- New biomanufacturing campaign under GMP conditions using the
recently announce innovative and robust industrial process
- Subscription of equity-linked financing facility for up to
€12 million with IRIS
Disclaimer in accordance with the position-recommendation
2020-06 of the Autorité des Marchés Financiers: ABIONYX Pharma
set up a financing in the form of Bonds Redeemable in New Shares
with the company IRIS. It is not expected that IRIS will remain a
shareholder of ABIONYX Pharma after receiving the new shares
allocated in redemption of the bonds. The shares resulting from the
redemption of the bonds are expected to be sold on the market at
very short notice, which may create strong downward pressure on the
share price. Shareholders may suffer a loss of their invested
capital due to a significant decrease in the value of the company's
shares, as well as a strong dilution due to the large number of
securities issued to IRIS. Investors are invited to be very careful
before taking the decision to invest in the securities of the
company admitted to trading which carries out such dilutive
financing operations, particularly when they are carried out
successively. Investors are notably invited to take note of the
risks related to these operations, mentioned in the press release
below.
Regulatory News:
ABIONYX Pharma, (FR0012616852 - ABNX - PEA PME eligible),
a new generation biotech company dedicated to the discovery and
development of innovative therapies based on the world's only human
recombinant ApoA-I, announces the acceleration of its development
by launching a new bioproduction campaign according to the new
innovative robust process through the setting up of an
equity-linked financing facility.
Cyrille Tupin, Chief Executive Officer of ABIONYX Pharma,
stated: “ABIONYX achieves a major milestone in its development
towards the market launch of its most advanced biotherapeutic
product. After an uninterrupted series of positive clinical and
preclinical results in very severe indications, followed by the
successful manufacturing of a new batch under GMP conditions based
on a new innovative and robust industrial process, we are launching
a new biomanufacturing campaign to accelerate our development and
deploy our strategy on all target indications: the rare LCAT
deficiency or Norum disease, sepsis and ophthalmology. To support
this strategy, we have chosen to set up an equity-linked financing
facility to secure a maximum investment of €12 million within two
years. This facility gives us exceptional financial flexibility
given the biotech environment, the requirements from biotech funds
in terms of discount and the exceptionally high interest rates for
loans. We remain independent without any collateral on our patent
portfolio, knowing that this financing facility can be suspended at
any time and without penalty. This biomanufacturing campaign will
enable us to respond to the requests for compassionate access that
we are receiving from hospitals around the world to treat patients
with Norum disease and to anticipate the needs in other development
areas, particularly in sepsis, the third leading cause of death
worldwide, for which we are initiating discussions for a strategic
partnership.”
I - Rationale of the operation and financing outlook
This €12,000,000 financing will enable ABIONYX Pharma to launch
a brand new biomanufacturing campaign of the bioproduct CER-001 and
to finance other current expenses. The use of these batches will be
dedicated initially to "compassionate" use in LCAT deficiency,
supporting the clinical and manufacturing aspects for submission of
a marketing application, but will also make it possible to consider
future clinical studies in the fields of sepsis and
ophthalmology.
The manufacturing of these new batches follows the successful
manufacturing of the first batch of human recombinant Apoa-I,
CER-001, according to a new innovative and robust industrial
bioprocess, announced on May 10th, 2023, following its relocation
to France. ABIONYX Pharma thus demonstrated that the new production
line constitutes an innovative and efficient approach to access the
Apotherapy market, based on the only human recombinant ApoA-I
protein. All the steps of the biomanufacturing process have been
reviewed, improved and requalified allowing to significantly
increase future production yields and to anticipate validation for
phase 3 and commercialization. This will allow the initiation of
larger global therapeutic trials for Apotherapy programs.
Under the terms of the agreement, IRIS has committed to finance
the Company up to a maximum amount of €12,000,000 for a period of
24 months by subscribing to a maximum of 4,800 bonds redeemable in
shares to be issued with a par value of €2,500 each, in twenty (20)
tranches of €600,000, (i.e. €570,000 Net) each represented by 240
bonds.
A first tranche of €600,000 was immediately subscribed by IRIS
via the exercise of 240 warrants of Bonds Redeemable in New Shares.
The following tranches will be subscribed at the Company's
initiative, subject to the previous tranche having been fully
repaid.
It is specified that the Company may adjust upwards or downwards
the number of bonds subscribed for under a tranche within the limit
of the minimum number of 120 bonds and the maximum number of 480
bonds.
In the event that the Company does not call all of the bond
tranches, it will have to seek alternative sources of financing to
complete its manufacturing campaign, in particular by setting up
partnerships.
The investor will not retain the shares resulting from the
redemption of the bonds. They will be sold on the market or in
blocks. Thus, the investor concluded on May 10, 2023 with DOMUNDI,
a shareholder of the Company controlled by the Chairman of the
Board of Directors, a share lending agreement with the aim of
avoiding the time lag between the delivery of the shares resulting
from the redemption of bonds by the Company and their sale by the
investor.
It is reminded that, to date, ABIONYX has a cash position of
€2.9 million before the receipt of the research tax credit of
approximately €1.5 million, which will enable it to meet its needs
for 12 months.
It is reminded that over the last 24 months ABIONYX has carried
out the following operations on its capital:
- a capital increase in cash by private placement for an amount
of €4.2 million at a price of €3.60 per share (December 2021)
- a capital increase in remuneration of the contribution in kind
of all Iris Pharma Holding shares for an amount of €5,000,000, with
the issuance by the Company of 1,388,888 ordinary Abionyx shares at
a price of €3.60 per share (December 2021)
- final allocations of bonus shares covered by the delivery of
new shares which took place on December 10, 2021 for 713,277
shares, on November 18, 2022 for 437,500 shares and on February 27,
2023 for 87,608 shares.
No other capital transactions have been carried out over the
past 24 months.
II - Dilution
The dilution likely to be generated by this operation is as
follows:
II.1 - Impact of the issue on the shareholding of a
shareholder currently holding 1% of the Company's share
capital
Shareholder's interest (in %)
Non-diluted basis
Diluted basis (*)
Before issue
1.00%
0.96%
1st tranche
total tranches
1st tranche
total tranches
After redemption of the bonds and issue of
the new shares resulting from this redemption:
Based on an assumption of a redemption
price for the bonds as at the date of this press release, according
to the rules set out in §VI, i.e. €1.8262
0.99%
0.81%
0.95%
0.78%
On the basis of the maximum potential
dilution authorised by the Annual General Meeting on June 28, 2022
under the 20th resolution, i.e. a capital increase of a maximum
nominal amount of €450,000
-
0.76%
-
0.73%
(*) assuming the full exercise of the
warrants and the final allocation of the free shares giving the
right to subscribe to 139,750 and 1,151,945 new shares
respectively.
II-2 - Impact of the issue on the distribution of the share
capital
(Assuming a sale to the public of all new shares issued in
redemption of the bonds)
Shareholders
Before issue
After redemption of the bonds
and the issue of new shares resulting
from this reimbursement
Based on an assumption of a redemption
price for the bonds as at the date of this press release, according
to the rules set out in §VI, i.e. €1.8262
On the basis of the maximum potential
dilution authorised by the Annual General Meeting on June 28, 2022
under the 20th resolution, i.e. a capital increase of a maximum
nominal amount of €450,000
Number of shares
% of capital
Number of shares
% of capital
Number of shares
% of capital
DOMUNDI SC (represented by Emmanuel
Huynh)
3,320,198
11.67%
3,320,198
9.48%
3,320,198
8.87%
Sadok Belmokhtar
1,859,098
6.54%
1,859 098
5.31%
1,859,098
4.97%
BPI Participations (FR)
1,630,451
5.73%
1,630,451
4.66%
1,630,451
4.35%
Cyrille Tupin
1,592,214
5.60%
1,592,214
4.55%
1,592,214
4.25%
Jean-Louis Dasseux
1,286,781
4.52%
1,286,781
3.68%
1,286,781
3.44%
Luc Demarre
1,104,619
3.88%
1,104,619
3.16%
1,104,619
2.95%
Public
17,646,021
62.05%
24,217,043
69.17%
26,646,021
71.17%
TOTAL
28,439,382
100.00%
35,010,404
100.00%
37,439,382
100.00%
III - The risks
The Company draws attention to the risks to which current
shareholders and investors are exposed in the context of the
implementation of the present operation to issue securities giving
access to the capital in a staggered manner, and in particular:
- Risk of dilution of the Company's shareholders: the
Company's shareholders, who cannot participate in the transaction,
will be diluted when new shares will be issued to redeem the bonds
issued upon exercise of the warrants;
- Risk in the event of non-fulfilment of all the tranches:
the Company may have to seek additional financing. The total amount
of the bonds issue is not guaranteed and will depend in particular
on market conditions;
- Volatility risk and liquidity of the Company's shares:
the sale of shares on the market could have a significant impact on
the volatility and liquidity of the share;
- Risk of a decrease in the nominal value of the shares:
the massive issue of shares following the exercise of the bonds is
likely to have a downward impact on the Company's share price. In
this context and in order to be able to continue exercising the
bonds, the Company may reduce the nominal value of the shares. The
conditions for the realisation of the financing initially limited
to the nominal value of the shares on the date of the press release
may be called into question;
- Risk relating to the evolution of the stock market
price: as the intermediary is not intended to remain a
shareholder, sales of new shares issued in redemption of the bonds
could have an unfavourable impact on the Company's share
price.
In addition, shareholders are invited to consult the risks
specific to the Company described in paragraph 3 of its 2022
Universal Registration Document, available on its website as well
as that of the AMF (www.amf-france.org).
IV - Legal basis of the issue
The issue was decided by the Chief Executive Officer on May
23rd, 2023, acting on the authority of the Board of Directors
meeting on May 10, 2023, on the basis of the authority granted by
the Company's Annual General Meeting held on June 28, 2022, under
the terms of its 20th extraordinary resolution, which authorized
the issue of shares with cancellation of the preferential
subscription rights of existing shareholders in favor of categories
of persons within the limit of a maximum nominal amount of a
capital increase of €450,000.
V - Conflict of interest
There are no elements that could generate a conflict of interest
related to the proposed transaction.
However, it is specified that the obtaining of this financing
will be taken into account in the evaluation of the financial
criteria of the variable compensation of the Chief Executive
Officer that may be granted to him for the year 2023.
VI - Terms of the operation
Main characteristics of the Bonds Redeemable in New
Shares
Number of warrants
4,800 warrants
Subscription price
Free
Maturity
24 months
Exercise price
The exercise of a warrant will result in
the issuance of one bond with a nominal value of €2,500 to be
subscribed at par.
Terms of exercise
Warrants exercisable, at the initiative of
the issuer, by tranche of 240 giving right to 240 bonds for a value
of €600,000 (with an adjustment option at the initiative of the
issuer within the limit of a minimum number of 120 and a maximum
number of 480).
Undertaking by the subscriber to exercise
a first tranche of 240 warrants as soon as they are issued, the
issuer having the sole right, at its own initiative, to request the
exercise of additional tranches.
Commitment by the subscriber to exercise a
new tranche, subject in particular to the prior redemption of the
bonds from the previous tranche.
Option for the issuer not to call all the
bond tranches without penalty.
Ratio
Each warrant gives the right to subscribe
to one bond
Expenses related to the exercise of the
warrants
5% of the nominal amount of the drawdown
of each tranche, i.e. €30,000 before tax per tranche of
€600,000
Other information
Warrants issued in registered form,
unlisted and assignable or transferable only with the consent of
the issuer.
No warranty is given to the subscriber of
the bonds, in any form whatsoever, in particular by way of pledge
of its assets.
Main characteristics of the Bonds Redeemable in New Shares to
which the Warrants give right
Maximum number of bonds
4,800 bonds
Nominal value
€2,500
Issue price
At par (€2,500)
Reimbursement price
90% of the lowest daily VWAP for a period
of twenty (20) Trading Days immediately preceding the date of the
request for redemption of the bonds, which may not be less than 95%
of the weighted average of the prices of the last 10 trading days
preceding the date of the request for redemption of the bonds.
In the event that the reference period of
20 Trading Days referred to above includes a trading day on which
the investor has traded, such trading day will not be taken into
account for the calculation of the Redemption Price of the
bonds.
The redemption price of the bonds may not
be lower than the higher of (i) the minimum price set by the Annual
General Meeting on June 28, 2022 in its 20th resolution, i.e. 90%
of the weighted average of the prices of the last 10 trading days
preceding the date of the request for redemption of the bonds and
(ii) the nominal value of the shares.
Dilution
The number of shares issued in redemption
of the bonds will depend on the redemption price of the bonds.
The maximum number of shares to be created
may not represent a capital increase of a nominal amount exceeding
€450,000 (corresponding to the ceiling of the delegation used).
Term of the bonds
60 months from the date of issue
Number of tranches - Conditions for
drawing the tranches
A maximum of 20 bond tranches over a
period of 24 months.
1st drawdown was immediately
subscribed.
The following drawdowns assume the full
repayment of the previous tranches.
For more details, see: terms for
exercising the warrants.
Interest rates
Non-interest bearing bonds, callable and
redeemable at the issuer's initiative
Cases of default
Usual events of default, such as
non-performance of any repayment, delisting from Euronext Paris,
issuer's failure to pay a debt exceeding €500,000, cessation of
business, etc.
Structuring Commission
The Company will pay to KAPABE,
simplified joint stock company (“SAS”), with a share capital of
€40,000, with registered office at 55 Boulevard de Glatigny, 78000
Versailles, a structuring fee of €30,000 per drawdown of €600,000,
payable at the time of each drawdown
Structuring Commission
Limited to the fee payable only in the
event of a drawing on the exercise of the warrants (see above)
Penalty clauses
No penalty for non-drawing and if the
share price decreases below the par value of the shares
Other information
Bonds issued in registered form, unlisted
and assignable or transferable only with the consent of the
issuer
If, taking into account the shares issued in redemption of the
bonds, the Company were to issue over a period of less than 12
consecutive months more than 20% of the ordinary shares of the
Company already listed on Euronext Paris, it would prepare a
prospectus subject to the prior approval of the Autorité des
marchés financiers (AMF).
Next financial press release:
Cash position and activity update for Q2 2023, August 17,
2023
About ABIONYX Pharma
ABIONYX Pharma is a new generation biotech company that aims to
contribute to health through innovative therapies in indications
where there is no effective or existing treatment, even the rarest
ones. Thanks to its partners in research, medicine,
biopharmaceuticals and shareholding, the company innovates on a
daily basis to propose drugs for the treatment of renal and
ophthalmological diseases, or new HDL vectors used for targeted
drug delivery.
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version on businesswire.com: https://www.businesswire.com/news/home/20230523006037/en/
NewCap Investor relations Louis-Victor Delouvrier Nicolas
Fossiez abionyx@newcap.eu +33 (0)1 44 71 98 53 NewCap Media
relations Arthur Rouillé abionyx@newcap.eu +33 (0)1 44 71 94 98
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