REG - Shield Therapeutics - Business Update

Shield TherapeuticsAnnouncement

21/11/2024 07:00

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RNS Number : 0479N  Shield Therapeutics PLC  21 November 2024

  Shield Therapeutics plc

("Shield" or the "Company" or the "Group")

 

Business Update

Recruitment completed of the Phase 3 confirmatory Study in China in adult
patients

with inflammatory bowel disease (IBD) and Iron Deficiency Anemia (IDA)

 

Progress towards the provision of $10 million of new equity by AOP Health by
the end of 2024

 

Strong sales of ACCRUFeR® in the month of October 2024,

guidance reiterated to meet the Group revenue covenant target of $31.5 million
for the full year 2024

 

 

London, UK, 21 November 2024: Shield Therapeutics plc (LSE: STX), the
commercial stage pharmaceutical company specialising in iron deficiency,
provides an update covering recent activities.

 

Clinical Program in China

The Phase 3 confirmatory study in China is jointly sponsored by Shield and its
partner Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK), the exclusive license
holder for the development and commercialisation of ACCRUFeR®/ FeRACCRU® in
China, Hong Kong, Macau and Taiwan. This trial is the final study required to
support the filing of an NDA in China for the commercialisation of
Feraccru®/Accrufer and recruitment has recently been completed of adult
patients with IBD and IDA. The Company expects the NDA to be filed with the
Chinese National Medical Products Administration (NMPA) in 2025. Further
details will be announced in due course.

 

AOP Health subscription

On 29 October 2024 the Company announced that it had entered into a
non-binding term sheet with AOP Health International Management AG ("AOP
Health") for the potential provision of $10 million of new equity. The Company
is engaged with The Panel on Takeovers and Mergers (the "Takeover Panel") to
seek a waiver from the obligation of AOP Health to make an offer under Rule 9
of the Takeover Code and expects to convene a meeting of Shield's shareholders
(the "General Meeting") before the end of 2024.

 

ACCRUFeR® sales performance

Based on strong sales of ACCRUFeR® in October 2024, driven primarily by an
increase in Net Selling Price to more than $225 per prescription compared to
$167 per prescription in Q3 2024, the Company remains on track to meet the
total Group revenue covenant target of $31.5 million for full year 2024 under
the debt facility agreement with SWK Funding LLC.

 

Anders Lundstrom, interim CEO commented: "We are delighted that our partner,
ASK, has completed recruitment into the confirmatory Phase 3 study that will
support the filing in China to commericalise ACCRUFeR®/FeRACRRU®,
significantly increasing the global availability of a welcome additional
well-tolerated and effective therapeutic option for the treatment of IDA. In
addition, solid growth of ACCRUFeR® revenues in October give us a promising
outlook for the rest of the fourth quarter, leaving us on track to meet our
2024 Group revenue covenant target and market expectations for the year."

 

For further information please contact:

 

 Shield Therapeutics plc                                                                        www.shieldtherapeutics.com (http://www.shieldtherapeutics.com/)
 Anders Lundstrom, 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/ Rory Sale/Nigel Birks/Harriet
 Ward

                                                                                                +44 (0)20 7220 0500

 Financial PR & IR Advisor
 Walbrook PR
 Alice Woodings / Lianne Applegarth                                                             +44 (0)20 7933 8780 or shield@walbrookpr.com (mailto:shield@walbrookpr.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 anemia (IDA) affect about 20 million people in the US 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. The drug 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 anemia. The Company has
launched ACCRUFeR® in the U.S. with an exclusive, multi-year collaboration
agreement with Viatris. Outside of the U.S., the Company has licensed the
rights to four specialty pharmaceutical companies. FeRACCRU® is
commercialized in the UK and European Union by Norgine B.V., 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 commercialization of ACCRUFeR®/ FeRACCRU® in China, Hong
Kong, Macau and Taiwan, with Korea Pharma Co., Ltd. for the Republic of Korea,
and with KYE Pharmaceuticals Inc. for Canada.

 

ACCRUFeR®/FeRACCRU® has patent coverage until the mid-2030s.

ACCRUFeR®/FeRACCRU® are registered trademarks of Shield Therapeutics.

 

Forward-Looking Statements

This press release contains forward-looking statements. All statements
contained in this press release that do not relate to matters of historical
fact should be considered forward-looking statements.  These forward-looking
statements are based on management's current expectations and include
statements related to the commercial strategy for ACCRUFeR®/FeRACCRU®. These
statements are neither promises nor guarantees, but involve known and unknown
risks and uncertainties, many of which are beyond our control, that may cause
actual results and performance or achievements to be materially different from
management's expectations expressed or implied by the forward-looking
statements, including, but not limited to, risks associated with the Company's
business and results of operations, competition and other market factors.
The forward-looking statements made in this press release represent
management's expectations as of the date of this press release, and except as
required by law, the Company disclaims any obligation to update any
forward-looking statements contained in this release, even if subsequent
events cause its views to change.

 

Details of the ASKC109-LC-1 Phase 3 study

This study was based on the design of the Phase 3 study that supported the
approval of ACCRUFeR®/FeRACCRU® in the EU, USA, and other countries.  It is
a multicenter, randomized, double-blind and placebo controlled 12 week study
confirming the safety and efficacy of ferric maltol capsules (30mg elemental
iron) as a twice-daily treatment of IDA in subjects with IBD (Ulcerative
Colitis (UC) or Crohn's disease (CD)) where oral ferrous preparations have
failed or cannot be used.

 

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