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Executive interview - Genkyotex

Edison TV: | Pharmaceutical & healthcare | 05 Dec 2017

In this interview, Genkyotex CEO Mr Elias Papatheodorou explains the core technology of its business and the products it is developing. He provides an overview of the competitive advantages of Genkyotex’s products with respect to its competitors. Furthermore, he discusses the current landscape for fibrosis and the market opportunity for its products. Finally, he provides timelines for the next value inflection points.


Termination of coverage

Termination | Pharmaceutical & healthcare | 07 Aug 2018

Edison Investment Research is terminating coverage on Genkyotex (GKTX). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant.


Ready to make a dent in the fibrosis market

Update | Pharmaceutical & healthcare | 03 Jul 2018

Genkyotex has initiated a Phase II investigator-sponsored trial in patients with Type 1 diabetes (T1D) and kidney disease (DKD). Separately, it has announced the positive outcome of a safety review of its Phase II trial with GKT831 in patients with primary biliary cholangitis (PBC) with no adverse events or patient dropouts. Interim data have been pushed back slightly to autumn 2018 from mid-2018 and full data to H119 from end-2018 due to a slow rate of activation of a number of research centres. Additionally, the original deal with the Serum Institute of India Ltd (SIIL) has been expanded and Genkyotex is now eligible to an additional EUR 100m in milestone payments plus royalties on sales. We include the DKD indication and the new terms with SIIL in our valuation, which is now EUR 338.7m or EUR 4.35/share.


GKT831 clinical development on track

Update | Pharmaceutical & healthcare | 06 Jul 2017

As expected, Genkyotex has initiated enrolment in the Phase II trial of GKT831 in patients with primary biliary cholangitis (PBC) in the first clinical trial site in the US. The trial plans to test GKT831 in 102 patients over 24 weeks. Interim data are expected in H118 and full data in H218. Moreover, the company has announced a Phase II investigator-sponsored trial in patients with Type 1 diabetes (T1D) and kidney disease. The trial will start in Australia in H217 and will be entirely funded and run by public bodies. These new trials demonstrate that Genkyotex is executing on its clinical development plan. Our valuation is EUR 268m.


Targeting obNOXious fibrosis

Outlook | Pharmaceutical & healthcare | 30 May 2017

Genkyotex is a Euronext-listed company formed by the merger of Genticel and Genkyotex focused on NOX science and its application in fibrosis and other indications. The lead asset, GKT831, will start a Phase II trial in primary biliary cholangitis (PBC) in Q217, with data expected in 2018. Positive results could justify future development in other large fibrotic diseases including non-alcoholic steatohepatitis (NASH). GKT771 will be Phase I ready in late 2017 and will focus on inflammation and angiogenesis. A partnership for immunotherapies with the Serum Institute of India (SIIL) for up to $57m in milestone payments plus royalties is also in place. Cash of €21.8m at end March 2017 should be sufficient to fund operations for two years. Our valuation is €268m.


Final preclinical SIIL milestone achieved

Update | Pharmaceutical & healthcare | 19 Dec 2016

Genticel has received a milestone payment of $1.2m from the Serum Institute of India (SIIL). This is the last milestone Genticel will receive associated with the preclinical development of GTL003 in new multivalent vaccines that contain pertussis (whooping cough). SIIL can now finish formal preclinical development before moving to clinical development, which could unlock further milestone payments. Under the collaboration with SIIL, Genticel is entitled to up to $57m development and sales milestone payments and single-digit royalties on net sales. Cash and equivalents at end Q316 were EUR 12.3m. Our valuation is under review following the termination of the GTL001 and GTL002 programmes.


Further Phase II data announced

Update | Pharmaceutical & healthcare | 28 Jun 2016

Genticel has announced 18-month data from the Phase II trial of the GTL001 vaccine to treat early-stage human papillomavirus 16 and 18 infections (HPV16/18). In this update, GTL001 showed no statistically significant difference in any subgroup. Safety remains positive. Genticel will present 24-month data in Q117, which will include the full data set and inform next steps. The company continues leveraging its Vaxiclase platform in collaboration with the Serum Institute of India (SIIL) and plans to expand its pipeline. We have revised our valuation down to €2.31/share (€5.75/sh previously) as we have cut the probability of success for GTL001.


A deeper look into Phase II data

Update | Pharmaceutical & healthcare | 07 Jun 2016

Genticel has announced further analysis of its Phase II results on the GTL001 vaccine to treat early-stage human papillomavirus (HPV) 16 and 18 infections. The pre-specified group of patients with normal cytology had a significantly higher viral clearance than those taking placebo (p=0.018). Post-hoc analysis of the combined group of normal and ASCUS patients also shows a statistically significant difference (p=0.0029) between groups. In our view, this indicates that GTL001 could be effective in 80% of women positive for HPV 16/18. Management expects 18-month data in Q316 to enable partnering and Phase III initiation.


Mixed fortunes

Update | Pharmaceutical & healthcare | 10 Feb 2016

Genticel has announced the Phase II results of its GTL001 vaccine to treat early-stage human papillomavirus 16 and 18 (HPV 16 and 18) infections. The primary 12-month endpoint, focused on women with early cervical cellular abnormalities, was not achieved. Positively, in the subgroup of women with normal cytology, a significant clearance rate was seen. Further clearance data after 18 months are expected by Q316 and management expects this to enable Phase III preparations and partnering.


Destroying dangerous sexual viruses

Initiation | Pharmaceutical & healthcare | 04 Jan 2016

Genticel develops therapeutic vaccines to treat early-stage human papillomavirus 16 and 18 (HPV 16 and 18) infections. Currently, there are no therapeutic options for infected women who remain at risk of progressing to high-risk, pre-cancerous cervical lesions requiring surgery; HPV 16 and 18 cause about 70% of cervical cancer. GTL001 Phase II data are due in Q116. A statistically significant outcome could lead to a major deal. Genticel is funded into 2017, with Q315 cash of €21.5m.


Gentle therapy; dangerous infections

QuickView | Pharmaceutical & healthcare | 01 Sep 2015

Genticel develops gentle therapeutic vaccines to treat early-stage human papilloma virus infections. The lead vaccine, GTL001, targets high-risk HPV 16 and 18 infections causing c 75% of cervical cancers in North America and the EU. There is no therapeutic vaccine to treat up to 12m women (in these markets). Phase II data, due in H116, could enable a major partnering deal to fund Phase III. A second product, GTL002, based on an improved proprietary platform (Vaxiclase), could enter trials in 2017 and should extend the therapy to cover other HPV types. Genticel is funded into 2017 (H115 cash €25.2m).