Year marked by successful transition to
clinical-stage, cancer focused publicly listed company
Regulatory News:
NOXXON Pharma N.V. (Paris:ALNOX) (Alternext Paris:
ALNOX), a biotechnology company focused on improving cancer
treatment by targeting the tumor microenvironment, today announced
its financial results for the fiscal year ending December 31, 2016.
The consolidated financial statements of NOXXON Pharma N.V. and its
subsidiaries have been prepared in accordance with International
Financial Reporting Standards (IFRS) as adopted by the European
Union (EU).
Aram Mangasarian, PhD, Chief Executive Officer of NOXXON
commented: “The year 2016 was an important time for NOXXON as we
completed our transition to a clinical-stage, cancer-focused
company. By narrowing our focus to our lead clinical program,
NOX-A12, we were able to take major steps towards securing a
stronger financial future: We significantly decreased costs,
completed a public listing and converted the majority of
outstanding debt to equity.”
He continued: “Already by the end of 2016 we saw our new
strategy bear fruit: We entered a collaboration with Merck to
evaluate NOX-A12 with Keytruda® in tumor types that traditionally
have not responded to treatment with an immune checkpoint inhibitor
alone. We also non-exclusively licensed our Spiegelmer® technology
and assigned our preclinical Spiegelmer® programs in a deal that
provides NOXXON with potential upside as these programs advance and
without our incurring additional costs."
Recent Business Highlights
- September 2016: Private placement
executed consisting of equity contributions, a debt-to-equity
conversion and further contributions. Under a new agreement, €7.0
million of €9.6 million debt converted to equity.
- September 2016: NOXXON becomes public
company, lists on Alternext Paris.
- Fall 2016: Preclinical data presented
at major medical conferences. Synergy demonstrated between NOX-A12
and therapies working through T cells, such as checkpoint
inhibitors, or through NK cell-mediated antibody-dependent cellular
cytotoxicity (ADCC).
- December 2016: Clinical trial
collaboration with Merck & Co./MSD consummated to evaluate
NOX-A12 and anti-PD-1 inhibitor, Keytruda® (pembrolizumab), in
patients with metastatic solid tumors that do not usually respond
to checkpoint inhibitor monotherapy.
- January 2017: NOXXON announces that it
licensed preclinical Spiegelmer® program to Aptarion in exchange
for cash, royalties and equity stake in Aptarion.
- February 2017: Experienced industry
cancer clinician Dr. Jarl Ulf Jungnelius increases his involvement
with NOXXON to serve as Chief Medical Officer. Of relevance to
NOXXON is his prior experience in immune-oncology and his
involvement with two therapeutics that have been approved for
pancreatic cancer, one of the indications pursued in the upcoming
clinical trial of NOX-A12.
2016 Financial Summary
Revenue was €83 thousand for 2016 compared to €43 thousand for
2015. Research and development expenses decreased by 30% to €5.3
million (2015: €7.6 million). In third quarter of 2016, NOXXON
decided to focus all of its business activities on the NOX-A12
clinical program. This strategic change in focus and the related
headcount reduction, decreased personnel expenses by €1.0 million
in 2016.
Other operating income increased from €74 thousand to €437
thousand in 2016, mainly due to income from government grants
related to research and development projects of €385 thousand
compared to nil in 2015 and income from the sale of financial
assets and property, plant and equipment of €20 thousand compared
to nil in 2015.
General and administrative expenses decreased by 48% to €3.8
million (2015: €7.3 million). This decrease was mainly due to lower
legal and consulting expenses related to financing transactions.
Additionally, restructuring costs and settlement benefits, which
were mainly related to the restructuring initiated in July 2015,
decreased in 2016 compared to 2015. Restructuring expenses were €22
thousand for 2016 compared to €510 thousand in 2015; settlement
benefits were €33 thousand in 2016 compared to €521 thousand in
2015.
Finance income was €1 thousand for 2016 (2015: € 0), and finance
cost was €2.1 million (2015: €1.3 million), mainly related to the
interest incurred on financial liabilities, applying the effective
interest rate method, the modifications of and the debt-for-equity
conversion on two venture loans.
Net loss for the full year 2016 was €10.8 million, compared to
€16.1 million in 2015, a reduction of 33%. The decrease was
primarily due to the €6.2 million decreased operating loss (2016:
€8.6 million; 2015: €14.8 million).
As of December 31, 2016, cash and cash equivalents amounted to
€2.2 million, compared to €4.1 million at December 31, 2015.
The consolidated financial statements for 2016, approved by the
board of directors on April 28, 2017, are available on
NOXXON’s website (www.noxxon.com).
2016 Financial Results
NOXXON’s key financial figures for fiscal year 2016 compared
to the same period in 2015 are summarized below:
[in € thousands]
2016 2015 Revenues
83 43 Other operating
income 437 74 Research and
development expenses (5,327)
(7,587) General and administrative expenses
(3,780) (7,319) Foreign exchange losses
(12) (41)
Loss from operations
(8,599) (14,830) Finance
income 1 0 Finance cost
(2,127) (1,294)
Loss before income
tax (10,725)
(16,124) Income tax (27)
22
Net loss (10,752)
(16,102)
Outlook 2017
As disclosed in the financials and the annual report available
on NOXXON’s website (www.noxxon.com), NOXXON expects to sign
shortly a financing agreement composed of 1) a private placement
for an amount of €1.0 million financed by existing investors and a
new investor and 2) a convertible bond vehicle financed by a new
investor for up to €10.0 million, of which €3.5m may be received at
the discretion of NOXXON over the 12 months following the transfer
of the NOXXON shares from the “private placement” compartment to
the “public offering” compartment of Alternext Paris, provided that
certain conditions are met, principally the approval of a
prospectus relating to such transfer by the Dutch regulator, the
AFM, which will then be passported to France and approved by the
French regulator the AMF.
NOXXON expects to see rapid and significant progress in the
achievement of clinical data points. Based on these findings,
NOXXON expects a sufficient data base to enable a Go/No-Go for
pivotal studies with NOX-A12 as a combination therapy with
Keytruda® in microsatellite stable (MSS) metastatic colorectal
cancer (mCRC) and/or pancreatic cancer. NOXXON also plans to
initiate clinical combination trials of NOX-A12 and radiotherapy
for the therapy of glioblastoma. Additional financing is needed to
secure the execution of the planned clinical trials, including the
collaborative trial evaluating the combination of
NOX-A12/Keytruda®.
About NOXXON
NOXXON Pharma N.V. is a clinical-stage biopharmaceutical company
focused on improving cancer treatment by targeting the tumor
microenvironment. NOXXON’s goal is to significantly enhance the
effectiveness of cancer treatments including immuno-oncology
approaches (such as immune checkpoint inhibitors) and current
standards of care (such as chemotherapy and radiotherapy). NOXXON’s
Spiegelmer® platform has generated a proprietary pipeline of
clinical-stage product candidates including its lead cancer drug
candidate NOX-A12, which is the subject of a clinical
immuno-oncology collaboration agreement with Merck & Co. / MSD
(NYSE: MRK) to study NOX-A12 combined with Keytruda®
(pembrolizumab) in pancreatic and colorectal cancer. NOXXON is
supported by a strong group of leading international investors,
including TVM Capital, Sofinnova Partners, Edmond de Rothschild
Investment Partners, DEWB, NGN and Seventure. NOXXON has its
statutory seat in Amsterdam, The Netherlands and its office in
Berlin, Germany. Further information can be found at:
www.noxxon.com
Disclaimer
Certain statements in this communication contain formulations or
terms referring to the future or future developments, as well as
negations of such formulations or terms, or similar terminology.
These are described as forward-looking statements. In addition, all
information in this communication regarding planned or future
results of business segments, financial indicators, developments of
the financial situation or other financial or statistical data
contains such forward-looking statements. The company cautions
prospective investors not to rely on such forward-looking
statements as certain prognoses of actual future events and
developments. The company is neither responsible nor liable for
updating such information, which only represents the state of
affairs on the day of publication.
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NOXXON Pharma N.V.Aram Mangasarian, Ph.D., +49 (0) 30 726
2470Chief Executive
Officeramangasarian@noxxon.comorNewCapFlorent Alba, +33 (0)
1 44 71 98 55falba@newcap.fr