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OSE Immunotherapeutics Announces H1 2023 Results and Provides Corporate Update

Financial highlights


Clinical pipeline highlights

NANTES, France–(BUSINESS WIRE)–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 SIRPα inhibitor on the SIRPα/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

  • The basic and diluted result per common share (€/share)

(0,64)

(0,11)

  • Diluted result per share

(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.

Contacts

OSE Immunotherapeutics
Sylvie Détry

sylvie.detry@ose-immuno.com

Nicolas Poirier

Chief Executive Officer

nicolas.poirier@ose-immuno.com

French Media: FP2COM
Florence Portejoie

fportejoie@fp2com.fr
+33 6 07 768 283

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