OSE Immunotherapeutics Announces Historic H1 2024 Results and
Provides Corporate Update
OSE Immunotherapeutics Announces Historic
H1 2024 Results and
Provides Corporate Update
Financial and business highlights
- Total H1
2024 incomes of €82.5 million thanks to Company’s new
partnerships.
- New
strategic partnership with AbbVie for up to $713 million, including
$48 million received upon signature.
- Major partnership expansion
with Boehringer Ingelheim:
-
Amendment of the collaboration and licensing agreement on
first-in-class SIRPα compounds developed both in immuno-oncology
and now expected in Phase 2 in cardiovascular-renal-metabolic
diseases: a one-time payment of €25.3 million.
- New
asset acquisition of a preclinical program from the OSE’s cis-
targeting anti-PD1/cytokine platform: €13.5 million received upon
signature and €17.5 potential near-term milestone.
- €8.4
million in non-dilutive funding under the “i-Démo” call for
projects as part of the “France 2030” program to support the
registration Phase 3 clinical trial of cancer vaccine
Tedopi®.
- Level of
cash of €80.7 million as of June 30, 2024: €25.9 million available
cash1 + €54.9 million
financial assets2,
providing solid financial position and visibility to support
implementation of the strategy until 2027. This cash position also
includes the research tax credit of €5.8 million received in June
2024.
Clinical pipeline highlights
- Positive
efficacy and safety results from the Phase 1/2 clinical trial
evaluating PD1- antagonist antibody OSE-279 monotherapy in solid
tumors.
- Positive
results from the FIRsT Phase 1/2 study from first use of
FR104/VEL-101 immunotherapy in renal transplantation.
Main post-semester
highlights
- First
positive efficacy results from the CoTikiS Phase 2 study evaluating
IL-7R antagonist Lusvertikimab in ulcerative colitis.
- Global launch of Artemia
Phase 3 registration study for cancer vaccine Tedopi® in
second-line non-small cell lung cancer.
NANTES, France, September 26, 2024 –
6:00pm CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo:
OSE), today reported its consolidated half-year financial
results and provided updates on key milestones achieved during the
H1 2024 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: “The major
milestones achieved during H1 2024 are paving the way for a
transformative year for OSE. During this period, thanks to the OSE
teams, the Company made significant outstanding progress.
The half-year has seen continued execution
of our partnership-focused business model through
three strategic pharmaceutical agreements with major partners,
AbbVie and Boehringer Ingelheim, related to our differentiated
immunological pipeline. These key achievements trigger a solid
financial position supporting the Company’s growth, relying on
our promising clinical and preclinical proprietary
programs in immuno-inflammation and immuno-oncology conducted and
supported by highly skilled OSE teams.
We also achieved two significant inflection
points on our late-stage proprietary clinical assets. In
immuno-inflammation, the positive clinical efficacy and safety
results for Lusvertikimab in ulcerative colitis represent a strong
catalyst for potential future partnership opportunities. We have
generated exciting data that we plan to communicate with our
investigators at an upcoming global medical conference. In
immuno-oncology, the international registration study Artemia for
cancer vaccine Tedopi® in second-line non-small cell lung cancer
treatment is now on track globally. In parallel, in order to ensure
continuous portfolio development, we continue accelerating and
strengthening first-in-class preclinical programs from our
innovative research platforms”.
Anne-Laure Autret-Cornet, Chief
Financial Officer of OSE Immunotherapeutics, said:
“With more than €90 million non-dilutive cash-in in
2024, our financial visibility is strongly reinforced until 2027.
This allows us to prioritize funding of our recently globally
launched Artemia Phase 3 registration study for our cancer vaccine
Tedopi® in lung cancer and to further invest in our other
proprietary clinical products and innovative R&D engine to
increase the value and interest of our assets.”
THREE PHARMACEUTICAL AGREEMENTS SIGNED
DURING H1 2024 PROVIDING A SOLID FINANCIAL POSITION TO SUPPORT
IMPLEMENTATION OF THE STRATEGY UNTIL 2027
- In February
2024, OSE Immunotherapeutics and AbbVie concluded a strategic
partnership to develop OSE-230 (renamed ABBV-230), a monoclonal
antibody designed to resolve chronic and severe inflammation.
Under the terms of the agreement, AbbVie
received an exclusive global license to develop, manufacture and
commercialize ABBV-230. OSE Immunotherapeutics received a $48
million upfront payment and will be eligible to receive up to an
additional $665 million in clinical development, regulatory and
commercial milestones. In addition, OSE Immunotherapeutics will be
eligible to receive potential tiered royalties on global net sales
of ABBV-230.
- In May 2024, OSE
Immunotherapeutics and Boehringer Ingelheim expanded their
partnership through the addition of two new projects:
- A new
preclinical program will be launched to develop immune-cell
activating treatments based on OSE’s cis-targeting3
anti-PD1/cytokine platform via an asset acquisition.
Under the terms of this preclinical asset
acquisition, OSE Immunotherapeutics received €13.5 million in
upfront payment and a potential near-term milestone of EUR 17.5
million.
- An amendment to
the existing collaboration and license agreement for the anti-SIRPα
immuno-oncology compounds BI 765063 and BI 770371 (being
investigated in Phase 1b clinical studies in advanced solid
tumors), development will now also be pursued in
cardiovascular-renal-metabolic (CRM) diseases with the initiation
of a Phase 2 clinical study planned for end of 2024.
Under the terms of this amendment, the parties
agreed on partial royalty buy-out monetizing with a one-time
payment of EUR 25.3 million. Furthermore, Boehringer is granted an
option for an additional buy-out during further development
triggering a one-time payment plus the increase of one sales
milestone. All other agreed development, regulatory and sales
milestone payments of up to €1.1 billion remain as agreed between
the parties under the initial agreement.
UPDATE ON CLINICAL PROGRESS IN IMMUNO-ONCOLOGY AND
IMMUNO-INFLAMMATION
First positive efficacy results from the Phase 2
clinical trial evaluating Lusvertikimab in ulcerative
colitis.
- Following completion of enrolment in
March 2024, OSE Immunotherapeutics announced in July first positive
efficacy results for Lusvertikimab in the Phase 2 trial for the
treatment of ulcerative colitis (CoTikiS study):
- Lusvertikimab demonstrated
significant efficacy during the 10 week-induction phase of
treatment measured by the improvement of the Modified Mayo Score,
in the randomized double blind study,
- A favorable safety and tolerability
profile was observed in the whole patient population across the two
doses tested and during the open label phase of treatment.
Global launch of the Artemia Phase 3 registration trial
for the off-the-shelf neo-epitope-based cancer vaccine Tedopi® in
second-line non-small cell lung cancer (NSCLC) after secondary
resistance to immune checkpoint inhibitors (ICI).
- In September
2024, the Company launched its international Phase 3 clinical trial
named ‘Artemia’ of Tedopi® in second-line treatment in HLA-A2
positive patients with metastatic NSCLC. This dossier, reviewed and
accepted in 14 countries by international health agencies (US FDA,
Canada, Europe and the United Kingdom) is a pivotal study
supporting the registration of Tedopi®, in parallel with the
companion diagnostic for HLA-A2 positive patients.
- Other Phase 2
trials, sponsored by clinical oncology groups, of Tedopi® in
combination are ongoing in solid tumors.
OSE-279, proprietary anti-PD1: positive
efficacy and safety results from Phase 1/2 study in advanced solid
tumors.
- In February
2024, updated positive results from Phase 1/2 of OSE-279 were
presented at the ESMO Targeted Anticancer Therapy Congress. These
results showed a good pharmacokinetic/pharmacodynamic (PK/PD) and
manageable safety profile in line with previous anti-PD1
development and with a high signal of efficacy in the first 20
patients representing 13 different tumor types.
Positive Phase 1/2 analysis from first
use of FR104/VEL-101 immunotherapy in kidney
transplantation.
- In June 2024,
OSE Immunotherapeutics and Nantes University Hospital presented
positive data from the completed Phase 1/2 clinical trial FIRsT
evaluating FR104/VEL-101 in patients undergoing renal transplant at
the « American Transplant Congress » (ATC) in
Philadelphia. The data showed the safety of the product used in
combination and the first signs of efficacy with no episodes of
acute rejection after one year follow-up in the 8 patients of the
study who completed 1-year treatment.
Two additional oral communications were
presented during this congress:
- A communication
presented by OSE partner Veloxis Pharmaceuticals, featured the
results from its Phase 1 dose escalation clinical trial evaluating
the safety, tolerability, pharmacodynamics and pharmacokinetics of
single ascending doses of subcutaneous administration of
FR104/VEL-101 in healthy participants.
- A communication
presented by the group of Pr. Richard Pierson (Massachusetts
General Hospital, Harvard university, Boston, USA), reported on the
positive preclinical efficacy data of FR104/VEL-101 injection in
monotherapy or in combination with anti-CD40L antibody to protect
from acute and chronic heart allograft rejection.
Advancement of clinical development of
first-in-class SIRPα cancer immunology treatment BI
770371
- In July 2024,
Boehringer Ingelheim and OSE Immunotherapeutics announced that
Boehringer Ingelheim will be progressing their first-in-class SIRPα
immuno-oncology program into the next phase in clinical
development. As part of the program, Boehringer will move forward
with an improved next generation SIRPα inhibitor antibody, which
will now be tested in a Phase 1b study in solid tumors.
- The initiation of a Phase 2 study
in cardiovascular-renal-metabolic (CRM) diseases is planned for the
end of 2024.
PROGRESS ON EARLY-STAGE PROGRAMS
- In April 2024,
novel data in the peer-reviewed Journal of Immunology on a
first-in-class research program with CLEC-1, its novel myeloid
immune checkpoint target for cancer immunotherapy. The
collaborative work with Dr Elise Chiffoleau’s team at the Center
for Translational Research in Transplantation and Immunology has
shown, for the first time, that CLEC-1 acts as an immune checkpoint
for the control of acute immune responses in the context of sterile
inflammation.
- In June 2024,
the Company presented preclinical data on novel mRNA (messenger
RiboNucleic Acid) Therapeutic platform for the treatment of
inflammatory and autoimmune disorders at the Federation of Clinical
Immunology Societies (FOCIS) annual meeting held in San
Francisco.
The mRNA therapeutic platform has been designed
for the local delivery of mRNA into inflammatory tissue using lipid
nanoparticles. This platform has the potential to deliver
innovative immunotherapeutic drugs and to address new biology that
cannot be targeted with standard biologic treatments. This novel
IL-35 mRNA therapeutics is generating potential opportunities for
the treatment of inflammatory and autoimmune disorders, in
particular in autoimmune hepatitis, a severe immune-mediated
inflammatory disorder of the liver with strong unmet medical
need.
- In June 2024,
OSE Immunotherapeutics also entered into a commercial and revenue
sharing agreement with leading global cancer center Memorial Sloan
Kettering Cancer Center (MSK).
This exclusive and worldwide agreement covers
OSE Immunotherapeutics’ patent rights and jointly owned OSE/MSK
patent rights in the field of Chimeric Antigen Receptor (CAR) cell
therapy for the treatment of Interleukin-7 Receptor (IL-7R)
expressing cancers, in particular hematological tumors such as
Acute Lymphoblastic Leukemia. As part of this agreement, MSK will
lead the research, development, and commercialization efforts, and
subsequently share potential future revenues with OSE
Immunotherapeutics.
CORPORATE GOVERNANCE
- Marc Dechamps,
Martine George, Markus Goebel and Cécile Nguyen-Cluzel were
appointed new independent Directors of OSE Immunotherapeutics on
June 19, 2024. Together, they bring a wealth of experience from
leadership roles in the biopharmaceutical and health financial
industry reenforcing the key strategic skills of the Board.
- The newly installed Board appointed
Didier Hoch as its Chairman. He succeeds Dominique Costantini who
did not run for a new mandate at the 2024 Shareholders’
meeting.
H1 2024 RESULTS
The key figures of the 2024 consolidated half-year results are
reported below:
In k€ |
June 30, 2024 |
June 30, 2023 |
Operating result |
63,321 |
(13,504) |
Net result |
57,175 |
(11,860) |
In k€ |
June 30, 2024 |
December 31, 2023 |
Available cash and cash equivalents |
25,856 |
18,672 |
Financial assets (deposit > 3 months) |
49,890 |
0 |
Consolidated balance sheet |
140,921 |
82,054 |
As of June 30, 2024, available cash
(1) and financial assets
(2) amounted to €80.7 million, giving a
financial visibility until 2027.
During the first half of 2024, the Company
secured:
- $48 million
upfront payment as part of global license and collaboration
agreement with AbbVie for ABBV-230 (formerly OSE-230), a novel
monoclonal antibody for the treatment of chronic inflammation.
- €13.5 upfront
payment as part of a purchase agreement with Boehringer Ingelheim
of a novel cis-targeting anti-PD-1/cytokine asset developed by
OSE.
- €25.3 million
one-time payment as part of an amendment of the existing
collaboration and licensing agreement with Boehringer Ingelheim for
the anti-SIRPα immuno-oncology compounds BI 765063 and BI
770371.
- €5.8 million in
2023 research tax credit.
- €8.4 million in
public funding under the “i-Démo” call for projects as part of the
plan “France 2030” to support the registration Phase 3 clinical
trial of cancer vaccine Tedopi® in NSCLC. This financing will be
spread over the life of the project.
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 2024, the Company
recorded a consolidated net result of €57.2 million.
Current operating expenses were €19.3 million
(versus €14.9 million for the same period in 2023) of which 77% are
related to R&D.
The Board of Directors of September 26, 2024,
has approved the Company’s semester accounts as of June 30, 2024.
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 2024 |
H1 2023 |
Turnover |
|
|
|
|
69,046 |
1,358 |
Other products |
|
|
|
|
13,527 |
0 |
OPERATING INCOME - RECURRING |
|
|
82,573 |
1,358 |
Research & Development expenses |
|
|
|
(13,884) |
(9,693) |
Overhead expenses |
|
|
|
|
(4,286) |
(3,604) |
Expenses related to share-based payments |
|
|
|
(1,082) |
(1,562) |
OPERATING PROFIT/LOSS - RECURRING |
|
|
63,321 |
(13,501) |
Other operating income and expenses |
|
|
|
0 |
(4) |
OPERATING RESULT |
|
|
|
63,321 |
(13,504) |
Financial income |
|
|
|
|
391 |
2,658 |
Financial expenses |
|
|
|
|
(2,998) |
(1,608) |
PROFIT/LOSS BEFORE TAX |
|
|
(2,606) |
(11,943) |
INCOME TAX |
|
|
|
3,540 |
84 |
CONSOLIDATED NET RESULT |
|
|
|
57,175 |
(11,860) |
Of which consolidated net result attributable to
shareholders |
57,175 |
(11,860) |
Net earnings attributable to shareholders |
|
|
Weighted average number of shares outstanding |
|
|
21,759,035 |
18,624,665 |
- The basic and diluted result per
common share (€/share)
|
|
|
2.63 |
(0.64) |
|
|
|
2.27 |
(0.64) |
In K€ |
|
|
|
|
H1 2024 |
H1 2023 |
NET RESULT |
|
|
|
|
57,175 |
(11,860) |
Amounts to be recycled in the income statement: |
|
|
|
|
Unrealized gains on securities available for sale, net of tax |
|
|
Currency conversion difference |
|
|
|
|
42 |
(7) |
Amounts not to be recycled in the income statement: |
|
|
|
Actuarial gains and losses on post-employment benefits |
|
|
|
0 |
Other comprehensive income in the period |
|
(42) |
(7) |
GLOBAL PROFIT/LOSS |
|
|
|
57,217 |
(11,867) |
CONSOLIDATED BALANCE
SHEET
ASSETS in K€ |
|
|
June 30, 2024 |
December 31, 2023 |
NON-CURRENT ASSETS |
|
|
|
Acquired R&D costs |
|
45,211 |
46,401 |
Tangible assets |
|
386 |
464 |
Rights of use |
|
3,261 |
3,606 |
Financial assets |
|
6,084 |
910 |
Deferred tax assets
|
|
195 |
195 |
TOTAL NON-CURRENT ASSETS |
|
55,136 |
51,576 |
CURRENT ASSETS |
|
|
|
Trade receivables |
4,966 |
982 |
Other current assets |
|
54,963 |
10,824 |
Cash and cash equivalents |
25,856 |
18,672 |
TOTAL CURRENT ASSETS |
|
85,785 |
30,478 |
TOTAL ASSETS |
|
140,921 |
82,054 |
|
|
|
|
|
EQUITY & LIABILITIES in K€ |
|
|
June 30, 2024 |
December 31, 2023 |
SHAREHOLDERS’ EQUITY |
|
|
|
Stated capital |
|
4,366 |
4,330 |
Share & Merger premium |
|
76,822 |
76,643 |
Treasury stock |
|
(393) |
(408) |
Reserves and retained earnings |
(56,522) |
(34,587) |
Consolidated result |
|
57,175 |
(23,003) |
TOTAL SHAREHOLDERS’ EQUITY |
|
81,448 |
22,975 |
NON-CURRENT DEBTS |
|
|
Non-current financial liabilities
Lease non current liabilities |
37,152 |
35,508 |
Non-current lease liabilities |
|
2,812 |
3,032 |
Non-current deferred tax liabilities |
|
1,658 |
1,311 |
Non-current provisions |
|
464 |
429 |
TOTAL NON-CURRENT DEBTS |
|
42,086 |
40,280 |
CURRENT DEBTS |
|
|
|
Current financial liabilities |
3,236 |
6,403 |
Current lease liabilities |
685 |
858 |
Trade payables |
8,344 |
9,299 |
Corporate income tax liabilities |
|
0 |
20 |
Social and tax payables |
|
2,219 |
1,867 |
Other debts and accruals |
|
|
2,901 |
351 |
TOTAL CURRENT DEBTS |
|
17,387 |
18,799 |
TOTAL LIABILITIES |
140,921 |
82,054 |
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): most advanced therapeutic cancer vaccine in
development; positive results from a randomized Phase 3 trial
(Atalante 1) in Non-Small Cell Lung Cancer patients in third-line
secondary resistance after checkpoint inhibitor failure. Ongoing
randomized registration Phase 3 study (Artemia) in second-line
NSCLC in HLA-A2+ patients with secondary resistance. Other Phase 2
trials, sponsored by clinical oncology groups, of
Tedopi® in combination are ongoing in solid tumors.
- OSE-127 -
Lusvertikimab (humanized monoclonal antibody antagonist of
IL-7 receptor); Positive Phase 2 (CoTikiS) study in Ulcerative
Colitis; ongoing preclinical research in leukemia.
- OSE-279
(anti-PD1): first positive results in the ongoing Phase 1/2 in
solid tumors.
- 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.).
- Anti-SIRPα monoclonal
antibody developed in partnership with Boehringer
Ingelheim in advanced solid tumors and
cardiovascular-renal-metabolic diseases (CRM); positive Phase 1
dose escalation results in monotherapy and in combination; Phase 2
in CRM diseases planned to be initiated end of 2024.
- ABBV-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. ABBV-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.
-
BiCKI®
Platform is a bifunctional fusion protein platform
built on the key backbone component of anti-PD1 combined with a new
immunotherapy target to increase anti-tumor efficacy by
“cis-potentiating” tumor-specific T cells. A first program has been
acquired by Boehringer Ingelheim.
- mRNA Therapeutic
platform allows local delivery into the inflammatory site
of innovative immunotherapies encoded by RNA to locally controls
and/or suppress immune responses and inflammation.
Additional information about OSE
Immunotherapeutics assets is available on the Company’s website:
www.ose-immuno.com. Follow us on X and LinkedIn
Contacts
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
|
|
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 April 30, 2024, including the annual financial
report for the fiscal year 2023, 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 Cash & cash equivalent
2 Non-current & current financial assets are deposit which
maturity > 3 months (IAS 7); classified as non-current for
deposits with maturities > 12 months
3 Cis-targeting: Bispecific antibodies have the capability to
target cells either in a cis- or in a trans-binding orientation.
During trans-binding, the antibody recognizes two different
antigens, each expressed on a different cell population, and can
link two different cell populations with each other (e.g. T-cell
engagers). Cis-binding bispecific antibody targets two antigens
expressed on the very same cell enabling preferential activation of
the desired immune cell types while minimizing the activation of
others (Segués A. et al. International Review of Cell and Molecular
Biology 2022).
- EN_240926_Half-year results
Ose Immunotherapeutics (LSE:0RAD)
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過去 株価チャート
から 12 2023 まで 12 2024