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Nanobiotix(NBTX) - 2024 Q2 - Quarterly Report
NBTXNanobiotix(NBTX)2024-09-18 20:15

Financial Performance - Revenue and other income for the six-month period ended June 30, 2024, was €9.3 million, a significant increase from €3.3 million in the same period of 2023, primarily due to the Janssen Agreement[12]. - Total revenues of €6.2 million for the first half of 2024 included €2.7 million from services linked to the Janssen license, €1.1 million from technology transfer, and €2.4 million from other sales[12]. - The net loss for the six-month period ended June 30, 2024, was €21.9 million, an improvement from a net loss of €28.1 million in the same period of 2023[16]. - The financial result for the first half of 2024 showed a loss of €1.9 million, an improvement from a loss of €2.7 million in the same period of 2023[16]. - For the six months ended June 30, 2024, the company reported a net loss of €21.9 million, compared to a net loss of €28.1 million for the same period in 2023, representing a 22.5% improvement[30]. - The company experienced a net cash outflow of €5.8 million from operating activities in the first half of 2024, compared to €17.3 million in the same period of 2023[24]. - The company recorded total operating expenses of €32.9 million for the six months ended June 30, 2024, compared to €28.7 million for the same period in 2023, marking a 14.5% increase[34]. - The basic loss per share for the six months ended June 30, 2024, was €0.46, compared to €0.80 for the same period in 2023[34]. - The company incurred operating losses since its inception in 2005 and expects to continue incurring significant losses in the near term[105]. Research and Development - The overall response rate (ORR) in evaluable anti-PD-1 naïve patients was 48%, while the disease control rate (DCR) was 76% in a Phase 1 study evaluating NBTXR3[9]. - The Company aims to replicate the NBTXR3 model across any solid tumor indication treated by radiotherapy alone or with immunotherapy[9]. - The Company is focusing on expanding the use of NBTXR3 in head and neck cancers and non-small-cell lung cancer (NSCLC) through collaborations with Janssen and MD Anderson[9]. - The company is focused on advancing the development of NBTXR3 while also exploring two additional nanoparticle-based therapy platforms, Curadigm and OOcuity[18]. - Research and development expenses increased to €22.0 million for the six months ended June 30, 2024, compared to €17.8 million for the same period in 2023, reflecting a 23.9% rise[34]. - The company has not recognized deferred tax assets related to tax losses carry forwards due to insufficient reliable income projections[56]. Collaborations and Agreements - Nanobiotix received a 20millionmilestonepaymentfromJansseninQ22024followingtheachievementofoperationalrequirementsintheNANORAY312study[9].ThecollaborationwithJanssenincludesaprotocolamendmenttoremovetheplannedfutilityanalysisfortheNANORAY312trial[9].TheJanssencollaborationcontinuestoprogress,withtheFDAissuingaStudyMayProceedLetterforaPhase2studyevaluatingNBTXR3forstage3unresectableNSCLC[11].ThecompanyenteredintoamasterservicesagreementwithJanssen,receivingpurchaseorderstotaling4.7millionforclinicalmanufacturingandtechnicalassistanceservices[155].ThecompanyreceivedpurchaseordersfromJanssenforrawmaterialsandclinicalbatchesamountingto3.8millionandtechnologytransferservicesof0.9million[155].AssetsandLiabilitiesCashandcashequivalentsdecreasedto66.3millionasofJune30,2024,downfrom75.3millionasofDecember31,2023[30].Thecompanystotalassetsdecreasedto86.7millionasofJune30,2024,from93.9millionasofDecember31,2023[31].Currentliabilitiesincreasedto56.5millionasofJune30,2024,comparedto49.9millionasofDecember31,2023,indicatinga13.220 million milestone payment from Janssen in Q2 2024 following the achievement of operational requirements in the NANORAY-312 study[9]. - The collaboration with Janssen includes a protocol amendment to remove the planned futility analysis for the NANORAY-312 trial[9]. - The Janssen collaboration continues to progress, with the FDA issuing a Study May Proceed Letter for a Phase 2 study evaluating NBTXR3 for stage 3 unresectable NSCLC[11]. - The company entered into a master services agreement with Janssen, receiving purchase orders totaling €4.7 million for clinical manufacturing and technical assistance services[155]. - The company received purchase orders from Janssen for raw materials and clinical batches amounting to €3.8 million and technology transfer services of €0.9 million[155]. Assets and Liabilities - Cash and cash equivalents decreased to €66.3 million as of June 30, 2024, down from €75.3 million as of December 31, 2023[30]. - The company's total assets decreased to €86.7 million as of June 30, 2024, from €93.9 million as of December 31, 2023[31]. - Current liabilities increased to €56.5 million as of June 30, 2024, compared to €49.9 million as of December 31, 2023, indicating a 13.2% rise[31]. - Total liabilities as of June 30, 2024, amounted to €68.3 million, an increase from €66.8 million in the previous period[104]. - The company’s total shareholders' equity as of June 30, 2024, was negative €21.8 million, a decline from negative €1.8 million as of December 31, 2023[31]. Cash Flow and Financing - The company expects to finance its operating activities through equity offerings, debt financings, and government subsidies until sufficient revenue is generated[27]. - The company reported a favorable variance in cash flows used in operating activities of €11.5 million, primarily driven by the recognition of €6.2 million in revenues during the first half of 2024[25]. - Cash flows from operating activities after tax and before changes in working capital were negative €18.1 million for the six months ended June 30, 2024, compared to negative €22.9 million in the prior year, indicating a 21% reduction in cash outflows[41]. - The company has reduced its consolidation scope, with four wholly owned subsidiaries as of June 30, 2024, reflecting strategic adjustments in its operational structure[51]. Employee and Shareholder Information - The average headcount increased to 105 employees as of June 30, 2024, compared to 98 in the previous year[122]. - Total compensation to related parties increased to €2.7 million for the six-month period ended June 30, 2024, compared to €1.8 million in 2023, reflecting higher salaries and share-based payments[156]. - The total number of BSPCEs authorized ranges from 450,000 to 500,000 across various grants, with a total number of shares likely to be subscribed varying from 50,000 to 129,250[130]. - The total number of shares available for subscription as of June 30, 2024, is not specified for several BSAs[132]. Financial Instruments and Market Conditions - The company does not use financial instruments for speculative purposes and has no derivative financial instruments[105]. - The dollar-to-euro exchange rate as of June 30, 2024, was 1.0705, compared to $1.0866 as of June 30, 2023[53]. - The estimated fair value of the debt as of June 30, 2024, is €35.4 million, with an estimated fair market rate of 22.4% due to increased spreads[90].