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NANTES, France, March 26, 2020 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE) today reported its consolidated annual financial results for 2019 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: “The current COVID-19 situation is a major public health concern and also an important factor impacting our ongoing and upcoming clinical trials. Health agencies and expert groups have said in the past few days that the continuation of clinical trials in hospitals would be very disrupted due to the mobilization of medical teams, containment and the potential risks associated with the epidemic of COVID-19 for fragile patients. Our short-term priority is to do our part to ensure healthcare systems have the resources to fight COVID-19 and to reduce the demands on healthcare professionals, while safeguarding patients currently taking part in our clinical trials.
“OSE Immunotherapeutics made significant clinical progress with our lead assets in immuno-oncology and auto-immune diseases in 2019 and early 2020.
“In 2019, our drug candidates being developed with partners Boehringer Ingelheim and Servier generated €25 million in milestone payments and both achieved key clinical milestones: initiation of the ongoing Phase 1 trial of myeloid checkpoint inhibitor BI 765063 in advanced solid tumors and completion of Phase 1 trial of anti-IL-7 receptor antagonist OSE-127 with positive results. Based on these results, two Phase 2 studies with OSE-127 are planned to start in 2020. Furthermore, a recent amendment to our license option agreement with Servier on OSE-127 confirms our partner’s commitment and strong belief in the potential of the product.
“In 2020, we plan to continue the company’s value creation by advancing our clinical and preclinical programs while adapting our organization to the COVID-19 crisis. In line with our business model, we will continue to secure financial resources to invest in R&D to discover and develop novel therapeutics for patients. In particular, the milestone payment associated with the recently-amended agreement with Servier on OSE-127 will reinforce our cash position and flexibility to progress on our development strategy. With these considerations in mind, we have provided expectations for the impact that COVID-19 could have on our clinical programs, given the current assessment of the situation. We continue to monitor the situation and will provide updates on any changes in timelines as they arise."
2019 KEY ACHIEVEMENTS
Major clinical progress with four differentiated therapeutic programs in immuno-oncology and autoimmune diseases
Tedopi®, a combination of 10 neoepitopes intended to induce specific T-lymphocyte activation, is OSE Immunotherapeutics’ most advanced drug candidate and is currently in a Phase 3 pivotal clinical trial, called Atalante 1, to treat non-small cell lung cancer (NSCLC) following failure of immune checkpoint inhibitor treatment (PD-1/PD-L1). Due to the COVID-19 outbreak situation and associated considerations of the safety of trial participants, compliance with good clinical practice (GCP), and risks to trial integrity during the COVID-19 pandemic following the specific guidelines of regulatory agencies, OSE Immunotherapeutics is reviewing the potential impact of this outbreak on the Atalante 1 trial. The Company will provide an update on the status of this review and on the results of the trial’s pre-defined step 1 as soon as possible in the coming next weeks.
Tedopi® also is in Phase 2 development in combination with Opdivo® (nivolumab) in patients with pancreatic cancer, called TEDOPaM, a trial sponsored by the GERCOR cooperative group in oncology and supported by Bristol Myers Squibb. Patients screening and accrual in the TEDOPaM study are expected to be impacted by the COVID-19 situation in the coming months.
The Company will maintain an open dialogue with updates to these and other trials as more clarity arises on the overall impact this public health crisis has on expected timelines.
BI 765063 (formerly OSE-172), a myeloid checkpoint inhibitor and SIRPα antagonist, being developed in partnership with Boehringer Ingelheim, is in Phase 1 trial in advanced solid tumors.
OSE-127 is a monoclonal antibody antagonist of the interleukin-7 receptor (IL-7R) being developed in partnership with Servier.
FR104, a monoclonal antibody antagonist of CD28, is a Phase-2 ready asset with potential to be developed in either autoimmune disease or in transplantation.
A dynamic partnership business model based on innovative products to generate revenues to broaden R&D programs
Research & Development
Focused on novel target discovery to generate innovative agonists or antagonists of the immune response, the Company is pursuing advancement of new innovative research programs.
A meeting of the Board of Directors of OSE Immunotherapeutics was held on March 26, 2020 according to the ordinance n° 2020-321. Following the opinion of the Audit Committee, the Board approved the annual and consolidated financial statements prepared under IFRS at 31 December 2019.
The key figures of the 2019 consolidated annual results are reported below (and presented in the attached tables):
|In k€||December 31, 2019||December 31, 2018|
|Current operating result||(1 469)||4 974|
|Operating result||(1 472)||4 847|
|Net result||(4 652)||5 490|
|Available cash*||25 842||12 433|
|Consolidated balance sheet||88 933||76 903|
As of December 31, 2019, the Company’s available cash* amounted to €25.8 million, giving financial visibility until Q1 2021, taking into account €3 million from research tax credit and an additional planned milestone payment of €5 million from Servier, following amendment to the global license option agreement on OSE-127, and expected at the start of a Phase 2 in Sjögren's syndrome.
During 2019, additional cash influx of €25 million has been generated by milestone payments related to partnerships (€15 million from Boehringer Ingelheim upon CTA for the Phase 1 trial with BI 765063 and upcoming first patient dosed and €10 million from Servier upon exercising of the first option under the two-step option within global license agreement). Moreover, the Company received a €5.4 million payment from Bpifrance triggered by the successful completion of development milestones related to its collaborative program EFFI-CLIN, program focused on evaluating BI 765063.
This available cash will enable the Company to finance its clinical development costs and R&D costs on earlier stage products until Q1 2021 at least. If there are significant delays or clinical trial holds as a result of COVID-19, our cash runway will be extended beyond the current Q1 2021 projection, given that the bulk of our expenses are mainly related to clinical development expenditures.
The turnover amounted to €26 million due to the milestone payments from the collaboration agreement with Boehringer Ingelheim and Servier. During 2019, the Company recorded a consolidated operating loss of (€1.5) million.
Current operating expenses were €27.4 million (€19.5 million in 2018) of which 81% related to R&D. Among R&D expenses of €21.6 million, 85% are dedicated to the Company’s ongoing clinical projects, in line with the broadening and progress of its pipeline.
*Available 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) in patients in failure after checkpoint inhibitor treatment (anti PD-1 and anti PD-L1) and in Phase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo®. BI 765063 (OSE-172) (anti-SIRPα monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim; this checkpoint inhibitor is currently under Phase 1 clinical trial in advanced solid tumors. BiCKI® is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) is partnered with Servier under a two-step licensing option agreement. The Phase 1 clinical phase of OSE-127 is completed and has shown positive results; two independent Phase 2 studies planned in ulcerative colitis (OSE sponsor) and Sjögren’s syndrome (Servier sponsor) to start in 2020, subject to the evolution of the COVID-19 situation.
For more information: https://ose-immuno.com/en/
+33 153 198 757
|U.S. Media: LifeSci Communications|
Darren Opland, Ph.D.
+1 646 627 8387
|French Media: FP2COM|
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|U.S. and European Investors|
Guillaume van Renterghem
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 2019, including the annual financial report for the fiscal year 2018, 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.
|CONSOLIDATED PROFIT & LOSS|
|P&L IN K€||December 31, 2019||December 31, 2018|
|Turnover||25 952||24 456|
|Other operating income||0||0|
|Total Revenues||25 952||24 456|
|Research and development expenses||(21 655||)||(15 057||)|
|Overhead expenses||(3 898||)||(3 448||)|
|Expenses related to shares payments||(1 868||)||(977||)|
|OPERATING PROFIT/LOSS - CURRENT||(1 469||)||4 974|
|Other operating products (badwill)||0||0|
|Other operating expenses||(2||)||(127||)|
|OPERATING PROFIT/LOSS||(1 472||)||4 847|
|PROFIT/LOSS BEFORE TAX||(1 464||)||4 707|
|Income Tax||(3 188||)||783|
|NET PROFIT/LOSS||(4 652||)||5 490|
|Of which consolidated net result attributable to shareholders||(4 652||)||5 490|
|Net earnings attributable to shareholders|
|Weighted average number of shares outstanding||14 892 496||14 634 760|
|Basic earnings per share||(0,31||)||0,38|
|Diluted earnings per share||(0,31||)||0,35|
|NET RESULT||(4 652||)||5 490|
|Amounts to be recycled in the income statement:|
|Unrealized gains on securities available for sale, net of tax|
|Currency conversion difference||(43||)||(42||)|
|Amounts not to be recycled in the income statement:||(37||)||12|
|Actuarial gains and losses on post-employment benefits|
|Other comprehensive income in the period||(80||)||(30||)|
|GLOBAL PROFIT/LOSS||(4 732||)||5 460|
|CONSOLIDATED BALANCE SHEET|
|ASSETS IN K€||December 31, 2019||December 31, 2018|
|Intangible assets||52 600||52 600|
|Tangible assets||1 009||904|
|Right-of-use assets||1 692||0|
|Differed tax assets||283||272|
|TOTAL NON CURRENT ASSETS||55 871||53 879|
|Trade receivables||747||2 253|
|Other current assets||6 474||3 834|
|Tax accounts receivables||0||4 504|
|Current financial assets||0||2 861|
|Cash and cash equivalents||25 842||9 573|
|TOTAL CURRENT ASSETS||33 062||23 024|
|TOTAL ASSETS||88 933||76 903|
|EQUITY & LIABILITIES in K€||December 31, 2019||December 31, 2018|
|Stated capital||3 001||2 963|
|Share premium||21 670||21 708|
|Merger premium||26 827||26 827|
|Reserves and retained earnings||11 838||4 934|
|Consolidated result||(4 652||)||5 490|
|TOTAL SHAREHOLDERS’ EQUITY||58 536||61 754|
|Non-current financial liabilities||9 211||3 832|
|Non-current lease liabilities||1 413||0|
|Non-current deferred tax liabilities||5 066||2 010|
|TOTAL NON-CURRENT DEBTS||16 067||6 074|
|Current financial liabilities||548||628|
|Current lease liabilities||309||0|
|Trade payables||6 918||6 555|
|Corporate income tax liabilities||20||86|
|Social and tax payables||1 723||1 231|
|Other debts and accruals||4 812||575|
|TOTAL CURRENT DEBTS||14 330||9 075|
|TOTAL LIABILITIES||88 933||76 903|
|CONSOLIDATED CASH FLOW STATEMENT|
|In K€||December 31, 2019||December 31, 2018|
|CONSOLIDATED RESULT||(4 652||)||5 490|
|+/-||Depreciation, amortization and provision expenses||323||116|
|+||Amortization on "right-of-use"||251||0|
|+/-||Shares based payments (1)||1 511||845|
|CASH FLOW BEFORE TAX||(2 568||)||6 450|
|-||Income tax expenses||3 188||0|
|+/-||Working capital variation (2)||8 555||(4 590||)|
|CASH FLOW FROM OPERATING ACTIVITIES (A)||9 135||1 077|
|-||Tangible assets increase||(336||)||(593||)|
|+/-||Financial assets variation||2 861||40|
|+/-||Mutual finds units accounted in current financial assets||34||22|
|+/-||Loans and advances variation||(184||)||(27||)|
|CASH FLOW FROM INVESTING ACTIVITIES (B)||2 375||(558||)|
|+||Capital increase (including share premium)||0||23|
|+/-||Own shares transactions||0||(67||)|
|+||Loans subscription||5 628||0|
|-||Lease debt repayment (3)||(251||)||0|
|CASH FLOW FROM FINANCING ACTIVITIES (C)||4 759||(592||)|
|+/-||Currency translation transactions (D)||0||0|
|CASH VARIATION E = (A + B + C + D)||16 269||(73||)|
|CASH OPENING BALANCE (F)||9 573||9 646|
|CASH CLOSING BALANCE (G)||25 842||9 573|
|DIFFERENCE: E (G-F)||0||0|
(1) Warrants and free shares awards granted in 2019 and valuated for 1 511 K€
(2) Mainly explained by:
- Decrease of trade receivable for 1 506 K€
- Decrease of other current assets for 1 864 K€
- Increase of trade accounts payable for 363 K€
- Increase of social and tax payable for 493 K€
- Increase of other debts for 4 237 K€
(3) Explained by IFRS16 application, which corresponds to reimbursement of lease debt for 251 K€
|As of December 31, 2019, the available cash is as follows:|
|In K€||December 31, 2019||December 31, 2018|
|Cash & equivalents according to IAS 7||25 842||9 573|
|Current financial assets||0||2 861|
|AVAILABLE CASH||25 842||12 433|
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