Core Insights - OSE Immunotherapeutics has appointed Thomas Gidoin as Chief Financial Officer, bringing over 15 years of international expertise in capital markets and financial strategy [1][5][6] - Gidoin has a strong background in biopharma finance, having previously served as CFO at Advesya and GenSight Biologics, where he led financing strategies from Series B to IPO [2][3] - The company is positioned for growth with two late-stage assets in oncology and inflammation, supported by an innovative research platform [6][7] Company Overview - OSE Immunotherapeutics is focused on developing first-in-class assets in immuno-oncology and immuno-inflammation to address unmet patient needs [7] - The company collaborates with leading academic institutions and biopharmaceutical companies to bring transformative medicines to market [7] - OSE Immunotherapeutics is based in Nantes and Paris and is listed on Euronext [7]

[DBV Technologies Second Quarter and Half-Year 2025 Financial Results](index=1&type=section&id=DBV%20Technologies%20Second%20Quarter%20and%20Half-Year%202025%20Financial%20Results) [Financial Highlights](index=1&type=section&id=Financial%20Highlights) DBV Technologies reported a net loss of $69.0 million in H1 2025, with cash increasing to $103.2 million, yet faces going concern doubts [Operating Income](index=1&type=section&id=Operating%20Income) - Operating income for the first six months of 2025 decreased compared to the same period in 2024, primarily due to a lower French Research Tax Credit as more study activities were conducted in North America and were therefore ineligible[4](index=4&type=chunk) Operating Income (U.S. GAAP) | Operating Income (U.S. GAAP) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | **In millions of USD** | | | | Research tax credit | $2.2 | $2.6 | | Operating income | $2.2 | $2.6 | [Operating Expenses](index=2&type=section&id=Operating%20Expenses) - Operating expenses for the first six months of 2025 increased by **$4.9 million** year-over-year, mainly driven by the launch of the COMFORT Toddlers supplemental safety study[6](index=6&type=chunk) Operating Expenses (U.S. GAAP) | Operating Expenses (U.S. GAAP) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | **In millions of USD** | | | | Research & Development | $(55.2) | $(46.8) | | Sales & Marketing | $(0.7) | $(1.7) | | General & Administrative | $(14.1) | $(16.4) | | **Total Operating Expenses** | **$(69.9)** | **$(65.0)** | [Net Loss and Net Loss Per Share](index=2&type=section&id=Net%20Loss%20and%20Net%20Loss%20Per%20Share) - The company's net loss widened for the first half of 2025 compared to the prior year, while the net loss per share showed a slight improvement[8](index=8&type=chunk) Net Loss Metrics (U.S. GAAP) | Net Loss Metrics (U.S. GAAP) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net loss (in millions of USD) | $(69.0) | $(60.5) | | Basic / diluted net loss per share (USD/share) | $(0.58) | $(0.63) | [Cash Position and Going Concern](index=2&type=section&id=Cash%20Position%20and%20Going%20Concern) - The company's cash and cash equivalents significantly increased to **$103.2 million** as of June 30, 2025, from **$32.5 million** at the end of 2024, primarily due to a new financing arrangement[10](index=10&type=chunk)[14](index=14&type=chunk) - In March 2025, the company announced a financing of up to **$306.9 million** to advance its Viaskin® Peanut patch, with initial gross proceeds of **$125.5 million** received in April 2025[11](index=11&type=chunk) - Despite the recent financing, the company states there is substantial doubt about its ability to continue as a going concern, as its current cash is estimated to fund operations only into the **second quarter of 2026**[10](index=10&type=chunk)[11](index=11&type=chunk) [Condensed Consolidated Financial Statements](index=4&type=section&id=Condensed%20Consolidated%20Financial%20Statements) Condensed financial statements as of June 30, 2025, show total assets of **$143.4 million** and a net loss of **$69.0 million** [Statements of Financial Position](index=4&type=section&id=Statements%20of%20Financial%20Position) Balance Sheet Highlights (U.S. GAAP) | Balance Sheet Highlights (U.S. GAAP) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **In millions of USD** | | | | Cash & cash equivalents | $103.2 | $32.5 | | **Total Assets** | **$143.4** | **$65.7** | | **Total Liabilities** | **$57.2** | **$38.3** | | **Shareholders' equity** | **$86.2** | **$27.4** | [Statements of Operations](index=4&type=section&id=Statements%20of%20Operations) Income Statement (U.S. GAAP) | Income Statement (U.S. GAAP) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | **In millions of USD** | | | | Operating income | $2.2 | $2.6 | | Research & Development | $(55.2) | $(46.8) | | Operating expenses | $(69.9) | $(65.0) | | **Net loss** | **$(69.0)** | **$(60.5)** | | **Basic/diluted net loss per share** | **$(0.58)** | **$(0.63)** | [Company Overview and Forward-Looking Statements](index=5&type=section&id=Company%20Overview%20and%20Forward-Looking%20Statements) DBV Technologies, a clinical-stage biopharmaceutical company, focuses on Viaskin Peanut development and includes standard forward-looking statements - DBV Technologies is a clinical-stage biopharmaceutical company developing treatments for food allergies via its proprietary epicutaneous immunotherapy (EPIT) platform, Viaskin[18](index=18&type=chunk) - The company's primary focus is on the clinical trials of Viaskin Peanut for peanut-allergic toddlers (1-3 years) and children (4-7 years)[18](index=18&type=chunk) - The press release contains forward-looking statements regarding its financial condition and the potential of Viaskin® Peanut, which involve substantial risks as its product candidates are not yet authorized for sale[20](index=20&type=chunk)

Part I – [Financial Information](index=5&type=section&id=Part%20I%20%E2%80%93%20Financial%20Information) [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements, including the statements of financial position, operations and comprehensive loss, cash flows, and changes in shareholders' equity, along with detailed notes explaining significant accounting policies, clinical program updates, financing events, and other financial details [Condensed Consolidated Statements of Financial Position (Unaudited)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Financial%20Position%20%28Unaudited%29) Condensed Consolidated Statements of Financial Position (in thousands) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------- | | **Assets** | | | | Cash and cash equivalents | $103,207 | $32,456 | | Total current assets | $121,241 | $44,388 | | Total non-current assets | $22,188 | $21,271 | | **Total Assets** | **$143,429** | **$65,658** | | **Liabilities** | | | | Total current liabilities | $49,425 | $31,136 | | Total non-current liabilities | $7,780 | $7,135 | | **Total Liabilities** | **$57,205** | **$38,271** | | **Shareholders' Equity** | | | | Total Shareholders' equity | $86,224 | $27,387 | | **Total Liabilities and Shareholder's equity** | **$143,429** | **$65,658** | - Total Assets increased significantly from **$65.7 million** at December 31, 2024, to **$143.4 million** at June 30, 2025, primarily driven by a substantial increase in cash and cash equivalents[16](index=16&type=chunk) - Total Shareholders' Equity rose from **$27.4 million** at December 31, 2024, to **$86.2 million** at June 30, 2025, reflecting recent financing activities[16](index=16&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20%28Unaudited%29) Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Operating income | $1,465 | $1,161 | $2,217 | $2,568 | | Research and development expenses | $(33,693) | $(25,374) | $(55,176) | $(46,777) | | Sales and marketing expenses | $(419) | $(986) | $(681) | $(1,744) | | General and administrative expenses | $(8,463) | $(8,643) | $(14,089) | $(16,447) | | Total Operating expenses | $(42,575) | $(35,003) | $(69,946) | $(64,968) | | Loss from operations | $(41,111) | $(33,842) | $(67,728) | $(62,400) | | Financial income (expense) | $(648) | $726 | $(1,109) | $1,986 | | Net loss | $(41,875) | $(33,116) | $(68,954) | $(60,461) | | Basic/diluted Net loss per share | $(0.31) | $(0.34) | $(0.58) | $(0.63) | - Net loss increased to **$(41.9) million** for the three months ended June 30, 2025, from **$(33.1) million** in the prior year, and to **$(69.0) million** for the six months ended June 30, 2025, from **$(60.5) million** in the prior year[19](index=19&type=chunk) - Research and development expenses significantly increased by **33%** for the three months and **18%** for the six months ended June 30, 2025, reflecting increased clinical trial activities[19](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows (Unaudited)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20%28Unaudited%29) Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash flow used in operating activities | $(53,573) | $(69,765) | | Net cash flows used in investing activities | $(413) | $(1,441) | | Net cash flows provided by (used in) financing activities | $116,992 | $(95) | | Effect of exchange rate changes on cash and cash equivalents | $7,746 | $(3,853) | | Net (decrease) / increase in cash and cash equivalents | $70,752 | $(75,154) | | Net Cash and cash equivalents at the end of the period | $103,207 | $66,213 | - Net cash provided by financing activities was **$117.0 million** for the six months ended June 30, 2025, a significant increase from **$(95) thousand** in the prior year, primarily due to a recent financing operation[21](index=21&type=chunk)[181](index=181&type=chunk) - Net cash used in operating activities decreased by **$16.2 million** to **$53.6 million** for the six months ended June 30, 2025, compared to **$69.8 million** in the prior year, due to contained costs and extended payment terms[21](index=21&type=chunk)[178](index=178&type=chunk) [Condensed Consolidated Statements of Changes in Shareholders' Equity (Unaudited)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders%27%20Equity%20%28Unaudited%29) Condensed Consolidated Statements of Changes in Shareholders' Equity (in thousands) | Equity Component (in thousands) | Balance at January 1, 2025 | Balance at June 30, 2025 | | :------------------------------ | :------------------------- | :----------------------- | | Ordinary shares (Amount) | $11,651 | $15,393 | | Additional paid-in capital | $315,613 | $391,546 | | Treasury stock | $(1,309) | $(1,238) | | Accumulated deficit | $(286,375) | $(315,136) | | Accumulated other comprehensive income | $905 | $861 | | Accumulated currency translation effect | $(13,097) | $(5,202) | | **Total Shareholders' Equity** | **$27,387** | **$86,224** | - Total Shareholders' Equity increased from **$27.4 million** at January 1, 2025, to **$86.2 million** at June 30, 2025, primarily due to capital increases from the issuance of ordinary shares and share warrants[26](index=26&type=chunk)[101](index=101&type=chunk) - The Company's share capital increased from **€10,285,886.80** to **€13,694,887.20** due to the full subscription and payment of **34,090,004 new ordinary shares**[101](index=101&type=chunk) [Notes to the Condensed Consolidated Financial Statements (Unaudited)](index=10&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) [Note 1: The Company](index=10&type=section&id=Note%201%3A%20The%20Company) - DBV Technologies S.A. is a clinical-stage biopharmaceutical company developing Viaskin, a novel epicutaneous immunotherapy platform, for food allergies[27](index=27&type=chunk)[118](index=118&type=chunk) - The financial statements are prepared in accordance with U.S. GAAP and are unaudited, with estimates and assumptions used that may differ from actual results[28](index=28&type=chunk)[30](index=30&type=chunk)[31](index=31&type=chunk) - The Company has incurred operating losses and negative cash flows since inception, and despite recent financing, there is substantial doubt about its ability to continue as a going concern into the second quarter of **2026**[34](index=34&type=chunk)[37](index=37&type=chunk)[164](index=164&type=chunk) [Note 2: Significant Events and Transactions](index=11&type=section&id=Note%202%3A%20Significant%20Events%20and%20Transactions) - For Viaskin Peanut in toddlers (**1-3 years**), the FDA has agreed to an Accelerated Approval pathway, requiring the COMFORT Toddlers safety study (initiated June **2025**) and a confirmatory effectiveness study to be initiated at BLA submission[55](index=55&type=chunk)[56](index=56&type=chunk)[65](index=65&type=chunk)[72](index=72&type=chunk)[73](index=73&type=chunk) - For Viaskin Peanut in children (**4-7 years**), the COMFORT Children supplemental safety study is no longer required, as VITESSE Phase **3** safety data will suffice for BLA filing, with submission planned for H**1 2026**, potentially accelerating launch by **one year**[57](index=57&type=chunk)[77](index=77&type=chunk)[120](index=120&type=chunk) - The Company completed a financing on April **7**, **2025**, raising **$125.5 million** (**€116.3 million**) in gross proceeds, with potential for up to an additional **$181.4 million** (**€168.2 million**) from warrant exercises, contingent on VITESSE Phase **3** results[36](index=36&type=chunk)[38](index=38&type=chunk)[78](index=78&type=chunk)[163](index=163&type=chunk)[165](index=165&type=chunk) [Note 3: Cash and Cash Equivalents](index=15&type=section&id=Note%203%3A%20Cash%20and%20Cash%20Equivalents) Cash and Cash Equivalents (in thousands) | Category | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--------- | :----------------------------- | :------------------------------- | | Cash | $29,371 | $32,456 | | Cash equivalents | $73,836 | — | | **Total** | **$103,207** | **$32,456** | - Total cash and cash equivalents increased significantly to **$103.2 million** as of June **30**, **2025**, from **$32.5 million** at December **31**, **2024**, primarily due to the inclusion of **$73.8 million** in cash equivalents[90](index=90&type=chunk) [Note 4: Other Current Assets](index=15&type=section&id=Note%204%3A%20Other%20Current%20Assets) Other Current Assets (in thousands) | Category | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :------------------ | :----------------------------- | :------------------------------- | | Research tax credit | $2,378 | $3,980 | | Other tax claims | $10,428 | $4,452 | | Prepaid expenses | $2,343 | $1,541 | | Other receivables | $2,885 | $1,959 | | **Total** | **$18,034** | **$11,932** | - Other current assets increased by **$6.1 million** to **$18.0 million** at June **30**, **2025**, mainly due to a significant rise in other tax claims (primarily VAT reimbursement) and prepaid expenses[91](index=91&type=chunk)[93](index=93&type=chunk) - The research tax credit receivable decreased from **$3.98 million** to **$2.38 million**, with **$2.2 million** estimated for the first six months of **2025**[91](index=91&type=chunk)[92](index=92&type=chunk) [Note 5: Lease contracts](index=15&type=section&id=Note%205%3A%20Lease%20contracts) Lease contracts (in thousands) | Lease Liability (in thousands) | June 30, 2025 | December 31, 2024 | | :----------------------------- | :------------ | :---------------- | | Current portion | $998 | $654 | | Long-term lease liabilities | $6,696 | $6,297 | | **Total Present value of lease liabilities** | **$7,695** | **$6,951** | | Weighted average remaining lease term (years) | 7.17 | 7.49 | | Weighted average discount rate | 5.13% | 5.02% | - Operating lease expense decreased to **$562 thousand** for the six months ended June **30**, **2025**, from **$1,255 thousand** in the prior year, partly due to a net restructuring impact[95](index=95&type=chunk) - Cash paid for operating leases decreased significantly to **$180 thousand** for the six months ended June **30**, **2025**, from **$1,019 thousand** in the prior year[95](index=95&type=chunk) [Note 6: Trade Payables and Other Liabilities](index=17&type=section&id=Note%206%3A%20Trade%20Payables%20and%20Other%20Liabilities) Trade Payables and Other Liabilities (in thousands) | Liability Category (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Trade payables | $40,792 | $22,032 | | Employee related liabilities | $6,293 | $7,294 | | Tax liabilities | $625 | $188 | | Other debts | $600 | $846 | | **Total Other current liabilities** | **$7,518** | **$8,328** | - Trade payables increased by **$18.8 million** to **$40.8 million** at June **30**, **2025**, reflecting increased clinical trials and manufacturing expenditures[16](index=16&type=chunk)[96](index=96&type=chunk) - Other current liabilities decreased to **$7.5 million** at June **30**, **2025**, from **$8.3 million** at December **31**, **2024**, mainly due to changes in bonus accruals within employee-related liabilities[16](index=16&type=chunk)[97](index=97&type=chunk) [Note 7: Shareholders' equity](index=17&type=section&id=Note%207%3A%20Shareholders%27%20equity) - As of June **30**, **2025**, the share capital is **€13,697,370**, divided into **136,973,697 ordinary shares** with a par value of **€0.10**[98](index=98&type=chunk) - The Company's share capital increased from **€10,285,886.80** to **€13,694,887.20** following the full subscription of **34,090,004 new ordinary shares** as part of the March **2025** financing[101](index=101&type=chunk) - Net income for FY**2024** was allocated to retained earnings, resulting in a debit balance of **€102.3 million**, and the share premium account was cleared, leaving a debit balance of **€67.1 million** on retained earnings[99](index=99&type=chunk) [Note 8: Share-Based Payments](index=19&type=section&id=Note%208%3A%20Share-Based%20Payments) Share-Based Payments | Share-Based Instrument | Balance as of Dec 31, 2024 | Granted | Forfeited | Exercised/Released | Expired | Balance as of June 30, 2025 | | :--------------------- | :------------------------- | :------ | :-------- | :----------------- | :------ | :-------------------------- | | Non-employee warrants (BSA) | 244,693 | — | — | — | (49,185) | 195,508 | | Stock options (SO) | 10,452,903 | 215,000 | (66,100) | — | (128,100) | 10,473,703 | | Restricted stock units (RSUs) | 2,813,366 | 35,000 | (82,850) | (36,192) | — | 2,729,324 | Share-Based Compensation Expense (in thousands) | Expense Category (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research & development | $(543) | $(697) | $(1,124) | $(1,466) | | Sales & marketing | $(19) | $(29) | $(37) | $(61) | | General & administrative | $(683) | $(799) | $(1,786) | $(1,956) | | **Total share-based compensation (expense)** | **$(1,246)** | **$(1,525)** | **$(2,947)** | **$(3,483)** | - Total share-based compensation expense decreased to **$(1.2) million** for the three months and **$(2.9) million** for the six months ended June **30**, **2025**, compared to the prior year periods[105](index=105&type=chunk) [Note 9: Contingencies](index=20&type=section&id=Note%209%3A%20Contingencies) Contingencies (in thousands) | Contingency Type (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------ | :------------ | :---------------- | | Current contingencies | $117 | $122 | | Non-current contingencies | $1,084 | $838 | | **Total contingencies** | **$1,201** | **$961** | - Total contingencies increased to **$1.2 million** at June **30**, **2025**, from **$961 thousand** at December **31**, **2024**, driven by increases in pension retirement obligations and other contingencies, along with currency translation effects[106](index=106&type=chunk) [Note 10: Operating income](index=20&type=section&id=Note%2010%3A%20Operating%20income) Operating income (in thousands) | Operating Income (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research tax credit | $1,465 | $1,161 | $2,217 | $2,568 | | **Total** | **$1,465** | **$1,161** | **$2,217** | **$2,568** | - Research tax credit increased by **$0.3 million** for the three months ended June **30**, **2025**, due to more eligible activities, particularly the launch of the COMFORT Toddlers clinical trial[107](index=107&type=chunk) - Research tax credit decreased by **$0.4 million** for the six months ended June **30**, **2025**, as a greater proportion of clinical studies were conducted in North America, making them ineligible for the French Research tax credit[107](index=107&type=chunk) [Note 11: Operating Expenses](index=20&type=section&id=Note%2011%3A%20Operating%20Expenses) Personnel Expenses by Function (in thousands) | Personnel Expenses by Function (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and Development expenses | $5,697 | $5,177 | $10,327 | $10,225 | | Sales & Marketing expenses | $194 | $233 | $350 | $567 | | General & Administrative expenses | $3,908 | $3,413 | $6,904 | $6,650 | | **Total personnel expenses** | **$9,799** | **$8,824** | **$17,581** | **$17,442** | - Total personnel expenses increased for both the three-month and six-month periods ended June **30**, **2025**, primarily due to recruitments in Q**2 2024** and retroactive salary increases in Q**2 2025**[109](index=109&type=chunk) - The average number of employees increased to **109** during the six months ended June **30**, **2025**, from **106** in the prior year, supporting development and quality activities[108](index=108&type=chunk) [Note 12: Commitments](index=21&type=section&id=Note%2012%3A%20Commitments) - There were no significant changes in other commitments from those disclosed in the Annual Report[110](index=110&type=chunk) [Note 13: Relationships with Related Parties](index=21&type=section&id=Note%2013%3A%20Relationships%20with%20Related%20Parties) - The Company authorized **three** new related party transactions as part of the March **27**, **2025** financing, including Securities Purchase Agreements with Baker Brothers Advisors LP and BPIfrance Participations SA, and a Registration Rights Agreement with investors[111](index=111&type=chunk)[113](index=113&type=chunk) [Note 14: Loss Per Share](index=21&type=section&id=Note%2014%3A%20Loss%20Per%20Share) Loss Per Share | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Basic/diluted Net loss per share | $(0.31) | $(0.34) | $(0.58) | $(0.63) | | Weighted average shares outstanding | 134,476,503 | 96,170,285 | 118,545,638 | 96,179,388 | Excluded Potential Shares | Excluded Potential Shares | As of June 30, 2025 | As of June 30, 2024 | | :------------------------ | :------------------ | :------------------ | | Non-employee warrants | 195,508 | 244,693 | | Stock options | 10,473,703 | 7,535,091 | | Restricted stock units | 2,729,324 | 2,188,071 | | Prefunded warrants | 127,361,991 | 28,276,331 | - Diluted loss per share is equal to basic loss per share because the Company was in a net loss position, making the effects of potentially dilutive shares anti-dilutive[111](index=111&type=chunk) [Note 15: Events after the Close of the Period](index=21&type=section&id=Note%2015%3A%20Events%20after%20the%20Close%20of%20the%20Period) - There were no significant events after the close of the period[113](index=113&type=chunk) [Note 16: Reportable segment disclosure](index=22&type=section&id=Note%2016%3A%20Reportable%20segment%20disclosure) - The Company operates and is managed as **one** operating segment, focusing on the development of the Viaskin Peanut patch[114](index=114&type=chunk) Reportable segment disclosure (in thousands) | Expense Category (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Clinical studies | $16,258 | $13,056 | $23,060 | $21,229 | | BLA & Regulatory | $2,298 | $1,610 | $3,683 | $3,090 | | Manufacturing & Supply and Quality | $12,786 | $8,507 | $23,380 | $17,403 | | Sales & Marketing | $419 | $986 | $681 | $1,744 | | General & Administrative | $8,463 | $8,643 | $14,089 | $16,447 | | **Total expenses** | **$42,575** | **$35,003** | **$69,946** | **$64,968** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the Company's financial condition, results of operations, and liquidity, including an overview of its clinical programs, critical accounting policies, and detailed comparisons of financial performance for the three and six months ended June **30**, **2025** and **2024** [Overview](index=23&type=section&id=Overview) - DBV Technologies is a clinical-stage biopharmaceutical company focused on epicutaneous immunotherapy (EPIT) using its Viaskin patch technology, which delivers biologically active compounds through intact skin to target Langerhans cells and activate the immune system with minimal systemic exposure[118](index=118&type=chunk) - The Company is developing **two** Viaskin Peanut patch candidates for peanut allergy: **one** for toddlers aged **1-3 years** (original patch, supported by EPITOPE study and COMFORT Toddlers safety study under Accelerated Approval pathway) and another for children aged **4-7 years** (modified patch, evaluated in VITESSE Phase **3** study, BLA filing planned for H**1 2026**)[119](index=119&type=chunk)[120](index=120&type=chunk)[121](index=121&type=chunk)[123](index=123&type=chunk)[125](index=125&type=chunk) - Regulatory alignment has been achieved with the FDA for the Accelerated Approval pathway for toddlers, and the COMFORT Children supplemental safety study for **4-7 year-olds** is no longer required[123](index=123&type=chunk)[125](index=125&type=chunk)[120](index=120&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=24&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) - There have been no new policies or significant changes to the Company's critical accounting policies as disclosed in the Annual Report[129](index=129&type=chunk) [Business Trends and Results of Operations](index=24&type=section&id=Business%20Trends%20and%20Results%20of%20Operations) [Comparison of the Three Months Ended June 30, 2025 and 2024](index=24&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) Comparison of the Three Months Ended June 30, 2025 and 2024 (in thousands) | Metric (in thousands) | Q2 2025 | Q2 2024 | $ Change | % Change | | :-------------------------------- | :------ | :------ | :------- | :------- | | Operating income | $1,465 | $1,161 | $303 | 26% | | Research and development expenses | $(33,693) | $(25,374) | $(8,319) | 33% | | Sales and marketing expenses | $(419) | $(986) | $567 | (58)% | | General and administrative expenses | $(8,463) | $(8,643) | $180 | (2)% | | Total Operating expenses | $(42,575) | $(35,003) | $(7,572) | 22% | | Financial income (expense) | $(648) | $726 | $(1,374) | (189)% | | Net loss | $(41,875) | $(33,116) | $(8,759) | 26% | - Research and Development expenses increased by **$8.3 million** (**33%**) due to the launch of the COMFORT Toddlers study, progress of the VITESSE Phase **3** study, and increased regulatory and production activities[134](index=134&type=chunk)[135](index=135&type=chunk) - Sales and Marketing expenses decreased by **$0.6 million** (**58%**) due to lower activities, reduced sales headcount, and decreased travel expenses[137](index=137&type=chunk) - Financial income shifted to an expense of **$(0.6) million** from an income of **$0.7 million**, primarily due to unfavorable foreign exchange results from the appreciation of EUR vs USD[143](index=143&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=26&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) Comparison of the Six Months Ended June 30, 2025 and 2024 (in thousands) | Metric (in thousands) | H1 2025 | H1 2024 | $ Change | % Change | | :-------------------------------- | :------ | :------ | :------- | :------- | | Operating income | $2,217 | $2,568 | $(351) | (14)% | | Research and development expenses | $(55,176) | $(46,777) | $(8,399) | 18% | | Sales and marketing expenses | $(681) | $(1,744) | $1,063 | (61)% | | General and administrative expenses | $(14,089) | $(16,447) | $2,358 | (14)% | | Total Operating expenses | $(69,946) | $(64,968) | $(4,978) | 8% | | Financial income (expense) | $(1,109) | $1,986 | $(3,095) | (156)% | | Net loss | $(68,954) | $(60,461) | $(8,493) | 14% | - Operating income decreased by **$0.4 million** (**14%**) due to a greater proportion of clinical studies being conducted in North America, making them ineligible for the French Research tax credit[149](index=149&type=chunk) - Research and Development expenses increased by **$8.4 million** (**18%**) due to the launch of the COMFORT Toddlers study, progress of the VITESSE Phase **3** study, and regulatory/production activities[150](index=150&type=chunk)[151](index=151&type=chunk) - General and Administrative expenses decreased by **$2.4 million** (**14%**) due to lower external professional services (non-recurring costs, office relocations, trademarks) and reduced depreciation/amortization[155](index=155&type=chunk)[156](index=156&type=chunk)[157](index=157&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) [Financial Condition](index=28&type=section&id=Financial%20Condition) - Cash and cash equivalents increased to **$103.2 million** at June **30**, **2025**, from **$32.5 million** at December **31**, **2024**, following a **$125.5 million** financing on April **7**, **2025**[162](index=162&type=chunk)[163](index=163&type=chunk) - The Company estimates its cash and cash equivalents are sufficient to fund operations into the second quarter of **2026**, but there is substantial doubt about its ability to continue as a going concern due to ongoing operating losses[164](index=164&type=chunk) - The financing includes potential additional gross proceeds of up to **$181.4 million** from warrant exercises, which could be accelerated by positive VITESSE Phase **3** study results[165](index=165&type=chunk) [Sources of Liquidity and Material Cash Requirements](index=28&type=section&id=Sources%20of%20Liquidity%20and%20Material%20Cash%20Requirements) - The **2025** PIPE financing included a share capital increase of **€38 million** (issuance of ABSA) and an issue of **€79 million** in PFW-BS-PFW units, with proceeds allocated to working capital, Viaskin Peanut program development, BLA submission, and US launch readiness[169](index=169&type=chunk)[181](index=181&type=chunk) - The Company's material cash requirements include operating lease obligations for its French headquarters (**$6.8 million** ending March **2033**) and US offices (**$1.6 million** ending December **2029**)[170](index=170&type=chunk)[171](index=171&type=chunk) - Obligations under CRO agreements for ongoing clinical trials amounted to **$272.7 million** as of June **30**, **2025**, an increase from **$170.3 million** at December **31**, **2024**, driven by the COMFORT Toddlers and VITESSE studies[174](index=174&type=chunk)[175](index=175&type=chunk) [Summary Statement of Cash Flows](index=29&type=section&id=Summary%20Statement%20of%20Cash%20Flows) Summary Statement of Cash Flows (in thousands) | Cash Flow Activity (in thousands) | H1 2025 | H1 2024 | $ Change | % Change | | :-------------------------------- | :------ | :------ | :------- | :------- | | Net cash flow used in operating activities | $(53,573) | $(69,765) | $16,192 | (23)% | | Net cash flow used in investing activities | $(413) | $(1,441) | $1,027 | (71)% | | Net cash flow provided by (used in) financing activities | $116,992 | $(95) | $117,087 | (123261)% | | Net (decrease) increase in cash and cash equivalents | $70,752 | $(75,154) | $145,906 | (194)% | - Net cash flow used in operating activities decreased by **$16.2 million**, primarily due to contained costs, extended payment terms, and deferral of R&D and S&M activities[178](index=178&type=chunk)[179](index=179&type=chunk) - Net cash flow provided by financing activities significantly increased to **$117.0 million**, driven by the financing operation completed on April **7**, **2025**[181](index=181&type=chunk) [Off-Balance Sheet Arrangements](index=29&type=section&id=Off-Balance%20Sheet%20Arrangements) - The Company has not entered into any off-balance sheet arrangements[182](index=182&type=chunk) [Smaller Reporting Company Status](index=29&type=section&id=Smaller%20Reporting%20Company%20Status) - The Company is a smaller reporting company, allowing it to take advantage of scaled disclosures[183](index=183&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, DBV Technologies is not required to provide quantitative and qualitative disclosures about market risk - The Company is exempt from providing quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company[184](index=184&type=chunk) [Item 4. Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the Company's disclosure controls and procedures, management's assessment of their effectiveness, and any changes in internal control over financial reporting, while also acknowledging the inherent limitations of any control system [Disclosure Controls and Procedures](index=30&type=section&id=Disclosure%20Controls%20and%20Procedures) - Management, including the CEO and CFO, concluded that the Company's disclosure controls and procedures were effective as of June **30**, **2025**, providing reasonable assurance for timely and accurate reporting[186](index=186&type=chunk) [Changes in Internal Control Over Financial Reporting](index=30&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) - There were no changes in internal control over financial reporting that materially affected, or are reasonably likely to materially affect, the Company's internal control during the period[187](index=187&type=chunk) [Limitation on Effectiveness of Controls and Procedures](index=30&type=section&id=Limitation%20on%20Effectiveness%20of%20Controls%20and%20Procedures) - Management acknowledges that control systems provide only reasonable, not absolute, assurance and are subject to inherent limitations such as faulty judgments, simple errors, circumvention by individuals or collusion, and management override[188](index=188&type=chunk) Part II – [Other Information](index=31&type=section&id=Part%20II%20%E2%80%93%20Other%20Information) [Item 1. Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The Company is not currently subject to any material legal proceedings, as referenced in the notes to the condensed consolidated financial statements - The Company is not currently subject to any material legal proceedings[89](index=89&type=chunk)[190](index=190&type=chunk) [Item 1A. Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) This section refers to the risk factors detailed in the Annual Report, emphasizing the substantial doubt about the Company's ability to continue as a going concern due to ongoing operating losses and liquidity challenges - As of June **30**, **2025**, substantial doubt exists about the Company's ability to continue as a going concern due to ongoing operating losses and liquidity challenges[192](index=192&type=chunk) - The Company's business is subject to various risks that could adversely affect its financial condition, results of operations, and stock trading price[192](index=192&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Details of unregistered equity securities issued during the six months ended June **30**, **2025**, including ordinary shares issued upon RSU settlements and shares/warrants from the **2025** PIPE financing, all exempt from Securities Act registration - During the six months ended June **30**, **2025**, the Company issued unregistered securities, including ordinary shares from RSU settlements to US and non-US employees[193](index=193&type=chunk)[200](index=200&type=chunk) - The Company also issued **34,090,004** New Shares with ABSA Warrants and **71,005,656** First Pre-Funded Warrants as part of the **2025** PIPE financing on March **27**, **2025**, completed on April **7**, **2025**[193](index=193&type=chunk)[200](index=200&type=chunk) - These transactions were exempt from registration under Section **4(a)(2)** or Regulation S of the Securities Act, as they did not involve a public offering[193](index=193&type=chunk) [Item 3. Defaults Upon Senior Securities](index=31&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The Company reported no defaults upon senior securities during the period - There were no defaults upon senior securities[195](index=195&type=chunk) [Item 4. Mine Safety Disclosures](index=31&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to the Company - Mine safety disclosures are not applicable to the Company[197](index=197&type=chunk) [Item 5. Other Information](index=31&type=section&id=Item%205.%20Other%20Information) No Rule **10b5-1** trading arrangements were adopted, modified, or terminated by the Company's directors and officers during the three months ended June **30**, **2025** - None of the Company's directors and officers adopted, modified, or terminated a "Rule **10b5-1** trading arrangement" or a "non-Rule **10b5-1** trade arrangement" during the three months ended June **30**, **2025**[199](index=199&type=chunk) [Item 6. Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Quarterly Report on Form **10-Q**, including by-laws, CEO/CFO certifications, and XBRL documents - The exhibits include by-laws, CEO and CFO certifications (pursuant to Sections **302** and **906** of Sarbanes-Oxley Act), and various XBRL taxonomy documents[202](index=202&type=chunk)

Core Viewpoint - DBV Technologies has initiated the COMFORT Toddlers supplemental safety study for the Viaskin® Peanut patch, targeting peanut-allergic children aged 1 to 3 years, marking a significant step towards advancing this treatment option to market [1][3][4]. Group 1: Study Details - The COMFORT Toddlers study aims to enroll approximately 480 subjects across 80 to 90 study centers in the U.S., Canada, Australia, the UK, and Europe [2]. - The study is a Phase 3 double-blind, placebo-controlled safety trial designed to supplement safety and efficacy data from the completed Phase 3 EPITOPE study [3]. - The study duration is six months, followed by an optional 18-month open-label treatment phase, allowing for up to 24 months of active treatment for participants in the active group [3]. Group 2: Investigator Insights - Dr. Jeffrey Leflein, the Principal Investigator, expressed enthusiasm about the first subject being screened and highlighted the commitment to peanut-allergic children and their families [3][4]. - Julie Wang, Global Principal Investigator, noted the significant unmet need for this specific cohort, reinforcing the importance of the study [4]. Group 3: Regulatory and Future Plans - The data generated from the COMFORT Toddlers study is expected to support a Biologics License Application (BLA) submission to the FDA, anticipated in the second half of 2026 under the Accelerated Approval Pathway [4]. - The company is focused on advancing the development of the Viaskin Peanut patch, which aims to address food allergies through epicutaneous immunotherapy [9].

Company Overview - DBV Technologies S.A. (DBVT) is a notable stock within the Medical sector, which consists of 999 companies and currently ranks 4 in the Zacks Sector Rank [2] - The company is categorized under the Medical - Biomedical and Genetics industry, which includes 506 stocks and is ranked 70 in the Zacks Industry Rank [6] Performance Metrics - DBVT has experienced a year-to-date gain of approximately 210.7%, significantly outperforming the average loss of 4.4% in the Medical sector [4] - The Zacks Consensus Estimate for DBVT's full-year earnings has increased by 78.9% over the past quarter, indicating a positive shift in analyst sentiment [4] Comparison with Peers - Hims & Hers Health, Inc. (HIMS) is another Medical stock that has shown strong performance, with a year-to-date return of 153.1% and a Zacks Rank of 2 (Buy) [5] - The Medical Info Systems industry, to which HIMS belongs, has seen a year-to-date increase of 16.9%, contrasting with the performance of DBVT's industry [7]

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Exhibit 99.1 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a clinical-stage biopharmaceutical company, today reported financial results for the First Quarter of 2025. The quarterly and three months financial statements were approved by the Board of Directors on April 30, 2025. Financial Highlights for the First Quarter Ended March 31, 2025 The Company's interim condensed consolidated financial statements for the three months ended March 31, 2025, are p ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________ FORM 10-Q ____________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to _______________ Commission file number 001-36697 DBV TECHNOLOGIES S.A. (Exact name of registrant a ...

Core Viewpoint - DBV Technologies reported its financial results for the first quarter of 2025, highlighting significant cash usage in operations and ongoing clinical trials, while also announcing a financing plan to support its product development [1][5]. Financial Highlights - Cash and cash equivalents decreased to $13.0 million as of March 31, 2025, from $32.5 million at the end of 2024, reflecting a net decrease of $19.5 million, primarily due to $19.7 million used in operating activities [4][8]. - The company incurred operating losses and negative cash flows since inception, with no product revenue generated to date [6]. Cash Flow Analysis - The net cash flow used in operating activities was $19.7 million for Q1 2025, compared to $34.7 million for the same period in 2024, indicating an improvement in cash flow management [21]. - The company received gross proceeds of $125.5 million on April 7, 2025, as part of a financing plan of up to $306.9 million to support the Viaskin® Peanut Patch [5]. Operating Income and Expenses - Operating income for Q1 2025 was $0.8 million, down from $1.4 million in Q1 2024, attributed to a lower French Research Tax Credit due to more activities being conducted in North America [10][12]. - Total operating expenses decreased to $27.4 million in Q1 2025 from $30 million in Q1 2024, mainly due to reduced General & Administrative expenses [13][15]. Net Loss - The net loss for the first quarter of 2025 was $27.1 million, slightly improved from a net loss of $27.3 million in the same quarter of 2024 [16][17]. Financial Position - As of March 31, 2025, total assets were $50.6 million, down from $65.7 million at the end of 2024, with liabilities increasing to $47.7 million from $38.3 million [18]. Company Overview - DBV Technologies is focused on developing treatment options for food allergies using its proprietary Viaskin technology, which aims to provide non-invasive immunotherapy [22]. - The company is currently conducting clinical trials for its Viaskin Peanut product targeting peanut allergies in young children [22].