- A solid cash position of €12.6 million at June 30, 2024, not
including the gross amount of €4.5 million share offering which
occurred at the end of July and other non-dilutive financing
currently being obtained, ensuring financial visibility assured
until the end of 2026.
The first half of 2024 was marked by:
- The last patient last visit in the Phase 2B trial with
AEF0117 for the treatment of cannabis use disorders (CUD) in April
2024. Although the primary endpoint was not met the preliminary
results of this study show a statistically significant decrease in
cannabis consumption in participants with moderate CUD.
- The end of recruitment for a phase 1/2 study with AEF0217 in
people with Down syndrome. The results of the study will be
announced in Q4 2024.
- The expansion of research capabilities with the transfer of
the screening laboratory responsible for identifying new CB1-SSi
molecules to the IECB (Institut Européen de Chimie et de Biologie)
in Pessac (Bordeaux).
Regulatory News:
Aelis Farma (ISIN: FR0014007ZB4 – Ticker: AELIS), a
clinical-stage biopharmaceutical company specializing in the
development of treatments for brain diseases, today announces its
results for the first half of 2024 and provides an update on its
development.
Pier Vincenzo Piazza, CEO of Aelis Farma, said: “Overall,
we are satisfied with the progress made over the first six months
of 2024. Thanks to the efficiency, motivation, and commitment of
our teams, key clinical milestones have been achieved with our two
first-in-class drug candidates, AEF0117 and AEF0217.
Regarding AEF0117, we have completed a Phase 2B clinical study
in cannabis use disorders (CUD), the largest ever carried out in
this field. The main goal of this study was to demonstrate that
AEF0117 reduces cannabis use and to determine the optimal endpoints
and doses to be used in future studies. The preliminary results of
this study, released on September 4, 2024, showed that the primary
endpoint (proportion of patients using cannabis ≤ 1 day per week)
was not met. However, AEF0117 at the highest dose (1mg/day) led to
a statistically significant reduction in quantitative measures of
cannabis use in participants with moderate CUD, confirming that
AEF0117 is pharmacologically active. We are currently completing
further analysis in order to determine the next regulatory and
development steps.
AEF0217, after proving to be safe, well tolerated and with good
pharmacokinetic characteristics in healthy volunteers in Phase 1
studies, has just completed in June 2024 the recruitment of 30
participants in a Phase 1/2 study in people with Down syndrome.
This multicenter study (Barcelona, Madrid) aims primarily to
confirm the safety and pharmacokinetic properties of this drug
candidate in people with Down's syndrome. The results of this study
will be announced in Q4 2024.
Finally, at the end of July, we also announced the success of a
€4.5 million fund-raising round aimed at strengthening the
development of new CB1-SSi molecules produced by our platform. This
fund raising plus new non-dilutive funding currently being
obtained, will ensure financial visibility until the end of
2026.
The results obtained with AEF0117 in Phase 2B confirm the
pharmacological activity of the new pharmacological class developed
by Aelis Farma, the “Signaling Specific inhibitors of the CB1
receptor (CB1-SSi)”. We strongly believe that the CB1-SSi represent
a major discovery which could lead to the development of a whole
new class of treatments for many pathologies with no therapeutic
solution available today.”
Half-year results 2024 (IFRS)
Simplified income statement1 (in
€K)
06/30/2024
06/30/2023
Revenue from ordinary activities
4,124
5,701
Research and development costs
(6,115)
(7,151)
General and administrative expenses and
other operating income and expenses
(1,673)
(992)
Operating income
(3,665)
(2,442)
Financial result
83
813
Income taxes
0
(4)
Net income (loss)
(3,583)
(1,633)
In the first half of 2024, Aelis Farma recorded revenue from
ordinary activities of €4.1 million, including:
- €2.2 million (vs. €3.7 million at June 30,
2023) 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 and yet to be
recognized over the residual term of the option amounts to €0.4
million. - €1.9 million (€2 million at June 30, 2023) in other
income from ordinary activities, comprising the Research Tax Credit
(€809,000), operating subsidies and studies charged back
(€1,082,000) relating to Aelis Farma's research programs.
Research and development costs
In €K
06/30/2024
06/30/2023
Raw materials, other purchases and
external expenses
(4,857)
(6,167)
Personnel costs
(1,041)
(907)
Intellectual property
(217)
(78)
Research and development costs
(6,115)
(7,151)
Research and development costs are decreasing compared to June
30, 2023, taking into account in particular the end of recruitment
for the AEF0117 Phase 2B study at the end of the 2023 financial
year; the first half of 2024 having been devoted essentially to
monitoring the study data before the database is locked.
General and administrative expenses
In €K
06/30/2024
06/30/2023
Other purchases and external charges
(639)
(484)
Staff costs
(1,034)
(508)
General and administrative
expenses
(1,673)
(992)
General and administrative expenses at June 30, 2024 amounted to
€1,673,000, an increase of €681,000 compared to June 30, 2023. This
increase mainly concerns personnel expenses, due to an increase in
the number of employees and the valuation of BSA and BSPCE plans in
accordance with IFRS 2.
The operating result recorded at June 30, 2024 was therefore a
loss of €3,665,000, compared with a loss of €2,442,000 at June 30,
2023.
Financial income showed a profit of €83,000 at June 30, 2024,
compared with a profit of €813,000 at June 30, 2023. This mostly
comprises income from cash investments. At June 30, 2023, it
corresponded mainly to financial income recognized on settlement of
R&D transactions, which were self-hedged in dollars.
The net result was a loss of €3,583,000 for the first half of
2024, compared with a loss of €1,633,000 for the same period of
2023.
Cash flow
Cash flow (in €K)
06/30/2024
06/30/2023
Cash flow from operating
activities
(8,177)
(8,041)
Net cash flow from investing
activities
(165)
(82)
Net cash flow from financing
activities
719
(673)
Impact of exchange rate changes
(4)
(149)
Change in cash and cash
equivalents
(7,626)
(8,945)
Opening cash position
20,211
34,396
Closing cash position
12,585
25,450
Financial structure
Financial structure (in €K)
06/30/2024
12/31/2023
Liquid assets
a
12,585
20,230
Gross financial debt
b
(5,085)
(4,040)
Net cash position
a+b
7,500
16,190
Aelis Farma’s financial structure remains strong, with a closing
cash position of 12,6 M€ at the end of the first half of 2024. The
Company’s cash consumption is in line with its forecasts and the
progress of its research and development program.
Given its cash position at June 30, 2024, the funds raised in
the end-July 2024 transaction, and several non-dilutive financing
in the process of being obtained, Aelis Farma expects to have
sufficient cash to carry out its R&D program up to and
including the fourth quarter of 2026.
Highlights of the first half of 2024
Last patient last visit for AEF0117 Phase 2B study in
cannabis addiction
This pioneering study is the largest and best-controlled ever
conducted in the field of cannabis addiction. The study enrolled
333 patients at 11 clinical centers in the US and the last patient
last visit had been achieved in April 2024.
Completion of phase 1/2 enrolment with AEF0217 in the
treatment of cognitive impairments in Down syndrome
In June 2024, the recruitment of 30 participants with Down
syndrome for a multicenter phase 1/2 study (Barcelona, Madrid) was
completed. The main objective of this phase 1/2 study is to
evaluate the safety and pharmacokinetics of AEF0217 in people with
Down syndrome. The results of this study will be announced in Q4
2024.
Transfer of the screening laboratory for the identification
of new CB1-SSi
In April 2024, Aelis Farma transferred its discovery research
teams to a new laboratory at the IECB (Institut Européen de Chimie
et de Biologie) in Pessac (Bordeaux).
The new 200 m² laboratory is equipped with state-of-the-art
technologies and proprietary screening platforms, enabling Aelis
Farma to accelerate its drug discovery process. With these enhanced
capabilities, Aelis Farma will be able to conduct in-depth
research, discovering promising new molecular entities and identify
their mechanism of action for the treatment of various
diseases.
Significant events after the closing
Successful capital increase of €4.5 million
At the end of July 2024, Aelis Farma successfully completed a
€4.5 million capital increase, which enabled the Company to expand
its shareholder base by including new high-quality investors, and
to accelerate the development of the new CB1-SSi families produced
by its platform, with the strategic priority of broadening its
therapeutic targets. These include, in particular, a treatment of
obesity related metabolic diseases, in which the CB1 receptor, the
target of the Company’s drug candidates, is strongly implicated. It
is important to recall that the drug candidates developed by Aelis
Farma belong to the same pharmacological class of CB1-SSi but have
distinct functional effects which enable them to target different
pathologies.
Publication of Phase 2B results with AEF0117 in participants
with cannabis use disorders (CUD)
As indicated in the press release of September 4, 2024, the
preliminary results of the Phase 2B with AEF0117 in CUD showed
that:
- AEF0117 was well tolerated, and no safety concerns were
identified.
- The primary endpoint, which measured the percentage of
participants who reduced the number of days of use ≤1 day per week
was not met by AEF0117.
- The endpoints measuring the quantitative consumption of
cannabis showed at the highest dose of AEF0117 (1mg/day) consistent
trends to decrease in the overall population and a statistically
significant reduction in participants with moderate CUD, according
to the DSM-5 diagnostic criteria.
- As already observed in the Phase 2A, these data confirm that
AEF0117 is pharmacologically active, thus providing further
validation of the new of drugs developed by Aelis Farma, the
“Signaling Specific inhibitors of the CB1 receptor (CB1-SSi)”.
The Company is currently investigating the results further to
determine the best strategic and regulatory action plan.
Strategy & outlook
Thanks to its solid financial position, Aelis Farma intends to
pursue the development of its various assets and to reach the next
value-creation milestones.
Finalization of quality control and data analysis of Phase 2B
results for AEF0117 in the treatment of cannabis addiction
The preliminary results and initial findings of this Phase 2B
study should be considered as non-definitive. Quality control and
complementary analysis of the data are currently underway before
determining the next regulatory and development steps which will be
communicated once this process is complete.
Indivior, Aelis Farma's partner for AEF0117, indicated that it
did not currently expect to exercise the option on AEF0117 before
seeing additional favorable clinical data.
Further development of AEF0217 to treat a range of cognitive
deficits, including those associated with Down syndrome
Results from the Phase 1/2 study in people with Down syndrome
are expected in Q4 2024.
Satisfactory safety and pharmacokinetic results would pave the
way for a multicenter Phase 2 study, which could start in the first
half of 2025. This study will aim to demonstrate the therapeutic
effects of AEF0217 for the treatment of the cognitive deficits
associated with Down syndrome.
Aelis Farma is also conducting additional preclinical studies to
better determine the range of potential indications of AEF0217 in
the broad field of cognitive deficits.
Developing new drug candidates on the Company's
platform
Thanks to its diversified and proprietary CB1-SSi library and
screening platform, Aelis Farma has discovered distinct families of
CB1 compounds that could address a broad spectrum of diseases
associated with the CB1 receptor.
Aelis Farma is initiating preclinical proof-of-concept studies
and early toxicity and pharmacokinetic studies to select the drug
candidates that could enter non-clinical development allowing first
in human studies.
***
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 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 related disorders, that has just completed a Phase 2B
study in the United States in CUD, and AEF0217 for cognitive
disorders, including those of Down syndrome (Trisomy 21), that has
just completed recruitment in a Phase 1/2 study in Spain in people
with Down syndrome, with results expected in Q4 2024. 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. The different drugs developed by the Company
belong to the same general pharmacological class, the CB1-SSi, but
have distinct functional effects allowing to target different types
of dysregulations 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
24, 2024, under number R.24-004.
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 interim financial statements were approved by the Board of
Directors on September 25, 2024. Limited review procedures have
been performed on these financial statements. The statutory
auditors' limited review report is currently being issued.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240925375968/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.eu +33
1 44 71 00 15
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