| [September 13, 2017] |
 |
Transgene: First Half-Year 2017 in Line with Our Objectives: All Clinical Programs Progressing and New Collaboration Agreements Signed
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 (News - Alert)-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 Transgene
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 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 (News - Alert): @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.
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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