- 2022 objectives successfully met, notably in the development
of the two drug candidates:
- AEF0117: phase 2b study in the United States progressing as
expected
- AEF0217: the compound’s safety and good tolerability in
healthy volunteers have enabled the start of a phase 1/2 clinical
trial in people with Down syndrome
- Strong cash position of €34.4 million at December 31, 2022,
strengthened by the successful IPO on Euronext in February 2022,
providing visibility through end 2025
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 to
December 31, 2022.
Pier Vincenzo Piazza, CEO of Aelis Farma, said: “2022 was
marked by a number of key events for Aelis Farma, beginning with
our IPO, which enabled us to raise substantial financial resources
in order to implement our development strategy. Thanks to the
efficiency, motivation, and dedication of our team, key clinical
milestones were achieved, enabling us to successfully meet our
ambitious objectives, particularly the ones regarding our two
first-in-class drug candidates. The phase 2b study in the United
States for AEF0117, aimed at treating cannabis addiction, is
progressing as planned and should provide the first results by
mid-2024. AEF0217 has proven to be safe and well tolerated in
healthy volunteers. These positive results represent real progress
in the development of this treatment for neurodevelopmental
cognitive disorders, including those associated with Trisomy 21
(Down syndrome). AEF0217 was thus able to enter at the end of 2022
a phase 1/2 study in people with Down syndrome which should be
completed by the end of this year. Executing our 2023 roadmap is
our priority and we are convinced that Aelis Farma is in an
excellent position to become a leading player in the treatment of
brain diseases”.
2022 annual results (IFRS)
Simplified income statement1 (in
€k)
2022
2021
Revenue from ordinary activities
8,364
10,762
Research & Development costs
(13,792)
(6,870)
General & Administrative expenses
(3,096)
(1,340)
Operating income
(8,525)
2,552
Financial result
(5,762)
(794)
Income taxes
(1)
(1,185)
Net income
(14,288)
574
In the year ended December 31, 2022, the Company recorded income
from ordinary activities of €8.4 million, of which:
- €3.8 million corresponding to the recognition, in accordance
with IFRS 15, of the share of revenue related to the license-option
agreement with Indivior PLC, a leading group in the treatment of
addictions, for AEF0117 in disorders associated with cannabis use.
The balance of the lump sum payment received and remaining to be
recognized over the residual term of the option is €11.7 million.
The decrease in this figure is due to the share of revenue
recognized in 2021 in accordance with IFRS 15, i.e. €9,075
thousand, including €7,921 thousand associated with the signing of
the contract.
- €4.6 million in other income from ordinary activities,
consisting of Research Tax Credit (€2,121 thousand) and operating
subsidies (€2,434 thousand) related to the research programs
undertaken by Aelis Farma. Their increase compared to the previous
year is correlated to the increase in Research & Development
expenses incurred in 2022.
Research & Development costs
In €k
12/31/22
12/31/21
Raw materials, other purchases, and
external expenses
(11,574)
(3,143)
Personnel costs
(2,052)
(1,808)
Intellectual Property
(166)
(1,919)
Research & Development
costs
(13,792)
(6,870)
The increase in Research & Development costs (+101%)
reflects the ramp-up of the development program for the drug
candidates AEF0117 and AEF0217 and the full-year impact of the
strengthening of the research teams, initiated in 2021. The
decrease in intellectual property costs was partly due to the
payment, in 2021, of royalties (€1,683 thousand) to patent owners
following the signing of the sub-licensing option agreement with
Indivior PLC.
General and administrative expenses at December 31, 2022,
amounted to €3,096 thousand, including in particular costs related
to the Company's IPO not charged to the share premium (€700
thousand), as well as additional costs related to the listing.
At December 31, 2022, the annual operating loss was thus -€8,525
thousand, compared to an operating profit of €2,552 thousand at
December 31, 2021. This change was primarily due to:
- the progress made by the phase 2b study of
AEF0117, in terms of opening clinical centers and recruiting
patients; - the completion of phase 1 studies and launch of the
phase 1/2 study of AEF0217; - preclinical and pharmaceutical
production activities (CMC) for both AEF0117 and AEF0217; and - the
schedule of revenue recognition associated with the licensing
option agreement with Indivior PLC, based on the costs incurred by
the phase 2b study of AEF0117.
Financial income showed a loss of -€5,762 thousand at December
31, 2022, compared to a loss of -€794 thousand at December 31,
2021. This change mainly reflects the impact of the conversion of
convertible bonds on the date of Aelis Farma’s Initial Public
Offering. This non-cash financial expense corresponds to the
difference between the fair value of the securities issued, based
on the stock market price on the date of listing, and the nominal
value of the initial debt.
The firm thus generated a net loss of -€14,288 thousand in 2022,
compared to a profit of €574 thousand in 2021.
Cash flow
In €k
12/31/22
12/31/21
Cash flow from operating
activities
(13,051)
18,970
Net cash flow from investing
activities
(86)
(212)
Net cash flow from financing
activities
22,097
180
Impact of exchange rate
changes
723
1,235
Change in cash and cash
equivalents
9,684
20,172
Opening cash position
24,710
4,538
Closing cash position
34,396
24,710
Financial structure
In €k
12/31/22
12/31/21
Liquid assets
a
34,396
24,710
Gross financial debt
b
(3,823)
(7,917)
Net cash position
a-b
30,572
16,793
Aelis Farma’s financial structure was strengthened in 2022
by:
- the increase in the net cash position of
€22.5 million from the capital increase carried out at the time of
the Company’s IPO on compartment B of Euronext Paris; - the
conversion into capital of the convertible bonds held by Inserm
Transfert Initiative and the Nouvelle Aquitaine Region, leading to
a €4,094 thousand reduction in the Company’s gross debt from €7,917
thousand to €3,823 thousand.
The increase in cash in dollars related to the licensing option
agreement with Indivior PLC enabled the recognition of a forex gain
of €0.7 million.
The cash position of €34,396 thousand at December 31, 2022, thus
represents a €9,684 thousand improvement compared to the previous
year.
Taking in to account new non-dilutive finances, that the Company
is confident to obtain, Aelis Farma has modified its forecast and
now believes that its current cash level will enable to finance its
development in accordance with the strategy presented at the time
of the IPO until at least the end of 2025.
2022 annual highlights
Inclusion of the first patient in the phase 2b study with
AEF0117 for treating cannabis addiction
At the beginning of June, Aelis Farma announced the enrollment
of the first patient in the phase 2b study with AEF0117, its most
advanced “CB1-SSi” drug candidate, for the treatment of cannabis
addiction. This study, coordinated by Prof. Frances Levin of
Columbia University, is set to include some 330 patients in 11
clinical centers in the United States. The AEF0117 program has
obtained overall funding of $7.8 million from the North American
National Institute on Drug Abuse of the National Institute of
Health (NIDA-NIH), including $4.5 million allocated at the end of
2021 for this new phase of development.
Positive results of the phase 1 studies undertaken on healthy
volunteers with AEF0217 developed for treating cognitive
deficits
In mid-November, Aelis Farma announced positive results from its
safety trials in healthy volunteers and the authorization to
initiate the first study in people with Down syndrome with its
AEF0217 drug candidate for treating cognitive disorders. The single
dose and multiple ascending dose trial of AEF0217 demonstrated the
safety, tolerability, and good bioavailability of AEF0217 in
healthy volunteers.
Inclusion of the first Down syndrome patient in the phase 1/2
study with AEF0217
On the basis of the positive results obtained in the phase 1
studies, the AEMPS (Spanish Agency of Medicines and Medical
Products) authorized a phase 1/2 study with AEF0217 in adults with
Down syndrome. On December 16, Aelis Farma announced the enrollment
of the first patient in this study. The primary objective is to
evaluate the safety and pharmacokinetics of AEF0217 in people with
Down syndrome, and this study could also provide the first
indications as to AEF0217’s potential as a treatment for the
cognitive deficits associated with Down syndrome.
The first patient was recruited by Prof. Rafael de la Torre
Fornell’s teams at the Hospital del Mar Medical Research Institute
(IMIM) in Barcelona, Spain. Depending on the rate of enrollment,
the study could be completed by the end of 2023.
Strategy & outlook
Bolstered by its sound financial situation, Aelis Farma intends
to continue the development of its various assets, in accordance
with the strategy presented at the time of its IPO:
Develop AEF0117 to address the adverse effects of excessive
cannabis use
The phase 2b clinical trial with AEF0117 is continuing with a
good level of enrollment. The results of the AEF0117 safety
evaluation committee (DSMB), conducted on the first 110 patients
treated for at least 4 weeks, are expected mid-2023. If they are
positive, this will allow the study to continue through to expected
completion in the first quarter of 2024. Positive efficacy results
from phase 2b will pave the way for phase 3 studies, the last step
before a marketing authorization application can be filed.
Develop AEF0217 to treat various cognitive deficits,
including those of Down syndrome
In 2023, the main objective will be to successfully complete the
phase 1/2 study. Obtaining satisfactory safety and pharmacokinetic
results for AEF0217 in Down syndrome individuals would pave the way
for a multicentric phase 2b study, which could begin in 2024, aimed
at confirming the therapeutic effects of AEF0217 for the treatment
of cognitive disorders associated with Down syndrome. The program
to develop AEF0217 as a treatment for cognitive deficits associated
with Down syndrome has received a €6 million grant from the
European community (ICOD Project No. 899986).
Aelis Farma is also working to expand the study of AEF0217’s
efficacy with regard to other indications, such as cognitive
disorders associated with other neurodevelopmental diseases, or
aging.
Identify new drug candidates
Given the involvement of the CB1 receptor in numerous
pathologies and thanks to its diversified and exclusive library of
CB1-SSi, Aelis Farma is continuing to characterize new CB1-SSi
liable to address other brain disorders dependent on the CB1
receptor.
***
About AELIS FARMA
Founded in Bordeaux 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). CB1-SSi have been developed by Aelis Farma based
on the discovery of a new natural brain defense mechanism by the
team led by Dr. Pier Vincenzo Piazza, the Company’s CEO, when he
was Director of the INSERM Magendie Neurocenter in Bordeaux. By
reproducing this natural mechanism, CB1-SSi appear to be capable of
selectively inhibiting the disease-related activity of the CB1
receptor without disrupting its normal physiological activity. They
thus have significant potential for the treatment of numerous brain
diseases.
Aelis Farma is developing two first-in-class clinical-stage drug
candidates: AEF0117 for the treatment of disorders due to excessive
cannabis use, currently in a phase 2b study in the United States;
and AEF0217 for cognitive disorders, including those of Down
Syndrome (Trisomy 21), currently in a phase 1/2 study in Spain. The
Company also has a portfolio of innovative CB1-SSi for the
treatment of other disorders associated with a dysregulation of the
activity of the CB1 receptor.
Aelis Farma draws on the talents of more than 20 highly
qualified employees.
For more information, visit www.aelisfarma.com and follow
us on LinkedIn and Twitter.
ISIN: FR0014007ZB4 Ticker: AELIS B Compartment
of Euronext Paris
Disclaimer
Forward-looking statements Some information contained in
this press release are forward-looking statements, not historical
data. These forward-looking statements are based on current
beliefs, expectations, and assumptions, including, but not limited
to, assumptions about Aelis Farma's current and future strategy and
the environment in which Aelis Farma operates. They involve known
and unknown risks, uncertainties, and other factors, which may
cause actual results, performance, or achievements, or industry
results or other events, to differ materially from those described
or implied by such forward-looking statements. These risks and
uncertainties include those set out and described in detail in
Chapter 3 "Risk Factors" of Aelis Farma's registration document
approved by the Autorité des Marchés Financiers on January 14,
2022, under number I.22-003.
These forward-looking statements are made only as of the date of
this press release and Aelis Farma expressly disclaims any
obligation or undertaking to release any updates or corrections to
the forward-looking statements included in this press release to
reflect any change in expectations or events, conditions, or
circumstances on which any such forward-looking statement is based.
Forward-looking information and statements are not guarantees of
future performance and are subject to various risks and
uncertainties, many of which are difficult to predict and generally
beyond Aelis Farma's control. Actual results could differ
materially from those described in, or implied or projected by,
forward-looking information and statements.
1 The annual financial statements were approved by the Board of
Directors on March 31, 2023. The audit of these financial
statements is complete. The certified auditors’ report is in the
process of being issued.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230403005655/en/
AELIS FARMA Pier Vincenzo Piazza CEO
contact@aelisfarma.com
NewCap Dusan Oresansky/Aurélie Manavarere Investor
Relations aelis@newcap.eu +33 1 44 71 94 92
NewCap Arthur Rouillé Media Relations aelis@newcap.fr +33
1 44 71 00 15
Aelis Farma (EU:AELIS)
Gráfico Histórico do Ativo
De Jan 2025 até Fev 2025
Aelis Farma (EU:AELIS)
Gráfico Histórico do Ativo
De Fev 2024 até Fev 2025
