Kiadis Pharma announces maiden Financial Results for the six months ended 30 …

AMSTERDAM–(BUSINESS WIRE)–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.

Operating highlights

  • Continued good progress made in developing lead product ATIR101™ for
    blood cancer:

    • 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 2016;
    • Establishing a closed manufacturing process that allows for
      automation is advancing according to plan.
  • 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.

Financial highlights

  • 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

Operating expenses

(11.7)

(2.9)

(8.8)

Research and development

(4.7)

(2.2)

(2.5)

General and administrative

(7.0)

(0.7)

(6.3)

Operating result

(11.7)

(2.9)

(8.8)

Net financial result

2.2

(0.6)

2.8

Net result

(9.6)

(3.5)

(6.1)

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.”

About ATIR™

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, 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 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.

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.