LTR Pharma Ltd Posts 93% Subgroup Response in 147 Patient SPONTAN Study

SPONTAN delivers 93% response in landmark 147-patient real-world study

LTR Pharma (ASX: LTP) has reported outcomes from its largest real-world dataset to date for SPONTAN, its rapid-onset intranasal vardenafil spray, covering 147 treatment-experienced men in routine Australian clinical practice.

The standout finding was a 93% response (42 of 45) among men seeking greater convenience and spontaneity, who reported improved erectile hardness and/or achieving penetration with SPONTAN. Across the full cohort, 68% (100 of 147) reported the same composite outcome.

For investors, the retrospective real-world evidence strengthens the commercial narrative ahead of planned US availability of ROXUS, the company’s rapid-acting intranasal erectile dysfunction treatment. The cohort included a substantial prostate cancer and post-prostatectomy population, a group in which erectile dysfunction (ED) is common, persistent and can be poorly served by existing oral therapies.

Breaking down the results across patient groups

The company assessed outcomes using a patient-reported composite measure defined as improved erectile hardness and/or achieving penetration following treatment. The results snapshot below breaks performance down by population.

Notably, among the more difficult-to-treat subgroup of 102 men who had previously reported inadequate efficacy with oral PDE5 inhibitor therapy, more than half still reported improved erectile hardness and/or achieving penetration.

The cohort had a mean age of 65.6 years. A total of 62% had a history of prostate cancer, and 59% had undergone prostatectomy. Men were grouped by their primary reason for seeking SPONTAN: convenience and spontaneity, or improved efficacy following an inadequate oral response.

Why the post-prostatectomy finding matters most

Post-prostatectomy ED represents a particularly challenging and clearly identifiable patient population. After radical prostatectomy, cavernous nerve injury reduces the nitric oxide pathway that oral pills such as Viagra (sildenafil) and Cialis (tadalafil) rely on, so these medicines can work poorly during the early recovery period.

Published literature illustrates the scale of the challenge:

• Oral PDE5 inhibitor response rates of approximately 12–17% in the first six months following radical prostatectomy
• The SPONTAN cohort achieved 64% (56 of 87) in this same post-prostatectomy group
• Men who remain inadequately treated may progress to invasive intracavernosal treatments such as CAVERJECT (alprostadil), which requires direct penile injection

Importantly, LTR Pharma noted that these results are not directly comparable with historical studies of oral PDE5 inhibitors. The findings nonetheless highlight the potential role of a rapid, non-invasive intranasal option in a population the company describes as clearly identifiable and underserved, which points to a targeted commercial opportunity.

A large, underserved market opportunity

Prostate cancer is the most commonly diagnosed cancer in Australian men, and the treatment-related ED burden underpins a sizeable addressable population across both domestic and international markets.

• Australia: an estimated 28,868 new prostate cancer cases in 2025, with approximately 8,500 radical prostatectomies performed annually
• United States: an estimated 333,830 new cases projected for 2026, with more than 3.5 million men living with a prostate cancer diagnosis
• Global incidence projected to reach approximately 2.9 million new cases annually by 2040
• ED rates published as high as 85% following radical prostatectomy
• Oral PDE5 inhibitor dropout rates exceeding 50%, with lack of spontaneity a consistently cited reason

The 93% result among convenience-seekers suggests the potential addressable population may extend beyond men who fail oral therapy. It may also include the broader group who obtain an effect from oral treatment but are constrained by its timing and planning requirements.

How this supports the US commercialisation strategy

The post-prostatectomy result is particularly relevant to the US market, where LTR Pharma is advancing SPONTAN via the FDA 505(b)(2) regulatory pathway. The company is preparing ROXUS for US commercial availability through patient-specific prescriptions compounded under Section 503A.

Definitive agreements have been executed with Shed Holdings LLC (ASX announcement, 17 July 2026) and Strive Specialties Inc. (ASX announcement, 20 July 2026). With these US commercial partnerships in place, the real-world evidence in a defined and clinically identifiable population may support targeted engagement with urologists and men’s health prescribers as the company progresses its US strategy.

The Shed agreement carries a 150,000-unit first-year commitment and grants two-year direct-to-consumer exclusivity through the Mavrox men’s health platform, with ROXUS already listed and a patient waitlist building ahead of a formal launch date.

What management and clinicians are saying

Lee Rodne, Executive Chairman, LTR Pharma

“We regard this as an important real-world dataset for LTR Pharma. The 93% response among men seeking greater convenience reinforces our belief that the opportunity for SPONTAN and ROXUS extends beyond patients who simply fail oral tablets – it includes men seeking greater spontaneity and control over their treatment. The finding that nearly two-thirds of post-prostatectomy patients reported improved erectile hardness and/or achieving penetration is particularly encouraging given the recognised difficulty in treating ED following prostate cancer surgery. Oral therapies may provide limited benefit for some men and patients may ultimately progress to invasive treatments such as penile injections. We believe rapid, non-invasive intranasal treatment has the potential to address an important unmet need in this clearly identifiable patient population. With our U.S. commercial partnerships now in place, these findings provide an important clinical narrative as we engage urologists, men’s health prescribers and commercial partners ahead of ROXUS U.S. availability.”

Clinical commentary reinforced the significance of the convenience-seeker cohort.

Melissa Hadley Barrett, Nurse Practitioner and Sexologist

“What stands out in this cohort is who responded. These were treatment-experienced men, the majority with a prostate cancer history, a population where oral therapy frequently disappoints. The response in men who wanted spontaneity rather than a stronger drug tells me timing and ease of use are clinical variables in their own right. I look forward to presenting these findings at APCC.”

For disclosure, Melissa Hadley Barrett is Director of Restorative Health Clinic, in which LTR Pharma holds a joint venture interest.

Next steps and what to watch

LTR Pharma outlined the following forward-looking activities:

1. Presentation of the cohort data at APCC in Melbourne on 13–15 August 2026

2. Progression of the submitted manuscript through peer review at Sexual Medicine

3. Evaluation of a prospective study in the post-prostatectomy population

4. Continued Australian real-world evidence collection

5. Implementation activities with Shed and Strive ahead of ROXUS US commercial availability

Investors should note the data status. The findings are derived from a retrospective, single-centre real-world cohort based on patient-reported outcomes and should be interpreted in the context of that design. SPONTAN is not registered on the Australian Register of Therapeutic Goods and is made available in Australia under the Therapeutic Goods Administration’s Special Access Scheme and Authorised Prescriber pathways.

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