NANTES, France–(BUSINESS WIRE)–Regulatory news:
OSE Immunotherapy (ISIN: FR0012127173; Mnemo: OSE) announces today that the Company has signed a loan agreement for a maximum amount of 25 million euros with the European Investment Bank (EIB).
The loan facility for a maximum amount of €25 million is divided into three tranches, including two tranches of €10 million each and a third tranche of €5 million.
The first tranche of 10 million euros, unconditional and for which OSE will request payment before the end of May 2021, will make it possible to extend the clinical development of Tedopi® in combination with a checkpoint inhibitor in other cancer indications. This first tranche 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 leverage it across OSE’s product portfolio in combination with other drug candidates. In addition, OSE-279 is the core anti-PD-1 component of the BiCKI® platform, a bifunctional checkpoint inhibitor, targeting PD-1 and other novel targets, combined with novel immunotherapy targets .
The two remaining tranches of 10 and 5 million euros, available upon reaching specific clinical milestones, should be used to accelerate the clinical development of the Company’s other programs, in particular the CD28 antagonist FR104 and the new agonist anti-ChemR23 OSE-230.
Alexis Peyroles, CEO of OSE Immunotherapy, 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 allows OSE to extend its financial visibility until Q2 2022. This new flexible financing tool will allow us to expand and accelerate the development of our clinical-stage portfolio and to explore new therapeutic indications with high medical need, reinforcing 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 biotech 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 different therapeutic areas such as immuno-oncology, autoimmune diseases and a vaccine project against SARS-CoV-2, makes OSE Immunotherapeutics a potential major player in the field of 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 year paid annually, with a maturity of five years (each drawing is treated separately in terms of maturity). Reimbursement of each tranche will therefore be made at the end of a period of five years after the date of disbursement of the 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 at the time of the drawing. 550,000 additional warrants could be issued if the second tranche of 10 million euros was drawn by OSE Immunotherapeutics.
Each BSA 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 weighted average by the volumes of the 3 trading sessions preceding the listing ( which will take place at the end of May 2021), with a discount of 2.5%.
The warrants will be exercisable for a period of 12 years.
Subject to certain usual exceptions, the warrants will only be exercisable after a period of five years from the drawing of the relevant tranche, thus limiting the impact in terms of dilution and volatility in the years to come.
The warrant contract includes an exercise parity adjustment clause which could apply, under certain conditions, in the event of a capital increase. The EIB will be granted the possibility, under certain conditions, of asking OSE Immunotherapeutics to buy back its BSAs for a maximum amount of 15 million euros and, beyond this amount, to find a buyer and pay interest on the price of the remaining BSAs.
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 on the capital markets and lends them on very favorable terms to support projects that contribute to the achievement of EU objectives. The EIB is working to put the EU at the forefront of the next wave of innovation, particularly 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 to treatments. As a European climate bank, the EIB is one of the main financiers of the green transition towards a more low-carbon and sustainable growth model.
ABOUT OSE Immunotherapy
OSE Immunotherapeutics is an integrated biotechnology company focused on developing and partnering 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-based vaccination, immuno-oncology (focus on myeloid targets), autoimmunity and inflammation. Its top-notch balanced clinical and preclinical portfolio presents a diversified risk profile:
– Tedopi® (innovative combination of neoepitopes): the company’s most advanced product; positive results for stage 1 of the phase 3 trial (Atalante 1) in non-small cell lung cancer after checkpoint inhibitor failure.
In Phase 2 in pancreatic cancer (TEDOPaM, sponsor GERCOR) in combination.
Due to the COVID-19 crisis, the recruitment of new patients in TEDOPaM is expected to restart in 2021.
- CoVépiT: a second-generation prophylactic vaccine against COVID-19, developed using optimized SARS-CoV-2 epitopes against several variants. Positive human preclinical and ex vivo results in August 2020, clinical trial to start in Q1 2021.
- 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.
- CLEC-1 (new myeloid checkpoint target): identification of CLEC-1 antagonist mAbs blocking the “Don’t Eat Me” signal that increase both the phagocytosis of tumor cells by macrophages and the uptake of antigens by the cells dendritic.
- BiCKI®: bispecific fusion protein platform built on the key anti-PD-1 backbone component (OSE-279) combined with novel immunotherapy targets; 2n/a generation of PD-(L)1 inhibitors to increase antitumor efficacy.
Autoimmunity and inflammation platform
- FR104 (anti-CD28 monoclonal antibody): positive Phase 1 results; phase 1/2 ongoing in kidney transplantation, 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 from phase 1; in Phase 2 in ulcerative colitis (OSE sponsor) and an independent Phase 2 planned in Sjögren’s syndrome (Servier sponsor).
- OSE-230 (ChemR23 agonist mAb): first class therapeutic agent with the potential to resolve chronic inflammation by driving affected tissues towards tissue integrity.
For more information:
This press release contains express or implied information and statements that could be considered forward-looking information and statements regarding OSE Immunotherapeutics. They are not historical facts. Such 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, expected future developments and other factors they deem appropriate. .
These forward-looking statements include statements generally using the conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan” or “estimate”, their declensions and conjugations and words of of similar importance. Although OSE Immunotherapeutics’ management believes that forward-looking statements and information are reasonable, OSE Immunotherapeutics shareholders and other investors are cautioned that the achievement of such expectations is inherently subject to various known and unknown risks and uncertainties that 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, 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. These forward-looking statements are not guarantees of future performance. This press release contains only summary information and should be read together with OSE Immunothérapie’s Universal Registration Document filed with the AMF on April 15, 2020, including the annual financial report for the 2019 financial year, available on OSE Immunotherapy website. Except as required by applicable law, OSE Immunotherapeutics is issuing this press release as of the date hereof and undertakes no obligation to update or revise any forward-looking information or statements.