Kiadis Pharma announces results for the six months ended June 30, 2019
10 Setembro 2019 - 02:00AM
Kiadis Pharma announces results for the six months ended June 30,
2019
Kiadis to hold conference call with investors
today at 15:00 CEST
Amsterdam, The Netherlands, September 10, 2019 – Kiadis
Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext
Amsterdam and Brussels: KDS), a clinical-stage
biopharmaceutical company, today announces its unaudited interim
results for the six months ended June 30, 2019, which have been
prepared in accordance with International Financial Reporting
Standards (IFRS) as adopted by the European Union.
Arthur Lahr, CEO of Kiadis Pharma,
commented: “In the first six months of 2019, through the
acquisition of Cytosen, we have transformed Kiadis into a company
with two cell therapy platforms to help patients with
life-threatening diseases. Kiadis now has a pipeline with therapies
in all stages of development focused on both hematopoietic stem
cell transplantation (HSCT) and novel cell therapies for patients
with cancer. Through these programs we are leveraging the natural
strengths of humanity and our collective immune system to source
the best cells for life.”
Mr. Lahr continued: “While the review by
the European Medicines Agency of the marketing authorization
application continues, we have advanced the global phase 3 study
for ATIR101 with major transplant centers in the US, EU,
Canada and Israel participating in the study; and we plan to open
the NK-REALM transplant phase 1/2 study for CSTD002 and a NK phase
1/2 study to treat AML R/R patients in 2020.”
Operating highlights (including
post-reporting period)
- Kiadis’ marketing authorization application (MAA) for ATIR101
is currently under review. Kiadis responded to the day 180
outstanding issues in May 2019. In early September, the Committee
for Advanced Therapeutics (CAT) convened a Strategic Advisory Group
(SAG) related to the review of the application; the next step in
the regulatory process is for the application to be reviewed by the
CAT in October. The company continues to expect to receive a
decision from the EMA in 2020.
- The global phase 3 trial for ATIR101, CR-AIR-009, is ongoing.
The study, which will enroll approximately 250 patients, is
comparing ATIR101 to the post-transplant cyclophosphamide (PTCy) or
‘Baltimore’ protocol.
- In June, after receiving customary shareholder approvals,
Kiadis closed the transaction to acquire US-based CytoSen
Therapeutics, Inc. The combination of Kiadis and CytoSen
creates a leader in cell-based cancer immunotherapy, with
complementary T-Cell and NK-cell platforms.
- In the first half of 2019, Kiadis raised gross proceeds of
€27.6 million through a private placement of 3,684,200 shares. As
of June 30, 2019 Kiadis had €62.7 million in cash and cash
equivalents.
Financial highlights for the six months ended June 30, 2019
(including post reporting period)
(Amounts in EUR million, except per share data) |
2019 |
2018 |
Change |
Total revenue and other income |
- |
- |
- |
Total operating expenses |
(25.7) |
(11.1) |
(14.6) |
Research and development |
(16.2) |
(7.7) |
(8.5) |
General and administrative |
(9.5) |
(3.4) |
(6.1) |
Operating result |
(25.7) |
(11.1) |
(14.6) |
Net financial result |
(0.2) |
(3.0) |
2.8 |
Net result |
(25.9) |
(14.1) |
(11.8) |
Net operating cash flow |
(21.4) |
(10.6) |
(10.8) |
Cash position at end of period |
62.7 |
60.3 |
2.4 |
Equity |
59.7 |
44.1 |
15.6 |
Earnings per share before dilution (EUR) |
(1.03) |
(0.74) |
(0.29) |
Financial highlights for the six months ended June 30, 2019,
presented above and discussed below, include less than one
month of activity related to the operations of CytoSen Therapeutics
Inc. from the completion of the acquisition in early June
2019. The comparable period of 2018 does not include any
results of CytoSen Therapeutics operations.
Operating expenses
- Operating expenses increased to EUR 25.7 million in 2019 from
EUR 11.1 million in 2018, an increase of EUR 14.6 million.
- Research and Development expenses increased to EUR 16.2 million
in 2019 from EUR 7.7 million in 2018. Without the expenses for
share-based compensation, Research and Development expenses
increased to EUR 15.3 million in 2019 from EUR 7.3 million in 2018,
an increase of EUR 8.0 million. This increase was primarily caused
by a further expansion of the workforce in all areas of the
organization, clinical expenses related to the CR-AIR-009 study,
the move to a larger building which includes a commercial
manufacturing facility, laboratories and office space.
- General and Administrative expenses increased to EUR 9.5
million in 2019 from EUR 3.4 million in 2018. Without the expenses
for share-based compensation, General and Administrative expenses
were EUR 5.4 million higher at EUR 8.4 million in 2019 compared to
EUR 3.0 million in 2018. The increase was due to the
expansion of the workforce, higher consultancy expenses related to
market access preparations, financing rounds and the acquisition of
CytoSen.
Operating results
- As a result of the overall increase in total operating
expenses, the Group's operating loss increased EUR 14.6 million
from EUR 11.1 million in 2018 to EUR 25.7 million in 2019.
Net financial result
- Net finance expenses for 2019 decreased to EUR 0.2 million from
EUR 3.0 million in 2018. The decrease of EUR 2.8 million is due to
favorable results of the adjustments of loans of EUR 1.2 million,
favorable results of net foreign exchange of EUR 1.1 million and
favorable fair value adjustments of EUR 0.7 million related to the
contingent consideration of CytoSen in 2019 and unfavorable fair
value adjustment of derivatives in 2018.
Net result
- As a result of the above items, the loss for the year to date
increased by EUR 11.8 million to EUR 25.9 million in 2019 versus a
loss of EUR 14.1 million in 2018.
Cash position
- The Company strengthened cash position in 2019 with private
placements of 3.7 million ordinary shares raising net proceeds of
EUR 25.4 million
- The cash position increased by EUR 2.4 million to EUR 62.7
million at June 30, 2019 compared to EUR 60.3 million at the end of
2018. This increase mainly results from the net proceeds of the
share offering for a total amount of EUR 25.4 million and EUR 3.1
million cash balances as part of the assets of CytoSen. In 2019,
the net operating cash outflow amounted to EUR 21.4 million and
further included the acquisition of PP&E, repayments of loans
and lease liabilities for a total amount of EUR 4.8 million.
- The Company’s cash position at June 30, 2019 was EUR 62.7
million.
Equity
- The Company's equity position amounted to EUR 59.7 million at
June 30, 2019 versus EUR 44.1 million at the end of 2018, an
increase of EUR 15.6 million. The main drivers of this increase are
net proceeds of the share offerings of EUR 25.4 million, shares
issued upon the acquisition of CytoSen for EUR 14.5 million, partly
offset by the loss for the year of EUR 25.9 million and currency
translation of EUR 0.4 million.
Earnings per share
- The undiluted loss per share for 2019 increased to EUR 1.03
compared to EUR 0.74 in 2018.
A full financial report for the six months ended
June 30, 2019 is available on Kiadis Pharma’s website at
www.kiadis.com/financial-news/.
Conference Call and Presentation The
Kiadis management will host a conference call for analysts and
investors today, Tuesday, September 10th at 3:00pm CEST / 2:00pm
BST / 9:00am EDT. To participate in the conference call, please
call one of the following numbers ten minutes prior to commencement
of the call:
Standard International Dial-in Number: +44 (0) 2071
928000Netherlands, Amsterdam: +31 (0) 2071 43545UK, London: +44 (0)
84457 18892Toll free US Dial-in Number: +1 866 966 1396Conference
ID: 3788834 Live webcast:
https://edge.media-server.com/mmc/p/fn6ptpyfA live audio webcast of
the call can be accessed from the Events section of the Company’s
website, https://www.kiadis.com/news-and-events/events/.
For more information, please contact:
Kiadis
Pharma:Amy Sullivan, SVP, Corporate AffairsTel. +1 508 479
3480a.sullivan@kiadis.com |
Optimum
Strategic Communications:Mary Clark, Supriya Mathur, Hollie
VileTel: +44 203 714 1787David Brilleslijper (Amsterdam)Tel: +31
610 942 514kiadis@optimumcomms.com |
About Kiadis PharmaFounded in 1997,
Kiadis Pharma is a fully integrated biopharmaceutical company
committed to developing innovative therapies for patients life
threatening diseases. With headquarters in Amsterdam, the
Netherlands, and offices and activities throughout the US and EU,
Kiadis Pharma is leveraging the natural strengths of humanity and
our collective immune system to source the best cells for life. The
Company’s shares are listed on Euronext Amsterdam and Brussels
under the ticker KDS. Learn more at www.kiadis.com.
Forward Looking StatementsCertain
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, our ability to
successfully integrate Cytosen into our business, 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.