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Shield Therapeutics (STX) has announced the appointment of a new chief executive officer (CEO), Greg Madison, with effect from 1 June 2021. Greg is a seasoned CEO with previous experience of the US iron deficiency market. Notably, he led the transformation of Keryx Biopharmaceuticals (2015–18) into a US commercial stage company focused on Auryxia (ferric citrate), an oral product for the treatment of iron deficiency anaemia and hyperphosphatemia. Given the primary focus for STX now is to establish and expand its US-based operations ahead of a Q221 launch of lead asset Accrufer (oral ferric maltol), the appointment of a US-based CEO makes sense in our view. Our valuation of STX is unchanged at £505.7m or 234p/share.

Shield Therapeutics (STX) has announced the appointment of a new chief executive officer (CEO), Greg Madison, with effect from 1 June 2021. Greg is a seasoned CEO with previous experience of the US iron deficiency market. Notably, he led the transformation of Keryx Biopharmaceuticals (2015–18) into a US commercial stage company focused on Auryxia (ferric citrate), an oral product for the treatment of iron deficiency anaemia and hyperphosphatemia. Given the primary focus for STX now is to establish and expand its US-based operations ahead of a Q221 launch of lead asset Accrufer (oral ferric maltol), the appointment of a US-based CEO makes sense in our view. Our valuation of STX is unchanged at £505.7m or 234p/share.

Shield Therapeutics - Greg Madison succeeds Tim Watts as CEO

Shield Therapeutics’ (STX’s) interim results highlight the progress made year to date. Re-analysis of the Feraccru/Accrufer AEGIS-H2H data show it is a credible alternative to IV iron therapy for iron deficiency anaemia (IDA) in the long term. With the product out-licensed in China to partner ASK Pharm, all eyes remain on the announcement of a US commercial partner (expected this year). Royalties received from H120 sales of the product (UK and Germany) by partner Norgine are slowly building, but pricing and reimbursement discussions resuming in Europe could lead to ongoing rollouts in key countries (France, Spain and Italy) in 2021. STX’s cash runway extends into Q121, an upfront licensing payment from a US deal would ameliorate the need for further capital. We value Shield at £379.1m.

Shield Therapeutics’ (STX’s) interim results highlight the progress made year to date. Re-analysis of the Feraccru/Accrufer AEGIS-H2H data show it is a credible alternative to IV iron therapy for iron deficiency anaemia (IDA) in the long term. With the product out-licensed in China to partner ASK Pharm, all eyes remain on the announcement of a US commercial partner (expected this year). Royalties received from H120 sales of the product (UK and Germany) by partner Norgine are slowly building, but pricing and reimbursement discussions resuming in Europe could lead to ongoing rollouts in key countries (France, Spain and Italy) in 2021. STX’s cash runway extends into Q121, an upfront licensing payment from a US deal would ameliorate the need for further capital. We value Shield at £379.1m.

Shield Therapeutics - US partner next major inflection point

Shield Therapeutics (STX) has announced a technical update to findings from the AEGIS-H2H post-marketing study. The re-analysis demonstrates that Feraccru/Accrufer is a credible alternative to IV iron therapy for iron deficiency anaemia (IDA) in the long term. We note the product did not meet the primary endpoint of non-inferiority at 12 weeks vs IV iron, but did correct anaemia and maintain Hb levels over the long term phase (as defined by the 40-week extension phase of the trial). While we note AEGIS H2H was not required as a registration study (thus the regulatory status of the product is unaffected by the study), the headline results of long-term Hb correction is comparable to IV iron for chronic conditions of anaemia. We believe this will have positive implications for health economic outcomes, pricing strategies and partnering opportunities. The next key inflection point is a US partnering deal; we expect Accrufer launch later this year once a partner has been found. Our valuation of STX is unchanged at £381.7m or 326p/share.

Shield Therapeutics (STX) has announced a technical update to findings from the AEGIS-H2H post-marketing study. The re-analysis demonstrates that Feraccru/Accrufer is a credible alternative to IV iron therapy for iron deficiency anaemia (IDA) in the long term. We note the product did not meet the primary endpoint of non-inferiority at 12 weeks vs IV iron, but did correct anaemia and maintain Hb levels over the long term phase (as defined by the 40-week extension phase of the trial). While we note AEGIS H2H was not required as a registration study (thus the regulatory status of the product is unaffected by the study), the headline results of long-term Hb correction is comparable to IV iron for chronic conditions of anaemia. We believe this will have positive implications for health economic outcomes, pricing strategies and partnering opportunities. The next key inflection point is a US partnering deal; we expect Accrufer launch later this year once a partner has been found. Our valuation of STX is unchanged at £381.7m or 326p/share. 

Shield Therapeutics - AEGIS-H2H update – non-inferiority at 24 weeks

Shield Therapeutics (STX) has reported FY19 results; total revenue of £0.7m reflects royalties on Feraccru sales from European partner Norgine. 2019 achievements include FDA approval of STX’s key asset for the treatment of iron deficiency in patients with any underlying cause – the broadest possible label – in the critical US market. Momentum has continued into 2020 with an out-licensing deal with China-based Beijing Aosaikang Pharmaceutical (ASK Pharm) that covers China, Hong Kong, Macau and Taiwan. The next key inflection point is a US partnering deal, and discussions are ongoing with the aim of closing a transaction at the earliest opportunity in 2020. We expect Accrufer launch later this year once a partner has been found. STX reported a cash balance of £10.4m at 30 April 2020 implying a cash runway to Q121. We value Shield at £381.7m.

Shield Therapeutics (STX) has reported FY19 results; total revenue of £0.7m reflects royalties on Feraccru sales from European partner Norgine. 2019 achievements include FDA approval of STX’s key asset for the treatment of iron deficiency in patients with any underlying cause – the broadest possible label – in the critical US market. Momentum has continued into 2020 with an out-licensing deal with China-based Beijing Aosaikang Pharmaceutical (ASK Pharm) that covers China, Hong Kong, Macau and Taiwan. The next key inflection point is a US partnering deal, and discussions are ongoing with the aim of closing a transaction at the earliest opportunity in 2020. We expect Accrufer launch later this year once a partner has been found. STX reported a cash balance of £10.4m at 30 April 2020 implying a cash runway to Q121. We value Shield at £381.7m.

Shield Therapeutics - All eyes on a US partnering deal

Shield Therapeutics (STX) has provided an updated trading statement ahead of FY19 results, expected at the end of May. In its January trading update, STX had guided to FY19 revenues of £2.9m. However, this has been revised down to £0.7m with repayment of the €2.5m Norgine milestone. In Europe, Feraccru has continued to grow during Q120 in its launched countries (the UK and Germany), and STX has reported minimal COVID-19 disruption to its commercial progress and manufacturing supply chain to date. The company reported an unaudited cash balance of £11.3m at 31 March. The next key inflection point is a US partnering deal, and STX has been able to advance discussions with potential commercial partners in recent weeks. We expect Accrufer launch later this year once a partner has been found.

Shield Therapeutics (STX) has provided an updated trading statement ahead of FY19 results, expected at the end of May. In its January trading update, STX had guided to FY19 revenues of £2.9m. However, this has been revised down to £0.7m with repayment of the €2.5m Norgine milestone. In Europe, Feraccru has continued to grow during Q120 in its launched countries (the UK and Germany), and STX has reported minimal COVID-19 disruption to its commercial progress and manufacturing supply chain to date. The company reported an unaudited cash balance of £11.3m at 31 March. The next key inflection point is a US partnering deal, and STX has been able to advance discussions with potential commercial partners in recent weeks. We expect Accrufer launch later this year once a partner has been found. 

Shield Therapeutics - Next step a US partnering deal

United Kingdom

ImmuPharma plc, a pharmaceutical company, develops drug candidates based on peptide therapeutics to treat serious medical conditions. The company?s lead product candidates include the Lupuzor, which is in Phase III clinical trials for the treatment of lupus, a chronic, autoimmune, and inflammatory disease; IPP-204106, an anti-cancer nucleolin antagonis peptide program that has completed Phase I/IIa clinical trials to treat cancer; IPP-201007, which is in pre-clinical development stage for the treatment of inflammatory/allergic conditions, such as asthma and rheumatoid arthritis; IPP-102199 that is in pre-clinical development stage to treat moderate and severe pain; and IPP-203101, a peptide-based antibiotic, which is in pre-clinical development stage for the treatment of lethal infections, such as methicillin-resistant staphylococcus aureus and other hospital acquired infections. Its discovery pipeline includes heterocyclic ureas scaffolds; and peptide to drug converting technology, which enhances a peptide?s plasma half-life and efficacy. ImmuPharma plc has collaboration arrangements with the Centre National de la Recherch� Scientifique; and the Institut National de la Sante et de la Recherche Medicale. The company was founded in 1999 and is headquartered in London, the United Kingdom.

ECO Animal Health Group plc manufactures, supplies, and markets pharmaceutical products for the animal health markets worldwide. The company offers Aivlosin, a macrolide antibiotic for the treatment of respiratory and enteric diseases in pigs and poultry. It also provides generic drugs, such as Ecomectin, Ecoheart, Ecotraz, and Ecomintic, which are endectocides and other antiparasitics for the treatment and prevention of parasites in cattle, sheep, pigs, horses, and dogs; and Chlortet and Oxytet for the treatment of bacterial infections in pigs, poultry, and cattle. The company was founded in 1972 and is headquartered in New Malden, the United Kingdom.

4d Pharma PLC operates as a pharmaceutical company. The Company develops therapeutic drugs that target auto-immune diseases. 4D Pharma offers its products to the medical and healthcare industries.

Alliance Pharma plc, a specialty pharmaceutical company, engages in the acquisition, marketing, and distribution of pharmaceutical products in the United Kingdom, Ireland, and internationally. The company provides prescription only medicines, over the counter medications, cosmetics, and nutritional supplements, as well as medical devices. It offers products for use in various therapy areas, including acquired healthcare, cardiovascular, central nervous system, child health, consumer health, dermatology, endocrinology, gastroenterology, obstetrics and gynaecology, oral health, oncology, stoma care, toxicology, travel health, urology, vitamins and minerals, and others. The company distributes its products through pharmacies, supermarkets, healthcare distributors, and retailers, as well as online retailers. Alliance Pharma plc was founded in 1996 and is headquartered in Chippenham, the United Kingdom.

Benchmark Holdings Plc is an animal health, technical publishing and sustainability business. The Company's activities include the development, manufacture and commercialisation of animal health products with a key focus on aquaculture. Benchmark also provides consulting services.

Allergy Therapeutics plc, a specialty pharmaceutical company, focusing on allergy vaccination primarily in Europe. The company?s primary flagship product consists of the Pollinex Quattro for the treatment of allergic conditions; and monophosphoryl-lipid A, a substance that enhances the immune response to an antigen or allergen. It offers sublingual product, including Oralvac Compact; Venomil product, which is used for the wasp and bee treatment; probiotic products, such as Kallergen-Th, ATI Prob, and Pollagen; a novel tyrosine-adsorbed, modified-allergen product developed for treatment of perennial mite allergy; and DAP, a product for use in the diagnosis of type I or immediate hypersensitivity to benzylpenicillin and related antibiotics (betalactams) by means of cutaneous tests (prick and intradermal). The company markets its products in injectable and sublingual formats under various brands. Allergy Therapeutics plc was founded in 1934 and is based in Worthing, the United Kingdom.

Oncimmune Limited develops and commercializes products for the detection of cancerous. It develops autoantibody assay technologies that have the potential to early detection a range of solid cancer tumor types. It offers EarlyCDT-Lung, a blood test that is ordered by a doctor to aid in the risk assessment and early detection of lung cancer in high-risk patients and to stratify indeterminate pulmonary nodules for the risk of malignancy. The company is based in Nottingham, the United Kingdom.

Genedrive PLC operates as a biotechnology company. The Company offers diagnostic platform to offer quick and sensitive molecular analysis within an ultra compact unit. Genedrive provides its services in the United Kingdom and United States.

Akari Therapeutics PLC manufactures and develops anti-inflammatory drugs. The Company provides treatments for a wide range of autoimmune and inflammatory diseases. Akari Therapeutics markets it products in the United States and United Kingdom.

OptiBiotix Health plc, a life sciences company, engages in the research and development of microbiome modulators in the United Kingdom. The company has a pipeline of microbiome modulators that can impact on lipid and cholesterol management, energy harvest, and appetite suppression. Its products under development include novel microbial strains for cholesterol and lipid management; an ingredient formulation, which is scientifically formulated to support and maintain weight loss; and microbiome modulators that enhance the growth of specific microbial species in the human microbiome. The company is based in York, the United Kingdom.

Bal Pharma Limited researches and develops bulk drugs and intermediates.

Peterlabs Holdings Berhad manufactures, distributes and trades animal health and nutrition products for livestock and companion animals. The Company markets its products primarily to farmers and livestock breeders.

BLIS Technologies Limited activities include the commercialization of Bacteriocin-Like Inhibitory Substances.  The Company develops products used for the prevention of bacterial throat infections.

Agile Therapeutics, Inc. develops women's healthcare products. The Company provides contraceptive patch containing the active ingredients levonorgestrel and ethinyl estradiol, as well as progestin-only birth control patch. Agile Therapeutics discovers a pipeline of investigational contraceptive products in the United States.

Extrawell Pharmaceutical Holdings Limited, through its subsidiaries, markets and distributes imported pharmaceutical products, healthcare, and nutritional products.  The Company also develops, manufactures, and sells pharmaceutical products in China.  In addition, Extrawell exploits gene inventions, researches genome technology, and develops and manufactures genechips.

China Health Group Inc. researches, develops, and commercializes drug products.

AusCann Group Holdings Ltd operates as a holding company. The Company, through its subsidiaries, develops cannabis based medical products. AusCann Group Holdings produces and sells cannabinoid medicines for application in anti-convulsion, neuroprotectant, anti-inflammatory, anti-nausea, glaucoma, pain management, and appetite stimulation areas.

Invion Limited develops pharmaceutical products for the treatment of asthma and smoking cessation.  The Company also is involved in the treatment autoimmune and inflammatory diseases, such as rheumatoid arthritis.

KYUNG NAM PHARM CO., LTD. manufactures and research in the development of pharmaceutical ingredients. The Company provides human placenta ingredients to pharmaceutical manufacturers. It also provides vitamin and cosmetic products through its subsidiaries.

Woogene B&G Co., Ltd manufactures animal health products and veterinary medicines such as anti-infectives, pesticide, and antibiotics.  The Company also produces nutraceutical such as enzyme, and probiotics, feed supplement.

Shield Therapeutics plc, a specialty pharmaceutical company, focuses on the development and commercialization of secondary care-focused pharmaceuticals. Its lead product is Feraccru, a novel therapy for the treatment of iron deficiency anaemia (IDA) in patients with inflammatory bowel disease. Its products pipeline includes PT20, a novel iron-based phosphate binder for the treatment of hyperphosphatemia related to chronic kidney disease (CKD); PT30 and PT40 that are intravenous iron formulations; and Feraccru to treat patients with IDA related to CKD and other indications. The company was founded in 2008 and is based in Gateshead Quays, the United Kingdom.

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Shield Therapeutics (STX LN)

Shield Therapeutics - Greg Madison succeeds Tim Watts as CEO

Shield Therapeutics (STX) has announced the appointment of a new chief executive officer (CEO), Greg Madison, with effect from 1 June 2021. Greg is...

Edison Investment Research

Shield Therapeutics - US partner next major inflection point

Shield Therapeutics’ (STX’s) interim results highlight the progress made year to date. Re-analysis of the Feraccru/Accrufer AEGIS-H2H data show it...

Edison Investment Research

Shield Therapeutics - AEGIS-H2H update – non-inferiority at 24 weeks

Shield Therapeutics (STX) has announced a technical update to findings from the AEGIS-H2H post-marketing study. The re-analysis demonstrates that...

Edison Investment Research

Shield Therapeutics - All eyes on a US partnering deal

Shield Therapeutics (STX) has reported FY19 results; total revenue of £0.7m reflects royalties on Feraccru sales from European partner Norgine....

Edison Investment Research

Shield Therapeutics - Next step a US partnering deal

Shield Therapeutics (STX) has provided an updated trading statement ahead of FY19 results, expected at the end of May. In its January trading...

Edison Investment Research

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