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TG4010 and Pexa-Vec readouts to define 2019

Update | Pharmaceuticals & healthcare | 30 Nov 2018

Late-stage clinical trial readouts in 2019 will be critical to Transgene’s immunoncology (IO) aspirations and, if positive, could further its position in the sector; notably efficacy data expected from the Phase II TG4010 (+nivolumab +chemotherapy) trial in first line non-small cell lung cancer (NSCLC) and the Phase III Pexa-Vec (+sorafenib) trial in first line hepatocellular carcinoma (HCC) (trial conducted by partner SillaJen). Next-generation platforms Invir.IO and myvac continue to progress, with assets from both expected to enter the clinic in 2019. Additional financing is needed to ensure a cash reach beyond September 2019. We value Transgene at EUR 4.68 per share (EUR 290m).


Combination strategy awaiting validation

QuickView | Pharmaceuticals & healthcare | 19 Nov 2018

Transgene develops virus-based product candidates for use in oncologyand infectious diseases. Its five clinical products are currently in sevenclinical trials across a variety of indications; the most advanced is a PhaseIII trial with Pexa-Vec (+ sorafenib) in first-line Hepatocellular Carcinomawith interim data anticipated in 2019. Its strategy remains to develop itscandidates in combination with approved treatments, notably immunecheckpoint inhibitors (ICIs). Key to validating this strategy will be datafrom a first-line NSCLC trial testing TG4010 in combination with Opdivoand chemotherapy. Data is now forecast to be available in H219. We valueTransgene at €4.64/share vs €4.65/share previously.


Near-term data to define long-term strategy

Outlook | Pharmaceuticals & healthcare | 16 Jul 2018

Transgene develops virus-based product candidates for use in oncology and infectious diseases, its five clinical products are currently in 11 clinical trials across a variety of indications, its most advanced is Phase III trial with Pexa-Vec in first-line Hepatocellular Carcinoma with data anticipated in 2019. Its strategy remains to develop its candidates in combination with approved treatments, notably immune checkpoint inhibitors (ICIs). It anticipates eight clinical readouts across its five clinical candidates by year end, notably TG4010 in combination with Opdivo and chemo in first-line NSCLC. We value Transgene at EUR 4.65/share vs EUR 3.80/share previously.


2018: A year of clinical data

Update | Pharmaceuticals & healthcare | 23 Mar 2018

We anticipate nine of Transgene’s ongoing clinical trials to read out data later this year. This will be the first major test of the company’s strategy for combining its products with approved therapies. In our view, data packages from two trials testing the combination of TG4010 and Opdivo in advanced first- and second-line NSCLC will be key inflection points. Cash as of FY17 results will be sufficient to fund operations into 2019. We value Transgene at EUR 236m (EUR 3.8/share) vs EUR 207m (EUR 3.7/share) previously.


Multiple assets in the clinic as data readouts near

Update | Pharmaceuticals & healthcare | 01 Nov 2017

Transgene’s strategy is focused on combining its products with approved therapies with the aim of improving response rates in patients. The company now has nine ongoing clinical trials, which are expected to readout in the next 12-18 months, and data will inform Transgene’s future strategy. In addition to numerous trial initiations, Transgene recently presented data on TG1050 in hepatitis B patients, launched its next generation oncolytic virus platform Invir.IO and signed a collaboration agreement with Randox. We value Transgene at EUR 207m (EUR 3.7/share).


Building a strong immunotherapy portfolio

Outlook | Pharmaceuticals & healthcare | 18 Jul 2017

Combinations with immunotherapies are key to Transgene’s strategy. The company is focused on combining its main assets, TG4010 (cancer vaccine) and Pexa-Vec (oncolytic virus), with immune checkpoint inhibitors (ICIs), ipilimumab (Yervoy) and nivolumab (Opdivo). ICIs as monotherapies have proven successful in patients; however, positive efficacy has been limited to certain cancers and long-term responses remain difficult. Combinations with other immunotherapies may improve both addressable population and long-term efficacy. To this end, Transgene is conducting Phase I and II trials in collaboration with academic institutions and pharmaceutical companies. The first read-outs are expected later this year. Our updated valuation is EUR 208m.


Combination trials start, FY16 results

Update | Pharmaceuticals & healthcare | 24 Mar 2017

Transgene has announced the initiation of two clinical trials of its main assets in combination with immune checkpoint inhibitors (ICIs). A Phase I trial of oncolytic virus Pexa-Vec in combination with Yervoy in solid tumours has started. Additionally, a Phase II study of the therapeutic vaccine TG4010 with Opdivo in second-line advanced lung cancer has started at UC Davis in collaboration with Bristol-Myers Squibb; initial results from both trials are expected later this year. Cash and equivalents at end 2016 amount to €56.2m. Our updated valuation is €204m or €3.6/share.


Business update and Q316 results

Update | Pharmaceuticals & healthcare | 28 Oct 2016

During Q316 Transgene announced a collaboration agreement with Pfizer and Merck to develop TG4001 in combination with avelumab in a Phase I/II trial, the recruitment of the first patient in the multiple-dose cohort of Phase I/Ib of TG4001 in HBV patients and preclinical data from its vaccinia technology platform. The company plans to raise EUR 48.1m (gross) through a rights issue that will fund operations to the end of 2018. Cash and equivalents at end Q316 amount to EUR 25.4m. We value Transgene at EUR 161.5m or EUR 4.2/share.


Combinations define strategy

Update | Pharmaceuticals & healthcare | 21 Sep 2016

Transgene has further expanded on its new strategy announced in January 2016 and clarified timelines for combination trials of its product candidates with immune checkpoint inhibitors. Six clinical trials are due to start before 2017 year end; its lead product candidates, Pexa-Vec (oncolytic virus) and TG4010 (therapeutic vaccine) in combination with Yervoy and Opdivo respectively should start phase II trials by year end. Restructuring in 2015 has significantly reduced costs and it is now financed through major inflection points in 2017. HY16 net cash of €33.4m includes short-term financial assets. We value Transgene at €4.40/share (€169.5m).


Worth a fresh look

Outlook | Pharmaceuticals & healthcare | 13 Apr 2016

Transgene has successfully completed a major restructuring programme and secured fresh financing (up to €30m from the EIB and Institut Mérieux), which puts it in a strong position to advance its promising immunotherapy technologies once more. The focus is on conducting new Phase I/II studies for Pexa-Vec (oncolytic virus) and TG4010 (MUC1 cancer vaccine) in combination with immune checkpoint inhibitors, an eagerly anticipated approach for hard-to-treat cancers. Partner SillaJen has started a Phase III trial with Pexa-Vec for liver cancer. We re-initiate coverage of Transgene with a base-case valuation of €160m or €4.15 per share.


Restructuring to focus on R&D

QuickView | Pharmaceuticals & healthcare | 09 Nov 2015

Transgene is a biopharmaceutical company focused on the discovery, development and manufacture of immunotherapies for the treatment of cancer and infectious diseases. Its pipeline includes two Phase III-ready candidates, TG4010 (lung cancer) and Pexa-Vec (liver cancer), and TG1050 (hepatitis B), which is due to start Phase I in Q415. In June, Transgene announced a restructuring programme to focus the business on R&D, with plans to close its pharmaceutical development and bio-manufacturing capabilities (c €1.7m of revenue in 2014). Our valuation and financials are under review, pending further details.


Restructuring to focus on R&D

Flash note | Pharmaceuticals & healthcare | 30 Jun 2015

Transgene has announced restructuring plans to focus the business on research and development. This will result in closure of the pharmaceutical development and bio-manufacturing business (c €1.7m revenue in 2014) but should lead to long-term cost savings. We have placed our valuation and financials under review pending details on the likely impact of the restructuring and updated clinical development plans.