Regulatory News:
OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) today announces its consolidated half-year financial results and provides updates on key milestones achieved during H1 2023 as well as the Company's outlook for its immunotherapies in immuno-oncology and immuno-inflammation.
Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics comments: "OSE's key priorities for 2023 and beyond will lie in the successful conduct of the new Tedopi® pivotal Phase 3 program, along with the maximization of the near-term value of Lusvertikimab while strengthening our partnership business-model assuring recurrent revenues from our first-in-class programs. The full funding of these strategic programs will be secured in due course through additional financial resources to deliver on our goals for the benefit of both the patients and our stakeholders. OSE has today a solid late-stage clinical and preclinical diversified portfolio in immuno-oncology (IO) and immuno-inflammation (I&I). The increased interest of the scientific and medical community in cancer vaccine, in particular Tedopi®, encourages us to stay strategically focused and committed to make our drug candidate available to all eligible cancer patients in secondary resistance. We also look forward to the Lusvertikimab Phase 2 data readouts in ulcerative colitis in the next months and to generate additive value in both I&I and IO with our pre-IND OSE-230 and BiCKI®-IL7 programs. In parallel, at research level, we will continue to strengthen our first-in-kind platform built at the intersection of Antibody Engineering, Data Science, Artificial Intelligence (AI) and novel RNA Therapeutics technologies which is generating exciting clinical opportunities for future next-generation immunotherapies."
Anne-Laure Autret-Cornet, Chief Financial Officer of OSE Immunotherapeutics, adds: "We have strengthened our cash position and secured new financing in H1-2023 to extend our financial visibility for over the next 12 months. In parallel, we significantly reduced our cash burn compared to last year after a strict review of strategic expenses and prioritization for out-licensing. This financial strategy allows us to pursue strategic investments on Tedopi® and Lusvertikimab while pursuing innovative research programs to increase their value and interests. Our force is based on our recurrent ?20 million average annual turnover these last 5 years, driven mainly by collaborations and licensing agreements with pharma companies. This business model based mostly on non-dilutive revenues remains our priority and will be further reinforced."
CLINICAL PROGRESS IN IMMUNO-ONCOLOGY AND IMMUNO-INFLAMMATION
PROPRIETARY ASSETS
Tedopi®, T-cell epitope-based therapeutic cancer vaccine
Most advanced therapeutic cancer vaccine in clinical development. Confirmatory Phase 3 study with a companion diagnostic strategy under preparation to support the registration of Tedopi® as a potential new standard of care in second line for non-small cell lung cancer (NSCLC) patients in secondary resistance to immune checkpoint inhibitors (ICI) based on positive regulatory advice from FDA and EMA; Authorizations for compassionate use in NSCLC in third line in France, Italy and Spain.
(1) |
The Special Situation Authorization (Real Decreto 1015/2009) is intended to provide early access to medicines for patients with a severe or rare disease with high unmet need and for which no authorized therapeutic alternatives are available. |
Lusvertikimab (OSE-127), IL-7 Receptor (IL-7R) antagonist
Most advanced Interleukin-7 antagonist immunotherapy in clinical development with a strong biological rationale in refractory IBD patients.
OSE-279, proprietary PD1 antagonist
High affinity PD1 antibody, recent patent granted in US, Europe, China, Japan
PARTNERED ASSETS
BI 765063, first-in-class SIRP? inhibitor on the SIRP?/CD47 myeloid pathway in advanced solid tumors, developed in partnership with Boehringer Ingelheim
FR104/VEL-101, a monoclonal antibody antagonist of CD28, developed in partnership with Veloxis Pharmaceuticals, Inc. in kidney transplantation
RESEARCH PROGRAMS
OSE-230, novel monoclonal antibody to activate a pro-resolutive GPCR target (ChemR23), a novel and innovative approach in the management of the resolution of neutrophil-mediated chronic and severe inflammation
CLEC-1, novel myeloid immune checkpoint target in immune-oncology
BiCKI®IL-7v, a novel bispecific therapy combining anti-PD-1 and the cytokine IL-7
Novel RNA Therapeutics & Artificial Intelligence innovative research programs
CORPORATE GOVERNANCE
Eric Leire was appointed independent Director of OSE Immunotherapeutics on June 22, 2023.
Eric Leire is a Medical Doctor and American and French citizen. He brings a professional international experience, both in the US and in Europe, in listed biotechnology and pharmaceutical companies. He is currently President and Chief Executive Officer of Genflow Biosciences Ltd. Through his active experience in venture capital funds in the health field (Medwell Capital, Canada and Biofund Venture, Denmark), he has contributed to develop biotech companies.
Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, was appointed as Director and Anne-Laure Autret-Cornet, Chief Financial Officer, as Director representing the employee shareholders.
H1 2023 RESULTS
The key figures of the 2023 consolidated half-year results are reported below:
In k? |
June 30, 2023 |
June 30, 2022 |
Operating result |
(13,504) |
(3,425) |
Net result |
(11,860) |
(1,979) |
In k? |
June 30, 2023 |
December 31, 2022 |
Available cash |
15,018 |
25,620 |
Consolidated balance sheet |
80,391 |
91,781 |
As of June 30, 2023, available cash amounted to ?15 million, giving a financial visibility until Q4 2024.
During the first half of 2023, OSE Immunotherapeutics secured:
This available cash will enable the Company to finance its clinical development and R&D costs for earlier stage products.
During the first half of 2023, the Company recorded a consolidated net result of ?-11,9 million.
Current operating expenses were ?14.9 million (versus ?19.4 million for the same period in 2022) of which 77% are related to R&D. After a strategic review of costs and programs, operating expenses dropped dawn by 25% compared to H1 2022.
The Board of Directors of September 27, 2023, has approved the Company's semester accounts as of June 30, 2023. The full "Half-year financial report" (Regulated information) is available on: https://www.ose-immuno.com/en/financial-documents/. The limited review procedures on the consolidated accounts have been performed. The report on this limited review is being issued.
CONSOLIDATED PROFIT & LOSS
In K? |
H1 2023 |
H1 2022 |
Turnover |
1,358 |
16,047 |
OPERATING INCOME - RECURRING |
1,358 |
16,047 |
Research & Development expenses |
(9,693) |
(14,395) |
Overhead expenses |
(3,604) |
(3,813) |
Expenses related to share-based payments |
(1,562) |
(1,182) |
OPERATING PROFIT/LOSS - RECURRING |
(13,501) |
(3,341) |
Other operating income and expenses |
(4) |
(84) |
OPERATING RESULT |
(13,504) |
(3,425) |
Financial income |
2,658 |
2,023 |
Financial expenses |
(1,608) |
(708) |
PROFIT/LOSS BEFORE TAX |
(11,943) |
(2,110) |
INCOME TAX |
84 |
132 |
CONSOLIDATED NET RESULT |
(11,860) |
(1,979) |
Of which consolidated net result attributable to shareholders |
(11,860) |
(1,979) |
Net earnings attributable to shareholders |
|
|
Weighted average number of shares outstanding |
18,624,665 |
18,527,401 |
|
(0,64) |
(0,11) |
|
(0,64) |
(0,11) |
In K? |
H1 2023 |
H1 2022 |
NET RESULT |
(11,860) |
(1,979) |
Amounts to be recycled in the income statement: |
|
|
Unrealized gains on securities available for sale, net of tax |
|
|
Currency conversion difference |
(7) |
46 |
Amounts not to be recycled in the income statement: |
|
|
Actuarial gains and losses on post-employment benefits |
0 |
34 |
Other comprehensive income in the period |
(7) |
(13) |
GLOBAL PROFIT/LOSS |
(11,867) |
(1,992) |
CONSOLIDATED BALANCE SHEET
ASSETS in K? |
June 30, 2023 |
December 31, 2022 |
NON-CURRENT ASSETS |
|
|
Acquired R&D costs |
47,604 |
48,784 |
Tangible assets |
589 |
743 |
Rights of use |
3,712 |
4,236 |
Financial assets |
587 |
635 |
Deferred tax assets |
184 |
182 |
TOTAL NON-CURRENT ASSETS |
52,676 |
54,581 |
CURRENT ASSETS |
|
|
Trade receivables |
234 |
403 |
Other current assets |
12,463 |
11,177 |
Cash and cash equivalents |
15,018 |
25,620 |
TOTAL CURRENT ASSETS |
27,714 |
37,200 |
TOTAL ASSETS |
80,391 |
91,781 |
|
|
|
EQUITY & LIABILITIES in K? |
June 30, 2023 |
December 31, 2022 |
SHAREHOLDERS' EQUITY |
|
|
Stated capital |
3,806 |
3,705 |
Share premium |
39,169 |
38,784 |
Merger premium |
26,827 |
26,827 |
Treasury stock |
(483) |
(549) |
Reserves and retained earnings |
(34,932) |
(18,349) |
Consolidated result |
(11,860) |
(17,760) |
TOTAL SHAREHOLDERS' EQUITY |
22,529 |
32,658 |
NON-CURRENT DEBTS |
|
|
Non-current financial liabilities
Lease non current liabilities |
34,310 |
37,231 |
Non-current lease liabilities |
3,157 |
3,586 |
Non-current deferred tax liabilities |
1,430 |
1,514 |
Non-current provisions |
423 |
524 |
TOTAL NON-CURRENT DEBTS |
39,320 |
42,856 |
CURRENT DEBTS |
|
|
Current financial liabilities |
5,433 |
3,093 |
Current lease liabilities |
858 |
883 |
Trade payables |
9,421 |
8,539 |
Corporate income tax liabilities |
18 |
21 |
Social and tax payables |
2,662 |
2,916 |
Other debts and accruals |
151 |
816 |
TOTAL CURRENT DEBTS |
18,542 |
16,268 |
TOTAL LIABILITIES |
80,391 |
91,781 |
ABOUT OSE Immunotherapeutics
OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology and immuno-inflammation.
The Company's current well-balanced first-in-class clinical pipeline includes:
OSE Immunotherapeutics expects to generate further significant value from its two proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapeutics:
Additional information about OSE Immunotherapeutics assets is available on the Company's website: www.ose-immuno.com
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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 May 2, 2023, including the annual financial report for the fiscal year 2022, 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.
__________________________________
1 These conditions are described in the Company's press release dated April 27, 2023. The shares will therefore be issued on the basis of the lowest average daily price weighted by volumes over the period of the two trading sessions preceding each issue, reduced a maximum discount of 6%, in compliance with the price rule and the ceiling set by the general meeting. Under the terms of the delegation granted by the general meeting, the issue price of the shares must be "at least equal to the weighted average of the prices of the last three trading sessions preceding the fixing of the issue price, possibly reduced by a maximum discount of 20%".
2 21st resolution: delegation of capital increase with elimination of shareholders' preferential subscription rights for the benefit of categories of people meeting specific characteristics. Vester Finance falls well into the targeted category as a regular investor in so-called "small cap" growth companies, particularly in the health or biotechnology sector.
3 Based on the 21,641,101 shares issuable upon exercise of the dilutive instruments issued by the Company to date.
4 Based on the 1,830,000 shares that may be issued upon exercise of the dilutive instruments issued by the Company to date.
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