OSE Immunotherapeutics Reports Full Year 2023 Financial Results and
Provides Business Strategy Update
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.
Nantes, France – March 27, 2024, 6:00pm
CET – 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 |
- Warrants and free shares awards granted in 2023 and
valuated for 1,746 K€
- 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€
- Explained by IFRS16 application, which
corresponds to reimbursement of lease debt for 637 K€
ABOUT OSE IMMUNOTHERAPEUTICSOSE
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.For more information on Ose
Immunotherapeutics : http://ose-immuno.comFollow us on
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Contacts
OSE ImmunotherapeuticsSylvie
Détrysylvie.detry@ose-immuno.com Nicolas
PoirierChief Executive
Officer nicolas.poirier@ose-immuno.com |
French Media: FP2COMFlorence
Portejoiefportejoie@fp2com.fr+33 6
07 768 283 U.S. Media
ContactRooneyPartners LLCKate
Barrettekbarrette@rooneypartners.com+1 212 223 0561 |
|
Forward-looking statementsThis
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.
- EN_240327_Annual results_VF
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