OSE Immunotherapeutics Announces Historic H1 2024 Results and Provides Corporate Update
OSE Immunotherapeutics Announces Historic H1 2024 Results and
Provides Corporate Update
Financial and business highlights
- Total H1 2024 incomes of €82.5 million thanks to Company's new partnerships.
- New strategic partnership with AbbVie for up to $713 million, including $48 million received upon signature.
- Major partnership expansion with Boehringer Ingelheim:
- Amendment of the collaboration and licensing agreement on first-in-class SIRPα compounds developed both in immuno-oncology and now expected in Phase 2 in cardiovascular-renal-metabolic diseases: a one-time payment of €25.3 million.
- New asset acquisition of a preclinical program from the OSE's cis- targeting anti-PD1/cytokine platform: €13.5 million received upon signature and €17.5 potential near-term milestone.
- €8.4 million in non-dilutive funding under the "i-Démo” call for projects as part of the "France 2030” program to support the registration Phase 3 clinical trial of cancer vaccine Tedopi®.
- Level of cash of €80.7 million as of June 30, 2024: €25.9 million available cash1 + €54.9 million financial assets2, providing solid financial position and visibility to support implementation of the strategy until 2027. This cash position also includes the research tax credit of €5.8 million received in June 2024.
- Positive efficacy and safety results from the Phase 1/2 clinical trial evaluating PD1- antagonist antibody OSE-279 monotherapy in solid tumors.
- Positive results from the FIRsT Phase 1/2 study from first use of FR104/VEL-101 immunotherapy in renal transplantation.
- First positive efficacy results from the CoTikiS Phase 2 study evaluating IL-7R antagonist Lusvertikimab in ulcerative colitis.
- Global launch of Artemia Phase 3 registration study for cancer vaccine Tedopi® in second-line non-small cell lung cancer.
Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: "The major milestones achieved during H1 2024 are paving the way for a transformative year for OSE. During this period, thanks to the OSE teams, the Company made significant outstanding progress.
The half-year has seen continued execution of our partnership-focused business model through three strategic pharmaceutical agreements with major partners, AbbVie and Boehringer Ingelheim, related to our differentiated immunological pipeline. These key achievements trigger a solid financial position supporting the Company's growth, relying on our promising clinical and preclinical proprietary programs in immuno-inflammation and immuno-oncology conducted and supported by highly skilled OSE teams.
We also achieved two significant inflection points on our late-stage proprietary clinical assets. In immuno-inflammation, the positive clinical efficacy and safety results for Lusvertikimab in ulcerative colitis represent a strong catalyst for potential future partnership opportunities. We have generated exciting data that we plan to communicate with our investigators at an upcoming global medical conference. In immuno-oncology, the international registration study Artemia for cancer vaccine Tedopi® in second-line non-small cell lung cancer treatment is now on track globally. In parallel, in order to ensure continuous portfolio development, we continue accelerating and strengthening first-in-class preclinical programs from our innovative research platforms”.
Anne-Laure Autret-Cornet, Chief Financial Officer of OSE Immunotherapeutics, said: "With more than €90 million non-dilutive cash-in in 2024, our financial visibility is strongly reinforced until 2027. This allows us to prioritize funding of our recently globally launched Artemia Phase 3 registration study for our cancer vaccine Tedopi® in lung cancer and to further invest in our other proprietary clinical products and innovative R&D engine to increase the value and interest of our assets.”
THREE PHARMACEUTICAL AGREEMENTS SIGNED DURING H1 2024 PROVIDING A SOLID FINANCIAL POSITION TO SUPPORT IMPLEMENTATION OF THE STRATEGY UNTIL 2027
- In February 2024, OSE Immunotherapeutics and AbbVie concluded a strategic partnership to develop OSE-230 (renamed ABBV-230), a monoclonal antibody designed to resolve chronic and severe inflammation.
- In May 2024, OSE Immunotherapeutics and Boehringer Ingelheim expanded their partnership through the addition of two new projects:
- A new preclinical program will be launched to develop immune-cell activating treatments based on OSE's cis-targeting3 anti-PD1/cytokine platform via an asset acquisition.
- An amendment to the existing collaboration and license agreement for the anti-SIRPα immuno-oncology compounds BI 765063 and BI 770371 (being investigated in Phase 1b clinical studies in advanced solid tumors), development will now also be pursued in cardiovascular-renal-metabolic (CRM) diseases with the initiation of a Phase 2 clinical study planned for end of 2024.
UPDATE ON CLINICAL PROGRESS IN IMMUNO-ONCOLOGY AND IMMUNO-INFLAMMATION
First positive efficacy results from the Phase 2 clinical trial evaluating Lusvertikimab in ulcerative colitis.
- Following completion of enrolment in March 2024, OSE Immunotherapeutics announced in July first positive efficacy results for Lusvertikimab in the Phase 2 trial for the treatment of ulcerative colitis (CoTikiS study):
- Lusvertikimab demonstrated significant efficacy during the 10 week-induction phase of treatment measured by the improvement of the Modified Mayo Score, in the randomized double blind study,
- A favorable safety and tolerability profile was observed in the whole patient population across the two doses tested and during the open label phase of treatment.
- In September 2024, the Company launched its international Phase 3 clinical trial named 'Artemia' of Tedopi® in second-line treatment in HLA-A2 positive patients with metastatic NSCLC. This dossier, reviewed and accepted in 14 countries by international health agencies (US FDA, Canada, Europe and the United Kingdom) is a pivotal study supporting the registration of Tedopi®, in parallel with the companion diagnostic for HLA-A2 positive patients.
- Other Phase 2 trials, sponsored by clinical oncology groups, of Tedopi® in combination are ongoing in solid tumors.
- In February 2024, updated positive results from Phase 1/2 of OSE-279 were presented at the ESMO Targeted Anticancer Therapy Congress. These results showed a good pharmacokinetic/pharmacodynamic (PK/PD) and manageable safety profile in line with previous anti-PD1 development and with a high signal of efficacy in the first 20 patients representing 13 different tumor types.
- In June 2024, OSE Immunotherapeutics and Nantes University Hospital presented positive data from the completed Phase 1/2 clinical trial FIRsT evaluating FR104/VEL-101 in patients undergoing renal transplant at the " American Transplant Congress " (ATC) in Philadelphia. The data showed the safety of the product used in combination and the first signs of efficacy with no episodes of acute rejection after one year follow-up in the 8 patients of the study who completed 1-year treatment.
- A communication presented by OSE partner Veloxis Pharmaceuticals, featured the results from its Phase 1 dose escalation clinical trial evaluating the safety, tolerability, pharmacodynamics and pharmacokinetics of single ascending doses of subcutaneous administration of FR104/VEL-101 in healthy participants.
- A communication presented by the group of Pr. Richard Pierson (Massachusetts General Hospital, Harvard university, Boston, USA), reported on the positive preclinical efficacy data of FR104/VEL-101 injection in monotherapy or in combination with anti-CD40L antibody to protect from acute and chronic heart allograft rejection.
- In July 2024, Boehringer Ingelheim and OSE Immunotherapeutics announced that Boehringer Ingelheim will be progressing their first-in-class SIRPα immuno-oncology program into the next phase in clinical development. As part of the program, Boehringer will move forward with an improved next generation SIRPα inhibitor antibody, which will now be tested in a Phase 1b study in solid tumors.
- The initiation of a Phase 2 study in cardiovascular-renal-metabolic (CRM) diseases is planned for the end of 2024.
- In April 2024, novel data in the peer-reviewed Journal of Immunology on a first-in-class research program with CLEC-1, its novel myeloid immune checkpoint target for cancer immunotherapy. The collaborative work with Dr Elise Chiffoleau's team at the Center for Translational Research in Transplantation and Immunology has shown, for the first time, that CLEC-1 acts as an immune checkpoint for the control of acute immune responses in the context of sterile inflammation.
- In June 2024, the Company presented preclinical data on novel mRNA (messenger RiboNucleic Acid) Therapeutic platform for the treatment of inflammatory and autoimmune disorders at the Federation of Clinical Immunology Societies (FOCIS) annual meeting held in San Francisco.
- In June 2024, OSE Immunotherapeutics also entered into a commercial and revenue sharing agreement with leading global cancer center Memorial Sloan Kettering Cancer Center (MSK).
CORPORATE GOVERNANCE
- Marc Dechamps, Martine George, Markus Goebel and Cécile Nguyen-Cluzel were appointed new independent Directors of OSE Immunotherapeutics on June 19, 2024. Together, they bring a wealth of experience from leadership roles in the biopharmaceutical and health financial industry reenforcing the key strategic skills of the Board.
- The newly installed Board appointed Didier Hoch as its Chairman. He succeeds Dominique Costantini who did not run for a new mandate at the 2024 Shareholders' meeting.
The key figures of the 2024 consolidated half-year results are reported below:
| In k€ | June 30, 2024 | June 30, 2023 |
| Operating result | 63,321 | (13,504) |
| Net result | 57,175 | (11,860) |
| In k€ | June 30, 2024 | December 31, 2023 |
| Available cash and cash equivalents | 25,856 | 18,672 |
| Financial assets (deposit > 3 months) | 49,890 | 0 |
| Consolidated balance sheet | 140,921 | 82,054 |
During the first half of 2024, the Company secured:
- $48 million upfront payment as part of global license and collaboration agreement with AbbVie for ABBV-230 (formerly OSE-230), a novel monoclonal antibody for the treatment of chronic inflammation.
- €13.5 upfront payment as part of a purchase agreement with Boehringer Ingelheim of a novel cis-targeting anti-PD-1/cytokine asset developed by OSE.
- €25.3 million one-time payment as part of an amendment of the existing collaboration and licensing agreement with Boehringer Ingelheim for the anti-SIRPα immuno-oncology compounds BI 765063 and BI 770371.
- €5.8 million in 2023 research tax credit.
- €8.4 million in public funding under the "i-Démo” call for projects as part of the plan "France 2030” to support the registration Phase 3 clinical trial of cancer vaccine Tedopi® in NSCLC. This financing will be spread over the life of the project.
During the first half of 2024, the Company recorded a consolidated net result of €57.2 million.
Current operating expenses were €19.3 million (versus €14.9 million for the same period in 2023) of which 77% are related to R&D.
The Board of Directors of September 26, 2024, has approved the Company's semester accounts as of June 30, 2024. 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 2024 | H1 2023 | ||||
| Turnover | 69,046 | 1,358 | ||||
| Other products | 13,527 | 0 | ||||
| OPERATING INCOME - RECURRING | 82,573 | 1,358 | ||||
| Research & Development expenses | (13,884) | (9,693) | ||||
| Overhead expenses | (4,286) | (3,604) | ||||
| Expenses related to share-based payments | (1,082) | (1,562) | ||||
| OPERATING PROFIT/LOSS - RECURRING | 63,321 | (13,501) | ||||
| Other operating income and expenses | 0 | (4) | ||||
| OPERATING RESULT | 63,321 | (13,504) | ||||
| Financial income | 391 | 2,658 | ||||
| Financial expenses | (2,998) | (1,608) | ||||
| PROFIT/LOSS BEFORE TAX | (2,606) | (11,943) | ||||
| INCOME TAX | 3,540 | 84 | ||||
| CONSOLIDATED NET RESULT | 57,175 | (11,860) | ||||
| Of which consolidated net result attributable to shareholders | 57,175 | (11,860) | ||||
| Net earnings attributable to shareholders | ||||||
| Weighted average number of shares outstanding | 21,759,035 | 18,624,665 | ||||
| 2.63 | (0.64) | ||||
| 2.27 | (0.64) | ||||
| In K€ | H1 2024 | H1 2023 | ||||
| NET RESULT | 57,175 | (11,860) | ||||
| Amounts to be recycled in the income statement: | ||||||
| Unrealized gains on securities available for sale, net of tax | ||||||
| Currency conversion difference | 42 | (7) | ||||
| Amounts not to be recycled in the income statement: | ||||||
| Actuarial gains and losses on post-employment benefits | 0 | |||||
| Other comprehensive income in the period | (42) | (7) | ||||
| GLOBAL PROFIT/LOSS | 57,217 | (11,867) | ||||
| ASSETS in K€ | June 30, 2024 | December 31, 2023 | ||
| NON-CURRENT ASSETS | ||||
| Acquired R&D costs | 45,211 | 46,401 | ||
| Tangible assets | 386 | 464 | ||
| Rights of use | 3,261 | 3,606 | ||
| Financial assets | 6,084 | 910 | ||
| Deferred tax assets | 195 | 195 | ||
| TOTAL NON-CURRENT ASSETS | 55,136 | 51,576 | ||
| CURRENT ASSETS | ||||
| Trade receivables | 4,966 | 982 | ||
| Other current assets | 54,963 | 10,824 | ||
| Cash and cash equivalents | 25,856 | 18,672 | ||
| TOTAL CURRENT ASSETS | 85,785 | 30,478 | ||
| TOTAL ASSETS | 140,921 | 82,054 | ||
| EQUITY & LIABILITIES in K€ | June 30, 2024 | December 31, 2023 | ||
| SHAREHOLDERS' EQUITY | ||||
| Stated capital | 4,366 | 4,330 | ||
| Share & Merger premium | 76,822 | 76,643 | ||
| Treasury stock | (393) | (408) | ||
| Reserves and retained earnings | (56,522) | (34,587) | ||
| Consolidated result | 57,175 | (23,003) | ||
| TOTAL SHAREHOLDERS' EQUITY | 81,448 | 22,975 | ||
| NON-CURRENT DEBTS | ||||
| Non-current financial liabilities Lease non current liabilities | 37,152 | 35,508 | ||
| Non-current lease liabilities | 2,812 | 3,032 | ||
| Non-current deferred tax liabilities | 1,658 | 1,311 | ||
| Non-current provisions | 464 | 429 | ||
| TOTAL NON-CURRENT DEBTS |
| |||