Financial highlights
- Financial visibility secured over the next 12 months, until
Q4 2024, supported by additive financing secured in H1-2023 and
reduction of operating expenses.
- €15 million available cash as of June 30, 2023, supplemented
by R&D tax credit of €5.4 million and additive financing
secured post-H1-2023 for almost €14 million, including a capital
increase of €11.6 million driven by the bridge financing announced
in Q2 2023 and amended (1) in September 2023 to support clinical
programs.
Clinical pipeline
highlights
- Tedopi® (T-cell specific immunotherapy - cancer vaccine):
Based on final results of positive data on survival, safety and
quality of life from the first Phase 3 trial in 3rd line in
non-small cell lung cancer published in the international leading
medical journal ‘Annals of Oncology’, confirmatory Phase 3 in
preparation for 2024 in 2nd line, combined with a strategy of
unique companion diagnostic development. Completion of patient
enrollment in the Phase 2 in pancreatic cancer announced in May
2023, clinical readout expected in 2024.
- OSE-127/Lusvertikimab (IL-7R antagonist antibody): Phase 2
in ulcerative colitis with last patient enrollment expected in Q4
2023 and top-line results in the next months.
- OSE-172/BI765063 (SIRPα antagonist antibody): Ongoing
clinical expansion trial in advanced solid tumors by Boehringer
Ingelheim.
- FR104/VEL-101 (CD28 antagonist antibody): Ongoing Phase 1/2
study in kidney transplantation with last patient enrollment
completed in July 2023. International Phase 2 study in kidney
transplantation under preparation by Veloxis.
- OSE-279 (PD1 antagonist antibody): Phase 1/2 clinical trial
in solid tumors and lymphomas initiated in Q4 2022. First clinical
results will be presented in international conference in October
2023.
Regulatory News:
OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo:
OSE) today announces its consolidated half-year financial
results and provides updates on key milestones achieved during H1
2023 as well as the Company’s outlook for its immunotherapies in
immuno-oncology and immuno-inflammation.
Nicolas Poirier, Chief Executive Officer of OSE
Immunotherapeutics comments: “OSE’s key priorities for 2023 and
beyond will lie in the successful conduct of the new Tedopi®
pivotal Phase 3 program, along with the maximization of the
near-term value of Lusvertikimab while strengthening our
partnership business-model assuring recurrent revenues from our
first-in-class programs. The full funding of these strategic
programs will be secured in due course through additional financial
resources to deliver on our goals for the benefit of both the
patients and our stakeholders. OSE has today a solid late-stage
clinical and preclinical diversified portfolio in immuno-oncology
(IO) and immuno-inflammation (I&I). The increased interest of
the scientific and medical community in cancer vaccine, in
particular Tedopi®, encourages us to stay strategically focused and
committed to make our drug candidate available to all eligible
cancer patients in secondary resistance. We also look forward to
the Lusvertikimab Phase 2 data readouts in ulcerative colitis in
the next months and to generate additive value in both I&I and
IO with our pre-IND OSE-230 and BiCKI®-IL7 programs. In parallel,
at research level, we will continue to strengthen our first-in-kind
platform built at the intersection of Antibody Engineering, Data
Science, Artificial Intelligence (AI) and novel RNA Therapeutics
technologies which is generating exciting clinical opportunities
for future next-generation immunotherapies.”
Anne-Laure Autret-Cornet, Chief Financial Officer of OSE
Immunotherapeutics, adds: “We have strengthened our cash
position and secured new financing in H1-2023 to extend our
financial visibility for over the next 12 months. In parallel, we
significantly reduced our cash burn compared to last year after a
strict review of strategic expenses and prioritization for
out-licensing. This financial strategy allows us to pursue
strategic investments on Tedopi® and Lusvertikimab while pursuing
innovative research programs to increase their value and interests.
Our force is based on our recurrent €20 million average annual
turnover these last 5 years, driven mainly by collaborations and
licensing agreements with pharma companies. This business model
based mostly on non-dilutive revenues remains our priority and will
be further reinforced.”
CLINICAL PROGRESS IN IMMUNO-ONCOLOGY AND
IMMUNO-INFLAMMATION
PROPRIETARY ASSETS
Tedopi®, T-cell epitope-based therapeutic cancer
vaccine
Most advanced therapeutic cancer vaccine in clinical
development. Confirmatory Phase 3 study with a companion diagnostic
strategy under preparation to support the registration of Tedopi®
as a potential new standard of care in second line for non-small
cell lung cancer (NSCLC) patients in secondary resistance to immune
checkpoint inhibitors (ICI) based on positive regulatory advice
from FDA and EMA; Authorizations for compassionate use in NSCLC in
third line in France, Italy and Spain.
- In September, positive Phase 3 data from Tedopi® in HLA-A2 lung
cancer patients with resistance to previous immunotherapy were
published in the peer-reviewed journal ’Annals of Oncology’.
- In July, the United States Patent and Trademark Office granted
a new patent protecting Tedopi® for its use in cancer patients
after failure with PD1/PD-L1 immune checkpoint inhibitor treatment
and providing protection until year 2037 in the US.
- In June, the Company received €1.5 million in funding from
Bpifrance for the development of a companion diagnostic for Tedopi®
in NSCLC. This test will be used to identify HLA-A2 positive NSCLC
patients eligible for treatment with Tedopi® in the next pivotal
Phase 3 clinical trial under preparation.
- In June, OSE Immunotherapeutics presented a poster at the ASCO
(American Society of Clinical Oncology) annual meeting showing new
data on prognostic factors of overall survival from the ATALANTE-1
Phase 3 study in NSCLC highlighting the correlation between
Tedopi®’s mechanism of action and patients’ overall survival.
- In May, patient enrollment was completed in TEDOPaM Phase 2
clinical trial (sponsored by the oncology group GERCOR) evaluating
Tedopi® in advanced pancreatic cancer. A total of 136 patients were
recruited and the final results are expected in 2024.
- In March, the Spanish Drug Agency has made a new early access
program available allowing access to Tedopi® through a Special
Situation Authorization (1) in the treatment of advanced or
metastatic NSCLC after ICI failure. This Special Situation
Authorization was based on the positive clinical data from the
initial Phase 3 trial of Tedopi® (ATALANTE-1) in third line
treatment and the high unmet need for these patients.
(1)
The Special Situation Authorization (Real Decreto 1015/2009) is
intended to provide early access to medicines for patients with a
severe or rare disease with high unmet need and for which no
authorized therapeutic alternatives are available.
Lusvertikimab (OSE-127), IL-7 Receptor (IL-7R)
antagonist
Most advanced Interleukin-7 antagonist immunotherapy in
clinical development with a strong biological rationale in
refractory IBD patients.
- In July, the trial’s Independent Drug Safety Monitoring Board
(DSMB) provided a positive recommendation on the continuation until
its completion of the Phase 2 clinical trial on Lusvertikimab in
ulcerative colitis. Last patient enrollment is expected for Q4
2023.
- In July, positive opinion for Orphan Drug Designation was
granted by the European Medicines Agency to Lusvertikimab in the
treatment of Acute Lymphoblastic Leukemia based on preclinical
results presented and awarded at last American Society of
Hematology (ASH) annual conference (December 2022) in New Orleans
(US).
- In May, OSE Immunotherapeutics earned the full worldwide rights
on Lusvertikimab for all indications.
- In March, positive Phase 1 results on Lusvertikimab for the
treatment of chronic autoimmune diseases were published and
selected as ‘Top Read’ in the peer-reviewed journal “Journal of
Immunology”.
OSE-279, proprietary PD1 antagonist
High affinity PD1 antibody, recent patent granted in US,
Europe, China, Japan
- In December 2022, first patient dosed in a Phase 1/2 clinical
trial in patients with advanced solid tumors or lymphomas.
- First clinical data will be presented at AACR-NCI-EORTC
(Boston, 11 – 15th October 2023).
PARTNERED ASSETS
BI 765063, first-in-class SIRPα inhibitor on the SIRPα/CD47
myeloid pathway in advanced solid tumors, developed in partnership
with Boehringer Ingelheim
- Phase 1b clinical expansion trial initiated in May 2022 with BI
765063, sponsored and conducted by Boehringer Ingelheim in advanced
hepatocellular carcinoma and head and neck cancer.
- In April, a poster highlighting the predictive response
biomarkers from Phase I clinical trial of BI765063, stand-alone and
in combination with ezabenlimab, has been presented at the AACR
2023 annual conference (Orlando).
FR104/VEL-101, a monoclonal antibody antagonist of CD28,
developed in partnership with Veloxis Pharmaceuticals, Inc. in
kidney transplantation
- In July, patient enrollment was completed in the FIRsT Phase
1/2 clinical trial evaluating FR104/VEL-101 in renal
transplantation, sponsored and conducted by the University Hospital
of Nantes. A longer-term follow-up assessment will be performed one
year after transplantation.
- International Phase 2 clinical trial in kidney transplantation
is under preparation by Veloxis.
RESEARCH PROGRAMS
OSE-230, novel monoclonal antibody to activate a
pro-resolutive GPCR target (ChemR23), a novel and innovative
approach in the management of the resolution of neutrophil-mediated
chronic and severe inflammation
- In July, the second peer-reviewed results on OSE-230 were
published in the leading journal “Frontiers in Immunology” after a
publication in “Sciences Advances” (Trilleaud et al. 2021).
- In June, a poster highlighting the innovative mechanism of
action on neutrophils and inhibition of the pathogenic NETosis
process was presented at the FOCIS 2023 annual conference
(Boston).
CLEC-1, novel myeloid immune checkpoint target in
immune-oncology
- In April, two posters reporting the latest research updates on
CLEC-1 were presented at the 2023 American Association for Cancer
Research (AACR) meeting.
- In November 2022, publication in the peer-reviewed journal
“Sciences Advances” of fundamental discoveries and preclinical
results showing that CLEC-1 is a novel myeloid checkpoint
interacting with a new ligand and highlighting the therapeutic
potential of CLEC-1 antagonist antibodies as innovative cancer
immunotherapy.
BiCKI®IL-7v, a novel bispecific therapy combining anti-PD-1
and the cytokine IL-7
- In June, an invited oral communication and a poster reporting
the differentiated advantages of the IL-7 cytokine to sustain
long-term survival and functions of tumor-reactive T lymphocytes
were presented at the annual cytokine-based drug development summit
(Boston) and at the Antibody Engineering and Therapeutics 2023
Europe conference (Amsterdam).
Novel RNA Therapeutics & Artificial Intelligence
innovative research programs
- OSE Immunotherapeutics is building a first-in-kind research
platform at the intersection of Antibody Engineering, Data Science
and Artificial Intelligence (AI) development programs dedicated to
monoclonal antibodies (AI programs initiated in 2020 and reinforced
in 2021 with the MabSilico collaboration). This cutting-edge
platform adds novel RNA Therapeutics and RNA Delivery methods
recently patented by our research team to continue to develop
next-generation immunotherapy medicines modulating immune cell
responses in the field of immuno-inflammation and
immuno-oncology.
- In August, OSE Immunotherapeutics received a grant from the
French Government and Region Pays de la Loire to support the
Company’s research programs in the field of RNA Therapeutics.
CORPORATE GOVERNANCE
Eric Leire was appointed independent Director of OSE
Immunotherapeutics on June 22, 2023.
Eric Leire is a Medical Doctor and American and French citizen.
He brings a professional international experience, both in the US
and in Europe, in listed biotechnology and pharmaceutical
companies. He is currently President and Chief Executive Officer of
Genflow Biosciences Ltd. Through his active experience in venture
capital funds in the health field (Medwell Capital, Canada and
Biofund Venture, Denmark), he has contributed to develop biotech
companies.
Nicolas Poirier, Chief Executive Officer of OSE
Immunotherapeutics, was appointed as Director and Anne-Laure
Autret-Cornet, Chief Financial Officer, as Director representing
the employee shareholders.
H1 2023 RESULTS
The key figures of the 2023 consolidated half-year results are
reported below:
In k€
June 30, 2023
June 30, 2022
Operating result
(13,504)
(3,425)
Net result
(11,860)
(1,979)
In k€
June 30, 2023
December 31, 2022
Available cash
15,018
25,620
Consolidated balance sheet
80,391
91,781
As of June 30, 2023, available cash amounted to €15 million,
giving a financial visibility until Q4 2024.
During the first half of 2023, OSE Immunotherapeutics
secured:
- (1) An equity financing line with Vester Finance, set up
on April 27, 2023. This financing has triggered at the end of
September a capital increase of €11.6 million (without any discount
on the share price at the date of signature). To supplement its
financial resources and in order to extend its financial visibility
until the fourth quarter of 2024, OSE Immunotherapeutics signed on
27 September 2023, an extension to this equity financing line
agreement with Vester Finance, at the same conditions1. This
extension, approved by the Board of Directors of September 27,
2023, acting on delegation from the general assembly meeting of
shareholders of June 22, 20232, relates to a maximum of 900,000
shares of the Company, representing a maximum of 4,16% of the share
capital, that Vester committed to subscribe on its own initiative,
over a maximum period of 24 months, subject to certain usual
contractual conditions. Assuming that the totality of this
additional line of financing is used in full, a shareholder holding
1.00% of the capital of OSE Immunotherapeutics before its
establishment, would see his stake increase to 0.96% of the capital
on an undiluted basis3 and 0.96% of the share capital on a diluted
basis4. This transaction does not give rise to the preparation of a
prospectus subject to the approval of the “Autorité des Marchés
Financiers,” based on Article 1 of the Prospectus Regulation
granting an exemption when a transaction relates to a dilution less
than 20% of the Company's share capital. The number of shares
issued under this agreement and admitted to trading will be
communicated monthly on the Company's website.
- Loans and “PGE Resilience” The Company obtained the
formal agreement on loans for a total amount of €5.3 million with
the collective support of “La Région Pays de la Loire,” Bpifrance
and its banking pool composed by banks CIC, Crédit Mutuel and BNP
to finance its strategic R&D programs. Favorable conditions
were granted for these loans, with an interest range of 2-4% and
reimbursement timelines within 3 to 5 years. Part of these loans is
composed by a “PGE Resilience” ("Prêt Garanti par l’État") loan
guaranteed by the French State, implemented in the context of the
Ukrainian crisis. At the end of June 2023, €3.1 million have been
drawdown. The balance has been received in Q3 2023.
- €1.5 million in funding from Bpifrance for the
development of a companion diagnostic for the cancer vaccine
Tedopi® in non-small cell lung cancer.
This available cash will enable the Company to finance its
clinical development and R&D costs for earlier stage
products.
During the first half of 2023, the Company recorded a
consolidated net result of €-11,9 million.
Current operating expenses were €14.9 million (versus €19.4
million for the same period in 2022) of which 77% are related to
R&D. After a strategic review of costs and programs, operating
expenses dropped dawn by 25% compared to H1 2022.
The Board of Directors of September 27, 2023, has approved the
Company’s semester accounts as of June 30, 2023. The full
“Half-year financial report” (Regulated information) is available
on: https://www.ose-immuno.com/en/financial-documents/. The limited
review procedures on the consolidated accounts have been performed.
The report on this limited review is being issued.
CONSOLIDATED PROFIT & LOSS
In K€
H1 2023
H1 2022
Turnover
1,358
16,047
OPERATING INCOME - RECURRING
1,358
16,047
Research & Development expenses
(9,693)
(14,395)
Overhead expenses
(3,604)
(3,813)
Expenses related to share-based
payments
(1,562)
(1,182)
OPERATING PROFIT/LOSS -
RECURRING
(13,501)
(3,341)
Other operating income and expenses
(4)
(84)
OPERATING RESULT
(13,504)
(3,425)
Financial income
2,658
2,023
Financial expenses
(1,608)
(708)
PROFIT/LOSS BEFORE TAX
(11,943)
(2,110)
INCOME TAX
84
132
CONSOLIDATED NET RESULT
(11,860)
(1,979)
Of which consolidated net result
attributable to shareholders
(11,860)
(1,979)
Net earnings attributable to
shareholders
Weighted average number of shares
outstanding
18,624,665
18,527,401
- The basic and diluted result per common share (€/share)
(0,64)
(0,11)
(0,64)
(0,11)
In K€
H1 2023
H1 2022
NET RESULT
(11,860)
(1,979)
Amounts to be recycled in the income
statement:
Unrealized gains on securities available
for sale, net of tax
Currency conversion difference
(7)
46
Amounts not to be recycled in the income
statement:
Actuarial gains and losses on
post-employment benefits
0
34
Other comprehensive income in the
period
(7)
(13)
GLOBAL PROFIT/LOSS
(11,867)
(1,992)
CONSOLIDATED BALANCE SHEET
ASSETS in K€
June 30, 2023
December 31, 2022
NON-CURRENT ASSETS
Acquired R&D costs
47,604
48,784
Tangible assets
589
743
Rights of use
3,712
4,236
Financial assets
587
635
Deferred tax assets
184
182
TOTAL NON-CURRENT
ASSETS
52,676
54,581
CURRENT ASSETS
Trade receivables
234
403
Other current assets
12,463
11,177
Cash and cash equivalents
15,018
25,620
TOTAL CURRENT ASSETS
27,714
37,200
TOTAL ASSETS
80,391
91,781
EQUITY & LIABILITIES in K€
June 30, 2023
December 31, 2022
SHAREHOLDERS’ EQUITY
Stated capital
3,806
3,705
Share premium
39,169
38,784
Merger premium
26,827
26,827
Treasury stock
(483)
(549)
Reserves and retained earnings
(34,932)
(18,349)
Consolidated result
(11,860)
(17,760)
TOTAL SHAREHOLDERS’
EQUITY
22,529
32,658
NON-CURRENT DEBTS
Non-current financial liabilities
Lease non current liabilities
34,310
37,231
Non-current lease liabilities
3,157
3,586
Non-current deferred tax liabilities
1,430
1,514
Non-current provisions
423
524
TOTAL NON-CURRENT
DEBTS
39,320
42,856
CURRENT DEBTS
Current financial liabilities
5,433
3,093
Current lease liabilities
858
883
Trade payables
9,421
8,539
Corporate income tax liabilities
18
21
Social and tax payables
2,662
2,916
Other debts and accruals
151
816
TOTAL CURRENT DEBTS
18,542
16,268
TOTAL LIABILITIES
80,391
91,781
ABOUT OSE Immunotherapeutics
OSE Immunotherapeutics is a biotech company dedicated to
developing first-in-class assets in immuno-oncology and
immuno-inflammation.
The Company’s current well-balanced first-in-class clinical
pipeline includes:
- Tedopi® (immunotherapy activating tumor specific
T-cells, off-the-shelf, neoepitope-based): this cancer vaccine is
the Company’s most advanced product; positive results from the
Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients
in secondary resistance after checkpoint inhibitor failure. Other
Phase 2 trials, sponsored by clinical oncology groups, of Tedopi®
in combination are ongoing in solid tumors.
- OSE-279 (anti-PD1): ongoing Phase 1/2 in solid tumors or
lymphomas (first patient included). OSE-279 is the backbone therapy
of the BiCKI® platform.
- OSE-127 - lusvertikimab (humanized monoclonal antibody
antagonist of IL-7 receptor); ongoing Phase 2 in Ulcerative Colitis
(sponsor OSE Immunotherapeutics); ongoing preclinical research in
leukemia (OSE Immunotherapeutics).
- FR-104/VEL-101 (anti-CD28 monoclonal antibody):
developed in partnership with Veloxis Pharmaceuticals, Inc. in
transplantation; ongoing Phase 1/2 in renal transplant (sponsor
Nantes University Hospital); Phase 1 ongoing in the US (sponsor
Veloxis Pharmaceuticals, Inc.).
- OSE-172/BI 765063 (anti-SIRPα monoclonal antibody on
CD47/SIRPα pathway) developed in partnership with Boehringer
Ingelheim in advanced solid tumors; positive Phase 1 dose
escalation results in monotherapy and in combination, in particular
with anti-PD-1 antibody ezabenlimab; international Phase 1b ongoing
clinical trial in combination with ezabenlimab alone or with other
drugs in patients with recurrent/metastatic head and neck squamous
cell carcinoma (HNSCC) and hepatocellular carcinoma (HCC).
OSE Immunotherapeutics expects to generate further significant
value from its two proprietary drug discovery platforms, which are
central to its ambitious goal to deliver next-generation
first-in-class immunotherapeutics:
- BiCKI® platform focused on immuno-oncology (IO) is a
bispecific fusion protein platform built on the key backbone
component of anti-PD1 combined with a new immunotherapy target to
increase anti-tumor efficacy. BiCKI-IL-7 is the most advanced
BiCKI® candidate targeting anti-PD1xIL-7.
- Myeloid platform focused on optimizing the therapeutic
potential of myeloid cells in IO and immuno-inflammation (I&I).
OSE-230 (ChemR23 agonist mAb) is the most advanced candidate
generated by the platform, with the potential to resolve chronic
inflammation by driving affected tissues to tissue integrity.
Additional information about OSE Immunotherapeutics assets is
available on the Company’s website: www.ose-immuno.com
Click and follow us on Twitter and LinkedIn.
Forward-looking statements
This press release contains express or implied information and
statements that might be deemed forward-looking information and
statements in respect of OSE Immunotherapeutics. They do not
constitute historical facts. These information and statements
include financial projections that are based upon certain
assumptions and assessments made by OSE Immunotherapeutics’
management in light of its experience and its perception of
historical trends, current economic and industry conditions,
expected future developments and other factors they believe to be
appropriate.
These forward-looking statements include statements typically
using conditional and containing verbs such as “expect,”
“anticipate,” “believe,” “target,” “plan,” or “estimate,” their
declensions and conjugations and words of similar import. Although
the OSE Immunotherapeutics management believes that the
forward-looking statements and information are reasonable, the OSE
Immunotherapeutics’ shareholders and other investors are cautioned
that the completion of such expectations is by nature subject to
various risks, known or not, and uncertainties which are difficult
to predict and generally beyond the control of OSE
Immunotherapeutics. These risks could cause actual results and
developments to differ materially from those expressed in or
implied or projected by the forward-looking statements. These risks
include those discussed or identified in the public filings made by
OSE Immunotherapeutics with the AMF. Such forward-looking
statements are not guarantees of future performance. This press
release includes only summary information and should be read with
the OSE Immunotherapeutics Universal Registration Document filed
with the AMF on May 2, 2023, including the annual financial report
for the fiscal year 2022, available on the OSE Immunotherapeutics’
website. Other than as required by applicable law, OSE
Immunotherapeutics issues this press release at the date hereof and
does not undertake any obligation to update or revise the
forward-looking information or statements.
__________________________________ 1 These conditions are
described in the Company's press release dated April 27, 2023. The
shares will therefore be issued on the basis of the lowest average
daily price weighted by volumes over the period of the two trading
sessions preceding each issue, reduced a maximum discount of 6%, in
compliance with the price rule and the ceiling set by the general
meeting. Under the terms of the delegation granted by the general
meeting, the issue price of the shares must be "at least equal to
the weighted average of the prices of the last three trading
sessions preceding the fixing of the issue price, possibly reduced
by a maximum discount of 20%”. 2 21st resolution: delegation of
capital increase with elimination of shareholders' preferential
subscription rights for the benefit of categories of people meeting
specific characteristics. Vester Finance falls well into the
targeted category as a regular investor in so-called “small cap”
growth companies, particularly in the health or biotechnology
sector. 3 Based on the 21,641,101 shares issuable upon exercise of
the dilutive instruments issued by the Company to date. 4 Based on
the 1,830,000 shares that may be issued upon exercise of the
dilutive instruments issued by the Company to date.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230927782139/en/
OSE Immunotherapeutics Sylvie Détry
sylvie.detry@ose-immuno.com
Nicolas Poirier Chief Executive Officer
nicolas.poirier@ose-immuno.com
French Media: FP2COM Florence Portejoie
fportejoie@fp2com.fr +33 6 07 768 283
Grafico Azioni OSE Immunotherapeutics (EU:OSE)
Storico
Da Apr 2024 a Mag 2024
Grafico Azioni OSE Immunotherapeutics (EU:OSE)
Storico
Da Mag 2023 a Mag 2024