Quarterly Activities/Appendix 4C Cash Flow Report
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LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
29 October 2025
Quarterly Activities Report & Appendix 4C
For the Period Ending 30 September 2025
Highlights
ROXUS®
development milestones achieved with stability testing progressing well, on track for US
market launch H1 CY2026.
World-class US-based Scientific Advisory Board established with appointments of leading US
erectile dysfunction specialists, Dr Amy Pearlman and Dr Andrew Sun, to accelerate US market
entry.
Peer-reviewed publication in European Journal of Pharmaceutical Sciences validates SPONTAN®
delivers up to 5 times faster onset than oral tablets, strengthening regulatory pathway.
100% patient satisfaction demonstrated in post-prostatectomy erectile dysfunction case series
presented at the Asia-Pacific Prostate Cancer Conference, targeting a significant underserved
market.
Strategic 33% equity stake secured in LevOmega Pty Ltd at nil cost to shareholders, providing
exposure to the multi-billion-dollar omega-3 market through pharmaceutical-grade ingredient
development.
LTR Pharma Limited (ASX:LTP) (“LTR Pharma” or “the Company”), a company focused on improving men’s health
through clinical development and commercialisation of innovative nasal spray treatments for erectile
dysfunction (“ED”), SPONTAN®
and ROXUS®
, is pleased to provide its Appendix 4C and an overview of its
activities for the period ended 30 September 2025 (the “Reporting Period” or the “Quarter”).
Commenting on the activity for the Quarter, Executive Chairman, Lee Rodne, stated:
"This quarter represents a transformative period for LTR Pharma as we systematically built the foundations for
our US market entry. The appointments of Dr Amy Pearlman and Dr Andrew Sun provide access to US prescriber
networks, accelerating ROXUS adoption in the world's largest erectile dysfunction market. Our peer-reviewed
publication, 18-month shelf-life achievement, and 100% patient satisfaction in post-prostatectomy cases provide
compelling clinical validation. Our strategic position in LevOmega extends our innovation platform without
diluting shareholder capital. With a strong cash position and operational momentum, we are well-positioned to
deliver our US market entry and advance SPONTAN through regulatory milestones in 2026."
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LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
Corporate & Operational Update
During the Quarter, LTR Pharma achieved significant milestones across clinical validation, product development,
strategic leadership appointments, and portfolio expansion.
Scientific Advisory Board Strengthened for US Market Entry
The Company appointed two leading US erectile dysfunction specialists to its Scientific Advisory Board during the
Quarter, substantially de-risking the planned H1 CY2026 ROXUS launch in the US$3.7 billion US market.
Dr Amy Pearlman, M.D. (appointed 11 August 2025)
Dr Pearlman is a Board-certified urologist and co-founder of Prime Institute in Coral Gables, Florida. She is a
former Director of the Men's Health Programme at the University of Iowa and a member of the board of the Sexual
Medicine Society of North America. Her influence on US prescriber networks and understanding of the American
healthcare landscape will help to accelerate ROXUS market penetration.
Dr Andrew Y. Sun, M.D. (appointed 18 August 2025)
Dr Sun is the Director of Men's Health at Urology Partners of North Texas, one of the state's largest men's health
clinics. He is a Harvard-trained urologist who contributes to the US national clinical guidelines and leads training
programmes in erectile restoration. His extensive experience with PDE5 inhibitor prescribing provides critical
insight into commercial positioning.
These appointments position LTR Pharma to enable prescriber adoption and market penetration ahead of
ROXUS's planned H1 CY2026 launch.
Clinical Data Publication and Validation
Peer-Reviewed Publication Validates Differentiated Profile.
LTR Pharma's Phase I pharmacokinetic data were published in the peer-reviewed European Journal of
Pharmaceutical Sciences in August 2025, providing independent validation of SPONTAN's clinical differentiation.
The study confirmed SPONTAN’s 5x faster onset vs oral tablets and superior dose-normalised bioavailability
despite using half the dose, with no serious adverse events.
This third-party validation strengthens regulatory submissions across US, European, and Asian markets and de-
risks the commercial value proposition for both SPONTAN and ROXUS, which share the same rapid-onset platform
technology.
100% Patient Satisfaction in Post-Prostatectomy Population
A four-patient case series presented at the 25th Asia-Pacific Prostate Cancer Conference (APCC) in August 2025
demonstrated 100% patient satisfaction with SPONTAN in post-prostatectomy erectile dysfunction, with all
patients preferring SPONTAN over traditional oral treatments.
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LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
With ~8,500 radical prostatectomies annually in Australia1 and hundreds of thousands globally2, this validates a
significant commercial opportunity. Studies show 50% of men discontinue oral PDE5 inhibitors3, positioning
SPONTAN as a differentiated first-line therapy for this underserved, high-value population.
Commercial Readiness Confirmed
SPONTAN achieved an 18-month shelf life under ICH stability conditions in August 2025, confirming commercial-
scale manufacturing capability and meeting international distribution standards. This removes technical barriers
to global market entry and partnership discussions, whilst strengthening regulatory submissions with robust
Chemistry, Manufacturing, and Controls data.
Portfolio Expansion
In September 2025, LTR Pharma secured a one-third ownership stake in LevOmega Pty Ltd at nil cost to
shareholders, recognising the Company's pharmaceutical development and commercialisation expertise.
LevOmega is developing nature-identical, pharmaceutical-grade omega-3 products to address supply constraints
in the multi-billion-dollar global omega-3 market, where demand already exceeds sustainable marine supply.
Subsequent to the end of the Quarter, LTR Pharma invested $1 million to increase its ownership in LevOmega to
43%, further strengthening its strategic exposure to the pharmaceutical-grade omega-3 sector and expanding its
platform innovation strategy into a high-growth market.
Financial Update
LTR Pharma maintained a strong financial position during the Quarter, with a cash balance of $29,733,623 as at
30 September 2025, providing substantial runway to execute strategic objectives across multiple markets.
The Company's disciplined capital allocation during the Period focused on advancing key development
programmes and commercial initiatives. Research and development activities represented the primary
investment area, with $1,161,003 directed towards development programmes. Marketing and advertising
expenditure of $168,613 supported the continued commercial expansion of SPONTAN.
Receipts of $32,800 represent SPONTAN prescriptions under the TGA’s Special Access Scheme (SAS), which
provides controlled access for patients with unmet medical needs, particularly those who have unsatisfactory
outcomes with PDE5 inhibitors such as Viagra (sildenafil) or Cialis (tadalafil). The Company continues to collect
valuable prescriber insights through the SAS pathway, which helps shape the Company’s commercial strategy
ahead of broader market approval.
In accordance with Listing Rule 4.7C, payments made to related parties and their associates included in item 6.1
of Appendix 4C totalled A$168,000 and included Director fees, salary, and superannuation for the Executive
Chairman and Non-Executive Directors.
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LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
The Company's robust financial position provides confidence in executing planned activities, including the
completion of ROXUS development for the H1 CY2026 US launch, the commencement of the Phase II
pharmacokinetic study in Q1 CY2026, the progression of OROFLOW development, European regulatory
engagement, and continued commercial expansion of SPONTAN through pharmacy networks.
Looking Ahead
LTR Pharma is focused on executing key value-creating milestones across multiple growth drivers:
FDA Phase II pharmacokinetic study
Commence Phase II pharmacokinetic study with patient enrolment in Q1 CY2026, a key milestone for SPONTAN's
FDA regulatory pathway.
US Market Launch (H1 2026)
Complete ROXUS development and establish commercial infrastructure to enable launch in the US via the 503A
personalised healthcare pathway. Leverage Dr Pearlman and Dr Sun's prescriber networks to accelerate adoption
within men’s health clinics and telehealth channels, targeting first sales in H1 CY2026 in the US$3.7 billion erectile
dysfunction market.
The Company remains well-capitalised to execute these strategic priorities and is building substantial momentum
towards transforming erectile dysfunction treatment globally.
This announcement has been approved by the Board of Directors.
1
Source: Australian Commission on Safety and Quality in Health Care, Australian Atlas of Healthcare Variation, 2012-13 hospital admissions
data.
2
Source: PMC9974222, "Trends in surgical treatment for prostate cancer: Analysis of National Database," published in 2023.
3
Carvalheira et al., "Dropout in the Treatment of Erectile Dysfunction with PDE5: A Study on Predictors and a Qualitative Analysis of Reasons
for Discontinuation," Journal of Sexual Medicine, May 2012.
- ENDS –
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LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
About LTR Pharma
LTR Pharma is an emerging pharmaceutical company committed to developing and commercialising innovative
therapies that address significant unmet medical needs. The Company is leveraging its proprietary intranasal
drug delivery platform to enable rapid, non-invasive treatment options across multiple therapeutic areas.
LTR’s lead products, SPONTAN®
and ROXUS®
, are fast-acting intranasal sprays for the treatment of erectile
dysfunction, enabling onset of action in 10 minutes or less. Building on this proven technology, the Company is
now advancing OROFLOW®
, a novel intranasal spray under development for the treatment of Oesophageal
Motility Disorders (OMD) – a debilitating group of conditions affecting swallowing function.
Through strategic partnerships, LTR Pharma is expanding its pipeline and global footprint to deliver differentiated,
patient-centric treatments that enhance quality of life.
.
LTR Pharma Investor Centre
Stay informed with LTR Pharma’s latest announcements and
market updates by visiting our Investor Centre or scan the QR code.
For further information please contact:
Media Enquiries Investor Enquiries
Haley Chartres Peter McLennan
haley@hck.digital investors@ltrpharma.com
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 6
+ See chapter 19 of the ASX Listing Rules for defined terms.
Appendix 4C
Quarterly cash flow report for entities
subject to Listing Rule 4.7B
Name of entity
LTR Pharma, LTR Pharma Inc
ABN Quarter ended (“current quarter”)
September 2025
Consolidated statement of cash flows Current quarter
$A
Year to date
(12 months)
$A
1. Cash flows from operating activities
32,800 32,800
1.1 Receipts from customers
1.2 Payments for
(1,161,003) (1,161,003)
(a) research and development
(b) product manufacturing and operating
costs
-
(c) advertising and marketing (168,613) (168,613)
(d) leased assets -
(e) staff costs (640,892) (640,892)
(f) administration and corporate costs (297,060) (297,060)
1.3 Dividends received (see note 3) -
1.4 Interest received 200,072 200,072
1.5 Interest and other costs of finance paid (30) (30)
1.6 Income taxes paid -
1.7 Government grants and tax incentives - -
1.8 Other (provide details if material) -
1.9 Net cash from / (used in) operating
activities
(2,034,728) (2,034,728)
2. Cash flows from investing activities
- -
2.1 Payments to acquire or for:
(a) entities
(b) businesses - -
(c) property, plant and equipment - -
(d) investments (40,000) (40,000)
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 7
+ See chapter 19 of the ASX Listing Rules for defined terms.
Consolidated statement of cash flows Current quarter
$A
Year to date
(12 months)
$A
(e) intellectual property - -
(f) other non-current assets - -
2.2 Proceeds from disposal of:
- -
(a) entities
(b) businesses - -
(c) property, plant and equipment - -
(d) investments - -
(e) intellectual property - -
(f) other non-current assets - -
2.3 Cash flows from loans to other entities - -
2.4 Dividends received (see note 3) - -
2.5 Other (provide details if material) - -
2.6 Net cash from / (used in) investing
activities
(40,000) (40,000)
3. Cash flows from financing activities
- -
3.1 Proceeds from issues of equity securities
(excluding convertible debt securities)
3.2 Proceeds from issue of convertible debt
securities
- -
3.3 Proceeds from exercise of options - -
3.4 Transaction costs related to issues of
equity securities or convertible debt
securities
- -
3.5 Proceeds from borrowings - -
3.6 Repayment of borrowings - -
3.7 Transaction costs related to loans and
borrowings
- -
3.8 Dividends paid - -
3.9 Other (provide details if material) - -
3.10 Net cash from / (used in) financing
activities
- -
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 8
+ See chapter 19 of the ASX Listing Rules for defined terms.
Consolidated statement of cash flows Current quarter
$A
Year to date
(12 months)
$A
4. Net increase / (decrease) in cash and
cash equivalents for the period
31,808,532 31,808,532
4.1 Cash and cash equivalents at beginning of
period
4.2 Net cash from / (used in) operating
activities (item 1.9 above)
(2,034,728) (2,034,728)
4.3 Net cash from / (used in) investing activities
(item 2.6 above)
(40,000) (40,000)
4.4 Net cash from / (used in) financing activities
(item 3.10 above)
- -
4.5 Effect of movement in exchange rates on
cash held
- -
4.6 Cash and cash equivalents at end of
period
29,733,804 29,733,804
5. Reconciliation of cash and cash
equivalents
at the end of the quarter (as shown in the
consolidated statement of cash flows) to the
related items in the accounts
Current quarter
$A’000
Previous quarter
$A’000
5.1 Bank balances 29,733,804 31,808,532
5.2 Call deposits - -
5.3 Bank overdrafts - -
5.4 Other (provide details) - -
5.5 Cash and cash equivalents at end of
quarter (should equal item 4.6 above)
29,733,804 31,808,532
6. Payments to related parties of the entity and their
associates
Current quarter
$A
6.1 Aggregate amount of payments to related parties and their
associates included in item 1
168,000
6.2 Aggregate amount of payments to related parties and their
associates included in item 2
-
Note: if any amounts are shown in items 6.1 or 6.2, your quarterly activity report must include a description of, and an
explanation for, such payments.
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 9
+ See chapter 19 of the ASX Listing Rules for defined terms.
7. Financing facilities
Note: the term “facility’ includes all forms of financing
arrangements available to the entity.
Add notes as necessary for an understanding of the
sources of finance available to the entity.
Total facility
amount at quarter
end
$A
Amount drawn at
quarter end
$A
7.1 Loan facilities - -
7.2 Credit standby arrangements - -
7.3 Other (please specify) - -
7.4 Total financing facilities - -
7.5 Unused financing facilities available at quarter end -
7.6 Include in the box below a description of each facility above, including the lender, interest
rate, maturity date and whether it is secured or unsecured. If any additional financing
facilities have been entered into or are proposed to be entered into after quarter end,
include a note providing details of those facilities as well.
8. Estimated cash available for future operating activities $A
8.1 Net cash from / (used in) operating activities (item 1.9) (2,034,909)
8.2 Cash and cash equivalents at quarter end (item 4.6) 29,733,804
8.3 Unused finance facilities available at quarter end (item 7.5)
8.4 Total available funding (item 8.2 + item 8.3) 29,733,804
8.5 Estimated quarters of funding available (item 8.4 divided by
item 8.1)
15
Note: if the entity has reported positive net operating cash flows in item 1.9, answer item 8.5 as “N/A”. Otherwise, a
figure for the estimated quarters of funding available must be included in item 8.5.
8.6 If item 8.5 is less than 2 quarters, please provide answers to the following questions:
8.6.1 Does the entity expect that it will continue to have the current level of net operating
cash flows for the time being and, if not, why not?
Answer:
8.6.2 Has the entity taken any steps, or does it propose to take any steps, to raise further
cash to fund its operations and, if so, what are those steps and how likely does it
believe that they will be successful?
Answer:
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 10
+ See chapter 19 of the ASX Listing Rules for defined terms.
8.6.3 Does the entity expect to be able to continue its operations and to meet its business
objectives and, if so, on what basis?
Answer:
Note: where item 8.5 is less than 2 quarters, all of questions 8.6.1, 8.6.2 and 8.6.3 above must be answered.
Compliance statement
1 This statement has been prepared in accordance with accounting standards and policies which comply with
Listing Rule 19.11A.
2 This statement gives a true and fair view of the matters disclosed.
Date: 29 October 2025
Authorised by: The Board of Directors
(Name of body or officer authorising release – see note 4)
Notes
1. This quarterly cash flow report and the accompanying activity report provide a basis for informing the market about the entity’s activities for
the past quarter, how they have been financed and the effect this has had on its cash position. An entity that wishes to disclose additional
information over and above the minimum required under the Listing Rules is encouraged to do so.
2. If this quarterly cash flow report has been prepared in accordance with Australian Accounting Standards, the definitions in, and provisions of,
AASB 107: Statement of Cash Flows apply to this report. If this quarterly cash flow report has been prepared in accordance with other
accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the corresponding equivalent standard applies to this report.
3. Dividends received may be classified either as cash flows from operating activities or cash flows from investing activities, depending on the
accounting policy of the entity.
4. If this report has been authorised for release to the market by your board of directors, you can insert here: “By the board”. If it has been
authorised for release to the market by a committee of your board of directors, you can insert here: “By the [name of board committee – eg
Audit and Risk Committee]”. If it has been authorised for release to the market by a disclosure committee, you can insert here: “By the
Disclosure Committee”.
5. If this report has been authorised for release to the market by your board of directors and you wish to hold yourself out as complying with
recommendation 4.2 of the ASX Corporate Governance Council’s Corporate Governance Principles and Recommendations, the board should
have received a declaration from its CEO and CFO that, in their opinion, the financial records of the entity have been properly maintained,
that this report complies with the appropriate accounting standards and gives a true and fair view of the cash flows of the entity, and that their
opinion has been formed on the basis of a sound system of risk management and internal control which is operating effectively.
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