CARMAT announces its 2023 annual results and provides an update on its progress and prospects for 2024

• With a cash position of €44.0 million at June 30, 2018, financial resources will allow the continuation of clinical and industrial developments through to the granting of CE marking, expected in 2019
• Operating expenses are in line with the transformation of CARMAT into an industrial and commercial company
• The 1^st part of the PIVOTAL study has confirmed the bioprosthesis’ fundamentals and its adaptability to a broader patient population than initially expected
• More than 50% of patients in the PIVOTAL study have now been implanted

Paris, September 28, 2018 – 7.00 am CEST

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announced its results for the first half of the year at June 30, 2018^[1] and provides an update on its developments.

Stéphane Piat, Chief Executive Officer of CARMAT, commented: “The first half of 2018 was marked by a significant acceleration of our project, as we have so far completed the enrollment of half of the patients in the PIVOTAL study and reached a decisive industrialization milestone with the opening of our new manufacturing site. The PIVOTAL study has now moved into its second phase. Indeed, the first phase of this study showed the ability of our prosthesis to provide effective support to patients suffering from end-stage heart failure. Furthermore, the successful heart transplant of the first Kazakh patient, after 8 months of support provided by the CARMAT heart, demonstrates that the latter can also be used in patients suffering from comorbidities that prevent an immediate transplant.

Beyond this success, one of the main lessons lies in the fact that the size of our bioprosthesis allows us to target a broader patient population than initially expected, as it has been correctly implanted in patients with a smaller thorax size.

Today, we are at a turning point in our project, and are delighted to be able to count on the expertise of the medical teams who are accompanying us in France and abroad. Our objective is to move forward towards the completion of the PIVOTAL study at a dynamic and controlled pace, and we continue our efforts to expand the study to other leading European centers, as well as our discussions with the FDA to obtain the approval to initiate a feasibility study in the United States by the end of the year.”

• 2018 half-year results

CARMAT recorded no revenue over the first half of 2018, as its total artificial heart project is still in clinical development. The CE marking process, which is a prerequisite to marketing the product in Europe, is progressing in line with the Company’s expectations.

In the first half of 2018, operating expenses increased by 37% to €20.1 million, driven by a number of developments undertaken during the half year, and in particular:

• progress in the CE marking process, with the finalization of all technical modules;
• preparatory work for the opening of the new manufacturing site in Bois-d’Arcy, now operational;
• the ramping up of the PIVOTAL study, with the training of the teams from the international investigation centers involved in the study and the acceleration in patient enrollment.

Once the financial loss (-€455.4 thousand), exceptional items (-€2.7 thousand) and Research Tax Credit (€1.0 million) are taken into account, the net loss at June 30, 2018 was €18.9 million, versus a loss of €14.1 million over the six months to June 30, 2017.

• Strong financial structure

Cash and marketable cash instruments totaled €44.0 million at June 30, 2018, versus €60.7 million at December 31, 2017, due to:

• cash burn of €20.7 million over the first half of 2018;
• drawdowns on the second tranche of the contingent equity line subscribed to with Kepler Cheuvreux, for a gross total of €4.0 million. Given the expiry of the initial contract and in order to continue to benefit from an equity financing reserve, CARMAT[2] has signed a new contract, under identical conditions[3] and for a sum equal to the unused balance, i.e. €25 million, with Kepler Cheuvreux, again acting as financial intermediary. This additional financing ability, to which Kepler Cheuvreux has committed to subscribe to on its own initiative providing the contractual conditions are respected, may be adjusted by the Company in accordance with its requirements and market conditions over the coming 36 months[4]. This operation did not require a prospectus to be submitted to the AMF for a visa.

These financial resources will allow the Company to continue its industrial and clinical development until it receives CE marking expected in 2019. 

• PIVOTAL study continuing in line with the aim of completing patient enrollment by end-2018

• Enrollment in the 1^st part of the study has been completed

In July 2018, CARMAT announced that patient enrollment in the first part of the PIVOTAL study had been completed, corresponding to the inclusion of the 10^th patient, out of 20 planned for the entire study.

During this first phase, the Company was able to gather important information for its remaining clinical development:

• the bioprosthesis fulfilled its role in accordance with the requirements of the clinical protocol;
• the surgical procedures, 100% successful, showed that the size of the bioprosthesis – equivalent to that of a sick heart – could adapt even to a smaller patient thorax. Initial assumptions, indicating anatomic compatibility for 86% of men and 14% of women, are now considered very conservative;
• the National Research Center for Cardiac Surgery (Astana, Kazakhstan) surgical teams successfully carried out the first heart transplant on a patient who benefited from the CARMAT heart for 8 months. This procedure, a world first, highlighted the possibility of using the CARMAT bioprosthesis not only as a definitive therapy, but also as a treatment option while awaiting a transplant (a bridge to transplantation), significantly expanding the targeted patient population. The feasibility of the bridge to transplantation was confirmed by a second heart transplant performed by the Astana teams in a patient who had benefited from the CARMAT bioprosthesis for 5 months.

• Start of the 2^nd part of the study in the 3 approved countries

Following the analysis of the clinical data available to date on the first 10 patients, the health authorities of the countries participating in the trials have approved the continuation of the PIVOTAL study without any changes in the protocol.

Patient enrollment in the second part of the study has therefore begun in the investigation centers, under the control of Principal Investigator, Professor Ivan Netuka (Director of the Cardiovascular Surgery Department at the IKEM institute, Prague, Czech Republic), and Co-Principal Investigator, Professor Finn Gustafsson (Rigshospitalet, Copenhagen, Denmark).

Furthermore, CARMAT is still working intensely to expand the PIVOTAL study to other European countries and complete the implantations at the end of 2018.

• Enrichment of the PIVOTAL study learning curve

To date, 11 patients have been treated, i.e. over 50% of the planned number of patients in the study. The efforts of the clinical team are focused on enrolling patients that best meet the inclusion criteria in order to complete the study in line with the schedule and maximize the chances of success.

The CARMAT heart cumulative support time has reached 3 years 5 months. This accumulated experience shows the ability of the CARMAT technology to offer numerous benefits to patients, as well as the stability of its performances observed so far:

• the 1-month survival rate is 91%, versus 75% in the feasibility study, which can be explained by the generally less compromised clinical profile of patients than previously;
• surgery time has been reduced to 5 hours (versus almost 7 hours for the first three implants) with just 2 hours 40 minutes of extracorporeal circulation (versus close to 3 hours 30 minutes for the first three implants);
• the time before leaving intensive therapy has been cut to 6 days;
• the hospitalization time before patients can return home has been reduced to 35 days.

• Transformation of CARMAT into an industrial and commercial company

• Certification of the Bois-d’Arcy manufacturing plant

Following the recent certification of its new automated manufacturing site in Bois-d’Arcy, near Paris, CARMAT now has an industrial site that meets the highest technological standards enabling it to produce up to 800 prostheses a year at full capacity. The assembly of the hybrid membranes with the help of industrial robots is already performed on site.

• Development of remote patient monitoring

In order to ensure a better therapeutic follow-up, CARMAT has initiated the development of a remote monitoring solution to record the cardiac parameters of patients as well as the CARMAT heart function data remotely. This solution was developed in collaboration with WISNAM (Acireale – Italy), an expert in the field of connected objects.

• Ongoing restructuring of the teams

CARMAT recently announced the appointment of Thierry Dupoux, previously Worldwide Vice President of Quality Assurance at LivaNova, as Senior Director of Quality Assurance. Following the appointments of a Marketing Manager and a Director of Manufacturing last year, the Company is thus continuing to expand its managerial team in key positions with experts who will support its transformation into an industrial and commercial company.

[1] First-half accounts were approved by the Board on September 27, 2018, and have been the subject of a limited review by the statutory auditors.

[2] In accordance with the 8^th resolution approved by the Shareholders’ Meeting of April 5, 2018

[3] Shares will be issued on the basis of the volume-weighted average share price over the two trading days preceding each issue, minus a maximum discount of 6.0%

[4] Should the entire equity line be utilized, a shareholder with a 1.00% stake in CARMAT beforehand would see this stake reduced to 0.91% on a non-diluted basis