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Regeneus has revised expected timing of an osteoarthritis (OA) clinical development licence deal for Progenza in Japan to Q4 CY18 (vs Q218); it is currently in active discussions with several parties. A licence deal would trigger a US$5m milestone payment from partner AGC and would effectively see Progenza commence a Phase II trial in knee OA in Japan. Regeneus is in separate discussions with potential licensees for other indications and territories for Progenza, as well as for its other pipelin
Companies: Regeneus Ltd.
Edison
Regeneus is aiming to sign one or more clinical development licence deals for Progenza in the current financial year. It is well placed to achieve this goal, having already granted AGC an exclusive licence to manufacture Progenza for Japan, reported promising signs of efficacy from the successful Phase I trial of Progenza in knee osteoarthritis and been granted a Progenza patent in Japan. Regeneus reported an A$3.3m profit in FY17, thanks to the US$5.5m upfront payment and US$1m milestone from t
Regeneus announced that its Phase I STEP knee osteoarthritis (OA) trial met its primary safety endpoint at 12 months and produced promising signs of efficacy, including clinically meaningful reductions in pain for the majority of patients and improvement in knee cartilage volume. Separately, it has also been granted a key patent that protects Progenza in Japan until 2032. The positive data and patent grant will be helpful as the company seeks to advance licensing discussions for Progenza for OA
Regeneus has entered into a US$16.5m collaboration with AGC Asahi Glass (AGC) for manufacture of Progenza for the Japanese market. Regeneus and AGC have formed a 50:50 JV for clinical development and commercialisation of Progenza in Japan – we expect the JV to sub-license one or more partners to undertake clinical trials in a number of indications in Japan. We welcome the deal, which strengthens Regeneus’s balance sheet and provides significant validation for the Progenza technology and IP. Our
Regeneus anticipates entering a binding arrangement with a manufacturing and commercialisation partner for its Progenza mesenchymal stem cell therapy technology in Japan by the end of the current quarter. Following on from the positive safety review of its STEP Phase I trial of Progenza in patients with knee osteoarthritis, it has already begun procuring donor material in preparation for manufacturing Progenza for a Phase II trial in Japan. Our valuation is virtually unchanged at A$108m (A$0.52/
Regeneus reported that its STEP Phase I trial of Progenza in patients with knee osteoarthritis has completed recruitment and that a review of safety data did not identify any safety concerns. The study will complete in H117 when all patients have completed 12 months follow-up. We believe the positive safety review augurs well for the company’s plan to secure a manufacturing and commercial partner for its Progenza mesenchymal stem cell therapy technology in Japan in the current quarter, which may
The agreement with one of the top five veterinary pharma companies to collaborate on the development of CryoShot Canine is recognition of the good progress that Regeneus has made developing its regenerative medicine products and cancer vaccines. At its recent AGM, Regeneus confirmed that it anticipates winning the much bigger prize of a manufacturing and development partner in Japan for its Progenza off-the-shelf human stem cell product by Q116. We maintain our valuation of A$106m (A$0.51/share)
Regeneus has sharpened its focus on its area of expertise in early-stage development of regenerative medicine products and cancer vaccines. This strategy appears to be bearing fruit, with partnering arrangements for both its human and veterinary off-the-shelf stem cell therapies expected to be finalised before the end of CY15. A partnering deal for Progenza in Japan is likely to be a re-rating catalyst. Our valuation is A$106m (A$0.51/share).
Research Tree provides access to ongoing research coverage, media content and regulatory news on Regeneus Ltd.. We currently have 8 research reports from 1 professional analysts.
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Cavendish
Verici’s $8.2m gross raise means the company can now focus on scaling Tutivia and invest further into the development of existing and new products. With a uniquely well balanced Tutivia test, a growing sales team and LCD coverage expected later this year, we forecast Tutivia revenues of $2.6m/$4.5m in FY24E/FY25E. The Thermo Fisher deal was a huge validation of Clarava and Verici’s technology and in addition to licensing/milestone payments, we forecast double digit royalties on net Clarava sales
Companies: Verici Dx Plc
Singer Capital Markets
26th March 2024 @HybridanLLP Status of this Note and Disclaimer This document has been issued to you by Hybridan LLP for information purposes only and should not be construed in any circumstances as an offer to sell or solicitation of any offer to buy any security or other financial instrument, nor shall it, or the fact of its distribution, form the basis of, or be relied upon in connection with, any contract relating to such action. This document has no regard for the specific investment object
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Hybridan
SkinBioTherapeutics has reported on the 6-months to December 2023, noting steady revenue growth from lead product AxisBiotix-Ps, progress on the development of SkinBiotix with partner Croda (Sederma) and post-period end, the acquisition of Dermatonics. The company has updated on several positive developments through the start of 2024, including AxisBiotix Acne positive interim results, initiation of research on the MediBiotix Pillar and progress with the oral and inflammation programmes. The com
Companies: SkinBioTherapeutics Plc
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The Hardman & Co Healthcare Index (HHI) has been running since 2009. Its main function is to highlight the attractions of life sciences investments over the long term. For the second year running, apart from global economic influences affecting world markets, performance in 2023 was dented by the capital-intensive nature of the sector. The HHI fell 3.7%, to 483.8, underperforming the main London markets – FTSE 100 (+3.8%) and FTSE All-Share (3.8%) but outperforming the FTSE AIM All-Share Index (
Companies: TXG NDVA TSVT BCOW Z29 TXG NCYT GNS SUN AMS OMG APH EKF EAH IMM AGL DEMG AGY TSTL IPO GDR ETX TRX HVO CTEC AVO OXB DEST VLG IXI VAL INDV AGR AVCT BAI 123F IMCR BCOW
Hardman & Co
On 18th December 2023 Incanthera announced a deal with Marionnaud in Switzerland to distribute ‘Skin+CELL’, its advanced dermatological solution for the delivery of vitamin B3 for skin protection and cosmetic rejuvenation. This gives Incanthera access to a high-end cosmetics distribution presence in Europe, and in addition, ownership of Marionnaud by AS Watson, the largest cosmetics distributor in Asia, offers significant new market opportunities further afield.
Companies: Incanthera Plc
Stanford Capital Partners
FY EBITDA and EBIT came in materially above consensus FY EBITDA came in at EUR98.8m, down 4% yoy and 12% above consensus. The EBITDA margin was 12.6%. Restated for one-off costs, it was 13.1%, more than 2 percentage points above the guidance. It was fully explained by price increases, notably on X-ray, mix and control of fixed costs. FY EBITA came in at EUR38m, 46% above consensus. 2024 guidance looks conservative Guerbet is aiming for organic growth above 8% (8.8%e). With markets growing at
Companies: Guerbet (GBT:EPA)Guerbet SA (GBT:PAR)
BNP Paribas Exane - Sponsored Research
IRLAB Therapeutics has confirmed the FDA’s alignment with its proposed Phase III programme for mesdopetam in levodopa-induced dyskinesias (PD-LIDs), following receipt of the minutes from its end-of-Phase II (EoP2) meeting held last month. Notably, the FDA has agreed on the primary endpoint being the Unified Dyskinesia Rating Scale (UDysRS), on which mesdopetam demonstrated a statistically significant improvement (p=0.026) in the Phase IIb study (secondary endpoint of that study). IRLAB will now
Companies: Irlab Therapeutics Ab
Tissue Regenix has reported on strong performance through 2023, noting record revenues driven by product adoption and expanded distribution, positive adjusted EBITDA for the first time and an increased cash position versus H1/23. FY23 revenues grew 20% to $29.5m supported by 25% growth from BioRinse products and 17% growth from dCELL products. Significantly, Tissue Regenix reported its first adjusted EBITDA profit for the year, +$0.9m, supported by revenue growth and cost management. We expect t
Companies: Tissue Regenix Group plc
Companies: Aptamer Group Plc
Turner Pope Investments
Creo Medical has published a trading update for the 12 months to December 2023, during which the company focused on commercialising its core technology. Revenue for the period increased 13% YoY to £30.8m, while the underlying operating loss improved to £16.4m. Operationally, during the period, the number of confirmed users of Creo’s Speedboat range more than doubled over the year, the first procedures with MicroBlate Flex to ablate lung tumours were performed and Creo expects to receive regulato
Companies: Creo Medical Group Plc
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LungLife AI is a medical diagnostics company focused on the development of AI-supported blood-based tests for the early detection of lung cancer. It has identified a significant medical need for non-invasive, sensitive and specific tests in early-stage lung cancer. The company’s core technology, the LungLB test, seeks to detect circulating tumour cells (CTCs) to identify malignant lung nodules. It aims to apply machine learning/AI (ML/AI) to derive algorithms to increase test accuracy. Following
Companies: LungLife AI, Inc.
This month's feature article is entitled 'Gold and a Chinese Credit Event'. A Western phenomenon? If you own, or are considering owning, gold or gold equities, it’s likely that you’re concerned about protecting your wealth, or the performance of your fund, in the expectation of some kind of financial instability. Maybe your confidence in policymakers is ebbing, or you’ve researched debt bubbles in history and concluded that physical gold and silver have been the safest places to be invested whe
Companies: NBPE ICGT ARBB CSN RECI CLIG HAT AVO STX VTA APAX
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