TG4050: first patients treated in two clinical trials
of the novel individualized immunotherapy based on the
myvac® technology – First data expected in 4Q 2021
TG4001: expanded randomized Phase II trial to start in
HPV-positive anogenital cancers, based on encouraging Phase Ib/II
data
BT-001: the first candidate from the Invir.IO™
platform has entered the clinic
Financial visibility until 2022 following the partial
sale of the stake in Tasly BioPharmaceuticals in 2020
Conference call in English scheduled today at
6:00 p.m. CET – Video conference in French on March 10 at 10:00
a.m. CET (details at the end of the release)
Regulatory News:
Transgene (Paris:TNG), a biotech company that designs and
develops virus-based immunotherapies for the treatment of
cancer, today publishes its financial results for 2020 and
provides an update on its product pipeline.
Hedi Ben Brahim, Chairman and Chief Executive Officer of
Transgene since January 1, 2021, commented:
“It is a great honor to join Transgene as Chairman and Chief
Executive Officer at the beginning of 2021, taking over from
Philippe Archinard. Over the last several months, Transgene has
delivered multiple significant milestones, particularly from our
new cutting-edge platforms myvac® and Invir.IO™ as we have
continued to operate successfully despite the Covid-19
pandemic.
We treated the first patients with TG4050, our individualized
immunotherapy based on the myvac® technology. This achievement
illustrates how Transgene is positioning itself at the forefront of
innovation globally by developing new solutions that could deliver
important benefits for patients, clinicians and potential
pharmaceutical partners. This customized immunotherapy is
particularly promising, and I look forward to reporting the first
data from TG4050 in the fourth quarter of 2021.
The very encouraging results with TG4001 which we announced in
2H 2020, have allowed us to rapidly initiate a Phase II randomized
trial. The protocol of this study has already been approved in the
U.S. and we expect patient inclusion to start in the coming months,
with the aim of providing the first clinical results around the end
of 2022.
This acceleration of our development is also reflected in the
progress we made with BT-001, the first oncolytic virus of our
Invir.IO™ platform to enter the clinic and supported by a very
exciting preclinical data set. We have also seen another clinical
oncolytic virus candidate TG6002 advance and deliver first
promising translational data.
With financial visibility until 2022, we have the funds needed
to deliver the important clinical results we expect in 2021 and
2022. Our strategy aims to leverage Transgene’s exciting new drug
candidates, notably through large-scale partnerships, to generate
significant value for our shareholders. I am very confident that
the globally competitive product pipeline that we have today will
allow us to deliver on our ambitious goals.”
GLOBAL TECHNOLOGY LEADERSHIP WITH THE MYVAC® PLATFORM AND THE
THERAPEUTIC VACCINE TG4050
Transgene is developing an individualized immunotherapy based
on multiple advanced genetic engineering technologies that have
been developed by the company. TG4050 is the first drug candidate
based on the myvac® platform. Together with NEC, Transgene has
set up a customized approach that combines its expertise in viral
engineering with NEC’s artificial intelligence capabilities.
NEC’s algorithms enable the customization of the treatment for each
patient, by indicating the most relevant targets (patient-specific
neoantigens).
The Phase I clinical trials assessing TG4050 started in January
2020 in Europe and in the United States. The first patients have
been treated in these two clinical trials (ovarian and
oropharyngeal cancers). NEC is financing 50% of these studies.
The first data are expected in the fourth quarter of
2021.
The Company has set up an in-house production unit dedicated to
the manufacturing of the individualized clinical batches of TG4050
needed for each patient. This unit is operational and complies with
good manufacturing practice (GMP) norms.
The myvac® platform integrates leading-edge innovations that
are based on Transgene’s technological leadership in individualized
immunotherapies.
- Data validating the vaccine design principle and the
underlining accuracy of the algorithm and AI used to personalize
TG4050 were presented at the AACR congress (June 2020).
- Transgene has implemented the first block chain solution
dedicated to the traceability of this personalized treatment in
clinical trials. This solution monitors and orchestrates all of the
processes related to the design and manufacturing of Transgene’s
individualized therapeutic vaccine TG4050.
- Transgene has set up a translational research program that
includes a number of very innovative genomic and transcriptomic
analyses. The goal is to characterize the effect of the treatment
and identify predictors of response to TG4050 in the tumor and the
genome environment that may impact each patient’s response to the
vaccine. These data are important as they could lead to an
optimized and accelerated development pathway for TG4050.
RANDOMIZED PHASE II TRIAL OF TG4001 IN HPV16-POSITIVE
ANOGENITAL CANCERS TO START, BASED ON PROMISING INITIAL DATA FROM
PHASE IB/II
Transgene has amended the initial Phase Ib/II trial protocol
to allow the more rapid start of this randomized Phase II study
comparing the efficacy of TG4001 + avelumab versus avelumab
monotherapy. This trial will be supported by a continuing
collaboration with the alliance of Merck KGaA, Darmstadt, Germany,
and Pfizer, which is supplying avelumab. Transgene retains all
rights to TG4001.
The trial will focus on patients with recurrent or metastatic
HPV16-positive anogenital cancer without liver metastases. This
patient population, without liver metastases, was shown in the
Phase Ib/II study to derive improved clinical benefit from the
combination regimen.
In spite of recent progress, median overall survival is less
than 11 months with chemotherapy and immune checkpoint inhibitors.
The 25,000 patients who are diagnosed with these diseases every
year (U.S., Europe 27, UK) with these HPV16-positive malignancies
still need better treatment options.
Transgene received U.S. FDA clearance of the revised protocol
under an IND for TG4001. The submission of the amended
protocol has been initiated in Europe (France and Spain) where
clinical sites that participated in the Phase Ib/II part study are
ready to resume patient inclusion after regulatory approval.
Patient enrollment is expected to start in 2Q 2021.
Transgene expects to communicate the interim analysis data
around the end of 2022. This timeline is based on patient
enrollment starting in 2Q 2021 and there being no major impact on
recruitment from the Covid-19 pandemic.
Transgene today issued a press release providing more background
on this TG4001 trial.
BT-001, THE FIRST ONCOLYTIC VIRUS BASED ON INVIR.IO™, HAS
ENTERED THE CLINIC AND FIRST OBSERVATIONS FROM TG6002 CONFIRM THE
POTENTIAL OF OUR NEXT-GENERATION ONCOLYTIC VIRUSES
BT-001 is a patented VVcopTK-RR- oncolytic virus, with
high antitumor potential, based on the Invir.IO™ platform. It
is being co-developed with BioInvent. By selectively targeting the
tumor microenvironment, BT-001 is expected to elicit a much
stronger and more effective antitumoral response. In addition,
delivering the anti-CTLA4 antibody directly to the tumor
microenvironment aims to induce local Treg depletion and strong
therapeutic activity. As a consequence, by reducing systemic
exposure, the safety and tolerability profile of the anti-CTLA4
antibody should be greatly improved. Promising preclinical results
for BT-001 were presented at the AACR and SITC annual congresses
(June and Nov. 2020). A Phase I/IIa trial targeting solid tumors
has started in France and Belgium at the beginning of 2021.
Initial data from the Phase I trial of TG6002 confirm the
good tolerability of TG6002 and demonstrate that this Vaccinia
Virus, which is the same viral backbone on which the Invir.IO™
platform is based, can reach the tumor, replicate within these
cancer cells and induce the production of 5-FU when administered
intravenously. These data will be detailed at the upcoming
meeting of the AACR (April 2021).
By developing the administration of TG6002 via the intravenous
and intrahepatic artery routes, Transgene aims to enlarge the
number of solid tumors that could be addressed by an oncolytic
virus. This includes gastrointestinal tumors that are being
investigated with TG6002. To-date, the oncolytic virus that has
received regulatory approval has to be given via intra-tumoral
administration, restricting its use to easily accessible
tumors.
Our collaboration with AstraZeneca continues to develop
new innovative oncolytic viruses. AstraZeneca can exercise an
option to further develop each of these novel drug candidates in
the clinic.
SUMMARY OF ONGOING CLINICAL TRIALS
myvac®
TG4050
Phase I
NCT03839524
Targets: tumor neoantigens
✓ Data demonstrating the high accuracy of AI-based neoantigen
prediction technology used to design TG4050 were presented at AACR
2020
Ovarian cancer – after surgery and
first-line chemotherapy
✓ Trial ongoing in the United States and in France
✓ First patient treated in 2020 – patient
enrollment progressing in line with forecast
> First data expected in 4Q 2021
TG4050
Phase I
NCT04183166
HPV-negative head and neck cancer – after
surgery and adjuvant therapy
✓ Trial ongoing in the United Kingdom and in France
✓ First patient treated in Jan. 2021 –
patient enrollment progressing in line with forecast
> First data expected in 4Q 2021
TG4001
+ avelumab Phase II
NCT03260023
Targets: HPV16 E6 and E7 oncoproteins
Recurrent/metastatic anogenital
HPV-positive – 1st and 2nd line
✓ Continued clinical collaboration with Merck KGaA and Pfizer,
for the supply of avelumab
✓ Promising Phase Ib/II results presented at SITC and ESMO IO
2020
✓ A randomized Phase II trial comparing
the efficacy of TG4001 + avelumab vs avelumab monotherapy has
received U.S. FDA clearance. In Europe, the amended protocol has
been submitted to French and Spanish health authorities
> Patient enrollment in the randomized trial expected to
start in 2Q 2021
> First data from the randomized trial are expected around
the end of 2022. This timeline is based on patient enrollment
starting in 2Q 2021 and there being no major impact on recruitment
from the Covid-19 pandemic.
Invir.IO™
BT-001
Phase I/IIa
Payload: anti-CTLA4 antibody and GM-CSF cytokine
Solid tumors
✓ Co-development with BioInvent
✓ Presentation of very encouraging preclinical results at AACR
and SITC 2020
✓ Trial authorized. Phase I ongoing in France and Belgium
✓ First patient enrolled in February
2021
> First Phase I data expected in 1H 2022
TG6002
Phase I/IIa
NCT03724071
Payload: FCU1 for the local production of a 5-FU
chemotherapy
Gastro-intestinal cancer (colorectal
cancer for Phase II) – Intravenous (IV) administration
✓ Multicenter trial ongoing in Belgium, France and Spain
✓ First findings confirm that 5-FU is
produced in the tumor (Sept. 2020)
> Phase I part ongoing
> A poster on the first Phase I observations has been
accepted at AACR 2021
TG6002
Phase I/IIa
NCT04194034
Colorectal cancer with liver metastasis –
Intrahepatic artery (IHA) administration
✓ Multicenter trial ongoing in the United Kingdom
✓ First patient treated in February 2020;
enrollment resumed in September 2020 after pausing due to
Covid-19
> First observations expected in 3Q 2021
KEY FINANCIALS FOR 2020
- Operating income of €9.9 million in
2020, compared to €13.7 million in 2019. R&D services for
third parties amounted to €3.0 million in 2020 (€6.7 million in
2019), mainly due to the collaboration with AstraZeneca, which
generated €2.9 million in revenues in 2020. The research tax credit
reached €6.3 million in 2020 (€6.5 million in 2019).
- Net operating expenses of €33.9 million
in 2020, compared to €39.2 million in 2019. R&D expenses
were €27.3 million in 2020 (€31.4 million in 2019) with the
reduction due to lower clinical trial expenses in 2020 and to the
decrease of external expenses related to the manufacturing of
clinical batches. General and administrative expenses amounted to
€6.5 million in 2020 (€7.1 million in 2019).
- Financial income of €6.8 million in
2020, compared to €6.7 million in 2019. The partial sale of the
Tasly BioPharmaceuticals shares in July 2020 generated a net gain
on asset disposal of €2.7 million. Transgene’s remaining
shareholding was revalued and resulted in financial income of €6.4
million in 2020. This figure corresponds to the difference between
the market price and the historical price.
- Net loss of €17.2 million in 2020,
compared to €18.8 million in 2019.
- Cash burn reduced to €17.0 million in
2020, versus €20.5 million in 2019 (excluding capital
increase). The net cash inflow of €18.2 million from the sale of
Tasly BioPharmaceuticals shares in July 2020 reduced net cash
consumption compared to 2019. This transaction enabled the Company
to reimburse in advance the €10 million bank loan from the European
Investment Bank (EIB) in October 2020 (against an initial maturity
scheduled for this loan of June 2021).
- Cash available at year-end 2020: €26.3
million, compared to €43.3 million at the end of 2019. In
addition, Transgene still has access to a credit line of €15
million and holds Tasly BioPharmaceuticals shares valued at €32.3
million at the end of December 2020.
- As a result, Transgene has a financial
visibility until 2022.
HEDI BEN BRAHIM APPOINTED CHAIRMAN AND CHIEF EXECUTIVE
OFFICER
Hedi Ben Brahim was appointed as the Company’s Chairman and CEO,
effective January 1, 2021. He has been a member of Transgene’s
Board since May 2019. Hedi Ben Brahim replaces Philippe Archinard,
who had led the company since 2005 and who remains a member of the
Board of Transgene.
The financial statements for 2020 as well as management’s
discussion and analysis are attached to this press release
(Appendices A and B).
The Board of Directors of Transgene met on March 10, 2021, under
the chairmanship of Hedi Ben Brahim and closed the 2020 financial
statements. Audit procedures have been performed by the statutory
auditors and the delivery of the auditors’ report is ongoing.
The Company’s universal registration document, which includes
the annual financial report, will be available early April 2021 on
Transgene’s website, www.transgene.fr.
A conference call in English is scheduled today, March 10,
2021, at 6:00 p.m. CET / 12:00 p.m. EST.
Webcast link to English language conference call:
https://channel.royalcast.com/landingpage/transgene/20210310_1/
Participant telephone numbers:
France: +33 (0) 1 7037 7166
United Kingdom: +44 (0) 33 0551 0200
United States: +1 212 999 6659
Confirmation code: Transgene
A replay of the call will be available on the Transgene website
(www.transgene.fr) following the live event.
A video conference in French is scheduled on March 11, 2021,
at 10:00 a.m. CET.
Webcast link to English language conference call:
https://channel.royalcast.com/landingpage/transgene/20210311_2/
Participant telephone numbers:
France: +33 (0) 1 7037 7166
Confirmation code: Transgene
A replay 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.
Transgene’s programs utilize viral vector technology with the goal
of indirectly or directly killing cancer cells. The Company’s
clinical-stage programs consist of two therapeutic vaccines (TG4001
for the treatment of HPV-positive cancers, and TG4050, the first
individualized therapeutic vaccine based on the myvac® platform) as
well as two oncolytic viruses (TG6002 for the treatment of solid
tumors, and BT-001, the first oncolytic virus based on the
Invir.IO™ platform). With Transgene’s myvac® platform, therapeutic
vaccination enters the field of precision medicine with a novel
immunotherapy that is fully tailored to each individual. The myvac®
approach allows the generation of a virus-based immunotherapy that
encodes patient-specific mutations identified and selected by
Artificial Intelligence capabilities provided by its partner NEC.
With its proprietary platform Invir.IO™, Transgene is building on
its viral vector engineering expertise to design a new generation
of multifunctional oncolytic viruses. Transgene has an ongoing
Invir.IO™ collaboration with AstraZeneca.
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
Universal Registration Document, 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
2020
CONSOLIDATED BALANCE SHEET, IFRS (in €
thousands)
Assets
December 31, 2020
December 31, 2019
CURRENT ASSETS
Cash and cash equivalents
5,277
1,343
Other current financial assets
21,077
42,028
Cash, cash equivalents and other
current financial assets
26,354
43,371
Trade receivables
1,667
2,324
Other current assets
2,666
3,943
Total current assets
30,687
49,638
NON-CURRENT ASSETS
Property, plant and equipment
13,110
13,283
Intangible assets
141
147
Financial fixed assets
34,042
42,931
Investments in associates
-
-
Other non-current assets
7,473
9,478
Total non-current assets
54,766
65,839
Total ASSETS
85,453
115,477
Liabilities and equity
December 31, 2020
December 31, 2019
CURRENT LIABILITIES
Trade payables
5,066
7,092
Financial liabilities
1,426
2,037
Provisions for risks
511
898
Other current liabilities
6,626
8,619
Total current liabilities
13,629
18,646
NON-CURRENT LIABILITIES
Financial liabilities
16,938
26,703
Employee benefits
4,526
4,427
Other non-current liabilities
110
4
Total non-current liabilities
21,574
31,134
Total liabilities
35,203
49,780
EQUITY
Share capital
41,921
83,265
Share premiums and reserves
40,938
39,738
Retained earnings
(14,327)
(37,444)
Profit (loss) for the period
(17,231)
(18,804)
Other comprehensive income
(1,051)
(1,058)
Total equity attributable to Company
shareholders
50,250
65,697
TOTAL LIABILITIES AND EQUITY
85,453
115,477
Consolidated income statement, IFRS (in
€ thousands, except for per-share data)
December 31, 2020
December 31, 2019
Revenue from collaborative and licensing
agreements
2,981
6,652
Government financing for research
expenditure
6,362
6,644
Other income
572
437
Operating income
9,915
13,733
Research and development expenses
(27,346)
(31,385)
General and administrative expenses
(6,547)
(7,134)
Other expenses
(15)
(668)
Net operating expenses
(33,908)
(39,187)
Operating income
(23,993)
(25,454)
Finance cost
6,762
6,650
Share of profit (loss) of associates
-
-
Income (loss) before tax
(17,231)
(18,804)
Income tax expense
-
-
NET INCOME
(17,231)
(18,804)
Basic loss per share (€)
(0.21)
(0.23)
Diluted earnings per share (€)
(0.21)
(0.23)
Cash Flow statement, IFRS (in €
thousands)
December 31, 2020
December 31,
2019
Cash flow from operating
activities
Net income/(loss)
(17,231)
(18,804)
Cancellation of financial income
(6,762)
(6,650)
Elimination of non-cash items
Income of associates
-
-
Provisions
722
993
Depreciation
1,786
770
Share-based payments
1,744
1,351
Others
(1,052)
1,066
Net cash generated from/(used in)
operating activities before change in working capital and other
operating cash flow
(20,793)
(21,274)
Change in operating working capital
requirements
Current receivables and prepaid
expenses
897
(1,269)
Inventories and work in progress
-
443
Research tax credit
(6,352)
(6,619)
Other current assets
717
(962)
Trade payable
(2,057)
2,270
Prepaid income
(2,015)
4,461
Other current liabilities
129
537
Net cash used in operating
activities
(29,474)
(22,413)
Cash flows from investing
activities
(Acquisitions)/disposals of property,
plant and equipment
(811)
(1,688)
(Acquisitions)/disposals of intangible
assets
(41)
(43)
(Acquisitions) / disposal of
non-consolidated equity securities without significant
influence
18,224
-
Other (acquisitions)/disposals
370
1,200
Net cash used in investing
activities
17,742
(531)
Cash flow from financing
activities
Net financial income
(123)
(980)
Gross proceeds from the issuance of
shares
-
48,710
Share issue costs
-
(1,763)
Conditional subsidies
655
237
(Acquisitions)/disposal of other financial
assets
21,041
(26,904)
Net tax credit financing
6,288
6,706
Bank loan
(11,406)
(2,371)
Financial leases and change in lease
obligations
(782)
(1,234)
Net cash generated from/(used in)
financing activities
15,673
22,401
Effect of changes in exchange rates on
cash and cash equivalents
(7)
1
Net increase/(decrease) in cash and
cash equivalents
3,934
(542)
Cash and cash equivalents at beginning of
period
1,343
1,885
Cash and cash equivalents at end of
period
5,277
1,343
Investments in other current financial
assets
21,077
42,028
Cash, cash equivalent and other current
financial assets
26,354
43,371
Appendix B: Management
Discussion of 2020 Financials
Revenue
Income from collaboration and licensing agreements represented
€3.0 million in 2020 versus €6.7 million in 2019. The income
consisted primarily of research and development services for third
parties amounting to €3.0 million in 2020 (versus €6.6 million in
2019), mainly due to €2.9 million in revenue being recognized from
the collaboration with AstraZeneca over the period (versus €5.3
million in 2019).
Public funding for research expenses accounted for €6.4 million
in 2020 versus €6.6 million in 2019. This is mainly due to the
research tax credit for €6.3 million in 2020 (€6.5 million in 2019)
and to grants received and receivable for €0.05 million in 2020
(€0.1 million in 2019).
Other income
Other income amounted to €0.6 million in 2020 versus €0.4
million in 2019. This consisted for €0.2 million of the NEOVIVA
repayable advances at a preferred rate.
Operating expenses
Research and development (R&D) expenses
R&D expenses amounted to €27.3 million in 2020 versus €31.4
million in 2019.
The following table details R&D expenses by type:
(In millions of euros)
Dec. 31, 2020
Dec. 31, 2019
Payroll costs
11.5
11.2
Share-based payments
0.8
0.9
Intellectual property expenses and
licensing costs
0.9
0.8
External expenses for clinical
projects
5.4
10.9
External expenses for other projects
2.4
1.6
Operating expenses
4.6
4.2
Depreciation and provisions
1.7
1.8
RESEARCH AND DEVELOPMENT
EXPENSES
27.3
31.4
Employee costs allocated to R&D (salaries, employer
contributions and related expenses) amounted to €11.5 million in
2020 compared to €11.2 million in 2019.
Share-based payments amounted to €0.8 million in 2020, versus
€0.9 million in 2019.
External expenses for clinical projects amounted to €5.4 million
in 2020, compared to €10.9 million in 2019. This decrease is mainly
due to the reduction of clinical trials expenses (€3.8 million in
2020 versus €7.4 million in 2019) and to the decrease of external
expenses related to the manufacturing of clinical batches (€1.6
million in 2020 versus €3.5 million in 2019).
Other external expenses, including expenses for research and
industrial activities, were €2.4 million in 2020, versus €1.6
million in 2019.
Operating expenses, including the cost of operating research and
manufacturing laboratories, amounted to €4.6 million in 2020,
compared to €4.2 million in 2019.
General and administrative (G&A) expenses
General and administrative (G&A) expenses amounted to €6.5
million in 2020 versus €7.1 million in 2019.
The following table details G&A expenses by type:
(In millions of euros)
Dec. 31, 2020
Dec. 31, 2019
Payroll costs
3.2
3.2
Share-based payments
0.9
0.4
Fees and administrative expenses
1.8
2.8
Other fixed costs
0.5
0.6
Depreciation and provisions
0.1
0.1
GENERAL AND ADMINISTRATIVE
EXPENSES
6.5
7.1
Employee costs allocated to G&A stood at €3.2 million in
2020, same as in 2019.
Share-based payments amounted €0.9 million in 2020 compared to
€0.4 million in 2019.
Fees and administrative expenses decreased to €1.8 million in
2020, versus €2.8 million in 2019. This decrease is mainly due to
consultancy fees linked to the collaboration and financing
contracts paid in 2019.
Financial income
Net financial income resulted in a net income of €6.8 million in
2020 versus a net income of €6.7 million in 2019.
Financial income amounted to €10.6 million in 2020 (compared to
€9.9 million in 2019), and mainly consisted of:
- the sale of 38% of Transgene’s shareholding in Tasly
BioPharmaceuticals, which generated a net gain on asset disposal of
€2.7 million;
- a revaluation gain on the remaining Tasly BioPharmaceuticals
shares held of €6.4 million, corresponding to the difference
between the market price and the historical price;
- the net proceeds from the agreements concluded for the sale of
ElsaLys Biotech SA for €1.4 million (sales of the equity securities
for €0.3 million, reversal of provision on receivables of €1.1
million);
- investment income remained stable at €0.1 million in 2020.
Financial expenses amounted to €3.8 million in 2020 (compared to
€3.2 million in 2019) and were mainly related to:
- the cancellation of the SillaJen earnout for €1.9 million
following the agreement reached between SillaJen and the former
Jennerex Inc. shareholders;
- accrued bank interest on the EIB loan (€0.7 million in 2020
versus €0.8 million in 2019);
- the discounting of the ADNA debt owed to Bpifrance for an
expense of €0.6 million in 2020 (versus an income of €8.7 million
in 2019);
- bank interest related to the assignment of 2019 research tax
credit receivables (€0.3 million in 2020 versus €0.4 million in
2019);
- bank interest related to the Natixis credit line (€0.2 million
in 2020 versus €0.4 million in 2019);
- interest on financial leases (€0.1 million in 2020 versus €0.2
million in 2019).
Net income (loss)
The net loss was €17.2 million in 2020, compared with a net loss
of €18.8 million in 2019.
The net loss was €0.21 per share in 2020 versus net loss of
€0.23 per share in 2019.
Investments
Investments in tangible and intangible assets amounted €2.4
million in 2020 (€2.6 million in 2019).
Repayable advances and loans
Since 2016, Transgene has benefited from a credit facility
granted by the European Investment Bank (EIB) of €10 million. In
October 2020, the company has repaid the capital of this loan as
well as the accrued interest due at this date.
In April 2019, the Company signed a revolving credit agreement
with Natixis for a maximum of €20 million, which can be drawn down
in one or more installments. An amendment has been signed in
September 2020 resizing this credit line to €15 million, following
the sale of 38% of Transgene’s stake in Tasly BioPharmaceuticals in
July 2020. Under this credit agreement, Transgene must pledge the
shares it holds in Tasly BioPharmaceuticals prior to the first
drawdown. This credit agreement is valid until June 2022 and,
according to the principles of a revolving credit, the capital
drawn down must be fully repaid at the latest at the end of the
program’s duration. The Company has not drawn on this credit
facility in 2020.
Since 2019, Transgene has been leading a research program,
NEOVIVA, supported by Bpifrance. The Company could receive up to
€2.6 million (€0.2 million in grants, €2.4 million in repayable
advances) over a five-year period.
Liquidity and capital resources
At December 31, 2020, the Company had €26.3 million in cash
available, compared with €43.3 million at December 31, 2019.
Cash burn
The Company’s net cash burn amounted to €17.0 million in 2020
versus €20.5 million in 2019.
Post-closing events
N/A
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210310005724/en/
Transgene: Lucie Larguier Director Corporate
Communications & IR +33 (0)3 88 27 91 04
investorrelations@transgene.fr
Media: Citigate Dewe Rogerson David Dible/Sylvie
Berrebi + 44 (0)20 7638 9571 transgene@citigatedewerogerson.com
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