Regulated

Mont-Saint-Guibert, Belgium – The biotechnology company, Cardio3 BioSciences SA (Cardio3 BioSciences), a leader in the discovery and development of regenerative, protective and reconstructive therapies for the treatment of cardiac diseases, today announces that it has been informed that Kempen & Co, acting as Sole Global Coordinator, has fully exercised the Overallotment Option in accordance with provisions contained in the initial public offering (IPO) prospectus.

As a result, after exercise of the over-allotment option, a total of 1,588,725 new shares will have been placed on the market at the IPO price of €16.65, amounting to total gross proceeds of €26.5 million.

Cardio3 BioSciences’ shares are listed on NYSE Euronext Brussels and NYSE Euronext Paris under the ticker symbol CARD. It is the first biotechnology company to be listed on both exchanges.

Dr Christian Homsy, CEO of Cardio3 BioSciences said: “The full exercise of the over-allotment option further demonstrates the success of our IPO and the demand for shares from institutional investors in Europe and the US. The funds raised through our IPO will put us in a good position to complete our European Phase III study for C-Cure® and progress an important new regenerative therapy for heart disease towards the market.”

Cardio3 BioSciences is developing its most advanced therapy, C-Cure®, for the treatment of heart failure, one of the world’s greatest unmet medical needs. C-Cure® is a unique cell therapy aimed at repairing damaged tissue and improving heart function, clinical outcomes and quality of life. It builds on research conducted at Mayo Clinic (Rochester, Minnesota, USA), Cardio3 BioSciences and Cardiovascular Centre Aalst (Aalst, Belgium).

The supporting science is the result of Mayo Clinic innovation leading to advanced product development, manufacturing scale-up, and clinical trial execution by Cardio3 BioSciences catalyzed by ongoing collaboration facilitated through Mayo Clinic Ventures. 

Funds to Drive Development of Unique Cell Therapy for Heart Failure 

Mont-Saint-Guibert, Belgium – The biotechnology company, Cardio3 BioSciences SA (Cardio3 BioSciences), a leader in the discovery and development of regenerative, protective and reconstructive therapies for the treatment of cardiac diseases, today announces it has successfully completed its Initial Public Offering. 

The IPO was priced at €16.65 per share. Cardio3 BioSciences will issue 1,381,500 new shares equivalent to €23.0m including the partially exercised increase option. Additionally, an overallotment option to subscribe to up to 207,225 additional shares at the IPO price, equivalent to €3.45m, has been granted to Kempen & Co, on behalf of the Joint Bookrunners, for the sole purpose to cover over-allotments, if any. If the over-allotment option is exercised in full, the total amount of the capital increase will amount to €26.45m.

The book was well covered with high quality demand from Belgium, France, UK, Scandinavia, The Netherlands and US.

Cardio3 BioSciences’ shares will be listed on NYSE Euronext Brussels and NYSE Euronext Paris and conditional trading is expected to commence as of 5 July 2013 under the ticker symbol CARD. It is the first biotechnology company to be listed on both exchanges.

Kempen & Co acted as Global Coordinator and Kempen & Co and Invest Securities acted as Joint Bookrunners. Portzamparc acted as Selling Agent. Merodis acted as financial advisor to the company.

Dr Christian Homsy, CEO of Cardio3 BioSciences said: “We expect that the success of our IPO will allow us to complete our European Phase III study for C-Cure®, a unique cell therapy for the treatment of heart failure. Heart failure is a significant burden to patients, families and society in general. We believe C-Cure® has the potential to go beyond symptom relief towards healing heart tissue and could mark a significant step forward in treatment for heart failure patients. Our new funds will put us in a good position to gain approval from the FDA to begin our US study and begin clinical trials with one of our pipeline products for acute myocardial infarction (AMI) or ‘heart attack’.

“We welcome our new investors, both institutional and private individuals, and look forward to advancing important new regenerative therapies for heart disease towards the market and generating value for shareholders.”

Cardio3 BioSciences is developing its most advanced therapy, C-Cure®, for the treatment of heart failure, one of the world’s greatest unmet medical needs. C-Cure® is a unique cell therapy aimed at repairing damaged tissue and improving heart function, clinical outcomes and quality of life. It builds on research conducted at Mayo Clinic (Rochester, Minnesota, USA), Cardio3 BioSciences and Cardiovascular Centre Aalst (Aalst, Belgium).

The supporting science is the result of Mayo Clinic innovation leading to advanced product development, manufacturing scale-up, and clinical trial execution by Cardio3 BioSciences catalyzed by ongoing collaboration facilitated through Mayo Clinic Ventures. 

“Historic advances in patient care treatments, like this, come about through close collaborations between medical centers and biotechnology companies. Their combined expertise accelerates the ability to effectively get new treatments to patients,” said Professor Andre Terzic, Director Mayo Clinic Center for Regenerative Medicine.

Having achieved positive Phase II results, recently published in the Journal of the American College of Cardiology (JACC) (Bartunek et al. 2013 – see below), the product is currently being tested in Europe in a Phase III trial (CHART-1). CHART-1 is the world’s first phase III trial using pre-programmed cardiac progenitor cells for the treatment of heart failure.

Offering Highlights

• The final IPO price was set at €16.65 per share and applies to both retail and institutional investors.
• The total number of shares that were sold amounts to 1,588,725 shares, including 81,500 shares resulting from the exercise of the increase option and 207,225 over-allotment shares.
• Retail investors have been allocated 9.3% of the total number of allocated shares. Retail investors will be allocated 100% of their requested shares.
• As a result of this IPO, Cardio3 BioSciences has raised €23.0m in gross proceeds. Together with the existing shares, the number of outstanding shares (before the exercise of the over-allotment option) amounts to 6,125,567 representing a market capitalization of approximately €102.0m based on the IPO price.
• The shares have been listed and conditional trading is expected to commence as of 5 July 2013 on NYSE Euronext Brussels and on NYSE Euronext Paris under the symbol CARD. Delivery and payment of the shares is expected to be made on 9 July 2013. 

Two long term investors secured for EUR 13.95m

Mont-Saint-Guibert, Belgium – The biotechnology company, Cardio3 BioSciences SA (Cardio3 BioSciences), a leader in the discovery and development of regenerative, protective and reconstructive therapies for the treatment of cardiac diseases, today announces the launch of its Initial Public Offering on NYSE Euronext Brussels and NYSE Euronext Paris.

Cardio3 BioSciences is developing its most advanced therapy, C-Cure®, for the treatment of heart failure, one of the world’s greatest unmet medical needs. C-Cure® is a unique cell therapy aimed at repairing damaged tissue and improving heart function, clinical outcomes and quality of life. 

Having achieved positive Phase II results, C-Cure® is currently being tested in Europe in a Phase III trial (CHART-1 – Congestive Heart failure Cardiopoietic Regenerative Therapy). CHART-1 is the world’s first phase III trial using pre-programmed cardiac progenitor cells for the treatment of heart failure.

Summary of the offering

• An offering to subscribe for up to 1,300,000 new ordinary shares which can be increased by a maximum of 15% to 1,495,000 new ordinary shares.
• An over-allotment option of additional shares equal to up to 15% of the number of new shares subscribed for in the offering covered by an over-allotment warrant.
• The indicative price range of the offering has been set at a minimum of €16.65 and a maximum of €19.00 per share.
• The offering comprises:
  • a public offering in Belgium and France to retail investors;
  • a placement to institutional investors in certain jurisdictions outside the US;
  • a private placement in the US to a limited number of “qualified institutional buyers” in a manner not requiring registration under the US Securities Act
• The offer period will run from June 21 st 2013 to July 3rd 2013 (inclusive), subject to acceleration or suspension (the “Offering Period”).
• The Company’s shares will be admitted to listing on the regulated markets of NYSE Euronext Brussels and NYSE Euronext Paris.
• The expected first date of (conditional) trading is July 5th 2013.
• The expected date of closing of the offering is July 9 th 2013.

Cardio3 BioSciences has secured two long-term investors pre-bookbuilding

• The investors have guaranteed a commitment of EUR 13.95m at any price within the price range.
• This allows Cardio3 BioSciences to upsize the transaction.
• SRIW group as current shareholder will commit EUR 4.45m.
• PMV as new shareholder will commit EUR 9.5m.
• Both investors will receive preferred allocation.

Dr Christian Homsy, CEO of Cardio3 BioSciences said: “Heart failure is associated with high morbidity, mortality and escalating healthcare costs. It remains a significant burden to patients, families and society in general. We believe C-Cure® has the potential to go beyond symptom relief towards healing heart tissue and could mark a significant step forward in treatment for heart failure patients. 

“The funds from our IPO could allow us to complete our European Phase III study for C-Cure®, gain approval from the FDA to begin our US study, and begin clinical trials with one of our pipeline products for acute myocardial infarction (AMI) or ‘heart attack’. In so doing, we believe we will be advancing important new regenerative therapies for heart disease towards the market and generating value for shareholders.”

Company Background

Cardio3 BioSciences’ focus is on developing novel therapies to treat cardiovascular diseases. Its most advanced product is C-Cure®, a cell therapy currently under development for the treatment of chronic heart failure, one of the world’s greatest unmet medical needs. 

• A person living to age 40 years has a one in five risk of developing heart failure and, once the disorder is apparent, a one in three chance of dying within a year of diagnosis (McMurray and Pfeffer 2005 – see below).
• Cardio3 BioSciences estimates more than 117 million people are suffering from heart failure worldwide and that this number is expected to double by 2040.
• US$32 billion per annum is spent on heart failure patients in the US alone (Go et al. 2013 – see below).

C-Cure® is a unique therapy that involves taking cells from a patient’s bone marrow. Through a proprietary process called cardiopoiesis, the cells are re-programmed so that they become heart precursor cells with the aim of replicating the normal process of cardiac development in the embryo and healing the failing heart. The cells, known as cardiopoietic cells, are then injected back into the patient’s heart through a minimally invasive procedure using a proprietary catheter called C-Cathez ® , with the goal of repairing damaged tissue and improving heart function, clinical outcomes and quality of life. 

C-Cure® builds on research conducted at Mayo Clinic (Rochester, Minnesota, USA), Cardio3 BioSciences and Cardiovascular Centre Aalst (Aalst, Belgium). The product is currently being tested in Europe in a Phase III trial (CHART-1), the world’s first phase III trial using pre-programmed cardiac progenitor cells for the treatment of heart failure.

The CHART-1 study follows the successful results of Cardio3 BioSciences’ Phase II trial of C-Cure®, which were recently published in the Journal of the American College of Cardiology (JACC) (Bartunek et al. 2013 – see below). The study showed treatment with C-Cure® led to: 

• An improvement in heart function, reflected in a statistically significant increase of 25% in the Left Ventricular Ejection Fraction (LVEF) (p
• An improvement in the ability of patients to be active as seen in a statistically significant increase in exercise capacity measured by the 6 minutes Walking Distance test (+77m change at 6 months versus baseline in comparison to the control group (p

An accompanying editorial in JACC (Murry et al. 2013 – see below) commented that “Six months after treatment, the cell therapy group had a 7 percent absolute improvement in EF (ejection fraction) over baseline, versus a non-significant change in the control group. This improvement in EF is dramatic, particularly given the duration between the ischemic injury and cell therapy. It compares favourably with our most potent therapies in heart failure.”

Cardio3 BioSciences intends to start a trial in the USA (the CHART-2 trial) when and if the FDA authorizes its start. The CHART programme is designed as two pivotal studies to obtain marketing authorisation in Europe and in the USA respectively, either alone, or in combination with other clinical trials.

In addition to C-Cure®, Cardio3 BioSciences has developed a proprietary technology aimed at maximising the delivery efficiency of therapeutics into the heart muscle. C-Cathez ® is an intramyocardial delivery catheter, designed to enhance the retention of myocardial therapeutic agents. The Company has obtained CE marking in April 2012 from NSAI (an Irish Notified Body) and C-Cathez ® is therefore available for commercialization in EEA.

The Company is also collaborating with Assistance Publique – Hôpitaux de Paris (AP-HP) and other academic and SME partners in view of developing a right ventricular outflow tract (RVOT) biodegradable prosthesis, seeded with cells and/or proteins, for the treatment of congenital defects of the heart, specifically those where replacement of the RVOT is required. The Company has been designated as the exploitation manager of the European consortium formed to develop this technology (TEH-TUBE). TEH-TUBE has passed the first selection of the European Commission FP7 programme and is awaiting clearance from the second in the second half of 2013.

Cardio3 BioSciences’ early stage programs include using protein therapeutics to treat acute myocardial infarction (AMI) or “heart attack”.

Use of Proceeds

The principal purposes of the offering are to support the Company’s development, obtain additional working capital, establish a public market for the shares and facilitate the Company’s future access to public equity capital markets.

The Company intends to use the net proceeds of the offering to:

• Advance C-Cure® into the CHART-1, the International Phase III trial, until public disclosure of the conclusions that may be drawn from the primary endpoint results;
• Obtain authorization to conduct CHART-2 in the US;
• Continue pre-clinical development and, potentially, start clinical development of selected product candidates in AMI indications;
• Advance the Company’s discovery programme and bring selected additional product candidates from advanced research to pre-clinical development;
• Potential future developments on C-Cure®;
• Commercialization of C Cathez®;
• If appropriate, gain access through in-licensing, acquisition or co-development to new technology platforms that strengthen the Company’s position and help its expansion;
• Apply funds for general corporate purposes, such as general and administrative expenses, capital expenditures, working capital needs, and the broadening, maintenance and defense of the Company’s intellectual property.

Financial Intermediaries Kempen & Co has been appointed as Global Coordinator and Kempen & Co and Invest Securities have been appointed as Joint Bookrunners. Portzamparc acts as Selling Agent.

Details of the offering

The Offer Price will be determined during the Offering Period through a book-building procedure in which only institutional investors can participate. The Offer Price is expected to be set within a price range of between €16.65 and €19.00 per share. The Offer Price will in no event exceed the upper end of the price range, although it may be set below the lower end of the price range.

In accordance with Belgian regulation, no less than 10% of the offered shares must be allocated to retail investors in Belgium. In accordance with French regulation, no less than 10% of the offered shares will be reserved for retail investors in Belgium and in France. However, the proportion of offered shares allocated to retail investors may be higher or lower than 10% of the offered shares (possibly substantially) if retail investors have applied in aggregate for more or less, respectively, than this percentage.

The Company has the right to proceed with a capital increase for a reduced number of shares. The minimum amount set for the offering is €17 million, below which the offering will not be completed.

The Company has granted to the Global Coordinator, on behalf of the Joint Bookrunners, an option to subscribe to up to 15% of the number of new shares allocated in the offering at the Offer Price for the sole purpose of allowing the Joint Bookrunners to cover over-allotments, if any. The overallotment option will be exercisable for a period of 30 days from the Listing Date.

Prospectus

The prospectus approved by the FSMA is available in English. A translation of the Prospectus in French and a summary of the Prospectus in French and in Dutch are available to investors at no cost at the registered office of the Company, at Axisparc Business Center, Rue Edouard Belin 12, 1435 Mont-Saint-Guibert, Belgium and can be obtained upon request by email (investors@c3bs.com). The prospectus is also available on the Company’s website: www.c3bs.com. 

Summary timetable

Date	Event
21 June 2013	Expected start of the Offering Period
3 July 2013	Expected end of the Offering Period
4 July 2013	Expected date of allocation of the new shares to investors Expected publication date of the Offer Price and results of the offering
5 July 2013	Expected listing date (listing and start of (conditional) trading)
9 July 2013	Expected closing date of the offering (payment, settlement and delivery)

Mont-Saint-Guibert, Belgium, June 4th, 2013 –The biotechnology company, Cardio3 BioSciences SA (Cardio3 BioSciences), a leader in the discovery and development of regenerative, protective and reconstructive therapies for the treatment of cardiac diseases, announces it is considering to raise new funds through an Initial Public Offering on NYSE Euronext Brussels and NYSE Euronext Paris.

Cardio3 BioSciences’ lead product is C-Cure®, a unique therapy that involves taking cells from a patient’s bone marrow. Through a proprietary process called cardiopoiesis, the cells are reprogrammed so that they become heart precursor cells with the aim of replicating the normal process of cardiac development in the embryo and healing the failing heart. The cells, known as cardiopoietic cells, are then injected back into the patient’s heart through a minimally invasive procedure using a proprietary catheter called C-Cathez ® , with the goal of repairing damaged tissue and improving heart function, clinical outcomes and quality of life.

Cardio3 BioSciences is developing C-Cure® for the treatment of heart failure, one of the world’s greatest unmet medical needs. A person living to age 40 years has a one in five risk of developing heart failure and, once the disorder is apparent, a one in three chance of dying within a year of diagnosis (McMurray and Pfeffer 2005 – see below). US$32 billion per annum is spent on heart failure patients in the US alone (Go et al. 2013 – see below).

C-Cure® builds on research conducted at Mayo Clinic (Rochester, Minnesota, USA), Cardio3 BioSciences and Cardiovascular Centre Aalst (Aalst, Belgium). The product is currently being tested in Europe in a Phase III trial (CHART-1 – Congestive Heart failure Cardiopoietic Regenerative Therapy). CHART-1 is the world’s first phase III trial using pre-programmed cardiac progenitor cells for the treatment of heart failure.

The CHART-1 study builds on the successful results of Cardio3 BioSciences’ Phase II trial of C-Cure, which were recently published in the Journal of the American College of Cardiology (JACC) (Bartunek et al. 2013 – see below). The study showed an increase of 25% of the Left Ventricular Ejection Fraction (LVEF) which was statistically significant (p

Cardio3 BioSciences intends to start a trial in the USA (the CHART-2 trial) when and if the FDA authorizes its start. The CHART programme is designed as two pivotal studies to obtain marketing authorisation in Europe and in the USA respectively, either alone, or in combination with other clinical trials.

In addition to C-Cure®, Cardio3 BioSciences has developed a proprietary technology aimed at maximising the delivery efficiency of therapeutics into the heart muscle. C-Cathez ® is an intramyocardial delivery catheter, designed to enhance myocardial therapeutic agents’ retention. The Company has obtained CE marking in April 2012 from NSAI (an Irish Notified Body).

Cardio3 BioSciences also has early stage programs in progress aimed at using protein therapeutics to treat acute myocardial infarction (AMI) or “heart attack”. The IPO is expected to consist of an offering of new shares which will be listed on NYSE Euronext Brussels and NYSE Euronext Paris. Kempen & Co has been appointed as Sole Global Coordinator and Kempen & Co and Invest Securities have been appointed as Joint Bookrunners.

Mont-Saint-Guibert, Belgium, May 8, 2013 –The Belgian biotechnology company, Cardio3 BioSciences (C3BS), a leader in the discovery and development of regenerative, protective and reconstructive therapies for the treatment of cardiac diseases, announces that it has increased its equity by €19 million through a private placement with existing investors. The new funds will be used to finance the on-going clinical development of the Company’s lead product, C-Cure®, currently tested in Europe in a Phase III trial (CHART-1 – Congestive Heart failure Cardiopoietic Regenerative Therapy) and the preclinical development of other product candidates. CHART-1 is the world’s first phase III trial using pre-programmed cardiac progenitor cells and targeting heart failure

Of the €19 million raised, €7 million is in new equity committed by existing investors with €12 million resulting from the conversion of existing convertible loans. The formal capital increase was approved at a shareholder meeting and is expected to complete by the end of May 2013.

C3BS’ C-Cure is a unique therapy that allows the reprogramming of bone marrow cells into ‘cardiopoïetic’ cells with the aim of growing new heart tissue thereby repairing damaged heart muscle. The cardiopoietic cells are injected into the patient’s heart through a minimally invasive procedure using a proprietary catheter called C-Cath®ez. 

C-Cure is the outcome of research conducted at Mayo Clinic (Rochester, Minnesota, USA), Cardio3 BioSciences (Mont-Saint-Guibert, Belgium) and Cardiovascular Centre Aalst (Aalst, Belgium).

Christian Homsy, CEO of Cardio3 BioSciences commenting on today’s announcement said, “Our ability to raise this significant amount of funding demonstrates the commitment of our investors and their confidence in the considerable value that we can generate from C-Cure. The new funding will allow us to proceed with our European Phase III trial in patients with Congestive Heart failure. We are confident that this study will confirm that C-Cure has the potential to significantly improve the disease course of those very sick patients, and could lead to a paradigm shift in the treatment of heart failure.” 

Mont-Saint-Guibert, Belgium, January 10, 2012 – The Belgian biotechnology company, Cardio3 BioSciences, a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiovascular diseases, today announces it has secured a total of €3.1 million in non-dilutive funding from the Walloon Region and the European Commission’s Seventh Framework Programme (FP7).

The Walloon Region funding takes the form of recoverable cash advances and will be used to industrialise a number of Cardio3 BioSciences projects including establishing a new bioreactor for the production of the Company’s lead product, C3BS-CQR-1 (C-Cure®), a highly innovative stem cell approach for the treatment of heart failure. The funding also supports Cardio3 BioSciences’ protein therapeutic programme which is aimed at the treatment of myocardial infarction (heart attack) and the regulatory approval of its advanced medical device, C-Cath®. C-Cath is a proprietary catheter designed to maximize the delivery efficiency of regenerative therapeutics to the heart.

The FP7 funding was awarded to Cardio3 BioSciences as part of a €5.9 million award from the European Commission to a Collaborative Research Consortium, BAMI (Bone marrow-derived mononuclear cells for Acute Myocard Infarct) of which Cardio3 BioSciences is a part. BAMI involves 21 partners in 11 European countries and is conducting the largest trial of adult stem cell therapy the treatment of heart attack patients. 

Dr Christian Homsy, CEO of Cardio3 BioSciences comments on today’s announcement: “We very much welcome the continued strong support of the Walloon region and this new funding from the European Commission which will help drive a number of projects within the company as we apply our technologies to address a range of cardiac diseases. The Walloon region has played a significant role through the history of Cardio3 BioSciences helping to bring us to the point where our core revolutionary technology, C-Cure, for the treatment of heart failure, has passed through successful completion of its Phase II clinical development stage and is expected to enter Phase III in 2012.”

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