Onxeo Reports its Full-Year 2021 Financial Results and Announces Additional Financing of €12 Million
Onxeo reported its fiscal year 2021 results, revealing revenues of €4.1 million, a decrease from €4.8 million in 2020. The net loss widened to €5.9 million from a profit of €1.1 million, attributed to stable operating expenses of €9.7 million, primarily from clinical developments. Cash position improved to €17.9 million, aided by €12 million financing from stakeholders. This funding extends financial visibility to Q2 2023. Onxeo focuses on advancing its lead product, AsiDNA, in various clinical trials while developing OX400 compounds and optimizing its strategic approach.
- Cash position increased to €17.9 million, up from €14.5 million in 2020.
- Secured €12 million additional financing from key shareholders, extending financial visibility to Q2 2023.
- Advancement of clinical trials for AsiDNA, including new studies with Institut Curie.
- Net loss of €5.9 million in 2021, a stark decline from a net profit of €1.1 million in 2020.
- Total revenues decreased from €4.8 million in 2020 to €4.1 million in 2021.
> Cash position of
> Additional financing of
> Financial visibility extended to the 2nd quarter of 2023
FY 2021 FINANCIAL RESULTS*
Consolidated income statement (IFRS) In thousands of euros |
|
|
Revenues, of which: Recurring revenues Non-recurring revenues |
4,062 233 3,829 |
1,776 1,077 699 |
Operating expenses, of which: R&D expenses |
(9,722) (4,904) |
(9,803) (3,946) |
Other recurring operating income |
78 |
213 |
Recurring operating income/loss |
(5,582) |
(7,814) |
Other non-recurring operating income and expenses |
439 |
10,008 |
Income from equity affiliates |
|
|
Operating income/loss after income from equity affiliates |
(5,143) |
2,194 |
Financial result |
(693) |
(347) |
Income tax |
111 |
(757) |
Net profit/loss |
(5,937) |
1,089 |
*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
- 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
2021 operating expenses were stable on the previous year at
The substantial decrease in other non-recurring operating income and expenses was due to the recognition, in 2020, of the licensing agreement with
- a net income of
- an expense of
- an income of
The financial result was a loss of
Once net tax income of
CASH POSITION AT
At
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
- On the preclinical front,
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-
Intellectual Property
- On
Governance
- In
- On
- The Company further strengthened its Board of the Directors during the second half of 2021 with the appointment of Dr.
- On
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
- 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
- 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
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
A total number of 19,512,195 new common shares with a nominal value of
Settlement-delivery of the new shares and reception of the funds will occur no later than
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
Distribution of capital
Prior to the operation, the Company’s share capital consisted of 91,944,935 shares, of which
Following completion of the capital increase, the shareholdings of
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
The convertible bond issue for a nominal amount of
Settlement-delivery of the convertible bonds and reception of the funds will occur no later than
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:
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)
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
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
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
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
***
About
platON is Onxeo’s proprietary chemistry platform of oligonucleotides acting as decoy agonists, which generates new innovative compounds and broaden the Company’s product pipeline.
AsiDNA, the first compound from platON, is a highly differentiated, clinical-stage first-in-call candidate in the field of DNA damage response (DDR) applied to oncology. Its decoy and agonist mechanism acting upstream of multiple DDR pathways results in distinctive antitumor properties, including the ability to prevent or abrogate tumor resistance to targeted therapies such as PARP inhibitors and strong synergy with tumor DNA-damaging agents such as radio-chemotherapy. AsiDNA is currently in combination clinical trials in difficult-to-treat solid tumors.
OX401 is a new drug candidate from platON, designed to be a next-generation PARP inhibitor acting on both the DNA Damage Response and the activation of immune response, without inducing resistance. OX401 is currently being optimized and is 0undergoing preclinical proof-of-concept studies, alone and in combination with immunotherapies.
For further information, please visit www.onxeo.com.
Forward looking statements
This communication expressly or implicitly contains certain forward-looking statements concerning
APPENDICE
CONSOLIDATED FINANCIAL STATEMENTS AT
The 2021 Financial Report will be available on the Company's website as of
Consolidated balance sheet
ASSETS in €K |
|
|
Non-current assets |
|
|
Intangible fixed assets |
20,531 |
20,534 |
Tangible assets |
180 |
83 |
Rights of use |
2,057 |
2,479 |
Other financial fixed assets |
162 |
233 |
Total non-current assets |
22,930 |
23,329 |
|
|
|
Current assets |
|
|
Trade receivables and related accounts |
8,526 |
6,654 |
Other receivables |
3,721 |
2,000 |
Cash and cash equivalents |
17,887 |
14,523 |
Total current assets |
30,133 |
23,177 |
|
|
|
TOTAL ASSETS |
53,063 |
46,506 |
|
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY K€ |
|
|
Shareholders' equity |
|
|
Capital |
22,999 |
19,579 |
Less: |
-181 |
-182 |
Share premium |
24,583 |
18,577 |
Reserves |
-8,522 |
-10,027 |
Earnings |
-5,937 |
1,089 |
Total shareholders’ equity |
32,942 |
29,036 |
|
|
|
Non-current liabilities |
|
|
Provisions |
1,508 |
1,640 |
Deferred tax liability |
204 |
415 |
Non-current financial debts |
5,082 |
2,498 |
Non-current lease liabilities |
1,428 |
1,780 |
Other non-current liabilities |
4,835 |
5,089 |
Total non-current liabilities |
13,057 |
11,423 |
|
|
|
Current liabilities |
|
|
Short-term borrowings and financial liabilities |
2,953 |
1,502 |
Current lease liabilities |
471 |
477 |
Trade payables and related accounts |
2,832 |
2,762 |
Other current liabilities |
807 |
1,306 |
Total current liabilities |
7,063 |
6,047 |
|
|
|
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY |
53,063 |
46,506 |
Consolidated statement of comprehensive income
In K€ |
|
|
Note |
Recurring revenues from licensing agreements |
233 |
1,077 |
|
Non-recurring revenues from licensing agreements |
3,829 |
699 |
|
Total revenues |
4,062 |
1,776 |
13.1 |
Purchases |
-368 |
-347 |
|
Personnel expenses |
-3,984 |
-4,265 |
13.2 |
External expenses |
-4,131 |
-3,882 |
13.3 |
Taxes and duties |
-99 |
-176 |
|
Net depreciation, amortization and provisions |
-468 |
-618 |
|
Other current operating expenses |
-672 |
-515 |
|
Operating expenses |
-9,722 |
-9,803 |
|
Other current operating income and expenses |
78 |
213 |
|
Current operating income |
-5,582 |
-7,814 |
|
Other non-current operating income |
439 |
13,500 |
13.4 |
Other non-current operating expenses |
|
-3,492 |
13.4 |
Share of income from equity affiliates |
|
|
|
Operating result after share of income from equity affiliates |
-5,143 |
2,194 |
|
Net cost of financial debt |
-840 |
-958 |
|
Other financial income |
513 |
1,006 |
|
Other financial expenses |
-366 |
-395 |
|
Financial income |
-693 |
-347 |
14 |
Tax expenses |
-100 |
-757 |
15 |
- of which deferred taxes |
211 |
-415 |
|
Consolidated net income |
-5,937 |
1,089 |
|
Earnings per share |
-0.07 |
0.01 |
16 |
Diluted earnings per share |
-0.07 |
0.01 |
16 |
|
|
|
|
In K€ |
|
|
Note |
Result for the period |
-5,937 |
1,089 |
|
Currency translation adjustments |
218 |
-71 |
|
Other items recyclable as a result |
218 |
-71 |
|
Actuarial gains and losses |
49 |
-22 |
|
Other items non-recyclable as a result |
49 |
-22 |
|
Other comprehensive income for the period, net of tax |
267 |
-93 |
|
Total comprehensive income for the period |
-5,670 |
996 |
|
Total comprehensive income attributable to |
|
||
the parent company owners |
-5,670 |
996 |
|
Minority interests |
|
|
Consolidated statement of net cash flows
K€ |
|
|
Note |
Consolidated net loss |
-5,937 |
1,089 |
|
+/- Depreciation, amortization and provisions, net |
511 |
-8,215 |
|
(excluding provisions against working capital) |
|
|
|
+/- Unrealized gain and losses associated with changes in fair value |
-182 |
-290 |
|
+/- Non-cash income and expenses on stock options and similar items |
224 |
79 |
|
+/- Other calculated income and expenses |
|
|
|
+/- Capital gains and losses on disposal |
|
57 |
|
+/- Dilution gains and losses |
|
|
|
+/- Share of equity affiliates |
|
|
|
Gross operating cash flow after cost of net debt and taxes |
-5,384 |
-7,280 |
|
+ Cost of net debt |
848 |
959 |
14 |
+/- Tax expenses (including deferred taxes) |
100 |
757 |
15 |
Gross Operating cash flow before cost of net debt and taxes |
-4,436 |
-5,564 |
|
- Taxes paid |
|
|
|
+/- Changes in operating WCR (including debt related to employee benefits) |
-4,136 |
886 |
|
NET CASH FLOW FROM OPERATING ACTIVITIES |
-8,572 |
-4,678 |
|
- Expenditures on acquisition of tangible and intangible assets |
-139 |
-119 |
|
+ Proceeds of disposal of tangible and intangible assets |
|
6,116 |
|
- Expenditures on acquisition of financial assets |
|
|
|
+ Proceeds of disposal of financial assets |
73 |
4 |
|
+/- Effect on changes in scope of consolidation |
|
14 |
|
+ Dividends received (equity affiliates, unconsolidated investments) |
|
|
|
+/- Change in loans and advances granted |
|
|
|
+ Capital grants received |
|
|
|
+/- Other changes from investment transactions |
|
|
|
NET CASH FLOW FROM INVESTING ACTIVITIES |
-66 |
6,015 |
|
+ Net amount received from shareholders on capital increase |
|
|
|
. Paid by shareholders of the parent company |
9,351 |
10,568 |
9 |
. Paid by minority interest in consolidated companies |
|
|
|
+ Amount received on exercise of stock options |
|
|
|
-/+ Purchase and Sale of treasury shares |
1 |
8 |
|
+ Amounts received on issuances of new loans |
|
|
|
- Reimbursements of loans (including lease debts) |
2,620 |
-3,094 |
|
o/w repayment of lease debts (IFRS16) |
-487 |
-475 |
|
+/- Others flows related to financing activities |
4 |
-1 |
|
NET CASH FLOW FROM FINANCING ACTIVITIES |
11,976 |
7,481 |
|
+/- Effects of fluctuations in foreign exchange rates |
25 |
-3 |
|
CHANGE IN CASH AND CASH EQUIVALENTS |
3,363 |
8,815 |
|
CASH AND CASH EQUIVALENTS AT START OF YEAR |
14,523 |
5,708 |
|
CASH AND CASH EQUIVALENTS AT YEAR END |
17,886 |
14,523 |
|
1 It is specified that Financière de la
2 This price was set in accordance with the limits defined by the thirteenth resolution approved by the Company’s Mixed General Meeting of
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Investor Relations
investors@onxeo.com
+33 1 45 58 76 00
Media Relations
Arthur Rouillé
NewCap
onxeo@newcap.eu
+33 1 44 71 94 98
Investor Relations / Strategic Communication
Dušan Orešanský /
NewCap
onxeo@newcap.eu
+33 1 44 71 94 92
Certified Adviser for Nasdaq First North
Kapital Partner
www.kapitalpartner.dk
info@kapitalpartner.dk
+45 89 88 78 46
Source:
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