in the US with female appropriate dosing Acrux has a unique opportunity to take
advantage in the near-term.
• 505 (b)(2) exclusivity period
• Exclusivity differentiation considerations:
o New improved MDTS applicator with
patent protection.
o Combination therapies with
patent protection.
• Expand proposed indication to include:
o Surgically postmenopausal women.
o Women with premature menopause.
o For post-chemotherapy/ radiotherapy.
• First-line and first-choice dosage form for
treatment of HSDD:
o Once a day administration.
o Applied to the abdomen.
• Enhancing sexual desire:
o With decreased sexual concerns including
sexual distress.
o Enhancement in overall mood and energy.
• Complement to hormone therapy:
o Highlighting testosterone's role in comprehensive
hormone optimisation, especially alongside
estrogen–progesterone approaches.
1
Expedited Market Entry
Strategy
• Clinical & Regulatory Strategy:
o Shortened regulatory pathway as Phase II
clinical trials completed.
o Define regulatory & clinical strategies for US
andtherestoftheworldthrough consulting with
regional authorities (e.g. TGA, FDA, EMA).
o Market entry based on regional regulatory
requirements.
• Partnering Strategy:
o Co-develop with global partner with clinical
trial expertise, sale force access, hormone
product experience and market education
and advocacy.
o No current female testosterone product
approved in the US
Acrux Ltd (ASX:ACR) | Strategic Update | April 2026 11
2
Product Positioning
3
Lifecycle Management
Development Roadmap: Target FY28 Market Launch
Acrux Ltd (ASX:ACR) | Strategic Update | April 2026 12
• Acrux is focused on progressing potential co-development partnerships in the near-term to de-risk the clinical trial
process and expedite market launch.
• Acrux is well positioned with existing distribution and product agreements in place with potential co-development
partners.
• Acrux will work proactively with its co-development partner to finalise the Phase III trial design and manufacturing
protocols.
• Multiple near-term and medium-term milestones will ensure strong investor engagement and catalysts through
to product launch in the US.
Co-development Partnering
CRO Contract
Manufacturing
Phase III Trials
Dossier to US FDA
Submission and Product Launch
Mid CY26
Early FY27
Early FY27 to launch
Early FY27 to submissions
Early FY28
Late FY28 to Early FY29
MILESTONES
13
Commercialised
Portfolio
Successful development and FDA registration of
topical pharmaceuticals now generates core Acrux
income
Powerful Partnerships
Acrux Ltd (ASX:ACR) | Strategic Update | April 2026 14
Proven Product Portfolio
Infrastructure & Capabilities
Experienced Team
FDA registered products commercialised in the US
• Nitroglycerin 0.4% ointment launched.
• Dapsone 5.0% gel launched.
• Dapsone 7.5% gel launched.
• Evamist® royalties continue.
Unprofitable assets removed from portfolio
R&D focus moved to Female Testosterone and next
generation products
Realisation of generic pipeline via partnerships
• Ophthalmic, Otic, and Topical.
Geographic expansion of FDA registered products
Further Female HRT licensing expansion
Generic Portfolio Revenue Performance
Acrux Ltd (ASX:ACR) | Strategic Update | April 2026 15
+305%
• Acrux continues to generate strong financial performance
from the Company’s portfolio of generic pharmaceuticals
that supports and subsidises group R&D activities.
• Quarterly revenues from product licensing are
growing, driven by the launch of Nitroglycerine 0.4%
Ointment at the end of Q2 FY25.
• With Q4 FY26 revenues to come, FY26 Product Licensing
Income is on track to be more than double that of the prior
year.
• Acrux will continue to review its asset portfolio to ensure
the optimal product mix to deliver shareholder value.
Proceeds from divestment of Prilocaine 2.5% and
Lidocaine 2.5% cream were received in 1H FY26. 0
0.5
1
1.5
2
2.5
FY25 FY26
License revenues from Generic portfolio
Q1 Q2 Q3 Q4
$M’s
Summary
Female Testosterone catalyses
Acrux’s investment proposition
Acrux Ltd (ASX:ACR) | Strategic Update | April 2026 17
• Phase III ready asset.
• Significant, fast-growing market.
• Early mover advantage.
• Patient preferred application.
• Co-development pathway.
• Existing commercial portfolio.
• IP & know-how.
Highly Experienced Executive Team
John Warmbrunn, BSc, MBA
CEO and Managing Director
• Joined Acrux in 2025.
• 25 years industry experience.
Felicia Colagrande, BSc(Hons), MBA
Product Development and Technical
Affairs Director
• 25 years with Acrux.
• 36 years industry experience.
Mark Hyman, BSc
Product and Technical Director
• 11 years with Acrux.
• 37 years industry experience.
Joanna Johnson, BEc, ACA
CFO and Company Secretary
• 5 years with Acrux.
• 30 years industry experience.
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