- H1 2022 marked by the start of recruitment for the phase 2b
study with AEF0117 for the treatment of cannabis addiction
- Solid cash position at €39.8 million as of June 30, 2022,
including the net proceeds of €22.5 million from the fundraising of
the initial public offering on Euronext the 18th of February
2022
Regulatory News:
Aelis Farma (Paris: AELIS)(ISIN: FR0014007ZB4 - ticker:
AELIS, PEA-PME eligible), a clinical-stage biopharmaceutical
company specialized in the development of treatments for brain
diseases, today announces its half-year results for the period
ended June 30, 2022 and takes stock of its development.
Pier Vincenzo Piazza, CEO of Aelis Farma, said: "We are
very happy with the progress made during the first months of our
listing on Euronext. Raising €25.3 million during our IPO in
February allowed us to considerably strengthen our financial
structure and be able to deploy our strategy with a high
visibility. In accordance with the roadmap presented to the
financial community, we have reached an important milestone with
the recruitment of the first patient in the phase 2b study with
Aelis Farma most advanced compound: AEF0117 for the treatment of
cannabis addiction. The second part of the year promises to be just
as dynamic, in particular with the expected passage of our second
drug candidate, AEF0217, into phase 1/2 in individuals with Down
Syndrome (Trisomy 21). Built around the discovery of a new class of
drugs, the CB1-SSi, we believe Aelis Farma to be one of the most
innovative companies in the field of brain diseases. Thanks to the
progress of our various clinical programs, we are convinced that we
can become one of the leading players in this space that has
significant unmet medical needs.”
Half-year results 2022 (IFRS)
Simplified income statement1 (in
thousand euros)
H1 2022
H1 2021
Revenue from ordinary activities
4,251
8,371
Research and development costs
(7,093)
(3,157)
General and administrative expenses and
other operating expenses and income
(1,800)
(569)
Operating income
(4,642)
4,647
Financial result
(5,710)
497
Income taxes
-
(1,365)
Net income (loss)
(10,352)
3,781
In the first half of 2022, Aelis Farma recorded income from
ordinary activities of €4.3 million, of which:
- €2 million corresponding to the recognition, according to IFRS
15, of the share of revenue related to the sub-license option
contract with Indivior PLC, a leading group in the treatment of
addictions, for AEF0117 in cannabis use disorders. The balance of
the lump sum payment received and remaining to be recognized over
the residual term of the option is €13.6 million.
- €2.3 million of other income from ordinary activities
consisting of the Research Tax Credit (€837 thousand) and operating
subsidies (€1.424 million) relating to the research programs
carried out by Aelis Farma. Their increase compared to the previous
year is correlated to the increase in research and development
expenses incurred over the half-year.
Research and development costs
In thousand euros
06/30/22
06/30/21
Raw materials, other purchases and
external expenses
(5,989)
(474)
Personnel costs
(1,045)
(866)
Intellectual Property
(58)
(1,817)
Research and development costs
(7,093)
(3,157)
The change in research and development costs (+124.7%) reflects
the ramp-up of the development program for drug candidates AEF0117
and AEF0217, and the strengthening of research team. The decrease
in intellectual property costs is explained by the payment, in
2021, of royalties (€1.2 million) to patent owners following the
signing of the sublicense option agreement with Indivior PLC.
As of June 30, 2022 the operating result shows a loss of €
(4.642) million against a profit of €4.647 million at June 30,
2021. This change is mainly due to:
- the start of the phase 2b study of AEF0117 and the
pharmaceutical production activities (CMC) for both AEF0117 and
AEF0217; and
- by the schedule of revenue recognition of the down payment of
the license-option contract with Indivior PLC for AEF0117, based on
the incurred costs of the phase 2b during the first half of 2022.
As a reminder, €7.921 million had been recognized when the contract
was signed in 2021.
As of June 30, 2022, the financial result shows a loss of €
(5.710) million against a profit of €497 thousand as of June 30,
2021. This change mainly reflects the impact of the conversion of
convertible bonds on the date of the Aelis Farma’s initial public
offer (IPO). 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 net result shows a loss of € (10.352) million for the first
half of 2022 compared to a profit of €3.781 million for the
previous financial year.
Cash flow
In thousand euros
06/30/22
06/30/21
Cash flow from operating
activities
(8,377)
24,268
Net cash flow from investing
activities
(122)
(2)
Net cash flow from financing
activities
22,644
(143)
Effect of exchange rate changes
933
598
Change in cash and cash
equivalents
15,078
24,721
Opening cash position
24,710
4,538
Closing cash position
39,789
29,258
Financial structure
In thousand euros
06/30/22
12/31/21
Liquid assets
a
39,789
24,710
Gross financial debt
b
(4,254)
(7,917)
Net cash position
a-b
35,535
16,793
The financial structure of Aelis Farma was strengthened during
the first half of 2022 by:
- the net proceeds of €22.5 million from the capital increase
carried out on the occasion of Aelis Farma’s initial public
offering in 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 reduction of €3.663 million in gross debt, which
decreased from €7.917 million to €4.254 million; and
- income from operating activities related to the license option
agreement with Indivior PLC. The positive evolution of this cash in
dollars allowed the recognition of a foreign exchange gain of €0.9
million.
Aelis Farma believes that its current cash level makes it
possible, according to its forecast, to finance its development in
accordance with the strategy presented during the IPO at least up
to the end of 2024.
Highlights of the first half of 2022
Inclusion of the first patient in the phase 2b study with
AEF0117
At the beginning of June, Aelis Farma announced the recruitment
of the first patient in the phase 2b study with AEF0117, its most
advanced “CB1-SSi” drug candidate, for the treatment of cannabis
addiction. The study, coordinated by Prof. Frances Levin of
Columbia University, should include approximately 330 patients in 9
participating clinical centers in the United States. The AEF017
program benefits from overall funding from the North American
National Institute on Drug Abuse of the National institute of
Health (NIDA-NIH) of $7.8 million, including $4.5 million allocated
at the end of 2021 for this new phase of development.
Participation in the T21RS international conference
Aelis Farma participated in the 4th international conference
organized by the Trisomy 21 Research Society (T21RS), which was
held in Long Beach, California from June 9 to 12, 2022.
Pier Vincenzo Piazza, Co-founder and CEO of Aelis Farma,
presented the drug candidate AEF0217 during a session entitled
“AEF0217: a new approach for the treatment of cognitive impairment
in Down syndrome”.
The Trisomy 21 Research Society (T21RS) is the leading
international scientific society dedicated to translational and
clinical research on Down syndrome (Trisomy 21). One of its main
activities is to support the dissemination and discussion of the
latest advances in clinical and preclinical research in this area
through a series of biennial meetings. T21RS also connects
researchers and patient & families associations which have very
active interactions with the society.
Strategy & Outlook
Over the coming months, thanks to the strength of its financial
position, Aelis Farma intends to pursue the development of its
various assets, in accordance with the strategy presented at the
time of its IPO:
Developing AEF0117 to address the adverse effects of
excessive cannabis use
The phase 2b clinical trial with AEF0117 is continuing with a
good level of recruitment and the results of the study are expected
in 2024. If this study proves to be positive, Aelis Farma and its
partner Indivior PLC intend to start phase 3 studies in late 2024
or early 2025, in order to quickly obtain approval for AEF0117 in
the United States and Europe.
Develop AEF0217 to treat various cognitive deficits,
including those of Down syndrome (Trisomy 21)
AEF0217 has completed the recruitment of its phase 1 program in
healthy volunteers. The audited results of these studies are
expected in the coming weeks. The launch of a phase 1/2 clinical
study in subjects with Down syndrome is planned for the 4th quarter
of 2022. This study will investigate the safety and
pharmacokinetics of AEF0217 in Down syndrome individuals and could
provide the first indications about the activity in the first half
of 2023. The development of AEF0217 as a treatment of the cognitive
deficits associated with Trisomy 21 has received a €6 million grant
from the European community (Project ICOD N° 899986).
Aelis Farma also works on the extension of the development of
AEF0217 for the treatment of other cognitive deficits such as the
ones associated to Fragile X syndrome or aging, for which AEF0217
has been shown to be effective in preclinical models.
Identify new drug candidates
Given the involvement of the CB1 receptor in numerous
pathologies, Aelis Farma is pursuing the characterization of its
diversified and exclusive library of CB1-SSi in order to identify
new candidate drugs to address other brain diseases dependent on
the CB1 receptor.
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 molecular entities 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 a dysregulation of the activity of the CB1
receptor.
AEF0117, which targets the disorders due to excessive cannabis
use (addiction and psychosis), has shown indications of efficacy in
a phase 2a clinical trial and has entered a phase 2b clinical trial
in the United States in Q2 2022. Aelis Farma has an exclusive
option-license agreement with Indivior PLC, a leading
pharmaceutical company in the treatment of addiction, for the
development and commercialization of AEF0117 for disorders due 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 on 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, has finished recruitments of
its phase 1 program in healthy volunteers and will start in Q4 2022
a phase 1/2 study in Down syndrome subjects. This compound has
undergone an extensive preclinical proof-of-concept program using
highly innovative assessing cognitive functions. In this context,
AEF0217 has demonstrated its ability to completely reverse
cognitive deficits observed in several animal 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 23 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
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 detailed in Chapter 3 "Risk Factors" of
Aelis Farma's registration document approved by the Autorité des
marchés financiers on 14 January 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.
1The half-year accounts were approved by the Board of Directors
on September 23, 2022. The limited review of these accounts has
been completed. The auditors’ limited review report is in the
process of being issued.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220925005021/en/
AELIS FARMA Pier Vincenzo Piazza CEO
contact@aelisfarma.com
NewCap Dusan Oresansky/Hugo Willefert Investor Relations
aelis@newcap.eu +33 1 44 71 94 92
NewCap Arthur Rouillé Relations médias aelis@newcap.eu
+33 1 44 71 00 15
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