Combination will create the European cell therapy leader with two marketed products and a promising pipeline.
TiGenix NV and Cellerix SA, a privately held company based in Spain, announce that the two cell therapy-focused biotechnology companies and Cellerix’ shareholders have entered into a contribution agreement to combine the operations of both companies by means of a share for share exchange. The combination of TiGenix’ marketed product portfolio and proprietary pre-clinical stem cell platform with a clinical stage allogeneic stem cell platform and pipeline is part of TiGenix’ external growth strategy and further strengthens its position as an international leading player in the fast-growing field of regenerative medicine and cell therapy.
TiGenix also announces its intention to raise approximately EUR 15 million through a public rights offering, of which EUR 10 million has already been secured via precommitments from certain existing shareholders and new investors. Together with a EUR 18 million capital increase by Cellerix investors prior to the transaction, the combined group is expected to have a proforma cash position of at least EUR 33 million at closing.
Background to Cellerix and Rationale for the Combination
Cellerix is a Spanish cell therapy company that was founded in 2004 as a spin-off from the Genetrix Group. The company has a clinical stage pipeline of cell-based products for indications of inflammatory and autoimmune origin. The products are based on Cellerix’ proprietary fat derived adult stem cell platform and represent a new generation of off-theshelf cell therapy medicines. Cellerix´ stem cell platform and manufacturing capabilities have been fully validated according to EMA requirements. The company recently completed a successful Phase IIa study in complex perianal fistula in Crohn’s patients and has received authorization to start a Phase I/II study in rheumatoid arthritis. Further to the Genetrix Group, Cellerix has a solid and outstanding investor base including specialized European healthcare funds (Ysios, LSP and Ventech), pharma corporate investment funds (Roche Venture Fund and Novartis Venture Fund), and Spanish private and institutional investors. Cellerix’ investors have committed to a capital increase of approximately EUR 18 million in Cellerix, which is to be completed before the closing of the proposed transaction (subject to approval by the shareholders’ meeting of Cellerix), providing the combined group with a solid financial foundation.
The combination of TiGenix and Cellerix will create a new European leader in cell therapy with a proven ability to develop, register, manufacture and commercialize novel cell therapies. The Boards of each company believe that the combination will allow the enlarged group to expedite the further development of the allogeneic stem cell platforms, as well as to exploit synergies between TiGenix’ and Cellerix’ platforms for the treatment of damaged and arthritic joints, particularly in osteoarthritis and rheumatoid arthritis. The combined group will enjoy the following characteristics:
• two commercial products on the market including ChondroCelect, the first and only centrally approved cell-based product in Europe;
• a unique commercial and manufacturing infrastructure for advanced therapies;
• an advanced clinical stage pipeline of products combining regenerative and immunemodulatory mechanisms of action;
• two proprietary stem cell platforms to enable long term pipeline development;
• an international management team and approximately 80 employees working in four sites in Belgium, the Netherlands, the United Kingdom and Spain;
• a solid cash position secured through an EUR 18 million investment in Cellerix prior to completion of the combination and a public rights offering of approximately EUR 15 million, of which EUR 10 million has already been secured via precommitments.
The initial focus of the combined group will remain on damaged and arthritic joints while ensuring long term upside potential through expansion to other inflammatory and autoimmune disorders of high unmet medical need. With headquarters in Leuven and focused operations in Spain, the Netherlands and the United Kingdom, the combined group will be well positioned to become the leading cell therapy company in Europe.
Terms of the Combination
The combination is to be effected pursuant to the terms of the contribution offer as accepted by the shareholders of Cellerix and resulting in a binding contribution agreement. Under the terms of the contribution agreement, TiGenix will issue approximately 44.8 million new TiGenix shares as consideration for the contribution in kind by Cellerix shareholders, holding all of the outstanding Cellerix shares, into TiGenix at an agreed subscription price of EUR 1.2977 per new TiGenix share, valuing Cellerix at approximately EUR 58 million, including Cellerix’ expected cash position of about EUR 18 million.
The transaction is subject to the approval of the contribution by TiGenix shareholders at an extraordinary shareholders’ meeting (“ESM”) to be convened by the Board of TiGenix. The transaction is also subject to certain other conditions, including the approval by the Belgian Banking, Finance and Insurance Commission (“Commissie voor het Bank-, Financie- en Assurantiewezen or CBFA”) of the prospectus relating to the subsequent public rights offering and the admission to trading of the new TiGenix shares.
In the aforementioned contribution agreement the Cellerix shareholders have agreed that the TiGenix shares to be issued to them in the contribution or the rights offering referred to below will be subject to an initial lock-up of six months as from the date of the ESM. Furthermore it is anticipated that the Cellerix shareholders will also enter into a separate agreement providing for an additional lock-up undertaking(gradually decreasing over time) for a subsequent period of six months.
At the ESM, TiGenix shareholders will also be asked to approve the appointment, with effect as of the completion of the contribution, of a new board of directors of TiGenix consisting of a total of up to nine members, including the current CEOs of the two companies. Other proposed board members will be former Cellerix directors Joël Jean- Mairet, representing Ysios Capital Partners, Eduard Enrico Holdener, independent director and Mounia Chaoui-Roulleau, representing Ventech; former TiGenix directors Willy Duron, independent director and Koenraad Debackere, representing KULeuven and Gemma Frisius Fund; and new director Nico Vandervelpen, representing LRM. One additional independent director remains to be proposed. Prof. Dr. Frank Luyten will continue to serve as chairman of the scientific advisory board of the combined group.
In view of the post-merger board composition, ING België NV, represented by Mr. Luc Van de Steen has resigned.
Following the completion of the contribution, it is anticipated that the executive leadership team consists of Eduardo Bravo as managing director and Chief Executive Officer, Gil Beyen as managing director and Chief Business Officer, Claudia D’Augusta as Chief Financial Officer and Wilfried Dalemans as Chief Technical Officer.
Rights offering with preferential subscription right for TiGenix shareholders
To support its growth strategy and allow it to reach key commercial and product development milestones, following the contribution, TiGenix intends to increase its capital in cash for an amount of approximately EUR 15 million in a financing round with preferential subscription rights for TiGenix’ shareholders. The proposed rights offering is subject to approval by TiGenix’ shareholders at the ESM. The final terms of the offering, including the final size of the offering, the issue price, the number of shares to be issued, and the subscription ratio, shall be announced prior to the actual launch of the rights offering. TiGenix received already commitments for EUR 10 million from certain existing and new institutional investors to subscribe to new TiGenix shares at a subscription price of EUR 1.00 per share.
Certain existing TiGenix shareholders that have provided pre-commitments have also agreed to certain lock-up undertakings for a period of six months as from the date of the ESM.
Gil Beyen, CEO of TiGenix, said: “This consolidation between the two leading European stem cell companies represents an important step in our strategy of becoming a powerhouse in the field of regenerative medicine and cell therapy. Cellerix’ stem cells technology is one of the very few allogeneic stem cell platforms that have been approved for and used in human clinical trials. We believe that Cellerix’ stem cell platform is a great fit for TiGenix allowing us to accelerate our path to off-the-shelf allogeneic cell based products and to rapidly broaden our therapeutic scope to other area’s of high unmet medical need.
TiGenix has decided to pursue the capital raising by way of a rights offering as it was important for us to provide all our shareholders with the opportunity to fully participate. We look forward to their continuing support. If approved, the proposed capital increase will provide us with additional financial resources and strength to continue to deliver our strategy.”
Eduardo Bravo, CEO of Cellerix, said: “We are very satisfied to have reached this important agreement with TiGenix, which stands out for its leadership in the area of regenerative medicine, having achieved the first and so far only registration of an advanced therapy medicinal product. Joining forces with TiGenix will position the new group at the top of the European biotechnology industry by creating a solid European cell therapy leader.
The combination will allow cross fertilization of the companies’ expertise in manufacturing, CMC, regulatory, pricing and reimbursement that will enable the acceleration of key value driving programs while speeding up further development of the allogeneic stem cell platforms, with the aim of widening the indications being pursued.
Cellerix’ current investors will become shareholders of the combined group with very promising plans for the near and long term future”.
Kempen & Co Corporate Finance is acting as TiGenix’ sole financial advisor on the combination, and as joint bookrunner, together with KBC Securities, on the public rights offering. Linklaters is acting as TiGenix’ legal counsel. Piper Jaffray is acting as financial advisor to Cellerix. Garrigues and Stibbe are acting as Cellerix’ legal counsels.
Based in Leuven, Belgium, TiGenix NV is a public biomedical company that focuses on ‘Regenerating Motion’. The company is exploiting the power of Regenerative Medicine to develop durable treatments for damaged and diseased skeletal tissues. TiGenix now has two products approved for marketing and sales in Europe: ChondroCelect®, the company’s lead product for cartilage regeneration in the knee, is the first cellbased product that successfully completed the entire development track from research, over clinical development to central European registration as a medicinal product. ChondroCelect consists of characterized cultured chondrocytes derived from the patient’s own cartilage and is used for autologous chondrocyte implantation (ACI), a surgical procedure to treat cartilage defects. ChondroCelect received European Marketing Authorization as the first Advanced Therapy Medicinal Product. ChondroMimetic™ is an off-the-shelf, collagen based implant for the treatment of small osteochondral (cartilage and underlying bone) defects. ChondroMimetic received CE-mark approval for the treatment of small chondral and subchondral lesions. It will be marketed as a procedure pack with the collagen implant preloaded in an accurate, easy to use delivery device.
TiGenix exploits a proprietary (stem) cell and biomaterials platform, which will continue to generate candidate products that address specific musculoskeletal problems.
With a fully operational sales team in place, TiGenix is ready for commercial expansion and reinforcement of its leading position in Europe in the regenerative medicine field.
Cellerix SA is a Spanish private biopharmaceutical company dedicated to the development, production and commercialization of innovative stem cell based medicinal products.
The Company is leading the development of a new generation of off-the-shelf products using expanded adult stem cells from adipose tissue (eASCs). Cellerix has shown that eASCs have strong anti-inflammatory and immunomudalatory properties and, as such, could represent a revolution in the
treatment of autoimmune and inflammatory diseases which to date represent an area of high medical unmet need. Development is at a clinically advanced stage with promising results having been obtained in phase I and II clinical trials.
Cellerix’ platform is based on an extensive preclinical and regulatory package that has been fully validated according to EMA requirements. The products are manufactured in Cellerix’ GMP facility in Madrid. The current pipeline includes Cx601 (orphan drug,) which received positive Phase IIa data for the treatment of complex perianal fistula in Crohn’s disease patients in 2010, Cx611, which has received authorization to start a Phase I/II trial in rheumatoid arthritis and several other programs in earlier development.