OSE Immunotherapeutics Announces Historic H1 2024 Results and Provides Corporate Update

OSE Immunotherapeutics Announces Historic H1 2024 Results andProvides Corporate Update Financial and business highlightsTotal 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...

Nantes, 26/09/2024 (informazione.it - comunicati stampa - salute e benessere)

OSE Immunotherapeutics Announces Historic H1 2024 Results and
Provides Corporate Update

Financial and business highlights

Clinical pipeline highlights

Main post-semester highlights

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

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.

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.

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.

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).

OSE-279, proprietary anti-PD1: positive efficacy and safety results from Phase 1/2 study in advanced solid tumors.

Positive Phase 1/2 analysis from first use of FR104/VEL-101 immunotherapy in kidney transplantation.

Two additional oral communications were presented during this congress:

Advancement of clinical development of first-in-class SIRPα cancer immunology treatment BI 770371

PROGRESS ON EARLY-STAGE PROGRAMS

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.

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

H1 2024 RESULTS
The key figures of the 2024 consolidated half-year results are reported below:

As of June 30, 2024, available cash and financial assets amounted to €80.7 million, giving a financial visibility until 2027.

During the first half of 2024, the Company secured:

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

CONSOLIDATED BALANCE SHEET

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:

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:

Additional information about OSE Immunotherapeutics assets is available on the Company's website: www.ose-immuno.com . Follow us on X and LinkedIn

Contacts

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).

Attachment