Nanobiotix(NBTX) - 2024 Q4 - Annual Report

Business and Operational Update Nanobiotix highlights significant progress in its global development program for JNJ-1900 (NBTXR3) and strengthened its financial position Operational Highlights Nanobiotix made significant progress in JNJ-1900 development, improved financial stability, and launched a new nanotherapeutic platform - The global development program for JNJ-1900 (NBTXR3) is proceeding as planned, targeting major oncology markets like head and neck and lung cancer[4] - A disciplined financial strategy has extended the company's cash runway into mid-2026, with €49.7 million in cash and cash equivalents as of December 31, 2024[4] - The company has launched Curadigm, a next-generation nanotherapeutic platform designed to enhance drug development across various therapeutic areas[4] - Clinical data readouts are expected in 2025 from Phase 1 and 2 studies in several cancers, including RM-HNSCC, pancreatic cancer, and NSCLC[4] JNJ-1900 (NBTXR3) Development Program JNJ-1900 development advanced with NANORAY-312 sponsorship transfer and first patient dosing in the CONVERGE study - The sponsorship of the pivotal Phase 3 NANORAY-312 study for locally advanced head and neck squamous cell carcinoma (LA-HNSCC) was transferred to Johnson & Johnson in the US in Q4 2024, with a global transfer intended by Q3 2025[5] - The first patient was dosed in the Johnson & Johnson-sponsored Phase 2 CONVERGE study in Q1 2025, evaluating JNJ-1900 for unresectable stage 3 non-small cell lung cancer (NSCLC)[5] - A Phase 1 study in pancreatic cancer was completed, and a new cohort was launched to evaluate JNJ-1900 combined with standard-of-care chemoradiation (CCRT)[5][8] - The dose escalation part of a Phase 1 study in NSCLC amenable to re-irradiation was completed, establishing the recommended Phase 2 dose and showing a favorable safety profile[8] Financial Strategy and Other Highlights Nanobiotix strengthened its financial position and extended cash runway through strategic agreements and launched the Curadigm platform - Received a $20 million milestone payment from Johnson & Johnson in May 2024 related to the NANORAY-312 study[8] - Amended the global licensing agreement for JNJ-1900 in Q1 2025, removing the majority of Nanobiotix's funding obligation for NANORAY-312 and extending the cash runway to mid-2026[8] - Launched the Curadigm Nanoprimer Platform in Q4 2024, a technology designed to increase the bioavailability and tissue accumulation of intravenously administered medicines[8] - Strengthened the Supervisory Board with the nomination of two board observers, Dr. Margaret A. Liu and Ms. Anat Naschitz, to support long-term growth[8] Full Year 2024 Financial Results Nanobiotix reported a net loss increase in FY2024, primarily due to a non-cash revenue adjustment, while managing expenses and cash position Financial Performance Summary FY2024 saw negative revenue due to a non-cash adjustment, increased R&D expenses, decreased SG&A, and a higher net loss FY 2024 Financial Performance vs. FY 2023 (€ millions) | Metric | FY 2024 | FY 2023 | Change | | :--- | :--- | :--- | :--- | | Total revenues and other income | (7.2) | 36.2 | N/A | | R&D Expenses | (40.5) | (38.4) | +5.5% | | SG&A Expenses | (20.5) | (22.0) | -6.8% | | Net Loss | (68.1) | (39.7) | +71.5% | | Loss per Share (€) | (1.44) | (1.08) | +33.3% | - Negative revenue of €7.2 million was primarily caused by a one-time, non-cash negative revenue impact of €19.3 million from the transfer of NANORAY-312 study sponsorship to Janssen, based on IFRS 15 accounting principles[9] - The 5% increase in R&D expenses was mainly due to increased clinical development activities for the NANORAY-312 and Study 1100 trials[10] - The 7% decrease in SG&A expenses resulted from one-off legal and financial advisory fees incurred in 2023 related to the license agreement and equity issuance[11] Financial Position and Guidance Nanobiotix maintained a strong cash position of €49.7 million as of December 31, 2024, extending its cash runway into mid-2026 - Cash and cash equivalents stood at €49.7 million as of December 31, 2024, compared to €75.3 million at the end of 2023[13] - The company anticipates its current cash position will fund operations into mid-2026[13][15] - The amended agreement with Johnson & Johnson provides a non-dilutive financing solution that is expected to reduce operational burn immediately and moving forward[15] About Nanobiotix and NBTXR3 (JNJ-1900) This section provides an overview of Nanobiotix as a company and details its lead product, NBTXR3 (JNJ-1900) About NBTXR3 (JNJ-1900) NBTXR3 (JNJ-1900) is a novel, physics-based radioenhancer for oncology, currently in a pivotal Phase 3 study for head and neck cancer - NBTXR3 is a physics-based radioenhancer composed of functionalized hafnium oxide nanoparticles, administered via a one-time intratumoral injection and activated by radiotherapy[19] - Its mechanism of action is designed to cause significant tumor cell death, which in turn triggers an adaptive immune response and long-term anti-cancer memory[19] - The lead clinical program is NANORAY-312, a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers, with FDA Fast Track designation for this indication[20] - Nanobiotix has a global co-development and commercialization license agreement for NBTXR3 with Janssen Pharmaceutica NV, a Johnson & Johnson company[21] About Nanobiotix Nanobiotix is a late-stage clinical biotechnology company pioneering physics-based therapeutic approaches, listed on Euronext Paris and Nasdaq - Nanobiotix is a late-stage clinical biotechnology company focused on disruptive, physics-based therapeutic approaches[22] - The company was incorporated in 2003, is headquartered in Paris, France, and is listed on Euronext Paris and Nasdaq[23] - It owns over 25 patent families associated with three nanotechnology platforms with applications in oncology, bioavailability, and central nervous system disorders[25] Consolidated Financial Statements This section presents the company's consolidated financial statements, including operations and financial position, for 2024 and 2023 Statements of Consolidated Operations This section presents the company's consolidated statements of operations for the years ended December 31, 2024, and 2023, detailing revenues, expenses, and net loss Statements of consolidated operations (Amounts in thousands of euros) | | For the year ended December 31, | | :--- | :--- | :--- | | | 2024 | 2023 | | Revenues and other income | | | | Revenues | (11,609) | 30,058 | | Other income | 4,419 | 6,150 | | Total revenues and other income | (7,191) | 36,207 | | Research and development expenses | (40,541) | (38,396) | | Selling, general and administrative expenses | (20,527) | (22,049) | | Other operating and income expenses | (134) | (2,542) | | Total operating expenses | (61,202) | (62,986) | | Operating income (loss) | (68,392) | (26,779) | | Financial income | 7,849 | 2,002 | | Financial expenses | (7,488) | (14,803) | | Financial income (loss) | 361 | (12,801) | | Income tax | (101) | (120) | | Net loss for the period | (68,132) | (39,700) | | Basic loss per share (euros/share) | (1.44) | (1.08) | | Diluted loss per share (euros/share) | (1.44) | (1.08) | Statements of Consolidated Financial Position This section provides the company's consolidated statements of financial position as of December 31, 2024, and 2023, outlining assets, liabilities, and shareholders' equity Statements of consolidated financial position (Amounts in thousands of euros) | | As of December 31, | | :--- | :--- | :--- | | | 2024 | 2023 | | Total non-current assets | 5,951 | 6,558 | | Cash and cash equivalents | 49,737 | 75,283 | | Total current assets | 61,466 | 87,339 | | TOTAL ASSETS | 67,418 | 93,897 | | Total shareholders' equity | (65,704) | (1,843) | | Total non-current liabilities | 74,187 | 45,866 | | Total current liabilities | 58,934 | 49,873 | | TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | 67,418 | 93,897 |