Quarterly Activities/Appendix 4C Cash Flow Report
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LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
28 October 2026
Quarterly Activities Report & Appendix 4C
For the Period Ending 30 September 2026
First U.S. ROXUS®
Prescriptions Fulfilled and Final Phase II Report Completes FDA
Pharmacokinetic Dataset
Highlights
• First ROXUS®
prescriptions fulfilled in the U.S. (subsequent to quarter end): prescriptions received
through Shed’s Mavrox telehealth platform and fulfilled by Strive Pharmacy, less than three months
after the definitive agreements.
• Final Phase II report completes the FDA pharmacokinetic dataset (subsequent to quarter end):
SPONTAN®
’s six-fold faster absorption than oral vardenafil tablets confirmed; Phase III study
targeted to commence 1H CY2027.
• U.S. commercial framework for ROXUS completed: definitive agreements executed with Shed (17
July 2026) and Strive Pharmacy, securing telehealth and pharmacy fulfilment.
• 147-patient real-world study: 93% response in men seeking greater convenience and spontaneity;
64% in post-prostatectomy patients; 68% overall.
• SPONTAN®
surpasses 2,000 bottles dispensed in Australia (subsequent to quarter end): more than
2,000 bottles dispensed under TGA Special Access Scheme and Authorised Prescriber pathways as
at 20 October 2026, with more than 120 clinicians having prescribed SPONTAN on more than one
occasion.
• Ethics approval received for SPONTAN®
PAH study (subsequent to quarter end): investigator-
initiated study led by Professor David Celermajer to evaluate the haemodynamic effects, safety and
tolerability of intranasal SPONTAN in patients with pulmonary arterial hypertension.
• Strong financial position: A$18.2 million cash, debt-free, at 30 September 2026; net operating cash
outflow A$1.6 million.
LTR Pharma Limited (ASX: LTP) (“LTR Pharma” or “the Company”) is pleased to provide its Quarterly Activities
Report and Appendix 4C for the three-month period ended 30 September 2026 (the “Quarter”). LTR Pharma is
developing and commercialising innovative intranasal treatments addressing unmet needs in men’s health and
other therapeutic areas.
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LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
Commenting on the activity for the Quarter, Executive Chairman, Lee Rodne, stated:
“This Quarter was about converting agreements into execution. In July we executed definitive agreements with
Shed and Strive Pharmacy, securing the telehealth and pharmacy fulfilment components of our U.S. commercial
framework for ROXUS®
. Less than three months later, on 6 October, the first patient-specific ROXUS prescriptions
received through Mavrox were fulfilled in the United States by Strive Pharmacy. We have moved from
implementation to serving patients, and our focus is now on supporting our partners as prescribing activity builds.
The 147-patient real-world study reported a 93% response among men seeking greater convenience and
spontaneity, and on 1 October the final Phase II report confirmed SPONTAN®
’s six-fold faster absorption and
completed the pharmacokinetic dataset agreed with the FDA. We remain disciplined in our capital allocation as
we support our U.S. partners in building ROXUS prescription activity and progress SPONTAN’s submission-
enabling workstreams and Phase III preparations.”
Milestone Timeline
Key milestones expected in the near term and their strategic impact are summarised below:
Program Milestone Expected Timing Strategic Impact
ROXUS U.S. prescription activity building
through Mavrox and Strive
Pharmacy, with further updates as
meaningful information becomes
available
Ongoing U.S. commercial activity via the Section
503A pathway, building from the first
fulfilled prescriptions
SPONTAN Submission-enabling workstreams:
CMC package finalisation, human
factors validation, leachables and
non-clinical toxicology
2H CY2026 Core components of the planned FDA
505(b)(2) submission
SPONTAN Phase III study commencement 1H CY2027 Key clinical step toward the FDA
505(b)(2) submission
SPONTAN SAS prescribing and real-world
evidence generation
Ongoing Build on more than 2,000 bottles
dispensed and continued Australian
prescribing experience
OROFLOW PILOT study initiation H2 CY2026 Expansion of rapid-acting intranasal
delivery platform
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LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
Program Milestone Expected Timing Strategic Impact
SPONTAN-
PAH
Commencement of investigator-
initiated study following ethics
approval
1H CY2027 Generate early clinical data on
SPONTAN’s haemodynamic effects,
safety and tolerability in PAH.
Collectively, these milestones position the Company to deliver a series of commercial, clinical and regulatory
catalysts over the coming twelve months.
Operational Update
During the Quarter and subsequent to its end, LTR Pharma progressed U.S. prescription fulfilment, Australian
patient access and clinical development across its intranasal platform.
ROXUS: U.S. Commercial Framework Completed and First Prescriptions Fulfilled
During the Quarter, LTR Pharma converted both U.S. commercial term sheets into definitive agreements: a
Telehealth Distribution Agreement with Shed Holdings LLC (“Shed”) on 17 July 2026, under which Shed
commercialises ROXUS®
through Mavrox, its dedicated men’s health telehealth platform, and is responsible for
patient acquisition, platform operations, clinical infrastructure and marketing; and a Compounding and Supply
Agreement with Strive Specialties Inc. (“Strive Pharmacy”) on 20 July 2026, covering manufacturing, quality
systems, API sourcing, fulfilment and nationwide supply. LTR Pharma remains the product owner, intellectual
property holder and supplier.
Subsequent to the end of the Quarter, on 6 October 2026, the Company announced that Mavrox had fulfilled the
first patient-specific ROXUS prescriptions in the United States. This milestone marks the start of ROXUS
prescription activity under the Shed and Strive Pharmacy arrangements within the H2 CY2026 timeframe indicated
in the June 2026 Quarterly Activities Report, and follows completion of the operational work required to support
U.S. prescription fulfilment. LTR Pharma is now focused on supporting its U.S. partners as prescribing and
prescription activity builds, and will provide further updates on U.S. prescription activity as meaningful
information becomes available.
ROXUS is a compounded medication prepared for identified individual patient needs based on a valid prescription from a prescribing
healthcare practitioner and, as such, is not reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy.
Compounded drugs are intended for patients whose prescriber has determined their medical needs are not met by an available FDA-approved
drug. These statements have not been evaluated by the FDA. Prescribers should use their independent clinical judgement when determining
appropriateness for individual patients.
SPONTAN: Australian Dispensing Milestone
Subsequent to quarter end, on 21 October 2026, the Company announced that more than 2,000 bottles of
SPONTAN had been dispensed in Australia as at 20 October 2026 under the TGA Special Access Scheme (SAS
Category B) and Authorised Prescriber pathways.
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LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
More than 120 clinicians had prescribed SPONTAN on more than one occasion, with dispensing across all six
Australian states and the Australian Capital Territory. Prescribing has been concentrated in men with moderate
or difficult-to-treat erectile dysfunction, including those with an inadequate response to oral PDE5 inhibitors
(Viagra, etc.) and men following prostate cancer surgery.
Australian prescribing experience and ongoing de-identified data collection continue to inform the planned
SPONTAN Phase III study and support the U.S. introduction of ROXUS.
SPONTAN: 147-Patient Real-World Study
On 11 August 2026, the Company reported outcomes from a retrospective real-world cohort of 147 treatment-
experienced men prescribed SPONTAN®
in routine Australian clinical practice, the largest real-world dataset
reported for SPONTAN to date. All participants had previously been treated with oral PDE5 inhibitors; 62% had a
history of prostate cancer and 59% had undergone prostatectomy.
Population Measure Result
Men seeking greater convenience and spontaneity Composite endpoint 93% (42 of 45)
Men seeking improved efficacy following inadequate
response to oral therapy
Composite endpoint 57% (58 of 102)
Post-prostatectomy subgroup Composite endpoint 64% (56 of 87)
Overall cohort Composite endpoint 68% (100 of 147)
Overall cohort Achieved penetration following
treatment
53% (78 of 147)
Source: ASX announcement 11 August 2026. The study was supported by an investigator-initiated grant from LTR Pharma. Melissa Hadley
Barrett has a paid consulting role with LTR Pharma.
The data were presented by Melissa Hadley Barrett, Nurse Practitioner and Sexologist, at the Asia-Pacific Prostate
Cancer Conference in Melbourne in August 2026 and, subsequent to quarter end, at the Sexual Medicine Society
of North America Fall Scientific Meeting in Orlando, Florida, in October 2026. The manuscript has been submitted
to Sexual Medicine for peer review.
SPONTAN: Final Phase II Report
Subsequent to the end of the Quarter, on 1 October 2026, the Company reported that the final Clinical Study
Report for the SPONTAN Phase II pharmacokinetic study confirms the interim results announced on 1 May 2026
with full statistical analysis and completes the pharmacokinetic dataset agreed with the FDA for the planned U.S.
505(b)(2) submission. The report was prepared by independent clinical research organisation Southern Star
Research.
Parameter SPONTAN®
5 mg SPONTAN®
2.5 mg Vardenafil 20 mg oral tablet
Tmax, median (range) 10 minutes (10–15) 11 minutes (5–60) 60 minutes (30–186)
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Parameter SPONTAN®
5 mg SPONTAN®
2.5 mg Vardenafil 20 mg oral tablet
Cmax (mean ± SD, ng/mL) 8.9 ± 6.8 5.8 ± 4.9 19.8 ± 8.8
Half-life (t½, mean) 4.4 hours 3.8 hours 4.4 hours
Accumulation ratio (5 days once-daily
dosing)
1.0 ± 0.9 n.a. n.a.
Serious adverse events / Grade 3+
TEAEs / discontinuations
0 0 0
Final Clinical Study Report results (n=27, including 14 participants aged 65 years and over). The Tmax difference between SPONTAN 5 mg and
oral vardenafil 20 mg was statistically significant (p<0.0001). Lower absolute exposure reflects lower administered doses.
Pharmacokinetics in men aged 65 and over, who made up 14 of the 27 participants, were comparable to younger
adults, a requirement agreed with the FDA at the Pre-IND meeting. The U.S. development programme now moves
to the submission-enabling workstreams scheduled for 2H CY2026 (CMC package finalisation, human factors
validation, leachables and non-clinical toxicology), with the Phase III study targeted to commence in 1H CY2027.
SPONTAN: Ethics Approval for Pulmonary Arterial Hypertension Study
Subsequent to quarter end, on 22 October 2026, the Company announced that the Bellberry Human Research
Ethics Committee had approved an investigator-initiated clinical study evaluating SPONTAN in patients with new
diagnosed, untreated pulmonary arterial hypertension (PAH).
The study is independently designed, led and conducted by Professor David Celermajer, Head of the Department
of Cardiology at Royal Prince Alfred Hospital, and his team. It will evaluate whether a single intranasal dose of
SPONTAN can rapidly reduce pulmonary vascular resistance, with haemodynamic effects assessed 15 minutes
after administration, together with safety and tolerability.
The study is funded through an LTR Pharma research grant administered by the Sydney Local Health District and
represents a further evaluation of the Company’s intranasal platform beyond erectile dysfunction.
KYZATREX: Australian Men’s Health Portfolio Expanded
On 1 September 2026, LTR Pharma entered into an exclusive pilot commercialisation agreement with Marius
Pharmaceuticals, Inc. to introduce KYZATREX®
(oral testosterone undecanoate), an FDA-approved therapy, to
Australia. Initial stock is in Australia, with patient access through the TGA Special Access Scheme. LTR Pharma
holds Australian exclusivity during a six-month evaluation period and a right to negotiate an exclusive Australian
licence thereafter. The agreement is not expected to materially affect the Company’s financial position.
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LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
Financial Position
LTR Pharma held A$18.2 million in cash and no debt at 30 September 2026. Net operating cash outflow for the
Quarter was A$1.6 million, including A$0.6 million in research and development expenditure. Customer receipts
totalled A$366,035, comprising approximately A$70,000 from SPONTAN supply under Australia’s TGA Special
Access Scheme, and approximately A$296,000 from the supply of ROXUS raw materials. The ROXUS receipts
relate to raw material supply rather than fulfilled patient prescriptions, which commenced after quarter end.
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$329,280, comprising Director fees, salary and superannuation for the Executive
Chairman and Non-Executive Directors.
This announcement has been approved by the Board of Directors.
- ENDS –
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LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
About LTR Pharma
LTR Pharma is a commercial-stage pharmaceutical company delivering innovative therapies to address significant
unmet medical needs through its proprietary intranasal drug-delivery platform. The Company has successfully
commercialised its rapid-acting treatment technology in Australia and is expanding access whilst advancing
regulatory pathways in the U.S. and other key markets.
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
Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 8
+ 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”)
64 644 924 569 September 2026
Consolidated statement of cash flows Current quarter
$A
Year to date
(3 months)
$A
1. Cash flows from operating activities
366,035 366,035
1.1 Receipts from customers
1.2 Payments for
(600,425) (600,425)
(a) research and development
(b) product manufacturing and operating
costs
(c) advertising and marketing (161,484) (161,484)
(d) leased assets
(e) staff costs (823,926) (823,926)
(f) administration and corporate costs (549,283) (549,283)
1.3 Dividends received (see note 3)
1.4 Interest received 181,914 181,914
1.5 Interest and other costs of finance paid (1,255) (1,255)
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
(1,588,423) (1,588,423)
2. Cash flows from investing activities
- -
2.1 Payments to acquire or for:
(a) entities
(b) businesses - -
(c) property, plant and equipment - -
(d) investments - -
(e) intellectual property - -
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.
Consolidated statement of cash flows Current quarter
$A
Year to date
(3 months)
$A
(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 (17,000) (17,000)
2.4 Dividends received (see note 3) - -
2.5 Other (provide details if material) - -
2.6 Net cash from / (used in) investing
activities
(17,000) (17,000)
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 129,230 129,230
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
129,230 129,230
4. Net increase / (decrease) in cash and
cash equivalents for the period
19,642,346 19,642,346
4.1 Cash and cash equivalents at beginning of
period
4.2 Net cash from / (used in) operating
activities (item 1.9 above)
(1,588,423) (1,588,423)
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Page 10
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Current quarter
Consolidated statement of cash flows
$A
Year to date
(3 months)
$A
Net cash from / (used in) investing activities
4.3
(item 2.6 above)
(17,000) (17,000)
Net cash from / (used in) financing activities
4.4
(item 3.10 above)
129,230 129,230
4.5 Effect of movement in exchange rates on
cash held
- -
Cash and cash equivalents at end of
4.6
period
18,166,153 18,166,153
Reconciliation of cash and cash
5.
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
Previous quarter
$A
18,166,153
Bank balances
5.1 19,642,346
-
Call deposits
5.2 -
-
Bank overdrafts
5.3 -
-
Other (provide details)
5.4 -
Cash and cash equivalents at end of
5.5
quarter (should equal item 4.6 above)
18,166,153 19,642,346
Payments to related parties of the entity and their
6.
associates
Current quarter
$A
Aggregate amount of payments to related parties and their
6.1
associates included in item 1
329,280
Aggregate amount of payments to related parties and their
6.2
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
Page 11
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
Financing
7. 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 - -
-
Other (please specify)
7.3 -
7.4 Total financing facilities - -
7.5 Unused financing facilities available at quarter end -
Include in the box below a description of each facility above, including the lender, interest
7.6
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
Net cash from / (used in) operating activities (item 1.9)
8.1 (1,588,423)
18,166,153
Cash and cash equivalents at quarter end (item 4.6)
8.2
Unused finance facilities available at quarter end (item 7.5)
8.3
8.4 Total available funding (item 8.2 + item 8.3) 18,166,153
8.5 Estimated quarters of funding available (item 8.4 divided by
item 8.1)
11
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.
If item 8.5 is less than 2 quarters, please provide answers to the following questions:
8.6
Does the entity expect that it will continue to have the current level of net operating
8.6.1
cash flows for the time being and, if not, why not?
Answer:
Has the entity taken any steps, or does it propose to take any steps, to raise further
8.6.2
cash to fund its operations and, if so, what are those steps and how likely does it
believe that they will be successful?
Answer:
Does the entity expect to be able to continue its operations and to meet its business
8.6.3
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.
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 12
+ See chapter 19 of the ASX Listing Rules for defined terms.
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: ...................................................................................
Authorised by: ...................................................................................
(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.
28 October 2026
the Board of Directors
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