NFL Biosciences: 2022 full-year business and earnings update
NFL Biosciences: 2022 full-year business
and earnings update
Phase II/III clinical trial for the drug
candidate NFL-101 for smoking cessation: 100% of volunteers
recruited. Initial results expected in the fourth quarter of
2023
Progress with the PRECESTO clinical trial to
demonstrate the potential complementarity of NFL-101 with other
smoking cessation treatments: final recruitment in the second
quarter and initial results expected in the third quarter of
2023
Co-development agreement continuing to move
forward for NFL-301, a drug candidate to reduce alcohol
consumption
Intellectual property extended with a patent
granted in China and South Korea and a new patent application
submitted in the United States
Diversified sources of financing set up at the
start of 2023: cash runway to the third quarter of 2024
NFL BIOSCIENCES (Euronext Growth Paris –
FR0014003XT0 – ALNFL), a biopharmaceutical company developing
botanical drugs for the treatment of addictions, is reporting its
full-year results for 2022, as
approved by the Board of Directors on April 24, 2023. At
this time, NFL Biosciences looks back on its many areas of progress
for its drug candidates and the success of its financing strategy,
with cash requirements covered through to the third quarter of
2024.
Ignacio Faus, NFL Biosciences
Chairman of the Board and
Chief Executive Officer:
“We are proud to announce the completion of the recruitment of the
318 volunteers taking part in our most important clinical study
with NFL-101 for smoking cessation. The study, code-named CESTO II,
was put in place following our initial public offering on Euronext
Growth Paris in July 2021. The many advances made since this
transaction contributed to the success of the €3.1m fundrasing
round carried out in January 2023, while also enabling us to obtain
non-dilutive financing with public organizations supporting
research in France. Our financial position is therefore secured
through to the third quarter of 2024 and we can confidently
continue, to develop our two priority drug candidates, NFL-101 and
NFL-301. The coming quarters will of course be decisive for
assessing the efficacy of NFL-101, with the initial results
expected by the end of the year. We are moving forward with
confidence into a key scientific period, in order to execute our
business plan”.
Phase II/III clinical trial for the drug
candidate NFL-101 for smoking cessation: 100% of volunteers
recruited and initial results
planned for the fourth quarter of 2023
Approved in France by the French National Agency
for the Safety of Medicines and Health Products (ANSM), the NFL-101
CESTO II Phase II/III clinical trial received a favorable opinion
from the French Ethical Review Board (CPP) in September 2021.
NFL-101 is a standardized version for pharmaceutical use derived
from a natural product, initially developed by the Institut Pasteur
for tobacco allergies among people working in tobacco factories.
CESTO II’s objectives are to select the best dose and assess the
efficacy of NFL-101 versus placebo, based on various primary and
secondary criteria set by the Food & Drug Administration (FDA)
for the United States and the European Medicines Agency (EMA) for
Europe.
Patient recruitment started in January 2022,
gradually mobilizing a total of eight Clinical Investigation
Centers (CIC) at CHU university hospital centers (Bordeaux,
Clermont-Ferrand, Dijon, Lorient, Marseille, Montpellier, Poitiers
and Rennes), as well as the Eurofins-Optimed research institute
(Grenoble). The final recruitments were completed by the end of
April 2023.
In terms of funding for CESTO II, NFL
Biosciences was awarded a €1,500,000 innovation advance on February
20, 2023 under Programme d’Investissement d’Avenir 4 from the
France 2030 plan. €1.05 million was received as a recoverable
advance when the financing contract was signed, with the balance to
be made available when requested by NFL Biosciences upon completion
of the study. In addition, around 55% of the €3.1m of funds raised
on January 31, 2023 has been allocated to finalizing this Phase
II/III clinical trial. Together, these resources will make it
possible to finalize the CESTO II study.
Progress with the PRECESTO clinical
trial to demonstrate the potential complementarity of NFL-101 with
other smoking cessation treatments
In September 2022, NFL Biosciences obtained the
necessary regulatory authorizations from the ANSM and CPP to carry
out the PRECESTO phase IIa clinical trial. Its main objective is to
validate the potential complementarity of NFL-101 with other
smoking cessation treatments, and particularly nicotine substitutes
(transdermal patches, tablets, gum, inhalers and nicotine sprays),
with a view to developing an innovative treatment method combining
NFL-101 with other smoking cessation methods. The PRECESTO study
targets 34 smokers who do not wish to quit and have high smoking
satisfaction. It compares the ability of NFL-101 to reduce
cigarette satisfaction and craving with placebo.
Volunteer recruitment started up in February
2023 and is still underway. The initial results are expected for
the third quarter of 2023. This study could increase the
attractiveness of NFL-101 to pharmaceutical companies, especially
those marketing smoking cessation drugs.
In terms of funding for PRECESTO, NFL
Biosciences was awarded a €200,000 grant (non-refundable) on
January 17, 2023 under Programme d’Investissement d’Avenir 4 from
the France 2030 plan, awarded jointly by the French State and the
Occitanie Region. In addition, around 20% of the €3.1m of funds
raised on January 31, 2023 have been allocated to carrying out this
Phase IIa clinical trial. Together, these resources will make it
possible to finalize the PRECESTO study, which is based on a format
and protocol that limits the costs involved.
Co-development agreement continuing to
move forward for NFL-301, a drug candidate to reduce alcohol
consumption
In February 2022, NFL Biosciences set up a
co-development agreement with ATHENA Pharmaceutiques, a market
leader for the development and manufacturing of oral delivery
drugs, to develop and produce NFL-301, a natural drug candidate
from NFL Biosciences aimed at reducing alcohol consumption. The
development of the formulation was launched during the first
quarter of 2022. Under this partnership, ATHENA Pharmaceutiques
will manage the development and manufacturing of NFL-301, while NFL
Biosciences will draw up and lead the clinical program, which is
expected to be launched in the United States over the coming
months. The partnership aims to develop NFL-301 at least until its
placebo-controlled efficacy has been demonstrated as a treatment
for reducing alcohol consumption.
For the advancement of the NFL-301 project, from
product formulation to clinical trial authorization, NFL
Biosciences obtained a €200,000 innovation advance as part of
Programme d'Investissement d'Avenir 4 from the France 2030 plan.
€140,000 was received as a recoverable advance when the support
contract was signed on February 20, 2023, with the balance to be
made available when requested by NFL Biosciences upon authorization
of the clinical trial. In addition, by allocating around 15% of the
funds raised on January 31, 2023 to this project, NFL Biosciences
will be able to continue developing NFL-301 and file a pre-IND
application with the FDA prior to a future clinical trial
application.
Intellectual property extended with a
patent registered in China and South Korea and a new patent
application submitted in the United States
NFL Biosciences has continued moving forward
with its intellectual property management and patent protection
strategy, securing exclusive rights to its drug candidate NFL-101
through two patent families, covering an “aqueous extract of
tobacco leaves and its use for the treatment of dependence”. The
innovation that NFL-101 is based on is already protected through to
2036 in France and the United States, in addition to China (since
April 2022) and South Korea (since May 2022). National registration
applications are still in the review phase in the following regions
and countries: Canada, Australia, Europe, Brazil, India, Indonesia,
Philippines, United Arab Emirates and Nigeria.
In addition, a new patent application,
corresponding to a third patent family, was submitted in October
2022 in the United States and will be extended to cover other
countries in line with the intellectual property protection
strategy put in place. This application aims to protect the
administration of NFL-101 in association other smoking cessation
treatments and particularly nicotine substitutes.
Partnership with Themis Medicare to
develop NFL-101 in India
In October 2022, NFL Biosciences set up a
partnership with Themis Medicare Ltd to develop NFL-101 on the
Indian market. Themis Medicare is a pharmaceutical company
headquartered in Mumbai with a legacy of over 50 years of making
new treatment options available to patients. India has
approximately 267 million smokers, and their options for smoking
cessation are very limited.
Diversified sources of financing set up
at the start of 2023: cash requirements covered through to the
third quarter of 2024
At the start of 2023, NFL Biosciences
successfully rolled out its financing strategy by applying for
various grants and cash advances, and by calling on the financial
markets. In total, €4.2m were received during the first quarter of
2023 and €0.7m are still to be received as findings are generated
confirming the success of the trials, representing a total secured
amount of €4.9m. This has enabled NFL Biosciences to secure
progress of the company´s priority projects, and it has a cash
horizon that now runs through to the third quarter of 2024.
Collaboration with the CEA to study the
mechanism of action of NFL-101
At the start of February 2023, NFL Biosciences
set up a research partnership with the French Alternative Energies
and Atomic Energy Commission (CEA) to study the mechanism of action
of its drug candidate NFL-101. This study, scheduled to run for
nine months, is being led by the CEA’s Paris-Saclay Pharmacological
Neuroimaging team. It will focus on following, by positron emission
tomography (PET) imaging, the modifications in the cerebral
function associated with the development of tobacco addiction in
mice, in order to highlight the central effects of NFL-101
treatment.
Governance changes
NFL Biosciences’ Board of Directors acknowledged
Mr Joël Besse’s resignation from his positions as a Company
director and Chairman of its Board of Directors on February 27,
2023. The Board of Directors decided to appoint Mr Ignacio Faus,
the Company’s Chief Executive Officer, as Chairman of the Board of
Directors for a period that will not exceed his term of office as a
director, i.e. through to the end of the General Meeting held in
2024 to approve the financial statements for the year ending
December 31, 2023.
2022 full-year earnings
The full-year financial statements for 2022
(January 1 2022 – December 31, 2022), prepared in accordance with
French GAAP, were approved by the Board of Directors during its
meeting on April 24, 2023. The procedures to audit the annual
accounts have been completed. The statutory auditors’ reports will
be issued when the 2022 Annual Report is published.
Corporate accounts
(€) |
December 31, 2021 |
December 31, 2022 |
Net revenues |
- |
- |
Total operating income |
39 |
22 |
EBIT |
(901,867) |
(3,083,170) |
Financial income (expense) |
(217,643) |
182,831 |
Non-recurring income (expense) |
- |
39,025 |
Net income |
(978,243) |
(2,443,484) |
|
|
|
Shareholders’ equity |
3,287,481 |
843,996 |
Intangible assets (patents) |
124,034 |
135,784 |
Liabilities
- Of which financial liabilities
- Of which operating liabilities
|
270,74985,007185,742 |
1,478,51083,2561,395,254 |
Cash and cash equivalents |
3,039,570 |
1,053,581 |
Balance sheet total |
3,685,207 |
2,395,484 |
In 2022, NFL Biosciences recorded €22
of operating income, compared with €39 in 2021. Still in
the clinical trials development stage, NFL Biosciences did not
record any revenues during the last two years.
In line with the resources allocated to drive
progress with the programs presented above, and the Company’s
operations, EBIT came to €(3.1)m in 2022, compared with €(0.9)m in
2021. Payroll and social security contributions totaled €0.7m for
four people at December 31, 2022, compared with €0.3m for three
people at the end of 2021.
In 2022, NFL Biosciences reported a research tax
credit (CIR) of €0.4m, compared with €0.1m in 2021, with this
change reflecting the ramping up of its research programs.
Financial income and expenses for 2022 totaled
€0.2m, compared with €(0.2)m in 2021, reflecting the reversal of
the provision for the NFL Australia receivables recorded in the
accounts in 2021, following the completion of the process to shut
this entity down. As a result, NFL Biosciences recorded €(2.4)m of
net income, compared with €(1.0)m in 2021.
As of December 31, 2022, the Company had €0.8m
of shareholders’ equity and €1.0m of cash. The total amount of
liabilities at December 31, 2022 came to €1.5m, with €0.1m of
financial liabilities and €1.4m of operating liabilities. These
cash and liability figures do not take into account the various
financing facilities set up in 2023 as presented above.
Outlook for 2023
The initial results from the two clinical
studies underway are expected to be available in the third quarter
of 2023 (PRECESTO) and the fourth quarter of 2023 (CESTO II).
Alongside this, NFL Biosciences has submitted a request for
scientific advice to the EMA with a view to determining the future
development of NFL-101 before its marketing authorization. This
scientific advice will be issued in the second quarter of 2023. NFL
BIOSCIENCES has also opened talks with several pharmaceutical
companies looking into a future partnership for NFL-101. Once the
PRECESTO and CESTO II results have been obtained, these discussions
could be accelerated.
The collaboration with CEA Paris-Saclay, which
aims to make progress with the understanding of the mechanism of
action of NFL-101, will continue moving forward in 2023.
Understanding NFL-101’s mechanism of action is considered to be a
very important element for several pharmaceutical companies.
Lastly, for NFL-301, the collaboration with
ATHENA Pharmaceutiques is moving forward in line with the action
plan. As the priority of this project is in the American market,
discussions will be launched in 2023 with the FDA to clearly define
the clinical development pathway. Non-dilutive financing options in
the United States could then be available.
NFL BIOSCIENCES has a cash horizon through to
the third quarter of 2024 and will continue to benefit from an
organization with limited fixed costs. Looking further ahead, NFL
Biosciences will need additional financing which, independently or
combined, may come from (1) capital increases, (2) non-dilutive
financing and (3) partnerships with pharmaceutical companies.
Next financial date:
2023 first-half earnings: September 19, 2023 (before start of
trading).
About NFL
Biosciences
NFL Biosciences is a biopharmaceutical company
based in the Montpellier area which develops botanical drug
candidates for the treatment of addictions. NFL Biosciences'
ambition is to bring new, natural, safer and more effective
therapeutic solutions to the entire world population, including
low- and middle-income countries. Its most advanced product, called
NFL-101, is a standardized, nicotine free tobacco leaf extract
protected by two patent families. NFL Biosciences intends to offer
smokers who want to quit a natural, safe, easy-to-administer and
personalized alternative. NFL Biosciences is also developing
NFL-301, a natural drug candidate for the reduction of alcohol
consumption and has a drug development project for the treatment of
cannabis use disorder.
The shares of NFL Biosciences are listed on
Euronext Growth Paris (FR0014003XT0 – ALNFL). Find out more at
www.nflbiosciences.com
Contacts
Bruno Lafont – info@nflbiosciences.com - +33 4
11 93 76 67 Agence
Calyptus – nflbiosciences@calyptus.net - +33 1 53 65 68 68
NFL Biosciences (EU:ALNFL)
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NFL Biosciences (EU:ALNFL)
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