Investor Presentation - Female Testosterone for HSDD
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Acrux Limited (ACR:ASX) | ACN 082 001 152
103-113 Stanley St, West Melbourne VIC, 3003 Australia
+61 3 8379 0100 | info@acrux.com.au
Acrux Limited (ACR:ASX)
ASX Announcement
6 August 2026
Investor Presentation – Bioshares Biotech Summit
Today our CEO and Managing Director, John Warmbrunn, is presenting at Bioshare’s 20th
Biotech Summit.
A copy of this Investor Presentation which has a clear focus on Female Testosterone
accompanies this release.
Authorised for release by the Chair of Board of Acrux Limited.
For more information, please contact:
John Warmbrunn
Acrux Limited
CEO & Managing Director
P: + 61 3 8379 0100
E: john.warmbrunn@acrux.com.au
About Acrux:
Acrux (ASX: ACR) has spent 25 years building deep expertise in transdermal and topical drug
delivery. We're now executing a focused strategy to address women’s health through
hormone replacement therapies. This is supported by a diversified portfolio of topical
generic pharmaceuticals, already commercialised in the US market.
Click here to sign up to our InvestorHub and keep up to date with company news and latest
developments or further information on Acrux Limited, visit www.acrux.com.au
END.
Acrux Ltd (ASX:ACR) | Bioshares Biotech Summit | 6 August 2026
Healthspan
John Warmbrunn
CEO & Managing Director
Acrux Ltd
August 2026
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Acrux Ltd (ASX:ACR) | Bioshares Biotech Summit | 6 August 2026
Disclaimer
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
reasonably expected 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.
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Acrux Ltd (ASX:ACR) | Bioshares Biotech Summit | 6 August 2026
LOW LIBIDO and HEALTHSPAN
Illustrative diagram only
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Acrux Ltd (ASX:ACR) | Bioshares Biotech Summit | 6 August 2026
What is Hypoactive Sexual Desire Disorder (HSDD)?
~4.9m
menopausal
women in the
US affected
~10%
of all adult
women impacted
Commonly expressed as low or absent
sexual desire and/or response to stimulation
Other symptoms include:
Low self-
esteem
Reduced
energy
Social
conflict
Depression Anxiety
References:
• Islam, RM, Bell, RJ, Green, S, Page, MJ, Davis, SR, (2019). Safety and efficacy of testosterone for women: a systematicreview and meta-analysis of randomisedcontrolled trial data. The Lancet Diabetes & Endocrinology. Vol. 7(10), 754–766.
• Ronghe V, Pannase K, Gomase KP, Mahakalkar MG, (2023) UnderstandingHypoactive Sexual Desire Disorder(HSDD) in Women: Etiology, Diagnosis,nd Treatment. Cureus. Vol. 15(11)
• Parish,SJ, Kling, JM, (2023). Testosteroneuse for hypoactive sexual desiredisorder 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: prevalenceand correlates. Obstetricsand gynecology,112(5), 970–978
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HSDD impacts more than desire SEXUAL HEALTH
Desire – Intimacy - Satisfaction
Addressing HSDD can help women reclaim their well-being - inside and out
It touches every
part of a
women’s well
being
SELF CONFIDENCE
Body image – Self esteem – Feeling like
yourself
RELATIONSHIP HEALTH
Connection – Communication - Closeness
EMMOTIONAL WELL-
BEING
Mood – Stress – Mental wellness
QUALITY OF LIFE
Fulfilment – Happiness – Life
satisfaction
Acrux Ltd (ASX:ACR) | Bioshares Biotech Summit | 6 August 2026
Professor Susan R Davis
AO, MBBS FRACP PhD FAHMS
• 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. ^
* Acrux Testosteroneis not yet registered for this indication. # MDTS – Metered Dose Transdermal System
^ Davis, SR, Baber, R, Panay, N, Bitzer,J, Perez, SC,Islam, RM, Kaunitz, AM, KingsbergSA, LambrinoudakiI, Liu J, Parish SJ, PinkertonJ, Rymer J, Simon JA, Vignozzi,L, WiermanME, (2019).
Global ConsensusPositionStatement onthe Use of TestosteroneTherapy for Women. The Journalof ClinicalEndocrinology & Metabolism. Vol 104(10), pp. 4660-4666.
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.
Acrux’s Testosterone* MDTS# has the advantages of
acting as a "patchless" patch with good
pharmacokinetic evidence of absorption
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Acrux Ltd (ASX:ACR) | Bioshares Biotech Summit | 6 August 2026
Significant Global Market Opportunity
18-44
years
$7.91
45-65
years
$8.85
65+ years
$4.54
Estimated US & EU HSDD Market
Potential p.a. (US$B)
US$21.3B
Total US HSDD
market potential
p.a
HSDD
postmenopausal
women
45%
HSDD premenopausal
women
9%
Post-cancer treatment
sexual dysfunction
8%
Premature
menopause
6%
IVF /
ovarian
priming
4%
Alzheimer's /
cognitive decline
28%
Potential Global Population for
Female Testosterone*
~120m
Women globally
estimated to
have HSDD
by 2030
*There is no known publishedmarket reportthat segmentsthe testosterone marketexclusively for women
by indication/population. The percentagesshown are derived estimatesconstructedfrom information,
real-worldprescribingpatterns, epidemiology, and othertherapy information. Estimates are intended for
strategic and illustrative purposesand are not sourced from a single proprietarymarket report."
Assumptions: 12.3% 45-65y, 8.9% 18-44 y and 7.4% >65 y have HSDD; Cost of annualtreatment= $USD
300 per month;40% may women respondto treatment/clinically meaningful improvements; and 75%
women would speak to doctor & 82% of these initiate discussionwith healthcareprovider.
References: Hill K., (1996) The demographyof menopause, Maturitas23:113-127. Parish SJ et al, (2021)
InternationalSociety for the Study of Women’sSexual Health ClinicalPractice Guidelinefor the Use of
SystemicTestosterone for Hypoactive Sexual Desire Disorder in Women J Sex Med 18:849-867.
~60m
women in the US estimated
to be affected by menopause
~4.9m
menopausal women
estimated with HSDD
~2m
US women are estimated to
use off-label testosterone
products for HSDD
Acrux Ltd (ASX:ACR)
Female Testosterone MDTS
Helping millions of women with
Hypoactive Sexual Desire Disorder (HSDD)
Bioshares Biotech Summit | 6 August 2026
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Acrux Ltd (ASX:ACR) | Bioshares Biotech Summit | 6 August 2026
Testosterone: A Transformative Opportunity in Women's Health
HSDD is the primary clinical application for testosterone therapy in
women, serving as the foundation of treatment.
• Sexual Health Spectrum
Testosterone influences multiple aspects of female sexual function including
FSAD and orgasmic disorders beyond HSDD.
• Cognition and Memory
Emerging research links testosterone to cognitive performance and healthy aging
in women.
• Bone and Musculoskeletal Health
Testosterone supports skeletal integrity, muscle strength, and physical well-being
in women.
Core Indication HSDD
Potential beyond HSDD
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Acrux Ltd (ASX:ACR)
Female Testosterone
MDTS
Blockbuster potential
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Acrux Ltd (ASX:ACR) | Bioshares Biotech Summit | 6 August 2026
Acrux History
Innovative Skin Delivery Technology Topical Generics
1998:
Acrux incorporated to
commercialise unique
drug delivery
technology invented at
Monash University
2001:
First US patent
granted
2004:
ASX listing
2011:
Axiron® launched by
Eli Lilly
2022:
Lidocaine 2.5%
and Prilocaine
2.5% Cream)
launched in USA
2024:
Launch
Nitroglycerine 0.4%,
Ointment
2003:
Recuvyra®
Veterinary product
licensed to Elanco
globally
2007:
Evamist® licensed to
KV Pharmaceutical
in US
2016:
Lenzetto® launched
in Europe by Gedeon
Richter
2024:
Launch Dapsone
5%, Gel
2025:
Launch Dapsone
7.5%, Gel
MALE TESTOSTERONE
ESTRADIOL
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Acrux Ltd (ASX:ACR) | Bioshares Biotech Summit | 6 August 2026
Acrux Proven MDTS Technology
Proprietary MDTS (Metered Dose
Transdermal System) Applicator
Delivers a controlled spray of
Female Testosterone through the skin
Patchless Patch forms an invisible
reservoir within the skin
No alternative competitor Applicator launched in 18 years
Lenzetto® and Evamist® delivery technology
ensures high scalability once in market.
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Acrux Ltd (ASX:ACR) | Bioshares Biotech Summit | 6 August 2026
Female Testosterone Awareness
Female Testosterone is gaining significant mainstream patient population awareness and
traction across key global markets.
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Acrux Ltd (ASX:ACR) | Bioshares Biotech Summit | 6 August 2026
Global Positioning of Testosterone Therapy for Women
Historical Barriers New Global Pathway
FDA“Black box" warnings:
On hormone therapy
products for over 20 years,
its strongest caution
creating a significant barrier
for providers and patients.
Off-Label Prescribing:
Testosterone therapy for women is
often based on male formulations
and lack standardised dosing.
Safety & Efficacy :
Inconsistent treatment
outcomes and dosing
raised risks and patient
safety issues.
Regulatory & Research Gaps:
Absence of female-specific products
and regulatory clarity hindered
pharmaceutical innovation.
First evidence-based
guidelines: For
testosterone therapy in
women worldwide from
Global Consensus Position
Statement (GCS) in 2019.
Removal of Black box warnings:
FDA with renewed focus on
menopause and hormone-therapy
policy, seeks to encourage treatments.
GCS noted an unmet medical need
for a testosterone transdermal
product formulated for female
clinical use. Female Testosterone
MDTS® (4.5 mg per spray) has been
shown to achieve this clinically.
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Acrux Ltd (ASX:ACR)
Phase III Study
Development roadmap in place
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Acrux Ltd (ASX:ACR) | Bioshares Biotech Summit | 6 August 2026
Clear Phase II Results
• Mean number of satisfactory sexual
events increased compared to placebo at
weeks 4, 8, 12 and 16 for all of the
testosterone groups.
• Statistically significant increase in the
primary endpoint in the 1 × 90 µL
testosterone group in the intent-to-treat
(ITT) population, with a mean increase of
2.00 satisfactory sexual events at week 16,
compared to a mean increase of 0.53
events in the placebo group (the mean
baseline frequency in each of these
groups was 1.3-1.4).
0.0
0.5
1.0
1.5
2.0
2.5
3.0
week 4 week 8 week 12 week 16
Number of Satisfactory Sexual Events:
Change from Baseline
placebo 1 x 56 uL 1 x 90 uL 2 x 90uL
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Acrux Ltd (ASX:ACR) | Bioshares Biotech Summit | 6 August 2026
Phase III Pivotal Clinical Trial Design - A Critical Next Step
Study Design
Title
A Phase III, Double-Blind, Placebo Controlled
Study of the Safety and Efficacy of
Testosterone Transdermal Spray for the
Treatment of Sexual Dysfunction (Hypoactive
Sexual Desire Disorder) in Postmenopausal
Women
Co-primary
Endpoints
• Sexually Satisfying Events and Sexual Desire
Score
• [Time Frame: baseline through 24 weeks]
Secondary
Endpoint
• Female Sexual Distress Score
• [Time Frame: baseline through 24 weeks]
USA
Australia
FDA Pre-IND recent
feedback
FDA Post end-of-Phase-II
response received July-2026
TGA recent feedback
TGA meeting held
December-2025
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Acrux Ltd (ASX:ACR) | Bioshares Biotech Summit | 6 August 2026
Lifecycle Strategy for Further Development
New improved MDTS
applicator with patent
protection
MDTS Companion
Smartphone App
Expand proposed indication/
population to include:
• Female sexual interest/arousal
disorder (FSIAD)
• Female sexual arousal disorder
(FSAD)
• Women with premature
menopause
• For women post-
chemotherapy/ radiotherapy
• Potential as part of IVF
treatment
• Cognitive symptoms
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Acrux Ltd (ASX:ACR)
Development Roadmap
Close to market - Clear regulatory pathway
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Acrux Ltd (ASX:ACR) | Bioshares Biotech Summit | 6 August 2026
Co-development Roadmap
• Focus is on progressing potential
co-development partnerships in
the near-term to de-risk the clinical
trial process and expedite market
launch.
• Well positioned with existing
distribution and product
agreements in place with potential
co-development partners.
• Strong interest from women’s
health specialist pharma
• Proactively work with its co-
development partner to finalise the
Phase III trial design and
manufacturing protocols.
2026 2027 2028 2029 2030
Co-development
Partnering
CRO Contract
Manufacturing
Phase III Trials & Trial
supply
Dossier to US FDA
Submission and
Product Launch
Multiple near-term and medium-term milestones will ensure strong investor engagement and
catalysts through to product launch in the US in 2019
Acrux Ltd (ASX:ACR)
Female Testosterone MDTS
Helping millions of women with
Hypoactive Sexual Desire Disorder (HSDD)
Bioshares Biotech Summit | 6 August 2026
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Acrux Ltd (ASX:ACR) | Bioshares Biotech Summit | 6 August 2026
Phase III stage asset.
Significant, fast-growing market.
Early mover advantage.
Patient preferred application.
Co-development pathway.
Female Testosterone MDTS catalyses Acrux’s investment proposition
Helping millions
of women with
Hypoactive
Sexual Desire
Disorder (HSDD)
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Acrux Ltd (ASX:ACR) | Bioshares Biotech Summit | 6 August 2026
Pooled Development Fund
Purpose
• Pooled Development Fund
Act 1992 was established by
the Federal Government
• Increase the supply of
capital to Australian small
and medium-sized
enterprises to enable those
businesses to grow and
develop their own markets,
creating industry and jobs
for Australia
Benefits
Capital gains made by PDF
shareholders are not
taxable
Shareholders can elect to
treat dividends paid by a
PDF as tax free
Capital losses on the sale of
PDF’s are not deductible
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Acrux Ltd (ASX:ACR) | Bioshares Biotech Summit | 6 August 2026
Successful development and FDA registration of topical pharmaceuticals
generates core Acrux income
• Nitroglycerin 0.4% ointment launched.
• Dapsone 5.0% gel launched.
• Dapsone 7.5% gel launched.
• Evamist® royalties continue.
• Ophthalmic, Otic, and Topical.
0
0.5
1
1.5
2
2.5
3
3.5
4
FY25 FY26
License revenues from Generic portfolio
Q1 Q2 Q3 Q4
FDA registered products commercialised in the US
Geographic expansion of FDA registered products
Further Female HRT licensing expansion
Unprofitable assets removed from portfolio
Realisation of generic pipeline via partnerships
Includes
$1.35M
upfront
payment
for
Lenzetto®
in
Australia
Acrux Ltd (ASX:ACR)
THANKYOU
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Bioshares Biotech Summit | 6 August 2026
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