AMSTERDAM-DUIVENDRECHT, Netherlands--(BUSINESS WIRE)--
Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative products to make bone marrow transplantations safer and more effective for patients suffering from blood cancers and inherited blood disorders, today announces its unaudited financial results for the six months ended June 30, 2017, which have been prepared in accordance with the IAS 34 “Interim Financial Reporting” as adopted by the European Union.
Operating highlights (including post reporting period)
- A Marketing Authorization Application (MAA) was submitted in April 2017 to the European Medicines Agency (EMA) for approval of Kiadis Pharma’s lead product for blood cancers, ATIR101™, across the European Union. The submission follows support from EMA Rapporteurs for filing based on the single dose Phase II trial CR-AIR-007. The MAA was validated by EMA in May 2017 and in accordance with applicable timelines, day-120 questions from EMA are expected in September 2017 with (conditional) marketing approval potentially following in the second half of 2018.
- The clinical protocol for a randomized, controlled, pivotal Phase III trial with a single dose of ATIR101™ CR-AIR-009 has been submitted to national authorities in the United States, Canada and Europe and has received regulatory approval in multiple countries to perform the trial. Kiadis Pharma aims to enroll the first patients in 2017.
- In the ATIR101™ second dose Phase II trial CR-AIR-008, a total of five patients have been treated with a single dose of ATIR101™ only, more than six months ago. Results so far (Graft-versus-Host-Disease, Overall Survival) are in line with the single dose Phase II trial CR-AIR-007.
- In April 2017 Mr. Arthur Lahr succeeded Dr. Manfred Rüdiger as Chief Executive Officer and Mr. Jan Feijen was appointed as Chief Operations Officer.
- The Supervisory Board was strengthened with an additional independent member, Dr. Otto Schwarz.
Financial highlights (including post reporting period)
- A private placement of shares with a small group of existing and new institutional investors in June 2017 raised gross proceeds of EUR5 million.
- A debt facility of up to EUR15 million was obtained from Kreos Capital in August 2017. The first tranche of EUR10 million was drawn down immediately, with a second tranche of EUR5 million being available conditionally. Part of the first tranche was used to repay the remaining EUR5.3 million of existing Dutch Government Loans.
|(Amounts in EUR million, except per share data)||30 June 2017||30 June 2016||Change|
|Total revenue and other income||-||-||-|
|Total operating expenses||(8.2)||(5.1)||(3.1)|
|Research and development||(5.9)||(3.8)||(2.1)|
|General and administrative||(2.3)||(1.3)||(1.0)|
|Net financial result||(0.4)||(1.4)||1.0|
|Net operating cash flow||(7.6)||(5.3)||(2.3)|
|Cash position at end of period||10.7||23.7||(13.0)|
|Earnings per share before dilution (EUR)||(0.61)||(0.48)||(0.13)|
A full financial report for the six months ended June 30, 2017 is available on Kiadis Pharma’s website at http://www.kiadis.com/financial-news/.
Commenting on the financial results, Arthur Lahr, CEO of Kiadis Pharma, said: “We have made good operational progress during the period whilst also strengthening the Company in preparation for the next stage of its development. Our operating expenses are as expected and we have bolstered our cash position through dilutive and non-dilutive financing in June and August. As Kiadis Pharma now moves further towards commercialization I would like to thank our shareholders for their continued support.”
For patients suffering from blood cancers and inherited blood disorders, an allogeneic hematopoietic stem cell transplantation (HSCT) can offer a cure, yet it has considerable risks. During an HSCT treatment, the patient’s diseased blood and immune system are destroyed and subsequently replaced by a healthy system from a donor. The key challenge with HSCT is that mature lymphocytes from the donor are required to provide immediate protection against infections and relapse, but may attack patient tissue, causing life threatening Graft-versus-Host-Disease (GVHD).
ATIR101™ (Allodepleted T-cell ImmunotheRapeutics) provides for a single dose donor lymphocyte infusion, with functional, mature immune cells from a haploidentical family member, given as an adjunctive to a haploidentical HSCT. The lymphocytes in ATIR101™ are very potent in fighting infections and remaining tumor cells, yet do so with minimal risk of causing severe GVHD. To provide protection to patients without attacking patient tissue, ATIR101™ is manufactured by depleting patient specific alloreactive lymphocytes ex vivo from donor material. ATIR101™ offers a strong improvement in relapse rates and GVHD over literature for other HSCT protocols, such as the Post Transplant Cyclophosphamide (PTCy) or ‘Baltimore’ protocol.
About Kiadis Pharma
Kiadis Pharma is focused on cell-based immunotherapy products, as an adjunctive to a haploidentical hematopoietic stem cell transplantation (HSCT), for the treatment of blood cancers and inherited blood disorders. The Company’s product candidates have the potential to make allogeneic HSCT safer and more effective for patients.
Based on the positive results from the single dose Phase II trial with lead product ATIR101™ in patients with blood cancer, the Company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in April 2017, for approval of ATIR101™ across the European Union as an adjunctive treatment in HSCT for malignant disease. In addition, Kiadis Pharma has received regulatory approval in various countries to start dosing patients in a Phase III trial with ATIR101™ that will be performed across Europe and North America. ATIR101™ has been granted Orphan Drug Designations both in the US and Europe.
The Company’s second product candidate, ATIR201™, will address beta thalassemia, an inherited blood disorder.
Kiadis Pharma was granted an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data by the EMA.
The Company’s shares are listed on Euronext Amsterdam and Euronext Brussels. For more information visit www.kiadis.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.