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November 18, 2020

November 18, 2020

OSE IMMUNOTHERAPEUTICS ANNOUNCES A SUCCESSFUL CAPITAL INCREASE OF € 18.6 M BY PRIVATE PLACEMENT

Offering close to 2.5 times oversubscribed versus the initial minimum target

Nantes, France, 18 November 2020, 7:30 am CET – OSE IMMUNOTHERAPEUTICS (Euronext – FR0012127173 – OSE or the “Company), an integrated biotechnology company developing innovative immunotherapies, directly or through partnerships, for immune activation and regulation in immuno-oncology and autoimmune diseases, today announces the successful completion of its capital increase with the cancellation of preferential subscription rights through a private placement to 25 qualified French and international investors, including a large majority of new shareholders, and carried out by accelerated building of an order book, for an amount of € 18.6 million (the “Offering”).

Thanks to this capital raising, the Company reinforces its financial visibility until the first quarter of 2022.

Capitalised terms not otherwise defined in this announcement have the meanings given to them in the announcement made by the Company on Monday, November 16 at 8 am CET.

We would like to thank the new shareholders who participated in this capital raise as well as the existing shareholders who continue to support the evolving business strategy of OSE Immunotherapeutics. This is a key milestone for the Company allowing us to create additional value by bringing more products to the clinic to be developed by our expert R&D teams. This new funding reinforces our financial position and allows us to accelerate and expand our clinical stage portfolio with the launch of three programs:

  • a Phase 2 study for FR-104 (anti CD28) in a niche indication.
  • the preparation of a clinical trial with OSE-230, the new monoclonal antibody driving resolution of chronic inflammation and
  • the preparation for clinical entry of CLEC-1, the novel “Don’t Eat Me” signal myeloid cell checkpoint target.

 

OSE Immunotherapeutics is at an inflection point and is well-positioned to become a key player in immunotherapy in the coming years. The new clinical programs to be built on this fundraising will complement our ongoing clinical trials of first-in-class products which include the positive results with Tedopi in Non Small Cell Lung Cancer (NSCLC) post checkpoint failure recently presented at ESMO, two partnered assets, OSE-127 (IL-7R) and OSE-172 (SIRPα-CD47), that are currently in clinical trials and CoVepit, our COVID-19 vaccine, due to start its clinical trial in Q1 2021.declared Alexis Peyroles, CEO of OSE IMMUNOTHERAPEUTICS.

The Offering was carried out pursuant to the decision by the Board of Directors of 12 November 2020 and the decision by the CEO upon delegation from the Board of Directors, in accordance with the authority delegated by the nineteenth resolution approved by the Combined General Shareholders’ Meeting of June 16, 2020[1]. The total amount of the capital increase amounts to € 18.6 m and corresponds to the issue of 2,517,589 New Ordinary Shares at a subscription price of € 7.40 per New Ordinary Share (including the issue premium), i.e. a dilution rate of 16.3 % of the capital before the Offering on a non-diluted basis and 14.0 % after the Offering. The subscription price of the New Shares was set at € 7.40, i.e. with a discount of 18.7 % to the last closing price (as of Friday November 13, 2020)[2]. In comparison with the minimum amount of 10 million euros targeted by the Company, the placement has been close to 2.5 times oversubscribed.

The settlement-delivery of the Offering should take place on 20 November 2020, according to the indicative timetable. The New Ordinary Shares will carry current dividend rights and will be admitted to trading on Euronext Paris, on the same trading line as the existing shares, under the ISIN code FR0012127173 – OSE.

An application has been made to Euronext Paris for admission of the New Ordinary Shares to trading on the regulated market of Euronext Paris (the “Admission”). It is expected that Admission will take place on or around 9 am CET on November 20, 2020 (or such later time as the Banks may agree with the Company) and that unconditional dealings in the New Ordinary shares issued pursuant to the Offering will commence at the same time.

The share capital of the Company, which currently consists of 15,442,824 shares, will therefore consist of 17,960,413 shares after the transaction. As an indication, the stake of a shareholder owning 1% of the Company’s share capital prior to the capital increase (calculated on the basis of the number of shares comprising the Company’s share capital as at 17 November 2020) and who did not participate in the Offering, would be 0.86 % of the capital after the issuance.

As an indication, the proportion of shareholders’ equity per share (calculated on the basis of shareholders’ equity at 31 December 2019 as adjusted for the number of shares comprising the Company’s share capital at 17 November 2020) will increase from € 3.65 to € 4.18 following Admission. As an indication, the net proceeds of the transaction should be of a minimum of € 17.5 million.

In connection with the private placement, the Company has agreed to a lock-up undertaking, not to issue additional shares for a period of 180 days following the settlement-delivery of the Offering (of which 90 days of hard lock-up), subject to usual exemptions and one specific exemption related to the issuance reserved to one financial institution. In addition, in connection with the Offering, senior managers and directors of the Company have agreed not to sell any shares in the Company for a period of 90 days following the settlement of the Offering, subject to customary exceptions.

Bank Degroof Petercam SA/NV (“Degroof Petercam”) and Invest Securities SA (“Invest”) are acting as Joint Global Coordinators and Joint Bookrunners (together the “Banks”) in connection with the Offering. The Offering is subject to a placement and underwriting agreement between the Company and the Banks (the “Placement and Underwriting Agreement“). The Placement and Underwriting Agreement may be terminated by the Banks at any time up to (and including) the settlement-delivery date of the Offering on November 20, 2020 subject to certain customary conditions for this type of agreement. If the Placement and Underwriting Agreement is terminated in accordance with its terms, all investor orders placed under the Offering will be null and void. The Placement and Underwriting Agreement does not constitute a firm underwriting (garantie de bonne fin) within the meaning of Article L. 225-145 of the French Code de commerce.

The Company draws the public’s attention to the risk factors presented in section 3 of the 2019 Universal registration document filed with the AMF on April 15, 2020 under number D.20-0298, which is available free of charge on the website of the Company (https://ose-immuno.com/) and of the AMF (https://www.amf-france.org). Detailed information about OSE IMMUNOTHERAPEUTICS, including its activity, results and the corresponding risk factors, was presented in the press release dated September 17, 2020. This press release, as well as other regulated information and press releases, can be found on the company’s investor website at (https://ose-immuno.com/).

Trading suspension

The Company recalls that it has requested Euronext Paris to suspend the trading of its shares as from Monday, November 16 before market opening. OSE Immunotherapeutics share trading will resume on Wednesday, November 18 at market opening.

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 monotherapy and in combination with checkpoint inhibitor Opdivo®.

  • CoVepiT: a prophylactic vaccine against COVID-19, developed using SARS-CoV-2 optimized neo-epitopes. 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): 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; Phase 2-ready asset in autoimmune diseases or in transplantation.
  • OSE-127 (humanized monoclonal antibody targeting IL-7 receptor): developed in partnership with Servier; positive Phase 1 results; two independent Phase 2 planned in ulcerative colitis (OSE sponsor) and in Sjögren’s syndrome (Servier sponsor) to start in Q4 2020.
  • OSE-230 (ChemR23 agonist mAb): first-in-class therapeutic agent with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity.

Due to the COVID-19 crisis, accrual of new patients in the clinical trial TEDOPaM is temporarily suspended and initiation timelines for both Phase 2 trials of OSE-127 could be impacted during the coming months.

[1] In accordance with such resolution, the subscription price per share must be at least equal to the weighted average by the volumes of the share prices over the three (3) trading days preceding the date the issue price is set, it being specified that it may be reduced by a discount of at most 20%

[2] The subscription price of € 7.40 per New Ordinary Share represents a discount of 19.9 % on the volume weighted average of the Company’s share price over the last three (3) trading days prior to the day on which the issue price is set, i.e. 11, 12 and 13 November 2020

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OSE Immunotherapeutics
Sylvie Détry
Sylvie.detry@ose-immuno.com
+33 153 198 757

French Media: FP2COM
Florence Portejoie
fportejoie@fp2com.fr
+33 607 768 283

U.S. Media: LifeSci Communications
Darren Opland, Ph.D.
darren@lifescicomms.com
+1 646 627 8387

U.S. and European Investors
Chris Maggos
chris@lifesciadvisors.com
+41 79 367 6254

Important Information

The release or distribution of this announcement may, in certain jurisdictions, be subject to restrictions. The recipients of this announcement in jurisdictions where this announcement has been published or distributed shall inform themselves of and follow such restrictions. This announcement does not constitute an offer, or a solicitation of any offer, to buy or subscribe for any securities in the Company in any jurisdiction, neither from the Company nor from someone else.

The information contained in this announcement is for background purposes only and does not purport to be full or complete. No reliance may or should be placed by any person for any purpose whatsoever on the information contained in this announcement or its accuracy or completeness. The information in this announcement is subject to change.

This announcement is an advertisement and not a prospectus for the purposes of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 (the “Prospectus Regulation”) and has not been approved by any regulatory authority in any jurisdiction.

In France, the Offering described above will take place solely as a placement to the benefit of categories of persons, in accordance with Article L. 225-138 of the French Commercial Code and applicable regulations. The Offering is reserved, in the European Economic Area (including in France), to “qualified investors”, as that term is defined in Article 2(e) of the Prospectus Regulation.

In relation to each member state of the European Economic Area other than France (each, a “Relevant Member State”), an offer of the New Ordinary Shares is not being made and will not be made to the public in that Relevant Member State, other than: (i) to any legal entity which is a qualified investor as defined in the Prospectus Regulation; (ii) to fewer than 150 natural or legal persons per relevant member state; or (iii) in any other circumstances falling within Article 1(4) of the Prospectus Regulation; provided that no such offer of the New Ordinary Shares shall require the Company to publish a prospectus pursuant to Article 3 of the Prospectus Regulation. For the purposes of the above, the expression an “offer to the public” in any Relevant Member State shall have the meaning ascribed to it (‘offer of securities to the public’) in article 2(d) of the Prospectus Regulation.

This press release may not be distributed, directly or indirectly, in or into the United States. This press release does not constitute an offer of securities for sale nor the solicitation of an offer to purchase securities in the United States or any other jurisdiction where such offer may be restricted. The New Ordinary Shares have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), or any state securities laws and may not be offered or sold in the United States of America absent registration or an applicable exemption from registration under the Securities Act and applicable state securities law. The securities have not been registered, and there is no intention to register any securities referred to herein in the United States or to make any public offering of securities of the Company in the United States.

Degroof Petercam is authorised by and under the supervision of the National Bank of Belgium and under the supervision on investor and consumer protection of the Belgian FSMA. Invest Securities is authorised by and under the supervision of the French ACPR and under the supervision of the French AMF. You should note that, in connection with the Offering, each of the Banks is acting exclusively for the Company and for no one else in connection with the Offering and will not be responsible to anyone (whether or not a recipient of this document) other than the Company for providing the protections afforded to clients of the Banks or for affording advice in relation to the Offering, the contents of this document or any matters referred to herein. The Banks are not responsible for, and have not approved, the contents of or any part of this document.

The Banks do not make any representations, express or implied, or accept any responsibility whatsoever for the contents of this document nor for any other statement made or purported to be made by the Banks or on their behalf in connection with the Company and the Offering. The Banks, any of their respective directors, officers, employees, agents, affiliates or advisers accordingly disclaim all and any liability whether arising in tort or contract or otherwise which they might otherwise have in respect of this document or any such statement.

Forward-looking statements

This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.

These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and 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 in or 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. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on 15 April 2020, including the annual financial report for the fiscal year 2019, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.