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OSE Immunotherapeutics Reports Full Year 2022 Financial Results and Provides Business Strategy Update

April 27, 2023 Off By BusinessWire

Financial highlights

  • 2022 total turnover of €18 million driven by strategic partnerships with pharmaceutical companies.
  • €25.6 million available cash as of December 31st 2022, including the drawdown of the second tranche of €10 million under a financing agreement with the European Investment Bank.
  • Reinforced financial visibility until Q2 2024 supported by a recent bridge financing (detailed below: “Additive financing secured in 2023”).

Clinical pipeline highlights

  • Tedopi® (T-cell specific immunotherapy – cancer vaccine): Positive data on survival, safety and quality of life from Phase 3 trial in 3rd line in non-small cell lung cancer presented at ASCO & ESMO 2022; Confirmatory pivotal Phase 3 trial in preparation in 2nd line following FDA and EMA positive advice; Ongoing compassionate use in 3rd line in 3 European countries.
  • OSE-127/S95011-lusvertikimab (IL-7R antagonist antibody): Phase 2 programs in Sjögren syndrome and ulcerative colitis with main results expected in 2023.
  • OSE-172/BI765063 (SIRPα antagonist antibody): Phase 1 clinical expansion trial initiated in advanced hepatocellular carcinoma and head and neck cancer.
  • FR104/VEL-101 (CD28 antagonist antibody): Clinical Phase 1 completed by Veloxis in the US and ongoing Phase 1/2 in kidney transplantation.
  • OSE-279 (PD1 antagonist antibody): First patient dosed in Phase 1/2 clinical trial in solid tumors and lymphomas.

NANTES, France–(BUSINESS WIRE)–Regulatory News:

OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) today reported its consolidated annual financial results for 2022 and provided an update on key clinical and preclinical achievements, on ongoing collaboration and licensing agreements, as well as on the 2023 Company’s outlook.

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments:

“We have achieved significant milestones in 2022, advancing our assets both in the clinical and preclinical stage, while strengthening our financial position despite a difficult economic environment. First, I would like to thank our team, our scientific, clinical, pharmaceutical experts and our pharma partners for their continuous commitment. I would also like to thank our institutional partners, the Region Pays de la Loire, our banks and Bpifrance for their contribution for securing a bridge financing to support our strategic leading immunotherapy programs.

We have recently seen renewed interest for cancer vaccines in the field of Immuno-Oncology and the Phase 3 results of Tedopi® post IO failure contributed significantly to this new momentum. Well protected by recent granted patents families and orphan status in the US for the HLA-A2 population, Tedopi® is the most advanced cancer vaccine candidate worldwide in the domain of acquired resistance to immune checkpoint. We are also dedicated to the development of the most-advanced anti-IL-7R product within the framework of a license option agreement with Servier. Our other international pharma partners Boehringer Ingelheim and Veloxis are actively engaged in the development of respectively OSE-172/BI 765063 in hepatocellular carcinoma and head and neck cancers and FR104/VEL-101 in kidney transplant.

Today, the Company has solid clinical and preclinical innovative assets and, like many European biotech companies, is striving to create more sustainable and higher value. My ambition for OSE is twofold: on the one hand, to generate near-term value by bringing our proprietary clinical assets until marketing registration with commercialization through regional established partners. This strategy is based on prioritizing investments when a selected niche indication is clearly identified based on a strong biological rationale and with acceleration opportunities in the development. On the other hand, to generate long-term recurrent revenue through collaborations and licensing agreements with global pharma partners for our programs targeting large indications and requiring larger investments.

We look forward reaching new key milestones in 2023 with significant potential inflection points, including clinical readouts and further updates on our preclinical programs. I am confident that we shall find the next strategic pharma partners and have all the relevant internal capabilities to support them in bringing our pre-IND assets to the next stage and demonstrating clinical proof of efficacy. OSE-230 (anti-ChemR23 agonist mAb) is one of our key preclinical assets with initiated IND-enabling studies to be ready for clinical Phase 1 in 2024 in the new attractive field of chronic inflammation resolution.

The progress we have made these last years has positioned OSE to deliver multiple major milestones in the next 12 months, including launching a registrational Phase 3 trial for the most advanced therapeutic vaccine candidate. I strongly believe that OSE has a very exciting future and is well positioned to meet all of its key stakeholders’ expectations. OSE is at the forefront to transform breakthrough scientific and technological discoveries into therapeutic innovations for the benefit of patients.”

Anne-Laure Autret-Cornet, Chief Financial Officer of OSE Immunotherapeutics, adds: “Recurrent turnover is driven by collaborations and licensing agreements with pharma companies. We have secured financial visibility for over the next 12 months, supported, in parallel, by a strict review of strategic expenses and their prioritization, to manage our cash level. This new flexible and scalable funding operating model, in addition to other available sources of financing, allows us to pursue our investments to increase the value and interest of our assets.”

CLINICAL PROGRESS IN IMMUNO-ONCOLOGY AND IMMUNO-INFLAMMATION

IN IMMUNO-ONCOLOGY

TEDOPI®, an immunotherapy activating tumor specific T-cells

Major regulatory progress on the clinical development plan; A further confirmatory Phase 3 trial 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); Authorizations for compassionate use in NSCLC in third line in France, Italy and Spain.

  • The US Food and Drug Administration (FDA) and the European Medicines Agencies (EMA) supported the continuation of the clinical development for Tedopi® through a new confirmatory phase 3 clinical trial versus standard of care in second line treatment for HLA-A2+ patients in advanced non-small cell lung cancer (NSCLC) with secondary resistance post-ICI (Immune Checkpoint Inhibitors) failure*. OSE Immunotherapeutics is progressing on the protocol development for this next confirmatory Phase 3 pivotal trial to support the regulatory registration in second line treatment. The protocol design is developed with the support of the international NSCLC clinician experts’ group which were already involved in the previous phase 3 ATALANTE trial.
  • The significant medical need for new therapeutic options in NSCLC patients post-ICI failure associated with promising efficacy, safety and quality of life data from the initial Phase 3 trial of Tedopi® (ATALANTE-1) resulted in authorizations for compassionate use** of Tedopi® delivered by Health Agencies in Europe – in September 2022 in France and in Italy and in March 2023 in Spain through a Special Situation Authorization*** – in third line post-chemotherapy and immunotherapy.

* Secondary resistance: after at least 12 weeks of ICI treatment in monotherapy (Task force SITC 2020 – Kluger H et al 2020).

** Compassionate use is a treatment option that allows for the use of an unauthorized medicine. Under strict conditions, products in development can be made available to nominative patients who have a disease with no satisfactory authorized therapies and who cannot enter clinical trials (https://www.ema.europa.eu/en/human-regulatory/research-development/compassionate-use).

*** 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.

Positive clinical results presented at the American Society of Clinical Oncology (ASCO) and at the European Society for Medical Oncology (ESMO) 2022 annual meetings.

  • Final data of Phase 3 Atalante-1 in NSCLC patients after failure to ICI were presented at ASCO 2022 with significantly better Patient Reported Outcomes (PROs) in the Tedopi® arm versus chemotherapy in the primary analysis for the population of interest (n=118 patients) and confirmed in the global population (n=219 patients).
  • The results presented at ESMO 2022 have shown that in advanced HLA-A2+ NSCLC patients with IO secondary resistance after sequential CT-IO (n=118), overall survival was longer with Tedopi® versus SoC regardless of the use (or not) of post progression anticancer treatment (with 13.5 months versus 10.6, HR=0.71; without 6.3 months versus 4.5, HR=0.76).
  • A second analysis presented at ESMO 2022 assessed the Net Treatment Benefit (NTB), a new statistical method combining efficacy, safety and quality of life, of Tedopi® versus SoC in patients with NSCLC who failed therapy with immune checkpoint inhibitors. NTB of Tedopi® in the overall population (n=219) was of 19% and reached statistical significance (p=0.035).
  • The first interim results from the Phase 2 clinical trial TEDOPaM evaluating Tedopi® in advanced or metastatic pancreatic ductal adenocarcinoma, in monotherapy or in combination with nivolumab or FOLFIRI after induction with FOLFIRINOX were presented at ASCO 2022. The primary endpoint of the trial is the one-year survival rate (Fleming- futility analysis; null hypothesis <25%), and the key secondary endpoint was the Time to maintenance Strategy Failure (TSF= maintenance time + FOLFIRI reintroduction). The GERCOR oncology clinician group and the PRODIGE Intergroup are sponsors of this study.

BI 765063/OSE-172, a myeloid checkpoint inhibitor developed in partnership with Boehringer Ingelheim

  • In May 2022, the initiation of the Phase 1 clinical expansion trial with BI 765063 sponsored and conducted by Boehringer Ingelheim triggered a €10 million milestone payment from Boehringer Ingelheim to OSE Immunotherapeutics. The trial is conducted in advanced hepatocellular carcinoma and head and neck cancer patients in combination, in particular with anti-PD-1 antibody ezabenlimab.

OSE-279, anti-PD1 monoclonal antibody: first patient dosed in the Phase 1/2 clinical trial in patients with advanced solid tumors or lymphomas

  • In December 2022, the first patient was dosed in this first-in-human open label Phase 1/2 dose escalation and expansion study. The trial aims to determine the Maximum Tolerated Dose and/or the recommended Phase 2 dose of OSE-279 in monotherapy in advanced solid tumors or lymphomas. Secondary objectives include assessment of OSE-279’s antitumor activity, evaluation of the safety profile, pharmacokinetic and receptor occupancy or pharmacodynamic profile.

IN IMMUNO-INFLAMMATION

OSE-127/S95011-lusvertikimab, a monoclonal antibody antagonist of the interleukin-7 receptor

The main results are expected for H1 2023 for the phase 2 in Sjögren syndrome (Servier sponsorship) and Q4 2023 for the phase 2 in ulcerative colitis (OSE Immunotherapeutics sponsorship). Servier has the right to exercise the second option provided in the license agreement based on the Phase 2 clinical studies.

VEL-101/FR104, a monoclonal antibody antagonist of CD28 developed in partnership with Veloxis Pharmaceuticals, Inc. in transplantation

  • In January 2022, Veloxis obtained acceptance of the IND from the Food & Drug Administration (FDA) for a clinical trial with VEL-101/FR104 sponsored and conducted by Veloxis in the US. Based on the global license agreement signed in April 2021, this first milestone triggered a €5 million payment from Veloxis to OSE Immunotherapeutics.
  • In February 2022, Veloxis obtained Fast Track Designation from the FDA for VEL-101/FR104 which is developed for prophylaxis of renal allograft rejection in recipients of kidney transplants.
  • In May 2022, the first patient was dosed in the Phase 1 conducted by Veloxis Pharmaceuticals, Inc. This study was completed in 2023.

PRECLINICAL PROGRESS IN IMMUNO-ONCOLOGY AND IMMUNO-INFLAMMATION

– MYELOID PLATFORM

OSE-230, first monoclonal antibody to activate a pro-resolutive GPCR target (ChemR23) in the resolution of inflammation

  • Presentation at the Protein & Antibody Engineering Summit (PEGS) 2022 annual meeting reporting on ChemR23’s over-expression is associated with chronic neutrophil accumulation in damaged tissues. OSE-230 is the first monoclonal antibody to activate a pro-resolutive GkPCR target (ChemR23). Its innovative mechanism of action drives inflammatory neutrophil tissue clearance through apoptosis and inhibition of the pathogenic NETosis**** process. This mAb triggered resolution demonstrated positive preclinical efficacy in chronic colitis or chronic arthritis models with significant decrease in tissue fibrosis and restoration of tissue healing.

CLEC-1***** (a C type lectin receptor), a novel myeloid immune checkpoint beyond the SIRPα/CD47 axis

– The identification and validation of CLEC-1 as novel immune checkpoint target and development of its antagonists as an innovation in cancer immunotherapy to enhance myeloid cell functions and promote tumor antigen presentation to bridge the innate and adaptative immune system.

– CLEC-1 has the ability to sense dead or stress tumor cells through the identification of a CLEC-1 protein ligand (CLEC-1 ligand) over-expressed in cancer cells. Mechanistically, CLEC-1’s expression by dendritic cells controls the cross-presentation of dead-cell tumor associated antigens and hence CD8+ T-cell cross-priming. Reversely, the absence of CLEC-1 increases the phagocytosis of tumor cells by macrophages in vivo. Proprietary anti-CLEC-1 mAbs increase survival in monotherapy in orthotopic model of hepatocellular carcinoma while combination with chemotherapy increases preclinical tumor eradication in colon carcinoma model.

– The article reported on fundamental discoveries and preclinical results showing that CLEC-1 is a novel myeloid checkpoint interacting with a new ligand TRIM-21 and highlighting the CLEC-1/TRIM21 axis as a new target for cancer immunotherapy.

**** NETosis is a program for formation of neutrophil extracellular traps (NETs), which consists of modified chromatin decorated with bactericidal proteins from granules and cytoplasm. Recent research has highlighted those neutrophils, and in particular NETs that can be released upon activation, have central roles in the initiation and perpetuation of systemic autoimmune disorders and trigger complex and chronic inflammatory responses that lead to organ damage and fibrosis.

*****Collaborative program between OSE Immunotherapeutics and Dr Elise Chiffoleau’s (https://cr2ti.univ-nantes.fr/research/team-1) research teams (Center for Research in Transplantation and Translational Immunology (CR2TI), UMR1064, INSERM, Nantes University at Nantes University Hospital).

– BiCKI® PLATFORM

BiCKI®IL-7v, a novel bispecific therapy combining anti-PD-1 and the cytokine IL-7

– The presentation highlighted the differentiation of the novel bispecific therapy combining anti-PD1 and IL-7 cytokine and positioned it as a high potential asset for cancer patients suffering from immune escape following checkpoint inhibitor treatments.

– High IL-7 receptor (IL-7R) pathway expression in TILs (Tumor-Infiltrating Lymphocytes) and tumor-specific T-cell clonotypes is predictive of long-term immune checkpoint inhibitor clinical responses. Reversely, decreased IL-7R pathway expression is associated with metabolic stress and apoptosis of tumor-specific T-cells. Redirecting IL-7 selectively on PD1 expressing T-cells provides stemness, proliferative and survival signals to tumor-specific T-cells inducing durable anti-tumor responses.

A STRONG GLOBAL INTELLECTUAL PROPERTY STRATEGY

37 new patents granted:

– Tedopi®

. Five new patents (Europe, United States, Japan, China – including Hong-Kong and Macao – and Mexico) related to a new emulsion manufacturing process validated for the ready-to-use peptides combination (process and product protected), until 2038.

. A Japanese patent for the use of Tedopi® after failure with PD-1 or PD-(L)1 immune checkpoint inhibitor treatment in HLA-A2 positive cancer patients, until 2037.

. A Eurasian patent covering the regimen of administration (inducing early T memory response) of Tedopi®, until 2035.

– OSE-127

. Seven patents (United States, Eurasia, New Zealand, Ukraine, Malaysia, Costa-Rica and Salvador) covering anti-CD127 antibodies (notably OSE-127), until 2035.

. Ten patents (Australia, Eurasia, Mexico, Malaysia, New-Zealand, Russia, Ukraine, Taiwan, Chili and Pakistan) covering humanized anti-CD127 antibodies, until 2037.

– OSE-172: Four patents (United States, Japan, Korea and ARIPO (Africa)) covering anti-SIRPα antibodies, until 2036-2037.

– OSE-279: Six patents (United States, Japan, Korea, China, Mexico and Colombia) for OSE-279 and its use in cancer treatment, until 2039.

– CLEC-1: Three patents (United States, Japan and Israel) covering CLEC-1, novel myeloid immune checkpoint target for cancer immunotherapy, until 2037.

CORPORATE GOVERNANCE – NEW CHIEF EXECUTIVE OFFICER (CEO), NEW BOARD OF DIRECTORS MEMBER AND NEW INTERNATIONAL SCIENTIFIC ADVISORY BOARD (SAB)

Appointment of Nicolas Poirier as CEO

Nicolas Poirier was appointed Chief Executive Officer of OSE Immunotherapeutics on October 7, 2022.

Throughout his career, Nicolas Poirier has demonstrated both his expertise as an international scientific leader, pioneering the discovery and development of innovative immunotherapies, and in-depth knowledge of the biotech sector through various strategic leadership roles. He has been instrumental in the development of OSE Immunotherapeutics, notably as the initiator of 5 programs in the Company’s portfolio that are now in clinic. He also played a major role in the signature of 4 strategic pharmaceutical partnerships for OSE Immunotherapeutics.

Appointment of Alexandre Lebeaut as an Independent Member of the Board of Directors

Alexandre Lebeaut was appointed independent Director of OSE Immunotherapeutics on February 18, 2022.

Alexandre Lebeaut has more than 25 years of a valuable experience and leadership both in innovation, research and development, from preclinical to post-marketing stage and with major achievements in particular in immunology, oncology, immuno-inflammation and infectious diseases. He has held various global positions, notably in the United States at Bluebird Bio, Sanofi, Novartis and Schering Plough Research Institute. Most recently, Alexandre Lebeaut served as Executive Vice-President R&D and Chief Scientific Officer at Ipsen in the US.

A newly formed SAB combining the expertise of renowned scientific and international key-opinion leaders in the fields of immunology, immuno-oncology, inflammation and immunotherapy

  • The SAB, appointed in June 2022, works with the Company’s leadership team and advises its Board of Directors on its scientific and medical strategy.
  • The SAB includes Pr. Wolf-Hervé Fridman (Université de Paris), Dr. Sophie Brouard (CRTI, Nantes), Dr. Bernard Malissen (CIML, Marseille), Pr. Miriam Merad (Mount Sinai, New-York), Pr. Charles Serhan (Harvard, Boston) and Dr. Jennifer Wargo (MD Anderson Cancer Center, Houston).

2022 FINANCIAL RESULTS

A meeting of the Board of Directors of OSE Immunotherapeutics was held on April 27, 2023. Following the Audit Committee opinion, the Board approved the annual and consolidated financial statements prepared under IFRS on 31 December 2022.

The key figures of the 2022 consolidated annual results are reported below (and presented in the attached tables):

In K€

December 31, 2022

December 31, 2021

Current operating result

(18,392)

(16,625)

Operating result

(18,476)

(16,625)

Net result

(17,760)

(16,850)

Available cash*

25,620

33,579

Consolidated balance sheet

91,781

101,876

As of December 31, 2022, the Company’s available cash totaled €25.6 million, versus €33.6 million as of December 31, 2021.

In 2022, OSE Immunotherapeutics received:

  • €10 million milestone payment as part of the global collaboration and license agreement with Boehringer Ingelheim for BI 765063, a SIRPα inhibitor on the SIRPα/ CD47 myeloid pathway.
  • €5 million milestone payment as part of the license agreement with Veloxis Pharmaceuticals Inc. for

    VEL-101/FR104, anti-CD28, in transplant indications.
  • €10 million payment corresponding to the second tranche of a €25 million loan agreement by the European Investment Bank.

ADDITIVE FINANCING SECURED IN 2023:

The global economic crisis and political uncertainty driven by the war in Russia-Ukraine have triggered a global major instability in the financial markets and high inflation that have strongly impacted the life sciences and biopharmaceutical industry since 2022. In this adverse context, OSE Immunotherapeutics has secured additional funding options to strengthen its financial visibility beyond 12 months.

Equity financing line

To supplement its financial resources and in order to extend its financial visibility until the second quarter of 2024, OSE Immunotherapeutics has signed on 27 April 2023, an equity financing line with Vester Finance1.

In accordance with the terms of the agreement, Vester Finance has undertaken to subscribe to a maximum of 2,800,000 shares of the Company, representing a maximum of 14.8% of the share capital, on its own initiative, over a maximum period of 24 months, subject to certain usual contractual conditions.

The shares will be issued on the basis of an average stock market price preceding each issue2, reduced by a maximum discount of 6%, in compliance with the price rule and the ceiling set by the general assembly meeting3.

OSE Immunotherapeutics is committed to a minimum use of the line of financing in the amount of 0.6 million euros, beyond which the Company retains the option of suspending or terminating this agreement at any time and without costs or penalties.

Contacts

OSE Immunotherapeutics
Sylvie Détry

[email protected]
+33 1 53 198 757

Investor Relations
Thomas Guillot

[email protected]
+33 6 07 380 431

French Media: FP2COM
Florence Portejoie

[email protected]
+33 6 07 768 283

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