AMSTERDAM--(BUSINESS WIRE)--Regulatory News:
Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces its audited annual results for the year ended 31 December 2015, which have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the European Union.
Operating highlights (including post the period end)
-
Strong progress was made in developing lead product ATIR101™ for blood
cancer:
- full enrolment of the single dose Phase II clinical trial was completed;
- positive data was presented at the American Society of Hematology (ASH) Annual Meeting in December 2015;
- positive results on the primary endpoint were presented at the Annual Meeting of the European Society of Blood and Marrow Transplantation (EBMT) in April 2016;
- a further repeat-dosing Phase II clinical trial with ATIR101™ commenced patient enrolment in October 2015;
- a closed manufacturing process for ATIR101™ was established which allows for automation;
- preparations to initiate a randomised Phase III trial with ATIR101™ in the second half of 2016 are underway;
- ATIR101™ was granted an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data by the European Medicinal Agency (EMA).
- Entered into a partnership with the U.S. Leukemia & Lymphoma Society, the world’s largest voluntary health agency dedicated to blood cancer in early 2016.
- Signed a collaboration with the Thalassaemia International Federation (TIF), an internationally renowned organisation that seeks to address the needs of patients, carers, healthcare professionals and the general public in the area of thalassaemia for ATIR201™ in inherited blood disorders.
Financial highlights
- Shares listed via an initial public offering (IPO) on Euronext Amsterdam and Euronext Brussels on 2 July 2015 raising gross proceeds of EUR34.7 million.
- The equity position of the Company improved significantly and increased to EUR25.7 million at year-end 2015 compared to EUR2.7 million at the end of 2014.
- With net proceeds of EUR31.2 million raised in the IPO, the Company’s cash position improved to EUR28.7 million at year-end 2015, which is an increase of EUR23 million compared to cash of EUR5.7 million at the end of 2014.
- Operating loss increased to EUR16 million in 2015 from a loss of EUR6.2 million in 2014.
- Operating expenses for 2015 included non-cash share-based payments of EUR7.8 million.
- Net loss increased from EUR7.8 million in 2014 to EUR16.5 million in 2015.
| (Amounts in EUR million, except per share data) | 2015 | 2014 | Change | |||||
| Total revenue and other income | - | - | - | |||||
| Total operating expenses | (16.0) | (6.2) | (9.8) | |||||
| Research and development | (7.7) | (4.7) | (3.0) | |||||
| General and administrative | (8.3) | (1.5) | (6.8) | |||||
| Operating result | (16.0) | (6.2) | (9.8) | |||||
| Net financial result | (0.5) | (1.6) | 1.1 | |||||
| Net result | (16.5) | (7.8) | (8.7) | |||||
| Net operating cash flow | (8.1) | (6.1) | (2.0) | |||||
| Cash position at end of year | 28.7 | 5.7 | 23.0 | |||||
| Earnings per share before dilution (EUR) | (1.36) | (0.73) | (0.63) | |||||
A full annual report for the year ended 31 December 2015 is available on Kiadis Pharma’s website.
Commenting on the annual results, Manfred Rüdiger, CEO of Kiadis Pharma, said: “2015 has been a very successful year for Kiadis Pharma. We reached significant milestones in our clinical programmes and also successfully listed the Company on Euronext Amsterdam and Euronext Brussels. The financial results are fully in line with our guidance and projections and show that Kiadis Pharma has been conscious and diligent on expenses whilst progressing with the development of its lead product ATIR101™ for patients suffering from acute leukaemia towards its last phase of clinical development. With a healthy year-end cash position, we are well positioned to begin Phase I/II clinical development with ATIR201™ for thalassaemia, scale-up our manufacturing and begin enrolment into our pivotal Phase III trial with ATIR101™. I would like to thank our investors for their continued support and look forward to providing further updates in due course.”
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), being graft-versus-host disease (GVHD), cancer relapse, opportunistic infections and limited matched donor availability. HSCT is generally regarded as the most effective curative approach to blood cancers and certain inherited blood disorders and 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.
In April 2016, the Company reported positive results on the primary endpoint of its single dose Phase II trial with its lead product ATIR101™, which allows a safe donor lymphocyte infusion (DLI) from a partially matched (haploidentical) family member without the risk of causing severe GVHD. The study was designed as an open-label trial in patients with blood cancer who had not found a matching donor and where a partially matched (haploidentical) family member was used as donor for HSCT. The primary endpoint of the trial was Transplant Related Mortality (TRM) within six months-post HSCT. The data confirmed that ATIR101™ can be safely infused, does not cause grade III-IV GVHD and shows a significant reduction in TRM and a significant improvement in Overall Survival (OS) in comparison to a historical control group of patients undergoing a T-cell depleted haploidentical donor transplantation only.
In addition, the Company is enrolling blood cancer patients in a further Phase II clinical trial to study the safety and efficacy of administrating a second dose of ATIR101™ to further improve the HSCT outcome.
ATIR101™ has been granted Orphan Drug Designations both in the US and Europe.
The European Medicines Agency (EMA) has issued an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data to the Company, and to date Kiadis Pharma is one of only five companies that have received such a certificate.
ATIR201™ will be developed for inherited blood disorders with an initial focus on thalassaemia, an inherited blood disorder which results in improper oxygen transport and destruction of red blood cells in a patient. ATIR201™ is expected to enter Phase I/II clinical development for thalassaemia in the second half of 2016. Kiadis Pharma is collaborating with the Thalassaemia International Federation (TIF), an internationally renowned organisation that seeks to address the needs of patients, carers, healthcare professionals and the general public in the area of thalassaemia.
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
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.