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Transgene: A Positive 2018, Moving Ahead with a Strong Portfolio

2018 Full-year results and business update

  • Clinical trials set to announce key data in 2019
  • Invir.IO™ platform designed to deliver a new generation of
    oncolytic viruses has demonstrated promising preclinical data and is
    progressing to clinical stage
  • Launch of myvacTM – our platform
    for highly innovative virus-based, individualized immunotherapy has
    already achieved multiple milestones translated into a strategic
    partnership with NEC
  • Received $48 million in Tasly Biopharmaceuticals Co., Ltd.
    (‘Tasly’) shares through the sale of TG1050 and TG6002 rights to Tasly
    in Greater China
  • Key financial elements:

    • €8 million in net income in 2018 as a result of the Tasly deal
    • €20 million revolving credit facility secured, using its Tasly
      shares as collateral
    • Financial visibility extended until mid-2020

Conference call scheduled today at 6:30 p.m. CET (in English)
(details at the end of this release)

STRASBOURG, France–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/Transgene?src=hash” target=”_blank”gt;#Transgenelt;/agt;–Regulatory News:

Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that
designs and develops virus-based immunotherapies to transform the fight
against solid tumors and infectious diseases, publishes its financial
results for 2018 and provides an update on its clinical and preclinical
portfolio, and its technology platforms.

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

“2018 was a year of intense activity for Transgene resulting in
significant progress across all aspects of the business. We continued to
advance our promising clinical assets and look forward to announcing
data from our key clinical trials in the second half of 2019.

Our R&D efforts were focused on our two cutting-edge technology
platforms: oncolytic viruses and therapeutic vaccines, engineered to
deliver a step change improvement in the treatment of solid tumors.

With the Invir.IOTM platform, we design a
new virus with a more potent oncolytic effect and are arming it with
strong immune-modulating agents to treat tumor which are today resistant
to existing therapies. Positive data were presented at the Society for
Immunotherapy of Cancer (SITC) Annual Meeting 2018. We have an ambitious
program and we are currently evaluating several preclinical Invir.IO
TM
candidates which we expect to bring to the clinic in H1 2020.

In September we launched myvacTM, a highly
innovative viral vector-based, individualized immunotherapy approach
combining the use of the tumor’s neoantigens with Transgene’s viral
vector expertise to create a completely novel patient specific treatment
option for solid tumors. We signed a strategic collaboration with NEC to
leverage its artificial intelligence capabilities to identify candidate
neoantigen targets. With the know-how and highly skilled experts at NEC
as well as Institut Curie, HalioDx and Traaser, we are targeting to
initiate two clinical trials in H2 2019 with our lead
myvacTM
candidate TG4050.

This is an exciting time for Transgene as we advance our viral-vector
based immunotherapies to transform the fight against solid tumors.”

Clinical Pipeline Review

Transgene has made significant progress with its key clinical trials,
the majority of which are designed to produce proof-of-concept clinical
data. Positive results from these trials would create significant value
and partnering opportunities.

TG4010

+ Opdivo® (ICI) (nivolumab)
+ chemotherapy

Phase 2

Non-small cell lung cancer (NSCLC) – 1st
line

Trial of TG4010 in combination with nivolumab and chemotherapy in
patients whose adenocarcinoma cells express low or undetectable
levels of PD-L1.

✓ Recruitment is progressing well in US and EU with the opening of
additional centers in EU; recruitment completion expected in Q2
2019

✓ Bristol-Myers Squibb supplying nivolumab through a clinical
collaboration

→ Data on the study’s primary endpoint (ORR) on all evaluable
patients (n=35) expected in H2 2019

Pexa-Vec

+ sorafenib

(PHOCUS)

Phase 3

Advanced liver cancer (hepatocellular
carcinoma – HCC) – 1
st
line

✓ Clinical trial being conducted by Transgene’s partner, SillaJen,
Inc. (sponsor)

✓ Ongoing global recruitment

→ Futility analysis expected mid-2019

→ First efficacy readout expected in 2020

Pexa-Vec

+ Opdivo® (ICI) (nivolumab)

Phase 1/2

Advanced liver cancer (hepatocellular
carcinoma – HCC) – 1
st
line

✓ Several active trial sites in France and Italy

✓ Safety confirmed by Safety Review Committee (SRC) in February
2019, Phase 2 part on-going

✓ US sites to be activated in Q2 2019

→ Interim analysis on 15 patients expected 2H 2019 (primary
endpoint: ORR)

TG4001

+ Bavencio® (ICI)

(avelumab)
Phase 1/2

HPV-positive cancers including
oropharyngeal head and neck cancer – 2
nd
line

✓ Clinical collaboration agreement with Merck KGaA and Pfizer, for
the supply of avelumab

✓ Following positive SRC the Phase 2 part is ongoing and
additional sites are being activated in Europe

→ Next clinical readout expected in H2 2019

TG6002

Phase 1/2a

TG6002 is the first candidate from Transgene’s next generation
oncolytic platform which is based on an improved viral backbone.
This oncolytic virus, given in combination with the prodrug 5-FC,
has been designed to produce the cytotoxic 5-FU locally in the
tumor

Gastro-intestinal adenocarcinoma
(colon cancer for Phase 2) – IV route

✓ Multi-center trial on-going in Belgium, France and Spain

→ First clinical readout expected in H2 2019

Metastatic colon cancer (liver
metastasis) – IHA route

✓ Coordinating investigator: Adel Samson, St James’s Hospital,
Leeds (UK)

✓ Multi-center trial in UK; INDs submitted in UK

→ First patient expected to be treated in Q4 2019

TG1050

+ Standard of care

Phase 1

Chronic hepatitis B

✓ Trial completed

→ Positive results from Phase 1 clinical trial of TG1050 in
Chronic Hepatitis B presented at the AASLD Liver Meeting 2018:
confirmation of safety, and immunogenicity

→ Transgene is looking for partner to further advance this product

TG4050

Two Phase 1 in preparation

✓ TG4050 is a therapeutic vaccine developed for individual
patients, based on the specific mutations identified in the
patient’s own tumor

✓ Collaboration with NEC; Transgene and NEC will co-finance 2
trials in:

Ovarian cancer (after first line
surgery and adjuvant therapy)

→ First patient expected Q4 2019 (evaluation of safety and
immunogenicity)

→ Trial will be conducted in the US and France

HPV-negative head & neck cancer (after
surgery and adjuvant therapy)

→ First patient expected in Q4 2019 (evaluation of safety and
immunogenicity)

→ Trial will be conducted in the UK and France

Transgene’s Cutting-edge Oncolytics and Vaccine Platforms Poised to
Change the Treatment of Solid Tumors

In 2018, Transgene significantly reinforced its preclinical
capabilities, capitalizing on its global leading viral vector expertise
in two of the most attractive fields of onco-immunotherapy: oncolytic
viruses (OV) and therapeutic vaccines.

With Invir.IO™, its new and more potent oncolytic virus platform
Transgene is designing multi-functional OVs that it believes will
deliver a step change in the treatment of advanced solid tumors. This is
still an area of significant medical need despite the rapid growth in
the use of immune checkpoint inhibitors either alone or in combination
with other anti-cancer agents.

With myvacTM its individualized immunotherapy
platform, Transgene is developing therapeutic vaccines designed for each
individual patient which are expected to deliver improved outcomes in
patients with less advanced solid tumors, as an adjuvant therapy
following surgery for the first proof of concept trials.

The lead candidates from both platforms are expected to enter clinical
development in the next 12 months.

Invir.IOTM: the next generation of
multifunctional oncolytic viruses to treat advanced solid tumors

With Invir.IOTM, Transgene is making good progress in the
increasingly attractive field of novel oncolytic viruses (OVs).
Oncolytic viruses are an emerging class of targeted anticancer therapies
designed to selectively infect, replicate in, and lyse malignant cells
without causing harm to normal, healthy tissues. In addition to direct
oncolytic activity, OVs have shown dual promise as immunotherapeutic
agents: the viral infection leads to an immunogenic tumor cell death,
triggers innate and adaptive immune responses that mediate further tumor
destruction and these viruses can also deliver very potent
immunotherapeutic agents selectively in the tumor micro environment.
Transgene expects its Invir.IO™ viruses to deliver a step change on
these two fronts.

The Invir.IO™ platform is designed to generate novel multifunctional
oncolytic virus that has a more potent oncolytic viral backbone and
incorporate several transgenes encoding for a range of specific
anticancer weapons that are capable of better modulating the tumor
micro-environment, with the aim of improving the treatment outcomes of
patients with solid tumors.

In November 2018, Transgene presented positive data of its
antibody-armed oncolytic vaccinia virus at the Society for Immunotherapy
of Cancer (SITC). This oncolytic vaccinia virus has demonstrated its
ability to ensure the expression of BioInvent’s anti-CTLA-4 antibody in
the tumor with low systemic exposure. It also showed improved efficacy
and a better safety profile compared to the combination of the antibody
and the non-armed corresponding oncolytic virus in pre-clinical models.

The Company is progressing very well in developing its large preclinical
portfolio of candidates. We are committed and on track to bring to the
clinic the OV encoding an anti-CTLA-4 antibody (collaboration with
BioInvent), as well as at least one other OV encoding for an anti-cancer
agent in H1 2020.

myvacTM: New generation of
individualized immunotherapy using Transgene’s unique MVA based platform

In September 2018, Transgene announced the launch of its myvacTM
platform, which has been designed to produce individualized, MVA-based
immunotherapies that stimulate and educate the immune system of patients
to recognize and destroy tumor cells.

The personalized immunotherapy product is based on the mutations that
are identified in the patient’s own tumor. These mutations are highly
relevant targets since they lead to the expression of tumor neoantigens
which are known to trigger a stronger immune response than tumor
associated antigens.

In March 2019, Transgene formalized its strategic collaboration with NEC
aimed at treating cancer patients. NEC’s artificial intelligence
algorithms will be used to predict which of the tumor neoantigens
identified by sequencing in a given patient’s solid tumor are the most
appropriate neoantigens to integrate into the genome of the viral vector
(MVA). Transgene will design and manufacture a personalized vaccine for
the treatment of this specific patient using the myvacTM
technology.

NEC will co-finance the first two clinical studies that Transgene will
conduct with the lead myvac™ vaccine TG4050. These two clinical
trials will be conducted in Europe and in US, in patients with
HPV-negative head and neck cancers and ovarian cancer. Both trials are
expected to start in Q4 2019.

Transgene has developed and validated its PilotClin manufacturing unit
in order to efficiently produce GMP batches of its personalized
vaccines. Several research tracks are also being pursued to optimize
further the immunogenicity of the myvacTM therapeutic
vaccines.

In March 2019, the NEOVIVA project which supports the industrial
development of the myvacTM platform, was awarded a
grant from Bpifrance’s ‘Investments for the Future’ program. Under the
agreement, Transgene will receive €2.6 million over the five-year
duration of the program from Bpifrance. The NEOVIVA project aims to
further develop this innovative technology in collaboration with its
three partners: HalioDx, Traaser and the Curie Institute. The NEOVIVA
project complements the already existing collaboration between Transgene
and NEC.

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. (‘Tasly’) under which Transgene sold both
the T101 Greater China patent rights and its entire 50% stake in the
Transgene Tasly (Tianjin) joint venture which already owned the T601
Greater China patent rights. Following these agreements, Tasly now holds
all rights to research, develop and commercialize T601 and T101 in
Greater China.

In return, Transgene received a total of 27.4 million new Tasly
shares valued at $48 million (€41 million)
based on the
subscription price in pre-IPO financing round of Tasly, which took place
concurrently with the transaction with Transgene. Transgene’s stake
represents 2.53% of Tasly’s expanded share capital. Tasly 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.

€20 million revolving credit facility secured with Natixis

Transgene has recently secured a €20 million loan (revolving credit)
facility with Natixis, the French Corporate and Investment bank. The
interest-bearing facility will have a 30-month term and Transgene will
be able to draw and reimburse the facility at its discretion during the
term. Transgene has used its shares in the Chinese biotech company Tasly
as collateral for this loan.

Key Financials

  • Net profit of €8.0 million in 2018, compared to a loss of €32.3
    million in 2017. The net profit that Transgene achieved in 2018 was
    mainly generated by the transaction with Tasly Biopharmaceuticals Co.,
    Ltd.
  • Net operating expenses of €35.5 million in 2018, compared to
    €36.1 million in 2017
  • Net cash burn for 2018 was reduced to €24.5 million compared to
    €28.1 million in 2017
  • Cash available at year-end 2018: €16.9 million, compared to
    €41.4 million at the end of 2017

“In 2018 we were able to continue a high level of investment in our
clinical and per-clinical programs while at the same time reducing our
cash burn via prudent financial management. Operating costs remain under
good control and following the recent financing agreement with Natixis
we now have extended our financial visibility until mid-2020.”
said Jean-Philippe
Del, Vice President, Finance
.

The financial statements for 2018 as well as management’s discussion and
analysis are attached to this press release (Appendices A and B).

Financial Outlook 2019

Transgene expects its cash burn for 2019 to be between €25 million
and €30 million. The Company has the financial resources to execute its
strategy through to mid-2020.

The Board of Directors of Transgene met on March 20, 2019, under the
chairmanship of Philippe Archinard and closed the 2018 financial
statements. Audit procedures have been performed by the statutory
auditors and the delivery of the auditors’ report is ongoing. The Board
will convene Transgene’s annual general meeting of shareholders for May
22, 2019 and proposes to renew all four directors whose terms are set to
expire at that meeting. The Board of directors was informed of the
decision of Mr Alain Mérieux to retire from his board seat effective as
of the AGM on May 22, 2019. The Board thanks Mr Mérieux for his
long-time continued support of Transgene and has named Mr Mérieux
Honorary President of Transgene in recognition of his contributions. The
Board has proposed the nomination of Mr Hedi Ben Brahim, Vice President
for immunotherapy at Institut Mérieux, to fill the seat vacated by Mr
Mérieux.

The Company’s registration document, which includes the annual
financial report, will be available in April 2019 on Transgene’s
website,
www.transgene.fr.

A conference call in English is scheduled today, on March 20th
at 6:30 p.m. CET

Webcast link to English language conference call:
https://edge.media-server.com/m6/p/nf6e6vaw

Participant telephone numbers:

France: +33 (0) 1 7099 4740

UK (Toll Free): 0808 109 0700

US (Toll Free): +1 866 966 5335

Password: Transgene

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

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

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. 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

Appendix A: Financial statements 2018

Consolidated balance sheet, IFRS
(in € thousands)

ASSETS

December 31,
2018

December 31,
2017

CURRENT ASSETS
Cash and cash equivalents 1,885 1,643
Other current financial assets 15,015 39,762
Cash, cash equivalents and other current financial assets 16,900 41,405
Trade receivables 784 2,564
Inventories 443 270
Other current assets 11,627 14,497
Assets available for sale
Total current assets 29,754 58,736
NON-CURRENT ASSETS
Property, plant and equipment 13,217 13,604
Intangible assets 180 250
Financial fixed assets 45,158 3,971
Investments in associates 2,916
Other non-current assets 20,234 21,396
Total non-current assets 78,789 42,137
TOTAL ASSETS 108,543 100,873
LIABILITIES AND EQUITY

December 31,
2018

December 31,
2017

CURRENT LIABILITIES
Trade payables 4,791 2,868
Financial liabilities 11,207 10,283
Provisions for risks 76 356
Other current liabilities 3,463 3,359
Total current liabilities 19,537 16,866
NON-CURRENT LIABILITIES
Financial liabilities 48,369 51,717
Employee benefits 3,778 3,710
Other non-current liabilities 158 491
Total non-current liabilities 52,305 55,918
Total liabilities 71,842 72,784
EQUITY
Share capital 62,276 62,075
Share premiums and reserves 512,581 512,228
Retained Earnings (545,468) (513,194)
Profit (loss) for the period 8,026 (32,274)
Other comprehensive income (714) (746)
Total equity attributable to Company shareholders 36,701 28,089
TOTAL EQUITY AND LIABILITIES 108,543 100,873

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

December 31,
2018

December 31,
2017

Revenue from collaborative and licensing agreements 1,335 2,099
Government financing for research expenditure 5,749 5,358
Other income 35,835 687
Operating income 42,919 8,144
Research and development expenses (27,349) (30,359)
General and administrative expenses (6,991) (5,674)
Other expenses (1,221) (154)
Net operating expenses (35,551) (36,187)
Operating income from continuing operations 7,368 (28,043)
Finance cost (2,017) (2,287)
Share of profit (loss) of associates 2,675 (1,944)
Income (loss) before tax 8,026 (32,274)
Income tax expense
Net income 8,026 (32,274)
Basic loss per share (€) 0.13 (0.52)
Diluted earnings per share (€) 0.13 (0.52)

Cash Flow statement, IFRS
(in € thousands)

December 31,
2018

December 31,
2017

Cash flow from operating activities
Net income/(loss) from continuing operations 8,026 (32,274)
Cancellation of financial income 2,017 2,287
Elimination of non-cash items
Income of associates (2,675) 1,944
Provisions (333) (1,070)
Depreciation 1,733 1,691
Share-based payments 467 436
Others (35,590) 60

Net cash generated from/(used in) operating activities before
change in

working capital and other operating cash flow

(26,355)

(26,926)
Change in operating working capital requirements
Current receivables and prepaid expenses 2,268 (2,117)
Inventories and work in progress (173) (49)
Research tax credit (5,899) (5,530)
Assets available for sale
Other current assets (23) 941
Trade payables 2,031 (1,778)
Prepaid income (368) 766
Employee benefits (6) (663)
Other current liabilities 144 (14)
Net cash used in operating activities (31,816) (35,370)
Cash flows from investing activities
(Acquisitions)/disposals of property, plant and equipment (1,359) (432)
(Acquisitions)/disposals of intangible assets (45) (30)
Other (acquisitions)/disposals 6 100
Net cash used in investing activities (1,398) (362)
Cash flow from financing activities
Net financial income proceeds (75) (113)
Gross proceeds from the issuance of shares 14,390
Share issue costs (1,118)
Conditional subsidies 30 2,528
(Acquisition)/disposal of other financial assets 24,790 11,651
Net tax credit financing 5,666 6,307
Bank loan
Financial leases (391) (1,121)
Net cash generated from/(used in) financing activities: 30,020 32,524
Effect of changes in exchange rates on cash and cash equivalents 1 (4)
Net increase/(decrease) in cash and cash equivalents 242 (3,212)
Cash and cash equivalents at beginning of period 1,643 4,855
Cash and cash equivalents at end of period 1,885 1,643
Investments in other current financial assets 15,015 39,762
Cash, cash equivalents and other current financial assets 16,900 41,405

Appendix B: Management Discu

Contacts

Transgene:
Jean-Philippe Del
+33 (0)3 88 27 91 04
[email protected]

Media:
Citigate Dewe Rogerson
EU : David Dible/
Sylvie Berrebi
US : Marine Perrier-Barthez
+ 44 (0)20 7638
9571 / +1 424 341 9140
[email protected]

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