NFL Biosciences: 2022 first-half business and earnings
NFL Biosciences: 2022 first-half business and
earnings
Phase II/III clinical trial for the drug
candidate NFL-101 for smoking cessation continues to move forward,
with the participation of eight clinical centers in France
Intellectual property extended. NFL Biosciences
patent registered in China and South Korea
Partnership with Themis Medicare to develop
NFL-101 in India
Partnership with Athena Pharmaceutiques for the
global development of NFL-301
Recruitment of a Finance Director
NFL BIOSCIENCES (Euronext Growth Paris –
FR0014003XT0 – ALNFL), a biopharmaceutical company that is
developing botanical drugs for the treatment of addictions, is
reporting its results for the first half of 2022, approved by the
Board of Directors on October 24, 2022. The half-year financial
statements at June 30, 2022 were
subject to a limited review by the Company’s Statutory Auditors.
NFL Biosciences, listed on the stock market
since July 2021,
continues to make progress
in the development of NFL-101, its drug
candidate for smoking cessation.
NFL-101 phase II/III clinical trial
continues to move forward, with
the participation of eight clinical centers in France
In recent months, the CESTO II phase II/III
clinical trial assessing the efficacy and dosing of its drug
candidate NFL-101 has been rolled out at eight clinical centers in
France: the CHU teaching hospital centers in Bordeaux,
Clermont-Ferrand, Dijon, Marseille, Montpellier, Poitiers and
Rennes, and the Eurofins-Optimed research institute in Grenoble,
which is also the contract research organization (CRO) of the
study.
The clinical trial is targeting men or women
aged 18 to 70 who smoke more than 11 cigarettes per day and are
genuinely committed to stopping smoking. The trial includes three
arms (two dose arms and one placebo arm) and will monitor patients
over 12 months. CESTO II’s primary objectives are to select the
best dose and assess the efficacy of NFL-101 versus placebo. The
main criterion for assessment is the subject’s continued abstinence
for four weeks (US Food & Drug Administration (FDA))
criterion). The main secondary criterion for assessment is the
subjects’s continued abstinence for six months (European Medicines
Agency (EMA) criterion). Many other secondary criteria will also be
assessed, including the number of cigarettes smoked, withdrawal
symptoms and level of craving. The biomarkers used to confirm
abstinence are exhaled carbon monoxide and urinary cotinine.
Considering the rate of recruitment of the eight
clinical centers, in the absence of events that are beyond the
Company’s control or linked to economic and geopolitical
developments, subject recruitment is expected to be completed
during the first half of 2023.
Co-development agreement 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 in the development and manufacturing of oral delivery drugs,
in order to jointly develop and manufacture NFL-301, a natural drug
candidate originated at NFL Biosciences. NFL-301 is indicated for
the reduction of alcohol consumption.
The development of the formulation, launched
during the first quarter of 2022, is still underway. The Company
will then establish dialogue with the European and American
regulatory agencies (EMA and FDA) for the product’s clinical
development.
Intellectual property extended with an
NFL Biosciences patent registered in China and South
Korea
NFL Biosciences is continuing to move forward
with its knowledge management and protection strategy. This has
resulted in the filing of two patent families granting it exclusive
rights to its drug candidate NFL-101. This product patent,
initially registered and approved in France, concerns an “aqueous
extract of tobacco leaves and its use for the treatment of
dependence”. The innovation that NFL-101 is based on is therefore
protected through to 2036 in France, the United States, and now
also in China (300 million smokers) since April 2022 and in South
Korea (9 million smokers) since May 2022.
National registration applications are still in
the review phase in the following regions and countries: Japan,
Canada, Australia, Europe, Brazil, India, Indonesia, Philippines,
Saudi Arabia, United Arab Emirates and Nigeria.
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 for the
Indian market. Themis Medicare, a pharmaceutical company
headquartered in Mumbai with a legacy of over 50 years of making
new treatment options available to patients, submitted an
investigational new drug (IND) application for a phase II / III
clinical trial to the Central Drugs Standard Control Organization
(CDSCO), India’s national regulatory authority (NRA).
India has approximately 267 million smokers, and
their options for smoking cessation are very limited. Once the
study is approved, the clinical trial will be conducted in India,
targeting 334 smokers. The cost of the process, from submission to
completion of the study, will be paid for by Themis Medicare.
Themis will purchase the NFL-101 active pharmaceutical ingredient
(API) from NFL Biosciences. NFL Biosciences will also receive
double-digit royalties on sales.
Recruitment of a
Finance Director
During the first half of 2022, the Company
further strengthened its team by recruiting a Finance Director.
Guillaume Audema has spent six years with an audit firm, where he
became a manager. He joined NFL Biosciences after an initial
experience as finance director in another company.
2022 first-half earnings (January 1 –
June 30, 2022)
The accounts for the first half of 2022,
prepared in accordance with French GAAP, were approved by the Board
of Directors during its meeting on October 24, 2022. The limited
review of the half-year financial statements has been completed and
the financial report for the first half of 2022 will be made
available on October 26, 2022; it can be consulted on
www.nflbiosciences.com, under “Investors” and “Documents”
The initial public offering on Euronext Growth
Paris in July 2022 led to a €4,960,724.34 issue premium, with a
gross total of €5m received (€4.2m net). Since then, NFL
Biosciences has rolled out its business plan in line with the
strategy presented at the time of its IPO, while further
strengthening its organization to accompany these new steps forward
in the development of its botanical drug candidates for the
treatment of addictions, and particularly NFL-101.
First-half EBIT totaled €(1,301)K, compared with
€(978)K in 2022, reflecting the costs incurred for the CESTO II
clinical trial, the strengthening of the teams from the third
quarter of 2021, the manufacturing of batches of active
ingredients, the intellectual property costs, and the payments to
different CROs. Following the decision taken to recruit patients in
France, the subsidiary in Australia will be dissolved during the
second half of this year. This decision to recruit all of the
patients in France was taken thanks to: (i) the good pace of
recruitment in the various French CHU centers, and (ii) the
significantly lower cost of clinical trials in France compared with
Australia.
The ramping up of the clinical trial is
reflected in the increase in accounts payables to €534K for the
first half of this year, compared with €120K at December 31, 2021,
primarily including accrued invoices. The Company still has an €85K
government-backed loan, with repayments based on one quarter per
year to start up in 2023. A previous financing line dependent on
the success of the NFL-101 phase I trial, recorded in quasi-equity,
is currently being repaid based on €18K per quarter and will be
paid back in full by December 2023.
Cash and cash equivalents at June 30, 2022
totaled €2,044,267 and do not include the research tax credit,
worth €100,670 for the first half of this year and
€159,447 for 2021, which had not yet been received by the
Company as of June 30, 2022.
NFL Biosciences operates with a very low level
of fixed costs and overheads, outsourcing activities to various
industrial firms. This strategic choice enables more flexibility
with the deployment of its financial resources with a view to
advancing its development programs. The majority of free cash is
allocated to its clinical programs.
Requests for funding submitted to BPI France are
currently at an advanced review stage, with repayments subject to
the success of the projects: (i) a €1.8m request concerning the
CESTO2 study, for an initial total of €1.3m, revised upwards
following the decision to recruit patients exclusively in France,
thus increasing the level of eligible expenses; (ii) a €245K
request concerning the formulation and clinical trial approval for
NFL-301, a drug candidate for reducing alcohol consumption. The
applications are currently being reviewed by BPI France, with a
response expected over the coming weeks.
The Company is continuously looking into the
various financing options available in France and other countries,
with a prefernce for non-dilutive financing.
Corporate accounts
(€) |
Jun 30, 2022(6 months) |
Dec 31, 2021(12 months) |
Jun 30, 2021(6 months) |
Net revenues |
- |
- |
- |
Total operating income |
5 |
39 |
0 |
EBIT |
(1,300,816) |
(901,867) |
(221,051) |
Financial income (expense) |
107,829 |
(217,643) |
(354) |
Non-recurring income (expense) |
- |
- |
- |
Corporate income tax |
-121,632 |
-141,266 |
- |
Net income |
(1,071,354) |
(978,243) |
(221,405) |
|
|
|
|
Shareholders’ equity |
2,216,127 |
3,287,481 |
(71,380) |
Intangible assets (patents) |
139,577 |
124,034 |
120,566 |
Liabilities |
736,661 |
270,749 |
1,247,447 |
Cash and cash equivalents |
2,044,267 |
3,039,570 |
175,972 |
Balance sheet total |
3,043,765 |
3,685,207 |
1,428,067 |
Outlook for 2022
Dr Ignacio Faus, NFL Biosciences CEO: “NFL
Biosciences is continuing to roll out the phase II/III clinical
trial for NFL-101 (smoking cessation), in addition to developing
NFL-201 (cannabis addiction) and NFL-301(reducing alcohol
consumption). As control over manufacturing know-how is a key
element in the NFL-101 value chain, the production of GMP batches
of the product is underway and a clinically ready batch is expected
in 2023. We are also continuing to look for partners for NFL-101
outside of Europe and the United States, in low or mid-income
countries. A first partnership has already been set up in
India”.
Progress with the NFL-301 product, the second
pillar of the Company’s global strategy, is moving forward in
partnership with the French firm Athena Pharmaceutiques. NFL
Biosciences hopes to obtain a first usable formulation in early
2023.
In line with its international development
strategy, NFL Biosciences will be ramping up its initiatives
enabling the development of NFL-101 and NFL-301 in the United
States and other countries. Within this framework, various meetings
are being scheduled with the US FDA, focused primarily on ensuring
that the development plan for the drug candidates and the future
clinical trials are acceptable for the FDA In the United
States.
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 disorders.
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 – nflbio@calyptus.net - +33 1 53 65 68 68
- 20221025_NFLBio_CP_RS_2022_EN_DEF
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