On April 6, 2022 Onxeo S.A. (Euronext Growth Paris: ALONX, Nasdaq First North Copenhagen: ONXEO), hereafter "Onxeo" or the "Company", a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR), reported its consolidated results for the fiscal year ending December 31, 2021 and announced additional funding of €12 million subscribed by its longstanding shareholders Invus and Financière de la Montagne (Press release, Onxeo, APR 6, 2022, View Source [SID1234611504]).
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FY 2021 FINANCIAL RESULTS*
*Audit procedures on the consolidated accounts have been carried out. The certification report will be issued once the management report has been verified.
Revenues for full-year 2021 totaled €4.1 million and consisted of:
– Non-recurring revenues essentially comprising contractual lump-sum royalties due from Biogen within the framework of a licensing agreement for a non-strategic product;
– Recurring revenues corresponding to royalties on sales received by the Group pursuant to the agreement with Biogen. In 2020, these revenues came exclusively from Beleodaq and were recognized in the Group’s accounts up to the date of the global agreement signed with Acrotech Biopharma in April 2020.
2021 operating expenses were stable on the previous year at €9.7 million, and resulted primarily from the clinical development of AsiDNA and the preclinical development of OX400 compounds.
The substantial decrease in other non-recurring operating income and expenses was due to the recognition, in 2020, of the licensing agreement with Acrotech Biopharma. This agreement was treated as a divestment under IFRS, leading to the booking of the following amounts:
– a net income of €5.7 million in proceeds from the transaction;
– an expense of €2.8 million corresponding to the net book value of the R&D assets related to Beleodaq;
– an income of €7.1 million corresponding to the royalties, evaluated by management, that the Group expected to receive after the date of the signing of the agreement and through which it will repay the balance of the SWK Holdings bond loan.
The financial result was a loss of €0.7 million in 2021, and primarily consisted of interest on the bond loan with SWK.
Once net tax income of €0.1 million is taken into account, the Group recorded a total net loss of €5.9 million in 2021 versus a net profit of €1.1 million in 2020.
CASH POSITION AT DECEMBER 31, 2021
At December 31, 2021, the Group had a cash position of €17.9 million, compared with €14.5 million at December 31, 2020. This increase was essentially a result of the financing obtained during the year, i.e. State-Guaranteed Loans of €5 million and a rights issue providing Onxeo with net proceeds of €9.4 million. These resources, added to the collection of license income for 1.4 million euros and the 2020 research tax credit of 1.1 million euros, made it possible to absorb operating expenses amounting to 13.5 million euros.
FULL-YEAR 2021 HIGHLIGHTS AND RECENT DEVELOPMENTS
AsiDNA
– On the clinical front, in February we entered into a research agreement with the Institut Curie to conduct a Phase 1b/2 study to evaluate the effect of AsiDNA in combination with radiotherapy in children with recurrent high-grade glioma (HGG), an orphan brain cancer with a poor prognosis. This study was approved in late 2021 and the first patients will be enrolled in early 2022. In parallel, we completed the DRIIV-1b trial of AsiDNA in combination with reference chemotherapies, carboplatin and then carboplatin and paclitaxel, in patients with advanced solid tumors that were progressing at inclusion. The very favorable safety profile of AsiDNA was confirmed and significantly longer control times were observed than with previous treatment lines, including those involving platinum salt chemotherapies. These results were published in March 2021. The Group also continued the Revocan Phase 1b/2 clinical trial to evaluate the combination of AsiDNA with PARP inhibitors in the 2nd line maintenance treatment of relapsed ovarian cancer. Gustave Roussy is the sponsor of this study. The pace of recruitment has been slower than expected, partly due to the health crisis, and the initial results are now expected in the second half of 2022.
– On the preclinical front, Onxeo presented results from preclinical studies at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2021 showing the ability of AsiDNA, to prevent drug-tolerant cell (DTC)-induced resistance to KRAS inhibitors (KRASi). The previous year, Onxeo had already demonstrated for the first time at the AACR (Free AACR Whitepaper) that these DTCs were involved in tumor resistance to PARP inhibitors. The role of persistent cells in resistance to other targeted therapies such as tyrosine kinase inhibitors has long been established. The effect of AsiDNA on these cells may allow it to become a gold standard combination therapy to counter resistance to multiple targeted therapies when induced by persistent cells and preclinical evaluation of novel combinations of AsiDNA in this setting is ongoing. The Group also presented its DTC results at the EACR-AstraZeneca virtual conference held in December 2021.
OX400
– During the year 2021, the Group continued to optimize OX401 to improve its action on the PARP protein, which is involved in the tumor DNA repair cascade, and its activation of the antitumor immune response via the cGAS-STING pathway. The Group plans to select the optimized compound and start preclinical development in 2022.
Intellectual Property
– On June 9, 2021, Onxeo received a notice of allowance from the US Patent and Trademark Office (USPTO) for a patent that extends, in the United States, AsiDNA’s protection in combination with any PARP inhibitor (PARPi). This patent protects both the combination of AsiDNA with a PARPi and its use for treating certain cancers for which the DNA repair pathway via homologous recombination (HR) is not impaired or deficient.
Governance
– In May 2021, Onxeo announced the creation of a Scientific Advisory Committee comprising leading scientific and clinical experts in the fields of DDR, treatment resistance and, more globally, oncology drug development. This committee will advise and guide the Company in advancing its exclusive DDR compound platform and developing innovative therapies to address unmet medical needs and improve the care provided to and outlook for cancer patients.
– On July 29, 2021, the Company announced the appointment of Dr. Shefali Agarwal as Chairwoman of the Board of Directors, replacing Mrs. Danièle Guyot-Caparros, who remains an independent member of the Board and Chairwoman of the Audit Committee.
– The Company further strengthened its Board of the Directors during the second half of 2021 with the appointment of Dr. Robert L. Coleman, Chief Scientific Officer of US Oncology Network, Dr. Jacques Mallet, former Senior Vice President Analytics/Corporate Strategy and Member of the Executive Leadership Team at Sanofi, and Mr. Bryan Giraudo, COO and CFO of Gossamer Bio, Inc., as independent Board members. These recognized health sector experts will bring their experience and their network, and will support the Company’s development program, and notably its expansion in the United States.
– On January 3, 2022, Onxeo announced – following the approval of the Board of Directors – the appointment of Julien Miara as interim Chief Executive Officer, replacing Judith Greciet, who remains a director of the Company.
Following these evolutions, the Board of Directors is composed of eight members, out of which five are independent.
OUTLOOK FOR 2022
In 2022, the Company will pursue its value creation strategy based on the development of its therapeutic innovations up to proof of concept in humans, with the following main steps:
AsiDNA
– Continued clinical development in high value-added indications and combinations, notably in the United States on the basis of an IND application;
– Preliminary results of the REVOCAN study of AsiDNA added to PARP inhibitors as second-line maintenance therapy in patients with relapsed ovarian cancer, as expected from study sponsor Gustave Roussy;
– Recruitment of the first patient and continuation, under the aegis of its sponsor, the Institut Curie, of the AsiDNA Children study (Phase 1b/2), which is evaluating the effect of AsiDNA combined with radiotherapy in the treatment of recurrent high-grade glioma in children;
– Submissions and publications in international scientific journals of the results of preclinical or clinical studies as part of the development plan to establish the potential of AsiDNA.
OX400
– Optimization of the most promising OX400 compound;
– Preclinical proof of concept in vitro and in vivo in combination with immunotherapies;
– Development of the translational and regulatory plan for clinical entry in early 2024.
platON
– Continued evaluation and optimization of new compounds.
ADDITIONAL FINANCING IN EQUITY AND ISSUANCE OF CONVERTIBLE BONDS
This financing, decided by the Board of Directors on April 6, 20221, comprises an €8 million capital increase and a €4 million convertible bond issue. It extends the Company’s financial visibility until the second quarter of 2023.
Terms and conditions of the capital increase
The capital increase will be carried out through the issuance of common shares with waiver of shareholders’ preferential subscription rights reserved for a category of persons in accordance with the thirteenth resolution approved by the Mixed General Meeting of June 10, 2021, based on the provisions of Articles L. 225-129 and following of the Commercial Code.
A total number of 19,512,195 new common shares with a nominal value of €0.25 each will thus be issued to the benefit of Invus Public Equities LP and Financière de la Montagne. These new shares will represent approximately 21% of the Company’s share capital before the implementation of the private placement. Following this placement, a shareholder with a 1% stake in the Company would see their stake reduced to 0.83%. The subscription price has been set at €0.410 per new share, corresponding to the weighted average share price over the 3 previous trading sessions (i.e. from April 1 to 5, 2021 inclusive) without a discount, giving net proceeds of €8 million.
Settlement-delivery of the new shares and reception of the funds will occur no later than April 8, 2022 and will be confirmed by the Chief Executive Officer, acting upon delegation on behalf of the Board of Directors.
The issue is not subject to a prospectus requiring a visa from the AMF French financial market authority.
Delivery and admission to trading of the new shares
The admission of the new shares to trading on the Euronext Growth market in Paris is scheduled for no later than April 12, 2022. They will be listed on the same line as the Company’s existing shares (ISIN: FR0010095596), will carry current dividend rights and will be immediately fungible with the Company’s existing shares.
Distribution of capital
Prior to the operation, the Company’s share capital consisted of 91,944,935 shares, of which 16.1% were held by Financière de la Montagne and 15.3% by Invus Public Equities LP.
Following completion of the capital increase, the shareholdings of Invus Public Equities LP and Financière de la Montagne will be 23.5% and 19.8% of the Company’s share capital respectively, based on a total number of 111,507,130 shares. To the Company’s knowledge, no other shareholders hold more than 5% of its share capital.
Convertible bond issue
This issuance of bonds convertible into common shares was decided by the Board of Directors in accordance with the thirteenth resolution approved by the Mixed General Meeting of June 10, 2021 (waiver of shareholders’ preferential subscription rights via a private placement reserved for a category of persons), based on the provisions of Articles L. 225-129 and following of the Commercial Code.
The convertible bond issue for a nominal amount of €4,000,000 is represented by 4,000,000 convertible bonds with a nominal value of one euro each, giving gross proceeds from the bond issue of €4 million. The convertible bonds will be subscribed by Invus Public Equities LP and Financière de la Montagne to the tune of €2.5 million and €1.5 million respectively.
Settlement-delivery of the convertible bonds and reception of the funds will occur no later than April 8, 2022 and will be confirmed by the Chief Executive Officer, acting upon delegation on behalf of the Board of Directors. The bonds will not be the subject of a request for admission to trading on the Euronext Growth market. However, any common shares resulting from the conversion of these convertible bonds will be, as soon as they are issued, on the same line as existing common shares (ISIN: FR0010095596).
The issue is not subject to a prospectus requiring a visa from the AMF.
The Company will regularly publish, on its website, the number of new shares issued upon conversion of convertible bonds.
The main characteristics of the convertible bonds are the following:
Maturity: April 6, 2027;
Conversion of bonds at maturity: any convertible bond that has not been converted seven trading days before the maturity date will automatically be converted into common shares on the maturity date according to the conversion ratio below;
Interest: the convertible bonds will not bear interest (except default interest applicable to any non-payment of a cash reimbursement with respect to an event default or change in control);
Conversion: the convertible bonds may be converted into common shares exclusively on the Company’s initiative between the issuance date and the maturity date; the convertible bonds will give their holders the right, should they be converted, to N new common shares equal to the nominal value of a convertible bond divided by X, X being the lower of (a) 0.410 euros2 and (b) the volume-weighted average share price over the three trading days preceding the conversion request with no discount;
Event default: standard in such matters (notably breach of the terms and conditions, delisting, divestment of a significant asset or cessation of activity) providing for (on the initiative of the representative of the group upon request from a convertible bond holder) to obtain early cash reimbursement of the convertible bonds at 110% of their value;
Change in control: should there be a change in control, ability (on the initiative of a convertible bond holder on all or a portion of the convertible bonds they hold) to obtain early cash reimbursement of the convertible bonds at 110% of their nominal value;
Guaranties: the cash reimbursement of the convertible bonds (in the case of an event default or change in control) is secured by pledges provided by the Company on certain intellectual property rights it holds, it being specified that these pledges are accepted subject to licenses and usage rights granted or to be granted by the Company on the rights pledged and that the pledges will be pari passu with the existing pledges given to SWK;
The convertible bonds are non-transferable, except to affiliates of the convertible bond holders or with the Company’s prior written consent;
Lock-up commitment from the Company (during which it may not issue additional convertible bonds): 90 days (subject to standard exceptions).
Use of proceeds
The net proceeds of the issue will be used (i) to develop AsiDNA, the Company’s leading product, both clinically and industrially within the framework of ongoing and future clinical trials, (ii) to finalize the optimization of and develop the preclinical program for OX401, both alone and with immune-oncology drugs, and (iii) more generally to finance the Company’s running costs.
This press release does not constitute an offer to sell shares or other financial securities of Onxeo or any solicitation of an offer to buy or subscribe for financial securities in the United States of America or in any other country, including in Canada, Australia and Japan. Shares, or any other securities, of Onxeo may only be offered, subscribed or sold in the United States of America following registration under the US Securities Act of 1933, as amended (" US Securities Act"), or as part of an exemption from this registration requirement. The shares of Onxeo have not been and will not be registered under the US Securities Act and Onxeo does not intend to register the offer mentioned in this document or any part of this offer in the United States. United States of America or to make any public offer of its shares or securities in the United States of America.
The dissemination, publication or distribution of this press release in certain countries may constitute a violation of the legal and regulatory provisions in force or be subject to restrictions under the legal and regulatory provisions in force. Persons physically present in these countries and in possession of the press release must therefore inform themselves of any local restrictions and comply with them. This press release must not be published, transmitted or distributed, directly or indirectly, in the territory of the United States of America, Canada, Australia or Japan.