Regulatory News:
NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX)
(Paris:ALNOX), a biotechnology company focused on improving
cancer treatments by targeting the tumor microenvironment (TME),
announced today its financial results for the fiscal year ending
December 31, 2020.
“The year 2020 has been a year of resilience for NOXXON, that
successfully continued its clinical development and activities
while adapting to the health situation. With its new Scientific
Advisory Board, composed of eminent experts in pancreatic cancer,
and a strong cash position, NOXXON is now in a perfect position to
accelerate the development of its main drug candidate, NOX-A12,
which showed promising results in its completed combination trial
with Merck’s Keytruda® in pancreatic and colorectal cancer patients
and has very recently advanced in the final phases of its Phase 1/2
dose-escalation study in combination with radiotherapy in
first-line brain cancer patients. We are thrilled by the prospects
that are waiting for NOXXON in 2021 and are more than ever
convinced that our unique approach to target the tumour
microenvironment can enhance the way cancer is treated,” said Aram
Mangasarian, CEO of NOXXON.
Highlights for 2020 and 2021 Year-to-Date
In 2020, NOXXON successfully raised €14.5 million which allowed
the company to advance its strategic goals. Cash secured in 2020
and 2021 combined with the available convertible bond financing
vehicle has extended NOXXON’s financial visibility to Q2 2022.
Despite the COVID-19 pandemic, the company has continued its
clinical development and investment activities as planned with
minimal delay or disruption.
NOX-A12 + Immunotherapy Clinical Trial in Heavily Pre-Treated
Metastatic Pancreatic and Colorectal Cancer Patients In 2020,
NOXXON completed the clinical trial of the combination of NOX-A12
with Keytruda® in heavily pre-treated metastatic micro-satellite
stable pancreatic and colorectal cancer patients. One of the most
interesting aspects of final top-line data, published by Prof.
Niels Halama at the European Society for Medical Oncology (ESMO)
Congress in September 2020, was the updated overall survival data
showing that three patients, including two receiving their fourth
line of therapy for metastatic pancreatic cancer, had lived more
than one year and one of them living for almost two years. Overall,
data from this study confirmed NOX-A12’s mechanism of action and
demonstrated that as monotherapy, NOX-A12 penetrates the tumor
tissue where it neutralizes its target. This mechanism allows
NOX-A12 to stimulate an increased immune response within the tumor,
making the tumor microenvironment immunologically “hotter”. In the
second part of the study, when NOX-A12 was then combined with
Merck’s anti-PD-1 immunotherapeutic antibody, Keytruda®, 25% of
patients achieved stable disease according to the iRECIST criteria,
despite only 5% having any response to their prior anti-cancer
treatment before entering the NOXXON clinical trial.
NOX-A12 + Radiotherapy Clinical Trial in First Line Brain
Cancer Patients Throughout 2020 and to date, NOXXON has
successfully advanced its Phase 1/2 dose-escalation study of
NOX-A12 in first-line brain cancer patients in combination with
radiotherapy, conducted in six clinical centers in Germany. The
company completed recruitment of patients into the last of the
three planned cohorts in April 2021. Preliminary data from the
first dose group showed tumor reductions in all three patients,
with one patient achieving a durable – longer than four months –
objective response (tumor volume reduction of >50%). Top-line
data from the second cohort will be reported in May 2021 and the
one from the third cohort later in November 2021.
Scientific Advisory Board In February 2021, NOXXON
appointed a Scientific Advisory Board (SAB) under the chairmanship
of Dr. Jose Saro. The SAB includes four leading pancreatic cancer
experts: Dr. Elena Gabriela Chiorean, Dr. Eileen M. O’Reilly, Prof.
Dr. Thomas T. W. Seufferlein and Dr. Daniel D. Von Hoff. The
formation and composition of the SAB reflect NOXXON’s clinical
development strategy as the company prepares to initiate a two-arm
Phase 2 trial in pancreatic cancer in Europe and the US.
Manufacturing & Drug Supply To meet the needs of
upcoming clinical trials leading to approval of NOX-A12, NOXXON has
made investment commitments and initiated manufacturing of drug
supply of NOX-A12. In addition, NOXXON also initiated NOX-E36
manufacturing for future clinical trials.
COVID-19 After careful assessment of risks associated
with the global COVID-19 pandemic, the company has implemented risk
mitigating steps that minimized the impact of the pandemic on the
organization. Overall, the impact of the pandemic on the
operations, clinical trials and finances has been manageable and
was limited in scope.
Strong Cash Position on December 31, 2020 On December 31,
2020, NOXXON had cash resources of €10.3 million. The company
successfully raised €14.5 million in cash in 2020 through multiple
private placements, exercises of outstanding warrants to purchase
NOXXON’s shares, and the Atlas Special Opportunities (ASO)
financing vehicle of which €12.8 million is still available.
Subsequent to December 31, 2020, the company raised an additional
€6.4 million from a private placement. These financings combined
with the potential of the ASO vehicle have extended the financial
visibility to Q2 2022.
2020 Financial Summary
In both, Fiscal Year 2020 (FY 2020) and Fiscal Year 2019 (FY
2019), NOXXON did not generate any revenues. The Group – NOXXON
Pharma N.V. and NOXXON Pharma AG – does not expect to generate
revenues from any product candidates currently in development,
until the Group either signs a licensing agreement, obtains
regulatory approval and commercializes its products, or enters into
collaborative agreements with third parties.
Other operating income decreased from €279 thousand in FY 2019
to €147 thousand in FY 2020. In 2020, other operating income
resulted from sale of raw materials, services provided, the
derecognition of benefits waived and the derecognition of
liability, as well as other income, mainly resulting from foreign
exchange differences.
Research and development (R&D) expenses increased from
€2,108 thousand in FY 2019 to €4,017 thousand in FY 2020. The
increase in R&D expenses in 2020 compared to 2019 was mainly
due to higher costs for drug manufacturing, service fees and other
costs related to clinical trials and preclinical testing. Personnel
expenses included non-cash share-based payment expenses amounting
to €51 thousand in 2020 and €53 thousand in 2019. When such
non-cash share-based payment expenses are not taken into account,
the remaining personnel expenses were €622 thousand in 2020 and
€530 thousand in 2019.
General and administrative (G&A) expenses decreased from
€2,115 thousand in FY 2019 to €1,881 thousand in FY 2020. The
decrease in G&A expenses in 2020 was mainly driven by lower
legal, consulting and audit fees as well as public and investor
relations expenses compared to 2019, partly offset by higher
personnel expenses. Personnel expenses included non-cash
share-based payment expenses amounting to €111 thousand in 2020 and
€54 thousand in 2019. When such non-cash share-based payment
expenses are not taken into account, the remaining personnel
expenses were €858 thousand in 2020 and €741 thousand in 2019.
Foreign exchange losses increased from €4 thousand in FY 2019 to
€18 thousand in FY 2020, due to a higher volume of purchases
denominated in currencies other than Euro in FY 2020.
Finance income (all non-cash) decreased from €3,091 thousand in
FY 2019 to €418 thousand in FY 2020. Finance income of €406
thousand resulted from the derecognition of conversion rights in
connection with the ASO financing upon conversion of the bonds and
of €12 thousand relating to the cashless exercise of warrants.
Finance cost in FY 2020 and FY 2019 was non-cash, except for
transaction costs of €123 thousand in 2020 borne by the Group in
conjunction with its issuance of convertible bonds. Finance cost of
€3,153 thousand related to the ASO financing entered into in 2020
and reflected losses on initial recognition of convertible bonds,
conversion losses and conversion right derivatives as well as
transaction costs. Further, €998 thousand of finance cost related
to the exercise of warrants by Yorkville, €878 thousand related to
the cashless exercise of all remaining Acuitas warrants outstanding
and €23 thousand related to the fair value adjustments of
detachable warrants issued to Kreos, Yorkville and certain other
investors and €3 thousand related to interest expense for lease
liabilities.
As a result of the above factors, the Group’s loss before income
tax increased by €9,546 thousand from €860 thousand in FY 2019 to
€10,406 thousand in FY 2020 (thereof loss from operations amounting
to €5,769 thousand in FY 2020 vs. €3,948 thousand in FY 2019,
resulting in an operating cash outflow of €5,224 thousand in FY
2020 vs. €4,286 thousand in FY 2019).
Income tax expenses decreased to nil in FY 2020 from €1 thousand
in FY 2019.
On December 31, 2020, the Group had cash resources of €10.3
million (compared to €1.4 million on December 31, 2019). The Group
succeeded in raising €14.5 million in 2020 from multiple sources,
including private placements, exercises of outstanding warrants and
the ASO financing vehicle. In 2021 to date, the Group has raised
further €6.4 million from a private placement. Importantly, no
warrants or other option-like instruments were attached to the
shares issued in these financings. The continued support of
investors willing to purchase shares in this manner is key for
NOXXON to reduce reliance on instruments that have the potential to
create divergent interests between various groups of investors.
These financings were essential to allow NOXXON to complete the
NOX-A12/Keytruda® trial in pancreatic and colorectal cancer
patients, to progress the NOX-A12/radiotherapy combination trial in
brain cancer patients and to initiate manufacturing of NOX-A12 and
NOX-E36 for upcoming clinical trials. On December 31, 2019, a
significant number of warrants linked to previous financings, that
are subject to anti-dilution adjustments affecting exercise price
and number of shares issued, were outstanding. During 2020,
Yorkville exercised a large portion of its detachable warrants and
Acuitas executed its right to cashless exercise for all of its
warrants. As a result, the company’s capital structure has become
less complex.
Outlook 2021
The current budget projects a cash need of approximately €1.5
million per month in 2021, including all planned activities for the
ongoing NOX-A12 brain cancer trial, drug production and trial
initiation of the upcoming NOX-A12 pancreatic cancer study as well
as the NOX-E36 trial. Current cash resources are projected to
finance the company into November 2021 and with the resources of
the ASO financing vehicle into May 2022. The company is pursuing
various financing alternatives to secure future budget
requirements, including outreach to well-known US healthcare
investors, obtaining further funding from existing investors
through additional funding rounds, seeking strategic partnering
deals as well as merger or acquisition opportunities.
NOX-A12 + Immunotherapy + Chemotherapy in Second Line
Pancreatic Cancer Patients With encouraging data from a
previous study and with guidance of the SAB, NOXXON is preparing to
initiate a two-arm clinical trial in pancreatic cancer. On top of
the combination therapy of NOX‑A12 plus anti-PD-1, the study will
test two different standard of care chemotherapy treatments in
second-line patients. The trial initiation is planned for H2 2021
and its completion is expected in 2023. This strategic approach
will enable NOXXON to choose the optimal regimen to move forward
into a randomized, controlled pivotal study targeting market
authorization application in 2026 and approval in 2027.
NOX-A12 + Radiotherapy in First Line Brain Cancer
Patients It is NOXXON’s key priority to ensure timely
completion of the ongoing Phase 1/2 dose escalation trial and
present top-line data in 2021. Aiming to obtain additional safety
data prior to launching the pivotal trial, NOXXON is currently
preparing to expand the number of patients at one of the tested
dose levels. Anticipating that the ongoing Phase 1/2 trial data
supports further development, NOXXON plans to initiate in 2022 a
pivotal trial of NOX-A12 combined with radiotherapy in first line
MGMT promoter-unmethylated glioblastoma patients vs. standard of
care, with first market authorization application targeted for 2024
and approval for 2025.
Clinical plans for NOX-E36 With its improved finances,
NOXXON plans to restart clinical trials with NOX-E36. Manufacturing
of clinical supply has been contracted and the drug supply is
projected to be available in H2 2021. Pre-clinical work comparing
combination strategies for NOX-E36 in solid tumors to identify the
most promising approaches are also advancing. The company plans to
initiate the first clinical trial of NOX-E36 combinations testing
safety in 2021.
The Annual Report 2020, as approved by the management and
supervisory boards on April 28, 2021, is available on NOXXON’s
website (www.noxxon.com).
2020 Financial Results
NOXXON’s Key Financial Figures for Fiscal Year 2020 Compared
to the Same Period in 2019
[in € thousands]
2020
2019
Other operating income
147
279
Research and development expenses
(4,017)
(2,108)
General and administrative expenses
(1,881)
(2,115)
Foreign exchange losses
(18)
(4)
Loss from operations
(5,769)
(3,948)
Finance income
418
3,091
Finance cost
(5,055)
(3)
Loss before income tax
(10,406)
(860)
Income tax
(0)
(1)
Net loss – attributable to owners of
the company
(10,405)
(861)
Net loss – attributable to
non-controlling interest
(1)
(0)
Loss per share (in €, basic and
diluted)
(0.32)
(0.08)
About NOXXON
NOXXON’s oncology-focused pipeline acts on the tumor
microenvironment (TME) and the cancer immunity cycle by breaking
the tumor protection barrier and blocking tumor repair. By
neutralizing chemokines in the TME, NOXXON’s approach works in
combination with other forms of treatment to weaken tumor defenses
against the immune system and enable greater therapeutic impact.
NOXXON’s lead program NOX-A12 has delivered final top-line data
from a Keytruda® combination trial in metastatic colorectal and
pancreatic cancer patients published at the ESMO conference in
September 2020 and based on the trial results, including overall
survival and safety profile, further studies are being planned in
pancreatic cancer. NOXXON is also studying NOX-A12 in brain cancer
in combination with radiotherapy which has been granted orphan drug
status in the US and EU for the treatment of certain brain cancers.
A trial of NOX-A12 in combination with radiotherapy in newly
diagnosed brain cancer patients who will not benefit from standard
chemotherapy has delivered preliminary data from the first cohort
showing consistent tumor reductions. The company’s second
clinical-stage asset NOX-E36 is a Phase 2 TME asset targeting the
innate immune system. NOXXON plans to test NOX‑E36 in patients with
solid tumors both as a monotherapy and in combination. Further
information can be found at: www.noxxon.com
Keytruda® is a registered trademark of Merck Sharp & Dohme
Corp
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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., Chief
Executive Officer Tel. +49 (0) 30 726247 0
amangasarian@noxxon.com
Trophic Communications Gretchen Schweitzer and Valeria
Fisher Tel. +49 (0) 172 861 8540 and +49 (0) 175 804 1816
noxxon@trophic.eu
NewCap Arthur Rouillé Tel. +33 (0) 1 44 71 00 15
arouille@newcap.fr