$71 million in funding would extend Nanobiotix cash visibility into early 2028Transaction enables Nanobiotix development beyond key milestones in head and neck cancer and lung cancerFinancing establishes financial foundation toward self-sustainability and the advancement of next wave nanotherapeutic platforms for long-term growthHealthCare Royalty (HCRx) will receive a capped portion of milestones and royalties on sales of JNJ-1900 (NBTXR3) payable to Nanobiotix under its global licensing agreement PARIS an ...

Core Insights - Nanobiotix has announced updates to the clinical development program for JNJ-1900 (NBTXR3), a late-stage clinical biotechnology product aimed at expanding treatment options for cancer patients [1][2]. Group 1: Clinical Development Updates - The transfer of NANORAY-312 sponsorship to Johnson & Johnson has been completed, along with the operational control of the Phase 3 clinical trial [2]. - Nanobiotix estimates that interim data for NANORAY-312 will be analyzed and reported in the first half of 2027, following the observation of the requisite number of events and recruitment of the last patient [2]. - Future guidance related to NANORAY-312 and other JNJ-1900 (NBTXR3)-related studies will be communicated by Johnson & Johnson, while Nanobiotix will continue to provide updates on its sponsored studies [3]. Group 2: Product Overview - JNJ-1900 (NBTXR3) is a novel oncology product utilizing functionalized hafnium oxide nanoparticles, administered via a one-time intratumoral injection and activated by radiotherapy [4]. - The product's mechanism of action is designed to induce significant tumor cell death in the injected tumor, triggering an adaptive immune response and long-term anti-cancer memory [4]. - The product is being evaluated across multiple solid tumor indications, with a focus on locally advanced head and neck squamous cell cancers in the NANORAY-312 Phase 3 study [5]. Group 3: Strategic Collaborations - Nanobiotix has engaged in a collaboration strategy to expand the development of JNJ-1900 (NBTXR3), including a comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center [6]. - In 2023, a license agreement was announced for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a subsidiary of Johnson & Johnson [6]. Group 4: Company Background - Nanobiotix is a late-stage clinical biotechnology company founded in 2003, headquartered in Paris, France, and listed on Euronext Paris and Nasdaq [8]. - The company holds over 25 umbrella patents associated with three nanotechnology platforms, focusing on oncology, bioavailability, and disorders of the central nervous system [9].

Market Overview - U.S. stock futures are higher, with Dow futures gaining approximately 0.2% on Monday [1] Company-Specific Movements - Olema Pharmaceuticals Inc (NASDAQ:OLMA) shares fell 18.3% to $7.64 in pre-market trading following the announcement of new data from the Phase 1b/2 trial of palazestrant plus ribociclib in ER+/HER2- metastatic breast cancer at ESMO 2025 [1] - Concord Medical Services Hldgs Ltd (NYSE:CCM) experienced a decline of 24.4% to $4.15 in pre-market trading after a 6% drop on Friday [3] - Addex Therapeutics Ltd – ADR (NASDAQ:ADXN) dipped 15.6% to $9.23 in pre-market trading after a significant gain of 28% on Friday [3] - Exelixis Inc (NASDAQ:EXEL) shares fell 8.3% to $36.00 after announcing detailed results from the Phase 3 STELLAR-303 pivotal trial evaluating zanzalintinib in combination with an immune checkpoint inhibitor in metastatic colorectal cancer, presented at ESMO 2025 and published in The Lancet [3] - Cellectis SA (NASDAQ:CLLS) shares declined 7.3% to $3.69 in pre-market trading [3] - Alumis Inc (NASDAQ:ALMS) saw a decline of 6.7% to $4.19 in pre-market trading [3] - Nanobiotix SA – ADR (NASDAQ:NBTX) fell 6.3% to $23.98 in pre-market trading after a 4% decline on Friday [3] - Genmab A/S – ADR (NASDAQ:GMAB) declined 4.1% to $31.81 in pre-market trading, with Rinatabart Sesutecan achieving a 50% objective response rate and two complete responses in advanced endometrial cancer [3] - Taysha Gene Therapies Inc (NASDAQ:TSHA) fell 4% to $4.53 in pre-market trading [3]

Group 1 - U.S. stock futures are lower, with Dow futures falling more than 350 points [1] - Orion SA expects third-quarter adjusted EBITDA to be around $55 million and full-year adjusted EBITDA in the range of $220-$235 million, leading to an 18.6% drop in shares to $5.56 in pre-market trading [1] Group 2 - ENDRA Life Sciences Inc shares fell 19.4% to $6.54 after a previous 25% increase due to $4.9 million in funding commitments [4] - Canaan Inc shares tumbled 11.8% to $1.34 after a 39% jump, despite a maintained Buy rating and $4 price target from Rosenblatt analyst [4] - DBV Technologies SA shares fell 11.8% to $14.48 after gaining around 10% previously [4] - Nanobiotix SA shares tumbled 10.2% to $27.23 after a previous increase of over 28% [4] - Draganfly Inc shares dipped 9.4% to $12.47 after filing for a mixed shelf of up to $200 million [4] - Bitdeer Technologies Group shares fell 9% to $18.61 after a 15% gain [4] - Diginex Ltd shares fell 9% to $23.40 [4] - HIVE Digital Technologies shares dipped 8.1% to $6.21, despite a maintained Buy rating and $10 price target [4] - Oatly Group AB shares fell 7.8% to $13.29 after a 5% gain [4] - Bit Digital Inc shares declined 7.7% to $3.69 after a previous gain of over 6% [4] - Upexi Inc shares fell 7.7% to $5.98 [4] - Sharplink Gaming Inc shares declined 7.1% to $14.98 after adding 5% previously [4] - Nio Inc shares fell 5% to $6.82, influenced by new port fees affecting US-listed Chinese stocks [4] - Alibaba Group Holding Ltd shares declined 4% to $160.20, also impacted by new port fees [4]

Core Insights - Nanobiotix (NBTX) is a clinical-stage nanomedicine company valued at $1.3 billion, focusing on innovative cancer treatment approaches with proprietary technology including NBTXR3 [1] Stock Performance - NBTX has shown exceptional price momentum, gaining 440% over the past year and 200.78% since a "Buy" signal was issued on August 27 [2][6] - The stock reached an all-time high of $27.77 in intraday trading on October 8 [4] - NBTX has made 13 new highs and gained 198.02% in the last month, with a Relative Strength Index (RSI) of 82.55 [7] Technical Indicators - Barchart indicates a 100% "Buy" opinion for NBTX, with a Weighted Alpha of +470.88 [7] - The stock has a technical support level around $25.96 [7] Revenue and Earnings Projections - Revenue is projected to grow by 643.31% this year and an additional 89.01% next year [7] - Earnings are estimated to increase by 79.86% this year and 235.61% next year [7]

Core Insights - NANOBIOTIX announced promising initial data from a Phase 1 study evaluating JNJ-1900 (NBTXR3) combined with chemoradiation for patients with locally advanced esophageal adenocarcinoma (EADC) [1][4][6] Company Overview - NANOBIOTIX is a late-stage clinical biotechnology company focused on physics-based therapeutic approaches to improve treatment outcomes for cancer patients [10][12] - The company is headquartered in Paris, France, and is listed on Euronext Paris and NASDAQ [12] Study Details - The study is sponsored by The University of Texas MD Anderson Cancer Center and involves a dose escalation and expansion study of JNJ-1900 (NBTXR3) [1][2] - The study includes two cohorts: cohort 1 with photon chemoradiation and cohort 2 with proton chemoradiation [1] Efficacy and Safety Results - The treatment was well-tolerated in the study population of 13 patients, with an 85% disease control rate (DCR) and a 69% objective response rate (ORR) [4][11] - Six patients underwent surgery post-treatment, with two achieving pathological complete response (pCR) [11] Mechanism of Action - JNJ-1900 (NBTXR3) consists of functionalized hafnium oxide nanoparticles that induce tumor cell death when activated by radiotherapy, potentially enhancing local control and reducing the need for invasive surgeries [7][3] Future Development - The study's results support further investigation of JNJ-1900 (NBTXR3) in combination with proton radiation therapy, which could open new indications for the product [6] - NANOBIOTIX has engaged in collaborations to expand the development of JNJ-1900 (NBTXR3) across various tumor types and therapeutic combinations [9]

Clinical Development - Nanobiotix reported ongoing clinical development for JNJ-1900 (NBTXR3) in head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC) as strategic priorities[24]. - The Phase 3 NANORAY-312 trial is progressing with sponsorship transferred to Janssen Pharmaceutica NV, enhancing financial support for the trial[24][30]. - In the first quarter of 2025, the first patient was dosed in the CONVERGE trial, a randomized global Phase 2 study for JNJ-1900 (NBTXR3) in Stage III unresectable NSCLC[26]. - Preliminary results from a Phase 1 trial showed a 12-month local progression-free survival (LPFS) of 64% and overall survival (OS) of 83% for JNJ-1900 (NBTXR3) in previously irradiated NSCLC patients[27]. - Full data from a Phase 1 trial in pancreatic cancer indicated that JNJ-1900 (NBTXR3) may enhance local tumor control after induction chemotherapy[28][29]. Financial Performance - Total revenue for the six-month period ended June 30, 2025, reached €24.9 million, a significant increase from €6.2 million in the same period of 2024, primarily driven by the Janssen Agreement contract modification[32][36]. - Operating expenses decreased to €25.8 million in the first half of 2025 from €32.9 million in the first half of 2024, with R&D expenses comprising 56% and SG&A expenses 44% of total operating expenses[37][41]. - The operating result for the six-month period ended June 30, 2025, was an income of €0.8 million, compared to a loss of €23.7 million for the same period in 2024[42]. - The net loss for the six-month period ended June 30, 2025, was €5.4 million, a reduction from a net loss of €21.9 million in the same period of 2024[44][65]. - Total revenues and other income for the six-month period ended June 30, 2025, increased to €26,638 thousand, up from €9,289 thousand for the same period in 2024, marking a growth of approximately 187%[81]. Cash Flow and Liquidity - Cash flows used in operating activities amounted to €17.4 million for the six months ended June 30, 2025, compared to €5.8 million in the same period of 2024, reflecting a negative change of €11.6 million[58]. - The company had €28.8 million in available cash and cash equivalents as of June 30, 2025, consisting of liquid cash and short-term bank deposits[66]. - The company estimates it will require additional liquidity in the range of €8 to €10 million to meet its obligations over the next 12 months[68]. - As of June 30, 2025, the company's cash and cash equivalents decreased to €28,818 thousand from €49,737 thousand as of December 31, 2024, representing a decline of approximately 42%[78]. - The company is in active discussions regarding non-dilutive financing to extend its cash runway beyond the next 12 months[70]. Shareholder Equity and Assets - The company’s total shareholders' equity as of June 30, 2025, was negative €68,952 thousand, compared to negative €65,704 thousand as of December 31, 2024[78]. - The company's total assets decreased to €45,174 thousand as of June 30, 2025, down from €67,418 thousand as of December 31, 2024, reflecting a decline of about 33%[78]. - Total liabilities decreased to €114,126 thousand as of June 30, 2025, from €133,122 thousand as of December 31, 2024, a reduction of approximately 14%[78]. Research and Development - Research and development expenses for the six-month period ended June 30, 2025, decreased to €14,529 thousand from €21,987 thousand in 2024, a reduction of about 34%[81]. - Clinical trial expenses are estimated quarterly, with provisions recognized accordingly, reflecting ongoing investment in research and development[134]. - The company expects to require substantial additional capital to continue its clinical development activities and potentially engage in commercialization activities[196]. Agreements and Collaborations - An amendment to the License Agreement with J&J transferred almost full financial responsibility for the NANORAY-312 study to J&J, with limited future milestone obligations reduced[30]. - The global licensing agreement with J&J includes a framework for potential co-development of new indications, with immediate priorities in locally-advanced head and neck squamous cell carcinoma and stage 3 NSCLC[46]. - An amendment to the Janssen agreement has reduced total expected payments from approximately $2.7 billion to $2.6 billion, with potential milestone payments of $105 million over the next 2-3 years[1]. Financial Risks - The principal financial risks include liquidity, foreign currency exchange, interest rate, and credit risks[193]. - The company may need to significantly curtail or delay its research or development programs if it cannot obtain necessary funding in a timely manner[71].

Core Insights - NANOBIOTIX reported significant operational progress and financial results for the first half of 2025, highlighting a strong increase in revenue and a reduction in net loss compared to the previous year [1][6]. Operational Highlights - The clinical development program for JNJ-1900 (NBTXR3) is gaining momentum, with the first patient dosed in the CONVERGE study for Stage 3 unresectable non-small cell lung cancer [4]. - Regulatory harmonization has been achieved, reclassifying JNJ-1900 (NBTXR3) from a medical device to a drug in major European countries [4]. - The company is actively pursuing non-dilutive financing to extend its cash runway beyond mid-2026 [4][11]. Financial Results - Revenue and other income for the six months ended June 30, 2025, increased to €26.6 million from €9.3 million in the same period of 2024, largely due to a positive non-cash revenue impact of €21.2 million from a J&J amendment [2]. - R&D expenses decreased to €14.5 million from €22.0 million year-over-year, primarily due to reduced clinical development activities following the transfer of the NANORAY-312 study sponsorship to J&J [3]. - SG&A expenses remained stable at €11.3 million compared to €10.8 million in the previous year [5]. Net Loss and Cash Position - The net loss attributable to common shareholders for the first half of 2025 was €5.4 million, a significant reduction from €21.9 million in the same period of 2024 [6]. - Cash and cash equivalents as of June 30, 2025, were €28.8 million, down from €49.7 million at the end of 2024 [6][9]. Financial Guidance - The company anticipates that its cash and cash equivalents will fund operations into mid-2026, consistent with prior guidance [7].

Core Insights - NANOBIOTIX presented updated data from Study 1100, a Phase 1 trial evaluating JNJ-1900 (NBTXR3) in combination with radiation therapy and anti-PD-1 inhibitors for patients with recurrent and/or metastatic head and neck squamous cell carcinoma [1][2][3] Study Results - The study included two cohorts: anti-PD-1 naïve patients and anti-PD-1 resistant patients, with a total of 103 heavily pre-treated participants [3][4] - In anti-PD-1 naïve patients, the disease control rate (DCR) was 63% and the objective response rate (ORR) was 37% [3][9] - In anti-PD-1 resistant patients, the DCR was 74% and the ORR was 32% [3][9] - Median overall survival (mOS) was 15.5 months for anti-PD-1 naïve patients and 11.4 months for anti-PD-1 resistant patients [3][9] Safety and Feasibility - The treatment was well-tolerated, with a favorable safety profile and no additional toxicities observed in lesions injected after re-irradiation [4][3] - A total of 71 patients experienced treatment-emergent adverse events (TEAEs) related to the therapeutic regimen [4] Efficacy Signals - The study indicated strong local control with an aggregate DCR of 95% in injected lesions, suggesting potential systemic responses beyond the injected area [5][3] - Early survival data suggests that JNJ-1900 may overcome prior resistance to immune checkpoint inhibitors [5][6] Product Overview - JNJ-1900 (NBTXR3) is a novel oncology product utilizing functionalized hafnium oxide nanoparticles, administered via intratumoral injection and activated by radiotherapy [7] - The product has shown proof-of-concept in soft tissue sarcomas and is being evaluated across multiple solid tumor indications [8][7] Collaboration and Development - NANOBIOTIX has engaged in a collaboration strategy to expand the development of JNJ-1900, including a partnership with The University of Texas MD Anderson Cancer Center and a license agreement with Johnson & Johnson for global co-development [11][12]

Group 1: Stitch Fix, Inc. - Stitch Fix reported a quarterly loss of $0.07 per share, which was better than the consensus estimate of a loss of $0.10 per share [1] - The company's quarterly revenue was $311.22 million, exceeding the Street estimate of $305.83 million [1] - Despite the positive revenue results, Stitch Fix shares dipped 7.6% to $5.21 in pre-market trading [1] Group 2: Other Stocks - Transocean Ltd. saw a decline of 14.7% to $3.10 following the announcement of an upsized public offering of shares [4] - Nanobiotix S.A. fell 9.8% to $14.83 after previously gaining over 15%, related to new results from a Phase 1 study [4] - MBX Biosciences, Inc. dropped 5.5% to $19.00 due to the pricing of an upsized public offering [4] - Other companies such as Galectin Therapeutics Inc., Amprius Technologies, Inc., and Canaan Inc. also experienced declines in pre-market trading [4]