CGNI Cardiogeni Plc

31 January 2025                                                 

Cardiogeni PLC
("Cardiogeni" or the "Company")

Admission on AQSE and First Day of Dealings

Cardiogeni (AQSE: CGNI), a UK clinical stage biotechnology company developing novel heart failure medicines, is pleased to announce that admission of its entire share capital consisting of ordinary shares of £0.01 each ("Ordinary Shares") to trading on the Access segment of the Aquis Stock Exchange ("AQSE") will take place and dealings will commence at 8.00 a.m. today ("Admission"), under the ticker CGNI and ISIN number GB00BTBLFC12.

On Admission, the Company will have 85,346,529 Ordinary Shares in issue and the market capitalisation of the Company will be approximately £125,459,398.

The commencement of trading of the Company's Ordinary Shares follows a £1,442,546.28 subscription completed by the Company for a total of 981,324 Ordinary Shares at £1.47 per Ordinary Share ("Issue Price") paid in cash and to satisfy accrued debt which was conditional on Admission ("Subscription").

On 12 May 2022, the Company secured a £100M share subscription facility agreement from GEM Global Yield LLC SCS and GEM Yield Bahamas Limited ("GEM Facility"). Today, the Company issued GEM Global Yield LLC ("GEM") with 1,360,545 Ordinary Shares at the Issue Price to satisfy the fee in the amount of £2,000,000 payable to GEM under GEM Facility and granted warrants over 2% of the fully diluted share capital on admission exercisable at the Issue Price for a term of three years. The GEM Facility grants the Company the right to draw down funds from GEM in consideration of the issue of Ordinary Shares to GEM up to a maximum aggregate subscription price of £100,000,000, subject to the terms and conditions set out in the GEM Facility.

Darrin Disley, Executive Chairman at Cardiogeni, said "I am delighted that today, with the admission of the Company's issued share capital to AQSE, we begin the next phase of our mission to bring first- and best-in class allogeneic cell therapy products to patients suffering early- to mid-stage heart-failure. Our initial product CLXR-001 is the subject of granted patents in the US, UK and thirty-four countries within the European Patent Organisation ("EPO") and has already been successfully evaluated in extensive pre-clinical studies and a Phase II human clinical trial. It is now the subject of a randomised controlled trial in an EU member country in which we expect to see a clinically meaningful benefit for patients undergoing Coronary Artery Bypass Graft surgery to treat mid-stage heart failure ("CABG")."

Through the Company's admission to AQSE our aim is to take the first steps towards increasing the scope of our current randomised controlled trial to include more patients and a dose escalation arm and file for the approval of a Pivotal Phase 3 study for CLXR-001 in the CABG indication. Additionally, we intend to perform additional Phase I/II studies for indications that target early-stage heart failure.

About Cardiogeni

Founded by Nobel Laureate, Professor Sir Martin Evans, the Cardiogeni Group is developing a new class of life-saving cellular medicines. The Group's platform technology enables the creation of unique (living) cells that are engineered with a specific therapeutic function.

The Group's lead product, CLXR-001, is a patented engineered cellular medicine to treat heart failure patients which is administered during coronary artery bypass grafting surgery. The Group's novel epigenetic cellular reprogramming technology was developed in-house by Professor Sir Martin Evans and the platform along with the pipeline of medicines in development are protected by a portfolio of ~100 international patents and trademarks.

CLXR-001 targets heart failure which will affect 1 in 4 people in their lifetime and is not reversible or curable. CLXR-001 consists of a novel allogeneic (off-the-shelf) cell type, iMP cells, engineered for cardiac regeneration whose mechanism of action is to regenerate damaged heart tissue and restoration of improved heart function improving both the life expectancy and quality of life of patients.

CLXR-001 targets the cardiac market niche of CABG surgery with ~400,000 patients per year in the US alone. The Group's two follow-on products target larger cardiac market segments of stent treatment (over two million patients per year) and myocardial infarction (heart attack, over one million patients per year). Each of the products has the potential to become a first or best-in-class blockbuster ($1B in annual sales) medicine.

CLXR-001 has successfully completed an EU Phase II investigator sponsored clinical trial in which patients showed a statistically significant (P<0.05) improvement in all end-point targets including heart function, reduction in heart scarring and an improvement in quality of life.

CLXR-001 has received regulatory approval to begin a randomised controlled trial from the national regulatory authority of a European Union member country and this trial has begun dosing patients with interim data expected to read-out within 18 months of Admission.

The Company's admission document is available to view on its website: www.cardiogeni.com

The directors of Cardiogeni accept responsibility for this announcement.

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