Invex Therapeutics raises $26 million as it plans for Phase 3 clinical trial

Invex Therapeutics ASX IXC Idiopathic Intracranial Hypertension headache
Invex aims to commence its Phase 3 trial in the second half of 2021.

Two days since publishing its Phase 2 clinical trial results and announcing “clear evidence” that its Exeatide drug is effective at reducing intracranial pressure in Idiopathic Intracranial Hypertension (IIH) patients, Invex Therapeutics (ASX: IXC) followed up this morning by announcing a successful $26.2 million capital raise in the form of a share placement.

On Wednesday, Invex declared that its clinical trial showed “clear statistical and clinical evidence of efficacy” in the primary and in some key secondary endpoints, which demonstrates both an immediate reduction in intracranial pressure and a strong and sustained clinical benefit for patients at 12 weeks.

Furthermore, the trial showed that Exeatide reduced intracranial pressure at the 2.5-hour, 24-hour and 12-week time points “in a statistically significant manner” which Invex described as both “rapid and sustained”.

In terms of secondary endpoints including headache and vision, Exeatide also showed amiable results.

Measured headache frequency highlighted a statistically significant, beneficial reduction in monthly headache days in the Exenatide treated patients.

For visual acuity, the trial demonstrated a “statistically significant improvement” in patients treated with Exenatide.

“We believe these Phase 2 data strongly support moving Presendin [Invex’s proprietary, patented formulation of Exenatide] into a Phase 3 clinical trial in the first half of 2021,” the company said.

According to Invex’s chairman Dr Jason Loveridge, the trial’s data is “invaluable” when designing and executing Invex’s single Phase 3 registration study and “increases our confidence that Presendin will prove a valuable therapeutic option to patients suffering IIH and who currently have no approved or effective medication.”

Funding development

With strong results in hand and a phase 3 trial on the horizon, Invex moved quickly to raise $26.2 million via a placement to institutional, professional, sophisticated Australian and overseas investors.

Invex issued a total of 20.15 million new fully paid ordinary shares at an issue price of $1.30 per share – representing an approximate 4% discount to the average market price and a 13% discount compared to the closing price before the company’s trading halt on 18 May.

The share placement is set to occur in two tranches – the first tranche will issue 12.5 million shares at $1.30 to raise $16.25 million while the second will mean issuance of a further 7.65 million shares at $1.30 to raise $9.95 million.

However, the completion of Tranche 2 is subject to obtaining shareholder approval at Invex’s Extraordinary General Meeting (EGM), expected to be held on or around 29 June 2020.

The company received cornerstone commitments totalling $10.5 million from existing investors, including $5.0 million from Tattarang, formerly known as the Minderoo Group.

Dr Loveridge explained that Invex will now use the raised capital to conduct its phase 3 trial as well as funding a second clinical program, most likely in IIH-WOP, a second orphan indication.

“This funding provides the Company with a clear trajectory through to Phase III clinical results in an important orphan disease without any approved treatments in the market,” he said.

Following the completion of its placement, Invex said the cash infusion will put the company in a strong financial position with approximately $36.6 million cash to meet its clinical and other objectives.

Invex shares were up by more than 16% to $1.74 in morning trade.