Regulatory News:
- Seven active clinical trials:
- First patients treated in four
combination trials assessing TG4010 (lung cancer) or Pexa-Vec
(liver cancer and other solid tumors)
- Two collaboration agreements signed
with:
- Bristol-Myers Squibb, for a combination
clinical trial of TG4010 (1st-line treatment of lung cancer)
- Servier, for a scientific collaboration
to improve the production process for allogenic CAR-T cells
- Cash and cash equivalents as of June
30, 2017: €43.9 million, financial visibility confirmed to the end
of 2018
Transgene (Paris:TNG), a biotechnology company focused on
designing and developing viral-based immune-targeted therapies,
today announced its financial results for the six-month period
ended June 30, 2017, and reviews the progress of it products
portfolio since the beginning of the year.
Philippe Archinard, Chairman and Chief Executive Officer of
Transgene said: “Transgene is continuing to successfully execute
its strategy. We are making progress with our clinical development
plans with seven active trials as of today, and in parallel we are
continuing to advance our cutting edge research program.
Four of the clinical trials are aiming to confirm the potential
of TG4010 or Pexa-Vec in combination with immune checkpoint
inhibitors (ICIs), including in two high unmet need indications,
lung and liver cancer.
We have signed two collaborations, one with Bristol-Myers Squibb
(BMS) covering a combination study with TG4010 in the first-line
treatment of lung cancer, and one with Servier for the design of an
optimized production process of allogenic CAR-T cells using our
viral vectorization technology. These new deals build on our
existing collaborations with BMS for TG4010 in the 2nd-line
treatment of lung cancer and with Merck KGaA/Pfizer for TG4001
in head and neck cancers. We believe these agreements provide
strong validation of the potential of our immunotherapy
approach.
With our current funding, Transgene is well placed to progress
its programs through to the end of 2018. We will continue to focus
all of our energy to advance our multiple clinical trials and to
seize the development opportunities that they could create for
Transgene.”
Product pipeline review
1. Therapeutic Vaccines
TG4010: combination trial with
nivolumab (ICI); collaborations with Bristol-Myers
Squibb
TG4010 is a therapeutic vaccine being developed in
advanced-stage non-squamous non-small cell lung cancer (NSCLC).
TG4010’s mechanism of action, excellent safety profile and existing
clinical data make it a very suitable candidate for combinations
with other therapies.
The clinical trials aim to confirm the synergies that are
expected to result from the combination of a therapeutic vaccine
and an ICI. The expected clinical benefits of the combination are
an increase in the response rate, in the quality and in the
duration of the response to current and future standards of
care.
TG4010
+ Opdivo® (ICI)
(nivolumab)+ chemotherapy
Phase 2
Non-small cell lung
cancer (NSCLC) – 1st-line
- Collaboration deal signed in April 2017 with Bristol-Myers
Squibb, that will supply nivolumab
- Preparation of a Phase 2 clinical trial combining TG4010 with
nivolumab and with chemotherapy in patients with tumor cells
expressing low or undetectable levels of PD-L1
- FDA IND approval granted to begin the clinical trial in the
USA
- First patient expected to be enrolled at the end of
2017
TG4010
+ Opdivo® (ICI)
(nivolumab)
Phase 2
Non-small cell lung
cancer (NSCLC) – 2nd-line
- Trial of TG4010 in combination with nivolumab, that will be
provided by Bristol-Myers Squibb, within a collaborative agreement
with UC Davis Medical Center (USA) – Principal investigator: Dr.
Karen Kelly
- First patient treated in March 2017; the trial’s 4 sites are
now open
- First results expected beginning of 2018
TG4001: trial in combination with
avelumab (ICI), based on a collaboration agreement with
Merck KGaA and Pfizer
TG4001 is a therapeutic vaccine that has already been
administered to more than 300 subjects in previous clinical trials.
TG4001 has demonstrated good tolerability, a significant HPV
clearance rate and promising efficacy results. Its mechanism of
action and good safety profile make TG4001 an appropriate candidate
for combinations with other therapies.
TG4001
+ Bavencio® (ICI)
(avelumab)
Phase 1/2
HPV positive head
and neck cancer – 2nd-line
- Clinical collaboration agreement with Merck KGaA and Pfizer,
for the supply of avelumab for the trial
- Principal investigator: Prof. Christophe Le Tourneau
(Institut Curie, Paris); multi-center trial
- First patient expected to be treated shortly
TG1050: results expected in 2H
2017
TG1050 is a therapeutic vaccine for the treatment of chronic
hepatitis B. At the end of 2015, Transgene started a study
evaluating the safety and tolerability of TG1050 in patients who
are currently being treated for chronic HBV infection with
standard-of-care antiviral therapy. The technology of TG1050 is
also being developed in China, where Transgene operates a
joint-venture with Tasly Biopharmaceutical Technology.
TG1050
+ Standard-of-Care
Antiviral
Phase 1/1b
Chronic hepatitis
B
- Results from the first part of the study to be presented at
AASLD (October 2017)
- Several patents granted, extending protection to
2032
2. Oncolytic viruses
Pexa-Vec: ongoing Phase 3 trial,
initiation of the Phase 2 clinical combination
trials
Pexa-Vec is an oncolytic virus designed to selectively target
and destroy cancer cells through intracellular viral replication
(oncolysis), and by stimulating the body’s immune response against
cancer cells. Its mechanism of action and tolerability profile make
it an appropriate candidate for use in combinations.
Pexa-Vec
+ sorafenib
(PHOCUS)
Phase 3
Advanced liver
cancer (hepatocellular carcinoma - HCC) – 1st-line
- Clinical trial being conducted by SillaJen, Inc., Transgene’s
partner
- Ongoing recruitment. First patient treated in Europe in April
2017
- Trial recruitment authorized in China (July 2017)
- First data readout expected in 2019
Pexa-Vec
+ Opdivo® (ICI)
(nivolumab)
Phase 2
Advanced liver
cancer (hepatocellular carcinoma - HCC) – 1st-line
- Principal investigator: Prof. Olivier Rosmorduc (Pitié
Salpêtrière, Paris)
- First patient treated in July 2017; several active trial
sites
- First data readout expected in 2018
Pexa-Vec
+ metronomic
cyclophosphamide
Phase 1/2
HER2 negative breast
cancer et soft tissue sarcoma (METROmaJX)
- Principal investigator: Prof. Antoine Italiano (Institut
Bergonié, Bordeaux); Sponsor : INCa
- Positive results of the Phase 1 part presented at ESMO 2017
(Sept. 2017)
- First patient of the Phase 2a part treated in April
2017
Pexa-Vec
+ Yervoy® (ICI)
(ipilimumab)
Phase 1
Solid tumors
(ISI-JX)
- Principal investigator: Dr. Aurélien Marabelle, MD, PhD (Centre
Léon Bérard, Lyon)
- First patient treated in February 2017
- First readout expected around the end of 2017
TG6002: preparation of first-in-human
trial
TG6002 is a next generation oncolytic immunotherapy. It has been
designed to induce the breakdown of cancer cells (oncolysis) and
express the FCU1 gene in the cancer cells it has infected leading
to the local production of 5-FU, a widely-used chemotherapy. TG6002
could potentially be used both in combination or as monotherapy in
recurrent cancers.
TG6002
Phase 1
Glioblastoma
- Principal investigator: Prof. J-Y Delattre (AP-HP, Paris), with
the support of INCa (French national cancer institute)
- First patient expected in the coming weeks
3. Research and preclinical portfolio
Research and preclinical highlights during the first half
were:
- The signing of a collaboration
agreement with Servier in June 2017 aimed at designing an
original process for the production of allogenenic CAR-T cells
which would provide better yield and a reduced number of steps.
This collaboration highlights Transgene's expertise in viral
vectorization;
- A poster presentation at the
American Association for Cancer Research (AACR) meeting in April
2017 and the publication of preclinical data supporting the
clinical development of TG6002 in Cancer Research in July
2017;
- The filing of several patent
applications ensuring the protection of the innovative
technologies developed by Transgene for new products (therapeutic
vaccines and oncolytic viruses).
- A R & D Day for investors on
22 June 2017 in Paris. At this meeting, Transgene presented its
new generation of immunotherapies based on multifunctional (armed)
oncolytic viruses aimed at improving the treatment of
cancer.
Key financials
The Board of Directors of Transgene met on September 12, 2017,
and reviewed the financial statements for the six-month period
ended June 30, 2017. The Statutory Auditors have conducted a review
of the interim consolidated financial statements. The half-year
financial report is available on Transgene’s website,
https://www.transgene.fr.
Key elements of the income statement
(in thousands of euros)
June 30, 2017 June
30, 2016 Operating revenues 3,898
5,339 Research and development expenses (16,855)
(12,504) General and administrative expenses (3,066) (3,406)
Other revenue and (expenses), net (107) (128)
Operating expenses (20,028)
(16,038) Operating income / (loss)
(16,130) (10,699) Net income / (loss)
(18,346) (11,639) Net income /
(loss) from discontinued operations -
(514) Comprehensive net income (18,346)
(12,153)
Operating revenues amounted to €3.9 million for the first six
months of 2017 compared to €5.3 million for the same period in
2016. Excluding the €1.3 million one-off revenue received from
Sanofi Chimie in 2016, Transgene’s revenues remained stable
compared to the first half of 2016.
- Revenues from collaboration and
licensing agreements amounted to €0.5 million for the first six
months of 2017 versus €1.9 million in the same period in 2016, that
included €1.3 million from Sanofi Chimie. Under the collaboration
agreement with Servier signed in June 2017, Transgene invoiced an
initial amount of €1.0 million. Revenue recognition of this amount
will be spread over the initial term of the contract, i.e. 3
years.
- Government financing of research
expenditures amounted to €3.0 million for the first half of 2017,
stable compared to the first half of 2016. These figures included a
research tax credit of €3.0 million for the first six months of
2017 compared to €2.9 million for the same period in 2016.
Research and Development (R&D) expenses amounted to
€16.9 million for the first half of 2017 compared to €12.5 million
for the same period in 2016. This increase was mainly due to the
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). External expenses for clinical
projects also increased by €0.4 million with the development plan
progressing notably with our products TG4010, Pexa-Vec and
TG1050.
General and administrative expenses decreased to €3.1 million
for the first half of 2017 compared to €3.4 million for the
same period in 2016.
Net loss amounted to €18.4 million for the first half of
2017 compared to €12.2 million for the same period in 2016.
As of June 30, 2017, the Company’s cash, cash equivalents,
available-for-sale financial assets and other financial assets
amounted to €43.9 million versus €56.2 million as of December 31,
2016.Cash burn was €12.3 million for the first half of 2017
compared to €8.2 million for the same period in 2016. This cash
burn increase was mainly explained by the milestone payment to
Sillajen in H1 2017.
Transgene confirms that it expects 2017 cash burn to be
around €30 million, which includes an increase of expenses
linked to clinical trials due to the acceleration of the clinical
development plan and the milestone payment to SillaJen, Inc.
“Our results for the first six months of 2017 are in line with
our expectations. We confirm our financial visibility through to
the end of 2018”, commented Jean-Philippe Del, Chief Financial
Officer of Transgene.
As a reminder, the Company still benefits from access to further
additional funding that can be activated in 2017: namely the second
tranche of the European Investment Bank (EIB) loan (€10
million).
About TransgeneTransgene (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 and preclinical development, including
TG1050 (chronic hepatitis B) and TG6002 (solid tumors). Transgene
is based in Strasbourg, France, and has additional operations in
Lyon, as well as a joint venture in China. Additional information
about Transgene is available at www.transgene.fr.Follow us on
Twitter: @TransgeneSA
DisclaimerThis 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.
Appendices
Consolidated balance sheet, IFRS(in €
thousands)
ASSETS June 30, 2017 Dec. 31,
2016
Current
assets:
Cash and cash equivalents 3,091 4,855 Other current
financial assets 40,852 51,352
Cash, cash equivalents and other
current financial assets: 43,943 56,207 Trade
receivables 2,499 2,385 Inventories 194 221 Other current assets
14,094 15,242 Assets available for sale - -
Total
current assets 60,730 74,055
Non-current
assets:
Property, plant and equipment 14,054 14,580 Intangible assets 330
423 Non-current financial assets 4,229 5,023 Investments in
associates 3,625 3,923 Other non-current assets 18,900
24,946
Total non-current assets 41,138
48,895 Total assets 101,868
122,950
LIABILITIES AND EQUITY June 30, 2017
Dec. 31, 2016
Current
liabilities:
Trade payables 4,394 4,504 Current financial liabilities 10,275
10,198 Provisions for risks 536 1,456 Other current liabilities
4,204 3,761
Total current liabilities
19,409 19,919
Non-current
liabilities:
Non-current financial liabilities 50,044 52,803 Employee benefits
3,874 3,725
Total non-current liabilities
53,918 56,528 Total liabilities
73,327 76,447
Equity:
Share capital 56,432 56,432 Share premiums et reserves 504,555
504,248 Retained Earnings (513,194) (487,987) Profit/(loss) for the
period (18,346) (25,207) Other comprehensive income/(loss)
(906) (983)
Total equity attributable to Company
shareholders 28,541 46,503 Total
equity and liabilities 101,868
122,950
Consolidated income statement, IFRS(in €
thousands, except for per-share data)
June 30, 2017 June 30, 2016
Revenue from collaborative and licensing agreements 472
1,905 Public funding for research expenses 3,028 2,970 Other
income 398 464
Operating income
3,898 5,339 Research and development expenses
(16,855) (12,504) General and administrative expenses (3,066)
(3,406) Other expenses (107) (128)
Operating
expenses (20,028) (16,038)
Operating income/(loss) (16,130)
(10,699) Net finance cost (981) (526) Share of profit/(loss)
of associates (1,235) (414)
Income/(loss) before
tax (18,346) (11,639) Income tax
expense - -
Net income/(loss)
(18,346) (11,639) Net income/(loss) from
discontinued operations - (514)
Comprehensive net income/(loss) (18,346)
(12,153) Basic loss per share (€) (0.33) (0.32)
Diluted earnings per share (€) (0.33) (0.32)
Cash Flow statement, IFRS(in €
thousands)
June 30, 2017 June 30, 2016
Cash flow from operating activities: Net
income/(loss) from continuing operations (18,346) (11,638) Net
income/(loss) from discontinued operations - (514) Cancellation of
financial income 981 526
Elimination of non-cash items
Income of associates 1,235 414 Provisions (770) (6,593)
Depreciation 747 1,291 Share-based payments 218 87 Other 18
6,220
Net cash generated from/(used in)
operating activities before change in working capital and
other operating cash flow:
(15,917) (10,207) Change in
operating working capital requirements: Current receivables and
prepaid expenses (78) (2,186) Inventories and work in progress 27
1,013 Research tax credit (RTC) (3,113) (2,997) Disposal of
available-for-sale assets - 2,000 Other current assets 1,119
(2,347) Trade payables (408) 414 Prepaid income 1,026 (65) Employee
benefits (563) (348) Other current liabilities (20)
(2)
Net cash used in operating activities:
(17,927) (14,725) Cash flows from investing
activities: (Acquisitions)/disposals of property, plant and
equipment 160 159 (Acquisitions)/disposals of intangible assets
(10) (4) Other (acquisitions)/disposals 10 330
Net
cash used in investing activities: 160
485 Cash flows from financing activities: Net
financial income/(loss) proceeds (239) (130) Gross proceeds from
the issuance of shares - - Share issue costs - - Conditional
subsidies 29 - (Acquisition)/disposal of other financial assets
10,499 605 Net amounts received for financing of tax credits 6,294
6,760 Bank borrowing - 10,000 Financial leases (578)
(670)
Net cash generated from/(used in) financing
activities: 16,005 16,566 Effect of
changes in exchange rates on cash and cash equivalents (2)
(2)
Net increase/(decrease) in cash and cash
equivalents: (1,764) 2,324 Cash and
cash equivalents at beginning of period 4,855 3,285
Cash and cash equivalents at end of period:
3,091 5,609 Investments in other current
financial assets 40,852 27,760
Cash, cash
equivalents and other current financial assets:
43,943 33,369
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Transgene:Lucie Larguier, +33 (0)3 88 27 91
04Director Corporate Communications &
IRinvestorrelations@transgene.frorMedia contacts:Citigate
Dewe RogersonDavid Dible / Marine Perrier, + 44 (0)20 7638
9571transgene@citigatedr.co.uk