- An exceptional fiscal year 2021, marked by positive phase 2a
results for AEF0117, the recognition of the first sub-licensing
revenues thanks to the signature of an industrial partnership with
Indivior PLC, and securing major grants for AEF0217 (EU’s Horizon
2020 program) and AEF0117 (NIH-NIDA USA).
- A solid financial structure, with a closing cash position of
€24.7 million, strengthened by the success of the IPO carried out
at the beginning of 2022, which raised €25.3 million.
Regulatory News:
Aelis Farma (ISIN: FR0014007ZB4 - ticker: AELIS, PEA-PME
eligible) (Paris: AELIS), a clinical-stage biopharmaceutical
company specialized in the development of treatments for brain
diseases, today announced its annual results for the year ended
December 31, 2021.
Pier Vincenzo Piazza, CEO of Aelis Farma, said: "On
behalf of Aelis Farma, I would like to thank once again all our
shareholders, both long-standing and new, as well as our partner
Indivior, for their contribution to the success of our initial
public offering in February. The fundraising of more than €25
million realized on this occasion gives us the necessary means to
accelerate the development of Aelis Farma and deploy its strategic
plan presented to the financial community. The success of this
transaction is based on the solid foundations put in place in
particular during the 2021 financial year with the signature of our
first industrial partnership with Indivior PLC, through an
option-license agreement for AEF0117 to treat the adverse effects
of excessive cannabis use. This asset, which is the most advanced
of our pipeline and is on the verge of a phase 2b clinical study,
also received a new grant of $4.5 million from the U.S. National
Institute of Health (NIH) at the end of 2021. Our second drug
candidate, AEF0217, has received a European grant of €6 million for
the ICOD program which support the clinical program aiming to
confirm its potential to treat cognitive deficits of Down syndrome
(Trisomy 21). These different programs make Aelis Farma a company
on the forefront of the brain diseases space, a position that, with
the support of our investors, we are convinced to be able to
consolidate and eventually become one of the leading players in
this sector that has significant unmet medical needs.”
Annual results 2021 (IFRS)
Simplified income statement1 (in
€k)
2021
2020
Revenue from ordinary activities
10,762
1,137
Research and development costs
(6,870)
(3,388)
General and administrative expenses and
other operating expenses and income
(1,340)
(589)
Operating income
2,552
(2,840)
Financial result
(794)
(202)
Income taxes
(1,185)
956
Net income (loss)
574
(2,086)
In June 2021, the Company entered into a sub-license option
agreement with Indivior PLC, the leading addiction treatment group,
for AEF0117 to treat cannabis related disorders, addictions, and
other compulsive behaviors. Aelis Farma's revenues from this
contract are as follows:
- upon signing the contract, the Company received an upfront
payment of $30 million;
- if the option is exercised by Indivior PLC, the Company will
receive a lump sum payment of $100 million;
- depending on the achievement of technical, regulatory and
commercial milestones supplementary payments of up to $340
million;
- royalties on net sales between 12% and 20%.
The accounting principles applied to the revenues from this
contract, resulting from IFRS 15, have led to the recognition of
revenues of €9,075,000 for the year 2021. The balance of the
upfront payment received, i.e., €15,541,000, will be recognized
over the remaining term of the option.
Other income from ordinary activities (€1,687,000) consists of
the Research Tax Credit (€1,089,000) and operating grants
(€598,000) related to the research programs led by the Company.
Their increase compared to the previous year is correlated to the
increase in research and development expenses incurred during the
year.
Research and development costs
In €k
31/12/21
31/12/20
Raw materials, other purchases and
external expenses
(3,143)
(1,741)
Personnel costs
(1,808)
(1,351)
Intellectual Property
(1,919)
(296)
Research and development costs
(6,870)
(3,388)
The increase in research and development expenses (+103%)
reflects the ramp-up of the development program for drug candidates
AEF0117 and AEF0217, the strengthening of research teams, and the
increase in intellectual property expenses related to the payment
of royalties to patent owners following the signature of the
sub-licensing option agreement with Indivior PLC (€1,683,000).
The operating result at December 31, 2021 was a profit of
€2,552,000 compared to a loss of €2,840,000 at December 31, 2020.
This change is mainly due to the recognition of revenues from the
license option contract signed in 2021 with Indivior PLC.
The financial result shows a loss of -€794,000 at December 31,
2021 compared to a loss of -€202,000 at December 31, 2020 in
particular due to the application of the IFRS standard on financial
instruments applied to the convertible bonds contracted by the
company in 2019.
The net result for the year 2021 is a profit of €574,000
compared to a loss of -€2,086,000 for the previous year.
Cash flow
In €k
31/12/21 31/12/20
Cash flow from operating
activities
18,970
(2,478)
Net cash flow from investing
activities
(212)
(34)
Net cash flow from financing
activities
180
1,277
Effect of exchange rate
changes
1,235
-
Change in cash and cash
equivalents
20,172
(1,235)
Opening cash position
4,538
5,771
Closing cash position
24,710
4,538
The fiscal year 2021 was characterized by the strengthening of
the company's financial structure thanks to the revenues from
operating activities resulting from the signing of the license
option agreement with Indivior PLC, and the payment of $30 million
upon signing of the agreement. The positive evolution of this cash
flow in dollars allowed the recognition of a foreign exchange gain
of €1.2 million. The cash position at December 31, 2021 of
€24,710,000 thus reflects an improvement of €20,172,000 in cash
compared to the previous year.
Financial structure
In €k
31/12/21
31/12/20
Liquid assets
a
24,710
4,538
Gross financial debt
b
7,917
6,336
Total net financial
debt
b-a
(16,793)
1,798
Aelis Farma's financial structure was strengthened in February
2022 by:
- the net proceeds of €22.1 million from the capital increase
carried out at the time of the Company's listing on compartment B
of Euronext Paris;
- the conversion into capital of the convertible bonds held by
Inserm Transfert Initiative and the Nouvelle-Aquitaine Region,
resulting in a decrease of €3,591,000 in gross indebtedness, from
€7,917,000 to €4,326,000.
The Company's current cash position allows it to finance the
development of Aelis Farma in accordance with the strategy
presented during the IPO.
Strategy & outlook
In 2022, with a financial position strengthened by the funds
raised during the IPO in February of €25.3 million, the Company
intends to pursue the development of its various assets and
accelerate the ramp-up of CB1-SSi development:
1. Development of AEF117 to treat the
adverse effects of excessive cannabis use
A phase 2b clinical trial, including approximately 330 patients
and whose protocol has been discussed with the FDA, will start in
the second quarter of 2022 in the United States, in accordance with
expectations, to evaluate the efficacy of AEF0117 for the treatment
of cannabis addiction. The study will be coordinated by its
principal investigator, Prof. Frances Levin of Columbia University.
The new development phases of AEF0117 have received a grant of $4.5
million from NIH, which had already provided funding for phases 1
and phase 2a of $3.3 million.
2. Development of AEF0217 to treat various
cognitive deficits, including those of Down syndrome (Trisomy
21)
AEF0217 is currently being evaluated in phase 1 clinical studies
in healthy volunteers, with no significant adverse events reported
to date in the first five cohorts of subject. Results from these
studies will be available in the second quarter of 2022.
A phase 1/2 clinical study of AEF0217 in Down syndrome subjects
is planned to start in the fourth quarter of 2022. These studies
could provide initial efficacy results in the first half of 2023.
This clinical program is being conducted in the framework of the
"Improving Cognition in Down syndrome" ("ICOD") consortium in
collaboration with the Institut Hospital del Mar d'Investigacions
Mèdiques ("IMIM") in Barcelona and other European clinical centers.
The European Union's Horizon 2020 program has awarded the ICOD
project a grant of €6 million (H2020 Program N° 899986).
Aelis Farma also plans to finalize in 2022 the preparation of
the phase 2 research program for AEF0217, which will expand the
study of the compound's efficacy to other indications, such as
cognitive disorders associated with Fragile X syndrome or aging, in
which AEF0217 has demonstrated efficacy in preclinical models.
3. Development of new drug candidates via
the proprietary platform
Given the involvement of the CB1 receptor in numerous
pathologies and with its diversified and proprietary library of
CB1-SSi, Aelis Farma plans to pursue the characterization of new
CB1-SSi that may address other CB1 receptor-dependent brain
diseases.
***
About AELIS FARMA
Founded in 2013, Aelis Farma is a biopharmaceutical company that
is developing a new class of drugs, the Signaling Specific
inhibitors of the CB1 receptor of the endocannabinoid system
(CB1-SSi). These new molecules hold great potential in the
treatment of many brain diseases. CB1-SSi were developed by Aelis
Farma on the basis of the discovery of a new natural defense
mechanism of the brain made by the team of Dr. Pier Vincenzo
Piazza, CEO of the Company, when he was Director of the Inserm
Magendie Neurocenter in Bordeaux. For these discoveries, Dr. Piazza
was awarded the Inserm Grand Prix and the Grand Prix of Neurology
of the French Academy of Sciences, which are among the most
prestigious French prizes in medicine and neurology.
Aelis Farma is developing two first-in-class drug candidates
that are at the clinical stage, AEF0117 and AEF0217, and has a
portfolio of innovative CB1-SSi for the treatment of other diseases
associated with dysregulation of CB1 receptor activity.
AEF0117, which targets the disorders due to excessive cannabis
use (addiction and psychosis), has demonstrated efficacy in a phase
2a clinical trial and will enter a phase 2b clinical trial in the
United States in 2022. Aelis Farma has an exclusive license option
agreement with Indivior PLC, a leading pharmaceutical group in the
treatment of addiction, for the development and commercialization
of AEF0117 to treat disorders linked to excessive cannabis use. As
part of this agreement, Aelis Farma received $30 million (option
payment). If Indivior exercises the license option at the end of
the phase 2b, Aelis Farma will receive a $100 million license fee
(potentially in 2024) and up to $340 million in additional payments
contingent upon the achievement of development, regulatory and
commercial milestones, as well as royalties on net sales of AEF0117
ranging between 12% and 20%.
AEF0217, which targets various cognitive disorders including
those associated with Down syndrome, is successfully progressing in
its phase 1/2 program and could provide the first evidence of
efficacy in the first half of 2023. This compound has undergone an
extensive preclinical proof-of-concept program using highly
innovative and highly predictive tests to assess cognitive
functions. In this context, AEF0217 has demonstrated its ability to
completely reverse cognitive deficits observed in several models of
neurodevelopmental disorders, such as Down syndrome and Fragile X
syndrome, as well as in models of certain cognitive deficits
associated with aging.
Based in Bordeaux, within the Magendie Neurocenter, Aelis Farma
has a team of 24 highly qualified employees and has benefited from
investments from the Nouvelle-Aquitaine Region, Inserm Transfert
Initiative, Bpifrance, regional funds ACI, NACO and Aqui-invest and
IRDI Capital Investissement.
For more information: www.aelisfarma.com
ISIN: FR0014007ZB4 Ticker: AELIS B Compartment
of Euronext Paris
Disclaimer
This press release contains statements that are not factual,
including, but not limited to, certain statements regarding future
results and other future events. These statements are based on the
current views and assumptions of the Company's management. They
involve known and unknown risks and uncertainties that could cause
actual results, profitability and events to differ materially from
expectations. In addition, Aelis Farma, its shareholders and its
respective affiliates, directors, executives, consultants and
employees have not verified the accuracy of, and make no
representations or warranties with respect to, any statistical
information or forward-looking information contained in this press
release that is derived from third-party sources or industry
publications. Such statistical data and forward-looking information
are used in this release for informational purposes only.
1 The annual accounts were approved by the Board of Directors on
April 1, 2022. The audit of these accounts has been completed. The
certified auditors’ report is in the process of being issued.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220403005039/en/
AELIS FARMA Pier Vincenzo Piazza Co-founder and CEO
contact@aelisfarma.com
NewCap Dusan Oresansky/Marine de Fages Investor Relations
aelis@newcap.eu +33 1 44 71 94 92
NewCap Nicolas Merigeau Media Relations
nmerigeau@newcap.fr +33 1 44 71 94 98
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