Amsterdam, The Netherlands, June 17, 2015 – Kiadis Pharma N.V. (“Kiadis Pharma”, “Kiadis” or the “Company”), a clinical stage biopharmaceutical company developing innovative cell- based immunotherapy treatments, today announces the terms of its Initial Public Offering and listing on Euronext Amsterdam and Euronext Brussels (the “Offering”).
Highlights of the Offering
- Offering up to 2,272,727 new ordinary shares, which may be increased by up to 15% (the Increase Option, as defined below) resulting in a maximum of 2,613,636 new ordinary shares to be offered (the “Offer Shares”).
- Over-allotment option of additional ordinary shares equal to up to 15% of the number of new shares subscribed for in the Offering, that is exercisable within 30 calendar days after the Listing Date (as defined below) to cover short positions resulting from any over- allotments made in connection with the Offering (if any) (the Over-Allotment Option, as defined below).
- The Offering comprises:
- A public offering to retail and institutional investors in the Netherlands and Belgium;
- A private placement in the United States to persons who are reasonably believed to be
qualified institutional buyers (“QIBs”) as defined in Rule 144A (“Rule 144A”) under the US Securities Act of 1933, as amended (the “US Securities Act”), in reliance on Rule 144A; and
- Private placements to certain qualified and/or institutional investors under applicable laws of the relevant jurisdiction, in the rest of the world. The Offering outside the United States will be made in compliance with Regulation S under the US Securities Act (“Regulation S”).
- The price range for the Offering is set at EUR 11.00 and EUR 13.75 per Offer Share (the “Price Range”), implying a pre-money valuation of EUR 118m to EUR 147m.
- Based on the mid-point of the Price Range of the Offering, the size of the Offering will range between EUR 28.1m and EUR 37.2m (assuming the placement of all Offer Shares including the exercise in full of the Increase Option and Over-Allotment Option) and the implied market capitalization of the Company will range between EUR 160m and EUR 170m at listing.
- Certain existing shareholders of the Company and new investor Nyenburgh Investment Partners have committed to subscribe for Offer Shares in the Offering for a total amount of EUR 12m.
- The Company anticipates using the net proceeds of the Offering for inter alia the further clinical development of ATIR™101, an exploratory clinical trial with ATIR™201, production process optimisation and automation, working capital needs and general corporate purposes.
- The results of the Offering, the allocation for retail investors, and the final offer price are expected to be published in a pricing statement on or about 1 July 2015.
- The Company’s shares are expected to be admitted to trading on the regulated markets of Euronext Amsterdam and Euronext Brussels on or about 2 July 2015.
Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, commented: “We believe our products truly have the potential to save lives for patients suffering from blood cancers and inherited blood disorders. The funds raised through this Offering will enable Kiadis to continue to support the further clinical development of ATIR™ in order to bring this potentially life-saving therapy to market and to the patients who so desperately need it.”
Mark Wegter, Chairman of the Supervisory board of Kiadis Pharma, commented: “Kiadis Pharma is one of the Netherlands’ most promising biotech businesses and a successful IPO will enable the company to further develop its life saving product for blood cancer patients and patients with inherited blood disorders.”
- Innovative cell-therapy for HSCT: Kiadis Pharma develops ATIR™, an innovative cell-therapy
for allogeneic hematopoietic stem cell transplantation (HSCT). HSCT is generally regarded as the most effective curative approach to blood cancers and certain inherited blood disorders, yet not a viable option for many patients given the risks and limitations of current HSCT treatments.
- Meets significant unmet medical need: ATIR™ addresses the key risks and limitations of current HSCT treatments in blood cancers and inherited blood disorders, being: opportunistic infections, graft-versus-host-disease (GVHD), cancer relapse and limited donor availability. ATIR™ also enables the safer use of partially matched (haploidentical) family members as stem cell donors for those patients that would otherwise not find a matching donor in time, thereby meeting a significant unmet medical need.
- Phase II trial for leukaemia: The Company’s lead product, ATIR™101, is currently in an international Phase II trial for leukaemia. The trial is being conducted in hospitals in Belgium, Canada, Germany and the UK. Trial results are expected at the beginning of 2016.
- Phase II interim data: Interim data from the on-going Phase II clinical trial for ATIR™101 were announced in December 2014, supporting the safety profile and showing efficacy of ATIR™101.
- Market potential: Kiadis Pharma believes that ATIR™101 has the potential to provide a life- saving therapy to approximately 19,000 patients in key countries worldwide, with an expanding primary market and complementary product trends.
- Second product for thalassemia: Kiadis Pharma’s second product, ATIR™201, is expected to be developed for inherited blood disorders with an initial focus on thalassemia.
- Granted EMA manufacturing quality certificate: The Company has a robust, GMP-compliant robust manufacturing process in use in North America and Europe. It is one of five companies to have ever been issued an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data by the European Medicines Agency (EMA).
Clinical development plan
- Subject to the outcome of the on-going Phase II trial, which is expected in the first quarter of 2016, the Company intends to file for conditional approval in the European Union and Canada for ATIR™101 in the fourth quarter of 2016.
- A Phase III trial for ATIR™101 is envisaged to start in the second quarter of 2016 which is expected to result in filing for marketing authorisation with EMA, FDA and Health Canada in 2019.
- ATIR™201 is expected to enter clinical development for thalassemia with a Phase I/II trial in the first quarter of 2016.
Details of the Offering
The Offering consists of (i) a public offering to retail and institutional investors in the Netherlands and Belgium and (ii) a private placement to certain institutional investors in various jurisdictions. The Offer Shares are being offered (i) within the United States to QIBs as defined in Rule 144A under the U.S. Securities Act in reliance on Rule 144A or pursuant to another exemption from, or in a transaction not subject to, the registration requirements of the U.S. Securities Act, and (ii) outside the United States in offshore transactions in reliance on Regulation S. The Offer Shares are being offered only in those jurisdictions in which, and only to those persons to whom, offers of shares may lawfully be made.
The Company is offering up to a total of 2,272,727 Offer Shares within a price range of EUR 11.00 to EUR 13.75 (inclusive) per Offer Share.
The Company reserves the right, after consultation with the Joint Bookrunners, to increase the total number of Offer Shares by up to 15% (the “Increase Option”) to a maximum of 2,613,636 Offer Shares or to decrease the total number of Offer Shares.
The Company has granted an option (the “Over-Allotment Option”) to the Sole Global Coordinator exercisable within 30 calendar days after 2 July 2015 (the “Listing Date”) pursuant to which the Sole Global Coordinator, on behalf of the Underwriters, may require the Company to issue up to 340,909 additional Shares (or up to 392,045 in the event that the Increase Option is exercised in full), comprising up to 15% of the total number of Offer Shares sold in the Offering (the “Additional Shares”), to cover short positions resulting from any over-allotments made in connection with the Offering and to cover stabilisation transactions (if any).
Provided that there is sufficient demand, it is intended that approximately 10% of the Offer Shares (including Additional Shares, if any) will be allocated to retail investors in the Netherlands and Belgium.
The Offering will begin on 17 June 2015 and is expected to end on 30 June 2015 (the “Offering Period”). On the final day of the Offering Period, subject to acceleration and extension of the timetable for the Offering and barring unforeseen circumstances, prospective retail investors may submit offers to purchase shares until 12:00 Central European Summer Time (“CEST”) and institutional investors may subscribe for Offer Shares until 16:00 CEST.
The offer price, the exact number of Offer Shares offered and the allocation for retail investors will be stated in a pricing statement which will be published in a press release that will also be posted on Kiadis’ website and filed with the AFM (as defined below). Respective publications will be made in the Belgian financial press.
Kempen & Co is acting as Sole Global Coordinator and Kempen & Co and KBC Securities together act as Joint Bookrunners. Peel Hunt has been appointed as Co-Manager. Kempen & Co, KBC Securities and Peel Hunt are jointly the Underwriters. Kempen & Co also acts as the stabilisation, listing and paying agent with respect to the shares on Euronext Amsterdam and Euronext Brussels.
|￼￼￼￼￼Event||￼￼￼Time and date|
|￼￼￼￼￼Commencement of the Offering Period||￼￼￼17 June 2015|
|￼￼￼￼￼End of the retail offering||￼￼￼￼￼￼￼￼￼30 June 2015, 12:00 CEST|
|￼￼￼￼End of the institutional offering||￼￼￼￼30 June 2015, 16:00 CEST|
|End of the Offering Period￼￼￼||￼￼￼30 June 2015|
|￼￼￼￼￼Pricing and allocation||￼￼￼￼￼￼￼￼￼1 July 2015|
|￼￼￼￼Commencement of trading on an ‘as-if- and-when-issued‘ basis||￼￼￼2 July 2015|
|￼￼￼￼￼Settlement (payment and delivery)￼￼￼￼￼￼||￼￼￼3 July 2015|
Kiadis Pharma has prepared a prospectus relating to the Offering and the contemplated listing of its shares on Euronext Amsterdam and Euronext Brussels dated 16 June 2015 (the “Prospectus”). The Prospectus constitutes a prospectus for the purposes of article 3 of the Directive 2003/71/EC as amended (the “Prospectus Directive”) and has been prepared pursuant to article 5:2 of the Dutch Financial Supervision Act (Wet op het financieel toezicht) and the rules promulgated thereunder. This Prospectus has been approved by and filed with the Netherlands Authority for the Financial Markets (Stichting Autoriteit Financiële Markten, the “AFM”) and will be notified to the Belgian Financial Services and Markets Authority (the “FSMA”) for passporting in accordance with article 18 of the Prospectus Directive. The Prospectus includes a section entitled “3. Risk Factors” and prospective investors should carefully consider the risks described in this section prior to making an investment decision. The Prospectus is available on Kiadis Pharma’s website: www.kiadis.com/ipo and on the websites www.kbc.be/kiadis, www.kbcsecurities.be and www.bolero.be/nl/kiadis.
About Kiadis Pharma
Kiadis Pharma is a clinical stage biopharmaceutical company focused on research, development and future commercialisation of cell-based immunotherapy products for the treatment of blood cancers and inherited blood disorders. The Company believes that its innovative products have the potential to address the current risks and limitations connected with allogeneic hematopoietic stem cell transplantation (HSCT). Although currently not a viable option for many patients, HSCT is generally regarded as the most effective curative approach to blood cancers and certain inherited blood disorders. The Company expects that HSCT could become a first-choice treatment for blood cancers and inherited blood disorders once current risks and limitations are addressed, thereby meeting a significant unmet medical need with its products.
Currently, ATIR™101 is being tested in an open-label Phase II trial in patients with blood cancer who have not found a matching donor and where a partially matched (haploidentical) family member is used as donor for HSCT.
Kiadis Pharma is supported by a group of leading international investors including LSP, Alta Partners, DFJ Esprit, Quest for Growth, MedSciences Capital and NOM. Kiadis Pharma is based in Amsterdam, the Netherlands. Further information can be found at: www.Kiadis.com
During HSCT treatment the bone marrow, harbouring the diseased cells, is completely destroyed and subsequently replaced by stem cells from a healthy donor. After an HSCT treatment it usually takes at least six to twelve months to recover to near-normal blood cell levels and immune cell functions in a patient that has received a transplant. During this period, the patient is highly susceptible and vulnerable to infections caused by bacteria, viruses and fungi. Immune cells in ATIR™ (Allodepleted T-cell ImmunotheRapeutics) will help fight these opportunistic infections and bridge the time until the immune system has fully re-grown from stem cells in the transplanted graft.
In ATIR™, T-cells that cause Graft-versus-Host-Disease (GVHD) are eliminated from the donor lymphocytes, which minimises the risk of GVHD and any related morbidity and mortality. At the same time, ATIR™ contains potential cancer killing T-cells from the donor that could eliminate residual cancer cells and avoid the return of the disease. ATIR™ allows the use of haploidentical grafts that are almost entirely depleted of T-cells, which eliminates the need for immune suppressive drugs. ATIR™ subsequently provides the patient with immune cells that do not cause GVHD. As a result, ATIR™ solves the problem of not finding a matched donor in time and has the potential to make curative HSCT a viable option to many more patients.
The Company estimates that approximately 35% of patients who are eligible for, and who are in urgent need of, HSCT will not find a matching donor in time. A partially matched (haploidentical) family donor, however, will be available to over 95% of patients. The use of haploidentical donor grafts without ATIR™ is only feasible in conjunction with severe immunosuppression which renders the patient highly vulnerable to infections with severe clinical complications, resulting potentially in death.
Manfred Rüdiger, CEO Kiadis Pharma
Tel. +31 20 314 02 50 communication@Kiadis.com
International Media and Investor Contact:
Mary-Jane Elliott, Jessica Hodgson, Lindsey Neville, Hendrik Thys Consilium Strategic Communications
Tel: +44 (0) 203 709 5708
Ian Bickerton, Christa Nooitgedagt HuijskensBickerton
Tel. +31 (0) 20 685 5955 email@example.com
Important Legal Information
Not for distribution, directly or indirectly, in or into the United States (including its territories and possessions, any state of the United States or the District of Columbia), Australia, Canada, Japan or South Africa or any jurisdiction where to do so would constitute a violation of the relevant laws of such jurisdiction. This announcement is not a prospectus and does not contain or constitute an offer for sale or the solicitation of an offer to purchase securities in the United States, Australia, Canada, Japan, South Africa or any other jurisdiction.
This communication is not an offer to sell or a solicitation of any offer to buy the securities of Kiadis Pharma N.V. (the “Company”, and such securities the “Securities”) in the United States or in any other jurisdiction.
￼￼The Securities have not been and will not be registered under the US Securities Act of 1933, as amended (the “Securities Act”) and may not be offered or sold in the United States unless registered under the Securities Act or an exemption from such registration is available. No public offering of Securities of the Company is being made in the United States.
This announcement does not constitute a prospectus. The offer to acquire securities pursuant to the proposed offering will be made, and any investor should make his investment, solely on the basis of information that will be contained in the prospectus to be made generally available in the Netherlands and Belgium in connection with such offering.
When made generally available, copies of the prospectus may be obtained at no cost through the Company’s website.
This communication is directed only at (i) persons outside the United Kingdom, or (ii) persons having professional experience in matters relating to investments who fall within the definition of “investment professionals” in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”) or (iii) high net worth companies, unincorporated associations and partnerships and trustees of high value trusts as described in Article 49(2) of the Order or (iv) any other person to whom the communication can lawfully be made in accordance with the Order. Any investment or investment activity to which this communication relates is available only to and will be engaged in only with such persons. Persons within the United Kingdom who receive this communication (other than persons falling within (ii), (iii) and (iv) above) should not rely on or act upon this communication.