On the rise: Erectile dysfunction nasal spray inventor LTR Pharma firms for ASX and major market disruption

Spontaneity can play a large part in intimacy. But when spontaneity hinges on the timing and mechanism of a slow-acting oral pill, things can flop. LTR Pharma believes it’s cracked the code with a revolutionary erectile dysfunction nasal spray called Spontan.

Notwithstanding spontaneous combustion, flatulence in lifts, and in-law pop-ins, spontaneity is usually viewed as a positive.

It’s well established, for instance, that spontaneity is a highly conducive ingredient when it appears a bonk could be on the cards. Or the table. Maybe a sturdy card table. Okay, a bed would be better.

And that, somehow, leads us to erectile dysfunction (ED). The topic of it, just to be clear. Although if we were being more literal, thankfully there are ways to deal with the issue.

To be even clearer, the worldwide prevalence of ED has doubled in the past 30 years and is expected to increase to 322 million in 2025 – think huge demand in a huge market.

We’ve been able to pop a little pill for the big ED problem since about 1998 – when a class of drugs called PDE5 inhibitors hit the market, including household names like Viagra.

But these sexy pills – now pretty old and mainly in the land of generics – look set for semi-retirement, as a newer, sexier and faster tool of the trade is launched by an Australian company, clinical-stage biopharmaceutical firm LTR Pharma.

Set to provide stiff competition

That new-look tool? It’s a “first in class” rapid, on demand nasal spray dubbed Spontan, which is positioning as a vastly improved treatment for ED. And it’s a product that’s risen quickly in development and testing, and is firming (yep) to hit the market within 1-2 years.

Its market launch will transpire after LTR Pharma’s IPO and raise (led by Alpine Capital – see further below) when the company lists on the ASX in December, and after a final trial and regulatory approvals are in place.

From what we’ve been told, Spontan works within just 10 minutes – about six times faster than the blue pills of yore and other options currently at market.

Sprayed directly into nostrils, it’s said to dramatically improve the effectiveness of an (already proven and regulatory-cleared) ED drug, bypassing the impact of things like food and booze on ingested pills. Smart, huh?

It seems about time. And we thought it was about time, too, to speak to a doctor about all this – LTR Pharma’s Dr Julian Chick – to get the full-blooded info.

‘A raging… positive response!’

According to the company’s investor presentation, LTR Pharma is gearing up to commercialise Spontan. It notes, in simple terms, that the product’s IP lies in “the ability to convert the active ingredient in the ED pill to a fast-onset nasal spray”.

Useful? Potentially market disrupting? Super easy to understand for investors? Yep, yep and yep.

Dr Julian Chick is on the company’s board as an independent non-executive director, and confirmed with us that LTR Pharma’s product is indeed a world first, has gone through clinical testing, and is set to put the Aussie company in a firm position in what is already a blockbuster global market.

Says the good doctor, at the core of Spontan “is a very simple proposition”, a simple unique selling point – speed and spontaneity.

“As the name suggests, the main factor is this is a product that helps those with ED to engage in the level of spontaneity they need for the drug to be effective in their environment,” said Dr Chick.

“It was when we started to dig further into the ED market we realised how prolific not only the ED condition is [it affects more than 60% of Aussie men over 45], but also how big the issue of spontaneity is for that market. It’s a significant proportion of the market that views that as an extremely important component.

“The more we spoke to people about it, we’d hear these stories,” continued Dr Chick. “For example, one person told me: ‘Yeah, look I tried Viagra once and took it the night we were going out…’ and he said it didn’t actually work on the night but the next day he woke up with a raging… positive response!”

Spray and pray? Nope, it’s a potential game changer

Essentially it’s different strokes for different folks when it comes to response times on ED treatments to date. Most of them take about an hour to work, though, before users are able to function at, let’s say, full-barred sexual capacity. Sometimes it can take a lot longer than that.

“Hang on a sec… [checks watch] I’ll be ready in about… 42 minutes… Shall we watch a Scandi crime show first?” – this probably isn’t the greatest pillow talk.

Dr Chick notes that a couple of sprays through the mucosal layer of the nose, however, brings on far more rapid onset of delivery than a slowly dissolving pill taken orally – and with what amounts to a lower dosage, too, and no severe adverse effects.

“It’s not complex, but that’s why we also think it’s a game changer in this area,” he adds.

“The testing data we’ve got for Spontan is that it works within about 10 minutes and even quicker in some recorded instances.”

A faster delivery and onset of effectiveness can likely solve the issue of up to 50% of ED-drug users discontinuing with treatments in the first year, believes the company.

Testing, testing, 1, 2, 3…

And regarding its testing, Spontan is a long way down the track, with a fast path to market.

A successful proof of concept and clinical study for the product has been conducted in the US but there are no long-winded Phase 1, 2 or 3 trials ahead as PDE5 inhibitor drugs (such as Viagra and Vardenafil), on which Spontan is based, are already cleared by regulators and primed to re-purpose. So up the nose, guided by clever nasal delivery tech, we go.

No extensive trials to come, then, although Dr Chick says that “part of the reason for doing the IPO and capital raise now is to put in place a remaining five-day bioequivalence trial and then a bridging study”.

Those will occur in February and will have the aim of providing further data and confirming existing data to submit to regulatory bodies the FDA (US Food and Drug Administration) and Australia’s TGA (Therapeutic Goods Administration) for their approvals.

Those trial results pending, first sales of Spontan are planned in a special-access capacity in Australia in Quarter 2 2024.

‘Even bigger than expected’

As you can see on the LTR Pharma investor presentation chart below, size matters.

The estimated market size for ED drugs is a grower and a shower – we’re talking a compound annual growth rate of about 7% globally and about US$6b in total by 2028.

But adding to this: “We think it could be even bigger than we expected,” noted the doctor, “simply because the response we’ve had from people about this has been quite amazing – and that the spontaneity factor is out there, yet it hasn’t been brought properly to light.

“I actually think that if you can provide the spontaneity that’s not available right now, then this market will really open up a lot further.

“We think we can take significant market share globally from those generic products that are already selling $1.1, $1.2 billion dollars, with a product that we believe will be more enduring.”

A healthy raise

Working with Alpine Capital, an Australian wealth management and corporate finance firm, LTR Pharma has entered into an IPO and is looking to raise $7 million. The company plans to list on the ASX before the end of the year under the ticker code LTP.

“We have ASX clearance to list,” notes Dr Chick, “and we’ve had significant interest so far as you might well expect.

“It’s a relatable story for investors. Not everyone might want to talk about it, but a lot can certainly relate to it.”

Bringing the experience

We asked the doctor what sort of relevant experience the company’s team brings to the table…

“Management and board have all been involved in drug development and marketing with experience across ASX listings and product launches, and we have a very strong advisory presence in the essential health and medicine spaces, and a very good regulatory team,” he replied.

“So, boxes ticked – corporately we know how to function; marketing – we’ve done this before; regulatory pathways and clinical development – we’ve done this before; and then we have the support of the underlying men’s health sexual community.

“We’ve purposely built the team that way.”

Final thoughts from you and the team, then?

“Like I said earlier, it’s not a complicated story for investors, but it’s an important one in that it’s helping to bring back some love into people’s lives,” concluded Dr Chick.