Quarterly Activities/Appendix 4C Cash Flow Report
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LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
28 July 2026
Quarterly Activities Report & Appendix 4C
For the Period Ending 30 June 2026
LTR Advances Toward U.S. Commercial Launch Following Key Clinical and
Commercial Milestones
Highlights
• SPONTAN®
Phase II interim data delivered: Median Tmax of 10 minutes versus 60 minutes for oral
vardenafil, with no repeat-dose accumulation and a consistent safety profile. Final analysis
expected Q3 CY2026.
• Definitive U.S. commercial agreements executed for ROXUS®
: Agreements with Shed and Strive
secure the core telehealth and Section 503A pharmacy fulfilment components supporting the
planned U.S. commercial launch.
• Intranasal platform expanded: OROFLOW®
investigator-initiated clinical study received Human
Research Ethics Committee approval.
• Strong financial position: A$19.6 million cash, debt-free as at 30 June 2026, supporting planned
near-term clinical, regulatory and commercial milestones.
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 June 2026 (the “Quarter”). LTR Pharma is developing
and commercialising innovative intranasal treatments addressing unmet needs in men’s health and other
therapeutic areas.
Commenting on the activity for the Quarter, Executive Chairman, Lee Rodne, stated:
“During the Quarter we advanced our lead programmes on two fronts: clinical validation and commercial
execution. Our SPONTAN®
Phase II interim data reinforced the rapid-absorption profile of our intranasal platform,
including in men aged 65 and over, and characterised the pharmacokinetic parameters requested by the FDA. For
ROXUS®
, we secured the two-core U.S. commercial partners supporting launch, covering telehealth and pharmacy
fulfilment, and both term sheets have since converted into definitive agreements. OROFLOW®
's ethics approval
marked our first clinical step in extending the platform beyond erectile dysfunction.
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LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
With our key U.S. commercial partnerships now in place and SPONTAN approaching completion of Phase II, our
focus has shifted firmly from partner selection to execution as we prepare for commercial launch while advancing
SPONTAN toward FDA submission. We remain disciplined in our capital allocation as we deliver the clinical,
regulatory and commercial milestones that progressively de-risk the business, and we believe disciplined
execution against these milestones has the potential to materially enhance shareholder value.”
Milestone Timeline
Key milestones expected in the near term and their strategic impact are summarised below:
Program Milestone
Expected
Timing
Strategic Impact
SPONTAN Phase II PK study: Final Data
Report and analysis to inform
regulatory engagement and
future prescribing information
Q3 CY2026 Key clinical inflection point supporting FDA
505(b)(2) pathway
SPONTAN Submission-enabling activities,
including CMC package
finalisation and human factors
validation
H2 CY2026 Advances the technical and usability
workstreams supporting the planned
505(b)(2) submission
SPONTAN SAS prescribing and real-world
evidence generation
Ongoing Continued generation of Australian real-world
usage and prescribing data
ROXUS Targeted U.S. commercial
launch and first sales via the
Section 503A pathway
H2 CY2026 Commencement of U.S. first commercial
revenues, subject to completion of launch-
readiness conditions
OROFLOW PILOT Study initiation H2 CY2026 Expansion of rapid-acting intranasal delivery
platform
Collectively, these milestones position the Company to deliver a series of clinical, regulatory and commercial
catalysts over the remainder of CY2026.
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LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
Operational Update
SPONTAN Phase II Clinical Study: Interim Data Delivered
On 1 May 2026, the Company reported interim pharmacokinetic (PK) and safety data from its SPONTAN Phase II
study. The treatment phase of the study, which enrolled 27 subjects, including a substantial geriatric cohort aged
65 years and over, has been completed and a preliminary analysis undertaken. The study was designed in
accordance with FDA Pre-IND guidance agreed in 2025.
Interim PK Outcomes SPONTAN (5 mg intranasal) Vardenafil (20 mg oral)
Median Tmax 10 minutes 60 minutes
Tmax range 10 to 15 minutes 30 to 180 minutes
Repeat-dose accumulation ratio 1.0 ± 0.9 (no accumulation) n.a.
Serious / Grade 3-4 adverse events None observed None observed
Interim data based on 27 subjects who completed the dosing phase. Final statistical analysis remains ongoing.
SPONTAN demonstrated a median Tmax of 10 minutes, compared with 60 minutes for oral vardenafil, with a
narrower observed Tmax range. Pharmacokinetic profiles in subjects aged 65 years and over were comparable to
those in the adult cohort, addressing a key FDA requirement. Intranasal administration over five consecutive days
did not result in drug accumulation, with an accumulation ratio of 1.0 ± 0.9.
The preliminary safety analysis identified no serious adverse events, no Grade 3 or 4 treatment-emergent adverse
events, and no treatment-related discontinuations.
The interim dataset substantially completes the pharmacokinetic objectives requested during the FDA Pre-IND
process and supports the Company's planned FDA 505(b)(2) regulatory pathway following completion of final
statistical analysis.
ROXUS: U.S. Commercialisation Agreements Executed
During the Quarter, LTR Pharma completed the key commercial infrastructure required to support the planned
launch of ROXUS via the Section 503A personalised medicine pathway: patient acquisition and pharmacy
fulfilment.
On 9 June 2026, the Company announced the execution of a binding term sheet with Shed Holdings LLC, a U.S.
direct-to-consumer (DTC) telehealth platform, establishing ROXUS' first commercial route-to-market in the United
States. Under the proposed arrangement, LTR Pharma remains the product owner, intellectual property holder
and supplier, while Shed provides patient acquisition, telehealth services and commercial infrastructure through
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LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
its men's health platform, Mavrox. The arrangement includes a performance-based minimum commercial volume
target of not less than 150,000 ROXUS prescription units during the first 12 months following commercial launch,
together with two years of DTC telehealth exclusivity, subject to ongoing performance requirements.
On 11 June 2026, the Company announced the execution of a binding term sheet with Strive Specialties Inc. (Strive
Pharmacy), securing exclusive U.S. Section 503A pharmacy fulfilment rights for ROXUS. Strive Pharmacy operates
an established Section 503A compounding platform across five U.S. states, with licensure supporting nationwide
compounding, packaging, fulfilment and shipping of prescription treatments, providing the operational capability
to fulfil prescriptions generated through telehealth, healthcare providers and future commercial channels.
Subsequent to the end of the Quarter, both term sheets were converted into definitive long-form agreements: a
Telehealth Distribution Agreement with Shed executed on 17 July 2026, and a Compounding and Supply
Agreement with Strive Pharmacy executed on 20 July 2026. With both agreements in place, LTR Pharma has
secured the two core contractual components of its U.S. commercialisation framework. The Company’s focus has
shifted from partner selection to technology transfer, manufacturing readiness and satisfaction of the remaining
launch-readiness conditions.
OROFLOW Development
On 24 June 2026, the Company announced that OROFLOW had received Human Research Ethics Committee
(HREC) approval for an investigator-initiated clinical study in patients with Oesophageal Motility Disorders (OMD).
This is the first formal clinical evaluation of the Company's proprietary intranasal platform outside erectile
dysfunction and, if successful, could support development of additional intranasal therapies, expanding the
platform's long-term commercial potential. OROFLOW remains a longer-term opportunity and does not alter the
Company's capital allocation priorities, which stay focused on SPONTAN and the U.S. commercialisation of ROXUS.
The study will be led independently by Dr Peter Wu, Director of St George Motility Services, and follows preliminary
clinical observations suggesting that intranasal PDE5 inhibitor therapy may improve swallowing function and
reduce eating-related chest pain in patients with OMD. Funding is provided through a research grant administered
by the South Eastern Sydney Local Health District.
Oesophageal Motility Disorders are a group of conditions characterised by impaired swallowing and painful or
abnormal contractions of the oesophagus. Study initiation is expected during Q3 CY2026.
Financial Position
LTR Pharma maintained a strong financial position during the Quarter, with a cash balance of A$19.6 million as at
30 June 2026 and zero debt. Net operating cash outflow was A$4.4 million, of which A$3.8 million was research
and development expenditure, principally invoices for the SPONTAN Phase II clinical study, the treatment phase
of which was completed during the Quarter. These payments were concentrated during the Quarter and
principally related to the completed treatment phase of the SPONTAN Phase II study. Accordingly, the Quarter’s
R&D expenditure is not considered representative of the Company’s expected recurring quarterly operating run-
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LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
rate. Net operating cash outflow across the trailing twelve months averaged approximately A$2.8 million per
Quarter.
Receipts from customers of A$57,873 represent SPONTAN prescriptions issued under the TGA Special Access
Scheme (SAS), which is not a commercial sales programme and continues to provide real-world insights that
inform the Company's clinical, regulatory and commercial planning. The Quarter also included A$0.5 million
received under the Australian Government's Research and Development Tax Incentive.
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, comprising Director fees, salary and superannuation for the Executive
Chairman and Non-Executive Directors.
The Company's financial position provides the resources to execute its near-term value creation strategy,
including completion of SPONTAN Phase II, FDA submission-enabling activities and the planned U.S. commercial
launch of ROXUS.
This announcement has been approved by the Board of Directors.
- ENDS –
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.
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LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
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 7
+ 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”)
June 2026
Consolidated statement of cash flows Current quarter
$A
Year to date
(12 months)
$A
1. Cash flows from operating activities
57,873 164,500
1.1 Receipts from customers
1.2 Payments for
(3,830,391) (7,114,091)
(a) research and development
(b) product manufacturing and operating
costs
-
(c) advertising and marketing (301,869) (875,562)
(d) leased assets -
(e) staff costs (621,663) (2,625,041)
(f) administration and corporate costs (509,172) (2,002,566)
1.3 Dividends received (see note 3) -
1.4 Interest received 253,003 865,811
1.5 Interest and other costs of finance paid (1,082) (2,424)
1.6 Income taxes paid -
1.7 Government grants and tax incentives 534,132 534,132
1.8 Other (provide details if material) -
1.9 Net cash from / (used in) operating
activities
(4,419,169) (11,055,240)
2. Cash flows from investing activities
- -
2.1 Payments to acquire or for:
(a) entities
(b) businesses - -
(c) property, plant and equipment - -
(d) investments (5,945) (1,110,946)
(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 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
(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
(5,945) (1,110,946)
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
- -
4. Net increase / (decrease) in cash and
cash equivalents for the period
24,067,461 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)
(4,419,169) (11,055,240)
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
(12 months)
$A
4.3 Net cash from / (used in) investing activities
(item 2.6 above)
(5,945) (1,110,946)
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
19,642,346 19,642,346
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
Previous quarter
$A
5.1 Bank balances 19,642,346 24,067,461
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)
19,642,346 24,067,461
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 10
+ 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) (4,419,169)
8.2 Cash and cash equivalents at quarter end (item 4.6) 19,642,346
8.3 Unused finance facilities available at quarter end (item 7.5)
8.4 Total available funding (item 8.2 + item 8.3) 19,642,346
8.5 Estimated quarters of funding available (item 8.4 divided by
item 8.1)
4
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:
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.
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 11
+ 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.
28 July 2026
Date: ...................................................................................
The Board of Directors
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.
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