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RNS Number : 8865U Shield Therapeutics PLC 03 July 2024
Shield Therapeutics plc
("Shield" or the "Company" or the "Group")
Shield Enters into $5.7 million Milestone Monetization Agreement with AOP
Dr. Rudolf Widmann, Founder of AOP, joins the Shield Board as Non-Executive
Director
London, UK, July 3 2024: Shield Therapeutics plc (LSE: STX), a commercial
stage pharmaceutical company that delivers Accrufer®/Feraccru® (ferric
maltol), an innovative and differentiated specialty pharmaceutical product, to
address a significant unmet need for patients suffering from iron deficiency
(with or without anaemia) announces it has entered into a $5.7 million
monetization agreement (the "Milestone Monetization Agreement" or "the
Agreement") with AOP Health International Management AG ("AOP"), the largest
shareholder in the Company, owning c. 39.8% of the Company's issued share
capital. The Company also announces that AOP's founder, Dr. Rudolf Widmann,
will join the Shield Board as a Non-Executive Director, effective immediately.
Under the terms of the Agreement, AOP will provide Shield $5.7 million (the
"Advance") in cash, in exchange for the right to receive the $11.4 million
China approval milestone payment (the "Approval Milestone") that may be paid
to Shield by Jiangsu Aosaikang Pharmaceutical Co., Ltd (ASK Pharma, Shield's
commercial partner for Accrufer® in China). ASK Pharma continues to enroll
patients into a Phase 3 study and enrollment is expected to complete late in
2024. Subject to the Phase 3 reading out successfully and regulatory approval
by the Chinese regulator Shield believes the Approval Milestone may be payable
by the year ending 2026. Further details of the Milestone Monetization
Agreement are set out below.
Greg Madison, Shield CEO, commented: "We are pleased to work with AOP on this
Milestone Monetization Agreement to bring in additional capital to support our
growing business. We are encouraged by the recent Accrufer® commercial trends
in the US and will continue to be opportunistic to further support our growing
business. This agreement, following our recently announced Sallyport deal,
provides us with additional operational and financial flexibility. The $5.7
million, along with approximately $8 million cash on hand at the end of May
2024 allows us to further fortify our balance sheet and expand our working
capital.
"It is also a pleasure to welcome AOP's Founder, Dr. Rudolf Widmann, to the
Shield Board of Directors. I believe that Rudi's strong track record of
building a successful pharmaceutical business and strategic perspective will
complement Shield 's current Board of Directors."
Dr. Widmann, Founder of AOP, commented: "I have long believed in Accrufer®'s
global growth potential and what it could do for patients worldwide suffering
from iron deficiency, with or without anaemia. We are pleased to expand our
stake in the Company's success through the Agreement announced today.
"I am delighted to join the Board of Directors and look forward to working
closely with Shield's leadership team and the Board to achieve the Company's
mission of making Accrufer®/Feraccru® the oral iron of choice."
Further details of the Milestone Monetization Agreement
Under the terms of the Agreement, in the event that the Approval Milestone
falls due Shield is required to pay its full value to AOP 30 days after the
Approval Milestone has been achieved.
Further, if the Approval Milestone has not been triggered by 31 December 2026,
or in the event the Agreement is terminated, including at Shield's election or
due to a breach by Shield of its terms, the Advance plus accrued interest and
fees at the interest rate of SOFR+9.25% (calculated from the date of the
Advance until the day of payment) and an exit fee of 6.5% of the Advance will
be payable by Shield to AOP. The Advance will be secured inter alia by AOP's
right to receive the ASK Approval Milestone.
Related Party Transaction
In view of the size of the Milestone Monetization Agreement and the fact that
AOP is a substantial shareholder in Shield for the purposes of the AIM Rules
for Companies (in that AOP currently has an interest of more than 10 per cent.
of the Company's issued share capital), the Company's entry into the Agreement
constitutes a related party transaction for the purposes of Rule 13 of the AIM
Rules for Companies. The Directors consider, having consulted with Peel Hunt
LLP, the Company's Nominated Adviser, that the terms of the Milestone
Monetization Agreement are fair and reasonable insofar as its shareholders are
concerned.
Biography of Dr. Rudolf Widmann
Dr. Rudolf Widmann is an experienced pharmaceutical scientist, seasoned
executive and entrepreneur who has devoted his career to advancing the care of
patients with rare diseases. He founded AOP Health (AOP Orphan Pharmaceuticals
GmbH) in 1996, starting as Chief Executive Officer and Chief Therapeutics
Development Officer and later elected to serve as a governing Board Member of
the AOP Health Group. Dr. Widmann holds a degree in pharmacy studies and a PhD
in pharmacology from the University of Innsbruck.
Shield also discloses the following information in accordance with Schedule
2(g) of the AIM Rules for Companies.
Full name: Dr. Rudolf Stefan Widmann
Age: 67 years
Current directorships/partnerships:
· AOP Health International Management AG
· Wirucon GmbH
Previous directorships/partnerships held in the past 5 years:
· AOP Orphan Limited
· Irorph GmbH
· Orphanidis Pharma Research GmbH
· OrphaCare GmbH
Dr. Widmann does not hold any ordinary shares in Shield.
There are no other disclosures required in connection with the appointment Dr
Widmann under Schedule 2(g) of the Aim Rules for Companies.
The following details are disclosed regarding the Letter of Appointment for Dr
Widmann:
· Non-Executive Directors (including Dr Widmann) receive the same base
fee of £40,000 together with additional fees for chairmanship of a Board
Committee (if applicable).
· All Non-Executive Directors may be reimbursed for expenses reasonably
incurred in the performance of their duties.
· As a Non-Executive Director Dr Widmann is not eligible to participate
in the Group's incentive arrangements.
· Dr Widmann's Letter of Appointment is for an initial term of three
years subject to annual reappointment at each AGM and contains a notice period
of 3 months.
The information contained within this announcement is deemed by the Company to
constitute inside information as stipulated under the Market Abuse Regulation
(EU) No. 596/2014 (as it forms part of domestic law by virtue of the European
Union (Withdrawal) Act 2018). Upon the publication of this announcement via
the Regulatory Information Service, this inside information is now considered
to be in the public domain.
For further information please contact:
Shield Therapeutics plc www.shieldtherapeutics.com (http://www.shieldtherapeutics.com/)
Greg Madison, CEO +44 (0) 191 511 8500
Santosh Shanbhag, CFO
Nominated Adviser and Joint Broker
Peel Hunt LLP
James Steel/Patrick Birkholm +44 (0)20 7418 8900
Joint Broker
Cavendish Ltd
Geoff Nash/ George Dollemore/Nigel Birks/Harriet
Ward
+44 (0)20 7220 0500
Financial PR & IR Advisor
Walbrook PR
Alice Woodings +44 (0)20 7933 8780 or shield@walbrookpr.com (mailto:shield@walbrookpr.com)
Investor Contact (US Advisor)
LifeSci Advisors, LLC
Joyce Allaire jallaire@lifesciadvisors.com (mailto:jallaire@lifesciadvisors.com)
About Iron Deficiency and Accrufer®/Feraccru®
Clinically low iron levels (aka iron deficiency, ID) can cause serious health
problems for adults of all ages, across multiple therapeutic areas. Together,
ID and ID with anaemia (IDA) affect about 20 million people in the U.S. and
represent a $2.3B market opportunity. As the first and only FDA approved oral
iron to treat ID/IDA, Accrufer® has the potential to meet an important unmet
medical need for both physicians and patients.
Accrufer®/Feraccru® (ferric maltol) is a novel, stable, non-salt-based oral
therapy for adults with ID/IDA. Accrufer®/Feraccru® has a novel mechanism of
absorption compared to other oral iron therapies and has been shown to be an
efficacious and well-tolerated therapy in a range of clinical trials. More
information about Accrufer®/Feraccru®, including the product label, can be
found at: www.accrufer.com (http://www.accrufer.com) and www.feraccru.com
(http://www.feraccru.com) .
About Shield Therapeutics plc
Shield is a commercial-stage specialty pharmaceutical company that delivers
Accrufer®/Feraccru® (ferric maltol), an innovative and differentiated
pharmaceutical product, to address a significant unmet need for patients
suffering from iron deficiency, with or without anaemia. The Company has
launched Accrufer® in the U.S. with an exclusive, multi-year commercial
agreement with Viatris Inc. (Viatris). Outside of the U.S., the Company has
licensed the rights to four specialty pharmaceutical companies. Feraccru® is
commercialised in the UK and European Union by Norgine B.V. (Norgine), which
also has marketing rights in Australia and New Zealand. Shield also has an
exclusive license agreement with Beijing Aosaikang Pharmaceutical Co., Ltd.
for the development and commercialisation of Accrufer®/ Feraccru® in China,
Hong Kong, Macau and Taiwan; with Korea Pharma Co., Ltd. for the Republic of
Korea (Korea Pharma); and with KYE Pharmaceuticals Inc. for Canada. To learn
more about Shield Therapeutics, see our website at www.shieldtherapeutics.com
(http://www.shieldtherapeutics.com) or follow us on LinkedIn.
Accrufer®/Feraccru® has patent coverage until the mid-2030s.
Accrufer®/Feraccru® are registered trademarks of Shield Therapeutics.
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