- 2023 has been marked by key milestones for the Company's two
drug candidates:
- AEF0117: completion of patient recruitment for the phase 2b
study with 333 patients in excessive cannabis use
disorders
- AEF0217: opening of two new clinical centers in Spain in the
second half of the year for the phase 1/2 study in the treatment of
cognitive deficits associated with trisomy 21
- Strong cash position at €20.2 million as of December 31,
2023, ensuring financial visibility until the end of 2025
Regulatory News:
Aelis Farma (ISIN: FR0014007ZB4 – Ticker: AELIS), a
clinical-stage biopharmaceutical company specialized in the
development of treatments for brain diseases, today announces its
full year results for the year to December 31, 2023.
Pier Vincenzo Piazza, CEO of Aelis Farma, stated: “The
year 2023 was marked by significant progress for our two drug
candidates, AEF0117 and AEF0217, demonstrating our ability to
deliver on the development milestones announced to the market since
our IPO in 2022. For AEF0117, several key achievements stand out,
such as the publication in Nature Medicine presenting the molecule
discovery to preliminary phase 2a efficacy results. The positive
recommendation from the Data Safety Monitoring Board halfway
through the phase 2b study, and the completion of patient
recruitment for this study with 333 patients. Furthermore, the
positive results obtained from all regulatory non-clinical studies
will enable a rapid transition to phase 3 upon success of the phase
2b study. For AEF0217, the current phase 1/2 study assessing the
safety and tolerability of the compound in individuals with Down
syndrome will pave the way for a multicenter phase 2 study in
several European countries. This study aims to assess the efficacy
of AEF0217 in treating cognitive deficits associated with Down
syndrome is planned to start late 2024/early 2025. We are also
making progress in identifying new therapeutic indications for
AEF0217. Finally, our proprietary platform has enabled us to
identify several CB1-SSis with new properties targeting a broader
range of diseases involving the CB1 receptor. We have also
appointed Arsène Guekam as Chief Corporate Development Officer,
bringing his in-depth knowledge of financial markets and sector
trends. For the year 2024, our main objective is to deliver on the
announced clinical study timelines for our two drug-candidates. We
also aim to initiate the pre-clinical development of a third
CB1-SSi by the end of 2024. Thanks to the expertise and dedication
of our team, we are confident to achieve these goals and progress
towards becoming a leading player in the field of brain disease
treatments.”
Full-year results 2023 (IFRS)
Simplified income statement1 (in
€K)
2023
2022
Revenue from ordinary activities
12,358
8,364
Research and development costs
(16,212)
(13,792)
General and administrative expenses and
other operating income and expenses
(2,607)
(3,096)
Operating income
(6,461)
(8,525)
Financial result
1,386
(5,762)
Income taxes
(3)
(1)
Net income (loss)
(5,078)
(14,288)
For the full year 2023, Aelis Farma recorded revenue from
ordinary activities of €12.4 million, including:
- €9.1 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 the use of AEF0117 as a treatment of cannabis use
disorders. The balance of the lump-sum payment received in 2021 and
yet to be recognized over the residual term of the option amounts
to €2.7 million. The revenue recognized for the fiscal year 2023,
based on the progression of costs for the phase 2b of AEF0117, has
increased by €5.2 million compared to 2022. This increase is
attributed to the increased activity of the phase 2b clinical study
and the completion of its recruitment.
- €3.3 million in other income from ordinary activities,
comprising the Research Tax Credit (€1,597,000), operating
subsidies (€1,010,000) and studies re-invoiced without margin
(€696,000) related to Aelis Farma's research programs. The decrease
in other income compared to the previous fiscal year (-€1.3
million) is explained by the reduction in Research Tax Credit,
linked to fewer eligible activities in 2023, given the studies
carried out in the United States in particular, and the lesser
impact of grants recognized in income in 2023.
Research and development costs
In €K
12/31/2023
12/31/2022
Raw materials, other purchases, and
external expenses
(14,047)
(11,574)
Personnel costs
(2,002)
(2,052)
Intellectual property
(163)
(166)
Research and development costs
(16,212)
(13,792)
The increase in research and development expenses (+18%)
reflects significant progress in the clinical and non-clinical
development programs, observed particularly in the second half of
2023, of our drug candidates AEF0117 and AEF0217, as well as the
growth of activities of our proprietary discovery platform.
General and administrative expenses
In €K
12/31/2023
12/31/2022
Other purchases and external charges
(1,097)
(1,670)
Staff costs
(1,510)
(1,426)
General and administrative expenses
(2,607)
(3,096)
General and administrative expenses as of December 31, 2023
amounted to €2,607,000, down €489,000 compared to the previous
year. This decrease mainly relates to other purchases and external
expenses, which included in 2022 costs relating to the Company's
IPO not charged to the share premium.
The operating result recorded on December 31, 2023 was therefore
a loss of €6,461,000, compared with a loss of €8,525,000 at
December 31, 2022. This change was mainly due to:
- the progress and completion of recruitment for the phase 2b
study of AEF0117 during the fiscal year 2023;
- the speeding up of recruitments and expansion of the clinical
centers for the phase 1/2 study with AEF0217, primarily in the
second half of 2023;
- the continuation of development activities for the
pharmaceutical production (CMC) of AEF0117 for phase 3 and of
AEF0217 for phase 2, as well as other regulatory clinical and
non-clinical studies required for AEF0117 to enter phase 3;
- the pace of revenue recognition related to the license option
agreement with Indivior PLC, based on the advancement of AEF0117
phase 2b costs.
Financial income showed a profit of €1,386,000 as of December
31, 2023, compared with a loss of €5,762,000 at December 31, 2022.
This mainly comprises the financial income recognized at the moment
of the payment of R&D charges, which were self-hedged in
dollars. To be noted, as of December 31, 2022, the non-cash
financial expense associated with the conversion of convertible
bonds on the date of Aelis Farma’s IPO was also recognized.
The net result was a loss of €5,078,000 for the full year 2023,
compared with a loss of €14,288,000 for the same period of
2022.
Cash flow
Cash flow (in €K)
12/31/2023
12/31/2022
Cash flow from operating
activities
(12,959)
(13,051)
Net cash flow from investing
activities
(88)
(137)
Net cash flow from financing
activities
(967)
22,149
Impact of exchange rate changes
(170)
723
Change in cash and cash
equivalents
(14,184)
9,684
Opening cash position
34,396
24,710
Closing cash position
20,211
34,396
Financial structure
Financial structure (in €K)
12/31/2023
12/31/2022
Liquid assets
a
20,230
34,396
Gross financial debt
b
(4,040)
(3,823)
Net cash position
a+b
16,190
30,572
The year 2022 was marked by the capital increase carried out in
connection with the Company's IPO, generating a net financing cash
flow of €22.1 million. In 2023, in addition to the repayment of the
Company's debt maturities (-€1 million) and payments to the
liquidity contract (€0.5 million), this cash flow includes interest
received on financial investments (€0.5 million).
Aelis Farma’s financial structure remains robust at the end of
the full year 2023, with a net cash position of €16,190,000. The
Company’s cash consumption is in line with its forecasts and the
progress of its research and development program.
Aelis Farma believes that its current cash position will enable
it to finance its development, in line with the strategy presented
during the IPO, until at least the end of 2025.
Highlights of the full year 2023
Publication of the first article on AEF0117 in Nature
Medicine
In June 2023, the prestigious scientific journal Nature Medicine
published the first article describing the new pharmacological
class discovered by Aelis Farma, the CB1-SSi, and the discovery and
development of the first of these compounds, AEF0117, including the
positive data from a phase 2a clinical trial in volunteers with
cannabis addiction.
This article provides a scientific validation of the quality of
the work carried out and the potential of AEF0117, and more
generally of the new CB1-SSi pharmacological class.
Favorable review by a DSMB (Data and Safety Monitoring Board)
in the phase 2b study of AEF0117
The conclusions of a DSMB, the committee of independent experts
to monitor the trial, were released at the end of the first
semester of 2023. Safety and tolerability data from the initial 115
patients treated with AEF0117 for at least 4 weeks were assessed,
and no serious adverse or significant treatment-related events were
reported by the committee, which recommended continuing the study
without modification to the protocol.
Positive results from regulatory non-clinical studies of
AEF0117
AEF0117 demonstrated a highly favorable therapeutic index, over
13,000 times greater than the active dose, in in vivo toxicological
studies including a chronic oral toxicity study (6 months in rats
and 9 months in dogs), allowing for chronic treatments without
duration restriction in humans. Additionally, reproductive
toxicology studies demonstrated that AEF0117 does not alter
embryonic and embryofetal development. With the successful early
completion of additional non-clinical and current clinical
development complementary to toxicity studies, AEF0117 will be
ready to enter phase 3 clinical trials for the treatment of
cannabis addiction upon successful completion of the present phase
2b clinical trial and regulatory approval of the phase 3
protocol.
Completion of recruitment for the phase 2b clinical study
with AEF0117 for the treatment of cannabis addiction
Under the coordination of Professor Frances Levin from Columbia
University (New York), recruitment and randomization of the 333
patients for the phase 2b trial of AEF0117 at 11 clinical centers
in the United States were completed in December 2023. The Company
expects to announce the results of the study after 2024 summer
break.
Strengthening of the recruitment capacity for the phase 1/2
study of AEF0217 with the opening of two clinical centers
The transition of the phase 1/2 study to a multicenter trial has
been completed with the aim of significantly increase the
recruitment of subjects of this initial safety evaluation of
AEF0217 in people with Down Syndrome. In addition, this study and
the multiple encounters with Down syndrome family association is
anticipating the groundwork for the establishment of a network
capable of swiftly executing the future phase 2 study, evaluating
the efficacy of AEF0217 for the treatment of cognitive deficits
associated with Down syndrome. This study is expected to start in
late 2024/early 2025.
Strategy & outlook
Develop AEF0117 to address the adverse effects of excessive
cannabis use
Aelis Farma expects to announce the efficacy results of the
phase 2b study with AEF0117 after 2024 summer break. Following
these results, Indivior could exercise its licensing option,
triggering a license fee payment of $100 million, and up to an
additional $340 million in milestone payments contingent upon the
achievement of development, regulatory, and commercial milestones,
as well as royalties on net sales of AEF0117 ranging from 12% to
20%.
Aelis Farma aims also to finalize in 2024 additional clinical
studies required for the entry into phase 3 of AEF0117. These
studies, combined with positive results from the phase 2b trial and
the positive results already obtained in regulatory non-clinical
studies, would allow the start of phase 3 trials, upon approval by
regulatory agencies of their clinical protocols.
Develop AEF0217 to address various cognitive deficits,
including those associated with Down syndrome
The primary objective for 2024 is to successfully complete the
phase 1/2 study and the initiation of the phase 2 study. The phase
1/2 study aims primarily to analyze the safety and pharmacokinetics
of AEF0217 in Down syndrome people. The obtention of convincing
safety and pharmacokinetic results would pave the way for a
multicenter phase 2 study, expected to start late 2024/early 2025,
that will aim to demonstrate the therapeutic effects of AEF0217 for
the treatment of cognitive deficits associated with Down syndrome.
The development of AEF0217 in Down syndrome benefits from a grant
of €6 million of the European community (Project ICOD No.
899986).
In 2024, the Company also aims to strength the knowledge on the
additional therapeutic indications of AEF0217 which include the
cognitive deficits observed in genetic forms of autism spectrum
disorders, during aging and in neuropsychiatric conditions such as
schizophrenia and Parkinson’s disease.
Identifying new drug candidates
Given the involvement of the CB1 receptor in numerous
pathologies and leveraging its diversified and exclusive library of
CB1-SSi, Aelis Farma continues to characterize new CB1-SSi
candidates which aim to treat other CB1 receptor-dependent
disorders.
***
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 natural regulatory
mechanism of CB1 hyperactivity made by the team led by Dr. Pier
Vincenzo Piazza, the Company’s CEO, when he was the director of the
Neurocentre Magendie of the INSERM in Bordeaux. By mimicking this
natural mechanism, CB1-SSi appear to selectively inhibit the
disease-related activity of the CB1 receptor without disrupting its
normal physiological activity. CB1-SSi have consequently the
potential to provide new safe treatments for several brain
diseases.
Aelis Farma is currently developing two first-in-class
clinical-stage drug candidates: AEF0117 for the treatment of
cannabis use disorder (CUD), currently being tested 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 in people with Down syndrome. The Company also
has a portfolio of new 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 25 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 Universal Registration
Document approved by the Autorité des Marchés Financiers on April
26, 2023, under number R.23-018.
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.
1e annual financial statements were approved by the Board of
Directors on April 2,2024. Review procedures have been performed on
these financial statements. The statutory auditors' review report
is currently being issued.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240402407315/en/
AELIS FARMA Arsène Guekam Chief Corporate Development
Officer 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)
Historical Stock Chart
Von Apr 2024 bis Mai 2024
Aelis Farma (EU:AELIS)
Historical Stock Chart
Von Mai 2023 bis Mai 2024