Press Release: OSE Immunotherapeutics Announces Historic H1 2024 Results and Provides Corporate Update

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 EUR82.5 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 SIRP<ALPHA> compounds developed both in 
             immuno-oncology and now expected in Phase 2 in 
             cardiovascular-renal-metabolic diseases: a one-time payment of 
             EUR25.3 million. 
 
          -- New asset acquisition of a preclinical program from the OSE's cis- 
             targeting anti-PD1/cytokine platform: EUR13.5 million received 
             upon signature and EUR17.5 potential near-term milestone. 
   -- EUR8.4 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$(R)$. 
   -- Level of cash of EUR80.7 million as of June 30, 2024: EUR25.9 million 
      available cash1 + EUR54.9 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 EUR5.8 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(R) 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(R) 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 EUR90 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(R) 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 EUR13.5 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-SIRP<ALPHA> 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 EUR1.1 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(R) in second-line non-small cell lung cancer (NSCLC) after secondary resistance to immune checkpoint inhibitors $(ICI.AU)$.

   -- In September 2024, the Company launched its international Phase 3 
      clinical trial named 'Artemia' of Tedopi(R) 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(R), in parallel with the companion diagnostic for 
      HLA-A2 positive patients. 
 
   -- Other Phase 2 trials, sponsored by clinical oncology groups, of Tedopi(R) 
      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 >> $(ATC.AU)$ 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. 

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