Median Technologies securing up to €47.5 million to support AI lung cancer diagnostic eyonis™ regulatory filings and commercialization in U.S. and EU

Press release – For immediate release  – 8:00 am CET

Median Technologies securing up to €47.5 million to support AI lung cancer diagnostic eyonis™ regulatory filings and commercialization in U.S. and EU

• Repayment of 2020 EIB loan to be rescheduled to October 2025 from April
• New €37.5 million 2025 EIB loan under appraisal, final authorization stage
• New up to €10 million equity line completed with IRIS to enable 2025 EIB loan

• eyonis™ LCS RELIVE pivotal study data in Q1 2025
• eyonis™ LCS U.S. FDA 510(k) and EU CE mark filings on track for Q2 2025
• US commercial launch on track for Q4 2025 in U.S.
• Active discussions ongoing with leading U.S. AI diagnostics commercial organizations for potential eyonis™ LCS marketing deal
• Operational improvements enhancing profitability of iCRO business
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Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, “Median” or “The Company”), a leading developer of eyonis™, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnostics, and a globally leading provider of AI analyses and imaging services for oncology drug developers, today announces the Company has agreed on a non-binding term sheet with the European Investment Bank (EIB) for a new loan facility for up to € 37.5 m€ and has signed an equity line for up to €10 million with IRIS Capital Investment (IRIS). The funds will be used to carry out eyonis™ Lung Cancer Screening (LCS) Software as a Medical Device (SaMD) FDA regulatory approval and CE mark as well as completing ongoing active commercialization partnership discussions with leading U.S. providers of AI diagnostics in the United States.

Fredrik Brag, CEO and Founder of Median Technologies, said: “The imminent drawdown of the first €4 million tranche from the IRIS equity line, the extension of the EIB’s 2020 loan maturity from April to October 2025 combined with the implementation of significant operational improvements to enhance the profitability of the iCRO business and decrease our cash burn rate, enable us to extend the Company’s cash runway into Q4, 2025 and achieve our upcoming 2025 key value inflection milestones. Tranches of the new EIB loan would be made available upon completion of certain undisclosed milestones. Successful completion of these milestones would extend the cash runway beyond Q4 2025, well into 2026.

In addition, we are in active discussions with several of the leading U.S. AI diagnostics commercial organizations, who have expressed their interest in marketing eyonis™ LCS, and we look forward to announcing our choice of commercialization partner. I’d like to thank EIB and IRIS for their confidence as the combination of these financings enables us to bring eyonis™ LCS to commercialization.

We are confident that eyonis™ LCS will offer medical professionals increased efficiency and accuracy so that they can scale up the currently painstaking lung cancer diagnostic process. We believe more patients will cure their cancer through early detection thanks to eyonis™ LCS SaMD; in turn, early detection will reduce the overall costs of treating uncurable later stage lung cancer. The future of eyonis™ AI diagnostics represents a win for patients, doctors, payers and our shareholders.”

New financings based on imminent eyonis™ LCS regulatory filings

Median is working with the European Investment Bank on finalizing an agreement, based on a mutually agreed non-binding term sheet, for financing of up to €37.5 million to enable the regulatory and commercialization activities of eyonis™ LCS. In addition, Median and the European Investment Bank (EIB) have agreed to extend the maturity of the 2020 EIB loan by six months, from April to October 2025, subject to signature of legal documentation. The legal documentation for the 2025 loan and the 2020 loan maturity extension are expected to be finalized in Q1 2025.

Under the expected terms, tranches of the new EIB loan would be made available upon completion of certain undisclosed milestones. Successful completion of these milestones would extend the cash runway beyond Q4, well into 2026.

Concurrently, Median Technologies announces today that it has signed a financing with IRIS that already partially fulfills the EIB’s independent financing requirement. The IRIS financing consists in bonds redeemable into ordinary shares of the Company for a maximum amount of €10 million, with the first tranche of €4 million to be drawn immediately, extending cash for operations to Q4 2025.

Median Technologies will be entitled to suspend and reactivate at any time the withdrawal of any tranche without penalty. The main terms and conditions of the IRIS equity line are further described in the appendix of this press release (pdf version).

This operation does not give rise to publication of a prospectus requiring approval by the French regulator, the Autorité des Marchés Financiers (AMF).

Strategic commercialization partnership

Considering the forthcoming eyonis™ LCS regulatory milestones and the excellent pivotal results already achieved in the REALITY study, Median is in active discussions with several leading U.S. AI diagnostic commercial organizations for eyonis™ LCS sales.  The Company is working to conclude the best possible partnering option(s) for the commercialization of eyonis™ LCS.

Median Technologies operational guidance

The Company reiterates that it is on track to communicate eyonis™ LCS RELIVE (Clinicaltrials.gov identifier: NCT06751576) pivotal study data in Q1 2025. The second eyonis™ LCS pivotal study, RELIVE, is a Multi-Reader Multi-Case (MRMC) trial that will offer clinical validation of eyonis™ LCS to complement the analytical validation already achieved with the first pivotal study, REALITY. The RELIVE study objective is to compare the ability of radiologists to successfully diagnose lung cancer in patients with or without the help of eyonis™ LCS.  Median reported in August that eyonis™ LCS, met all primary and secondary endpoints with statistical significance in REALITY (Clinicaltrials.gov identifier: NCT06576232). A recently held webinar on the REALITY data featured two globally leading U.S. pulmonologists discussing how eyonis™ LCS will be used to help people at risk of lung cancer.

Regulatory filings, for U.S. FDA 510(k) clearance and for European Economic Area (EEA) CE mark, will be submitted in Q2 for eyonis™ LCS. Marketing authorizations are expected in Q3 2025 and Q1 2026, for U.S. and EEA, respectively, assuming normal review times.

About eyonis™ LCS: eyonis™ Lung Cancer Screening (LCS) is an artificial intelligence (AI) powered diagnostic device that uses machine learning to help analyze imaging data generated with low dose computed tomography (LDCT) to diagnose lung cancer at the earliest stages, when it can still be cured in many patients. eyonis™ LCS has been classified by regulators as “Software as Medical Device”, or SaMD, and is the subject of two pivotal studies required for marketing approvals in the U.S. and Europe: REALITY (successfully completed) and RELIVE (ongoing). Filing applications including these pivotal data are scheduled to be submitted for FDA 510(k) premarket clearance and CE marking in 2025. Separately, Median’s AI technology is being sold and deployed across cancer indications, via Median’s iCRO business unit, to companies performing clinical trials of experimental cancer therapeutics, including many of the world’s leading pharmaceutical companies.

Forward-Looking Statements – Disclaimer

This press release contains forward-looking statements. These statements are not historical facts. They include projections and estimates as well as the assumptions on which these are based, statements concerning projects, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, or future performance.

These forward-looking statements can often be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates” or “plans” and any other similar expressions. Although Median’s management believes that these forward-looking statements are reasonable, investors are cautioned that forward-looking statements are subject to numerous risks and uncertainties, many of which are difficult to predict and generally beyond the control of Median Technologies, including the risks set forth in the annual financial report of the Company published on April 25, 2024, which is available on the Company’s website (https://mediantechnologies.com/). Readers’ attention is drawn in particular to the fact that the Company’s current financing horizon is limited to Q4 2025 (based on the assumptions provided for in the second page of this press release) and that, given its financing requirements and the dilutive instruments in circulation, the shareholders of the Company are likely to suffer significant dilution of their stake in the Company in the short term. The occurrence of all or part of such risks could cause actual results and events to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.

All forward-looking statements in this press release are based on information available to Median Technologies as of the date of the press release.  Median Technologies does not undertake to update any forward-looking information or statements, subject to applicable regulations, in particular Articles 223-1 et seq. of the General Regulation of the French Autorité des Marchés Financiers.

This press release and the information contained herein do not constitute an offer of sale, purchase or subscription or the solicitation of a sale, purchase or subscription order for Median Technologies ‘s shares in any country.

In addition to the above, on February 14, 2023, the Autorité des Marchés Financiers (AMF) invited companies issuing equity securities or securities giving access to capital over a period of time to adopt a standard communication and warning on the associated risks. This warning is shown below:

Warning

Median Technologies is launching an equity line in the form of bonds redeemable in shares with the company IRIS, which, after receiving the shares resulting from the redemption of these bonds, does not intend to remain a shareholder in the Company. The shares resulting from the redemption of the above-mentioned bonds will generally be sold on the market at very short notice, which may create strong downward pressure on the share price. Shareholders may suffer a loss of their invested capital due to a significant fall in the value of the Company’s shares, as well as significant dilution due to the large number of shares issued to Iris. Investors are advised to exercise caution before deciding to invest in Median Technologies securities. Investors are invited to familiarize themselves with the risks associated with this transaction, as mentioned in the above press release.