TIDMN4P
RNS Number : 5296P
N4 Pharma PLC
08 February 2019
The information contained within this announcement is deemed by
the Company to constitute inside information as stipulated under
the Market Abuse Regulations (EU) No. 596/2014 ("MAR"). With the
publication of this announcement via a Regulatory Information
Service, this inside information is now considered to be in the
public domain.
08 February 2019
N4 Pharma Plc
("N4 Pharma" or the "Company")
Placing to raise GBP1.05 million
N4 Pharma Plc (AIM: N4P), the specialist pharmaceutical company
developing a novel delivery system for vaccines and cancer
treatments, announces that it has raised GBP1.05 million before
expenses (approximately GBP1.0 million net of expenses) through a
placing of 10,500,000 new ordinary shares of 0.4p each in the
Company (the "Placing Shares") at an issue price of 10 pence per
Placing Share (the "Placing").
Highlights
-- The Placing Shares will represent approximately 10.35 per
cent. of the enlarged issued share capital of the Company and have
been subscribed for by a combination of new investors and existing
shareholders
-- The net proceeds of the Placing will be applied to:
o fund Nuvec(R) process improvement and moving towards GMP
manufacture readiness;
o fund further biological research to demonstrate Nuvec(R)
capability; and
o fund research into additional potential applications of
Nuvec(R)
Nigel Theobald, Chief Executive of N4 Pharma, said: "We have
made continued progress with Nuvec(R) and believe that it has the
potential to significantly improve patient outcomes and generate
value for investors and partners. I would like to thank investors,
new and existing, for their support which will enable us to further
develop this exciting opportunity."
Background to and reasons for the Placing
Since the publication of its interim results in September 2018,
and notification of its decision to close its generics division,
the Company has been focussed on undertaking research studies on
the pharmacology and pharmacokinetics of its Nuvec(R) delivery
system for vaccines and cancer therapeutics. This has involved
improving the manufacturing of the particles to make them more
effective and capable of being easily scaled up to commercial
manufacturing requirements. The Directors of the Company view this
as essential work to enable the Company to successfully conclude,
in due course, commercial research collaboration agreements with
its target partners.
As announced on 29 October 2018, the results have shown that the
Nuvec(R) particles themselves have a clear adjuvant effect to help
deliver a level of immune response for the standard test antigen
Ovalbumin ("OVA"). The type of response observed is consistent with
that required for a vaccine. The Company also started working with
EUNCL (European Nanomedicine Characterisation Laboratory) in
September 2018, to fully characterise the Nuvec(R) particle, which
has strengthened the Company's intellectual property position,
through the patent application for an improvement in the particle
manufacturing process. In addition, and as announced on 20 December
2018, the Company extended its license to the original patent from
University of Queensland, and now has an exclusive global licence
for the commercialisation of Nuvec(R) in all human therapeutic
treatments (and licenced back certain defined fields that are of no
commercial interest to the Company).
During the second half of 2018, N4 Pharma added to its team with
the appointments of Dr Allen Hey as Head of Nuvec(R) CMC Program
Development and Dr Melody Janssen as a Consultant for the Nuvec(R)
biological research program. During this period, the Company has
also identified further essential pre-clinical research to be
undertaken, focussing on demonstrating actual immune efficacy of
the particles in combination with an alternative tool antigen as
well as OVA. It has also established the work that will be needed
for both scaling up and getting the Nuvec(R) particle ready for GMP
manufacture.
In preparing its work programme for the next 12 months, the
Directors have fully considered the likely data requirements and
expectations of potential collaboration and commercial partners,
including MedImmune which, in recent discussions with the Company,
has provided its input to the scope and targets of various studies
N4 Pharma should undertake prior to MedImmune committing further
resource on the back of the results of those studies. This approach
ensures that the work being done remains relevant to the
progression of Nuvec(R) towards achieving its commercial objectives
whilst giving maximum flexibility on multiple potential
partners.
The Directors believe that the Placing provides the funds
required to complete this research, putting the Company in a strong
position to carry out detailed commercial discussions with multiple
potential research collaboration partners on opportunities in the
fields of vaccines and cancer therapeutics.
Use of proceeds
The net funds raised from the Placing will be used to fund the
program in the following areas:
Process improvement and move to GMP manufacture readiness
In order for Nuvec(R) to be ready to enter clinical studies with
any partner molecule, it must be capable of being provided at the
required scale and under GMP manufacturing conditions. The
Directors believe it is prudent to develop Nuvec(R) towards this
level of readiness to provide comfort to potential collaboration
partners. This work will focus on: improving the particle
resuspendability; investigating formulation stability with research
DNA; transferring the manufacturing process to a GMP capable
partner; and ensuring N4 Pharma can make the required quantum at
that partners facility. Subject to achieving this, the technology
transfer would be expected to start in Q3 2019.
Further pharmacokinetic/pharmacodynamic ("PK/PD") research to
demonstrate capability
Having established the level of immune response using the
antigen OVA, the Company will seek to demonstrate whether this
level of immune response is sufficient to produce an effective
level of immunity or cancer destroying effect. The Company will
undertake efficacy work using pDNA and mRNA with OVA and also look
to complete additional work using other tool antigens. OVA is the
industry standard research tool, and the Board considers that using
additional tools will further demonstrate Nuvec(R)'s capability
beyond the industry standard. OVA efficacy work with pDNA is
expected to commence in Q2 2019, with other model antigen work
commencing in the second half of 2019.
Additional Nuvec(R) versions and applications
Having extended its licence agreement with the University of
Queensland, the Company will investigate alternative linkers in
addition to than the existing PEI it uses and investigate which
alternative molecule such as peptides or small molecules, should be
the next area of development for Nuvec(R) to follow.
Details of the Placing and Total Voting Rights
A total of 10,500,000 Placing Shares are to be issued pursuant
to the Placing at a price of 10 pence per Ordinary Share. The
Placing has been conducted utilising the Company's existing share
authorities. Allenby Capital acted as the Company's sole broker.
The Placing is conditional, inter alia, admission of the Placing
Shares to trading on AIM ("Admission") becoming effective.
Application has been made to the London Stock Exchange for the
Placing Shares to be admitted to trading on AIM. It is expected
that Admission will become effective and that dealings in the
Placing Shares on AIM will commence on or around 14 February
2019.
On Admission, the Company's issued ordinary share capital will
consist of 101,462,537 ordinary shares of 0.4p each ("Ordinary
Shares"), with one vote per Ordinary Share. The Company does not
hold any Ordinary Shares in treasury. Therefore, on Admission, the
total number of Ordinary Shares and voting rights in the Company
will be 101,462,537. With effect from Admission, this figure may be
used by shareholders in the Company as the denominator for the
calculations by which they will determine if they are required to
notify their interest in, or a change to their interest in, the
share capital of the Company under the FCA's Disclosure Guidance
and Transparency Rules.
Information to Distributors
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
"Product Governance Requirements"), and disclaiming all and any
liability, whether arising in tort, contract or otherwise, which
any "manufacturer" (for the purposes of the 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 retail investors and investors who meet the
criteria of professional clients and 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,
investors should note that: the price of the Placing Shares may
decline and investors could lose all or part of their investment;
Placing Shares offer no guaranteed income and no capital
protection; and an investment in 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 Placing. Furthermore, it is noted that,
notwithstanding the Target Market Assessment, only investors who
have met the criteria of professional clients and eligible
counterparties have been procured. For the avoidance of doubt, the
Target Market Assessment does not constitute: (a) an assessment of
suitability or appropriateness for the purposes of MiFID II; or (b)
a recommendation to any investor or group of investors to invest
in, or purchase, or take any other action whatsoever with respect
to Placing Shares.
Enquiries:
N4 Pharma Plc Via Alma PR
Nigel Theobald, CEO
Allenby Capital Limited Tel: +44(0)203 328 5656
James Reeve/Asha Chotai
Alma PR
Josh Royston Tel: +44(0)778 090 1979
Helena Bogle Tel: +44(0)758 021 6203
About N4 Pharma plc
N4 Pharma is a specialist pharmaceutical company developing a
novel delivery system for vaccines and cancer treatments using its
unique silica nanoparticle delivery system called Nuvec(R).
Nuvec(R) has already shown to be capable of loading and
delivering mRNA and pDNA into cells to the required level needed to
generate an immune response capable of strong antibody
production.
N4 Pharma's business model is to partner with companies
developing novel antigens for vaccines and cancer treatments to use
Nuvec(R) as the delivery vehicle to deliver their antigen into
cells to express the protein needed for the required immunity. As
these products progress through pre-clinical and clinical programs,
N4 Pharma will seek to receive upfront payments, milestone payments
and ultimately royalty payments once products reach the market.
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END
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