OSE Immunotherapeutics signs loan agreement for up to € 25 million with European Investment Bank

NANTES, France – () – Regulatory news:

OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE) announced today that the Company has signed a loan agreement for a maximum amount of EUR 25 million with the European Investment Bank (EIB).

The loan facility for a maximum amount of 25 million euros is divided into three tranches comprising two tranches of 10 million euros each and a third tranche of 5 million euros.

The first tranche of € 10 million, unconditional and for which OSE will request payment before the end of May 2021, will allow the clinical development of Tedopi® in combination with a checkpoint inhibitor in additional cancer indications to be extended. This first phase will also support the entry into phase 1/2 of OSE-279, OSE’s proprietary anti-PD-1 antibody, in a niche indication in oncology. This development of OSE-279 will allow OSE Immunotherapeutics to have its own proprietary anti-PD-1 antibody and to exploit it in OSE’s product portfolio in combination with other drug candidates. In addition, OSE-279 is the key component of the anti-PD-1 backbone of the BiCKI® bifunctional checkpoint inhibitor platform, targeting PD-1 and other innovative targets, associated with novel immunotherapy targets. .

The remaining two tranches of 10 and 5 million euros, available upon completion of specific clinical steps, should be used to accelerate the clinical development of the Company’s other programs, in particular the CD28 FR104 antagonist and the new anti-agonist. -ChemR23 OSE-230.

Alexis Peyroles, CEO of OSE Immunotherapeutics, comments: “We are very grateful for the support of the EIB, a major European financial institution, as the company is at an inflection point in its growth. The first tranche of 10 million euros allows OSE to extend its financial visibility until Q2 2022. This new flexible financing tool will make it possible to broaden and accelerate the development of our clinical stage portfolio and to explore new therapeutic indications with strong medical need, thus strengthening OSE’s status as a key global player in immunotherapy. “

Ambroise Fayolle, Vice-President of the EIB, explains: “The EIB is pleased to announce its support for OSE, a biotechnology combining a high level of research and innovation, highly qualified employees and cutting-edge expertise in the field of monoclonal and bispecific antibodies. The portfolio of products under development in various therapeutic areas such as immuno-oncology, autoimmune diseases and a SARS-CoV-2 vaccine project, makes OSE Immunotherapeutics a major potential player in the health. This project is fully in line with the mandate given to the EIB by its shareholders – the EU Member States – to support innovation across Europe. “

This loan will bear a fixed interest of 5% per annum paid annually, with a maturity of five years (each drawdown is treated separately in terms of maturity). The reimbursement of each tranche will therefore be made at the end of a period of five years after the date of disbursement of said tranche.

The loan agreement is supplemented by an agreement to issue warrants to the EIB for the first two tranches of the financing, in particular 850,000 warrants for the first tranche to be issued upon drawing. 550,000 additional warrants could be issued if the second tranche of 10 million euros were drawn by OSE Immunotherapeutics.

Each warrant will give the right to subscribe to one ordinary share of OSE Immunotherapeutics at the subscription price of € 0.01 and at the exercise price calculated on the basis of the volume-weighted average of the 3 trading days preceding the listing (which will take place at the end of May 2021), with a discount of 2.5%.

The warrants may be exercised for a period of 12 years.

Subject to certain customary exceptions, warrants can only be exercised after a period of five years from the withdrawal of the tranche concerned, thus limiting the impact in terms of dilution and volatility in the years to come.

The subscription warrant includes an exercise parity adjustment clause which could apply, under certain conditions, in the event of a capital increase. The EIB will have the possibility, under certain conditions, to ask OSE Immunotherapeutics to buy back its warrants for a maximum amount of 15 million euros and, beyond this amount, to find a buyer and to pay interest on the price. of the remaining warrants. .

ABOUT THE EUROPEAN INVESTMENT BANK

The EIB is the long-term financing institution of the European Union (EU) and its shareholders are the 27 EU Member States. Its mission is to contribute to the integration, balanced development and economic and social cohesion of EU Member States. It borrows large volumes of funds from the capital markets and lends them on very favorable terms to support projects which contribute to the achievement of EU objectives. The EIB is working to put the EU at the forefront of the next wave of innovation, especially in the health sector. In response to the Covid-19 health crisis, the EIB has released € 6 billion for investments in the health sector to support medical infrastructure, additional research activities or other funding related to vaccines and treatments. As a European bank supporting the climate, the EIB is one of the main donors in the green transition towards a more low-carbon and sustainable growth model.

ABOUT OSE Immunotherapeutics

OSE Immunotherapeutics is an integrated biotechnology company focused on the development and partnership of therapies to control the immune system for immuno-oncology and autoimmune diseases. The company’s immunology research and development platform focuses on three areas: T cell vaccination, immuno-oncology (focus on myeloid targets), autoimmunity and inflammation . Its leading balanced clinical and preclinical portfolio has a diversified risk profile:

Vaccine platform

  • Tedopi® (innovative combination of neoepitopes): the company’s most advanced product; positive results for step 1 of the phase 3 trial (Atalante 1) in the failure of the post-control inhibitor of non-small cell lung cancer.

    In phase 2 in pancreatic cancer (TEDOPaM, sponsor GERCOR) in combination.

    Due to the COVID-19 crisis, the accumulation of new patients in TEDOPaM is expected to restart in 2021.

  • CoVepiT: a second generation prophylactic vaccine against COVID-19, developed using epitopes optimized for SARS-CoV-2 against several variants. Positive human preclinical and ex vivo results in August 2020, the clinical trial is expected to start in the first quarter of 2021.

Immuno-oncology platform

  • BI 765063 (OSE-172, anti-SIRPα mAb on the SIRPα / CD47 pathway): developed in partnership with Boehringer Ingelheim; Phase 1 myeloid checkpoint inhibitor in advanced solid tumors.
  • ESLC-1 (new myeloid checkpoint target): identification of CLEC-1 mAb antagonists blocking the “Don’t Eat Me” signal which increase both phagocytosis of tumor cells by macrophages and antigen uptake by cells dendritic.
  • BiCKI®: bispecific fusion protein platform built on the key component of the anti-PD-1 backbone (OSE-279) combined with new immunotherapy targets; 2nd generation of PD- (L) 1 inhibitors to increase anti-tumor efficacy.

Autoimmunity and Inflammation Platform

  • FR104 (anti-CD28 monoclonal antibody): positive phase 1 results; Phase 1/2 in kidney transplant, active ready for phase 2 in a niche indication in autoimmune diseases.
  • OSE-127 / S95011 (humanized monoclonal antibody targeting the IL-7 receptor): developed in partnership with Servier; positive results of phase 1; in phase 2 in ulcerative colitis (sponsor OSE) and an independent phase 2 in Sjögren syndrome (sponsor Servier).
  • OSE-230 (MAb agonist ChemR23): First-order therapeutic agent with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity.

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Forward-looking statements

This press release contains express or implied information and statements which could be considered as forward-looking information and statements regarding OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections based on certain assumptions and assessments made by the management of OSE Immunotherapeutics in light of its experience and perception of historical trends, current economic and industry conditions, future developments. expected and other factors they deem appropriate. .

These forward-looking statements include statements that generally use conditional verbs and contain verbs such as “expect”, “anticipate”, “believe”, “target”, “plan” or “estimate”, their declensions and conjugations and words of similar importance. Although the management of OSE Immunotherapeutics believes that the forward-looking statements and information are reasonable, the shareholders of OSE Immunotherapeutics and other investors are cautioned that the achievement of these expectations is inherently subject to various risks, known or not, and to difficult uncertainties. to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed or implied or projected by forward-looking statements. These risks include those discussed or identified in the public files filed by OSE Immunotherapeutics with the AMF. These forward-looking statements are not guarantees of future performance. This press release contains only summary information and should be read together with the Universal Reference Document of OSE Immunotherapeutics filed with the AMF on April 15, 2020, including the annual financial report for fiscal year 2019, available on the website from OSE Immunotherapeutics. Except as required by applicable law, OSE Immunotherapeutics is issuing this press release as of the date hereof and does not undertake any obligation to update or revise any forward-looking information or statements.

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