CARMAT announces updates in its governance

• Equitization of the first tranche of the EIB loan will reduce its repayment in cash and optimize the Company’s cash position
• Set-up of a trust and issuance of share warrants to the trustee, enabling it to subscribe shares of the Company to be then sold on the market, the proceeds of which being allocated to the repayment of the tranche
  

Paris, June 13, 2024 – 6:00 pm (CEST)

CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure (the “Company” or “CARMAT”), today announces the equitization of the first tranche of its loan contracted with the European Investment Bank (EIB) by the set-up of a trust and issuance of share warrants to the trustee.

This implementation is part of the final agreement reached on March 22, 2024 by CARMAT with its financial creditors^[1], including the EIB, on new repayment terms for its bank loans. The terms of the equitization are in all respects similar to those described when the agreement was announced.

Stéphane Piat, CEO of CARMAT, comments: “The equitization of the first tranche of the loan contracted with the EIB is part of the agreement we reached last March with all our financial creditors on the rescheduling of our bank loans and their new  repayment terms.

The effective start of this equitization is an important step and very good news, since it will enable us to significantly reduce the cash repayment of our debt, thereby contributing to contain our funding requirements.

As our cash runway currently extends to mid-August 2024, we continue to work on several options to strengthen our equity and cash position over the coming months; and remain fully mobilized to pursue the commercial development of our therapy, which at this stage is very encouraging.”

[1] Press release March 22, 2024

• EFICAS study reaches the milestone of 20 implants
• Interim study results above expectations
• Confirmation of short-term financial support from several key shareholders

Paris, May 6, 2024 – 7.00 am CEST

CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure (the “Company” or “CARMAT”), today provides an update on the EFICAS study and reiterates confidence in its 2024 outlook.

Stéphane Piat, Chief Executive Officer of CARMAT, commented: “I’m very pleased with the progress of the EFICAS study, both in terms of the pace of inclusion and results observed to date.

With 20 patients implanted, we have already completed 38% of the planned inclusions (out of a total of 52), which once again underlines the very strong interest shown by French doctors and hospitals in the Aeson® heart. Moreover, the interim results of the study are better than expected, although we are treating increasingly sick patients.

These achievements make us optimistic not only about the completion of the EFICAS study in the first half of 2025, but also about the growth potential of Aeson® sales over the coming months.

I am also delighted to be able to rely on several of our reference shareholders who have already confirmed their intention to support CARMAT financially in the short term, which will enable us to focus on our objectives and our development.”

• EFICAS study on track

To date, 20 patients have been implanted with the Aeson® heart as part of the EFICAS study, 9 of them in the first 4 months of 2024.

The EFICAS study is conducted exclusively in France, in 10[1] hospitals whose teams are fully trained and ready to carry out the implants. To date, 8 hospitals have already enrolled patients in the study.

The primary objective of the study is a minimum survival of 6 months on CARMAT support, without disabling stroke, or a successful heart transplant within the first 6 months.

The study’s interim success rate of 75%[2], which exceeds expectations, is very promising compared to previous CARMAT studies[3] and existing therapies, given the poor state of health of the patients concerned.

In view of these advances, CARMAT confirms its target of completing the EFICAS study, with a total of 52 Aeson® implants, in the first half of 2025.

The EFICAS study is essential both for the reimbursement of Aeson® in France and for obtaining PMA (marketing authorization in the United States, issued by the FDA), which the Company anticipates for 2027.

Study data are also an important catalyst for the adoption of Aeson® across Europe.

• 2024 outlook reiterated

Bolstered by the clinical results of the EFICAS study, the progression in implants over the first 4 months of 2024, and its solid base of 39 hospitals trained in commercial implants, CARMAT reiterates its sales forecast of around €14 million for 2024.

Given its cash position and business plan, the Company’s financial horizon currently extends to the end of May 2024, and CARMAT estimates its 12-month financing requirement at around €45 million.

The Company is working very actively on strengthening its equity, with the already-confirmed participation of some of its reference shareholders, enabling it to extend its financial horizon in the short-term.

[1] AP-HP GHU Pitié Salpêtrière, Hôpital Européen Georges Pompidou, CHU de Rennes, CHU de Strasbourg, Hospices Civils de Lyon, CHRU de Lille, Hôpital Marie-Lannelongue, CHU de Montpellier, CHU de Nantes and CHU de Dijon.

[2] Among the 8 patients who have already crossed the 6-month threshold.

[3] CE-marked PIVOTAL study: 73% success rate on 15 patients.

• 2023 sales of €2.8 million, i.e. 17 Aeson® implants, including 11 in the last quarter
• 2024 sales forecast of around €14 million
• Active exploration of financing options to extend, in the short-term, the Company’s financial horizon beyond May 2024.
• 12-month financing requirements estimated at around €45 million

Paris, April 24, 2024 – 7.00 am CEST

CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure (the “Company” or “CARMAT”), today reports its annual results for the year ending December 31, 2023, and provides an update on its progress and prospects for 2024.

The annual financial statements were approved by the Board of Directors on April 22, 2024, on a going concern basis. On April 30, 2024, the Company will publish its 2023 Universal Registration Document, including the annual financial report and the statutory auditor’s report, whose audit procedures are being finalized.

Readers’ attention is drawn to the fact that the Company’s cash runway extends to mid-May 2024. Should the financings anticipated by the CARMAT not materialize by that date, the Company would then have to make significant adjustments to his annual financial statements.

Stéphane Piat, Chief Executive Officer of CARMAT, commented: “In many respects, 2023 has been a structuring year for CARMAT, crowned in December by the symbolic milestone of 50 CARMAT heart implants since the start of our clinical experience, and by the opening of a second production building in Bois-d’Arcy.

Backed by a first-class industrial tool, sized to support our growth, we can now look forward with confidence to the commercial deployment of our therapy. The momentum in Aeson® sales that began in the last quarter of 2023, with 11 implantations, has continued since the start of 2024, at an average rate of around 3 implants per month.

To date, we are on track with our targets for the training of additional hospitals, and implants as part of the EFICAS study. Our geographical deployment is continuing, and 25 of the 39 hospitals trained to commercial implants have already referred patients to CARMAT, confirming the medical community’s strong interest in our therapy and its potential. All these advances enable us to anticipate a substantial gradual growth in our sales over the coming months, and revenue of around €14 million for 2024.

I would like to thank all our teams for their resilience, particularly over the past two challenging years. I would also like to express my gratitude to our shareholders, both historical and more recent, whose trust enables us to make progress towards our goal of making CARMAT a leading player in the treatment of advanced heart failure.”