Toripalimab

Global development program for JNJ-1900 (NBTXR3) proceeding as planned, with opportunity to address one of the largest untapped markets in oncology through lead programs in head and neck cancer and lung cancer Disciplined financial strategy toward long-term sustainability and growth continues to strengthen financial position through focused allocation of capital, the receipt of a planned milestone payment, the transfer of sponsorship for NANORAY-312, and an amendment to the global licensing agreement for JNJ-1900 (NBTXR3) Curadigm, a next generation nanotherapeutic platform designed to reshape drug design and development across multiple therapeutic classes and disease areas, has launched Cash runway extended into mid-2026 and reduction of operational cash burn expected beyond mid-2026 with €49.7 million in cash and cash equivalents as of December 31, 2024 Clinical data readouts in 2025 from Phase 1 and 2 studies in RM-HNSCC, pancreatic cancer, NSCLC amenable to re-irradiation, melanoma and esophageal cancer Conference call and webcast scheduled for April 3, 2025 at 8:00 A.M. EDT / 2:00 P.M. CEST PARIS and CAMBRIDGE, Mass., April 02, 2025 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO - NASDAQ: NBTX - the “Company”), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, provided an update on operational progress, reported financial results for the year ended December 31, 2024, and announced the filing of its universal registration document (URD) for the financial year ended December 31, 2024 with the French financial market authority (Autorité des marchés financiers or AMF), as well as of the annual report on Form 20-F for the financial year ended December 31, 2024 with the U.S. Securities and Exchange Commission (SEC). Operational Highlights Addressing One of the Largest Untapped Markets in Oncology with JNJ-1900 (NBTXR3)1 Lead programs in head and neck cancer and lung cancer proceeding as planned Ongoing Pivotal Phase 3 LA-HNSCC Study (NANORAY-312) Aligned on intent to transfer the global NANORAY-312 sponsorship from Nanobiotix to Janssen Pharmaceutica NV, a Johnson & Johnson Company (“Johnson & Johnson”) in 2Q2024 to begin preparations for interim analysis. Completed the NANORAY-312 US sponsorship transfer from Nanobiotix to Johnson & Johnson, in 4Q2024, with intent to transfer NANORAY-312 globally to Johnson & Johnson by 3Q2025. Ongoing Randomized Phase 2 Study in Unresectable Stage 3 NSCLC (CONVERGE) First patient dosed in the Johnson & Johnson-sponsored Phase 2 randomized CONVERGE study evaluating JNJ-1900 (NBTXR3) for patients with unresectable stage 3 non-small cell lung cancer (“NSCLC”) in 1Q2025 Multiple early-stage studies across solid tumor types beyond the lead programs continue to progress RM-HNSCC (Phase 1 Study 1100 sponsored by Nanobiotix) Presented new data showing disease control and tumor response in patients treated with JNJ-1900 (NBTXR3) followed by anti-PD-1 as a second-or-later line (2L+) therapy for patients with recurrent or metastatic (“RM”) head and neck squamous cell carcinoma (“HNSCC”) in 2Q2024 Locally Advanced or Borderline Resectable Pancreatic Cancer (Phase 1 Study MDA 2019-1001 sponsored by The University of Texas MD Anderson Cancer Center) Completed a Phase 1 study evaluating JNJ-1900 (NBTXR3) for patients with locally advanced or borderline resectable pancreatic cancer in 4Q2024 and investigators recommended that the encouraging oncologic outcomes coupled with a favorable safety profile warrant further exploration in a randomized study US FDA approved a protocol amendment to the completed Phase 1 pancreatic cancer study in 4Q2024 enabling the launch of a new cohort designed to evaluate JNJ-1900 (NBTXR3) combined with standard-of-care concurrent chemoradiation (“CCRT”) and recruitment is ongoing NSCLC Amenable to Re-irradiation (Phase 1 Study MDA 2020-0123 sponsored by MD Anderson) Completed the dose escalation part of a Phase 1 study evaluating JNJ-1900 (NBTXR3) for patients with inoperable, recurrent NSCLC amenable to re-irradiation (“reRT”) and established the recommended Phase 2 dose (RP2D) at 33% of gross tumor volume in 4Q2024 Presented first data from the Phase 1 NSCLC reRT study showing a favorable safety profile and early signals of efficacy in 1Q2025 Lead programs in head and neck cancer and lung cancer proceeding as planned Ongoing Pivotal Phase 3 LA-HNSCC Study (NANORAY-312) Aligned on intent to transfer the global NANORAY-312 sponsorship from Nanobiotix to Janssen Pharmaceutica NV, a Johnson & Johnson Company (“Johnson & Johnson”) in 2Q2024 to begin preparations for interim analysis. Completed the NANORAY-312 US sponsorship transfer from Nanobiotix to Johnson & Johnson, in 4Q2024, with intent to transfer NANORAY-312 globally to Johnson & Johnson by 3Q2025. Ongoing Randomized Phase 2 Study in Unresectable Stage 3 NSCLC (CONVERGE) First patient dosed in the Johnson & Johnson-sponsored Phase 2 randomized CONVERGE study evaluating JNJ-1900 (NBTXR3) for patients with unresectable stage 3 non-small cell lung cancer (“NSCLC”) in 1Q2025 Multiple early-stage studies across solid tumor types beyond the lead programs continue to progress RM-HNSCC (Phase 1 Study 1100 sponsored by Nanobiotix) Presented new data showing disease control and tumor response in patients treated with JNJ-1900 (NBTXR3) followed by anti-PD-1 as a second-or-later line (2L+) therapy for patients with recurrent or metastatic (“RM”) head and neck squamous cell carcinoma (“HNSCC”) in 2Q2024 Locally Advanced or Borderline Resectable Pancreatic Cancer (Phase 1 Study MDA 2019-1001 sponsored by The University of Texas MD Anderson Cancer Center) Completed a Phase 1 study evaluating JNJ-1900 (NBTXR3) for patients with locally advanced or borderline resectable pancreatic cancer in 4Q2024 and investigators recommended that the encouraging oncologic outcomes coupled with a favorable safety profile warrant further exploration in a randomized study US FDA approved a protocol amendment to the completed Phase 1 pancreatic cancer study in 4Q2024 enabling the launch of a new cohort designed to evaluate JNJ-1900 (NBTXR3) combined with standard-of-care concurrent chemoradiation (“CCRT”) and recruitment is ongoing NSCLC Amenable to Re-irradiation (Phase 1 Study MDA 2020-0123 sponsored by MD Anderson) Completed the dose escalation part of a Phase 1 study evaluating JNJ-1900 (NBTXR3) for patients with inoperable, recurrent NSCLC amenable to re-irradiation (“reRT”) and established the recommended Phase 2 dose (RP2D) at 33% of gross tumor volume in 4Q2024 Presented first data from the Phase 1 NSCLC reRT study showing a favorable safety profile and early signals of efficacy in 1Q2025 Ongoing Pivotal Phase 3 LA-HNSCC Study (NANORAY-312) Aligned on intent to transfer the global NANORAY-312 sponsorship from Nanobiotix to Janssen Pharmaceutica NV, a Johnson & Johnson Company (“Johnson & Johnson”) in 2Q2024 to begin preparations for interim analysis. Completed the NANORAY-312 US sponsorship transfer from Nanobiotix to Johnson & Johnson, in 4Q2024, with intent to transfer NANORAY-312 globally to Johnson & Johnson by 3Q2025. Ongoing Randomized Phase 2 Study in Unresectable Stage 3 NSCLC (CONVERGE) First patient dosed in the Johnson & Johnson-sponsored Phase 2 randomized CONVERGE study evaluating JNJ-1900 (NBTXR3) for patients with unresectable stage 3 non-small cell lung cancer (“NSCLC”) in 1Q2025 Aligned on intent to transfer the global NANORAY-312 sponsorship from Nanobiotix to Janssen Pharmaceutica NV, a Johnson & Johnson Company (“Johnson & Johnson”) in 2Q2024 to begin preparations for interim analysis. Completed the NANORAY-312 US sponsorship transfer from Nanobiotix to Johnson & Johnson, in 4Q2024, with intent to transfer NANORAY-312 globally to Johnson & Johnson by 3Q2025. First patient dosed in the Johnson & Johnson-sponsored Phase 2 randomized CONVERGE study evaluating JNJ-1900 (NBTXR3) for patients with unresectable stage 3 non-small cell lung cancer (“NSCLC”) in 1Q2025 RM-HNSCC (Phase 1 Study 1100 sponsored by Nanobiotix) Presented new data showing disease control and tumor response in patients treated with JNJ-1900 (NBTXR3) followed by anti-PD-1 as a second-or-later line (2L+) therapy for patients with recurrent or metastatic (“RM”) head and neck squamous cell carcinoma (“HNSCC”) in 2Q2024 Locally Advanced or Borderline Resectable Pancreatic Cancer (Phase 1 Study MDA 2019-1001 sponsored by The University of Texas MD Anderson Cancer Center) Completed a Phase 1 study evaluating JNJ-1900 (NBTXR3) for patients with locally advanced or borderline resectable pancreatic cancer in 4Q2024 and investigators recommended that the encouraging oncologic outcomes coupled with a favorable safety profile warrant further exploration in a randomized study US FDA approved a protocol amendment to the completed Phase 1 pancreatic cancer study in 4Q2024 enabling the launch of a new cohort designed to evaluate JNJ-1900 (NBTXR3) combined with standard-of-care concurrent chemoradiation (“CCRT”) and recruitment is ongoing NSCLC Amenable to Re-irradiation (Phase 1 Study MDA 2020-0123 sponsored by MD Anderson) Completed the dose escalation part of a Phase 1 study evaluating JNJ-1900 (NBTXR3) for patients with inoperable, recurrent NSCLC amenable to re-irradiation (“reRT”) and established the recommended Phase 2 dose (RP2D) at 33% of gross tumor volume in 4Q2024 Presented first data from the Phase 1 NSCLC reRT study showing a favorable safety profile and early signals of efficacy in 1Q2025 Presented new data showing disease control and tumor response in patients treated with JNJ-1900 (NBTXR3) followed by anti-PD-1 as a second-or-later line (2L+) therapy for patients with recurrent or metastatic (“RM”) head and neck squamous cell carcinoma (“HNSCC”) in 2Q2024 Completed a Phase 1 study evaluating JNJ-1900 (NBTXR3) for patients with locally advanced or borderline resectable pancreatic cancer in 4Q2024 and investigators recommended that the encouraging oncologic outcomes coupled with a favorable safety profile warrant further exploration in a randomized study US FDA approved a protocol amendment to the completed Phase 1 pancreatic cancer study in 4Q2024 enabling the launch of a new cohort designed to evaluate JNJ-1900 (NBTXR3) combined with standard-of-care concurrent chemoradiation (“CCRT”) and recruitment is ongoing Completed the dose escalation part of a Phase 1 study evaluating JNJ-1900 (NBTXR3) for patients with inoperable, recurrent NSCLC amenable to re-irradiation (“reRT”) and established the recommended Phase 2 dose (RP2D) at 33% of gross tumor volume in 4Q2024 Presented first data from the Phase 1 NSCLC reRT study showing a favorable safety profile and early signals of efficacy in 1Q2025 Disciplined Financial Strategy Toward Long-Term Sustainability and Growth Received $20M first milestone payment related to NANORAY-312 from Johnson & Johnson in May 2024 Executed amendment to global licensing agreement for JNJ-1900 (NBTXR3) in 1Q2025, removing the vast majority Nanobiotix funding obligation for NANORAY-312 and releasing Johnson & Johnson from select future potential milestone payments, while safeguarding Nanobiotix’s path to sustainable cashflow through hundreds of millions in potential milestone payments related to lead programs expected in the coming years Extended cash runway to mid-2026 with a meaningful reduction in cash burn expected immediately and moving forward through and beyond mid-2026 Actively exploring preferably non-dilutive financing options to further extend cash visibility into 2027 Other Operational Highlights Strengthened Supervisory Board with the nominations of Dr. Margaret A. Liu and Ms. Anat Naschitz as board observers in 3Q2024, two key additions intended to further equip the Company for sustainable long-term growth. Dr. Liu brings a wealth of experience in US and international academia, pharmaceuticals, biotechnology and public policy Ms. Naschitz brings world-class expertise in raising and deploying capital to support disruptive innovation for the benefit of patients, healthcare professionals and investors Launched the Curadigm Nanoprimer Platform, the Company’s next lever for growth, in 4Q2024 The platform consists of nanoparticles designed with specific physico-chemical properties that allow temporary occupation of the liver cells responsible for therapeutic clearance. This mechanism is intended to increase the blood bioavailability and subsequent accumulation of therapeutics in the targeted tissues, potentially providing the opportunity to increase the efficacy or decrease the toxicity of intravenously administered medicines. As such, it is a potentially ideal technology to be used by both Nanobiotix and potential partners. Received $20M first milestone payment related to NANORAY-312 from Johnson & Johnson in May 2024 Executed amendment to global licensing agreement for JNJ-1900 (NBTXR3) in 1Q2025, removing the vast majority Nanobiotix funding obligation for NANORAY-312 and releasing Johnson & Johnson from select future potential milestone payments, while safeguarding Nanobiotix’s path to sustainable cashflow through hundreds of millions in potential milestone payments related to lead programs expected in the coming years Extended cash runway to mid-2026 with a meaningful reduction in cash burn expected immediately and moving forward through and beyond mid-2026 Actively exploring preferably non-dilutive financing options to further extend cash visibility into 2027 Strengthened Supervisory Board with the nominations of Dr. Margaret A. Liu and Ms. Anat Naschitz as board observers in 3Q2024, two key additions intended to further equip the Company for sustainable long-term growth. Dr. Liu brings a wealth of experience in US and international academia, pharmaceuticals, biotechnology and public policy Ms. Naschitz brings world-class expertise in raising and deploying capital to support disruptive innovation for the benefit of patients, healthcare professionals and investors Launched the Curadigm Nanoprimer Platform, the Company’s next lever for growth, in 4Q2024 The platform consists of nanoparticles designed with specific physico-chemical properties that allow temporary occupation of the liver cells responsible for therapeutic clearance. This mechanism is intended to increase the blood bioavailability and subsequent accumulation of therapeutics in the targeted tissues, potentially providing the opportunity to increase the efficacy or decrease the toxicity of intravenously administered medicines. As such, it is a potentially ideal technology to be used by both Nanobiotix and potential partners. Dr. Liu brings a wealth of experience in US and international academia, pharmaceuticals, biotechnology and public policy Ms. Naschitz brings world-class expertise in raising and deploying capital to support disruptive innovation for the benefit of patients, healthcare professionals and investors The platform consists of nanoparticles designed with specific physico-chemical properties that allow temporary occupation of the liver cells responsible for therapeutic clearance. This mechanism is intended to increase the blood bioavailability and subsequent accumulation of therapeutics in the targeted tissues, potentially providing the opportunity to increase the efficacy or decrease the toxicity of intravenously administered medicines. As such, it is a potentially ideal technology to be used by both Nanobiotix and potential partners. ____________________1 Potential first-in-class radioenhancer “NBTXR3” was licensed to Johnson & Johnson by Nanobiotix in 2023 and renamed “JNJ-1900” for the purposes of Johnson & Johnson-led clinical development. “2024 was a productive year focused on strong clinical execution and establishing a foundation for the next stage of growth. We expanded into lung cancer with the dosing of the first patient in the CONVERGE Phase 2 trial evaluating the potential of JNJ-1900 (NBTXR3) to enhance the treatment of first-line Stage III lung cancer patients.” said Laurent Levy, co-founder of Nanobiotix and chairman of the executive board. “Conviction in the broad potential of JNJ-1900 (NBTXR3) was further bolstered by the prolonged survival and well-tolerated safety reported across three key programs including Phase 1 data from Study 1100 evaluating NBTXR3 in combination with an anti-PD-1 in recurrent or metastatic head and neck cancer, as well as initial data supporting expansion potential in pancreatic and lung cancer as part of our MD Anderson collaboration. We also introduced our next generation first-in-class nanotherapeutic platform, Curadigm, late in 2024, which we expect to drive additional long-term value. With our financial position strengthened and new data this year in head and neck, lung, pancreatic, and esophageal cancer, we believe Nanobiotix is strongly positioned for impact in 2025 and beyond.” Full Year 2024 Financial Results Revenue and Other Income: Negative Revenues of €7.2 million were recognized in 2024, compared to €36.2 million for the year ended December 31, 2023, in which year significant revenue was recorded in connection with the execution of the license agreement with Janssen as well as the recognition of a development milestone. The negative non-cash revenue impact recognized in 2024 results from the transfer of NANORAY-312 study sponsorship to Janssen, signed at the end of 2024, which amounts to negative €19.3 million and is driven by a one-time recognition of a net liability towards Janssen to reflect this new situation. This one-off, non-cash negative revenue item, that results from application of IFRS 15 revenue recognition accounting principles, is partially offset by Other Revenues that do positively impact Nanobiotix’s cash position including: Sales of Clinical Products and goods to Janssen for €5.9 million, Technology Transfer Services billed to Janssen for €1.8 million, Research Tax Credit for €3.3 million and other income related to collaboration and supply services agreement in Asian territory for €1.0 million. Research and Development (“R&D”) Expenses: R&D expenses consist primarily of preclinical, clinical, and manufacturing expenses related to the development of NBTXR3 (JNJ-1900) and totaled €40.5 million for the twelve-month period ended December 31, 2024, as compared to €38.4 million for the twelve months ended December 31, 2023, a year over year increase of 5%. The increase in net R&D expenses was primarily due to an increase of clinical development activities, driven by the costs related to NANORAY-312 and of its Phase 1 multi-cohort trial of RT-activated NBTXR3 followed by anti-PD-1 checkpoint inhibitors (Study 1100), and the full-year impact of R&D positions that were recruited in 2023. Selling, General and Administrative (“SG&A”) Expenses: SG&A expenses were €20.5 million for the year ended December 31, 2024, compared to €22.0 million for the year ended December 31, 2023. This year-over-year decrease of 7% is mainly due to one-off fees incurred in 2023, consisting of license agreement execution and equity issuance related legal expenses and next to one-off fees paid to a financial advisor for €1.9 million in total. Net loss: Net loss attributable to shareholders was €68.1 million, a year-over-year increase of 72%, or €1.44 per share, for the twelve-month period ended December 31, 2024, which was primarily attributable to the one-off non-cash negative revenue recognition accounting impact. This compares to a net loss of €39.7 million, or €1.08 per share for the year ended December 31, 2023. Cash and Cash Equivalents: As of December 31, 2024, Nanobiotix had €49.7 million in cash and cash equivalents, compared to €75.3 million as of December 31, 2023. Financial Guidance: Based on the current operating plan and financial projections, Nanobiotix anticipates that the cash and cash equivalents of €49.7 million as of December 31, 2024 will fund its operations into mid-2026. The supervisory board of the Company has reviewed the financial statements 2024 on April 2nd, 2025 and the Company’s statutory auditors have finalized their audit and issued on March 31, 2025 a clean opinion on both statutory and consolidated financial statements 2024. “We have recently fortified our financial position and extended our cash runway into mid-2026 by amending our global agreement with Johnson & Johnson. We expect this action to reduce operational burn with immediate effect and this reduction will continue post mid-2026,” said Bart Van Rhijn, chief financial and business officer at Nanobiotix. “This non-dilutive financing solution achieved via the amendment, which we believe signals the increasing shared commitment to JNJ-1900 (NBTXR3), positions us to continue taking the necessary operational and financial steps to ensure the future of our business and our potential to benefit millions of patients around the world with our technology and signifies our continued financial discipline.” Availability of the Full Year 2024 Financial Reports The URD and 20-F are available on the Nanobiotix website here. In addition, the URD is available on the AMF website (www.amf-france.org) and the 20-F is available on the SEC website (www.sec.gov). The Company’s 2024 URD includes its: 2024 annual financial report including the report on corporate governance Reports from the Company’s statutory auditors and information on their feesRequired information in relation to the Company’s share buyback program Conference Call and Webcast Nanobiotix will host a conference call and live audio webcast on Thursday, April 3, 2025, at 8:00 AM EDT / 2:00 PM CEST, prior to the open of the U.S. market. During the call, Laurent Levy, chief executive officer, and Bart van Rhijn, chief financial and business officer, will briefly review the Company’s year-end results and provide an update on business activities for the full year of 2024 before taking questions from participants. Details of the call are as follows: Webcast link: click here Conference call link: click here Details of the call are also available in the investors section of the Company’s website at www.nanobiotix.com. It is recommended to join 10 minutes prior the event start. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Company’s website. Participants are invited to email their questions in advance to investors@nanobiotix.com. About NBTXR3 (JNJ-1900) NBTXR3 (JNJ-1900) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The product candidate’s physics-based mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physics-based MoA, Nanobiotix believes that NBTXR3 (JNJ-1900) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors. Radiotherapy-activated NBTXR3 (JNJ-1900) is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 (JNJ-1900) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study. Given the Company’s focus areas and balanced against the scalable potential of NBTXR3 (JNJ-1900), Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating NBTXR3 (JNJ-1900) across tumor types and therapeutic combinations. In 2023 Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 (JNJ-1900) with Janssen Pharmaceutica NV, a Johnson & Johnson company. About NANOBIOTIX Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life. Incorporated in 2003, Nanobiotix is headquartered in Paris, France and is listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. The Company has subsidiaries in Cambridge, Massachusetts (United States) amongst other locations. Nanobiotix is the owner of more than 25 patent families associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system. For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter. Disclaimer This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the use of proceed therefrom, and the period of time through which the Company’s anticipates its financial resources will be adequate to support operations. Words such as “expects”, “intends”, “can”, “could”, “may”, “might”, “plan”, “potential”, “should” and “will” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements which are based on the Company’ management’s current expectations and assumptions and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements, including risks related to Nanobiotix’s business and financial performance, which include the risk that assumptions underlying the Company’s cash runway projections are not realized. Further information on the risk factors that may affect company business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the SEC on April 2, 2025 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2024 universal registration document filed with the AMF on April 2, 2025, and subsequent filings Nanobiotix makes with the SEC from time to time which are available on the SEC’s website at www.sec.gov. The forward-looking statements included in this press release speak only as of the date of this press release, and except as required by law, Nanobiotix assumes no obligation to update these forward-looking statements publicly. Contacts Attachment 2025-04-02 -- NBTX -- FY24 Financial Results -- FINAL.html

– Remaining $60 Million of outstanding convertible notes to be repurchased post-close of pending UDENYCA divestiture – REDWOOD CITY, Calif., April 01, 2025 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus” or the “Company,” NASDAQ: CHRS) announced today that it has entered into privately negotiated transactions (the “Repurchases”) with certain holders (the “Holders”) of its 1.500% Convertible Senior Subordinated Notes due 2026 (the “Convertible Notes”), pursuant to which the Company agreed to repurchase approximately $170 million aggregate principal amount of the Convertible Notes from such holders at a cash repurchase price equal to 100% of their principal amount, together with the accrued and unpaid interest to, but excluding, the date of repurchase. The Repurchases are conditioned upon, among other things, the closing of the previously announced divestiture of the UDENYCA (pegfilgrastim-cbqv) franchise pursuant to that certain asset purchase agreement (the “Agreement”), dated as of December 2, 2024 between the Company and Intas Pharmaceuticals Ltd. (“Intas”), a limited company incorporated in India (the “Transaction”). Following the closing of the Repurchases, approximately $60 million aggregate principal amount of Convertible Notes will remain outstanding. Following the closing of the Transaction, Coherus intends to conduct a repurchase offer for such remaining Convertible Notes pursuant to the Fundamental Change Repurchase Right (as defined in the indenture, dated as of April 17, 2020 (the “Indenture”), between the Company and U.S. Bank Trust Company, National Association, as trustee (the “Trustee”)) at a cash repurchase price equal to 100% of their principal amount, together with the accrued and unpaid interest to, but excluding, the date of repurchase. Coherus also announced today that the Holders party to the Repurchases, which constitute a majority of the aggregate principal amount of the outstanding Convertible Notes, have agreed to provide their consent (the “Requisite Consents”) to adopt certain proposed amendments (the “Amendments”) to the Indenture. In connection with the Requisite Consents, the Company and the Trustee will execute a supplemental indenture (the “Supplemental Indenture”) to the Indenture effecting the Amendments. The Amendments will modify the Indenture to permit the proposed transaction for the divestiture of UDENYCA. About Coherus BioSciences Coherus is a fully integrated commercial-stage innovative oncology company with an approved next-generation PD-1 inhibitor, LOQTORZI® (toripalimab-tpzi), with growing revenues and a promising pipeline that includes two mid-stage clinical candidates targeting liver, lung, head & neck, and other cancers. Our strategy is to grow sales of LOQTORZI in nasopharyngeal carcinoma and advance the development of new indications for toripalimab in combination with both our pipeline candidates as well as our partners’, driving multiple development and sales synergies from proprietary combinations. Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust antitumor immunologic response and enhance outcomes for patients with cancer. Casdozokitug is a novel IL-27 antagonistic antibody currently being evaluated in three ongoing clinical studies: a Phase 1/2 study in advanced solid tumors including combination with toripalimab in NSCLC, a Phase 2 study in HCC, and a randomized Phase 2 study in HCC evaluating casdozokitug in combination with toripalimab and bevacizumab. CHS-114 is a highly selective, competitively positioned, cytolytic anti-CCR8 antibody currently in a Phase 1 study in patients with advanced solid tumors, including HNSCC and gastric cancer. Coherus markets LOQTORZI, a novel next-generation PD-1 inhibitor, and UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta. In December 2024, Coherus announced the planned divestiture of its UDENYCA franchise. The transaction is expected to close early in the second quarter of 2025. Neulasta® is a registered trademark of Amgen, Inc. Forward-Looking Statements The statements in this press release include express or implied forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 about the Repurchases, the Requisite Consents, the Supplemental Indenture and the proposed transaction between the Company and Intas that involve risks and uncertainties relating to future events and the future performance of the Company. Forward-looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar expressions concerning matters that are not historical facts. Words such as “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “future,” “opportunity,” “likely,” “target,” variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. You can also identify forward-looking statements by discussions of strategy, plans or intentions. Examples of such forward-looking statements include, but are not limited to, express or implied statements regarding: Coherus’ business, the Agreement and related matters, including, but not limited to, the consummation of the Repurchases, the Requisite Consents and the Supplemental Indenture, the ability to satisfy the closing conditions to consummate the proposed transaction at all or in the estimated time frame; prospective performance and opportunities with respect to the Company and its pipeline; statements about revenue or sales growth; statements about development and sales synergies; the ability of the Company’s product candidates to enhance outcomes for cancer patients; statements about the potential uses of proceeds from the proposed divestiture transaction including with respect to the repurchase offer for remaining Convertible Notes following the closing of the divestiture transaction; statements about the Company’s ability to repay its indebtedness in the future and the assumptions underlying or relating to such statements. These forward-looking statements are based on the Company’s current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, assumptions and changes in circumstances, many of which are beyond the control of the Company. A number of important factors, including those described in this press release, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: uncertainties as to the timing for completion of the proposed transaction, including the Repurchases, the Requisite Consents and the Supplemental Indenture; uncertainties as to the Company’s ability to satisfy the conditions necessary to consummate the proposed UDENYCA divestiture; the possibility that competing offers will be made by third parties; the occurrence of any event, change or other circumstance that may give rise to a right of one or both of Intas and the Company to terminate the Agreement; the possibility that the proposed transaction may not be completed in the time frame expected by the Company or at all; the risk that the proposed transaction disrupts the Company’s current plans and operations or diverts the attention of the Company’s management or employees from ongoing business operations; the effects of the proposed transaction on relationships with the Company’s employees, suppliers, business or collaboration partners or governmental entities, or other third parties as a result of the proposed transaction; the ability to retain and hire key personnel; significant or unexpected costs, charges or expenses resulting from the proposed transaction; the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, economic performance, indebtedness, financial condition and losses on the future prospects, business and management strategies for the management, expansion and growth of the Company after the consummation of the proposed transaction; potential negative effects related to this announcement or the consummation of the proposed transaction on the market price of the Company’s common stock and/or the Company’s operating or financial results; and the nature, cost and outcome of any litigation and other legal proceedings, including any legal proceedings related to the proposed UDENYCA divestiture transaction. While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. There can be no assurance that the transaction described above will in fact be consummated in the manner described or at all. For a further discussion of these and other factors that could cause the Company’s future results to differ materially from any forward-looking statements see the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 17, 2025, as updated by the Company’s subsequent periodic reports filed with the SEC and in other documents the Company files with the SEC, including the definitive proxy statement of the Company relating to the proposed transaction for the divestiture of UDENYCA filed with the SEC on January 28, 2025. Any forward-looking statements speak only as of the date of this press release and are made based on the current good faith beliefs and judgments of the Company’s management, and the reader is cautioned not to rely on any forward-looking statements made by the Company. Unless required by law, the Company is not under any duty and undertakes no obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, of new information, data or methods, future events or other changes UDENYCA® and LOQTORZI®, whether or not appearing in large print or with the trademark symbol, are trademarks of Coherus, its affiliates, related companies or its licensors or joint venture partners unless otherwise noted. Trademarks and trade names of other companies appearing in this press release are, to the knowledge of Coherus, the property of their respective owners. No Offer or Solicitation This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended. Additional Information and Where to Find It In connection with the proposed divestiture of UDENYCA, the Company filed with the SEC a definitive proxy statement on Schedule 14A on January 28, 2025, and it may also file other documents regarding the proposed transaction with the SEC. Promptly after filing its definitive proxy statement with the SEC, the Company started the process of mailing the definitive proxy statement and a proxy card to each stockholder entitled to vote at the special meeting relating to the proposed transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ CAREFULLY THE PROXY STATEMENT AND OTHER RELEVANT DOCUMENTS FILED OR TO BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS THERETO AND ANY DOCUMENTS INCORPORATED BY REFERENCE THEREIN, IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION, RELATED MATTERS AND THE PARTIES TO THE PROPOSED TRANSACTION. You may obtain a free copy of the proxy statement and other relevant documents (if and when they become available) that are or will be filed with the SEC for free at the SEC’s website at www.sec.gov. Copies of the documents filed with the SEC by the Company will be available free of charge on the Company’s website at https://investors.coherus.com/sec-filings or by contacting the Company’s Investor Relations Department at IR@coherus.com. Coherus BioSciences Contact Information: For investors:Jodi SieversVP, Investor Relations & Corporate CommunicationsIR@coherus.com