On September 27, 2023 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) reported 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 (Press release, OSE Immunotherapeutics, SEP 27, 2023, View Source [SID1234635487]).
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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.
In September, positive Phase 3 data from Tedopi in HLA-A2 lung cancer patients with resistance to previous immunotherapy were published in the peer-reviewed journal ’Annals of Oncology’.
In July, the United States Patent and Trademark Office granted a new patent protecting Tedopi for its use in cancer patients after failure with PD1/PD-L1 immune checkpoint inhibitor treatment and providing protection until year 2037 in the US.
In June, the Company received €1.5 million in funding from Bpifrance for the development of a companion diagnostic for Tedopi in NSCLC. This test will be used to identify HLA-A2 positive NSCLC patients eligible for treatment with Tedopi in the next pivotal Phase 3 clinical trial under preparation.
In June, OSE Immunotherapeutics presented a poster at the ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology) annual meeting showing new data on prognostic factors of overall survival from the ATALANTE-1 Phase 3 study in NSCLC highlighting the correlation between Tedopi’s mechanism of action and patients’ overall survival.
In May, patient enrollment was completed in TEDOPaM Phase 2 clinical trial (sponsored by the oncology group GERCOR) evaluating Tedopi in advanced pancreatic cancer. A total of 136 patients were recruited and the final results are expected in 2024.
In March, the Spanish Drug Agency has made a new early access program available allowing access to Tedopi through a Special Situation Authorization (1) in the treatment of advanced or metastatic NSCLC after ICI failure. This Special Situation Authorization was based on the positive clinical data from the initial Phase 3 trial of Tedopi (ATALANTE-1) in third line treatment and the high unmet need for these patients.
(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.
In July, the trial’s Independent Drug Safety Monitoring Board (DSMB) provided a positive recommendation on the continuation until its completion of the Phase 2 clinical trial on Lusvertikimab in ulcerative colitis. Last patient enrollment is expected for Q4 2023.
In July, positive opinion for Orphan Drug Designation was granted by the European Medicines Agency to Lusvertikimab in the treatment of Acute Lymphoblastic Leukemia based on preclinical results presented and awarded at last American Society of Hematology (ASH) (Free ASH Whitepaper) annual conference (December 2022) in New Orleans (US).
In May, OSE Immunotherapeutics earned the full worldwide rights on Lusvertikimab for all indications.
In March, positive Phase 1 results on Lusvertikimab for the treatment of chronic autoimmune diseases were published and selected as ‘Top Read’ in the peer-reviewed journal "Journal of Immunology".
OSE-279, proprietary PD1 antagonist
High affinity PD1 antibody, recent patent granted in US, Europe, China, Japan
In December 2022, first patient dosed in a Phase 1/2 clinical trial in patients with advanced solid tumors or lymphomas.
First clinical data will be presented at AACR (Free AACR Whitepaper)-NCI-EORTC (Boston, 11 – 15th October 2023).
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
Phase 1b clinical expansion trial initiated in May 2022 with BI 765063, sponsored and conducted by Boehringer Ingelheim in advanced hepatocellular carcinoma and head and neck cancer.
In April, a poster highlighting the predictive response biomarkers from Phase I clinical trial of BI765063, stand-alone and in combination with ezabenlimab, has been presented at the AACR (Free AACR Whitepaper) 2023 annual conference (Orlando).
FR104/VEL-101, a monoclonal antibody antagonist of CD28, developed in partnership with Veloxis Pharmaceuticals, Inc. in kidney transplantation
In July, patient enrollment was completed in the FIRsT Phase 1/2 clinical trial evaluating FR104/VEL-101 in renal transplantation, sponsored and conducted by the University Hospital of Nantes. A longer-term follow-up assessment will be performed one year after transplantation.
International Phase 2 clinical trial in kidney transplantation is under preparation by Veloxis.
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
In July, the second peer-reviewed results on OSE-230 were published in the leading journal "Frontiers in Immunology" after a publication in "Sciences Advances" (Trilleaud et al. 2021).
In June, a poster highlighting the innovative mechanism of action on neutrophils and inhibition of the pathogenic NETosis process was presented at the FOCIS 2023 annual conference (Boston).
CLEC-1, novel myeloid immune checkpoint target in immune-oncology
In April, two posters reporting the latest research updates on CLEC-1 were presented at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting.
In November 2022, publication in the peer-reviewed journal "Sciences Advances" of fundamental discoveries and preclinical results showing that CLEC-1 is a novel myeloid checkpoint interacting with a new ligand and highlighting the therapeutic potential of CLEC-1 antagonist antibodies as innovative cancer immunotherapy.
BiCKIIL-7v, a novel bispecific therapy combining anti-PD-1 and the cytokine IL-7
In June, an invited oral communication and a poster reporting the differentiated advantages of the IL-7 cytokine to sustain long-term survival and functions of tumor-reactive T lymphocytes were presented at the annual cytokine-based drug development summit (Boston) and at the Antibody Engineering and Therapeutics 2023 Europe conference (Amsterdam).
Novel RNA Therapeutics & Artificial Intelligence innovative research programs
OSE Immunotherapeutics is building a first-in-kind research platform at the intersection of Antibody Engineering, Data Science and Artificial Intelligence (AI) development programs dedicated to monoclonal antibodies (AI programs initiated in 2020 and reinforced in 2021 with the MabSilico collaboration). This cutting-edge platform adds novel RNA Therapeutics and RNA Delivery methods recently patented by our research team to continue to develop next-generation immunotherapy medicines modulating immune cell responses in the field of immuno-inflammation and immuno-oncology.
In August, OSE Immunotherapeutics received a grant from the French Government and Region Pays de la Loire to support the Company’s research programs in the field of RNA Therapeutics.
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:
(1) An equity financing line with Vester Finance, set up on April 27, 2023. This financing has triggered at the end of September a capital increase of €11.6 million (without any discount on the share price at the date of signature). To supplement its financial resources and in order to extend its financial visibility until the fourth quarter of 2024, OSE Immunotherapeutics signed on 27 September 2023, an extension to this equity financing line agreement with Vester Finance, at the same conditions1.
This extension, approved by the Board of Directors of September 27, 2023, acting on delegation from the general assembly meeting of shareholders of June 22, 20232, relates to a maximum of 900,000 shares of the Company, representing a maximum of 4,16% of the share capital, that Vester committed to subscribe on its own initiative, over a maximum period of 24 months, subject to certain usual contractual conditions.
Assuming that the totality of this additional line of financing is used in full, a shareholder holding 1.00% of the capital of OSE Immunotherapeutics before its establishment, would see his stake increase to 0.96% of the capital on an undiluted basis3 and 0.96% of the share capital on a diluted basis4.
This transaction does not give rise to the preparation of a prospectus subject to the approval of the "Autorité des Marchés Financiers," based on Article 1 of the Prospectus Regulation granting an exemption when a transaction relates to a dilution less than 20% of the Company’s share capital.
The number of shares issued under this agreement and admitted to trading will be communicated monthly on the Company’s website.
Loans and "PGE Resilience"
The Company obtained the formal agreement on loans for a total amount of €5.3 million with the collective support of "La Région Pays de la Loire," Bpifrance and its banking pool composed by banks CIC, Crédit Mutuel and BNP to finance its strategic R&D programs. Favorable conditions were granted for these loans, with an interest range of 2-4% and reimbursement timelines within 3 to 5 years. Part of these loans is composed by a "PGE Resilience" ("Prêt Garanti par l’État") loan guaranteed by the French State, implemented in the context of the Ukrainian crisis.
At the end of June 2023, €3.1 million have been drawdown. The balance has been received in Q3 2023.
€1.5 million in funding from Bpifrance for the development of a companion diagnostic for the cancer vaccine Tedopi in non-small cell lung cancer.
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: View Source The limited review procedures on the consolidated accounts have been performed. The report on this limited review is being issued.