STRASBOURG, France--(BUSINESS WIRE)--Regulatory News:
Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies against cancers and infectious diseases to transform the fight against solid tumors and infectious diseases, today announces its business update for the quarter ending March 31, 2019.
Operating revenue:
The following table summarizes the first quarter operating revenue for 2019 compared to the same period in 2018:
Q1 | ||||
In millions of euros | 2019 | 2018 | ||
Revenue from collaborative and licensing agreements | 0.4 | 0.2 | ||
Government financing for research expenditures | 1.5 | 1.6 | ||
Operating revenue | 1.9 | 1.8 |
During the first quarter of 2019, revenue from collaborative and licensing agreements was mainly composed of research services and royalties.
As of March 31, 2019, government financing for research expenditures mainly consisted of 25% of the research tax credit expected for 2019 (€1.5 million in the first quarter of 2019, compared to €1.6 million for the same period in 2018).
Cash, cash equivalents, available-for-sale financial assets and other financial assets:
In the first quarter of 2019, Transgene’s cash burn was €7.8 million, compared to €5.8 million for the same period in 2018. Cash, cash equivalents, available-for-sale financial assets and other financial assets stood at €9.1 million as of March 31, 2019, compared to €16.9 million as of December 31, 2018. This cash position does not include the €20 million credit facility available for the Company or the $10 million receivable from AstraZeneca.
Key achievements:
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Finance:
- Transgene secured a €20 million revolving credit facility with a 30-month term with Natixis. Transgene will be able to draw on and repay the facility at its discretion. Transgene has used its shares in the Chinese biotech company Tasly Biopharmaceuticals as collateral for this loan (press release distributed on March 18, 2019). As of May 13, 2019, the Company has not drawn down on this facility.
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Invir.IO™:
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Transgene and AstraZeneca signed a collaborative research,
option and exclusive license agreement to co-develop five armed
oncolytic vaccinia virus candidates deriving from the
Invir.IO™ platform.
Transgene is to receive $10 million in Q2 2019 and additional pre-clinical success milestones of up to $3 million. Transgene is eligible to receive an option exercise payment on each candidate in the event AstraZeneca exercises one or more of its license option, as well as development and commercial milestones and royalties (press release distributed on May 2, 2019).
- Transgene and BioInvent extend their collaboration to develop additional multifunctional oncolytic viruses encoding for antibodies capable of treating a broad range of solid tumors (press release distributed on March 26, 2019).
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Transgene and AstraZeneca signed a collaborative research,
option and exclusive license agreement to co-develop five armed
oncolytic vaccinia virus candidates deriving from the
Invir.IO™ platform.
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myvac™:
- Transgene announced that the NEOVIVA project, that is focused on Transgene’s individualized immunotherapy platform myvac™, was selected by the “Investments for the Future” Program (Programme d’Investissements d’Avenir) operated by Bpifrance. The NEOVIVA project will receive €5.2 million over the five-year duration of the program from Bpifrance, of which Transgene will receive €2.6 million (press release distributed on March 13, 2019).
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TG4050:
- Transgene announced its decision to initiate clinical developments of its lead myvac™ candidate, TG4050, and the finalization of its collaboration agreement with NEC (press release distributed on March 5, 2019).
- Transgene received FDA IND clearance for TG4050 to commence clinical development in ovarian cancer (press release distributed on May 13, 2019).
Outlook:
Transgene expects its cash burn for 2019 to be between €15 million and €20 million, based on its current development plan and cash-in from the collaboration with AstraZeneca.
As a result of the financing agreement with Natixis and the signing of the collaboration with AstraZeneca, Transgene has extended its financial visibility to Q4 2020.
Transgene confirms that it expects readouts from its key clinical trials in the second half of 2019.
- End -
Notes to editors:
About Transgene
Transgene (Euronext: TNG) 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 (a therapeutic
vaccine for the treatment of chronic hepatitis B) and TG6002 (an
oncolytic virus for the treatment of solid tumors).With its proprietary
Invir.IO™, Transgene builds on its expertise in viral vectors
engineering to design a new generation of multifunctional oncolytic
viruses.myvacTM, an individualized MVA-based
immunotherapy platform designed to integrate neoantigens, completes this
innovative research portfolio. TG4050, the first candidate selected from
the myvac™ platform, will enter the clinic for the treatment of
ovarian cancer and head and neck cancer.
Additional information about Transgene is available at www.transgene.fr
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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. The occurrence of any of these risks could have
a significant negative outcome for the Company’s activities,
perspectives, financial situation, results, regulatory authorities’
agreement with development phases, and development. The Company’s
ability to commercialize its products depends on but is not limited to
the following factors: positive pre-clinical data may not be predictive
of human clinical results, the success of clinical studies, the ability
to obtain financing and/or partnerships for product manufacturing,
development and commercialization, and marketing approval by government
regulatory authorities. 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 Risque”) 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.