NANTES, France, March 28, 2019 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE) today reported its consolidated annual financial results as of December 31, 2018 and provided an update on key achievements as well as the company’s outlook for its agonist and antagonist immunotherapies for cancers and autoimmune diseases.
Alexis Peyroles, chief executive officer of OSE Immunotherapeutics said, "OSE Immunotherapeutics achieved a number of important milestones in 2018, including expanding the clinical investigation of our lead product Tedopi, which is now being studied in Phase 3 and Phase 2 trials. We have further validated our business model by signing a landmark partnership deal with Boehringer Ingelheim for BI 765063 (OSE-172). In addition, we regained full control of FR104, a Phase 2-ready therapeutic candidate with broad potential to treat autoimmune diseases and secured preclinical validation of mechanisms of action for OSE-127 and BI 765063, both now in clinical phase status. These achievements, with multiple first- or best-in-class assets in clinical testing in multiple indications, provide a solid foundation to further accelerate OSE’s growth as an emerging leader in the immuno-oncology and autoimmune spaces in 2019."
KEY ACHIEVEMENTS
FINANCIAL HIGHLIGHTS
Key 2018 Achievements
Tedopi®, combination of optimized neoepitopes that induce specific T lymphocyte activation in immuno-oncology, in advanced lung cancer and in pancreatic cancer
BI 765063 (OSE-172), SIRPa antagonist and checkpoint inhibitor targeting suppressive myeloid/macrophage cells, in various solid tumors
BiCKI® platform, a novel bispecific checkpoint inhibitor platform targeting PD-1 and innovative targets
OSE-127, humanized monoclonal antibody antagonist of the interleukin-7 receptor (IL-7R), in inflammatory bowel diseases
FR104, CD28-antagonist, in rheumatoid arthritis
GOVERNANCE
2018 ANNUAL RESULTS
Meeting of Board of Directors of OSE Immunotherapeutics was held on March 28, 2019. Following the opinion of the Audit Committee, the Board approved the annual and consolidated financial statements prepared under IFRS at 31 December 2018.
The key figures of the 2018 consolidated annual results are reported below (and presented in the attached tables):
In k€ | 12/31/2018 | 12/31/2017 |
Current operating result | 4 974 | -12 626 |
Operating result | 4 847 | -12 626 |
Net result | 5 490 | -10 503 |
Available cash* | 12 433 | 12 528 |
Consolidated balance sheet | 76 903 | 77 353 |
As of December 31, 2018, available cash* amounted to €12.4 M. In addition, 2018 research tax credits amounted to €4.8 M.
During the first semester of 2019, additional cash influx of €25 M will be generated by milestone payments related to partnerships (€15 M from Boehringer Ingelheim upon CTA for the Phase 1 trial with BI 765063 and upcoming first patient dosed and €10 M from Servier upon exercising of the first option under the two-step option within global license agreement).
This available cash will enable the Company to finance its clinical development costs and R&D costs on earlier stage products.
Operating expenses amounted to €19.5 M (€19.3 M in 2017), of which 77 % are related to R&D. R&D expenses were up €15.1 M, in line with the broadening and progress of OSE’s pipeline.
The consolidated balance sheet amounted to €76.9 M compared to €77.4 M as of December 31, 2017, which is quite stable.
* Cash and cash equivalents and Current financial assets
ABOUT OSE Immunotherapeutics
OSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has a diversified first-in-class clinical portfolio consisting of several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. The most advanced therapeutic-candidate, Tedopi®, is a proprietary combination of 10 neo-epitopes aimed at stimulating T-lymphocytes and is currently in Phase 3 development in non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure (anti PD-1 and anti PD-L1) and in Phase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo®. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. BI 765063 (OSE-172) (anti-SIRPa monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim ; this checkpoint inhibitor has received CTA from French and Belgian health authorities for a Phase 1 clinical trial in multiple cancer indications. BiCKI® is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) is partnered with Servier under an option agreement up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases; in parallel, Servier plans a development in the Sjögren syndrome. OSE-127 is currently under Phase 1 clinical trial.
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Contacts
OSE Immunotherapeutics | U.S. Media: LifeSci Public Relations |
Sylvie Détry | Darren Opland, Ph.D. |
Sylvie.detry@ose-immuno.com | darren@lifescipublicrelations.com |
+33 153 198 757 | +1 646 627 8387 |
French Media: FP2COM | U.S. and European Investors |
Florence Portejoie | Chris Maggos |
fportejoie@fp2com.fr | chris@lifesciadvisors.com |
+33 607 768 283 | +41 79 367 6254 |
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 Reference Document filed with the AMF on 26 April 2018, including the annual financial report for the fiscal year 2017, 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.
APPENDICES
CONSOLIDATED PROFIT & LOSS | ||||
P&L IN KEUROS | 12/31/2018 | 12/31/2017 | ||
Turnover | 24 456 | 6 682 | ||
Other operating income | 0 | 0 | ||
Total Revenues | 24 456 | 6 682 | ||
Research and development expenses | (15 057 | ) | (14 641 | ) |
Overhead expenses | (3 448 | ) | (3 161 | ) |
Expenses related to shares payments | (977 | ) | (1 505 | ) |
OPERATING PROFIT/LOSS - CURRENT | 4 974 | (12 626 | ) | |
Other operating products (badwill) | 0 | 0 | ||
Other operating expenses | (127 | ) | 0 | |
OPERATING PROFIT/LOSS | 4 847 | (12 626 | ) | |
Financial products | 86 | 70 | ||
Financial expenses | (227 | ) | (185 | ) |
PROFIT/LOSS BEFORE TAX | 4 707 | (12 741 | ) | |
Income Tax | 783 | 2 238 | ||
NET PROFIT/LOSS | 5 490 | (10 503 | ) | |
Of which consolidated net result attributable to shareholders | 5 490 | (10 503 | ) | |
Net earnings attributable to shareholders | ||||
Weighted average number of shares outstanding | 14 634 760 | 14 360 869 | ||
Basic earnings per share | 0,38 | (0,73 | ) | |
Diluted earnings per share | 0,35 |
IN K€ | 2018 | 2017 | ||
NET RESULT | 5 490 | (10 503 | ) | |
Amounts to be recycled in the income statement: | ||||
Unrealized gains on securities available for sale, net of tax | ||||
Currency conversion difference | (42 | ) | 92 | |
Amounts not to be recycled in the income statement: | ||||
Actuarial gains and losses on post-employment benefits | 12 | 0 | ||
Other comprehensive income in the period | (30 | ) | 93 | |
GLOBAL PROFIT/LOSS | 5 460 | (10 410 | ) |
CONSOLIDATED BALANCE SHEET
ASSETS IN KEUROS | 12/31/2018 | 12/31/2017 | |||
Intangible assets | 52 600 | 52 600 | |||
Tangible assets | 904 | 429 | |||
Financial assets | 103 | 77 | |||
Deferred tax assets | 272 | 261 | |||
TOTAL NON CURRENT ASSETS | 53 879 | 53 367 | |||
Trade receivables | 2 253 | 127 | |||
Other current assets | 3 834 | 5 715 | |||
Tax accounts receivables | 4 504 | 5 615 | |||
Current financial assets | 2 861 | 2 882 | |||
Cash and cash equivalents | 9 573 | 9 646 | |||
Total current assets | 23 024 | 23 986 | |||
TOTAL ASSETS | 76 903 | 77 353 | |||
EQUITY & LIABILITIES in K€ | 12/31/2018 | 12/31/2017 | |||
SHAREHOLDERS’ EQUITY | |||||
Stated capital | 2 963 | 2 898 | |||
Share premium | 21 708 | 21 743 | |||
Merger premium | 26 827 | 26 855 | |||
Treasury stock | (168 | ) | (191 | ) | |
Reserves and retained earnings | 4 934 | 14 644 | |||
Consolidated result | 5 490 | (10 503 | ) | ||
TOTAL SHAREHOLDERS’ EQUITY | 61 754 | 55 446 | |||
NON-CURRENT DEBTS | |||||
Non-current financial liabilities | 3 832 | 4 296 | |||
Non-current deferred tax liabilities | 2 010 | 2 866 | |||
Non-current provisions | 233 | 247 | |||
TOTAL NON-CURRENT DEBTS | 6 074 | 7 410 | |||
CURRENT DEBTS | |||||
Current financial liabilities | 628 | 589 | |||
Trade payables | 6 555 | 8 776 | |||
Corporate income tax liabilities | 86 | 1 | |||
Social and tax payables | 1 231 | 1 060 | |||
Other debts and accruals | 575 | 4 071 | |||
TOTAL CURRENT DEBTS | 9 075 | 14 497 | |||
TOTAL LIABILITIES | 76 903 | 77 353 |
CONSOLIDATED CASH FLOW STATEMENT
In kEuros | 2018 | 2017 | ||||
Consolidated result | 5 490 | (10 503 | ) | |||
+/- | Depreciation, amortization and provision expenses | 116 | 123 | |||
- | Badwill | 0 | 0 | |||
+ | Derecognition of asset | 0 | 0 | |||
+/- | Shares based payments (1) | 845 | 1 373 | |||
+/- | Other calculated income and expenses | 0 | 0 | |||
Cash flow before tax | 6 450 | (9 007 | ) | |||
+ | Financial charges | 0 | 0 | |||
- | Income tax expenses (included deferred tax) | (783 | ) | (2 238 | ) | |
CASH FLOW FROM OPERATING ACTIVITIES (A) | 5 668 | (11 245 | ) | |||
- | Paid taxes | |||||
+/- | Working capital variation (2) | (4 590 | ) | 3 249 | ||
CASH FLOW FROM INVESTING ACTIVITIES (D) | 1 077 | (7 996 | ) | |||
- | Tangible assets increase | (593 | ) | (353 | ) | |
+/ | Current financial assets variation | 22 | (2 | ) | ||
+/- | Non-current financial assets variation | 40 | (10 | ) | ||
+/- | Change in scope of consolidation | 0 | 0 | |||
+/- | Loans and advances variation | (27 | ) | 66 | ||
CASH FLOW FROM INVESTING ACTIVITIES (E) | (558 | ) | (299 | ) | ||
+ | Capital increase (including share premium) | 23 | 17 | |||
+/- | Own shares transactions | (67 | ) | (67 | ) | |
- | Capital increase and merger expenses | 0 | 0 | |||
+ | Warrant subscription (3) | 7 | 18 | |||
+ | Loans subscription | 0 | 3 564 | |||
- | Loans repayment | (485 | ) | (465 | ) | |
- | Financial charges | (71 | ) | (11 | ) | |
+/- | Other flows from financing activities | 0 | 0 | |||
CASH FLOW FROM FINANCING ACTIVITIES (F) | (592 | ) | 3 056 | |||
+/- | Currency translation transactions (G) | 0 | 0 | |||
CASH VARIATION H = (D + E + F + G) | (73 | ) | (5 239 | ) | ||
CASH OPENING BALANCE (I) | 9 646 | 14 885 | ||||
CASH CLOSING BALANCE (J) | 9 573 | 9 646 | ||||
DIFFERENCE : H (J-I) | 0 | 0 |
(1) Warrants and free shares awards granted in 2018 and valuated for 845 K€
(2) Mainly explained by :
(3) 12 000 warrants subscripted with an unit value of 0.60€
As of December 31, 2018 the available cash is as follows:
In kEuros | 12/31/2018 | 12/31/2017 |
Cash & equivalents according to IAS 7 | 9 573 | 9 646 |
Current financial assets | 2 861 | 2 882 |
Available Cash | 12 433 | 12 528 |