TIDMSILF
RNS Number : 2995Q
Silver Falcon PLC
11 September 2017
THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN ARE NOT
FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY,
IN WHOLE OR IN PART IN, INTO OR FROM THE UNITED STATES, SOUTH
AFRICA OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION
OR DISTRIBUTION WOULD BE UNLAWFUL. PLEASE SEE THE IMPORTANT NOTICE
AT THE OF THIS ANNOUNCEMENT
This announcement is an advertisement and not a prospectus.
Neither this announcement nor anything contained herein shall form
the basis of, or be relied upon in connection with, any offer or
commitment or invitation to purchase, otherwise acquire, issue,
subscribe for, sell or otherwise dispose of any securities
whatsoever in any jurisdiction. Investors should not purchase or
subscribe for any transferable securities referred to in this
announcement except on the basis of information contained in the
prospectus in its final form published by Silver Falcon PLC in
connection with the admission of the Company's ordinary shares to
the Official List of the UK Listing Authority and to trading on the
main market for listed securities of London Stock Exchange plc
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES
OF ARTICLE 7 OF THE MARKET ABUSE REGULATION (EU) 596/2014
Silver Falcon Plc
(the "Company")
Proposed acquisition of Hemogenyx LLC
Change of Name to Hemogenyx Pharmaceuticals Plc
Placing & Subscription to raise GBP2m
Readmission to the Official List on 5 October 2017
Silver Falcon Plc (LSE: SILF) announces the agreement to acquire
Hemogenyx Pharmaceuticals Limited for GBP8m (the "Acquisition") to
be satisfied by the issue of 228,571,428 Consideration Shares at a
price of 3.5p per share.
Hemogenyx Pharmaceuticals Limited is the holding company for
Hemogenyx LLC ("Hemogenyx"), a US based biotechnology company
developing therapies to transform bone marrow and blood stem cell
transplantation. These therapies will replace the need for existing
methods of preparation of patients for a transplantation such as
chemotherapy and radiation treatments, and will address the problem
of finding a matching stem cell donor and reduce the risk of blood
stem cell rejection after transplantation.
In conjunction with the Acquisition, the Company has raised
GBP2m through the issue of 57,142,857 New Ordinary Shares in a
Placing and Subscription at a price of 3.5p per share, plus 1 for 2
warrants to qualifying shareholders over 62,021,429 New Ordinary
Shares at 4.0p per share. Optiva Securities Ltd, Shard Capital
Partners LLP and Peterhouse Corporate Finance Limited, acted as
agents for the Company.
In addition, 3,428,541 New Ordinary Shares will be issued to
directors and advisers and up to 24,566,952 New Ordinary Shares
will be available under options granted or to be granted to
employees, proposed directors and advisory board members.
As the Acquisition is classified as a reverse takeover for the
purpose of the Listing Rules, completion of the Acquisition,
together with the Placing and Subscription will require the
cancellation of the Existing Ordinary Shares on the standard
listing segment of the Official List and readmission of the
Existing Ordinary Shares and the admission of the New Ordinary
Shares to the standard listing segment of the Official List
maintained by the FCA and to trading on the main market for listed
securities of the London Stock Exchange.
Completion of the Acquisition, Placing and Subscription is
conditional upon the Resolutions being passed at the General
Meeting of the Company, to be held at the offices of Charles
Russell Speechlys LLP, 5 Fleet Place, London EC4M 7RD at 10.00 a.m.
on 4 October 2017.
Subject to passing of the Resolutions, it is expected that
Admission will become effective, and that dealings in the Ordinary
Shares will commence at 8.00 a.m. on 5 October 2017.
The Company will then trade under the new company name of
Hemogenyx Pharmaceuticals Plc and new ticker symbol "HEMO".
The market capitalisation of the Company is expected to be
GBP12.46m on Admission.
HIGHLIGHTS
-- Hemogenyx is a preclinical stage biopharmaceutical group
developing new treatments for blood diseases such as leukaemia,
lymphoma and blood marrow failure
-- Hemogenyx therapies are designed to provide new treatments in
bone marrow/stem cell transplants, improving the success and safety
of such treatments
-- Two products under development -
1. Conditioning product - This product, CDX bi-specific
antibodies, redirects a patient's own immune cells to eliminate
unwanted blood stem cells preparing a patient for bone marrow (also
known as haematopoietic stem cell) transplantation. The Directors
believe that this product could replace traditional methods of
conditioning such as chemotherapy and radiation which are damaging
to a patient's health.
2. Cell therapy product - This cell replacement product uses
human postnatal hemogenic endothelial cells ("HuPHECs") to generate
cancer-free, patient-matched blood stem cells after transplant into
the patient. Being patient-matched, the risk of rejection of the
cells and the problem of blood stem cell matching is greatly
reduced. Dr Sandler was the person to discover that these cells
continue to exist in adults.
-- Market size (2015) c. $8-9billion in USA and Europe
-- Hemogenyx products would substantially increase market size
by addressing current stem cell treatment problems of patient
suitability, stem cell donor availability and relapse/cell
rejection
Geoffrey Dart, current Chairman, commented: "We listed Silver
Falcon with the aim of finding a value-enhancing reverse
transaction. After a lengthy and extensive search, we believe we
have found an exciting transaction, acquiring a company with the
potential to transform blood stem cell transplant treatments, and
bring relief to sufferers of several severe diseases. It has the
potential, we believe, for substantial gains for new and existing
shareholders."
Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx,
commented: "We are encouraged by the extensive work done to date
and excited by the prospect of taking this forward into human
trials and beyond thanks to the fund-raising facilitated by the
reverse listing of our company on the London Stock Exchange. We
believe the products we are developing should greatly reduce the
dangers of patient conditioning procedures and create a new form of
blood stem cell transplantation which, if successful, would greatly
enhance the long-term success of stem cell replacement therapy. We
look forward to keeping shareholders fully abreast of developments
as they occur."
Enquiries:
Hemogenyx Pharmaceuticals Limited www.hemogenyx.com
Dr Vladislav Sandler, Chief Executive Via Walbrook PR
Officer & Co-Founder
Peter Redmond, Director
Optiva Securities Ltd Tel: +44 (0)20 3137 1902
Christian Dennis
Shard Capital Partners LLP Tel: +44 (0)20 7186 9950
Damon Heath, Erik Woolgar
Peterhouse Corporate Finance Limited Tel: +44 (0)20 7469 0930
Lucy Williams/Duncan Vasey
Walbrook PR Tel: +44 (0)20 7933 8780 or hemogenyx@walbrookpr.com
Paul McManus Mob: +44 (0)7980 541 893
Sasha Sethi Mob: +44 (0)7891 627 441 or sasha@flowcomms.com
Below are extracts from the Prospectus which is available on the
Company's website:
www.silverfalconplc.com
Definitions in this announcement are the same as those included
in the Prospectus.
About Hemogenyx (www.hemogenyx.com)
Hemogenyx Pharmaceuticals Ltd (whose name is to be changed to
Hemogenyx UK Ltd) is incorporated in England. As from Completion,
it will hold a wholly owned US operating subsidiary, Hemogenyx LLC,
which is incorporated in the state of Delaware.
Hemogenyx LLC is a pre-clinical stage biopharmaceutical group
developing new treatments for blood diseases, such as leukaemia,
lymphoma and bone marrow failure. Hemogenyx has two distinct and
complementary products:
1. Conditioning product
Proprietary CDX bi-specific antibodies for conditioning patients
(immunotherapy class product candidate). The CDX bi-specific
antibodies redirect a patient's own immune cells to eliminate
unwanted blood stem cells preparing a patient for bone marrow
("BM") (also known as haematopoietic stem cell ("HSC"))
transplantation. The Directors believe that this product could
replace traditional methods of conditioning of chemotherapy and
radiation which are damaging to a patient's health.
Hemogenyx has achieved proof of principle for the use of CDX
antibodies. It has functionally validated CDX bi-specific
antibodies in vitro and in vivo in humanised mouse models. It is
anticipated that the CDX bi-specific antibodies will be capable of
use as an "off-the-shelf" conditioning product available for
application in relation to patients for all BM/HSC transplantations
that require conditioning.
2. Cell Therapy product
Human Postnatal Hemogenic Endothelial Cells ("Hu-PHECs")
generate cancer-free, patient-matched blood stem cells. The
Hu-PHECs, being cancer-free cells, are intended to largely
eliminate traditional BM/HSC transplants by improving the efficacy
of the therapy and, for most patients, potentially eliminating the
problem of having to find a matching donor that the majority of
patients needing BM/HSC transplants currently face. The Directors
believe that Hu-PHEC based cell replacement therapy will expand
access to the BM/HSC transplants and, when fully developed, could
revolutionise the ability of the body to regenerate a functioning
blood system.
Hu-PHEC cell therapy is considered by the Directors to be the
only therapy on the market or in trials that could result in a
reset of the blood system to a "clean state" therefore diminishing
the risk of cancer relapse. Hemogenyx estimates a substantial
market expansion opportunity by providing Hu-PHEC therapy to
patients unable to find a donor match. Dr Vladislav Sandler,
Co-Founder and CEO of Hemogenyx, was the person to discover that
these cells continue to exist in adults.
The Conditioning and Cell Therapy products are designed to
address a range of problems that occur with current standard of
care treatments. Both technologies are complementary with one
another and are considered to have the potential to enhance current
clinical practice. As such, they also have potential as a
substantial driver in the growth and application of BM/HSC
transplants, individually and used in conjunction with one
another.
De-risking with proof of principle
The Company has established sound proof of principle for both
the conditioning and the transplant cell technology through studies
conducted in the human hematopoietic system of humanised animals.
Such studies demonstrate that the CDX antibody-targeted
conditioning regime provides a good environment for subsequent stem
cell transplantation. Studies in similar animal models indicate
that Hu-PHECs are capable of safe and efficient restoration of the
human hematopoietic system.
Fast tracked as FDA Orphan Drug
Hemogenyx LLC has been granted FDA Orphan Drug Designation for
the Hu-PHEC product in relation to the treatment of aplastic
anaemia, which will enable it to move forward to clinical trials
faster. Aplastic anaemia, or bone marrow failure, is a rare
disorder in which the bone marrow fails to create enough blood
cells. Hemogenyx applied for Orphan Drug Designation in this regard
as the results are capable of use in expanding the application of
Hu-PHEC treatment for more complex and frequently diagnosed blood
diseases, such as lymphomas and leukaemia.
Exclusive license and Patent Protection Pending
Hemogenyx LLC holds an exclusive, worldwide, sub-licensable
license from Cornell University for Dr Sandler's invention, the
Hu-PHEC, which is now at PCT stage covering various regions
including the US, Canada, Japan, EU, Israel, China and Australia.
Additionally, Hemogenyx LLC has filed a provisional "composition
matter" patent application for the CDX bi-specific antibody
product.
Hemogenyx expects to complete a pre-Investigative New Drug
("IND") consultation programme with the FDA in relation to the CDX
product and will apply to obtain Orphan Drug Designation ("ODD")
for the CDX product in relation to patient conditioning for
pre-BM/HSC transplantation in a number of different blood cancers
and disorders.
Milestones
The Company's further proposed milestones over the eighteen
months from Admission for its CDX product include completing a
preclinical evaluation and the required IND-enabling studies,
filing an IND application with the FDA and preparing to move into
Phase 1 clinical trials. To assist in the progression of its own
product candidates, Hemogenyx is collaborating with, and receiving
income from, third parties in deploying its proprietary animal
models to assist in the evaluation of the immunogenicity of such
third parties' biologics which are under development for clinical
usage.
Hemogenyx's objectives over the eighteen months from Admission
for the Hu-PHEC product candidate will be to take forward the
Hu-PHEC Umbilical product candidate so all actions necessary prior
to an IND application have been completed. The IND process is a key
part of the process for taking drugs and treatments into clinical
trials in the United States. The Company will concentrate on
pre-clinical toxicology studies and will continue development of
other Hu-PHEC applications, including applying for ODD status for
use of Hu-PHEC in a number of other blood diseases in addition to
that already achieved for aplastic anaemia.
Further Background
Blood cancers affect over 1.1 million people in the United
States each year, and it is estimated that 171,500 new blood cancer
diagnoses were made in 2016. After exhausting all conventional
treatment options, including chemotherapy, radiation therapy and
immunotherapy, a BM/HSC transplant is typically the only remaining
choice for blood cancer patients. Hemogenyx seeks to address the
following problems that arise with BM/HSC transplants:
-- Difficulties in preparing patients for BM/HSC transplants -
the broad range of adverse side effects of currently used methods
of conditioning patients for BM/HSC treatment has harmful and in
many cases life-threatening effects on patients undergoing such
conditioning, preventing many patients from receiving such
treatment.
-- Acute shortage of BM/HSC donors - at least 60% of eligible
patients in the US are unable to find an appropriately matched
donor.
-- High failure rate of BM/HSC transplants - up to 50% of BM/HSC
transplants fail due to the body's rejection of the transplant,
complications from the procedure or a relapse of the disease.
BM/HSC transplantations require conditioning (preparation) of
patients for the transplantation. Conditioning of a patient for
BM/HSC transplant is integral to the procedure and is traditionally
achieved by administering chemotherapeutic agents sometimes in
conjunction with radiation. These preparative regimens are toxic
and non-selective, resulting in severe side effects which can be
life-threatening as the entire body is targeted. These side effects
include death, radiation damage, fertility issues, damage to bone
and bone growth problems.
Notwithstanding the risks, HSC/BM transplantations are used in
an increasing range of blood cancers and other non-malignant
disorders. However, many patients are still unable to undergo the
procedure, with a large minority of patients who do facing
significant dangers in both the conditioning before the
transplantation and during the BM/HSC transplant procedure itself.
Additionally, matching donors are more likely to be found among
close relatives or from people with ethnically similar backgrounds
to the patient and, as the global population becomes more
heterogeneous, the problem of finding matching donors is also
likely to increase.
Use of proceeds of the Placing and the Subscription
Following the Placing, the Subscription and Admission, and
taking into account the Company's and Hemogenyx's existing funds
and contracted revenue from Hemogenyx's clinical collaboration
work, the Company will have cash resources of approximately
GBP3.1m.
The Company expects that its existing cash resources combined
with the net proceeds of the Placing and the Subscription should be
sufficient to complete the IND-enabling preclinical development of
its lead product, the CDX bi-specific antibody, and to finance
significant further preclinical development of certain of the
Company's Hu-PHEC cell therapy product candidates, as described
above.
Directors of the Enlarged Group
Vladislav Sandler Ph.D.
Chief Executive Officer
Dr. Vladislav Sandler is the Co-Founder and CEO of Hemogenyx and
a research Assistant Professor at the State University of New York
(SUNY) Downstate. Dr. Sandler is a widely-published stem cell
scientist with decades of experience in scientific research. In
particular, Dr. Sandler has extensive experience developing novel
methods of direct reprogramming of somatic cells into functional
and engraftable hematopoietic stem cells, as well as developing
novel sources of pluri- and multi-potent cells.
Dr. Sandler has conducted his research in Israel, Canada and the
United States, including at the Children's Hospital at Harvard
Medical School, the Salk Institute for Biological Sciences, Harvard
University and Albert Einstein College of Medicine. He also led a
team of scientists at Advanced Cell Technologies, Inc. and was most
recently on the faculty of Weill Cornell Medical College. While at
Cornell, Dr. Sandler made the significant discovery that the cells
that give rise to blood stem cells during mammalian development
continue to exist after birth, and he developed the method of
isolation of these cells from humans. As a result of this important
work, Dr. Sandler was awarded the inaugural Daedalus Fund Award for
Innovation at Cornell. He went on to found Hemogenyx in order to
further pursue this significant scientific discovery and his
dedication to the translation of science into clinical
practice.
Dr. Sandler has published numerous peer-reviewed papers, and has
received a number of awards and fellowships for his scientific
research. Dr. Sandler received his PhD from the University of
British Columbia. He is a member of the International Society for
Stem Cell Research.
Dr Robin Campbell
Chairman
Robin Campbell, PhD has more than 30 years' experience working
in the pharmaceutical industry with large companies (Shell
Research, Beecham International (now GSK)), start-ups (Porton
International, PafraBio) and in investment banking primarily in
life sciences investment research (including Credit Suisse,
Jefferies).
Currently his specialty is searching out investable
opportunities in the broader life sciences sector, and helping
smaller companies raise growth capital. Robin has helped list a
number of companies onto AIM and other international exchanges,
advised companies on secondary fundraisings, private equity raises,
M&A and has a broad reach into institutional and retail
investor networks.
Initial roles in industry with, inter alia, Shell Research and
Beecham International (now GSK) encompassed R&D, international
strategic marketing and market access. He has also worked with
start-ups such as Porton International and Pafra Biopreservation in
business development roles. As a pharmaceutical and biotech
analyst, his experience extends back more than twenty years with a
range of firms including Credit Suisse First Boston, Hoare Govett
and Jefferies International and more recently he has acted in a
consultancy role in relation to a range of life sciences IPOs, AIM
introductions and M&A activity.
He has a degree in Microbiology from King's College London and a
Ph.D. in Immunobiology from Liverpool University. Dr. Campbell
currently advises a number of private and listed businesses in
respect to strategic and financial market opportunities.
Lawrence Pemble
Chief Operating Officer
Lawrence Pemble has over the past six years developed experience
in establishing, financing and developing new businesses.
He has led financing rounds, M&A activities, worked for
public companies and has held executive roles, up to and including
CEO, for start-up and private equity backed ventures, both in
private and public capacities.
He has worked extensively in the Private Equity industry, where
he has held executive positions in life science and technology
focused companies, most recently a Director of Blackcomb
Technologies Limited, a Canadian private equity firm focused on
military electronics and in Bonsai Capital Limited, a life sciences
focused Private Equity company where he is currently a Director.
Prior to this, he held a number of managerial and development
positions in resources companies, in the gold and oil and gas
sectors.
Timothy Le Druillenec
Finance Director and Company Secretary
Timothy is a Fellow of the Chartered Institute of Management
Accountants and provides consultancy and accounting services to a
number of public and private companies in some cases fulfilling the
role of director and/or Company Secretary. During 2013 he acted in
the same capacity at the AIM listed Leed Resources Plc, Kennedy
Ventures Plc and Pires Investments Plc. From 2005 to 2012, he was
CEO of Richards Walford & Company Ltd, a fine wine importer.
Prior to that from 1995 to 2004, he was the group finance director
and company secretary of Pacific Media Plc, a Main Market Company,
and during that time occupied the same roles at Bella Media Plc an
AIM listed company. He is currently Financial Director of Dukemount
Capital plc.
Alexis M. Sandler
Non-Executive Director
Alexis M. Sandler is the co-founder of Hemogenyx, for which she
has served as the Chief Operating Officer. An attorney with fifteen
years of experience in intellectual property and copyright, Ms.
Sandler handles day-to-day legal and operational matters for the
Company.
Ms. Sandler began her legal practice in Los Angeles at Hogan
& Hartson LLP (now Hogan Lovells), specializing in media and
intellectual property law. She then worked for several years at
Katten Muchin Rosenman LLP representing studios, production
companies, television networks, technology companies and other
major media companies in all aspects of entertainment, media and
intellectual property law. For three years, Ms. Sandler worked as
the Director of Business and Legal Affairs for a division of the
Fox Entertainment Group, where she advised the company on important
intellectual property, corporate and other legal and business
matters. Ms. Sandler went on to become the General Counsel at a
Smithsonian affiliate museum in New York City, and is currently the
Associate General Counsel at The Museum of Modern Art and the
Secretary of the Board of Directors of its affiliate institution,
MoMA PS1.
Ms. Sandler received her AB from Harvard University, her JD from
the UCLA School of Law and her MA from New York University. She is
a member of the State Bar of New York and the State Bar of
California.
Peter Redmond
Non-Executive Director
Peter Redmond is a corporate financier with some 30 years'
experience in corporate finance and venture capital. He has acted
on and assisted a wide range of companies to attain a listing over
many years, on the Unlisted Securities Market, the Full List and
AIM, whether by IPO or in many cases via reversals, across a wide
range of sectors, ranging from technology through financial
services to natural resources and biotech, in recent years often as
a director and shareholder of the companies concerned. He has been
active over many years in corporate rescues and reconstructions on
AIM and in reverse transactions into a range of investing
companies. He was a founder director of Cleeve Capital plc (now
Satellite Solutions plc) and Mithril Capital plc (now BeHeard plc),
both of which were admitted to the Standard List of the London
Stock Exchange, and took a leading role in the reconstruction and
refinancing of AIM-quoted Kennedy Investments and 3Legs Resources
plc. He is a director of AIM-quoted Pires Investments plc.
Adrian Beeston
Non-Executive Director
Adrian Beeston specializes in the financing and structuring of
small to medium size businesses, and the flotation of these
companies on the American Stock Exchange, AIM Exchange and TSX
Venture Exchange. Prior to this, Adrian was at Altium Capital, a
major pan-European corporate finance house, where he focused
primarily on the raising of private equity.
IMPORTANT NOTICE/DISCLAIMER:
The information contained in this announcement is not for
release, publication or distribution to persons in the United
States, Australia, Canada or Japan or in any jurisdiction where to
do so would breach any applicable law. No public offer of
securities is being made by virtue of this announcement.
This announcement has been prepared for the purposes of
complying with the applicable laws and regulations of the United
Kingdom and the information disclosed may not be the same as that
which would have been disclosed if this announcement had been
prepared in accordance with the laws and regulations of any
jurisdiction outside of the United Kingdom.
This announcement may include statements that are, or may be
deemed to be, "forward-looking statements". These forward-looking
statements may be identified by the use of forward-looking
terminology, including the terms "targets", "believes",
"estimates", "plans", "projects", "anticipates", "expects",
"intends", "may", "will" or "should" or, in each case, their
negative or other variations or comparable terminology, or by
discussions of strategy, plans, objectives, goals, future events or
intentions. These forward looking statements include all matters
that are not historical facts and involve predictions.
Forward-looking statements may and often do differ materially from
actual results. Any forward-looking statements reflect the
Company's current view with respect to future events and are
subject to risks relating to future events and other risks,
uncertainties and assumptions relating to the Company's business,
results of operations, financial position, liquidity, prospects,
growth or strategies and the industry in which it operates.
Forward-looking statements speak only as of the date they are made
and cannot be relied upon as a guide to future performance. Save as
required by law or regulation, the Company disclaims any obligation
or undertaking to release publicly any updates or revisions to any
forward-looking statements in this announcement that may occur due
to any change in its expectations or to reflect events or
circumstances after the date of this announcement.
Except as explicitly stated, neither the content of the
Company's website, nor any website accessible by hyperlinks on the
Company's website is incorporated in, or forms part of, this
announcement.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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