Transgene Presents 2018 Half-Year Results and Business Update

September 19, 2018

STRASBOURG, France--(BUSINESS WIRE)--Sep 19, 2018--Regulatory News:

Transgene (Paris:TNG) (Euronext Paris: TNG), Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancers and infectious diseases, announces its financial results for the six-month period ended June 30, 2018, and provides an update on its clinical and preclinical portfolio.

Philippe Archinard, Chairman and Chief Executive Officer of Transgene, commented:

“2018 is a period of intense activity for Transgene. We obtained $48 million in the form of Tasly Biopharmaceuticals shares following the sale of TG1050 and TG6002 rights in Greater China. We presented new results on our oncolytic virus Pexa-Vec at ASCO that benefitted from a positive reception. We have continued to make progress with our clinical and preclinical programs.

Looking ahead we expect to announce more comprehensive clinical results from our strategic studies before the end of 2018 and over the course of 2019.

Our research efforts are focused on our world-leading viral vector expertise applied to our two core technologies: oncolytic viruses and therapeutic vaccines. With our Invir.IO TM platform, we are designing new viruses to provide a better modulation of the tumor micro-environment. We are also about to present our ambitious approach in neoantigen-based therapeutic vaccines at a scientific congress in the coming weeks.

The progress that we have made in 2018 further confirms Transgene’s strategic position as leading innovator in the fight against cancer.”

Clinical Pipeline Review

1. Update on company-sponsored strategic trials

Transgene has been making significant progress with its key clinical trials, which are aimed at generating proof-of-concept clinical data. Positive results from these trials would create significant partnering opportunities.

2. Update on investigator-sponsored trials evaluating Transgene’s products

Transgene is collaborating with leading physicians at world-renowned clinical centers to identify and evaluate novel treatment regimens based on the initiative of the clinicians. These trials are designed to generate further clinical data demonstrating the value of Transgene’s products in exploratory clinical settings. These trials also contribute to strengthening the data packages and increase the visibility of the products amongst the medical community.

Sale of the Rights of TG1050 and TG6002 in Greater China

On July 10, 2018, Transgene entered into a set of agreements with Tasly Biopharmaceuticals Co., Ltd. under which Transgene sold both the T101 Greater China patent rights and its entire 50% stake in the Transgene Tasly (Tianjin) BioPharmaceuticals Co. Ltd. joint venture which already owned the T601 Greater China patent rights. Following these agreements, Tasly Biopharmaceuticals now holds all rights to research, development and commercialization for T601 and T101 in Greater China.

In return, Transgene received a total of 27.4 million new Tasly Biopharmaceuticals shares valued at $48 million based on the subscription price in pre-IPO financing round of Tasly Biopharmaceuticals, which took place concurrently with the transaction with Transgene. Transgene’s stake represents 2.53% of Tasly Biopharmaceutical’s expanded share capital. Tasly Biopharmaceuticals has announced its intention to list its shares on the Hong Kong Stock Exchange.

The transactions were finalized in August 2018.

NB: T601 and T101 are products developed in China and respectively incorporating Transgene’s TG6002 and TG1050 patented technologies.

Research and preclinical portfolio

In the first half of 2018, Transgene significantly reinforced its preclinical capabilities, capitalizing on its leading viral vectors expertise in the most attractive fields of onco-immunotherapy.

With Invir.IO TM, Transgene is making progress in the increasingly attractive field of novel oncolytic viruses (OVs). The Invir.IO TM platform aims at generating multifunctional novel oncolytic viruses that incorporate several transgenes encoding for a range of specific anticancer weapons and that are capable of better modulating the tumor micro-environment.

The Company is currently evaluating several preclinical Invir.IO TM OV candidates to identify the most attractive one to progress into clinical development. Current candidates include OVs encoding an anti-CTLA-4 antibody in a collaboration with BioInvent, as well as other anti-cancer agents (ligands, cytokines, chemokines, enzymes, etc.). Transgene is on track to initiate the first clinical trial with the first Invir.IOTMdesigned virotherapy in 2019.

Transgene will shortly be presenting an ambitious personalized immunotherapy approach that will allow the Company to enter the promising field of personalized medicine. This approach combines the Company’s expertise in therapeutic vaccines with neoantigen vectorization and artificial intelligence.

Transgene will provide further updates on preclinical activities in the coming months, including at key upcoming immunotherapy congresses.

Key Financials

Key elements of the income statement

Operating revenues amounted to €3.6 million for the first six months of 2018 compared to €3.9 million for the same period in 2017.

Revenues from collaboration and licensing agreements amounted to €0.6 million for the first six months of 2018 versus €0.5 million in the same period in 2017. The research tax credit amounted to €2.8 million for the first half of 2018, compared to €3.0 million for the first half of 2017.

Research and Development (R&D) expenses amounted to €13.8 million in the first half of 2018 compared to €16.9 million for the same period in 2017. This decrease was mainly due to the 2017 milestone payment of €3.8 million ($4 million) to SillaJen, Inc. triggered by the first patient being recruited in Europe in the Phase 3 trial of Pexa-Vec (Phocus trial). External expenses for clinical projects increased by €0.5 million to €3.7 million as we continued to progress the development of all our products.

General and administrative expenses were stable at €3.0 million for the first half of 2018 compared to €3.1 million for the same period in 2017.

Net loss amounted to €14.9 million for the first half of 2018 compared to €18.3 million for the same period in 2017.

As of June 30, 2018, the Company’s cash, cash equivalents, available-for-sale financial assets and other financial assets amounted to €33.1 million versus €41.4 million as of December 31, 2017.

Transgene’s cash burn amounted to €8.4 million in the first half of 2018, compared with €12.3 million for the same period in 2017 (mainly due to the milestone payment of €3.8 million ($4 million) to SillaJen, Inc. in 2017).

Transgene confirms its net cash burn target of approximately €25 million for 2018.

“Our results for the first six months of 2018 are in line with our expectations. We confirm our financial visibility for the next 12 months, excluding the monetization of the Tasly Biopharmaceuticals shares,” commented Jean-Philippe Del, Chief Financial Officer of Transgene.

The Board of Directors of Transgene met on September 19, 2018 and adopted the financial statements for the six-month period ended June 30, 2018. The Statutory Auditors have conducted a limited review of the interim consolidated financial statements. The half-year financial report is available on Transgene’s website, .

A conference call in English is scheduled today, on September 19 th at 6:30 p.m. CET.

Webcast link to English language conference call: https://channel.royalcast.com/webcast/transgene/20180919_1/

Participant telephone numbers:

A replay of the call will be available on the Transgene website ( www.transgene.fr ) following the live event.

Notes to editors Transgene (Euronext: TNG), part of Institut Mérieux, is a publicly traded French biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing infected or cancerous cells. The Company’s lead clinical-stage programs are: TG4010, a therapeutic vaccine against non-small cell lung cancer, Pexa-Vec, an oncolytic virus against liver cancer, and TG4001, a therapeutic vaccine against HPV-positive head and neck cancers. The Company has several other programs in clinical development, including TG1050 (chronic hepatitis B) and TG6002 (solid tumors). With its proprietary Invir.IO TM, Transgene builds on its expertise in viral vectors engineering to design a new generation of multifunctional oncolytic viruses. Additional information about Transgene is available at www.transgene.fr. Follow us on Twitter: @TransgeneSA

Disclaimer This press release contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. There can be no guarantee that (i) the results of pre-clinical work and prior clinical trials will be predictive of the results of the clinical trials currently underway, (ii) regulatory authorities will agree with the Company’s further development plans for its therapies, or (iii) the Company will find development and commercialization partners for its therapies in a timely manner and on satisfactory terms and conditions, if at all. The occurrence of any of these risks could have a significant negative outcome for the Company’s activities, perspectives, financial situation, results and development. For a discussion of risks and uncertainties which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risques”) section of the Document de Référence, available on the AMF website ( http://www.amf-france.org ) or on Transgene’s website ( www.transgene.fr ). Forward-looking statements speak only as of the date on which they are made, and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.


Consolidated balance sheet, IFRS (in € thousands)

Consolidated income statement, IFRS (in € thousands, except for per-share data)

Cash Flow statement, IFRS (in € thousands)

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