Amsterdam, The Netherlands, August 25, 2015 – Kiadis Pharma N.V. (“Kiadis Pharma” or “Company”) (Euronext Amsterdam and Brussels: KDS), a recently-listed clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces its maiden unaudited financial results for the six months ended 30 June 2015, which have been prepared in accordance with the IAS 34 “Interim Financial Reporting” as adopted by the European Union.
- Continued good progress made in developing lead product ATIR101™ for blood cancer: o Full enrolment of the ongoing Phase II clinical study has been accomplished;
- Readout of the primary endpoint results of this study is still expected in Q1
- Establishing a closed manufacturing process that allows for automation is
advancing according to plan.
- Readout of the primary endpoint results of this study is still expected in Q1
- Preparations underway to run another study, testing repeat dose administration of
ATIR101™ in parallel with the ongoing Phase II trial.
- ATIR101™ granted an Advanced Therapy Medicinal Product (ATMP) certificate for
manufacturing quality and non-clinical data by the European Medicinal Agency (EMA).
- The Company further strengthened its Supervisory Board with the appointment of Dr.
Vincent Brichard as an independent member.
- Kiadis Pharma N.V. listed its shares with an initial public offering (IPO) on Euronext Amsterdam and Brussels on 2 July 2015. IPO proceeds (€34.7 million gross) did not contribute to the equity and cash position for the first six months ended 30 June 2015 and hence are not included in these financial results.
|(€ million)||30 June 2015||30 June 2014||Change|
|Total revenue and other income||–||–||–|
|– Research and development||(4.7)||(2.2)||(2.5)|
|– General and administrative||(7.0)||(0.7)||(6.3)|
|Net financial result||2.2||(0.6)||2.8|
|Net operational cash flow||(3.6)||(2.7)||(0.9)|
|Cash at end of period||2.5||3.6||(1.1)|
A full financial report for the six months ended 30 June 2015 is available on Kiadis Pharma’s website.
Commenting on the maiden financial results, Manfred Rüdiger, CEO of Kiadis Pharma, said: “We are pleased to be making continued good progress with our Phase II clinical trial using ATIR101™ and that we remain on track. Having completed our recent IPO we are now completely driven to create life-saving treatments for patients with blood cancers and inherited blood disorders and to create value for our shareholders.”
During an allogeneic hematopoietic stem cell transplantation (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, ATIRTM 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 immunosuppressive 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.
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 based in Amsterdam, the Netherlands and its shares are listed on Euronext Amsterdam and Euronext Brussels. Further information can be found at: www.kiadis.com
This press release contains regulated information (gereglementeerde informatie) within the meaning of the Dutch Financial Supervision Act (Wet op het financieel toezicht) which must be made publicly available pursuant to Dutch law. This press release is intended for information purposes only.
For more information, please contact:
Manfred Ruediger, CEO
1114 AA Amsterdam-Duivendrecht The Netherlands
Tel. +31 20 314 02 50 firstname.lastname@example.org
International Media and Investor Contact:
Mary-Jane Elliott, Lindsey Neville, Hendrik Thys Consilium Strategic Communications
Tel: +44 (0) 203 709 5708 email@example.com
Forward Looking Statements
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect Kiadis Pharma’s or, as appropriate, Kiadis Pharma’s directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, Kiadis Pharma expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither Kiadis Pharma nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.