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Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
---|---|---|---|---|---|
Poolbeg Pharma Plc | LSE:POLB | London | Ordinary Share | GB00BKPG7Z60 | ORD 0.02P |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.25 | 1.83% | 13.90 | 13.80 | 14.00 | 13.90 | 13.65 | 13.65 | 623,853 | 12:20:17 |
Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
---|---|---|---|---|---|
Coml Physical, Biologcl Resh | 0 | -3.93M | -0.0079 | -17.59 | 69.5M |
TIDMPOLB
RNS Number : 2280M
Poolbeg Pharma PLC
13 September 2023
Poolbeg Pharma plc
Interim results for the six months to 30 June 2023
Significant progress made and well positioned for future growth
13 September 2023 - Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, 'Poolbeg' or the 'Company'), a clinical-stage biopharmaceutical company targeting diseases with a high unmet medical need, announces its unaudited interim results for the six months to 30 June 2023.
Interim Results Highlights and Business Update
-- Strong cash balance of GBP14.1 million as at 30 June 2023 (31 December 2022: GBP16.2m)
-- Positive results from the POLB 001 LPS human challenge trial. The asset has the potential to be an effective treatment for severe influenza and potentially other acute inflammatory conditions
-- Strategic expansion of POLB 001 into oncology, including as a potential treatment option for Cytokine Release Syndrome (CRS), a side-effect associated with up to 95% of CAR T cell therapies
-- Further to discussions with prospective partners interested in this area, the Company is actively exploring a potential new indication for POLB 001 in oncology beyond CAR T
-- The Company's artificial intelligence (AI) programme with CytoReason provided unparalleled insights into influenza infection and successfully identified a number of novel and valuable drug targets
-- The lab-based validation of the Respiratory Syncytial Virus (RSV) drug targets and treatments identified from the Company's AI-led programme is progressing and expected to complete in H2 2023
-- The Poolbeg-led Oral Vaccine consortium (EncOVac), which was awarded EUR2.3 million in grant funding, progressed to the next phase of development, marked by the commencement of the encapsulation validation process
-- Continued progress on the Oral GLP-1 agonist proof-of-technology clinical trial preparation. As a result of adopting recommendations from a number of Key Opinion Leaders (KOLs), the clinical trial design has been refined and the trial is expected to commence in H1 2024
-- Industry veteran, Professor Brendan Buckley, appointed as Non-Executive Director in May 2023
Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg Pharma, commented: "During H1 2023, we made significant progress in advancing our pipeline, bolstered by the strong clinical trial data for POLB 001 and breakthroughs in our AI-led drug discovery programmes, we are building towards becoming an efficient one-stop-shop for biopharma seeking products to in-license. With a cost-effective R&D approach, complemented by a strong balance sheet and multiple non-dilutive funding opportunities, we are well positioned for ongoing development and future growth with a strong focus on our business development activities."
Investor presentation
Jeremy Skillington, PhD, Chief Executive Officer, will be presenting at the Master Investor Sector Focus: Healthcare Webinar on 20 September 2023.
Register to attend here .
Change of Name of Nominated Adviser and Joint Broker
The Company also announces that its Nominated Adviser and Joint Broker has changed its name to Cavendish Capital Markets Ltd following completion of its own corporate merger.
- Ends -
Enquiries
Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O'Connell, CFO +44 (0) 207 183 1499 Cavendish Capital Markets Ltd (Nominated Adviser & Joint Broker) Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward (ECM) +44 (0) 207 220 0500 Singer Capital Markets (Joint Broker) Phil Davies, Sam Butcher +44 (0) 207 496 3000 J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist +353 (0) 1 679 6363 Optimum Strategic Communications +44 (0) 208 078 4357 Nick Bastin, Hana Malik, Vici Rabbetts poolbeg@optimumcomms.com
About Poolbeg Pharma
Poolbeg Pharma specialises in the development of innovative medicines to address the unmet need in infectious and other prevalent diseases. Poolbeg Pharma has a disciplined portfolio approach to mitigate risk, accelerate drug development, and enhance investor returns. The Company simultaneously advances multiple programmes in cost-effective clinical trials, rapidly generating early human safety and efficacy data to enable early partnering / out-licensing, with the funds generated reinvested in the pipeline. Poolbeg Pharma also uses AI to interrogate human challenge trial data sets to quickly identify new targets and drugs, leading to faster development and greater commercial appeal.
The Company is targeting the growing infectious disease market. In the wake of the COVID-19 pandemic, infectious disease has become one of the fastest growing pharma markets and is expected to exceed $250bn by 2025. Through opportunistic identification of assets which complement Poolbeg Pharma's existing pipeline, the Company is progressing programmes in oncology and metabolic syndromes; adding disease areas with significant addressable markets.
With its initial assets from hVIVO plc , an industry leading infectious disease and human challenge trials business, Poolbeg Pharma has access to knowledge, experience, and clinical data from over 20 years of human challenge trials. The Company is using these insights to acquire new assets as well as reposition clinical stage products, reducing spend and risk. Amongst its portfolio of exciting assets, Poolbeg Pharma has a small molecule immunomodulator for severe influenza and other acute inflammatory conditions (POLB 001) which produces a highly significant reduction in p38 MAP kinase driven cytokines in a clinical setting; a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections (POLB 002); and a vaccine candidate for Melioidosis (POLB 003). The Company is progressing two A rtificial I ntelligence (AI) P rogrammes to add promising new assets to its pipeline as well as developing an Oral Vaccine Programme and an Oral Delivery Programme focussing on metabolic syndrome related diseases.
For more information, please go to www.poolbegpharma.com or follow us on Twitter and LinkedIn @PoolbegPharma.
CEO Statement
I am delighted to present the unaudited interim financial statements of Poolbeg Pharma plc ("Poolbeg" or the "Company") for the six months to 30 June 2023. Throughout this period, we've achieved substantial advancements across our programmes as outlined below.
Significant progress made
POLB 001 - Severe Influenza - We reported the positive results from our LPS human challenge trial for POLB 001 in March 2023 (see Figure 1) and the Clinical Study Report has been finalised. These findings demonstrated a significant reduction in both systemic and localised inflammatory responses in a manner that suggests expected utility in treating life-threatening infections, such as severe influenza, and supports continued development as a treatment for the Cytokine Release Syndrome ("CRS") associated with other acute inflammatory conditions.
Figure 1
POLB 001 - Oncology - Expanding the potential of POLB 001 beyond severe influenza remains a key objective for the Company to fully unlock the potential value of the molecule and strengthen Poolbeg's position for partnering and out-licensing. In line with this objective, we strategically expanded POLB 001 into oncology in January 2023 with the filing of a patent application for the use of POLB 001 as a treatment option for the Cytokine Release Syndrome (CRS) side-effect associated with CAR T cell therapy. CRS affects up to 95% of cancer patients receiving CAR T cell therapy, which, in its severe form, can be life threatening.
A potential new indication in oncology beyond CAR T is being actively explored further to discussions with prospective partners with interest in this area.
Clinical trial enabling activities to advance POLB 001 in oncology are progressing.
Influenza Artificial Intelligence Programme - In June 2023, our AI-led programme with CytoReason yielded a significant breakthrough. The programme identified multiple novel influenza drug targets by leveraging our unique disease progression data from human challenge trials combined with CytoReason's curated disease data and advanced AI platform. The insights gained offer an unparalleled understanding of influenza infection, focusing on the body's immune responses by identifying the drivers of disease, and identified multiple unique drug targets that hold the potential to block disease and aid recovery. The Company is actively exploring the most effective way to further develop the novel drug targets in order to generate value and is progressing towards drug target validation which is expected to complete in 2024.
RSV Artificial Intelligence Programme - In Q4 2022, the Company announced the successful identification of novel drug targets and treatments by our AI partner, OneThree Biotech. This significant breakthrough demonstrated the power of AI in accelerating drug discovery and identification and reaffirmed our confidence in the value of our data and our technology driven programmes. The lab-based validation of these treatments is expected to complete in H2 2023.
Oral Vaccine Programme - The Poolbeg-led Oral Vaccine consortium (EncOVac), which was awarded EUR2.3 million in grant funding, advanced into its next phase of development as the validation of the encapsulation process commenced in June 2023. The research plan, Consortium and Grant agreements have been completed and the programme is progressing well with validation expected to complete in H2 2023. This programme holds the potential to address a wide range of infectious diseases, contributing positively to global health.
Oral Delivery of Metabolic Disease Treatments - The Company continues to make progress on the Oral GLP-1 agonist proof-of-technology clinical trial preparation. We actively engaged with a number of KOLs to refine the clinical trial design and, as a result of adopting these recommendations, the trial is now expected to commence in H1 2024. The trial aims to determine that a Glucagon-like Peptide 1 receptor ("GLP-1") agonist can be successfully delivered orally in humans using our licensed technology. GLP-1 agonists such as Wegovy(R) (semaglutide) are used to treat obesity and diabetes, and this trial has the potential to tap into an industry that will be worth an estimated $150 billion by 2031(1) .
Other Updates - The Company continues to review partnering opportunities as well as actively exploring further non-dilutive funding opportunities to progress its programmes, including POLB 002 and POLB 003. The Company has taken another proactive step in enhancing its robust intellectual property by submitting a patent application for POLB 003 in the first half of this year.
As announced in March 2023, we successfully strengthened the patent portfolio of POLB 001 with another patent grant in the US, covering the use of certain p38 MAP kinase inhibitors for the treatment of hypercytokinaemia. Further to this, in January 2023 we filed patent applications for the use of POLB 001 in addressing the impact of CRS associated with CAR T cell therapy, as well as other oncology indications beyond CAR T. It is not unusual in the pharmaceutical industry for patents to be challenged. The Immunomodulators I European patent was opposed by an anonymous third party in September 2021. The European Patent Office's ("EPO") preliminary opinion on the opposition was received in March 2023, identifying a number of items to be discussed at a hearing set for November 2023. Based on specialist advice received, and the fact that the patent went through an extensive examination process prior to being granted by the EPO, Poolbeg continues to have full confidence in the validity and strength of the patent and will vigorously defend its intellectual property to the extent required.
Business Development - We continue to evaluate partnering opportunities for a number of our programmes in line with our operating model. With more than 50% of late-stage programmes originating from partnering within the pharmaceutical industry, there is significant scope to aid companies in their mission to accelerate the development of unique medicines that address diseases with high unmet medical need.
We have seen great progress in a number of our programmes since the start of 2023, including the positive data from our POLB 001 LPS human challenge trial, completion of the Clinical Study Report, the strategic expansion of POLB 001 into oncology, and the discovery of multiple novel drug targets and treatments using AI. We have attended several global partnering conferences so far in 2023 which have facilitated further engagement with potential partners. With excellent relationships across the sector, and the positive outputs to hand from a number of our programmes, we look forward to continuing deal making discussions and providing updates to our shareholders in due course.
Corporate & Financial
Poolbeg had a strong cash balance of GBP14.1m as at 30 June 2023. Loss for the period amounted to GBP1.8m; comprised of R&D expenses of GBP0.9m, administrative expenses of GBP1.4m and other income of GBP0.5m.
We welcomed Professor Brendan Buckley to the Board as Non-Executive Director in May 2023. Brendan's significant contributions to Poolbeg as a member of the Scientific Advisory Board, and his extensive industry experience, greatly benefits the Company.
Outlook
Poolbeg has continued to make significant strides in progressing our pipeline of products and platforms during H1 2023 and we are continuing at pace towards our aim of becoming a one-stop-shop for pharma and biotech's seeking programmes to in-license. With strong data from our POLB 001 clinical trial and novel drug targets and treatments identified using our cutting-edge AI-led programmes, we are excited by the future of Poolbeg. Our robust cash balance, cost effective R&D approach, and multiple near term value inflection points position Poolbeg to generate strong returns for shareholders over the coming years.
Jeremy Skillington, PhD
Chief Executive Officer
12 September 2023
Consolidated Statement of Comprehensive Income
For the six months to 30 June 2023
Unaudited Unaudited Audited Six months Six months Year ended to to 31 December 30 June 30 June 2022 2022 2023 Note GBP'000 GBP'000 GBP'000 ------------------------------------------ ----- ----------- -------------- ------------- Revenue - - - Cost of sales - - - ------------------------------------------ ----- ----------- -------------- ------------- Gross profit - - - ------------------------------------------ ----- ----------- -------------- ------------- Administrative expenses (1,395) (1,228) (3,060) Other operating income 177 133 278 Research and development expenses (865) (657) (2,204) ------------------------------------------ ----- ----------- -------------- ------------- Operating loss (2,083) (1,752) (4,986) ------------------------------------------ ----- ----------- -------------- ------------- Finance income 272 45 209 Loss before income taxation (1,811) (1,707) (4,777) ------------------------------------------ ----- ----------- -------------- ------------- Taxation 2 - 100 91 ------------------------------------------ ----- ----------- -------------- ------------- Loss and total comprehensive loss for the period attributable to the equity holders of the Company (1,811) (1,607) (4,686) ------------------------------------------ ----- ----------- -------------- ------------- Loss per share: Loss per share - basic and diluted, attributable to ordinary equity holders of the parent (pence) 3 (0.36) (0.32) (0.94)
Consolidated Statement of Financial Position
As at 30 June 2023
Unaudited Unaudited Audited 30 June 30 June 2022 31 December 2023 2022 Note GBP'000 GBP'000 GBP'000 ------------------------------- ----- ---------- ------------- ------------ Assets Non-current assets Intangible assets 4 2,183 1,935 2,134 Total non-current assets 2,183 1,935 2,134 ------------------------------- ----- ---------- ------------- ------------ Current assets Trade and other receivables 5 767 1,185 962 Cash and cash equivalents 14,120 18,894 16,193 Total current assets 14,887 20,079 17,155 ------------------------------- ----- ---------- ------------- ------------ Total assets 17,070 22,014 19,289 ------------------------------- ----- ---------- ------------- ------------ Equity and liabilities Equity attributable to owners of the parent Share capital 100 100 100 Share premium 23,100 23,100 23,100 Other reserves 2,192 1,930 2,145 Accumulated deficit (8,833) (3,943) (7,022) ------------------------------- ----- ---------- ------------- ------------ Total equity 16,559 21,187 18,323 ------------------------------- ----- ---------- ------------- ------------ Current liabilities Trade and other payables 6 511 827 966 ------------------------------- ----- ---------- ------------- ------------ Total current liabilities 511 827 966 ------------------------------- ----- ---------- ------------- ------------ Total liabilities 511 827 966 ------------------------------- ----- ---------- ------------- ------------ Total equity and liabilities 17,070 22,014 19,289 ------------------------------- ----- ---------- ------------- ------------
Consolidated Statement of Changes in Equity
For the six months to 30 June 2023
Share Share Share based payment Merger Accumulated capital premium reserve reserve deficit Total GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 ---------------------- ---------- ---------- ---------------- ---------- -------------- -------- At 1 January 2022 100 23,100 261 1,455 (2,336) 22,580 ---------------------- ---------- ---------- ---------------- ---------- -------------- -------- Loss and total comprehensive loss for the period - - - - (1,607) (1,607) Share based payments - - 214 - - 214 ---------------------- ---------- ---------- ---------------- ---------- -------------- -------- Balance at 30 June 2022 100 23,100 475 1,455 (3,943) 21,187 ---------------------- ---------- ---------- ---------------- ---------- -------------- -------- Loss and total comprehensive loss for the period - - - - (3,079) (3,079) Share based payments - - 215 - - 215 ---------------------- ---------- ---------- ---------------- ---------- -------------- -------- Balance at 31 December 2022 100 23,100 690 1,455 (7,022) 18,323 ---------------------- ---------- ---------- ---------------- ---------- -------------- -------- Loss and total comprehensive loss for the period - - - - (1,811) (1,811) Share based payments - - 47 - - 47 ---------------------- ---------- ---------- ---------------- ---------- -------------- -------- Balance at 30 June 2023 100 23,100 737 1,455 (8,833) 16,559 ---------------------- ---------- ---------- ---------------- ---------- -------------- --------
Consolidated Statement of Cash Flows
For the six months to 30 June 2023
Unaudited Unaudited Audited Six months Six months Year ended to to 31 December 30 June 30 June 2022 2022 2023 Note GBP'000 GBP'000 GBP'000 ------------------------------------------ ----- ------------ -------------- ------------- Cash flows from operating activities Loss on ordinary activities before taxation (1,811) (1,707) (4,777) Adjustments for: Finance income (272) (45) (209) Amortisation 4 13 13 26 Share based payment expense 47 214 429 SME R&D tax credit 2 - - 91 Movements in working capital and other adjustments: Change in trade and other receivables 5 195 (579) (456) Change in trade and other payables 6 (455) 389 528 Net cash flow used in operating activities (2,283) (1,715) (4,368) ------------------------------------------ ----- ------------ -------------- ------------- Cash flow from investing activities Payments for intangible assets 4 (62) (385) (597) Interest received from bank 272 45 209 Net cash flow generated/(used) in investing activities 210 (340) (388) ------------------------------------------ ----- ------------ -------------- ------------- Net cash flow from financing - - - activities ------------------------------------------ ----- ------------ -------------- ------------- Net change in cash and cash equivalents (2,073) (2,055) (4,756) Cash and cash equivalents at beginning of period 16,193 20,949 20,949 ------------------------------------------ ----- ------------ -------------- ------------- Cash and cash equivalents at end of period 14,120 18,894 16,193 ------------------------------------------ ----- ------------ -------------- -------------
Notes to the Interim Results
1. General information
Poolbeg Pharma plc ("Poolbeg" or the "Company") is a public limited company incorporated in England and Wales with company number 13279507. The Company is quoted on the AIM market of the London Stock Exchange (ticker: POLB.L, ISIN: GB00BKPG7Z60) and traded on the OTCQB Venture Market ("OTCQB") in the United States under the ticker POLBF.
Poolbeg specialises in the development of innovative medicines to address the unmet need in infectious and other prevalent diseases. Poolbeg has a disciplined portfolio approach to mitigate risk, accelerate drug development and enhance investor returns.
2. Basis of preparation
The Interim Results of the Company for the six months to 30 June 2023 comprise those of the Company and its subsidiaries (together the "Group"). The Interim Results have been prepared on the going concern basis under the historical cost convention in accordance with the recognition and measurement requirements of United Kingdom adopted International Financial Reporting Standards ("IFRS") and their interpretations issued by the International Accounting Standards Board ("IASB"), and in accordance with those parts of the Companies Act 2006 applicable to companies reporting under IFRS. As is permitted by the AIM rules, the Directors have not adopted the requirements of IAS 34 "Interim Financial Reporting" in preparing the financial statements. Accordingly, the financial statements are not in full compliance with IFRS and have neither been audited nor reviewed pursuant to guidance issued by the Auditing Practices Board.
The financial information for the six months to 30 June 2023 and 30 June 2022 is unaudited. The information for the year ended 31 December 2022 has been extracted from the Company's audited accounts on which the auditors issued an unqualified audit opinion. The information presented for that period does not constitute full accounts for that period. The 31 December 2022 audited accounts have been delivered to the Companies House.
The financial information is presented in GBP which is the functional and presentational currency of the Company. Balances are rounded to the nearest thousand (GBP'000) except where otherwise indicated.
The Interim Results were approved by the Board of Directors on 12 September 2023.
The accounting policies used in the preparation of the Interim Results are consistent with those used in the Company's audited financial statements for the year to 31 December 2022. The application of the accounting policies can involve significant estimation, uncertainty and critical judgement. The most significant judgement made in relation to the Interim Results is:
Research and development ("R&D") tax credits: R&D tax claims can be complex and require management to make significant assumptions in building the methodology for the claim, interpreting research and development tax legislation to the Group's specific circumstances, and agreeing the basis of the tax computations with HM Revenue & Customs or other tax authorities. As the Group has not yet built up a track record of R&D tax credit receipts, an estimation of the potential R&D tax credit receivable for the current period and prior year has not been recognised in the Income Statement. R&D tax claims in relation to the 2022 tax year have been submitted by the Group and rebates in relation to that period are anticipated.
3. Loss per share - basic and diluted
The Group presents basic and diluted loss per share ("LPS") data for its ordinary shares. Basic LPS is calculated by dividing the loss attributable to ordinary shareholders of the Company by the weighted average number of ordinary shares outstanding during the period. Diluted LPS is determined by adjusting the loss attributable to ordinary shareholders and the weighted average number of ordinary shares outstanding for the effects of all dilutive potential ordinary shares, which comprise warrants and share options granted by the Company.
The calculation of loss per share is based on the following:
Unaudited Unaudited Audited Six months Six months Year ended ended ended 31 December 30 June 30 June 2022 2022 2023 ------------------------------------------ ------------- --------------- -------------- Loss after tax attributable to equity holders of the Company (GBP'000) (1,811) (1,607) (4,686) Weighted average number of ordinary shares in issue 500,000,000 500,000,000 500,000,000 Fully diluted average number of ordinary shares in issue 500,000,000 500,000,000 500,000,000 ------------------------------------------ ------------- --------------- -------------- Basic and diluted loss per share (pence) (0.36) (0.32) (0.94) ------------------------------------------ ------------- --------------- --------------
Under IAS 33.43 "Earnings per Share", the calculation of loss per share does not assume conversion, exercise, or other issue of potential shares that would have an antidilutive effect on LPS. For the current and comparative periods, the effect of options would be to reduce the loss per share and as such the basic and diluted LPS are the same. There were 36,829,181 share options and warrants outstanding as at 30 June 2023 (30 June 2022 and 31 December 2022: 36,829,181) and these are potentially dilutive.
4. Intangible assets
Acquired Patents Licences & Trademarks Total & Data GBP'000 GBP'000 GBP'000 -------------------------------- ----------- --------------- -------- Cost At 31 December 2021 1,500 81 1,581 Additions 435 162 597 -------------------------------- ----------- --------------- -------- At 31 December 2022 1,935 243 2,178 -------------------------------- ----------- --------------- -------- Additions - 62 62 -------------------------------- ----------- --------------- -------- At 30 June 2023 1,935 305 2,240 -------------------------------- ----------- --------------- -------- Accumulated amortisation At 31 December 2021 18 - 18 Amortisation charge 25 1 26 -------------------------------- ----------- --------------- -------- At 31 December 2022 43 1 44 -------------------------------- ----------- --------------- -------- Amortisation charge 13 - 13 -------------------------------- ----------- --------------- -------- At 30 June 2023 56 1 57 -------------------------------- ----------- --------------- -------- Net book value -------------------------------- ----------- --------------- -------- Net book value at 30 June 2023 1,879 304 2,183 -------------------------------- ----------- --------------- -------- Net book value at 31 December 2022 1,892 242 2,134 -------------------------------- ----------- --------------- --------
Additions in the period relate to patent applications. Patents are measured initially at purchase cost and are amortised on a straight-line basis over their life from the date that they are available for use.
5 Trade and other receivables
Unaudited Unaudited Audited 30 June 30 June 31 December 2023 2022 2022 GBP'000 GBP'000 GBP'000 ------------------------------------- ------------ ------------ -------------- Trade receivables 6 - - Prepayments and accrued income 718 990 878 VAT and corporation tax receivables 43 195 84 Trade and other receivables 767 1,185 962 ------------------------------------- ------------ ------------ --------------
6 Trade and other payables
Unaudited Unaudited Audited 30 June 30 June 31 December 2023 2022 2022 GBP'000 GBP'000 GBP'000 --------------------------------------- ------------ ------------ -------------- Trade payables 124 295 293 Accrued expenses 321 489 623 Other payables 11 9 4 Social security costs and other taxes 55 34 46 Trade and other payables 511 827 966 --------------------------------------- ------------ ------------ --------------
7. Events after the reporting period
None to report.
8. Copy of the interim results
A copy of the Company's Interim Results for the six months to 30 June 2023 is available on the Company's website,
www.poolbegpharma.com/investors/documents/
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IR GPUWABUPWGMP
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September 13, 2023 02:00 ET (06:00 GMT)
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