TIDMFARN
RNS Number : 8595O
Faron Pharmaceuticals Oy
11 February 2021
THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS
RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN
WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM THE
UNITED STATES, AUSTRALIA, CANADA, JAPAN, THE REPUBLIC OF SOUTH
AFRICA, SINGAPORE, HONG KONG OR ANY OTHER JURISDICTION IN WHICH
SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES
OF ARTICLE 7 OF THE EU REGULATION 596/2014 ("MAR") AND ARTICLE 7 OF
MAR AS INCORPORATED INTO UK DOMESTIC LAW BY VIRTUE OF THE EUROPEAN
UNION (WITHDRAWAL) ACT 2018 ("UK MAR").
MEMBERS OF THE PUBLIC ARE NOT ELIGIBLE TO SUBSCRIBE FOR,
OTHERWISE ACQUIRE OR DISPOSE OF ANY SECURITIES IN FARON
PHARMACEUTICALS OY ("FARON") PURSUANT TO THE PROPOSED TRANSACTION
REFERRED TO IN THIS ANNOUNCEMENT. THIS ANNOUNCEMENT IS THEREFORE
DIRECTED ONLY AT, IN A MEMBER STATE OF THE EUROPEAN ECONOMIC AREA,
PERSONS WHO ARE "QUALIFIED INVESTORS" AS DEFINED IN ARTICLE 2(E) OF
THE EU PROSPECTUS REGULATION (WHICH MEANS REGULATION (EU)
2017/1129) (THE "PROSPECTUS REGULATION"). THIS ANNOUNCEMENT IS FOR
INFORMATION PURPOSES ONLY AND DOES NOT CONSTITUTE OR CONTAIN ANY
INVITATION, SOLICITATION, RECOMMATION, OFFER OR ADVICE TO ANY
PERSON TO SUBSCRIBE FOR, OTHERWISE ACQUIRE OR DISPOSE OF ANY
SECURITIES IN FARON OR ANY OTHER ENTITY IN ANY JURISDICTION IN
WHICH ANY SUCH OFFER WOULD BE UNLAWFUL.
IN ADDITION, IN THE UNITED KINGDOM, THIS ANNOUNCEMENT IS ONLY
DIRECTED AT PERSONS IN THE UNITED KINGDOM THAT ARE QUALIFIED
INVESTORS WITHIN THE MEANING OF ARTICLE 2(E) OF THE PROSPECTUS
REGULATION AS INCORPORATED INTO UK DOMESTIC LAW BY VIRTUE OF THE
EUROPEAN UNION (WITHDRAWAL) ACT 2018 THAT ARE ALSO (I) INVESTMENT
PROFESSIONALS FALLING WITHIN ARTICLE 19(5) OF THE FINANCIAL
SERVICES AND MARKETS ACT 2000 (FINANCIAL PROMOTION) ORDER 2005 (THE
"ORDER") AND/OR (II) HIGH NET WORTH ENTITIES, AND OTHER PERSONS TO
WHOM IT MAY LAWFULLY BE COMMUNICATED, FALLING WITHIN ARTICLE
49(2)(A) TO (E) OF THE ORDER (EACH SUCH PERSON, TOGETHER WITH
QUALIFIED INVESTORS AS DEFINED IN THE PROSPECTUS REGULATION, BEING
REFERRED TO AS A "RELEVANT PERSON").
ACCORDINGLY, THIS ANNOUNCEMENT AND ITS CONTENTS MUST NOT BE
ACTED ON OR RELIED ON BY PERSONS WHO ARE NOT RELEVANT PERSONS. ANY
INVESTMENT OR INVESTMENT ACTIVITY TO WHICH THIS ANNOUNCEMENT
RELATES IS AVAILABLE ONLY TO RELEVANT PERSONS AND WILL BE ENGAGED
IN ONLY WITH RELEVANT PERSONS. PERSONS INTO WHOSE POSSESSION THIS
ANNOUNCEMENT COMES ARE REQUIRED TO INFORM THEMSELVES ABOUT AND TO
OBSERVE ANY SUCH RESTRICTIONS.
THE PROPOSED TRANSACTION REFERRED TO IN THIS ANNOUNCEMENT WOULD
BE MADE PURSUANT TO A PRIVATE PLACEMENT EXEMPTION UNDER THE
PROSPECTUS REGULATION FROM THE REQUIREMENTS TO PRODUCE A PROSPECTUS
UNDER THE PROSPECTUS REGULATION FOR OFFERS OF SECURITIES . FARON
HAS NOT TAKEN ANY ACTION, NOR WILL IT TAKE ANY ACTION, TO OFFER ANY
OF THE PLACING SHARES THAT ARE TO BE SUBSCRIBED FOR PURSUANT TO THE
TRANSACTION REFERRED TO IN THIS ANNOUNCEMENT OR ANY DOCUMENTS
RELATING TO THE PLACING TO THE PUBLIC IN FINLAND, SWEDEN, NORWAY OR
DENMARK, OR IN ANY OTHER JURISDICTION IN ANY FORM WHICH WOULD
CONSTITUTE AN OFFER TO THE PUBLIC.
THE PLACING SHARES WILL NOT BE REGISTERED UNDER THE UNITED
STATES SECURITIES ACT OF 1933, AS AMED (THE "SECURITIES ACT"), OR
UNDER THE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE
UNITED STATES, AND MAY NOT BE OFFERED, SOLD OR TRANSFERRED,
DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM THE UNITED STATES EXCEPT
PURSUANT TO AN EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO,
THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN
COMPLIANCE WITH ANY APPLICABLE SECURITIES LAWS OF ANY STATE OR
OTHER JURISDICTION OF THE UNITED STATES. THE PLACING SHARES HAVE
NOT BEEN APPROVED OR DISAPPROVED BY THE US SECURITIES AND EXCHANGE
COMMISSION, ANY STATE SECURITIES COMMISSION OR OTHER REGULATORY
AUTHORITY IN THE UNITED STATES, NOR HAVE ANY OF THE FOREGOING
AUTHORITIES PASSED UPON ORORSED THE MERITS OF THE PLACING OR THE
ACCURACY OR ADEQUACY OF THIS ANNOUNCEMENT. ANY REPRESENTATION TO
THE CONTRARY IS A CRIMINAL OFFENCE IN THE UNITED STATES.
Faron Pharmaceuticals Oy
("Faron" or the "Company")
Proposed Issue and Placing of Shares to raise approximately EUR
15 million
Company announcement, 11 February 2021 at 4:30 p.m. GMT / 6:30
p.m. EET
Inside information
TURKU - FINLAND - Faron Pharmaceuticals Oy (First North: FARON,
AIM: FARN), the clinical stage biopharmaceutical company, today
announces a proposed private placement of new ordinary shares
("Placing Shares") to raise approximately EUR 15 million before
expenses to a limited number of institutional investors
("Placing"). Swedbank AB (publ), Finnish Branch ("Swedbank") is
acting as sole b ookrunner and financial adviser to the Company for
the Placing in association with Kepler Cheuvreux S.A.
The Placing will be conducted in a private placement by way of
an accelerated book-building process in which selected investors
may submit bids for the Placing Shares (the "Bookbuild"). The
subscription price per Placing Share is to be determined on the
basis of the bids received in the Bookbuild. The Bookbuild is
expected to commence immediately following this announcement and is
expected to end by 9:00 a.m. EET on 12 February 2021 at the latest.
The Bookbuild may be discontinued at any time during the
book-building process. Following the close of the Bookbuild, the
Board of Directors of Faron (the "Board") will make the decision on
the issue of the Placing Shares, including, as applicable,
acceptance of the received bids, the number of Placing Shares to be
issued and the subscription price per Placing Share (the "Issue
Price"). The Company has received non-binding indications of
interest from potential investors to subscribe for the Placing
Shares under the Placing during a pre-marketing process. In
addition, the Company and Swedbank have obtained from the European
Innovation Council (EIC) Fund ("EIC") a binding and irrevocable
pre-commitment to subscribe for one third (1/3) of the Placing
Shares for an aggregate amount of maximum EUR 10 million and
minimum EUR 3 million. EIC's pre-commitment is subject to certain
customary conditions.
As soon as practicable after the close of the Bookbuild, and
following receipt of binding commitments from investors, an
announcement will be made on the final number of the Placing Shares
to be issued and the Issue Price as well as the expected
registration date of the Placing Shares.
Further details on the terms and conditions of the Placing are
set out below.
The Placing Shares are expected to be issued and admitted to
trading on Nasdaq First North Growth Market Finland ("First North")
and AIM ("AIM") in London as set out below.
KEY HIGHLIGHTS
-- A proposed private placement to raise approximately EUR 15
million conducted by way of an accelerated book-building, directed
to a limited number of institutional and other investors, in which
Swedbank uses reasonable endeavours to procure subscriptions for
Placing Shares.
-- EIC has provided a binding and irrevocable pre-commitment to
subscribe for one third (1/3) of the Placing Shares for an
aggregate amount of maximum EUR 10 million and minimum EUR 3
million, subject to certain conditions.
-- The net proceeds of the Placing would be primarily used for
the expansion of the bexmarilimab clinical development programme
and manufacturing. Some proceeds would also be used to support the
clinical development of Traumakine (Ò) and its new manufacturing
process, and in strengthening the balance sheet.
-- As information not disclosed earlier, the cash balance held
by the Company as of 31 December 2020 was ca. EUR4.1 million.
-- Swedbank acts as Lead Manager and Sole Bookrunner of the
Placing and Financial Adviser to the Company in association with
Kepler Cheuvreux.
Dr Markku Jalkanen, Chief Executive Of ficer of Faron, said: "We
have continued to accelerate the clinical development of both of
our lead pipeline programs, bexmarilimab and traumakine, over
recent months and we are continually gaining valuable insights into
these promising immunotherapy candidates. It is a significant
achievement to have the support from the European Innovation
Council (EIC), firstly in the form of a grant in summer 2020 and
now with the pre-commitment, which is EIC's first investment in a
publicly listed company. This fundraise will enable us to continue
driving our two clinical programmes forward. I am looking forward
to providing further updates over the coming months."
REASONS FOR THE PROPOSED PLACING
The Faron pipeline has advanced significantly during the last
12-18 months. This pipeline development on both key projects
(bexmarilimab and Traumakine) provides an opportunity to build
further value for shareholders. The recent external support for
Traumakine's HIBISCUS study from the US Department of Defense (DoD)
allows the Company to focus on the design of new pivotal
bexmarilimab clinical trials, which could be accelerated with
further resources. This additional data generation, especially to
support bexmarilimab's expansion into new combination studies in
lung cancer and acute myeloid leukaemia, together with any MATINS
study cancer cohorts (hard-to-treat-solid tumours) will allow full
realisation of the potential upside connected to these projects.
Part of this development includes establishing a Company unit in
the US (Boston) to handle the increasing US activities (FDA and
clinical site interactions) that the pipeline development
requires.
The primary reason for conducting the Placing is to accelerate
and expand the clinical development of the Company's main drug
candidates, bexmarilimab and Traumakine (intravenous interferon
beta).
Bexmarilimab
-- testing h igher frequency of dosing to investigate potential for enhanced clinical responses;
-- three new trials to study bexmarilimab treatment in a
neoadjuvant setting, in combination with a PD(L)-1 checkpoint
inhibitor and in haematological malignancies; and
-- continuation of the MATINS trial, where five solid tumour
cohorts have demonstrated early signs of clinical benefit in the
first two stages (Part I and II) of the study.
Traumakine
-- launch of the phase II/III HIBISCUS study in the US; and
-- prepararations to expand into additional clinical indications.
General corporate
-- establishment of an operational unit in the US;
-- investment in the manufacturing of both bexmarilimab and intravenous interferon beta; and
-- strengthening of the Company's balance sheet.
DETAILS OF THE PROPOSED PLACING AND ISSUE OF EQUITY
The proposed Placing is being carried out within the
authorisation granted to the Board by shareholders at the Company's
Annual General Meeting held on 18 May 2020 to issue up to a total
of 8,650,000 ordinary shares in the Company in a directed share
issue and in deviation from the shareholders' pre-emptive rights.
As no shares have been issued within the outstanding authority, the
Company may issue up to a maximum of 8,650,000 new ordinary shares
pursuant to the Placing, which represents approximately 18.4 per
cent of all the issued shares and votes in the Company immediately
prior to the Placing.
The Placing, arranged by Swedbank in association with Kepler
Cheuvreux, will be conducted in a private placement by way of the
Bookbuild, which is an accelerated book-building process in which
selected investors may submit bids for the Placing Shares. The
Issue Price is to be determined on the basis of the bids received
in the Bookbuild. The Bookbuild is expected to commence immediately
following this announcement and is expected to end by 9:00 EET a.m.
on 12 February 2021 at the latest. The Bookbuild may be
discontinued at any time during the book-building process.
Following the close of the Bookbuild, the Board will make the
decision on the issue of the Placing Shares, including, as
applicable, acceptance of the received bids, the number of Placing
Shares to be issued and the Issue Price. As soon as practicable
after the close of the Bookbuild, receipt of binding commitments
from investors and the Board having resolved on carrying out the
Placing, an announcement will be made on the final outcome of the
Bookbuild and, as applicable, the number of the Placing Shares to
be issued and the Issue Price as well as the expected registration
date of the Placing Shares.
In connection with the proposed Placing, the Company has entered
into a placing agreement with Swedbank (the "Placing Agreement").
Pursuant to the terms of the Placing Agreement, Swedbank has agreed
to use its reasonable endeavours to procure the subscription of
Placing Shares. In addition, the Company and Swedbank have obtained
a binding and irrevocable pre-commitment from EIC to subscribe for
one third (1/3) of the total amount of the Placing Shares for an
aggregate amount of maximum EUR 10 million and minimum EUR 3
million. EIC's pre-commitment is subject to certain customary
conditions.
The Placing Agreement contains customary warranties and an
indemnity from the Company in favour of Swedbank together with
provisions which enable Swedbank to terminate the Placing Agreement
in certain circumstances before the completion of the Bookbuild and
the Board's resolution on carrying out the Placing, including where
there has been a material breach of any of the warranties contained
in the Placing Agreement or where there is a material adverse
change, e.g., in the business or financial affairs of the Company.
The Company has agreed to pay Swedbank certain commissions and fees
in connection with the Placing. Pursuant to the terms of the
Placing Agreement, Swedbank has agreed to a limited settlement
underwriting covering payments of the subscription prices to be
made by subscribers of the Placing Shares to the Company upon the
Board having resolved on carrying out the Placing after the close
of the Bookbuild, on the Issue Price, on approving the binding
subscriptions received through the Bookbuild and on confirming such
final number of the Placing Shares.
The Placing is conditional upon, inter alia:
-- the Placing Agreement having become unconditional in all respects;
-- binding commitments being received from investors;
-- the Board resolving to carry out the Placing at the Issue
Price and the Company and Swedbank entering into a separate pricing
agreement confirming the Issue Price and the number of the Placing
Shares; and
-- the Placing Shares being issued and being registered with the Finnish Trade Register.
In connection with the Placing, Faron has entered into a lock-up
undertaking, under which it has, subject to certain exceptions,
agreed not to issue or sell any shares in Faron for a period of
ninety days after the closing of the Placing.
Subject to all conditions being met, the Placing Shares are
expected to be entered in the Finnish Trade Register approximately
on 12 February 2021.
ISSUE OF THE PLACING SHARES AND ADMISSION TO TRADING
Subject to all conditions being met and the Placing Shares being
subscribed for, the Placing Shares are expected to be issued in one
tranche . To the extent shares are subscribed for and subject to
all conditions being met, application will then be made for the
admission of the Placing Shares to trading on First North and AIM
with said admission expected to become effective and trading to
commence on or around 16 February 2021 (the "Admission"). The dates
above may be subject to change.
A further announcement will be made to confirm the outcome of
the Placing (subject to, inter alia , satisfaction of the above
conditions) and to confirm the expected timing of issue of the
Placing Shares and the Admission.
Upon registration with the Finnish Trade Register, the Placing
Shares will rank pari passu in all respects with the existing
shares of the Company.
NOTE REGARDING THE COMPANY'S FINANCIAL REPORTING IN 2021
The Company will publish its Financial Statement Release and its
Annual Report 2020 (including financial statements) on 25 March
2021.
For more information please contact:
Faron Pharmaceuticals Oy
Dr Markku Jalkanen, Chief Executive Officer
investor.relations@faron.com
Swedbank AB (publ), Finnish Branch, Financial Adviser
Mika Karikoski (Corporate Finance)
Phone: +358 (0)40 741 6959
Cairn Financial Advisers LLP, Nomad
Sandy Jamieson, Jo Turner, Mark Rogers
Phone: + 44 207 213 0880
Sisu Partners Oy, Certified Adviser on Nasdaq First North
Juha Karttunen
Phone: +358 40 555 4727
Jukka Järvelä
Phone: +358 50 553 8990
Consilium Strategic Communications
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@consilium-comms.com
Stern Investor Relations
Julie Seidel
Phone: +1 (212) 362-1200
E-mail: julie.seidel@sternir.com
About Faron Pharmaceuticals Ltd
Faron (AIM: FARN, First North: FARON) is a clinical stage
biopharmaceutical company developing novel treatments for medical
conditions with significant unmet needs. The Company currently has
a pipeline based on the receptors involved in regulation of immune
response in oncology and organ damage. Bexmarilimab is its
investigative precision immunotherapy with the potential to provide
permanent immune stimulation for difficult-to-treat cancers through
targeting myeloid function. A novel anti-Clever-1 humanised
antibody, bexmarilimab targets Clever-1 positive (Common Lymphatic
Endothelial and Vascular Endothelial Receptor 1) tumour associated
macrophages (TAMs) in the tumour microenvironment, converting these
highly immunosuppressive M2 macrophages to immune stimulating M1
macrophages. With the ability to switch immune suppression to
immune activation in various conditions, bexmarilimab has potential
across oncology, infectious diseases and vaccine development.
Currently in phase I/II clinical development as a potential therapy
for patients with untreatable solid tumours, bexmarilimab has
potential as a single-agent therapy or in combination with other
standard treatments including immune checkpoint molecules.
Traumakine is an investigational intravenous (IV) interferon
beta-1a therapy for the treatment of acute respiratory distress
syndrome (ARDS) and other ischemic or hyperinflammatory conditions.
In addition to its profound antiviral effect, Traumakine
upregulates the cell surface protein Cluster of Differentiation 73
(CD73), an enzyme that suppresses pro-inflammatory responses in
endothelial cells. Using an IV administration of interferon beta-1a
provides optimal exposure to the lung vasculature, increasing
protection against serious lung complications and helping to
prevent vascular leakage by enhancing endothelial barrier function.
Traumakine is currently being evaluated in global trials as a
potential treatment for hospitalised patients with COVID-19. As
part of a working relationship established with Faron, the 59th
Medical Wing of the US Air Force and the US Department of Defense
are also evaluating Traumakine's role in preventing multiple organ
dysfunction syndrome (MODS) after ischemia-reperfusion injury
caused by a major trauma. Faron is based in Turku, Finland. Further
information is available at www.faron.com .
About the European Innovation Council Fund
Established in June 2020, the European Innovation Council
("EIC") Fund is a breakthrough initiative of the Commission to make
direct equity and quasi-equity investments (between EUR500.000 and
EUR15 million) in the capital of start-ups and SMEs. The EIC Fund
aims to fill a critical financing gap faced by innovative companies
when bringing their technologies to the commercialisation stage.
The Fund helps to fill this financing gap at the start-up stage
where the EU venture capital market still underperforms compared to
the global venture capital market. Its main purpose is not to
maximise the return on the investments, but to have a high impact
by accompanying companies with breakthrough and disruptive
technologies in their growth as patient capital investor.
IMPORTANT INFORMATION
Market Abuse Regulation
Market soundings, as defined in Regulation (EU) No 596/2014
("MAR"), were taken in respect of the proposed Placing with the
result that certain persons became aware of inside information, as
permitted by MAR. That inside information in relation to the
Placing is set out in this announcement and has been disclosed as
soon as possible in accordance with paragraph 7 of article 17 of
MAR. Therefore, those persons that received inside information in
such market sounding are no longer in possession of inside
information relating to the Company and its securities.
This announcement contains inside information for the purposes
of Article 7 of MAR and Article 7 of UK MAR.
MiFID II
Solely for the purposes of the product governance requirements
contained within: (a) EU Directive 2014/65/EU on markets in
financial instruments, as amended ("MiFID II"); (b) Articles 9 and
10 of Commission Delegated Directive (EU) 2017/593 supplementing
MiFID II; and (c) local implementing measures (together, the "MiFID
II Product Governance Requirements"), and disclaiming all and any
liability, whether arising in tort, contract or otherwise, which
any "manufacturer" (for the purposes of the MiFID II Product
Governance Requirements) may otherwise have with respect thereto,
the Placing Shares have been subject to a product approval process,
which has determined that the Placing Shares are: (i) compatible
with an end target market of: (a) retail investors, (b) investors
who meet the criteria of professional clients and (c) eligible
counterparties (each as defined in MiFID II); and (ii) eligible for
distribution through all distribution channels as are permitted by
MiFID II (the "Target Market Assessment"). Notwithstanding the
Target Market Assessment, distributors should note that: the price
of the Placing Shares may decline and investors could lose all or
part of their investment; the Placing Shares offer no guaranteed
income and no capital protection; and an investment in the Placing
Shares is compatible only with investors who do not need a
guaranteed income or capital protection, who (either alone or in
conjunction with an appropriate financial or other adviser) are
capable of evaluating the merits and risks of such an investment
and who have sufficient resources to be able to bear any losses
that may result therefrom. The Target Market Assessment is without
prejudice to the requirements of any contractual, legal or
regulatory selling restrictions in relation to the offer.
Caution regarding forward-looking statements
Certain statements in this announcement are, or may be deemed to
be, forward-looking statements. Forward-looking statements are
identified by their use of terms and phrases such as "believe",
"could", "should", "expect", "envisage", "estimate", "intend",
"may", "plan", "potentially", "will" or the negative of those,
variations or comparable expressions, including references to
assumptions. These forward-looking statements are not based on
historical facts but rather on the Directors' current expectations
and assumptions regarding the Company's future growth, results of
operations, performance, future capital and other expenditures
(including the amount, nature and sources of funding thereof),
competitive advantages, business prospects and opportunities. Such
forward-looking statements reflect the Directors' current beliefs
and assumptions and are based on information currently available to
the Directors.
A number of factors could cause actual results to differ
materially from the results and expectations discussed in the
forward-looking statements, many of which are beyond the control of
the Company. In addition, other factors which could cause actual
results to differ materially include the ability of the Company to
successfully licence its programmes, risks associated with
vulnerability to general economic and business conditions,
competition, environmental and other regulatory changes, actions by
governmental authorities, the availability of capital markets or
other sources of funding, reliance on key personnel, uninsured and
underinsured losses and other factors. Although any forward-looking
statements contained in this announcement are based upon what the
Directors believe to be reasonable assumptions, the Company cannot
assure investors that actual results will be consistent with such
forward-looking statements. Accordingly, readers are cautioned not
to place undue reliance on forward-looking statements. Subject to
any continuing obligations under applicable law or any relevant AIM
Rule requirements, in providing this information the Company does
not undertake any obligation to publicly update or revise any of
the forward-looking statements or to advise of any change in
events, conditions or circumstances on which any such statement is
based.
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END
IOEDKDBBABKDPBD
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