- This loan will further support the progression and expansion of OSE Immunotherapeutics’ core clinical development programs in diseases with unmet medical needs,
- Divided into three tranches, including two tranches of € 10 million each and a third tranche of € 5 million,
- Agreement in line with the European Investment Bank’s strategy to support biotechnology companies developing high-level expertise in various fields such as OSE’s immunotherapy programs, including its SARS vaccine program. CoV-2.
NANTES, France, February 15, 2021 (GLOBE NEWSWIRE) – OSE Immunotherapy (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, including two tranches of 10 million euros each and a third tranche of 5 million euros.
The first tranche of 10 million euros, unconditional and for which OSE will request payment before the end of May 2021, will allow the clinical development of Tedopi® to be extended in combination with a checkpoint inhibitor in other cancer indications. This first tranche will also support the Phase 1/2 entry 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 major component of the anti-PD-1 backbone of the BiCKI® bifunctional checkpoint inhibitor platform, targeting PD-1 and other innovative targets, associated with novel targets of immunotherapy.
The remaining two 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 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 portfolio of clinical stages and to explore new therapeutic indications with strong medical need, thus strengthening the status of OSE 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 various therapeutic areas such as immuno-oncology, autoimmune diseases and a vaccine project against SARS-CoV-2, makes OSE Immunotherapeutics a major potential player in the healthcare sector. . 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 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 during the drawdown. An additional 550,000 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 sessions 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 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, 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 finance 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 the 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 works 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 to treatments. As a European bank in the service of the climate, the EIB is one of the main donors of 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 balanced first-in-class clinical and preclinical portfolio presents a diversified risk profile:
- Tedopi® (innovative combination of neoepitopes): the company’s most advanced product; positive results for step 1 of the phase 3 trial (Atalante 1) in non-small cell lung cancer after failure of a checkpoint inhibitor.
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 multiple variants. Positive preclinical and human ex vivo results in August 2020, the clinical trial should start in the first quarter of 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 mAb antagonists blocking the “Don’t Eat Me” signal that increase both phagocytosis of tumor cells by macrophages and antigen uptake by macrophages. dendritic cells.
- BiCKI®: bispecific fusion protein platform built on the key component of the anti-PD-1 backbone (OSE-279) combined with new immunotherapy targets; 2sd 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 underway 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 of phase 1; in Phase 2 in ulcerative colitis (sponsor OSE) and an independent Phase 2 in Sjögren syndrome (sponsor Servier).
- OSE-230 (ChemR23 agonist mAb): A first-order therapeutic agent with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity.
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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. This 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 its perception of historical trends, current economic and industrial conditions, expected future developments 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 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, implied or projected by forward-looking statements. These risks include those discussed or identified in public documents 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 Registration Document of OSE Immunotherapeutics filed with the AMF on April 15, 2020, including the annual financial report for fiscal year 2019, available on OSE Immunotherapeutics website. Except as required by applicable law, OSE Immunotherapeutics is issuing this press release as of the date hereof and assumes no obligation to update or revise any forward-looking information or statements.