Update on the feasibility study of the first bioprosthetic artificial heart

• 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.”

Paris, April 4, 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”), announces today its participation in the following scientific and investor conferences during the second quarter of 2024:

Scientific Conferences

• 44^th ISHLT Annual Meeting

April 10 to 13, 2024 (Prague, Czech Republic)

Scientific Conference of the International Society of Heart and Lung Transplantation (ISHLT); one of the largest events dedicated to the treatment of advanced heart and lung diseases. The CARMAT team will be present on stand 36.

For more information, click here.

• Mechanical Circulatory Support (MCS) Master-Class 2024

June 7 to 8, 2024 (Turin, Italy)

International Society for Mechanical Circulatory Support (ISMCS) event dedicated to training in implantation techniques for mechanical circulatory support systems. CARMAT proctors will present the Aeson® heart implantation procedure during hands-on sessions.

For more information, click here.

• EACTAIC ECHO Course 2024

June 15 to 18, 2024 (Milan, Italy)

The European Association of Cardiothoracic and Vascular Anesthesia and Intensive Care (EACTAIC) ECHO 2024 course features innovations to enhance the learning experience and promote skills development.

For more information, click here.

Investor Conferences

• Gilbert Dupont Société Générale MidCap Forum

May 16, 2024 (Paris, France)

Investor forum organised by Gilbert Dupont (Société Générale Group), a leading player in the intermediation and financial operations in the French small and mid-cap segment.

• Portzamparc BNP Paribas Mid & Small Caps Seminar

June 12, 2024 (Paris, France)

Mid & Smallcaps conference organised by Portzamparc, BNP Paribas investment banking partner specialising in French small and medium-sized companies.

• Final maturity of all bank loans extended by at least 2 years
• Equitization of the loan contracted with the EIB to reduce its repayment in cash and optimize the Company’s cash position

Paris, March 22, 2024 – 5:45 pm (CET)
 

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 a final agreement with all its financial creditors on new loan repayment terms.
 
This agreement follows the conditional agreements^1,2 in principle announced on January 12 and February 22. It covers all of the Company’s bank loans, including the €30 million loan from the European Investment Bank (“EIB”)³ and the two State Guaranteed Loans (“PGE”), of a principal amount of €5 million each, from BNP Paribas (“BNPP”) and Bpifrance (“BPI”)⁴.
 
Given this agreement and its cash position, the Company can, according to its current business plan, fund its activities until mid-May 2024, and estimates its financing needs over the next 12 months at approximately €35m.
 
The Company carries on working very actively on other initiatives to strengthen its equity and alleviate its cash constraints in the short term, in order to be able to continue its activities beyond mid-May 2024.
 
Stéphane Piat, CEO of CARMAT, comments: “This agreement with the EIB, BNP Paribas and Bpifrance on new loan repayment terms is very good news for the Company.
 
Its implementation enables us to extend the maturity of all our financial debts by at least two years, and thus reduce our loan repayments by more than €30 million over the period 2024-2025. During this period, we will therefore be able to allocate our financial resources primarily to support our growth, while also significantly reducing the Company’s financing requirements.
 
I would like to thank our banking partners for their commitment to our project. Their support is a mark of confidence in the robustness of our project, and enables us to focus on our primary objective, which is to develop our sales and make Aeson® the reference therapy for advanced biventricular heart failure.”

• Agreement in principle on the rescheduling of State-Guaranteed Loans (“PGE”) obtained from BNP Paribas and Bpifrance
• Extension of the standstill granted by the EIB, BNP Paribas and Bpifrance until March 22, 2024, to facilitate the conclusion of a final agreement covering all financial debts by that date

Paris, February 22, 2024 – 7 am (CET)

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 renegotiation of the repayment terms of its loans with its financial creditors.

Conditional agreement in principle with the European Investment Bank (“EIB”)

As a reminder, CARMAT reached a conditional agreement in principle with the EIB[1] in January 2024 regarding all three tranches of its loan[2]. This agreement notably provides for the postponement of the due date for the first tranche of the loan (total amount of approximately €15 million[3] in principal and interest) to July 31, 2026, as well as the postponement of the due dates for the other two tranches, respectively to August 2027 and October 2028.

If implemented, this agreement would allow CARMAT to avoid having to repay this loan before July 31, 2026[4]. As a reminder, the first tranche of the loan was initially due on January 31, 2024, and the second and third tranches in 2025 and 2026, respectively.

This agreement in principle is not binding at this stage, as it is in particular subject to the conclusion of a rescheduling agreement for the State-Guaranteed Loans (PGE) contracted by the Company with BNP Paribas (BNPP) and Bpifrance (BPI), for a total principal amount of €10 million[5].

Agreement in principle on the rescheduling of State-Guaranteed Loans

During February 2024, CARMAT obtained an agreement in principle from both BNP Paribas and Bpifrance on the rescheduling of the two PGEs contracted with these banks, the initial maturity of which was set for the fourth quarter of 2026. This agreement is itself conditional, notably on the implementation of the agreement reached with the EIB.

Extension of the standstill to allow the finalization of a final agreement with all financial creditors by March 22, 2024

To facilitate the finalization of the discussions with the banks, the standstill applicable to the principal of the various loans, which had previously been granted by the EIB, BNPP, and BPI until February 22, 2024, has been extended until March 22, 2024.

By that date, the Company anticipates reaching a final agreement on the rescheduling of all its financial debts contracted with the EIB, BNP Paribas, and Bpifrance.

In such a case, given this agreement and its cash position, the Company could, based on to its current business plan, fund its activities until mid-May 2024, and estimates its financing needs over the next 12 months at approximately €35 million.

However, it is not guaranteed that such an agreement will be reached by March 22, 2024. In this scenario, which the Company does not consider the most likely, CARMAT could have its cash runway reduced to March 22, 2024, and its financing needs over the next 12 months increased to approximately €50 million.

The Company carries on working very actively on other initiatives to strengthen its equity and alleviate its cash constraints in the short term.

Stéphane Piat, CEO of CARMAT, comments: “The agreements in principle reached with the EIB on one hand, and BNP Paribas and Bpifrance on the other hand, regarding new repayment terms for their respective loans, represent a very positive development.

I am confident that by March 22, the discussions with these three banks will get finalised and a final agreement on the rescheduling of all our financial debts will be reached.

I would like to thank again our three banking partners for their commitment by our side.”

[1] Press Release from January 12, 2024, regarding the conditional agreement in principle with the EIB

[2] Under a contract concluded on December 17, 2018, the Company secured a loan from the EIB amounting to €30m disbursed in 3 tranches of €10m each, on January 31, 2019 (the “first tranche”), May 4, 2020 (the “second tranche”), and October 29, 2021 (the “third tranche” and, together with the other tranches, the “tranches”), each tranche to be repaid, in principal and interest, 5 years after its disbursement to the Company.

[3] Principal of €10m and interest of approximately €5m

[4] Except in cases of default or early repayment, which would remain unchanged.

[5] Two State-Guaranteed Loans (PGE) contracted in the fourth quarter of 2020, respectively from BNP Paribas and Bpifrance, with a principal amount of €5m each, amortizable from the fourth quarter of 2022 to the fourth quarter of 2026.

Paris, February 5, 2024 – 5:45 pm CET

CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aimed at providing a therapeutic alternative for patients suffering from advanced biventricular heart failure (the “Company” or “CARMAT“), today announces its indicative financial calendar for 2024.

This preliminary agenda may be modified. Each publication will be released before market opening.

CARMAT announces the completion of its capital increase for a gross amount of €16.5 million, including the exercise by the Lead Manager and Bookrunner of the overallotment option for an amount of €1.5 million

• The funds raised represent 110% of the Initial Offer; the net amount of €14.9 million will contribute to the Company’s short-term financing

• Together, demand and underwriting and guarantee commitments reached €18.8 million and were allocated as follows:
  €9.2 million as part of the global offering, including €7.8 million in subscription commitments (100% allocation) and €1.4 million in guarantee commitments (24% allocation), representing 56% of the Offer
  €7.3 million as part of the public offering, i.e. a 100% allocation, representing 44% of the Offer

• After the Offer, the Company’s 12-month financing need amounts to c. €50 million (with a cash runway to end-February 2024), which could be reduced to €35 million (with a cash runway to mid-May 2024) in the case of a definitive agreement with the EIB^[1]

^[1]     For further details on this agreement, please refer to the Company’s press release dated January 12, 2024.

Paris, January 29, 2024 – 7 am (CET)

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”), announces the completion of its capital increase by way of a public offering without preferential subscription rights for a total gross amount of €16.5 million, including the partial exercise of the overallotment option granted by the Company to the Lead Manager and Bookrunner, for a gross amount of €1.5 million.

Stéphane Piat, Chief Executive Officer of CARMAT, said: “I would like to thank all investors, both historical and new, individual and institutional, who have contributed to the success of this capital increase, and thus demonstrated their confidence in the development of our Company. The funds raised will, in the coming weeks and months, enable us to build on the sales momentum initiated in the fourth quarter of 2023. More and more patients will thus be able to benefit from our unique therapy. We are more than ever determined to move forward and make Aeson® a reference therapy in the treatment of advanced biventricular heart failure.”