From ED to omega-3: LTR Pharma picks up the pace even as it diversifies

• Well known for its nasal spray mist offering rapid onset to treat erectile dysfunction, LTR Pharma is expanding its portfolio
• The company’s strategy is to get into the market as quickly as possible with products targeting unmet needs
• LTR Pharma is now developing OMD treatment via intranasal spray tech and moving into omega-3 production

Like its core product Spontan, biotech LTR Pharma (ASX:LTP) is relying on speed as its advantage. The company is set on taking an agile approach, using its intranasal drug delivery technology and expanding portfolio to cut development risk while aiming to advance swiftly to market through a mix of established regulatory steps and fresh commercial strategies.

LTR has other products in the pipeline, but its nasal spray Spontan – developed for the ultra-rapid treatment of erectile dysfunction (ED) – remains the company’s best-known offering.

The spray reaches peak plasma concentrations in less than 10 minutes and can start working in as little as five, compared with up to an hour for conventional oral PDE5 inhibitors such as Viagra and Cialis.

LTR Pharma is eyeing US Food and Drug Administration (FDA) approval for Spontan, which is designed to overcome the delays, food interactions and strict timing that often lead to high discontinuation rates and a lack of spontaneity.

The product is also available in Australia through registered healthcare professionals under the Therapeutic Goods Administration’s (TGA) Special Access Scheme (SAS) and Authorised Prescriber Scheme (APS).

From Fortescue to LTR Pharma

Executive chairman Lee Rodne founded the company based on intranasal drug delivery technology to deliver PDE5 inhibitors acquired from California’s Strategic Drug Solutions (SDS), with pharmacologist Professor Moses Chow credited as the inventor.

Rodne was appointed by Andrew “Twiggy” Forrest to lead Allied Medical – the health spin-off of Fortescue (ASX:FMG) – and was based at Fortescue’s offices, a role he held for more than 10 years.

During this time he was also a senior executive with Sirius Minerals PLC, where he led the day-to-day operations and business development. Sirius secured major investment from Gina Rinehart’s Hancock Prospecting to further strengthen the project’s profile.

Rodne’s Allied Medical experience led him to a group of researchers and manufacturers looking to improve the effectiveness and consistency of ED treatments.

LTR Pharma made its ASX debut in December 2023, with the listing recognised as the Best IPO of the Year by the Australian Stockbrokers Foundation.

“There is no other nasal spray on the market for erectile dysfunction, so we’re the first one globally with the IP to do so,” Rodne told Stockhead.

“We’re the only company in the world with clinical data showing our product has peak concentration within 10 minutes and can start working within five minutes.

“There’s no other treatment for erectile dysfunction that comes in the oral tablets that can work that fast.”

Path to FDA approval, with Roxus driving early sales

Clinical data on the effectiveness of Spontan is now being supported in real-world settings through the TGA prescriber program.

“Some of the prescribers are collecting efficacy data in the real world and starting to present that at international medical conferences,” Rodne said.

“It is being used in hard-to-treat patient groups so men that are post prostate cancer for example.”

LTR Pharma is set to start recruitment into a phase II trial for Spontan in January as part of the company’s FDA progression strategy.

That study will be done in Sydney, and it will be looking at a patient group of 65 years or older because sometimes doctors prescribe medicines to that age group differently,” Rodne said.

“The FDA is wanting us to get some data particularly around that age group.

“Then we will be able to use that package to support first sales in the US market in mid CY26.”

As Spontan moves through the formal FDA process, LTR Pharma will launch another version called Roxus to achieve early US sales ahead of eventual FDA approval.

Like Spontan, Roxus is based on the common active ingredient vardenafil. However, LTR Pharma is taking Roxus down the 503A personalised healthcare pathway, which allows patient-specific medicines to be supplied without full FDA approval.

“It will be primarily launched through telehealth because that is a very large market in the US where men can get access to erectile dysfunction drugs,” Rodne said.

“Viagra and those types of drugs are sold online now so we are looking to tap into that sales infrastructure for early revenue.”

“As we go down the full regulatory approval route for Spontan, we can gain early sales with Roxus through 503A, which is a well-established pathway in the US with patients increasingly wanting access to personalised healthcare treatments.”

Rodne said while the US doesn’t have early-access schemes like Australia’s SAS or APS, it does have a well-established personalised healthcare market.

“In the US, doctors often prescribe treatments that FDA-approved products can’t provide – such as alternative dosage forms, customised strengths, or unique combinations – with specialised compounding pharmacies preparing and dispensing those patient-specific medicines,” he said.

“Our product is well-suited to both the TGA early access schemes and the FDA 503A personalised healthcare pathway, allowing us to generate early revenue while we progress through the full regulatory approval process.”

Expanding indications for intranasal spray tech

LTR Pharma is now expanding its novel intranasal spray drug delivery technology beyond ED, signing a development agreement with SDS to develop Oroflow, a treatment for oesophageal motility disorders (OMD) – conditions that impair swallowing (dysphagia).

Rodne said Oroflow aimed to deliver relief to sufferers in 10 minutes, improving on current substandard treatments including dilation, surgery, or Botox injections.

“These types of drugs help relax the muscles in the oesophagus to make swallowing easier,” he said.

“We are developing that product again for early access in the Australian market and to help individuals who primarily have difficulty swallowing food so will take it primarily before eating.”

Move into sustainable, high-purity omega-3 production

LTR Pharma is also broadening its portfolio into omega-3 production through a 33% equity stake in LevOmega, an Australian company co-founded with Levur and Green Blue Health.

LevOmega focuses on high-purity, nature-identical omega-3 ingredients suitable for nutritional and pharmaceutical applications.

With traditional fish oil sources under pressure from overfishing, pollution, and declining yields, nature-identical omega-3s offer a scalable and consistent alternative to meet increasing global demand for eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

“Everyone is quite familiar with fish oil and its benefits with cardiovascular health,” Rodne said.

“But there are supply constraints and the quality of fish oil ingredients on the market today can vary widely due to overfishing and ocean conditions.

“People don’t really know the difference in quality when they buy fish oil today.

“We would be the first mover in a multi-billion global market that has the capability to produce at scale Omega 3 fish oil so it wouldn’t be reliant on fishing.”

He said the approach with LevOmega is on early revenues through the nutrition market and as a supplier to the fish oil companies.

“Secondly, we would be looking at pharmaceutical applications for areas like reducing heart disease and stroke,” he said.

LevOmega is looking to have a readout of validation for its Omega3 product in Q3 CY26.

Targeting unmet needs with its portfolio

Rodne said LTR Pharma’s strategy was looking for opportunities to get into the market as quickly as possible with products targeting high unmet needs.

“In erectile dysfunction there’s a high unmet need because 50% of men stop taking oral PDE5 inhibitors like Viagra in the first year,” he said.

“Our product has shown it addresses the problems of traditional ED medications including consistency of performance and faster onset.”

He said for people with an OMD, Oroflow will address the issues of swallowing with its intranasal delivery.

“The Omega3 is a fast route to market because we are validating the production in the next year ahead and it’s an area of high need,” he said.

“We are focused on early revenue opportunities in large markets – with a portfolio that not only addresses unmet patient needs but also creates multiple scalable pathways for growth.”

This article does not constitute financial product advice. You should consider obtaining independent financial advice before making any financial decisions.

At Stockhead we tell it like it is. While LTR Pharma is a Stockhead advertiser at the time of writing, it did not sponsor this article.