Ikonisys publishes its 2021 annual financial results and provides an update on its latest developments

PARIS–(BUSINESS WIRE)–Regulatory news:

Ikonisys SA (ISIN Code: FR00140048X2 / Mnemonic: ALIKO) (Paris:ALIKO), a company specializing in the early and accurate detection of cancer with a unique fully automated solution for medical analysis laboratories, today announced its audited annual results for the fiscal year ended December 31, 2021, as approved by the Board of Directors on April 29, 2022 and provided an update on its recent developments.

Mario Crovetto, CEO of Ikonisys, said: “2021 was a pivotal year for our company. First of all, our successful IPO in July 2021 allowed us to be listed on Euronext Growth Paris, one of the most dynamic markets for biotechs and medtechs.This major milestone will help us accelerate our development efforts to become a global benchmark company in fully automated oncology molecular diagnostics.Alongside the implementation of our commercial programs, as evidenced by the recruitment of two commercial directors for the United States and France, we have also strengthened our Ikoniscope20 platform technology through targeted R&D investments.In particular, we are making progress in the very promising sector of CTC for the early detection of cancers and the monitoring In addition, we integrate artificial intelligence into our platform in order to constantly improve our performance and aim s technological excellence thanks to the best in class partnerships with universities and laboratories In conclusion 2021 and the beginning of 2022 presented a fundamental phase for Ikonisys. We have laid the foundations for the future and we will capitalize on all these efforts in the years to come.

2021 annual results Simplified income statement and cash update

Details of the main changes in the consolidated accounts

The 2021 net result shows a significant improvement compared to the previous year, in particular due to the reduction of debt and associated interest charges following the restructuring that took place in 2021.

As expected, in 2021 Operating Expenses increased compared to the previous year, both due to the new commercial structure that is being put in place and due to additional expenses linked to referencing, but, following the implementation sales and marketing organization after the IPO, the company began marketing the Ikoniscope20 and successfully sold its first device to a major reference laboratory.

Following the restructuring that took place and the initial public offering of Ikonisys SA in July 2021, shareholders’ equity improved significantly and was increased to €20,013,576 (consolidated shareholders’ equity), compared to €5,699,142. last year (combined pro forma equity).

Consolidated external debt (excluding related parties) remains stable, slightly reduced at the end of the 2021 financial year (-€52,735).

Consolidated cash and cash equivalents at the end of the 2021 financial year amounted to €1,516,526, compared to €37,596 last year.

Fiscal 2021 and post-closing highlights

Successful listing of Ikonisys on Euronext Growth® Paris

The IPO resulted in a capital increase of 4.0 million euros through the issue of 700,000 new ordinary shares.

First results of a study demonstrate the ability of the rare cell detection platform Ikoniscope20 to enumerate specific populations of CD8 T cells

Using the high-speed scanning of the Ikoniscope20 platform, 80 extremely rare antigen-specific CD8 T cells from more than one million blood cells were identified. Antigen-specific T cells play a central role in immunity against cancers and infectious agents through their ability to kill malignant cells upon recognition by the T cell receptor. This is further demonstration , in collaboration with the Faculty of Medicine of the University of Connecticut (USA), of the potential of Ikonisys technology in immuno-oncology thanks to its ability to detect rare cells in general, and circulating tumor cells in particular.

Recruitment of Manny Iglesias as Sales Director for the US market and Gabriel Plan as Sales Director France

On the one hand, Manny Iglesias will be responsible for accelerating sales of Ikoniscope20 in the United States by strengthening the Company’s presence in new geographic areas of the United States while optimizing the marketing and commercial strategy. Manny’s business leadership and extensive experience building strong customer relationships will support Ikonisys’ accelerated growth.

On the other hand, Gabriel Plan brings over ten years of sales and marketing experience to Ikonisys. Gabriel’s responsibilities will include accelerating sales of Ikoniscope20 in France and other French-speaking regions of Europe by acquiring new customers, KOLs (Key Opinion Leaders) and additional reference labs.

Successful installation of the Ikoniscope20 at Tomalab, one of the largest genetic laboratories in Italy

The Ikoniscope20 has been successfully installed at Toma Advanced Biomedical Assays and is used for daily patient care workflow. TomaLab will act as a reference laboratory for Ikonisys, stimulating R&D and commercialization opportunities. Future applications for new assays are being evaluated to further exploit the instrument’s capabilities to automate laboratory workflow and analyze samples otherwise impossible to study manually..

Preliminary Ikoniscope20 results obtained with the University of Connecticut School of Medicine (Neag Cancer Center of UConn) in detecting rare cells exceeds immuno-oncology test standards

The Ikoniscope20 performs immune monitoring functions in a more efficient, simpler and more competitive way than conventional flow cytometers (the standard tool used for such detection). The Ikoniscope20 detects rare cells at a rate higher than that provided by flow cytometers, also providing detailed morphological information through its high quality images. Monitoring immune responses in cancer patients is a growing need due to recently approved immunotherapy treatments. These results open the way to new marketing opportunities for the Ikoniscope20, a better alternative to the flow cytometer.

Strategy and outlook

The company intends to pursue its development and marketing strategy. Building on the successes of 2021 and early 2022, Ikonisys plans to continue accelerating its two-pronged global go-to-market strategy. Its revolutionary solution, ikoniscope20, is supported by renowned partners such as the University of Connecticut (immunology), Charité University of Berlin (FISH test in oncology), Sheba Medical Center and Tomalab (circulating tumor cells). This strong network will help leverage R&D and act as a catalyst to address future markets.

Indeed, the company is continuing its R&D efforts for the next generation Ikoniscope AI which will be a quantum leap for personalized medicine. Ikoniscope AI will bring new innovations, incorporating the latest advances in hardware and software. It is expected to launch in 2023.

There is a clear lack of fully automated systems in the US and Europe, Ikonisys is perfectly positioned to meet the need for over 80%¹ users who wish to purchase a fully automated and integrated system.

Next financial press release

HYR 2022: October 26, 2022

Availability of the 2021 Annual Financial Report

The annual financial report can be viewed and downloaded from today in the “Investors” section of the company’s website:

https://www.ikonisys-finance.com/index.php/2016-05-27-11-25-16/financial-reports

About Ikonisys

Ikonisys SA is a cell diagnostics company based in Paris (France), New Haven (Connecticut, USA) and Milan (Italy) specializing in the early and accurate detection of cancer. The company develops, produces and markets the proprietary Ikoniscope20® platform, a fully automated solution designed to provide accurate and reliable detection and analysis of rare cells. Ikonisys has received FDA clearance for several automated diagnostic applications, which are also marketed in Europe under CE certification. With its breakthrough fluorescence microscopy platform, the company continues to develop a stream of new tests, including liquid biopsy tests based on circulating tumor cells (CTCs).

For more information, visit www.Ikonisys.com

Warning

This press release contains forward-looking statements about the prospects and development of the Company. These statements are sometimes identified by the use of the future, conditional and forward-looking words such as “believe”, “aim”, “expect”, “intend”, “estimate”, “believe”. “, “should”, “could”, “will” or “will” or, where applicable, the negative form of these terms or any other variation or similar expression. This information is not historical data and should not be interpreted as a guarantee that the facts and data stated will occur. This information is based on data, assumptions and estimates considered reasonable by the Company. It is subject to change or change due to uncertainties related to the environment economic, financial, competitive and regulatory This information contains data relating to the intentions, estimates and objectives of the Company concerning in particular the market, strategy, growth, results, financial situation and Company cash. The forward-looking information contained in this press release speaks only as of the date of this press release. The Company does not undertake to update the forward-looking information contained in this press release, except as required by applicable law or regulation. The Company operates in a competitive and rapidly changing environment and therefore cannot anticipate all the risks, uncertainties or other factors that could affect its business, their potential impact on its business or the extent to which the materialization of a risk or of a combination of risks could cause the results to differ materially from those expressed in any forward-looking information, it being recalled that none of this forward-looking information constitutes a guarantee of actual results.

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¹ DLS Council 2018