Transgene anticipates significant progress from immunotherapy
pipeline in 2024 and extends financial visibility until Q4 2025
2023 Full-year results and business
update
- Lead program TG4050 to deliver data in 2024.
- Advancements in other clinical programs and Research and
Innovation (R&I) activity to deliver news flow and fuel growth
in Transgene’s portfolio over the next 24 months.
- New leadership team focused on successfully delivering TG4050
and portfolio products to patients.
- Extended financial visibility secured until Q4 2025
through a revised credit facility provided by the major shareholder
Institut Mérieux.
Conference call scheduled today at 6 p.m.
CET (in English). See details below.
Strasbourg, France, March 27, 2024,
5:45 p.m. CET – Transgene (Euronext Paris: TNG), a biotech
company that designs and develops virus-based immunotherapies for
the treatment of cancer, today publishes its financial results
for 2023, and provides an update on its product pipeline and
upcoming plans.
“During 2023 Transgene continued to make
significant progress, delivering compelling data that confirm the
value of our approach to treating cancer using our novel
immunotherapies” commented Dr. Alessandro Riva, MD,
Chairman and CEO of Transgene.
“At the upcoming AACR conference in April 2024,
we will be presenting additional data from the randomized Phase I
study in adjuvant head and neck cancer for our lead therapeutic
cancer vaccine, TG4050. Together with our partner NEC we are
expanding the Phase I trial in a randomized Phase I/II to further
strengthen the initial data in a larger patient population and set
the foundation for a registrational development strategy.”
“In the second half of 2024 we anticipate the
first topline data from our fully enrolled randomized Phase II
trial evaluating our shared antigens cancer vaccine TG4001 in
HPV-positive anogenital cancers.”
“Together with expected Phase I data from our
oncolytic virus programs BT-001 and TG6050 this promises to be a
key year for Transgene, with further important milestones in 2025
that we believe will enhance the value of our platform. Backed by
our extended financial visibility and our strong management team we
are confident in our ability to achieve our ambitious goals of
delivering transformative therapies for cancer patients. I look
forward to sharing updates on our continued progress.”
Key events and upcoming milestones
Neoantigen therapeutic cancer vaccine
(TG4050)
Additional data from the randomized Phase I
trial in adjuvant head and neck cancer to be presented in
H1 2024 The trial will be expanded in a randomized Phase I/II
trial in the same indication. The Phase II part will start in
Q2 2024.
In 2023, highly promising TG4050 data were
presented at AACR and ASCO 2023 (see poster here). These data
show that this individualized neoantigen cancer vaccine can
induce strong immune responses, which are expected to result in
longer remission periods for patients.
The initial data from the randomized Phase I
trial in the adjuvant treatment of head and neck cancer
(NCT04183166) presented at ASCO showed that all evaluable
patients treated with TG4050 developed a robust and specific immune
response against multiple cancer neoantigens and remained
disease-free. These data suggest that TG4050 can boost the
immune system of patients despite a challenging tumor
microenvironment at the time of tumor resection.
Transgene and its partner NEC plan to report
updated data at AACR (poster presentation on April-10, 2024)
and the additional data on the 24-month median follow up of
patients in H2 2024.
The randomized Phase I trial will be expanded
to a randomized Phase I/II trial in the adjuvant setting of
head and neck cancer. The Phase II part is expected to start
enrolling patients in Q2 2024 within the framework of an
extended collaboration between Transgene and NEC.
TG4050 has potential applicability across a
range of solid tumors where the medical need is still significant
despite the existing therapeutic option including immunotherapies.
As a consequence, Transgene is performing preliminary work on a
potential new Phase I trial in another undisclosed indication.
Shared antigens cancer vaccine
(TG4001)
Transgene has completed the enrollment of 86
patients in the ongoing randomized Phase II trial evaluating
TG4001 in HPV-positive anogenital cancers (NCT03260023).
Transgene confirms that top line readouts are expected in
H2 2024.
In 2023, immunological response data from
TG4001 were presented in a poster at ASCO, confirming that
TG4001 can induce de novo immune responses against HPV16
antigens E6 and E7 in patients with advanced HPV16-positive
anogenital cancers. Patients with a complete objective response
showed strong vaccine-induced immunoreactivity.
Promising results from the previous Phase
I/II trial evaluating TG4001 in combination with an immune
checkpoint inhibitor were published in the September 2023 issue of
the European Journal of Cancer
(https://doi.org/10.1016/j.ejca.2023.112981). This study showed
that TG4001 in combination with avelumab is safe and demonstrated
antitumor activity in heavily pretreated HPV16-positive cancer
patients. It also served as the basis for the ongoing randomized
Phase II trial.
Oncolytic Viruses
In 2023, clinical data presented at
AACR confirmed the mechanism of action and the safety of our
Invir.IO® based oncolytic viruses, which offer a key competitive
advantage with the ability to be administered intravenously.
These findings support the potential of Invir.IO®-based
oncolytic viruses to have multiple treatment applications in a
broad range of solid tumors, via intravenous, locoregional and
intratumoral administration.
TG6050: Initial Phase I data expected in
H2 2024, from this novel Invir.IO® candidate administered
intravenously
A first patient was dosed with TG6050, a novel
oncolytic virus from Transgene’s Invir.IO® platform, in 2023. This
innovative candidate has been designed to express human IL-12, a
cytokine known to trigger a potent antitumor immune response, and
an anti-CTLA4 antibody. The Phase I Delivir trial (NCT05788926) is
evaluating TG6050 in patients with advanced non-small cell lung
cancer who have failed standard therapeutic options. Initial
data from the trial is expected in H2 2024.
BT-001: Positive single agent data — Part B of
the Phase I trial (combination with pembrolizumab) to deliver
initial data in H2 2024
Transgene and its partner BioInvent have
communicated positive data from Part A (monotherapy) of the ongoing
Phase I trial in May 2023 (NCT04725331). Out of 18
patients who received escalating intratumoral doses of BT-001, two
showed a decrease of injected lesion size of 50% or more, and
eleven had a stabilization of the injected lesion. No safety
concerns were reported.
Part B of the Phase I trial in combination with
pembrolizumab (KEYTRUDA®) started in October 2023. KEYTRUDA® is
provided by MSD (Merck & Co). Initial data from this part of
the trial are expected in H2 2024.
As announced on May 5, 2023, AstraZeneca
terminated its oncolytic virus research and development
collaboration with Transgene following a strategic review of its
pipeline.
All clinical assets are expected to deliver
important data in 2024
In 2024, Transgene expects to communicate
progress and significant results and readout on all of its clinical
stage assets.
TG4050 |
Randomized Phase I trial (head and neck):
- Poster presentation
- Additional data
|
April 10, 2024 (AACR)H2 2024 |
|
Randomized Phase II to start (head and neck) |
H1 2024 |
|
Preliminary work to launch additional Phase I trial |
2024 |
TG4001 |
Randomized Phase II: topline results |
H2 2024 |
TG6050 |
Initial data from Phase I trial |
H2 2024 |
BT-001 |
Initial data from combination part of Phase I |
H2 2024 |
New leadership structure appointed to accelerate
the development of Transgene’s innovative immunotherapy
portfolio
On May 5, 2023, Transgene announced its Board
of Directors’ decision to appoint Dr. Alessandro Riva, MD, as the
Company’s Chairman and CEO. Alessandro Riva, who started as new
CEO on June 1, 2023, has been the Chairman of Board of Directors
since May 2022. Dr. Riva has an outstanding track record in
the pharmaceutical and biotechnology industry, including
responsibility for securing the approval of personalized oncology
treatments in the US and in Europe, in particular CAR-T cell
therapies.
Transgene’s Management Committee is comprised of
the following members:
- Alessandro Riva, Chairman & Chief Executive Officer
(CEO);
- Éric Quéméneur, Chief Scientific Officer (CSO);
- Christophe Ancel, Chief Pharmaceutical Operations Officer &
Qualified Pharmacist;
- Maud Brandely-Talbot, Chief Medical and Regulatory Officer
(CMO);
- Lucie Larguier, Chief Financial Officer (CFO) (as of March
2024);
- James Wentworth, Chief Business Officer (CBO);
- John Felitti, General Counsel, Corporate Secretary;
- Christelle Schwoerer, Chief Human Resources Officer (as of
April, 2024).
In addition, on May 5, 2023, the Combined
General Meeting appointed Carol Stuckley, MBA, as
an independent Director of the Company. Carol Stuckley brings
more than 35 years of experience as a strategic and international
financial executive, with proven success leading finance teams and
creating shareholder value for healthcare companies.
In March 2023, Transgene appointed
Dr. John C. Bell and Dr. Pedro Romero, key opinion
leaders in cancer immunotherapy, as scientific advisors. John
C. Bell is Senior Scientist, Cancer Therapeutics Program at Ottawa
Hospital Research Institute and Director, Canadian Oncolytic Virus
Consortium and is an internationally renowned expert in the use of
oncolytic viruses. Pedro Romero is an honorary professor at the
University of Lausanne, focusing on tumor immunology and cancer
immunotherapy, particularly on the biology and dynamics of
cytolytic CD8 T lymphocyte (CTL) responses. He has also been
Editor-in-Chief of the Journal for ImmunoTherapy of Cancer.
Key financials for 2023
- Operating revenue of €7.9 million in 2023, compared
to €10.3 million in 2022. R&D services for third parties
amounted to €1.2 million in 2023 (€3.1 million in 2022),
mainly due to the collaboration with AstraZeneca (terminated in May
2023).Research tax credit amounted to €6.4 million in 2023
(€6.8 million in 2022).
- Net operating expenses of €37.9 million in 2023,
compared to €40.2 million in 2022. R&D expenses were
€29.6 million in 2023 (€32.2 million in 2022). General
and administrative expenses amounted to €7.0 million in 2023
(€7.9 million in 2022).
- Financial income of €7.7 million in 2023, compared
to a financial loss of €2.9 million in 2022.
- Net loss of €22.3 million in 2023, compared to a
net loss of €32.8 million in 2022.
- During the reporting period, the Company reached an agreement
for the sale of its remaining shares held in Tasly
BioPharmaceuticals for a total amount of US$15.3 million (€14
million). The transaction was closed in July 2023 upon receipt of
the funds.
- Net cash burn of €24.0 million in 2023, compared to
€22.8 million in 2022 (excluding capital increase and Institut
Mérieux credit facility).
- Cash available at year-end 2023: €15.7 million,
compared to €26.8 million at the end of 2022.
- Transgene has a financial visibility until
Q4 2025.
Financial visibility extended until
Q4 2025
The Company has signed an amendment to the
current account advance agreement with Institut Mérieux (TSGH)
raising the available amount from €36 million to a new maximum of
€66 million. This credit facility extends Transgene’s
financial visibility until Q4 2025, enabling the Company to
deliver significant news flow on its portfolio in the next 24
months. The credit facility will be available until the end of
2025 and Transgene will be able to draw on and repay the facility
at its discretion. In September 2023, Transgene had signed an
initial facility for a maximum of €36 million (24-month
term).
The financial statements for 2023 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
27, 2024, under the chairmanship of Dr. Alessandro Riva and closed
the 2023 financial statements. Audit procedures have been performed
by the statutory auditors and the auditor’s reports is in the
process of being issued.
The Company’s universal registration document,
which includes the annual financial report, will be available early
April 2024 on Transgene’s website, www.transgene.fr.
A conference call
in English is scheduled today on March 27, 2024, at
6:00 p.m. CET (12:00 p.m. ET).
Webcast link to English language conference
call:https://edge.media-server.com/mmc/p/66eebfa3
Please log in to the following link to obtain
your personal telephone IDs.
https://register.vevent.com/register/BI1e9b40a25efe464fa60306adcf6632d5
A replay of the call will
be available on the Transgene website (www.transgene.fr) following
the live event.
About TransgeneTransgene (Euronext: TNG)
is a 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 a portfolio of therapeutic
vaccines and oncolytic viruses: TG4050, the first individualized
therapeutic vaccine based on the myvac® platform, TG4001 for the
treatment of HPV-positive cancers, as well as BT-001 and TG6050,
two oncolytic viruses based on the Invir.IO® viral backbone. 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. Additional information about
Transgene is available at: www.transgene.frFollow us on social
media: X (previously-Twitter): @TransgeneSA – LinkedIn:
@Transgene
Contacts
Transgene:Lucie LarguierChief Financial
Officer+33 (0)3 88 27 91 04investorrelations@transgene.fr |
Media: MEDiSTRAVA Frazer Hall /Sylvie
Berrebi+44
(0)203 928 6900transgene@medistrava.com |
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 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 2023
CONSOLIDATED BALANCE SHEET, IFRS
(in € thousands)
Assets |
December 31,2023 |
December 31,2022 |
CURRENT ASSETS |
|
|
Cash and cash equivalents |
15,666 |
4,403 |
Other current financial assets |
- |
22,423 |
Cash, cash equivalents and other current financial
assets |
15,666 |
26,826 |
Trade receivables |
778 |
2,789 |
Other current assets |
1,540 |
2,546 |
Assets available for sale |
- |
14,345 |
Total current assets |
17,984 |
46,506 |
NON-CURRENT ASSETS |
|
|
Property, plant and equipment |
12,314 |
11,177 |
Intangible assets |
80 |
77 |
Non-current financial assets |
1,347 |
1,673 |
Other non-current assets |
13,492 |
7,003 |
Total non-current assets |
27,233 |
19,930 |
TOTAL ASSETS |
45,217 |
66,436 |
Liabilities and equity |
December 31,2023 |
December 31,2022 |
CURRENT LIABILITIES |
|
|
Trade payables |
4,545 |
6,965 |
Current financial liabilities |
1,332 |
1,192 |
Provisions for risks and expenses |
494 |
23 |
Other current liabilities |
3,671 |
4,602 |
Total current liabilities |
10,042 |
12,782 |
NON-CURRENT LIABILITIES |
|
|
Non-current financial liabilities |
15,963 |
12,327 |
Employee benefits |
3,345 |
3,282 |
Provisions for risks and expenses |
255 |
- |
Other non-current liabilities |
- |
204 |
Total non-current liabilities |
19,563 |
15,813 |
Total liabilities |
29,605 |
28,595 |
EQUITY |
|
|
Share capital |
50,426 |
50,102 |
Share premiums and reserves |
71,588 |
71,621 |
Retained earnings |
(83,432) |
(50,628) |
Profit/(loss) for the period |
(22,328) |
(32,804) |
Other comprehensive income/(loss) |
(642) |
(450) |
Total equity attributable to the Company’s shareholders |
15,612 |
37,841 |
TOTAL LIABILITIES AND EQUITY |
45,217 |
66,436 |
Consolidated income statement, IFRS(in €
thousands, except for per-share data)
|
December 31,2023 |
December 31,2022 |
Revenue from collaborative and licensing agreements |
1,184 |
3,126 |
Government financing for research expenditure |
6,450 |
6,876 |
Other revenue |
266 |
342 |
Operating revenue |
7,900 |
10,344 |
Research and development expenses |
(29,588) |
(32,168) |
General and administrative expenses |
(6,987) |
(7,912) |
Other expenses |
(1,372) |
(168) |
Operating expenses |
(37,947) |
(40,248) |
Operating income/(loss) |
(30,047) |
(29,904) |
Financial income/(loss) |
7,719 |
(2,900) |
Income/(loss) before tax |
(22,328) |
(32,804) |
Income tax expense |
- |
- |
NET INCOME/(LOSS) |
(22,328) |
(32,804) |
Basic earnings per share (€) |
(0.22) |
(0.33) |
Diluted earnings per share (€) |
(0.22) |
(0.33) |
Cash Flow statement, IFRS(in €
thousands)
|
December 31,2023 |
December 31,2022 |
Cash flow from operating activities |
|
|
Net income/(loss) |
(22,328) |
(32,804) |
Cancellation of financial income/(loss) |
(7,719) |
2,900 |
Elimination of non-cash items |
|
|
Provisions |
506 |
191 |
Depreciation and amortization |
1,572 |
1,686 |
Share-based payments |
290 |
2,675 |
Others |
73 |
(41) |
Net cash generated from/(used in) operating activities before
change in working capital and other operating cash flow |
(27,606) |
(25,393) |
Change in operating working capital requirements |
|
|
Current receivables and prepaid expenses |
2,722 |
7,301 |
Research tax credit (RTC) |
(6,489) |
(198) |
Other current assets |
303 |
226 |
Trade payables |
(2,466) |
(750) |
Prepaid revenue |
(944) |
(804) |
Other current liabilities |
(191) |
(685) |
Net cash used in operating activities |
(34,671) |
(20,303) |
Cash flows from investing activities |
|
|
(Acquisitions)/disposals of property, plant and equipment |
(2,667) |
(1,497) |
(Acquisitions)/disposals of intangible assets |
(79) |
(38) |
(Acquisitions)/disposals of non-consolidated equity securities |
14,345 |
- |
Disposals of other financial assets |
22,641 |
21,500 |
Other (acquisitions)/disposals |
332 |
307 |
Net cash used in investing activities |
34,572 |
20,272 |
Cash flow from financing activities |
|
|
Net financial income/(loss) proceeds |
(298) |
(646) |
Gross proceeds from the issuance of shares |
- |
- |
Share issue costs |
- |
- |
Conditional subsidies |
- |
455 |
Current account advance |
12,859 |
- |
Net amounts received for financing of tax credits |
- |
(5) |
Financial leases and change in lease obligations |
(1,192) |
(1,281) |
Net cash generated from/(used in) financing activities |
11,369 |
(1,477) |
Exchange rate differences on cash and cash equivalents |
(7) |
- |
Net increase/(decrease) in cash and cash equivalents |
11,263 |
(1,508) |
Cash and cash equivalents at beginning of period |
4,403 |
5,911 |
Cash and cash equivalents at end of period |
15,666 |
4,403 |
Investments in other current financial assets |
- |
22,423 |
Cash, cash equivalent and other current financial
assets |
15,666 |
26,826 |
Appendix B: Management Discussion of 2023
Financials
Operating revenue
Revenue from collaboration and licensing
agreements represented €1.2 million in 2023 versus
€3.1 million in 2022. It came mainly from the collaboration
with AstraZeneca. In the first half of 2023, AstraZeneca informed
Transgene of its decision to end the collaboration following a
strategic review.
Public funding for research expenses accounted
for €6.4 million in 2023 (versus €6.9 million in 2022), mainly
due to research tax credit.
Other revenue
Other revenue amounted to €0.3 million in
2023 as in 2022.
Operating expenses
Research and development (R&D)
expenses
R&D expenses amounted to €29.6 million
in 2023 versus €32.2 million in 2022.
The following table details R&D expenses by
type:
(in € millions) |
Dec. 31, 2023 |
Dec. 31, 2022 |
Payroll costs |
11.6 |
12.2 |
Share-based payments |
0.6 |
1.4 |
Intellectual property expenses and licensing costs |
0.7 |
1.1 |
External expenses for clinical projects |
6.6 |
6.2 |
External expenses for other projects |
2.6 |
4.3 |
Operating expenses |
6.0 |
5.4 |
Depreciation, amortization and provisions |
1.5 |
1.6 |
RESEARCH AND DEVELOPMENT EXPENSES |
29.6 |
32.2 |
General and administrative (G&A)
expenses
General and administrative (G&A) expenses
stood at €7.0 million in 2023 (€7.9 million in 2022).
The following table details G&A expenses by
type:
(in € millions) |
Dec. 31, 2023 |
Dec. 31, 2022 |
Payroll costs |
3.4 |
3.3 |
Share-based payments |
(0.3) |
1.3 |
Fees and administrative expenses |
2.6 |
2.3 |
Other general and administrative expenses |
1.2 |
0.9 |
Depreciation, amortization and provisions |
0.1 |
0.1 |
GENERAL AND ADMINISTRATIVE EXPENSES |
7.0 |
7.9 |
Share-based payments generated a revenue of €0.3
million in 2023, compared to an expense of €1.3 million in 2022.
This change is due to departures that occurred in 2023 and to the
end of several significant free shares plans in 2022.
Financial income
Financial income stood at €7.1 million in
2023 compared to a net loss of €2.9 million in 2022.
The valuation of ADNA conditional advances as of
December 31, 2023, generated a financial revenue of €8.1 million,
compared to €2.2 million in 2022.
Net income (loss)
The net loss was €22.3 million in 2023, compared
with a net loss of €32.8 million in 2022. The net loss was
€0.22 per share in 2023, compared with a net loss per share of
€0.33 in 2022.
Investments
Investments in tangible and intangible assets
amounted €3.7 million in 2023 (€2.2 million in 2022).
Liquidity and capital resources
As of December 31, 2023, the Company had
€15.7 million in cash available, compared with
€26.8 million as of December 31, 2022.
In addition, Transgene signed in September 2023
a current account advance agreement with Institut Mérieux for
€36 million. Transgene used €12.9 million as of the end
of 2023.An amendment has been signed to extend this advance from
€36 million to €66 million. This credit facility extends
Transgene’s financial visibility until Q4 2025.
Cash burn
The Company’s net cash burn amounted to
€24 million in 2023, versus €22.8 million in 2022,
excluding capital increase and current account advance from
Institut Mérieux.
Post-closing events
An amendment to the current account service
agreement with Institut Mérieux has been signed on to increase the
amount of initial advance signed in September 2023 from €36 million
to €66 million. This credit facility extends Transgene’s
financial visibility until Q4 2025.
- 20240327-Transgene_Results_FY_2023_EN
Transgene (EU:TNG)
過去 株価チャート
から 5 2024 まで 6 2024
Transgene (EU:TNG)
過去 株価チャート
から 6 2023 まで 6 2024