LTR Pharma has gotten in bed with Shed, a young US direct-to-consumer tele-health company with 180,000 members. Shed will offer LTR Pharma's nasal spray ED drug via compounding pharmacies. The nasal spray will be branded as Roxus to preserve the Spontan brand for the future FDA approved launch.

While FDA approval is a few years away, the product can already be subscribed via a compounding pharmacy route because it is a reformulation of existing medicines. Over 1000 subscriptions have been sold under a similar arrangement in Australia.

Shed seems like a suitable partner, being young and looking for growth opportunities and having a compatible and non-competitive product suite. They currently sell GLP-1 weight-loss medication and various hair and longevity products. A promising and differentiated ED nasal spray could become a feature product for them.

The deal requires 150,000 units within the first year, allowing LTR Pharma the ability to see other people if Shed can't keep it up. No financial details were included but this is presumably a self-sustaining exercise to expose US ED customers to a superior product that they will want to try.

FDA ethics approval received for 2026 Spontan Phase 2 pharmacokinetic and multi-dose study.

FDA requested 50% of participants be aged over 65 to generate cohort-specific prescribing info.

Dates:

• Recruitment: Q1 CY 2026
• Initial data: Q2
• Full results: Mid 2026

It's a fast timeline, because this is a reformulation of already-approved Viagra-type chemicals, but in a nasal spray. Phase 1 showed much faster absorption, and the delivery method avoids common digestion upset side-effects that put some men off.

To be at Scientia Clinical Research in Sydney.

As a seperate business line, LTR Pharma has entered into a deal with 2 other companies to develop nature-identical pharma-grade omega-3 oil. There was no upfront cost, and LTR Pharma will own a third of the new business: 'LevOmega'.

The business case is that ocean-sourced omega 3 is facing increased demand and over-stretched and polluted supply.

On the surface, the 3 companies appear to be synergistic. Levur have a technique to produce 'ethical oils' for all kinds of consumer products. Green Blue Health currently sell omega 3 from algae for animal feed. And LTR focus on bringing pharmaceuticals to market.

The product will still need to progress through technical validation and pilot-scale production.

LTR Pharma are currently well-funded, so hopefully they will continue to invest sensibly and it'll be interesting to see how this develops. They now have 3 business lines.

It's hard not to get a bit excited about this product: simplistically, a reformulation of Viagra in a nasal spray.

Delivery method IP: The drugs in Viagra and similar are off-patent, and actually the patent here is around the ability to produce a crystal-free nasal spray. Others have tried and failed, including Pfizer apparently.

Advantages of a nasal spray:

• 12 minutes to liftoff verses 50 minutes with a pill
• avoids digestion side-effects which put some men off the pill
• can use less active ingredient to reach the same blood concentration

Proposed cost: 'More than generics, less than Viagra'. Unit sales: Existing generic pill prescriptions are at 700m per annum globally. Beyond that, God knows how much Horny Goat Weed people are snorting. Generics seem to range a bit from $1 to $5 per pill (as per my 30 seconds of online research). I'm sure you can get them for 30c if you answer one of those spam emails, do let us know how that went if you have!

Timeline:

• Under a special access scheme, Australian men can already be prescribed the nasal spray and it is available at Terry White pharmacies. Telehealth available via makehardeasy.com.au
• I'm still trying to get my head around the FDA clearance timeline, but it's a year or two rather than a decade - because the underlying active ingredient has been used for two decades.

Share price: At 30c the EV here seems to be about $20m. $32m in the bank. Funded to the end of 2026 'including commercial launch in the US'