REG - Shield Therapeutics - Audited results for the year ended 31 Dec 2024
24/04/2025 07:10
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RNS Number : 0176G Shield Therapeutics PLC 24 April 2025
Shield Therapeutics plc
("Shield" or the "Company" or the "Group")
Audited results for the year ended 31 December 2024
2024 Group net revenues and other income at $32.3m with ACCRUFeR® net
revenues growing 153% to $29.3m
Substantial progress made in expanding global patient access of
ACCRUFeR®/FeRACCRU®
London, UK, 24 April 2025: Shield Therapeutics plc (LSE: STX), a
commercial-stage pharmaceutical company specialising in iron deficiency,
confirms its audited results for the year ended 31 December 2024.
2024 reflected a significant step-up in revenue, alongside making substantial
progress in expanding global patient access of ferric maltol. The Company
reported total revenues and other income of $32.3m for FY24 (FY23: $17.5m) and
has seen strong improvements in ACCRUFeR® prescriptions with a 95% growth in
total prescriptions to c.150,000 in 2024 generating $29.3m of ACCRUFeR®
revenues (FY23: $11.6m), an increase of 153%.
During the final quarter of 2024, the Company took a decisive step to
strengthen its balance sheet by securing $10.0m in equity funding from its
largest shareholder AOP Health International Management AG ("AOP"), alongside
a small contribution from a RetailBook Offer. This funding, which was
completed at a premium to the prevailing share price, was received in January
2025. Shield held cash and cash equivalents of $6.5m as at 31 December 2024
(31 December 2023 was $13.9m), with an additional $10m of gross proceeds
received on 3 January 2025. The strengthened balance sheet, along with the
previously announced savings to the Group's operating cost base, will help the
Company achieve its aim of becoming cash flow positive by the end of calendar
2025.
2024 Financial Highlights
· Total 2024 net revenue and other income of $32.3m ($17.5m FY23).
o ACCRUFeR® net revenue of $29.3m, a 153% increase over 2023 reported
revenues.
o Ex-U.S. revenue of $2.9m of royalty and milestone related revenue from
partners.
· Loss for the year of $27.2m compared to $33.3m in FY23.
· Cash and cash equivalents of $6.5m as of 31 December 2024, with an
additional $10.0m of gross proceeds from the equity funding received post year
end, expected to provide sufficient capital to allow the Company to become
cash flow positive by the end of the year.
2024 Operational Highlights
· Commercialisation of ACCRUFeR® in the US: Continued growth and
strong market results with our partner, Viatris Inc.
o ACCRUFeR® Prescriptions of c.150,000 for FY24, almost double FY23.
o ACCRUFeR® average net price of $184 for FY24 and exiting Q4 2024 at $237
driven by successful execution of market access strategies.
o Realignment of US sales team in Q4 2024 focusing on territories with
highest potential, optimal coverage and strong ACCRUFeR® performance.
· Global ACCRUFeR®/FeRACCRU® development programs: Continued progress
in development stage partnerships in Canada, Republic of Korea, China, and the
pediatric program.
o Kye Pharmaceuticals ("Kye") in Canada: ACCRUFeR® approved by Health
Canada, the only oral iron therapy approved as a prescription drug in Canada.
The team at Kye announced the launch of ACCRUFeR® in March 2025. For the
remaining term of the agreement, Shield will receive additional revenue-based
milestone payments along with double-digit royalties on net sales of
ACCRUFeR®.
o Korea Pharma ("KP") in Korea: KP filed a New Drug Application for
ACCRUFeR® in the Republic of Korea (South Korea) following the successful
completion of a pharmacokinetic (PK) study. Pending a successful review,
approval of ACCRUFeR® in Korea is anticipated in 2025.
o ASK Pharma ("ASK") in China: ASK announced completion of the recruitment
of adult patients with IBD and IDA in the Phase 3 confirmatory study, which is
the final study required to support the filing of an NDA in China for the
commercialisation of ACCRUFeR®/ FeRACCRU®. The Company expects the NDA to be
filed with the Chinese National Medical Products Administration (NMPA) in
2025.
o Pediatric study: Results from the Phase 3 pediatric clinical trial
(FORTIS/ST10-01-305), confirmed the efficacy, safety, and tolerability of the
new oral liquid pediatric suspension in children with iron deficiency anemia
(IDA). The trial was the final study in the comprehensive pediatric
development program that Shield committed to implement with both the European
EMA and the US FDA.
2024 Annual Report and Notice of Annual General Meeting
The Annual Report and Accounts and Notice of AGM will be sent to shareholders
and in accordance with AIM Rule 26, these documents will also be available to
view on the Company's website: Results, Reports & Presentations | Shield
Therapeutics plc
(https://www.shieldtherapeutics.com/investors-and-media/results-reports-and-presentations/)
as of 25 April 2025.
This year the Company's AGM will be held at 2.00 pm (BST) on 22 May 2025 at
the offices of Shield Therapeutics plc, Northern Design Centre, Baltic
Business Quarter, Gateshead Quays, NE8 3DF. If you wish to attend the AGM in
your capacity as a shareholder, please bring proof of shareholding or if
shares are held through a nominee account, a letter of representation, to
facilitate your entry into the Meeting. The Company will provide a facility
for shareholders to join the AGM online and telephonically and there will be
an opportunity for shareholders to ask questions. To facilitate the process,
the Board would request that shareholders register for the meeting and submit
questions in advance, before 2.00 pm (BST) on 20 May 2025.
To register for dial-in details and to submit any questions please contact
Investor Relations via email at investorrelations@shiedtx.com
(mailto:at%C2%A0investorrelations@shiedtx.com) or call +44 (0)191 511 8500.
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 investorrelations@shieldtx.com (mailto:investorrelations@shieldtx.com)
Stephanie Hicks, Investor Relations
Nominated Adviser and Joint Broker
Peel Hunt LLP
James Steel +44 (0)20 7418 8900
Joint Broker +44 (0)20 7220 0500
Cavendish Ltd
Geoff Nash / Rory Sale / Nigel Birks / Harriet
Ward
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 launched
ACCRUFeR® in the U.S. with an exclusive, multi-year collaboration agreement
with Viatris Inc. Outside of the U.S., the Company 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.
Chairman and Chief Executive Officer's joint statement
As we reflect on Shield's performance during 2024, we are very proud of our
teams' efforts in making significant progress towards achieving our strategic
goal of positive cash flow by the end of 2025.
In 2024 Shield generated a total of $32.2 million in net revenues (excluding
Other Income), reflecting 146% growth over 2023 which was mainly driven by
sales growth in the US market. The team worked hard to ensure that we
strengthened our balance sheet by adding ~$31 million in additional financing
in 2024 and shortly post the year end and resetting our operating cost base to
put us in the best position to deliver against our core objective of being
cash flow positive by end of 2025. In the US, ACCRUFeR® prescriptions nearly
doubled while the average net selling price increased to $237 in Q4 2024,
compared to $143 in Q4 2023. Additionally, 2024 saw a 153% year-over-year
increase in net revenues from ACCRUFeR® reaching $29.3 million.
Our partnership with Viatris in the US has continued to progress steadily and
successfully. Both organisations are strategically aligned and the
commercialisation of ACCRUFeR® benefits from a strong collaboration and
focused execution. Together, we remain steadfast in our commitment to making
ACCRUFeR® the oral iron of choice in the US. Outside of the US we were
thrilled that in 2024 our partner in Canada, KYE Pharmaceuticals, was able to
secure regulatory approval for ACCRUFeR® as a prescription drug for the
treatment of adults with iron deficiency anemia (IDA) with Health Canada. This
milestone makes Health Canada the fifth regulatory agency in the world, after
the FDA (US), EMA (EU), TGA (Australia), and Swiss Medic (Switzerland),
addressing a significant unmet need for patients suffering from ID/IDA.
Similarly, our partner Korea Pharma, is working closely with the Korean
Ministry of Food and Drug Safety (MFDS) to secure approval of ACCRUFeR® in
South Korea, while our partner ASK Pharma has successfully completed
recruitment of the Phase III confirmatory study in China in adult patients
with inflammatory bowel disease (IBD) and IDA. We are also excited about the
prospect of receiving a label expansion from the FDA and EMA for pediatric
patients with IDA based on successfully proving highly clinically relevant
effectiveness in a pivotal trial in that patient population.
Royalty and milestone revenues accounted for $2.9 million (2023: $1.5 million)
including $2.1 million from FeRACCRU® sales in Europe by Norgine, with
Germany and United Kingdom accounting for 67% and 21% respectively. Therefore,
whilst the US market is the core near-term growth driver, we expect
incremental revenues from other territories to become increasingly significant
to the Group in the future.
We couldn't be prouder of the dedication, resilience, and performance shown by
our team throughout 2024. The
milestones we reached in 2024 not only highlight the strength of our team but
also the growing demand and receptivity to ACCRUFeR® by patients and
physicians across global markets.
Looking Ahead - Our goal is to be a self-sustaining business by the end of
2025. The solid financial foundation we have in place exiting 2024, empowers
us to move forward with confidence, fully equipped to execute our strategy.
With a stronger balance sheet, effective cost-saving measures, and a thriving
presence in the U.S. market, aiming at achieving cash flow positivity by the
end of 2025. As we look ahead, our focus is crystal clear:
• Grow ACCRUFeR® net revenues
• Turn cash flow positive by the end of 2025
• Expand Global access to ACCRUFeR®
We are just getting started on our journey to making ACCRUFeR® the oral iron
of choice.
Hans Peter Hasler, Chairman
Anders Lundstrom, Chief Executive Officer
Financial Review
Revenue
In 2024, total revenue (excluding other income) reached $32.2 million, up from
$13.1 million in 2023. This includes $29.3 million (2023: $11.6 million) in
net product revenue from ACCRUFeR® sales in the US, with c.150,000
prescriptions (2023: c.77,000 prescriptions). A significant portion of 2023
and 2024 prescription sales were subsidized through patient assistance
programs, resulting in a net average sales price of $184 in 2024 (2023: $137).
By the end of Q4 2024, the net average sales price had increased to $237.
Additionally, royalty and milestone revenues accounted for $2.9 million (2023:
$1.5 million) including $2.1 million from FeRACCRU® sales in Europe by
Norgine, with Germany and United Kingdom accounting for 67% and 21%
respectively. Milestone payments accounted for $0.8 million from our Canadian,
Korean and prospective Japanese partners.
Cost of sales
The cost of sales for 2024 totaled $17.3 million, compared to $9.0 million in
2023. This includes the manufacturing and shipping costs for prescriptions
sold in the US, finished packs supplied to Norgine for sale in Europe, and a
5% royalty on net sales payable to Vitra Pharmaceuticals Limited ("Vitra") who
are the original owners of the intellectual property behind
ACCRUFeR®/FeRACCRU®.
Selling, general and administrative expenses
Selling, general and administrative expenses were $36.0 million in 2024 (2023:
$38.0 million). The decrease was driven primarily due to the restructuring of
the ACCRUFeR® sales force announced in Q4 2024. The share-based payment
charge to the income statement was $0.9 million in 2023 and 2024.
Research and development
The Group spent $4.3 million (2023: $4.5 million) on research and development.
Of that total spend, $2.4 million (2023: $2.7 million) have been capitalised
as additions to intangible assets, as management deemed that it is probable
that these costs will generate future economic benefits. The balance of $1.9
million (2023: $1.8 million) was expensed in the current year. Research and
development expenditure is predominantly related to the ongoing pediatric
study.
Financial income
Financial income of $0.3 million was reported in 2024 (2023: $0.5 million).
This income was generated primarily through interest received from treasury
bank account interest.
Financial expense
Financial expense of $3.9 million was reported in 2024 (2023: $1.6 million).
The expense was primarily related to interest charged on the shareholder loan
and later the long-term loan with SWK Holdings alongside the AOP milestone
financing put in place during 2024.
Balance sheet
As of 31 December 2024, cash stood at $6.5 million, down from $13.9 million on
31 December 2023. As at 31 March 2025 cash and cash equivalents were $10.5
million reflecting the close of the equity financing just post the year end.
Intangible assets increased to $18.2 million as of 31 December 2024, up from
$16.9 million in 2023. This includes capitalized development costs for
FeRACCRU®, such as the ongoing pediatric pharmacokinetic study, and costs
related to FeRACCRU® patents and trademarks, which were incurred to
strengthen the Group's intellectual property.
Inventories grew to $5.7 million (31 December 2023: $3.2 million), reflecting
the Group's efforts to build inventory in response to growing demand in the US
market.
Trade and other receivables as of 31 December 2024 were $25.0 million, up from
$13.5 million at 31 December 2023. This increase is due to higher trading
volumes in the US, alongside $10.0 million owed by AOP from the equity placing
on 29 December 2024, which was paid on 3 January 2025.
The current tax asset stood at $0.3 million at 31 December 2024, down from
$0.6 million in 2023. This relates to the expected R&D tax credit claim
for the 2024 and 2023 financial years.
Non-current liabilities include a long-term loan from SWK Holdings for $19.8
million and milestone financing from AOP for $6.4 million. Both loans are
accounted for using an effective interest rate method in line with IFRS 9.
Trade and other payables were $23.2 million as of 31 December 2024, compared
to $12.7 million at 31 December 2023. This increase is primarily due to the
growth in trading volumes in the US.
Other liabilities were $9.2 million (2023: $0.8 million) which included $9.0
million (2023: $Nil) of accounts receivable financing with Sallyport
Commercial Finance.
Lease liabilities decreased from $0.4 million in 2023 to $0.2 million in 2024.
Cash flow
Net cash outflow in 2024 was $7.5 million, decreasing the cash on hand from
$13.9 million at 31 December 2023 to $6.5 million at 31 December 2024. Net
cash outflows from operating activities was $6.8 million, comprised of $27.2
million loss for the year, adjusted for non-cash items of $6.6 million
(including depreciation and amortisation of $1.4 million, share-based payments
of $0.9 million, net financial expense of $3.7 million and income tax of $0.6
million) and a net decrease in the Group's working capital of $13.8 million.
Net cash outflows from investing activities of $2.2 million are the result of
capitalised development expenditure of $2.4 million and financial income of
$0.3 million.
Net cash inflows from financing activities of $1.4 million are attributable to
$5.7 million received in relation to the AOP milestone monetisation agreement,
interest paid of $3.9 million, payment of lease liabilities of $0.2 million,
proceeds from equity raise of $0.1 million and legal fees paid in relation to
the equity raise of $0.2 million.
Going concern
At 31 December 2024, the Group held $6.5 million in cash. The Group's
unaudited cash balance at 31 March 2025 was $10.5 million.
Since year end the Group has received $10.0 million from AOP in relation to
the pre-year end equity placing.
The forecasts show that the Group's monthly cash flows start to turn positive
by the end of 2025 and the Group has sufficient cash to allow the business to
continue in operations for at least 12 months from the date of approval of the
Financial Statements. The Directors have considered scenarios in which sales
revenues fall below base case forecasts. In these circumstances mitigating
actions such as reduction of discretionary marketing, general and
administrative, and production related expenditure combined with the reliance
on the full $15.0 million accounts receivable facility could be taken to
preserve cash. The Directors also believe that other forms of finance, such as
royalty finance are likely to be available to the Group.
Based on the above factors, the Directors believe that it remains appropriate
to prepare the financial statements on a going concern basis.
Recent shifts in U.S. economic policy, including the imposition of tariffs on
imported goods such as pharmaceuticals and active pharmaceutical ingredients
(APIs), present ongoing risks and uncertainties for our business. These
measures may lead to increased costs, supply chain disruptions, and margin
pressure, particularly if alternative sourcing options are limited or
similarly affected. The evolving nature of U.S. trade policy, including the
potential for future tariffs or retaliatory actions by other countries,
creates added unpredictability that may impact our operational planning and
financial performance. We continue to monitor these developments and evaluate
strategies to mitigate potential impacts.
Financial outlook
On the back of significant expansion of ACCRUFeR® in the US in 2024, the
Company is poised for a fresh wave of growth in ACCRUFeR® primarily driven by
execution of an optimized sales force plan in close collaboration with our
partner, Viatris Inc., increasing patient and physician awareness, and
enhancing patient access. Globally, we see an oral iron market which has
clear needs based on physician and patient feedback for a product that
delivers both effectiveness and tolerability.
Contributions from our global partners including continued growth of
FeRACCRU® by Norgine in EU, launch of ACCRUFeR® by Kye Pharmaceuticals in
Canada, and the progression of the regulatory processes in Korea and China by
Korea Pharma and ASK respectively will contribute to revenues through both
royalties and milestones. Lastly, our efforts to be hyper focused on return on
our investments across the company and strong working capital management are
expected to allow us to be cash flow positive by the end of 2025. Despite the
weather-related impact on Q1 2025 revenues, on the back of a solid performance
in March 2025, we expect to see significant growth in 2025 as we continue to
drive the business to become cash flow positive and fully self-sustaining.
Santosh Shanbhag
Chief Financial Officer
Consolidated statement of profit and loss and other comprehensive income
for the year ended 31 December 2024
2024 2023
$'000 $'000
Revenue 32,180 13,085
Cost of sales (17,250) (9,058)
Gross profit 14,930 4,027
Other operating income 97 4,412
Operating costs - selling, general and administrative expenses (36,013) (37,960)
Research and development expenditure (1,887) (1,810)
Operating loss (22,873) (31,331)
Financial income 266 518
Financial expense (3,949) (1,562)
Loss before tax (26,556) (32,375)
Taxation (626) (918)
Loss for the year (27,182) (33,293)
Other comprehensive income
Items that are or may be reclassified subsequently to profit or loss:
Foreign currency translation differences - foreign operations (646) (1,890)
Total comprehensive expense for the year (27,828) (35,183)
Loss per share
Basic and diluted loss per share (in cents) (3) (5)
Group Balance Sheet
for the year ended 31 December 2024
2024 2023
$'000 $'000
Non-current assets
Intangible assets 18,168 16,863
Property, plant and equipment 373 673
Restricted cash 1,000 -
19,541 17,536
Current assets
Inventories 5,661 3,203
Trade and other receivables 24,968 13,498
Current tax asset 286 614
Restricted cash 500 -
Cash and cash equivalents 6,524 13,948
37,939 31,263
Total assets 57,480 48,799
Long-term loan (26,174) (19,836)
Lease liabilties - (195)
(26,174) (20,031)
Current liabilities
Trade and other payables (23,188) (12,721)
Other liabilities (9,239) (800)
Lease liabilities (196) (214)
(32,623) (13,735)
Total liabilities (58,797) (33,766)
Net (liabilities)/assets (1,317) 15,033
Equity
Share capital (19,908) (15,011)
Share premium (203,188) (198,759)
Merger reserve (43,240) (43,240)
Currency translation reserve 7,806 8,452
Retained earnings 259,847 233,525
Total equity 1,317 (15,033)
Group statement of changes in equity
for the year ended 31 December 2024
Issued capital Deposit for shares Share premium Merger reserve Currency translation reserve Accumulated deficit Total
$'000 $'000 $'000 $'000 $'000 $'000 $'000
Balance at 1 January 2023 5,371 (100) 169,482 43,240 (10,342) (201,107) 6,544
Loss for the year (33,293) (33,293)
Other comprehensive income:
Foreign currency translation differences 1,890 1,890
Total comprehensive expense for the year 1,890 (33,293) (31,403)
Transactions with owners, recorded directly in equity
Equity placing 6,556 100 19,819 26,475
Warrants exercised 98 345 443
Loan conversion 2,986 9,113 12,099
Equity-settled share-based payment transactions 875 875
Balance at 31 December 2023 15,011 0 198,759 43,240 (8,452) (233,525) 15,033
Loss for the year (27,182) (27,182)
Other comprehensive income:
Foreign currency translation differences 646 646
Total comprehensive expense for the year 646 (27,182) (26,536)
Transactions with owners, recorded directly in equity
Equity placing 4,897 4,429 9,326
Equity-settled share-based payment transactions 860 860
Balance at 31 December 2024 19,908 0 203,188 43,240 (7,806) (259,847) (1,317)
Group statement of cash flows
for the year ended 31 December 2024
2024 2023
Cash flows from operating activities $'000 $'000
Loss for the year (27,182) (33,293)
Adjustments for:
Depreciation and amortisation 1,425 1,071
Equity-settled share-based payment expenses 860 875
Financial income (266) (518)
Financial expense 3,949 1,562
Income tax 626 918
(20,588) (29,385)
Increase in inventories (2,458) (1,446)
Increase in trade and other receivables (1,142) (7,007)
Increase in restricted cash (1,500) -
Increase in trade and other payables 10,467 1,907
Increase/(decrease) in other liabilities 9,213 (478)
Income tax paid (762) (717)
Net cash flows from operating activities (6,770) (37,126)
Cash flows from investing activities
Financial income 266 518
Additions to tangible assets (35) (239)
Capitalised development expenditure (2,386) (2,709)
Net cash flows from investing activities (2,155) (2,430)
Cash flows from financing activities
Interest paid (3,949) (613)
Proceeds from equity raise 122 26,375
Legal fees in relation to equity raise (233) -
Warrants exercised - 442
Repayment of convertible shareholder loan - (5,448)
Proceeds from milestone monetisation 5,700 -
Proceeds from convertible shareholder loan - 10,000
Proceeds from long-term loan - 19,446
Payment of lease liabilities (213) (546)
Net cash flows from financing activities 1,427 49,656
Net (decrease)/increase in cash (7,498) 10,100
Effect of foreign exchange differences 74 446
Cash and cash equivalents at 1 January 13,948 3,402
Cash and cash equivalents at 31 December 6,524 13,948
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