- Acceleration of recruitment in AEF0117 phase 2b trial for
the treatment of cannabis addiction and approval obtained in July
2023 by an independent Data Safety Monitoring Board (DSMB) to
continue the trial with no amendments to the protocol
- Publication in Nature Medicine of an article presenting a
series of studies describing the new pharmacological class
developed by the company, cannabinoid receptor 1 signaling-specific
inhibitors (CB1-SSi), and its first drug candidate, AEF0117, for
the treatment of cannabis use disorder (CUD)
- Continued clinical development of AEF0217 in Phase 1/2 in
Down syndrome, and potential further expansion in autism spectrum
disorders
- Two new families of CB1 compounds discovered with potential
application in CB1-dependent psychiatric and neurological
disorders
- Strong cash position at €25.5 million on June 30, 2023,
ensuring financial visibility until the end of 2025 and allowing to
reach the development objectives announced at the IPO
Regulatory News:
Aelis Farma (ISIN: FR0014007ZB4 – Ticker: AELIS) (Paris:
AELIS), a clinical-stage biopharmaceutical company specializing in
the development of treatments for brain disorders, today announces
its results for the first half of 2023 and released an update on
its development.
Pier Vincenzo Piazza, CEO of Aelis Farma, said: “We are
very pleased with the progress made over the first six months of
2023. Thanks to the efficiency, motivation, and commitment of our
team, key planned clinical milestones have been achieved, allowing
us to meet the ambitious targets set for our two first-in-class
drug candidates, AEF0117 and AEF0217. For the second half of 2023,
fulfilling our roadmap for those key assets will remain our
priority, but we will also evaluate additional indications such us
Phelan-McDermid syndrome (PMS) for AEF0217 and expand our pipeline.
Our screening platform has made significant progress enabling us to
identify new molecules different from AEF0117 and AEF0217. This
discovery might pave the way for the treatment of other brain
disorders and for Aelis Farma to become a leading player in this
field.”
Half-year results 2023 (IFRS)
Simplified income statement1 (in
€K)
06/30/23
06/30/22
Revenue from ordinary activities
5,701
4,251
Research and development costs
(7,151)
(7,093)
General and administrative expenses and
other operating income and expenses
(992)
(1,800)
Operating income
(2,442)
(4,642)
Financial result
813
(5,710)
Income taxes
(4)
-
Net income (loss)
(1,633)
(10,352)
In the first half of 2023, Aelis Farma recorded revenue from
ordinary activities of €5.7 million, including:
- €3.7 million (vs. €2 million at June 30, 2022) 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 €8 million.
- €2 million (€2.3 million at June 30, 2022) in other income from
ordinary activities, comprising the Research Tax Credit (€883,000)
and operating subsidies (€1,084,000) relating to Aelis Farma's
research programs.
Research and development costs
In €K
06/30/23
06/30/22
Raw materials, other purchases and
external expenses
(6,167)
(5,989)
Personnel costs
(907)
(1,045)
Intellectual property
(78)
(58)
Research and development costs
(7,151)
(7,093)
Research and development costs are stable compared to June 30,
2022, taking into account R&D activities on the Company’s two
compounds AEF0117 and AEF0217, as well as the research programs of
Aelis Farma’s discovery platform.
General and administrative expenses
In €K
06/30/23
06/30/22
Other purchases and external charges
(484)
(1,127)
Staff costs
(508)
(673)
General and administrative
expenses
(992)
(1,800)
General and administrative expenses at June 30, 2023 amounted to
€992,000, down €808,000 compared to June 30, 2022. 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 (€700,000).
The operating result recorded at June 30, 2023 was therefore a
loss of €2,442,000, compared with a loss of €4,642,000 at June 30,
2022. This change was mainly due to:
- The timing of revenue recognition related to the license option
agreement with Indivior PLC, based on the advancement of AEF0117
phase 2b costs, during the first half of 2023. €1,990,000 had been
recognized in the first half of 2022;
- The costs associated with the Company’s IPO in the first half
of 2022.
Financial income showed a profit of €813,000 at June 30, 2023,
compared with a loss of €5,710,000 at June 30, 2022. This mainly
comprises financial income recognized on settlement of R&D
transactions, which were self-hedged in dollars. At June 30, 2022,
the non-cash financial expense associated with the conversion of
convertible bonds on the date of Aelis Farma’s IPO was
recognized.
The net result was a loss of €1,633,000 for the first half of
2023, compared with a loss of €10,352,000 for the same period of
2022.
Cash flow
Cash flow (in €K)
06/30/23
06/30/22
Cash flow from operating
activities
(8,041)
(8,377)
Net cash flow from investing
activities
59
(122)
Net cash flow from financing
activities
(814)
22,644
Impact of exchange rate changes
(149)
933
Change in cash and cash
equivalents
(8,945)
15,078
Opening cash position
34,396
24,710
Closing cash position
25,450
39,789
Financial structure
Financial structure (in €K)
06/30/23
12/31/22
Liquid assets
a
25,450
34,396
Gross financial debt
b
(4,305)
(3,823)
Net cash position
a+b
21,145
30,572
Aelis Farma’s financial structure remains robust at the end of
the first half of 2023, with a net cash position of €21,145,000.
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 first half of 2023
Publication of results from the development phases of AEF0117
in Nature Medicine
In June 2023, the prestigious scientific journal Nature Medicine
published an 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, the first to describe an Aelis Farma’s drug,
provides external validation of the efficacy and good tolerability
of AEF0117, as well as of the CB1-SSi in general.
Efficacy of AEF0217 in a mouse model of a genetic form of
autism spectrum disorder
Data from preclinical studies demonstrating the efficacy of
AEF0217 in a genetic mouse model of Phelan-McDermid syndrome (PMS)
was presented at the 2nd European Conference on Phelan-McDermid
syndrome in June 2023.
PMS is caused by deletion of chromosome 22q13 including the
SHANK3 gene or a variation in the sequence of this gene. It is one
of the genetic mutations most frequently observed in autism and a
rare disease for which there is currently no treatment available.
These mutations lead to development delays in multiple areas,
particularly language, intellectual deficiency and often autism
spectrum disorders.
The data presented was obtained in the context of a
collaboration between several laboratories coordinated by Dr.
Catalina Betancur. The results showed the ability of AEF0217 to
reverse, in a statistically significant way, behavioral, cognitive
and motor deficits, as well as a neurological alteration (cortical
hyperactivity) considered as a neurobiological marker of autism.
These promising results prompt the Company to analyze the
feasibility of a clinical development of AEF0217 in PMS and more
generally in autism spectrum disorder.
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 pace of recruitment.
The opinion of the AEF0117 Data Safety Monitoring Board (DSMB),
conducted on the first 115 patients treated for at least 4 weeks,
was announced early July 2023. The DSMB did not find any serious
adverse effect, or any significant adverse effect linked to the
treatment. Aelis Farma was therefore given a positive and unanimous
recommendation for the continuation, without any amendments to the
protocol, of the phase 2b clinical trial of the AEF0117 for the
treatment of cannabis addiction.
The first results of the study are expected mid-2024 as
initially announced. Positive efficacy results from phase 2b could
pave the way for phase 3 studies, the last step before a market
authorization application can be filed. If Indivior exercises the
license option at the end of the phase 2b, it will pay Aelis Farma
a $100 million license fee (potentially by the end of 2024) and up
to an additional $340 million subject to certain conditions,
including if development, regulatory and commercial milestones are
achieved, as well as royalties on net sales of AEF0117 of between
12% and 20%. Following the exercise of the option, all development,
registration, and commercialization costs of AEF0117 will be borne
by Indivior.
Develop AEF0217 to treat various cognitive deficits,
including Down syndrome
The main objective for 2023 is to successfully complete the
phase 1/2 study in Down syndrome people. Initially intended to be
monocentric (IMIM, Barcelona), the study has been transformed into
a multicentric study by adding two additional centers in Spain to
obtain more robust results.
The main aim of this study is to analyze the safety and the
pharmacokinetics of AEF0217 in people with Down syndrome. Obtaining
satisfactory safety and pharmacokinetic results would pave the way
for a multicentric phase 2b study, which could begin in 2024. The
phase 2b will be aimed at confirming the therapeutic effects of
AEF0217 in the treatment of cognitive disorders associated with
Down syndrome. The development program of AEF0217 as a treatment of
the cognitive deficits associated with Down syndrome has received a
€6 million grant from the European community (ICOD Project No.
899986).
The efficacy of AEF0217 in a genetic mouse model of
Phelan-McDermid syndrome (PMS), a common genetic cause of autism,
opens also the potential application of AEF0217 to another field of
neurodevelopmental disorders – Autism Spectrum Disorders (ASDs).
The Company is taking and will take the necessary steps, with the
help of international experts and consultations with regulatory
authorities, to validate clinical trials designs, development plan
and orphan disease designation for AEF0217 in PMS. These activities
could put the Company in the position to potentially start the
first clinical trial in PMS in Q4 2024.
Develop new drug candidates on the Company’s proprietary
platform
Thanks to its diversified and exclusive library of CB1-SSi and
screening platform, Aelis Farma has discovered two new distinct
families of CB1 compounds, that should allow to address a broad
spectrum of CB1-dependendent psychiatric and neurological diseases.
These new families of CB1 compounds could start preclinical
proof-of-concept-studies in the course of 2024.
***
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 brain defense
mechanism made by the team led by Dr. Pier Vincenzo Piazza, the
Company’s CEO, when he was director of 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 treatments
for several brain diseases. Aelis Farma is currently developing two
first-in-class clinical-stage drug candidates: AEF0117 for the
treatment of 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 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 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.
1 The interim financial statements were approved by the Board of
Directors on September 25, 2023. 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/20230925201021/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
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