Financial highlights
- €18.7 million available cash as of December 31st, 2023, not
including the upcoming $48 million payment as part of the recent
collaboration and license partnership (February 2024) with AbbVie1,
nor the €5.8 million of R&D Tax credit, providing reinforced
financial visibility until 2026.
Proprietary clinical pipeline
highlights
- Tedopi®, optimized epitope-based cancer vaccine: dossier and
protocol approved by the Food and Drug Administration (FDA) to
launch a new confirmatory Phase 3 clinical trial in second-line
lung cancer in patients with acquired/secondary resistance to
anti-PD(L)1. Completion of patient enrollment in the Phase 2 in
pancreatic cancer; ongoing Phase 2 in combination in ovarian cancer
and lung cancer.
- OSE-127/Lusvertikimab, anti-IL-7 receptor monoclonal
antibody: completion of patient enrollment in Phase 2 clinical
trial in ulcerative colitis; top-line results expected mid-2024.
Positive opinion from the European Medicines Agency (EMA) on Orphan
Drug Designation for Lusvertikimab in Acute Lymphoblastic
Leukemia.
- OSE-279, proprietary anti-PD1: positive efficacy and safety
results from Phase 1/2 study in advanced solid tumors.
Partnered Programs
- OSE-230, anti-ChemR23 agonist monoclonal antibody, in
IND-enabling studies: new partnership with AbbVie ($48 million
upfront, up to $665 million additional milestones) for severe and
chronic inflammatory diseases.
- BI 765063 and BI 770371, two selective SIRPα antagonist
programs in clinical development in solid tumors in partnership
with Boehringer Ingelheim.
- FR104/VEL-101, anti-CD28 selective monoclonal antibody,
developed in partnership with Veloxis Pharmaceuticals, Inc.: two
clinical trials, a Phase 1/2 and a Phase 1, completed in 2023;
results expected in 2024.
Regulatory News:
OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo:
OSE) today reported its consolidated annual financial results
for 2023 and provided an update on key proprietary clinical and
preclinical achievements, on ongoing collaboration and licensing
agreements, as well as on the 2024 Company’s outlook.
Nicolas Poirier, Chief Executive Officer of OSE
Immunotherapeutics, commented: “The Company has built today a
broad and independent portfolio of five clinical assets, three
pharmaceutical partnerships and three research platforms, all with
potential key milestones expected in 2024. We have achieved
significant steps in 2023 and all of which put in place during this
year will help advance our key priorities on our clinical and
preclinical stage products in immuno-oncology and inflammation in
the coming months. We started 2024 with a major achievement for the
Company’s growth as we also reinforced our financial resources with
a new license and collaboration agreement with AbbVie valued up to
$713 million, including a $48 million upfront payment, in line with
our business-model of recurrent and strategic pharmaceutical
partnerships. We will advance the Company’s clinical programs and
continue investing in our R&D drug discovery engine to identify
novel therapeutics for patients with high medical need in
inflammation, autoimmune diseases and immuno-oncology.
The conduct of our Tedopi® new pivotal Phase 3 clinical program
in second-line non-small cell lung cancer, in patients with
secondary/acquired resistance, is on track. Two dossiers were filed
to the Food & Drug Administration (FDA) end of 2023: a
companion test to identify HLA-A2 positive cancer patients eligible
(collaboration with the company GenDx) and a clinical protocol.
Both dossiers were approved mid-January 2024 and will be filed in
Europe in the coming weeks.
Completion of patient enrollment in the Phase 2 trial evaluating
Lusvertikimab in ulcerative colitis was recently announced, and we
are now eagerly looking forward to the top-line efficacy results
after the induction phase and first early assessment after 6 months
of therapy expected mid-2024.
The ongoing Phase 1/2 trial with proprietary anti-PD1 OSE-279 in
solid tumors has confirmed positive clinical efficacy results with
a high anti-tumor response rate in difficult-to-treat patients.
These results encourage further clinical development in the future,
used in monotherapy in already identified cancer niche indications
and to explore combinations with OSE drug candidates, in particular
with our neo-epitope cancer vaccine.
The positive interim data analysis from the FIRsT Phase 1/2
study evaluation of anti-CD28 FR104/VEL-101 in renal transplant
marks a key advancement in the clinical development towards a Phase
2 trial under preparation by our partner Veloxis
Pharmaceuticals.
Two clinical drug-candidates, BI 765063 and BI 770371, from our
selective SIRPa myeloid checkpoint technology are being evaluated
by Boehringer Ingelheim in combination in cancer patients, in
particular in metastatic or recurrent head and neck squamous cell
carcinoma (HNSCC) and hepatocellular carcinoma (HCC). Promising
results from the first Phase 1 study, with early clinical efficacy
data and biomarkers predictive of response and survival, were
presented at the 2023 AACR and ESMO conferences.
We also look forward to generating additive value in immunology
with our novel ‘pro-resolutive monoclonal antibody’ platform with
additional identified GPCR targets, as well as our ‘myeloid
checkpoint’ and ‘cytokine’ drug discovery platforms of which the
latest updates are steadily selected for presentation at
international scientific congresses. In parallel, at early research
level, we keep strengthening our first-in-kind platform built at
the intersection of Antibody Engineering, Data Science, Artificial
Intelligence (AI) and novel RNA Therapeutics technologies to
develop next-generation immunotherapy medicines modulating immune
cell responses in the field of immuno-inflammation and
immuno-oncology.
Looking ahead to 2024, we are excited by several key clinical,
preclinical and partnership milestones to advance the Company’s
growth path with the involvement of our teams, experts and
partners, all fully committed to innovation in service of
patients”.
Anne-Laure Autret-Cornet, Chief Financial Officer of OSE
Immunotherapeutics, adds: “Our business-model is mostly based
on recurrent and strategic partnerships with pharmaceutical
companies. Thanks to the collaboration and license agreement signed
with AbbVie, we strongly reinforced our financial visibility, which
will allow us to pursue our investments in our proprietary clinical
programs and our innovative R&D engine to increase their
intrinsic value and to prepare the next wave of Company’s
growth”.
2023 FINANCIAL RESULTS
A meeting of the Board of Directors of OSE Immunotherapeutics
was held on March 27, 2024. Following the Audit Committee opinion,
the Board approved the annual and consolidated financial statements
prepared under IFRS on 31 December 2023.
The key figures of the 2023 consolidated annual results are
reported below (and presented in the attached tables):
In K€
December 31, 2023
December 31, 2022
Current operating result
(22,980)
(18,392)
Operating result
(22,986)
(18,476)
Net result
(23,221)
(17,760)
Available cash*
18,672
25,620
Consolidated balance sheet
82,054
91,781
As of December 31, 2023, the Company’s available cash totaled
€18.7 million, versus €25.6 million as of December 31, 2022.
In 2024, the Company will reinforce its financial position with
a $48 million upfront payment as part of the global and exclusive
license and collaboration on OSE-230 signed with AbbVie in February
2024 giving a financial visibility until 2026.
In 2023, OSE Immunotherapeutics secured:
- 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 conditions2.
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, 20233, 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 basis4 and 0.96%
of the share capital on a diluted basis5.
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 are 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.
2023 Financial results
The audit procedures on the consolidated accounts have been
performed. The certification report will be issued after
finalization of the procedures required for the purposes of filing
the registration document.
The Company recorded a consolidated operating loss of €-23.0
million. Current operating expenses were €25.2 million (versus
€36.6 million in 2022) of which 74% related to R&D. R&D
expenses amounted to €17.1 million versus €26.9 million in
2022.
APPENDICES
CONSOLIDATED PROFIT & LOSS
P&L IN K€
December 31, 2023
December 31, 2022
Turnover
2,227
18,302
Total Revenues
2,227
18,302
Research and development expenses
(17,158)
(26,893)
Overhead expenses
(6,015)
(6,672)
Expenses related to shares payments
(2,034)
(3,130)
OPERATING PROFIT/LOSS - CURRENT
(22,980)
(18,392)
Other operating expenses
(6)
(84)
OPERATING PROFIT/LOSS
(22,986)
(18,476)
Financial products
2,177
2,079
Financial expenses
(2,412)
(1,624)
PROFIT/LOSS BEFORE TAX
(23,221)
(18,022)
Income Tax
219
263
NET PROFIT/LOSS
(23,003)
(17,760)
Of which consolidated net result
attributable to shareholders
(23,003)
(17,760)
Net earnings attributable to
shareholders
Weighted average number of shares
outstanding
19,562,147
18,527,401
Basic earnings per share
(1.18)
(0.96)
Diluted earnings per share
(1.18)
(0.96)
IN K€
2023
2022
NET RESULT
(23,003)
(17,760)
Amounts to be recycled in the income
statement:
Currency conversion difference
(77)
(61)
Amounts not to be recycled in the income
statement:
(9)
122
Other comprehensive income in the
period
(86)
(61)
GLOBAL PROFIT/LOSS
(23,089)
(17,699)
CONSOLIDATED BALANCE SHEET
ASSETS IN K€
December 31, 2023
December 31, 2022
Acquired R&D costs
46,401
48,784
Tangible assets
464
743
Right-of-use assets
3,606
4,236
Financial assets
910
635
Differed tax assets
195
182
TOTAL NON-CURRENT
ASSETS
51 ,576
54,581
Trade receivables
982
403
Other current assets
10,824
11,177
Cash and cash equivalents
18,672
25,620
TOTAL CURRENT ASSETS
30,478
37,200
TOTAL ASSETS
82,054
91,781
EQUITY & LIABILITIES IN K€
December 31, 2023
December 31, 2022
SHAREHOLDERS’ EQUITY
Stated capital
4,330
3,705
Share premium
49,816
38,784
Merger premium
26,827
26,827
Treasury stock
(408)
(549)
Reserves and retained earnings
(34,587)
(18,349)
Consolidated result
(23,003)
(17,760)
TOTAL SHAREHOLDERS’
EQUITY
22,975
32,658
NON-CURRENT DEBTS
Non-current financial liabilities
35,508
37,231
Non-current lease liabilities
3,032
3,586
Non-current deferred tax liabilities
1,311
1,514
Non-current provisions
429
524
TOTAL NON-CURRENT
DEBTS
40,280
42,856
CURRENT DEBTS
Current financial liabilities
6,403
3,093
Current lease liabilities
858
883
Trade payables
9,299
8,539
Corporate income tax liabilities
20
21
Social and tax payables
1,867
2,916
Other debts and accruals
351
816
TOTAL CURRENT DEBTS
18,799
16,268
TOTAL LIABILITIES
82,054
91,781
CONSOLIDATED CASH FLOW STATEMENTS
In K€
December 31, 2023
December 31, 2022
CONSOLIDATED RESULT
(23,003)
(17,760)
+/-
Depreciation, amortization and provision
expenses
2,574
2,744
+
Amortization on "right-of-use"
846
742
+/-
Shares based payments (1)
1,746
2,728
CASH FLOW BEFORE TAX
(17,838)
(11,545)
+
Financial charges
(657)
(3,066)
-
Income tax expenses
(219)
(263)
-
Tax paid
(216)
(236)
+/-
Working capital variation (2)
(835)
(3,142)
CASH FLOW FROM OPERATING
ACTIVITIES (A)
(19,764)
(18,252)
-
Tangible assets increase
(16)
(274)
+/-
Financial assets variation
0
0
+/-
Net variation in rights-of-use
(216)
0
+/-
Loans and advances variation
(275)
300
CASH FLOW FROM INVESTING
ACTIVITIES (B)
(507)
26
+
Capital increase (including share
premium)
11,357
+/-
Own shares transactions
0
+
Warrant subscription
300
+
Loan subscription
5,023
12,056
-
Loan repayment
(2,719)
(1,010)
-
Lease debt repayment (3)
(637)
(785)
-
Financial charges
CASH FLOW FROM FINANCING
ACTIVITIES (C)
13,324
10,267
+/-
Currency translation transactions (D)
CASH VARIATION E = (A + B + C
+ D)
(6,948)
(7,959)
CASH OPENING BALANCE (F)
25,620
33,579
CASH CLOSING BALANCE (G)
18,672
25,620
DIFFERENCE: E (G-F)
0
(1) Warrants and free shares awards granted in 2023 and valuated
for 1,746 K€ (2) Mainly explained by: - Increase in trade
receivable for 578 K€ Decrease in other current assets for 353 K€ -
Increase in trade accounts payable for 759K€ - Decrease in social
and tax payable for 1,048 K€ - Decrease in other debts for 464 K€
(3) Explained by IFRS16 application, which corresponds to
reimbursement of lease debt for 637 K€
ABOUT OSE IMMUNOTHERAPEUTICS
OSE Immunotherapeutics is a biotech company dedicated to
developing first-in-class assets in immuno-oncology (IO) and
immuno-inflammation (I&I).
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): first positive results in the
ongoing Phase 1/2 in solid tumors.
- 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); successful Phase 1 in the US (sponsor
Veloxis Pharmaceuticals, Inc.).
- BI 765063 and BI 770371 (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-230 (ChemR23 agonist mAb) developed in partnership
with AbbVie in chronic inflammation.
OSE Immunotherapeutics expects to generate further significant
value from its three proprietary drug discovery platforms, which
are central to its ambitious goal to deliver next-generation
first-in-class immunotherapies:
- Pro-resolutive mAb platform focused on targeting and
advancing inflammation resolution and optimizing the therapeutic
potential of targeting Neutrophils and Macrophages in I&I.
OSE-230 (licensed to AbbVie) is the first candidate
generated by the platform, additional discovery programs ongoing on
new pro-resolutive GPCRs.
- Myeloid Checkpoint platform focused on optimizing the
therapeutic potential of myeloid cells in IO by targeting immune
regulatory receptors expressed by Macrophages and Dendritic cells.
BI 765063 and BI 770371 (licensed to Boehringer
Ingelheim) are the most advanced candidates generated by the
platform. Ongoing additional discovery programs, in particular with
positive preclinical results obtained in monotherapy with new
anti-CLEC-1 mAbs.
- Cytokine platform focused on leveraging the Cis-Delivery
of cytokine in IO and I&I. BiCKI® 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-7v is the most advanced
BiCKI® candidate targeting anti-PD1xIL-7. Ongoing additional
discovery programs on Cis-Demasking technologies.
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 The transaction is subject to the satisfaction of customary
closing conditions, including the applicable waiting period under
the Hart-Scott-Rodino Antitrust Improvements Act. 2 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%”. 3 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. 4 Based on the 21,651,401 shares
issuable upon exercise of the dilutive instruments issued by the
Company to date. 5 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/20240327991047/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
U.S. Media Contact RooneyPartners LLC Kate Barrette
kbarrette@rooneypartners.com +1 212 223 0561
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