On March 27, 2024 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) reported its consolidated annual financial results for 2023 and provided an update on key proprietary clinical and preclinical achievements, on ongoing collaboration and licensing agreements, as well as on the 2024 Company’s outlook (Press release, OSE Immunotherapeutics, MAR 27, 2024, View Source [SID1234641520]).
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Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, commented: "The Company has built today a broad and independent portfolio of five clinical assets, three pharmaceutical partnerships and three research platforms, all with potential key milestones expected in 2024. We have achieved significant steps in 2023 and all of which put in place during this year will help advance our key priorities on our clinical and preclinical stage products in immuno-oncology and inflammation in the coming months. We started 2024 with a major achievement for the Company’s growth as we also reinforced our financial resources with a new license and collaboration agreement with AbbVie valued up to $713 million, including a $48 million upfront payment, in line with our business-model of recurrent and strategic pharmaceutical partnerships. We will advance the Company’s clinical programs and continue investing in our R&D drug discovery engine to identify novel therapeutics for patients with high medical need in inflammation, autoimmune diseases and immuno-oncology.
The conduct of our Tedopi new pivotal Phase 3 clinical program in second-line non-small cell lung cancer, in patients with secondary/acquired resistance, is on track. Two dossiers were filed to the Food & Drug Administration (FDA) end of 2023: a companion test to identify HLA-A2 positive cancer patients eligible (collaboration with the company GenDx) and a clinical protocol. Both dossiers were approved mid-January 2024 and will be filed in Europe in the coming weeks.
Completion of patient enrollment in the Phase 2 trial evaluating Lusvertikimab in ulcerative colitis was recently announced, and we are now eagerly looking forward to the top-line efficacy results after the induction phase and first early assessment after 6 months of therapy expected mid-2024.
The ongoing Phase 1/2 trial with proprietary anti-PD1 OSE-279 in solid tumors has confirmed positive clinical efficacy results with a high anti-tumor response rate in difficult-to-treat patients. These results encourage further clinical development in the future, used in monotherapy in already identified cancer niche indications and to explore combinations with OSE drug candidates, in particular with our neo-epitope cancer vaccine.
The positive interim data analysis from the FIRsT Phase 1/2 study evaluation of anti-CD28 FR104/VEL-101 in renal transplant marks a key advancement in the clinical development towards a Phase 2 trial under preparation by our partner Veloxis Pharmaceuticals.
Two clinical drug-candidates, BI 765063 and BI 770371, from our selective SIRPa myeloid checkpoint technology are being evaluated by Boehringer Ingelheim in combination in cancer patients, in particular in metastatic or recurrent head and neck squamous cell carcinoma (HNSCC) and hepatocellular carcinoma (HCC). Promising results from the first Phase 1 study, with early clinical efficacy data and biomarkers predictive of response and survival, were presented at the 2023 AACR (Free AACR Whitepaper) and ESMO (Free ESMO Whitepaper) conferences.
We also look forward to generating additive value in immunology with our novel ‘pro-resolutive monoclonal antibody’ platform with additional identified GPCR targets, as well as our ‘myeloid checkpoint’ and ‘cytokine’ drug discovery platforms of which the latest updates are steadily selected for presentation at international scientific congresses. In parallel, at early research level, we keep strengthening our first-in-kind platform built at the intersection of Antibody Engineering, Data Science, Artificial Intelligence (AI) and novel RNA Therapeutics technologies to develop next-generation immunotherapy medicines modulating immune cell responses in the field of immuno-inflammation and immuno-oncology.
Looking ahead to 2024, we are excited by several key clinical, preclinical and partnership milestones to advance the Company’s growth path with the involvement of our teams, experts and partners, all fully committed to innovation in service of patients".
Anne-Laure Autret-Cornet, Chief Financial Officer of OSE Immunotherapeutics, adds: "Our business-model is mostly based on recurrent and strategic partnerships with pharmaceutical companies. Thanks to the collaboration and license agreement signed with AbbVie, we strongly reinforced our financial visibility, which will allow us to pursue our investments in our proprietary clinical programs and our innovative R&D engine to increase their intrinsic value and to prepare the next wave of Company’s growth".
2023 FINANCIAL RESULTS
A meeting of the Board of Directors of OSE Immunotherapeutics was held on March 27, 2024. Following the Audit Committee opinion, the Board approved the annual and consolidated financial statements prepared under IFRS on 31 December 2023.
The key figures of the 2023 consolidated annual results are reported below (and presented in the attached tables):
In K€
December 31, 2023
December 31, 2022
Current operating result
(22,980)
(18,392)
Operating result
(22,986)
(18,476)
Net result
(23,221)
(17,760)
Available cash*
18,672
25,620
Consolidated balance sheet
82,054
91,781
As of December 31, 2023, the Company’s available cash totaled €18.7 million, versus €25.6 million as of December 31, 2022.
In 2024, the Company will reinforce its financial position with a $48 million upfront payment as part of the global and exclusive license and collaboration on OSE-230 signed with AbbVie in February 2024 giving a financial visibility until 2026.
In 2023, OSE Immunotherapeutics secured:
– 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 conditions2.
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, 20233, 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 basis4 and 0.96% of the share capital on a diluted basis5.
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 are 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.
2023 Financial results
The audit procedures on the consolidated accounts have been performed. The certification report will be issued after finalization of the procedures required for the purposes of filing the registration document.
The Company recorded a consolidated operating loss of €-23.0 million. Current operating expenses were €25.2 million (versus €36.6 million in 2022) of which 74% related to R&D. R&D expenses amounted to €17.1 million versus €26.9 million in 2022.
APPENDICES
CONSOLIDATED PROFIT & LOSS
P&L IN K€
December 31, 2023
December 31, 2022
Turnover
2,227
18,302
Total Revenues
2,227
18,302
Research and development expenses
(17,158)
(26,893)
Overhead expenses
(6,015)
(6,672)
Expenses related to shares payments
(2,034)
(3,130)
OPERATING PROFIT/LOSS – CURRENT
(22,980)
(18,392)
Other operating expenses
(6)
(84)
OPERATING PROFIT/LOSS
(22,986)
(18,476)
Financial products
2,177
2,079
Financial expenses
(2,412)
(1,624)
PROFIT/LOSS BEFORE TAX
(23,221)
(18,022)
Income Tax
219
263
NET PROFIT/LOSS
(23,003)
(17,760)
Of which consolidated net result attributable to shareholders
(23,003)
(17,760)
Net earnings attributable to shareholders
Weighted average number of shares outstanding
19,562,147
18,527,401
Basic earnings per share
(1.18)
(0.96)
Diluted earnings per share
(1.18)
(0.96)
IN K€
2023
2022
NET RESULT
(23,003)
(17,760)
Amounts to be recycled in the income statement:
Currency conversion difference
(77)
(61)
Amounts not to be recycled in the income statement:
(9)
122
Other comprehensive income in the period
(86)
(61)
GLOBAL PROFIT/LOSS
(23,089)
(17,699)
CONSOLIDATED BALANCE SHEET
ASSETS IN K€
December 31, 2023
December 31, 2022
Acquired R&D costs
46,401
48,784
Tangible assets
464
743
Right-of-use assets
3,606
4,236
Financial assets
910
635
Differed tax assets
195
182
TOTAL NON-CURRENT ASSETS
51 ,576
54,581
Trade receivables
982
403
Other current assets
10,824
11,177
Cash and cash equivalents
18,672
25,620
TOTAL CURRENT ASSETS
30,478
37,200
TOTAL ASSETS
82,054
91,781
EQUITY & LIABILITIES IN K€
December 31, 2023
December 31, 2022
SHAREHOLDERS’ EQUITY
Stated capital
4,330
3,705
Share premium
49,816
38,784
Merger premium
26,827
26,827
Treasury stock
(408)
(549)
Reserves and retained earnings
(34,587)
(18,349)
Consolidated result
(23,003)
(17,760)
TOTAL SHAREHOLDERS’ EQUITY
22,975
32,658
NON-CURRENT DEBTS
Non-current financial liabilities
35,508
37,231
Non-current lease liabilities
3,032
3,586
Non-current deferred tax liabilities
1,311
1,514
Non-current provisions
429
524
TOTAL NON-CURRENT DEBTS
40,280
42,856
CURRENT DEBTS
Current financial liabilities
6,403
3,093
Current lease liabilities
858
883
Trade payables
9,299
8,539
Corporate income tax liabilities
20
21
Social and tax payables
1,867
2,916
Other debts and accruals
351
816
TOTAL CURRENT DEBTS
18,799
16,268
TOTAL LIABILITIES
82,054
91,781
CONSOLIDATED CASH FLOW STATEMENTS
In K€
December 31, 2023
December 31, 2022
CONSOLIDATED RESULT
(23,003)
(17,760)
+/-
Depreciation, amortization and provision expenses
2,574
2,744
+
Amortization on "right-of-use"
846
742
+/-
Shares based payments (1)
1,746
2,728
CASH FLOW BEFORE TAX
(17,838)
(11,545)
+
Financial charges
(657)
(3,066)
–
Income tax expenses
(219)
(263)
–
Tax paid
(216)
(236)
+/-
Working capital variation (2)
(835)
(3,142)
CASH FLOW FROM OPERATING ACTIVITIES (A)
(19,764)
(18,252)
–
Tangible assets increase
(16)
(274)
+/-
Financial assets variation
0
0
+/-
Net variation in rights-of-use
(216)
0
+/-
Loans and advances variation
(275)
300
CASH FLOW FROM INVESTING ACTIVITIES (B)
(507)
26
+
Capital increase (including share premium)
11,357
+/-
Own shares transactions
0
+
Warrant subscription
300
+
Loan subscription
5,023
12,056
–
Loan repayment
(2,719)
(1,010)
–
Lease debt repayment (3)
(637)
(785)
–
Financial charges
CASH FLOW FROM FINANCING ACTIVITIES (C)
13,324
10,267
+/-
Currency translation transactions (D)
CASH VARIATION E = (A + B + C + D)
(6,948)
(7,959)
CASH OPENING BALANCE (F)
25,620
33,579
CASH CLOSING BALANCE (G)
18,672
25,620
DIFFERENCE: E (G-F)
0
(1) Warrants and free shares awards granted in 2023 and valuated for 1,746 K€
(2) Mainly explained by:
– Increase in trade receivable for 578 K€
Decrease in other current assets for 353 K€
– Increase in trade accounts payable for 759K€
– Decrease in social and tax payable for 1,048 K€
– Decrease in other debts for 464 K€
(3) Explained by IFRS16 application, which corresponds to reimbursement of lease debt for 637 K€