France: OSE Immunotherapeutics enters a loan agreement of up to €25 million with the EIB
France: OSE Immunotherapeutics enters a loan agreement of up to €25 million with the EIB
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  • This loan will further support the progress and expansion of OSE Immunotherapeutics’ lead clinical development programs in diseases with high unmet medical needs,
  • Divided into three tranches including two tranches of €10 million each and a third tranche of €5 million,
  • Agreement part of the European Investment Bank’s strategy to support biotech companies developing a high-level of expertise in various areas such as OSE’s immunotherapy programs, including its vaccine program against SARS-CoV-2.

OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE) today announced that the company has signed a loan agreement of up to €25 million with the European Investment Bank (EIB).

The loan facility of up to €25 million is divided into three tranches including two tranches of €10 million each and a third tranche of €5 million.

The first €10 million tranche, unconditional and which OSE will request payment before the end of May 2021, will help expand the clinical development of Tedopi® in combination with a checkpoint inhibitor in additional 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 oncology indication. 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. Moreover, OSE-279 is the key anti-PD-1 backbone component of the bifunctional checkpoint inhibitor BiCKI® platform, targeting PD-1 and other innovative targets, paired with novel immunotherapy targets.

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

Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, comments: “We are very grateful for EIB’s support, a major financial European institution, as the Company is at an inflection point of its growth. The first €10 million tranche allows OSE to extend its financial visibility to Q2 2022. This new flexible funding tool will help expand and accelerate the development of our clinical stage portfolio and explore new therapeutic indications with strong 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 of OSE, a biotech combining a high level of research and innovation, highly qualified collaborators 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, means that OSE Immunotherapeutics is a potential major player in the health sector. This project is fully in line with the mandate set for the EIB by its shareholders – the EU Member States – to support innovation across Europe“.

This loan will carry 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 repayment 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 when drawn.   550,000 additional warrants could be issued if the second tranche of €10 million is 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 pricing (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 customary exceptions, the warrants will only be exercisable after a five-year period starting from the drawdown of the relevant tranche, thus limiting the impact in terms of dilution and volatility in the coming years.

The warrant agreement includes an exercise parity adjustment clause which could apply, under certain conditions, in case of capital increase. The EIB will be granted with the possibility, under certain conditions, to request OSE Immunotherapeutics to buy back its warrants for a maximum amount of €15 million and, beyond that amount, to find a buyer and pay interests on the price of the remaining warrants.

About OSE Immunotherapeutics

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 is focused on three areas:  T-cell-based vaccination, Immuno-Oncology (focus on myeloid targets), Auto-immunity & Inflammation. Its balanced first-in-class 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 Non-Small Cell Lung Cancer post checkpoint inhibitor failure. In Phase 2 in pancreatic cancer (TEDOPaM, sponsor GERCOR) in combination. Due to the COVID-19 crisis, accrual of new patients in TEDOPaM should restart in 2021.
  • CoVepiT: a prophylactic second generation vaccine against COVID-19, developed using SARS-CoV-2 optimized epitopes against multi variants. Positive preclinical and human ex vivo results in August 2020, clinical trial expected to start in Q1 2021.

Immuno-oncology platform

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

Auto-immunity and inflammation platform

  • FR104 (anti-CD28 monoclonal antibody): positive Phase 1 results; ongoing Phase 1/2 in renal transplant, Phase 2-ready asset in a niche indication in autoimmune diseases.
  • OSE-127/S95011 (humanized monoclonal antibody targeting IL-7 receptor): developed in partnership with Servier; positive Phase 1 results; 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-in-class therapeutic agent with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity.
New project to look into the fundamental rights situation of long-term EU residents
New project to look into the fundamental rights situation of long-term EU residents

FRA (Fundamental Right Agency) held an online inception meeting of a new project looking into the fundamental rights situation of third-country nationals who are long-term residents in the EU. The meeting on will gather partners from FRA’s research network from nine EU Member States – Belgium, Czechia, France, Germany, Italy, Poland, Portugal, Spain and Sweden – covered by the research.

The project will look into the fundamental rights situation of long-term residents in the EU, including equal treatment and access to rights. FRA will collect the data through online interviews with experts and online focus groups and interviews with migrants who are long-term resident in the EU. The meeting took place on 27 January.

Supporting the training of guardians for unaccompanied children
Supporting the training of guardians for unaccompanied children

The training manual will be developed using the guidance set in the FRA’s and the European Commission’s Handbook on Guardianship for children deprived of parental care, as well as principles in the UN’s child rights convention and EU law. For its development, FRA will closely cooperate with the European Network of Guardianship, formed by representatives from different Member States.

Web Summit: EIB provides Bizay with €20 million to support its R&D programme and product development, promoting employment in Portugal
Web Summit: EIB provides Bizay with €20 million to support its R&D programme and product development, promoting employment in Portugal
>@Bizay. ©Bizay
    • The investment will boost the Portuguese company’s growth and market penetration in Portugal, rest of Europe and Latin America.
    • More than 120 highly skilled jobs to be created over the next four years.
    • These funds are provided under the European Growth Finance Facility programme loan.

The European Investment Bank (EIB) is investing €20 million in the Portuguese software company Bizay to finance the implementation of its research and development (R&D) programme and product development roadmap. One of Bizay’s main focuses will be its tech-based B2B marketplace for customised products targeted at small and medium-sized enterprises (SMEs), such as retail stores, restaurants, hotels and small corporates. This financing will also promote job creation in Portugal, a fundamental aspect for the European Union’s post-COVID-19 economic recovery. The agreement was announced today at Web Summit by EIB Vice-President Ricardo Mourinho Félix and Bizay CGO José Salgado.

This financing – in line with the European Commission’s strategy to strengthen competitiveness and innovation in digital technologies – will further support Bizay’s overall growth and geographic expansion plan and aims to create over 120 jobs in fields related to technology and business development over the next four years in Portugal.

Bizay’s marketplace, available in over 20 countries spanning from Europe to Latin America, offers a wide catalogue of customisable products, ranging from corporate gifts and promotional products to packaging, business cards and leaflets across all verticals. Thanks to the EU bank’s support, the company will further digitalise every step of the supply chain to make it more cost and time efficient. It uses artificial intelligence technologies like state-of-the-art machine learning algorithms for automating online marketing bidding processes, thereby improving overall marketing efficiency. Furthermore, Bizay’s business model enables an entire ecosystem of small businesses and manufacturing companies to connect and benefit from each other, giving them access to a wide catalogue of customisable products at a competitive price, which are otherwise very expensive for small businesses, and with a short delivery time.

The EIB will further support Bizay’s current technology developments, which include initiatives that will make use of learning models to forecast future traffic loads and of artificial intelligence to improve order aggregation and further improve production cost efficiency.

EIB Vice-President Ricardo Mourinho Félix, responsible for the Banks operations in Portugal, said: “The Web Summit is the ideal venue to announce the EIB backing for Bizay, underscoring the EU bank’s support for the digital and innovation sectors in Portugal. This is a very important project that will strengthen the competitiveness of a leading Portuguese software house and shows the EIB’s strong commitment to innovation digitalisation and the creation of high-quality jobs in Europe, key elements to boost a solid and inclusive economic recovery in the wake of the COVID-19 crisis, which is one of the EIB’s main priorities.”

European Commissioner for the Economy Paolo Gentiloni said: “Thanks to the Investment Plan for Europe, Portuguese software company Bizay will be able to further digitalise its supply chain. Even better, it will create over 120 highly skilled jobs in the process. This project is a great example of how Europe is working to boost competitiveness and employment through innovative digital technologies.”

Bizay co-founder and CGO José Salgado said: We are very proud to have the EIB as a partner for the next phase of our journey. With its support, we will further develop our R&D programme. In particular, we will invest in our AI technology that connects industrial manufacturers with more than 1 million SMEs across 21 countries. This is an important step towards our goal of becoming the leading tech-based B2B marketplace for all customisable products.”

This venture debt operation is part of the European Growth Finance Facility (EGFF), a program loan under the European Fund for Strategic Investments (EFSI) guarantee, which enables the EIB Group to increase its support for investments that promote innovation, economic growth and employment. Since it was launched by the EIB under the Juncker Plan in 2016, this initiative has granted over €2 billion in financing for projects in sectors such as robotics, artificial intelligence and biomedicine. EIB venture debt financing targets European companies with up to 3 000 employees in the fields of biotechnology and health sciences, software and ICT, engineering and automation, and renewable energy and clean technology.

About EIB venture debt and the Investment Plan for Europe

The EIB’s venture debt product is a financing instrument that supports start-up and fast-growing innovative companies in cutting-edge technology sectors. It combines the advantages of a long-term loan with a remuneration model based on the company’s performance. Venture debt transactions help strengthen the borrower’s economic capital without diluting the shares of existing investors. The product, developed four years ago in response to market needs, is backed by the European Fund for Strategic Investments (EFSI), the financial pillar of the Investment Plan for Europe.

The European Fund for Strategic Investments (EFSI) is the main pillar of the Investment Plan for Europe. It offers first-loss guarantees that enable the EIB to invest in increasingly risky projects. The projects and agreements approved for financing under EFSI have so far mobilised €535.4 billion in investment.

Background information

About Bizay

Founded in 2013, Bizay is currently one of the leading Portuguese technological start-ups, with a unique and differentiating platform for marketing products and services for SMEs and professionals. Bizay aims to become the “Amazon” for SMEs for fulfilling the needs of these businesses for customised products, such as merchandising, packaging and consumables, business essentials, decorations and uniforms, with professional quality at a fraction of the cost. Based in Portugal, Bizay sells to more than 1 million SMEs in 21 countries, with three production hubs in Europe, Brazil and North America.

About Web Summit

Web Summit is an annual technology conference with more than 70 000 attendees held in Lisbon, Portugal. It is considered one of the largest and most important tech events in the world.

Maharashtra: Book online for darshan in temples; decision on mass after Wednesday
Maharashtra: Book online for darshan in temples; decision on mass after Wednesday

MUMBAI: Post-lockdown guidelines will be firmly in place Monday as the state permits religious places to reopen to the public. Shirdi Sai temple and Siddhivinayak trust have instructed devotees to book online darshan before visiting. Churches will not resume public attendance at mass as yet, although devotees can visit for personal prayer from 10am to noon, and 4-7pm.
In a letter to parish priests on Sunday, the Archbishop of Bombay Oswald Cardinal Gracias advised a watch-and-wait approach. He will evaluate the situation on Wednesday and then take a call. Till then, he has urged priests to enforce the use of masks, sanitiser and social distancing every step of the way.
For the last eight months, devotees keen to enter places of worship were thwarted by locked gates. They often halted outside, said a silent prayer and went on their way. Monday will bring an end to this separation.
The post-lockdown protocol calls upon devotees to arm themselves with masks, prayer mats and avoid physical contact with the idol and one another. Universally, children below 10 years and the elderly and sick patients will be turned back.
The Shri Sai Baba Sansthan Trust in Shirdi has mandated visitors to make online bookings and obtain a time slot for darshan. People will have to show their booking receipts at the entrance. Up to 6,000 people will be allowed daily, in contrast to the average footfall of 20,000-30,000. While 50% will be paid darshan, the remainder will be free. There will be no distribution of sweets, although devotees will receive prasad in the halls built for the purpose.
Mumbai’s nodal Siddhivinayak shrine has instructed devotees to download its app to book darshan, or get a QR code. Here, 100 people will be allowed every hour, and a maximum of 1,000 per day.
Wadala’s Ram Mandir, which wore a forlorn look through Ram Navami and Dussehra, will reopen with
‘kakad aarti’ at 6am, said trust general secretary Ulhas Kamat.
After eight months, the muezzin will call Muslims to prayer from the local mosque. On Sunday, the long prayer carpet was removed from the Andheri Muslim Qabrastan Masjid at Four Bungalows. Trustee Atik Babar Kashmiri said, “We will follow all government guidelines and request namazis to bring their own prayer mats. We have requisitioned a foot-operated sanitiser dispenser as well.”
The Archdiocese of Bombay is treading cautiously under its shepherd, Cardinal Gracias. “He has said that people can pay a visit to the blessed sacrament or come for personal prayer but not attend mass just yet. He will evaluate the situation on Wednesday. Masses are in any case being streamed live,” said Fr Vincent Vaz, parish priest of Holy Family Church, Chakala.
Nasha R Jassawalla, managing trustee of the Rustomfaramna Agiary or fire temple at Dadar Parsi Colony, cautioned behdins (worshippers) against bringing flowers and offerings, maintain physical distance at celebrations or ceremonies, and use masks and sanitisers. The agiary has removed its prayer books for the public.
(Inputs by Ranjan Dasgupta from Nashik)

Poland: EIB provides additional support to chemical company PCC Rokita
Poland: EIB provides additional support to chemical company PCC Rokita
    • The Bank will increase the financing provided at the beginning of last year to €67.5 million.
    • The funds will support the company’s modernisation plans and the construction of the Process Innovation and Scaling Centre.
    • Both loan agreements are backed by an EFSI guarantee under the Investment Plan for Europe

On 28 September 2020, PCC Rokita SA signed an annex to the loan agreement with the European Investment Bank (EIB), under which the Bank has granted the company additional financing for €22.5 million, increasing the loan granted to PCC Rokita at the beginning of last year from €45 million to €67.5 million.

The funds obtained from the financing will support the company in the implementation of investments of a total estimated value of €110.5 million. These include the further expansion and modernisation of chemical plants, such as the pilot plant for the development of polyols and the pilot plant for the production of phosphates and phosphites. They also include investments related to the expansion and optimisation of electrolysis production and the propylene oxide plant, the construction of the Process Innovation and Scaling Centre, and other investments aimed at adapting the existing infrastructure to the increased scale of operations.

Teresa Czerwińska, EIB Vice-President who oversees operations in Poland, said: “The EIB as an institution has been consistently supporting projects with great potential for achieving EU policy goals, both in terms of economic development and employment growth. PCC Rokita is a trustworthy partner for us, and is valued as a reliable beneficiary of funds obtained as part of financing. This additional loan is intended to support the company at a time when the effects of the COVID-19 pandemic are most severely hitting the economy. The EIB intends to help PCC Rokita invest in innovation and low-carbon technologies and increase the company’s competitiveness when the economy recovers.”

Wiesław Klimkowski, President of the Management Board of PCC Rokita, said: “The increase in EIB financing is a recognition of its positive assessment of the company’s financial and economic situation. It is worth recalling that the EIB supports innovative projects that are not only environmentally friendly, but that also create prospects for long-term growth and new jobs.”

Rafał Zdon, Vice-President of the Management Board, said: “An important element of our financing structure is the loan granted by the EIB at the beginning of 2019. Considering the currently available sources of financing and the further development of the Company, we decided to expand our cooperation with the European Investment Bank. This cooperation is long-standing and the EIB is a stable financial partner.

Paolo Gentiloni, European Commissioner for the Economy, said: “Thanks to the Investment Plan for Europe, the EIB will build on its successful cooperation with Polish chemical company PCC Rokita. The additional funding will help the company to continue shifting its production towards renewable and low-emission materials and expanding its innovation and development activities. In short, yet another European investment that is good for the climate and good for jobs.”

The annex does not result in other significant changes to the loan agreement with the EIB, which – under the original provisions – contains a number of obligations, such as maintaining the level of financial indices specified in the agreement, as well as limitations regarding the payment of dividends. Both loan agreements benefit from the support of the European Fund for Strategic Investments (EFSI), the financial pillar of the Investment Plan for Europe (the Juncker Plan).

PCC Rokita is the parent company of a Capital Group comprising several companies operating mainly in the chemical and service industries.