Friday 24 July 2020
Here is our summary of the day's hottest RNS alerts from across London's Alternative Investments Market (AIM).
Integumen Plc (SKIN.LSE)
Labskin launches remote clinical skin trials
Labskin, a subsidiary of Integumen, announced the launch of the world's first remote clincal skin trials platform. By harvesting the microbiome of a human volunteer's skin, transporting it to the Labskin laboratory to be transplanted onto laboratory-grown skin, it creates an exact replica of the human volunteer's skin microflora - without them leaving their home.
Rinocloud software and AI division, another Integumen subsidiary, built a remote clinical skin trial platform; one that allows trials to happen ethically, efficiently with all protocols being followed and distantly controlled; where all data collected is stored according to the strictest of GDPR guidelines; and critically swabbing can be done under supervision in the human volunteer's own home - so no in-person contact is needed.
Labskin and Rinocloud together created the platform as an extensión to the Labskin AI virtual disease modeling development program that has already transformed the Integumen business model over the last 24 months. The platform is anchored in Labskin technology's ability to harvest and replicate a human subject's microbiome.
Gerard Brandon CEO Integumen plc commented:
"With the spread of COVID-19 continuing to accelerate globally, the science and AI teams advanced this development over the last 3 monhts to create a virtual Clinical Research platform that has been disrupted by the lockdown. This has increased access to immune-suppressed, aged or infirm human volunteers without placing them at risk. It is being further adapted to undertake skin trials for individual consumers for cosmetic, skin disease diagnostics."
I look forward to updating the market very soon on progress with Integumen and other COVID-19 related programmes"
Creo Medical Group (CREO.LSE)
Acquisition of Albyn Medical S.L.
Creo Medical Group plc, the medical device company focused on the emerging field of surgical endoscopy, announced the acquisition of Albyn Medical S.L., a European specialist in the supply and manufacture of Gastroenterology, Urology and Endoscopy products to healthcare providers, for an equity value of €24.8m plus up to €2.7m of performance related consideration payable over the next two years.
Synergistic acquisition that provides immediate market access
With a sales and marketing team of nearly 40 people and a direct presence in Spain, France, Germany and the UK, the acquisition of Albyn Medical fits with the strategy set out by Creo at the time of its fundraising last year and provides it with a commercial and distribution platform to accelerate the development of its business in Europe. Albyn Medical focuses on gastrointestinal products and the acquisition provides a direct route-to-market for Creo's full suite of CE marked GI advanced energy devices.
Albyn Medical sells its own and third-party consumables and systems with 90% of revenues derived from GI endoscopy products
Albyn Medical is a respected name in GI endoscopy and Urology with commercial relationships with doctors and hospitals across key European territories
The acquisition adds a highly complementary product range, expanding the GI product suite and providing an opportunity to broaden into Urology
Following the recent expansion of the Creo team and in combination with Albyn Medical's sales and marketing footprint, the enlarged business will have a 175 strong team, with direct operations in five countries
Acquisition combines deep global intellectual property, innovation, engineering and a pioneering product range from Creo, with an extensive sales, service, logistics, production and export capability of Albyn Medical
Transaction highlights & Financials
Fixed equity value of €24.8m plus up to €2.7m of performance related consideration payable over the next two years in cash
As part of the transaction, Albyn Medical will retain €4.3m of net debt
Albyn Medical reported PBT of €1.7m and EBITDA of €2.4m for the year ended 30 September 2019. As at 30 September 2019, Albyn Medical had gross assets of €15.4m
As a well-established and stable business, Albyn Medical has remained profitable on a monthly basis during the current pandemic
Albyn Medical President, Luis Collantes, has a beneficial interest in 45.3% of Albyn Medical with Sodena, the financial instrument of the Government of Navarra for the development of business in the region owning a further 22.98% and Investment Fund Orza Gestión y Tenencia de Patrimonios, A.I.E. owning 29.94%
Luis Collantes will remain with the business, joining the Creo senior management team in a non-board capacity, and the enlarged group will benefit from his significant experience and market expertise.90% of the issued share capital of Albyn Medical has been acquired at closing with the remaining 10% to be acquired over the next two years for a consideration calculated against performance targets
Cash position of the enlarged Creo group following acquisition of £52.5m
The acquisition is considered to be a substantial transaction, pursuant to AIM Rule 12
About Albyn Medical (www.albynmedical.com)
Albyn Medical was established in 1985 in Scotland, originally developing computer based Urodynamics and GI Motility systems. Now based in Navarra, Spain and with additional operations in the UK, France and Germany, Albyn Medical specialises in the manufacture and supply of systems and consumables for the Urology / Gynaecology, and GI endoscopy markets. A key attraction of Albyn Medical is that it also distributes third-party products within these fields, either under its own label or as third party branded products. Albyn Medical has a total of 85 employees, including a 40 strong sales and marketing team to support sales in the UK, Spain, France and Germany, and an extensive international distributor network.
Albyn Medical's product range covers diagnostic, therapeutic and hygiene / cross-contamination control to customers including hospitals, hospital groups and doctors' offices across both state and private sectors. Its own brand of GI products includes a range of biopsy forceps, snares, catheters, tubes and valves, as well as distributing a wide range of diagnostic and therapeutic endoscopy devices. Albyn Medical also has a range of endoscope cleaning, sterilisation, and storage products, as well as endoscopic accessories for hospitals. GI products account for 90% of Albyn Medical 's sales, with 10% of revenues derived from its own developed urology products and partner urology sales.
Over the last 18 years, Luis Collantes, Albyn Medical President, has succeeded in building Albyn Medical into a successful business, leveraging his energy and reputation in the industry in Europe to grow a resilient company, delivering great service and support to Albyn Medical's customers and a consistent and valuable business to Albyn Medical's suppliers. The Directors believe that the complementary nature of Creo's product range with Albyn Medical's product portfolio provides a clear opportunity to grow both businesses in the coming years.
Creo's suite of CE-marked advanced energy devices are optimised to utilise Bipolar radiofrequency (RF) and High frequency microwave (MW) energy for the core tissue effects of dissection, resection, haemostasis and ablation, and form the basis of four individual device platforms as detailed below:
1. Speedboat™ device technology - Range of unique bipolar RF blades with integrated MW coagulation, the first device technology launched by Creo.
2. SpydrBlade™ device technology - Tissue resection devices combining Speedboat resection capability with precise microwave coagulation - the only bipolar RF resection structure of which the Company is aware.
3. MicroBlate™ device technology - Tissue ablation devices including MicroBlate™ Fine and MicroBlate™ Flex - the smallest microwave ablation devices of which the Company is aware.
4. SlypSeal™ device technology - Range of haemostasis devices leveraging Creo's unique "Non-stick" haemostasis technology - the only non-stick advanced energy haemostasis technology of which the Company is aware.
Creo expects to introduce the devices into clinical practice and for commercialisation across Europe to commence in the second half of this year.
Hutchinson China MediTech Limited (HCM.LSE)
Chi-Med Initiates a Phase I Trial of IDH1/2 Dual Inhibitor in Patients with Hematological Malignancies in China
Hutchison China MediTech Limited has initiated a Phase I study of HMPL-306, its novel selective small molecule dual inhibitor of isocitrate dehydrogenase 1 and 2 mutations, in patients with hematological malignancies in China. The first patient was dosed today .
This is a multi-center study to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of HMPL‑306 in patients of relapsed or refractory hematological malignancies with an IDH1 and/or IDH2 mutation. The first stage of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of HMPL‑306 to determine the maximum tolerated dose and/or the recommended Phase II dose ("RP2D"). The second stage of the study is a dose expansion phase where three cohorts of patients will receive HMPL‑306 to further evaluate the safety, tolerability, and clinical activity at the RP2D. Additional details may be found at clinicaltrials.gov, using identifier NCT04272957.
HMPL-306 is Chi-Med's ninth innovative oncology asset discovered in house. Cytoplasmic mutant IDH1 and mitochondrial mutant IDH2 have been known to switch to the other form when targeted by an inhibitor of IDH1 mutant alone or IDH2 mutant alone. By targeting both IDH1 and IDH2 mutations, this drug candidate may provide therapeutic benefits in cancer patients harboring IDH mutations, and may address acquired resistance to IDH inhibition through isoform switching.
About IDH and Hematological Malignancies
IDHs are critical metabolic enzymes that help to break down nutrients and generate energy for cells. When mutated, IDH creates a molecule that alters the cell's genetic programming and prevents cells from maturing. IDH1 or IDH2 mutations are common genetic alterations in various types of blood and solid tumors, including acute myeloid leukemia ("AML") with approximately 20% of patients having mutant IDH genes, myelodysplastic syndrome (MDS), myeloproliferative neoplasms (MPNs), low-grade glioma and intrahepatic cholangiocarcinoma. Mutant IDH isoform switching, either from cytoplasmic mutant IDH1 to mitochondrial mutant IDH2, or vice versa, is a mechanism of acquired resistance to IDH inhibition in AML and cholangiocarcinoma.
According to the National Cancer Institute (NCI), there will be approximately 20,000 new cases of AML in the U.S. in 2020 and the five-year relative survival rate is 28.7%. Currently, the U.S. Food and Drug Administration (FDA) has approved one drug for IDH1 mutation and one drug for IDH2 mutation, but no dual inhibitor targeting both IDH1 and IDH2 mutants has been approved. There were an estimated 19,700 new cases of AML in China in 2018 and is estimated to reach 24,200 in China in 2030. In China no IDH inhibitor has been approved.