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 (XLON:0RAD, 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 RESULTSThe 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 ...
