DBV Technologies reports $64.5M net loss

Cover page 4 changes

3 unchanged paragraphs

For the quarterly period ended June September 30, 2026

8 unchanged paragraphs

10 Independence Blvd. Suite 302

Warren, New Jersey 07059

18 unchanged paragraphs

As of July 16, October 26, 2026, the registrant had 296,061,497 314,388,807 ordinary shares, nominal value 0.10 per share, outstanding including treasury shares.

1 unchanged paragraph

Condensed Consolidated Statements of Financial Position (Unaudited) as of September 30, 2026 and December 31, 3 changes

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three and Six Nine Months Ended June September 30, , 202 6 2026 and 202 5 2025

Condensed Consolidated Statements of Cash Flows (Unaudited) for the Six Nine Months Ended J une September 30, 2026 and 202 5 2025

Condensed Consolidated Statements of Changes in Shareholders Equity (Unaudited) for the Three and Six Months Ended J une as of September 30, 2026 and 2 025 2025

Forward-looking statements 10 changes

1 unchanged paragraph

our expectations regarding the timing or likelihood of regulatory submissions, filings, and approvals, including with respect to our anticipated submission of a Biologics License Application ( BLA ) for VIASKIN Peanut patch in 4-7 year olds and 1-3 year olds to the U.S. Food and Drug Administration ( FDA );

our expectations with respect to an actionable regulatory pathway, including an Accelerated Approval pathway, for toddlers ages 1-3 years-old for the VIASKIN Peanut patch;

our expectations regarding the timing and anticipated support for the BLA re-submission submission to FDA for VIASKIN Peanut patch to FDA; in 1 - 3 year olds;

our expectations regarding initiation of the confirmatory effectiveness study for VIASKIN Peanut patch in 1 - 3 years-old; year olds;

anticipated support for the BLA review for VIASKIN Peanut patch in 4 - 7 year olds;

our expectations with respect to the grant of Priority Review designation by FDA for BLA for VIASKIN Peanut patch in 4 - 7 year olds;

4 unchanged paragraphs

our ability to manufacture clinical and commercial supplies of VIASKIN Peanut patch and/or our other product candidates and comply with regulatory requirements related to the manufacturing of our product candidates, if approved;

1 unchanged paragraph

our ability to build our own sales and marketing capabilities, or seek collaborative partners, to commercialize VIASKIN Peanut patch and/or our other product candidates, if approved;

1 unchanged paragraph

our expectations regarding the potential market size and the size of the patient populations for VIASKIN Peanut patch and/or our other product candidates, if approved, and our ability to serve such markets;

1 unchanged paragraph

the rate and degree of market acceptance of VIASKIN Peanut patch and/or our other product candidates, if approved, by physicians, patients, third-party payors and others in the medical community;

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Financial statements 93 changes

3 unchanged paragraphs

Note June September 30, 2026 December 31, 2025

1 unchanged paragraph

Total Assets 223.2 233.7

Other current assets 5 27.0 23.9

Total current assets 201.9 189.6

Property, plant, and equipment, net 4 9.7 11.5

Right-of-use assets 6 5.9 5.5

Other non-current assets 5 5.8 8.8

Total non-current assets 21.3 25.8

Total Assets 215.4 233.7

2 unchanged paragraphs

Trade payables 7 39.4 42.0

1 unchanged paragraph

Current contingencies & Employee Benefits 11 0.4 0.3

Other current liabilities 7 13.8 15.3

Total current liabilities 54.3 58.5

Long-term operating leases' liabilities 6 6.9 6.5

Long-term financial debt 0.2

Non-current contingencies & Employee Benefits 11 1.6 1.5 1.5

1 unchanged paragraph

Total Liabilities 62.8

Total Liabilities 66.7

1 unchanged paragraph

Accumulated deficit ( 270.3 )

Ordinary shares, 0.10 par value; 296,061,497 314,388,807 and 235,670,864 shares authorized, and issued as of June 30, 2026 9/30/2026 and December 31, 2025, 12/31/2025, respectively,

Additional paid-in capital 408.3 459.2

Treasury stock, 146,321 185,270 and 74,680 ordinary shares as of June 30, 2026 9/30/2026 and December 31, 2025, 12/31/2025, respectively, at cost ( 0.8 1.0 )

Accumulated deficit ( 334.8 )

Accumulated other comprehensive income 0.5 0.6

Accumulated currency translation effect ( 11.2 11.5 )

Total Shareholders equity 160.4 148.6

Total Liabilities and Shareholder's equity 223.2 215.4 233.7

4 unchanged paragraphs

Note Three Months Ended June 30, Six Months Ended June 30,

Note Three Months Ended September 30, Nine Months Ended September 30,

Operating income 12 $ 0.7 1.6 $ 1.5 2.8 $ 1.6 3.1 $ 2.2 5.0

1 unchanged paragraph

Research and development expenses ( 31.2 ) ( 33.7 ) ( 64.6 ) ( 55.2 )

Sales and marketing expenses ( 5.5 ) ( 0.4 ) ( 10.4 ) ( 0.7 )

General and administrative expenses ( 14.6 ) ( 8.5 ) ( 25.1 ) ( 14.1 )

Total Operating expenses ( 51.3 ) ( 42.6 ) ( 100.1 ) ( 69.9 )

Loss from operations ( 50.6 ) ( 41.1 ) ( 98.5 ) ( 67.7 )

Loss before taxes ( 50.2 ) ( 41.8 ) ( 97.6 ) ( 68.8 )

Income tax ( 0.2 ) ( 0.1 ) ( 0.4 ) ( 0.1 )

Net loss $ ( 50.4 ) $ ( 41.9 ) $ ( 98.0 ) $ ( 69.0 )

Comprehensive loss $ ( 51.2 ) $ ( 34.8 ) $ ( 103.3 ) $ ( 61.1 )

Weighted average shares outstanding used in computing per share amounts: 16 433,535,486 134,476,503 424,587,737 118,545,638

Research and development expenses ( 47.0 ) ( 28.6 ) ( 111.6 ) ( 83.8 )

Sales and marketing expenses ( 5.3 ) ( 1.2 ) ( 15.7 ) ( 1.9 )

General and administrative expenses ( 14.0 ) ( 7.3 ) ( 39.1 ) ( 21.3 )

Total Operating expenses ( 66.3 ) ( 37.1 ) ( 166.4 ) ( 107.0 )

Loss from operations ( 64.8 ) ( 34.3 ) ( 163.3 ) ( 102.0 )

Financial income (expense) 0.4 ( 0.6 ) 0.9 ( 1.1 ) 1.5

Loss before taxes ( 64.2 ) ( 33.2 ) ( 161.7 ) ( 102.0 )

Income tax ( 0.3 ) ( 0.7 ) ( 0.1 )

Net loss $ ( 64.5 ) $ ( 33.2 ) $ ( 162.5 ) $ ( 102.1 )

Foreign currency translation differences, net of taxes ( 0.9 0.3 ) 7.2 ( 5.3 0.5 ) 7.9 ( 5.5 ) 7.4

Actuarial gains or losses on employee benefits, net of taxes 0.1 ( 0.2 0.4 ) 0.1 ( 0.4 )

Comprehensive loss $ ( 64.6 ) $ ( 34.0 ) $ ( 167.9 ) $ ( 95.1 )

Basic/diluted Net loss per share attributable to shareholders 16 $ ( 0.12 0.14 ) $ ( 0.31 0.24 ) $ ( 0.23 0.37 ) $ ( 0.58 0.82 )

Weighted average shares outstanding used in computing per share amounts: 16 451,026,667 136,811,952 433,484,635 124,723,638

4 unchanged paragraphs

Notes Six Months Ended June 30,

Notes Nine Months Ended September 30,

Net loss for the period $ ( 98.0 162.5 ) $ ( 69.0 102.1 )

1 unchanged paragraph

Inventory write-downs 5.6 10.3

Depreciation, amortization and accrued contingencies 4/11 1.5 1.7 2.1 2.5

Expenses related to share-based payments 10 6.0 2.9 10.9 3.5

Inventory write-downs 10.2 13.9

1 unchanged paragraph

Decrease (increase) in inventories and work in progress ( 5.6 10.2 ) ( 10.3 13.9 )

Decrease (increase) in other current assets 5 ( 9.0 5.8 ) ( 4.0 5.0 )

(Decrease) increase in trade payables 7 ( 0.4 ) 14.9 2.6 14.3

(Decrease) increase in other current and non-current liabilities ( 1.6 0.7 ) ( 1.5 0.7 )

Change in operating lease liabilities and right of use assets 6 ( 0.1 ) 0.3 0.5

Net cash flow used in operating activities ( 101.7 153.2 ) ( 53.6 86.0 )

1 unchanged paragraph

Change in property, plant, and equipment 4 ( 0.8 3.0 ) ( 0.2 )

Change in Other non-current assets 5 ( 0.1 3.2 ) ( 0.4 0.5 )

Net cash flows used in investing activities ( 0.9 6.2 ) ( 0.4 0.7 )

1 unchanged paragraph

Treasury shares ( 0.2 ) 0.2

Issuance from Net Capital increase and Share warrants 8 89.0 137.0 116.9

Other cash flows related to financing activities 0.2

Net cash flows provided by financing activities 89.0 117.0 137.1 117.1

Effect of exchange rate changes on cash and cash equivalents ( 5.6 6.2 ) 7.7 6.9

Net (decrease) / increase in cash and cash equivalents ( 19.2 28.5 ) 70.8 37.4

1 unchanged paragraph

Net cash and cash equivalents at the end of the period 3 174.9 165.7 $ 103.2 69.8

19 unchanged paragraphs

Balance at June 30, 2025 136,973,697 15.4 391.5 ( 1.2 ) ( 315.1 ) 0.9 ( 5.2 ) 86.2 ( 33.2 ) ( 33.2 )

Other comprehensive income (loss)

Issuance of ordinary shares

18 unchanged paragraphs

1 unchanged paragraph

and 13 more changes in the filing

Note 1: Nature of the business and principles and accounting methods 28 changes

Incorporated in 2002 under the laws of France, DBV Technologies S.A. ( DBV Technologies, or the Company , or we , or the group ) is a late-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. The Company s therapeutic approach is based on epicutaneous immunotherapy ( EPIT ), a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin.

1 unchanged paragraph

The condensed consolidated financial statements of the Company and its wholly-owned subsidiaries are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States ( U.S. GAAP ) and are presented in U.S. dollars. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation.

17 unchanged paragraphs

The assumptions used in the valuation of right-of-use assets & operating leases; and

2 unchanged paragraphs

As of June 30, 2026, the Company had cash and cash equivalents of $ 174.9 million. Following the revised timing of the anticipated BLA submission from the second to the third quarter of 2026, management updated the Company s forecasts to reflect the revised timing of related expenditures and activities, including cost-containment measures. Based on its current operations, plans and assumptions, management estimates that the Company has sufficient funding to support its operations for at least twelve months from the date of issuance of this Form 10-Q, into the third quarter of 2027.

These estimates are based on the Company s current forecasts and exclude any additional expenditures related to programs other than the VIASKIN Peanut or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. The Company may have based these estimates on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated.

The Company's net cash used in operating & investing activities increased to $ 102.6 million for the six months ended June 30, 2026, compared to $ 54.0 million for the six months ended June 30, 2025 reflecting continued investments in clinical development activities, manufacturing and supply-chain readiness, commercial launch preparedness, and the expansion of the Company s workforce in preparation for a potential launch of VIASKIN Peanut, if approved. While the Company expects operating cash outflows to remain significant as it advances toward BLA submission and potential commercialization, the Company s current forecasts incorporate measures intended to align spending with the revised regulatory timeline.

The timing and amount of the Company s future cash requirements may vary materially from current expectations depending on, among other factors, the timing and scope of regulatory interactions, the pace of clinical enrollment, manufacturing-related commitments, commercial readiness activities, foreign exchange rate fluctuations and other factors. The Company may seek additional capital in the future through new or existing financing strategies to support its long-term corporate strategy.

These condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and the satisfaction of liabilities in the normal course of business for at least twelve months from the date of issuance of these condensed consolidated financial statements. The Company has incurred operating losses and negative cash flows from operations since inception. The Company does not generate revenue and continues to prepare for the potential launch of VIASKIN Peanut in the United States and the European Union, if approved.

The Company has incurred operating losses and negative cash flows from operations since inception and expects operating cash outflows to remain significant as it continues to invest in clinical development, regulatory activities, manufacturing and supply-chain readiness and preparations for the potential commercialization of VIASKIN Peanut patch, if approved. Net cash used in operating & investing activities was $ 159.4 million for the nine months ended September 30, 2026, compared to $ 86.7 million for the nine months ended September 30, 2025, reflecting the continued advancement of these activities and the expansion of the Company s organization.

As of September 30, 2026, the Company had cash and cash equivalents of $ 165.7 million. During the third quarter of 2026, the Company achieved significant regulatory and financing milestones, including the submission of its BLA for VIASKIN Peanut patch in children ages 4 through 7 on September 29, 2026, for which the Company requested Priority Review, and the completion of a sale of $ 50.0 million in gross proceeds of ADSs under its ATM Program announced by the Company in July 2026. Following the BLA submission, management updated the Company s operating and liquidity forecasts to reflect the potential regulatory review pathway and the anticipated timing of related clinical, regulatory, manufacturing and commercial readiness activities. The Company s forecasts incorporate milestone-based spending assumptions designed to align the timing of certain expenditures with potential regulatory developments while continuing to advance activities necessary to support regulatory review and potential commercialization of VIASKIN Peanut patch in children ages 4 through 7, if approved. Based on its current operations, plans and assumptions, the Company estimates that its existing cash and cash equivalents will be sufficient to fund operations into the third quarter of 2027.

As such, Management has concluded that the Company's existing cash and cash equivalents are not sufficient to fund its operations for at least twelve months from the date of issuance of these interim condensed consolidated financial statements. Accordingly, substantial doubt exists about the Company's ability to continue as a going concern within twelve months after the date these condensed consolidated financial statements are issued.

The Company will require additional capital to fund its operations. Management is actively evaluating multiple financing alternatives, including, without limitation, potential additional sales under the Company s existing ATM Program, equity transactions, warrants exercise and other alternative forms of financing. The Company s continued advancement through the regulatory review process may provide additional financing opportunities. However, the availability, timing and terms of any additional financing will depend on regulatory developments, market conditions and investors interest, lenders and other counterparties, and there can be no assurance that additional financing will be available when needed, on acceptable terms or at all.

These estimates are based on the Company s current forecasts and exclude additional expenditures related to programs other than VIASKIN Peanut patch or resulting from the potential in-licensing or acquisition of additional product candidates or technologies. The timing and amount of the Company s future cash requirements may differ materially from current estimates depending on, among other factors, the timing and outcome of the regulatory review process, the pace of clinical development activities, manufacturing and supply-chain commitments, commercial readiness activities and foreign exchange rate fluctuations. These condensed consolidated financial statements do not include any adjustments to the carrying amounts and classification of assets and liabilities or reported expenses that may be necessary if the Company were unable to continue as a going concern.

4 unchanged paragraphs

Manufacturing Supply Agreement - Peanut Source Material - Fareva La Vall e

Fareva La Vall e - Manufacturing Infrastructure Agreements

The Company entered strategic manufacturing arrangements with Fareva La Vall e ("FLV") to secure dedicated manufacturing capacity for both Peanut Source Material ("PSM") and Peanut Drug Substance ("PDS"), supporting the future commercial supply chain for VIASKIN Peanut.

Peanut Source Material

On March 17, 2026, DBV Technologies S.A. the Company entered into a MS Manufacturing and Supply Agreement (the MS Agreement ) with Fareva La V allee ( FLV, ), under which FLV will manufacture and supply the VIASKIN Peanut source material ( PSM, ), exclusively for DBV Technologies S.A. the Company during the MS Agreement term. The term is effective for a period of eight ( 8 ) years and can be renewed for a period of two ( 2 ) years.

1 unchanged paragraph

The PSM Services Agreement includes the following services (i) construction activities, (ii) the acquisition of equipment, and (iii) the cGMP qualification of a dedicated PSM production line installed at FLV s premises. DBV The Company has funded capital expenditures amounting to $ 3.9 4.1 million (at the exchange rate of 1 = $ 1.14 ) , granting access to preferential pricing and to an exclusively dedicated PSM production line located at FLV s facilities, while ownership of the line remains with FLV. The assessment of the Manufacturing Supply Agreement concludes that the arrangement contains an embedded lease within the scope of ASC 842 (Leases), based on the following criteria:

Peanut Drug Substance

On July 8, 2026, the Company entered into a PDS Services Agreement and Binding Commercial Term Sheet with FLV relating to the construction development, installation and qualification of a dedicated PDS manufacturing line, as well as related transfer services for technical and validation batches.

The PDS facility services are expected to be completed no later than September 30, 2027, and the transfer services no later than September 1, 2028. The Company s commitments under the agreement include PDS facility services fees capped at $ 3.9 million (at the exchange rate of 1 = $ 1.14 ), of which the Company funded $ 3.3 million (at the exchange rate of 1 = $ 1.14 ). These fees, exclude certain capital expenditures directly supported by the Company, and transfer services fees are capped at $ 3.2 million (at the exchange rate of 1 = $ 1.14 ). The agreement also includes binding commercial terms expected to be incorporated into a future definitive manufacturing and supply agreement.

Accounting Treatment

Management has concluded that both the PSM and PDS arrangements contain embedded leases within the scope of ASC 842, Leases, based on the following considerations:

Identified asset: The dedicated PSM & PDS production line represents an lines are identified asset, assets, and the supplier FLV does not have substitution rights.

1 unchanged paragraph

The Company has non-cancellable minimum commitments for PSM, subject to the terms of the MS Agreement. At the end of a 36-month period starting from the first commercial batch delivery, if the Company has not ordered any batches, excluding technical and validation batches, the Company shall pay FLV an amount not to exceed $ 0.6 million. As of June 30, 2026, DBV expects to meet the purchase obligations and therefore did not record any liability or accrual related to these commitments

In accordance with ASC 842 10 25 2, the right of use asset assets will be recognized at the lease commencement date, defined as the date on which the production line is lines are made available for use following completion of cGMP qualification. At this stage, the Company has identified the embedded lease, leases, the separation of lease and non lease components of the arrangement, arrangements, and the reclassification of the payment related to the exclusive access right as prepaid rent under ASC 842 (Other non-current assets). Subsequent to September 30, 2026 , the first commercial PSM batch was successfully manufactured by FLV and incorporated into the pre-commercial inventory. Accordingly, management expects lease commencement to occur during the fourth quarter of 2026 and amortization of the PSM right-of-use asset to begin during the fourth quarter of 2026.

Under the PSM Manufacturing and Supply Agreement, the Company is subject to minimum purchase commitments tied to the commercial supply of PSM. Specifically, if cumulative commercial orders are below 940 kilograms at the end of the 36-month period following delivery of the first commercial batch, the Company may be required to compensate FLV for the shortfall, subject to a contractual cap of $ 0.6 million (at the exchange rate of 1 = $ 1.14 ). Based on management's operational forecasts as of September 30, 2026, the Company expects to meet the purchase obligations and therefore did not record any liability or accrual related to these commitments

Note 2: Significant Events and Transactions 16 changes

On June 25, 2026, the Company entered into a letter of intent with Fareva Amboise ( Fareva ) in connection with the planned commercial-scale manufacturing of the VIASKIN Peanut patch. Under the letter of intent, Fareva will undertake manufacturing readiness activities, infrastructure and equipment upgrades and workforce expansion intended to support commercial production of VIASKIN Peanut patch. The parties are currently negotiating a definitive commercial manufacturing and supply agreement. The planned investment for commercial manufacturing is estimated at $ 7.5 million, of which up to $ 5.2 million is expected to be supported by the Company through a combination of an FDA approval-contingent upfront payment and manufacturing-related pricing arrangements. The Company expects these activities to support preparedness for future commercialization of VIASKIN Peanut patch, if approved.

As of June 30, 2026, no material amounts had been incurred by the Company under the letter of intent. Accordingly, the arrangement has no material impact on the Company's condensed consolidated financial statements as of June 30, 2026.

Amendment to the Letter of intent signed with Fareva Amboise

On September 30, 2026, the Company entered into Amendment No. 1 to its June 25, 2026 Letter of Intent with Fareva Amboise concerning manufacturing readiness activities supporting the future commercial-scale manufacture of the VIASKIN Peanut patch. The planned investment is estimated at $ 5.5 million (at the exchange rate of 1 = $ 1.14 ). Under the amendment, the Company's $ 1.1 million (at the exchange rate of 1 = $ 1.14 ) upfront contribution to this project was modified such that payment is no longer contingent upon FDA approval of the Company's Biologics License Application. Instead, payment is contingent upon the successful completion of an independent Mock Pre-Approval Inspection, including the absence of critical findings or repeat observations and remediation of all findings by February 1, 2027.

In addition, the amendment finalized and secured the workforce expansion component of the project, including training and extended readiness activities. These personnel are dedicated to supporting industrial ramp-up, execution of the remediation plan and commercial manufacturing preparedness. The parties continue to negotiate a definitive commercial manufacturing and supply agreement. The Company expects the amended arrangement to support the timely execution of manufacturing readiness activities and further prepares the Amboise facility for future commercial production of VIASKIN Peanut, if approved, including activities necessary to support a successful FDA pre-approval inspection.

Submission of BLA FDA for the VIASKIN Peanut Patch in Children Aged 4-7 Years

On September 29, 2026, the Company announced the submission of a BLA to FDA seeking approval of the VIASKIN Peanut patch for the treatment of peanut allergy in children aged 4 through 7 years. The submission is supported by data from the Phase 3 VITESSE study, a randomized, double-blind, placebo-controlled trial, which enrolled 654 children. The Company has requested Priority Review designation, which, if granted, would reduce the standard review period from ten to six months . The FDA has 60 days from the submission date to determine whether the BLA is sufficiently complete to permit substantive review, following which the Company anticipates receipt of a Prescription Drug User Fee Act ( PDUFA ) target action date. The BLA filing represents a significant regulatory milestone and an important step toward the potential commercialization of VIASKIN Peanut patch in the United States. There can be no assurance that the FDA will accept the BLA for filing, grant Priority Review, or ultimately approve the VIASKIN Peanut patch.

In connection with the BLA submission, $ 4.7 million of previously deferred BLA-related costs were recognized as research and development expense during the quarter.

Shelf Registration Statement, ATM Program Refresh and Sale of $ 50 million in gross proceeds under ATM Program

On July 27, 2026, the Company filed an automatically effective shelf registration statement on Form S-3 ASR with the SEC. The shelf registration statement permits the Company to sell, from time to time, ordinary shares, American Depositary Shares ( ADSs ) representing ordinary shares and warrants. At the time of filing the shelf registration statement, the Company also filed a prospectus supplement with the SEC authorizing the sale of up to $ 150.0 million of ADSs under its existing at-the-market offering program (the "ATM Program") and shelf registration statement. On August 3, 2026, the Company announced the sale of $ 50.0 million in gross proceeds of ADSs to RA Capital Management, L.P. under the ATM Program. In connection with this transaction, the Company issued 18,288,220 new ordinary shares, underlying 3,657,644 new ADSs, at an at-the-market price of $ 13.67 per ADS.

The net proceeds from the offering were recorded as an increase to shareholders' equity, net of issuance costs, in the condensed consolidated statements of financial position.

Services Agreement with Fareva La Vall e - Peanut Drug Substance

On July 8, 2026, the Company entered into a PDS Services Agreement and Binding Commercial Term Sheet with FLV relating to the construction development, installation and qualification of a dedicated PDS manufacturing line, as well as related transfer services for technical and validation batches.

2 unchanged paragraphs

As of June September 30, 2026, negotiations of the definitive agreement remained ongoing and no material amounts had been incurred by the Company under the letter of intent. Management expects execution of the definitive agreement by the end of 2026. Accordingly, the arrangement has no material impact on the Company's condensed consolidated financial statements as of June September 30, 2026.

3 unchanged paragraphs

On January 16, 2026, the Company received the supplemental gross proceeds of $ 94.7 million ( 81 81.0 million) resulting in the full exercise of the warrants top to purchase 34,090,004 new shares at a part par value of 0.10 (the ABSA Warrants ) and of the warrants to subscribe for 1.75 shares of the Company (the BS Warrants ) issued in the March 2025 PIPE Financing.

1 unchanged paragraph

In During the second quarter of 2026, DBV Technologies S.A. the Company received notice from the French tax authorities of a routine, not-for-cause tax audit covering fiscal years 2022 through 2025. During the audit encompasses a review third quarter of 2026, the Company's compliance with applicable French tax laws Company addressed and transfer pricing requirements, including application of resolved all matters raised to date by the Organization for Economic Co-operation and Development ( OECD ) arm's length principle. tax authorities. The audit remains ongoing, and the Company continues to fully cooperate fully with the Tax administration.

Note 3: Cash and Cash Equivalents 9 changes

Cash Equivalents 151.0 67.1

Cash and cash equivalents totaled $ 174.9 million and $ 194.2 million as of June 30, 2026 and December 31, 2025, respectively. The Company received the receipt of $ 94.7 million of gross proceeds in January 2026 resulting from the full exercise of the ABSA Warrants and BS Warrants issued in connection with the March 2025 PIPE Financing, used to fund operating activities during the period.

The following tables summarize the Cash and Cash Equivalents as of June September 30, 2026 and December 31, 2025:

June September 30, 2026 December 31, 2025

Cash Equivalents 110.7 67.1

Total Cash and Cash Equivalents 174.9 165.7 194.2

Cash and cash equivalents totaled $ 165.7 million and $ 194.2 million as of September 30, 2026 and December 31, 2025, respectively.

During the period, the Company raised capital through two equity transactions. In July 2026, the Company announced $ 50.0 million in gross proceeds from the sale of American Depositary Shares (ADSs) to RA Capital Management, L.P. under the At-the-Market (ATM) Program. Additionally, in January 2026, the Company received $ 94.7 million in gross proceeds resulting from the acceleration and full exercise of the ABSA Warrants and BS Warrants originally issued in connection with the March 2025 PIPE Financing. The proceeds from both equity transactions supported the Company's operating and investing activities during the period.

As of June September 30, 2026 cash equivalents totaled $ 151.0 110.7 million, compared to $ 67.1 million as of December 31, 2025. Cash equivalents consist primarily of short-term interest-bearing deposits with original maturities of three months or less when purchased. Management considers these all investments to be readily convertible into known amounts of cash and subject to an insignificant risk of changes in value. Accordingly, they are classified as cash equivalents.

1 unchanged paragraph

Note 4: Property, Plant & Equipment 17 changes

1 unchanged paragraph

01/01/2026 Currency translation effect Increase Decrease Reclassification 06/30/2026 ( 0.8 )

Total, gross 33.2 ( 1.0 ) 0.8 33.0

December 31, 2025 Currency translation effect Increase Decrease September 30, 2026

Laboratory equipment 27.6 ( 0.9 ) 0.4 27.1

Fixture and installations 1.5 1.4

Computer equipment 2.0 ( 0.1 ) 0.2 2.2

Other property, plant and equipment 0.9 0.9

Property, plant, and equipment in progress 1.2 ( 0.1 ) 2.7 3.8

Total, gross 33.2 ( 1.2 ) 3.3 35.4

Accumulated depreciation of laboratory equipment ( 19.6 ) 0.7 ( 1.6 ) ( 20.5 )

Accumulated depreciation of fixtures and installations ( 0.3 ) ( 0.1 ) ( 0.4 )

Accumulated depreciation of computer equipment ( 1.6 ) ( 0.1 ) ( 1.7 )

Accumulated depreciation of other property, plant and equipment ( 1.3 ) ( 1.3 )

Less accumulated amortization and depreciation ( 22.9 ) 0.8 ( 1.8 ) ( 23.9 )

Total, net 10.4 ( 0.3 ) ( 0.4 ) 9.7 1.5 11.5

The increase in Property, Plant & Equipment for $ 3.3 million is driven by additions relating to ongoing Capacity expansion projects.

The depreciation and amortization expense for June September 30, 2026 was $ 1.2 1.8 million.

Note 5: Other Current & Non Current Assets 15 changes

The following tables summarize the Other Current & Non Current Assets as of June September 30, 2026 and December 31, 2025:

June September 30, 2026 December 31, 2025

Prepaid Right of Use Asset 3.9 7.4

Deposits, pledged securities and other non-current financial assets 1.2 0.9

Liquidity contract 0.4 0.6

2 unchanged paragraphs

Total Other Current Assets 27.0 23.9 18.8

1 unchanged paragraph

The $ 7.4 million included the $ 4.1 million prepaid rent of the dedicated PSM production line and the $ 3.3 million prepaid rent of the dedicated PDS production line located at Fareva La Vall e s facilities.

The $ 3.9 million presents of the prepaid rent of the dedicated PSM production line located at Fareva La Vall e s facilities. The right of use asset assets will be recognized when the production line is made available for use following completion of cGMP qualification.

8 unchanged paragraphs

+ Other operating income 1.6 3.1

- Adjustment and currency translation effect ( 0.2 0.3 )

Closing research tax credit receivable as of June September 30, 2026 7.2

1 unchanged paragraph

Of which - Current portion 7.2 8.7

In the fiscal year ended December 31, 2021, the Company recovered its Small & Medium Enterprise SME status under EU law, and became therefore eligible again for the immediate reimbursement of the Research Tax Credit. The Company received payment of the 2025 Research Tax Credit, of $ 5.6 million during the fourth quarter of 2026.

Value-added tax ( VAT ) receivables primarily consisted of recoverable value-added taxes incurred on purchases and operating expenditures. The balance decreased increased during the period, reflecting the receipt of VAT refunds from tax authorities related to previously submitted claims, partially offset by VAT generated from the Company s ongoing operating, clinical development and commercial readiness activities.

1 unchanged paragraph

Prepaid expenses & other receivables primarily consisted of a $ 4.7 million regulatory filing fee paid in connection with the planned BLA submission for VIASKIN Peanut for children aged 4 to 7, and deferred pending submission of the related application, $ 2.0 1.7 million related to directors' and officers' liability insurance coverage for the 2026 2027 policy period and $ 1.2 1.4 million of receivables arising from credit notes issued by contract research organizations ("CROs").

Note 6: Lease contracts 6 changes

3 unchanged paragraphs

Depreciation and amortization ( 0.5 0.8 )

1 unchanged paragraph

As of June September 30, 2026 5.8 5.5

1 unchanged paragraph

Future minimum lease payments under the Company s operating leases right of use as of June September 30, 2026 and December 31, 2025 are as follows:

June September 30, 2026 December 31, 2025

6 unchanged paragraphs

Weighted average remaining lease term (years) 4.99 5.67 0.01

1 unchanged paragraph

During the six nine months ended June September 30, 2026, the Company commenced a new operating lease for office facilities in Warren, New Jersey with an initial lease term of approximately 45 months. Upon commencement, the Company recognized $ 1.9 million of operating lease liabilities and corresponding right-of-use assets. The lease provides for approximately $ 0.6 million of landlord incentives, including tenant improvement allowances and rent credits, which reduced the initial carrying amount of the right-of-use asset.

2 unchanged paragraphs

Note 7: Trade Payables and Other Current Liabilities 13 changes

Accrued expenses and other current liabilities 27.6 29.6

Trade payables decreased from $ 40.9 million as of December 31, 2025 to $ 39.4 million as of June 30, 2026. The decrease primarily reflects the settlement of transaction costs accrued at year-end 2025. This reduction was partially offset by higher operating activity during the period, including expenditures related to the COMFORT Toddlers program, BLA readiness initiatives and commercial launch preparedness activities.

Other Current Liabilities

Social debt 12.4 13.7

June September 30, 2026 December 31, 2025

Accounts payable 11.8 13.8 11.3

Accrued expenses 28.2 29.6

Total Trade Payables 39.4 42.0

Trade payables increased from $ 40.9 million as of December 31, 2025 to $ 42.0 million as of September 30, 2026, reflecting higher activity (COMFORT Toddlers, the BLA and launch readiness), partly offset by the settlement of the PIPE transaction costs accrued at year-end 2025.

The following table summarizes the other liabilities as of June September 30, 2026 and December 31, 2025:

June September 30, 2026 December 31, 2025

Social debt 13.2 13.7

2 unchanged paragraphs

Other current liabilities decreased from $ 15.8 million as of December 31, 2025 to $ 13.8 15.3 million as of June September 30, 2026. The decrease was primarily driven by the payment during the first half of 2026 of annual bonuses and other employee-related accruals recorded at year-end 2025. This decrease was partially offset by the accrual of current-year compensation and benefit expenses associated with continued headcount growth, to support BLA readiness activities and commercialization preparations.

Note 8: Shareholders equity 14 changes

The share capital as of June September 30, 2026 is set at the sum of 29,606,149.70 31,438,880.70 ($ 33,961,702.00 36,064,786.19 converted at historical rates). It is divided into 296,061,497 314,388,807 fully authorized, subscribed and paid-up ordinary shares with a par value of 0.10 .

1 unchanged paragraph

The table below presents the changes in the share capital of the Company as of June September 30, 2026 compared to December 31, 2025 at historical rate:

9 unchanged paragraphs

09/01/2026 Capital increase by employee warrants RSU 192 1,650

1 unchanged paragraph

16/01/2026 Capital increase by employee warrants RSU 3,427 29,500

2 unchanged paragraphs

29/01/2026 Capital increase by employee warrants RSU 1,749 15,212

2 unchanged paragraphs

12/5/2026 Capital increase by ordinary shares employee RSU 47 400

16/05/2026 Capital increase by ordinary shares employee RSU 2,035 17,500

2 unchanged paragraphs

17/07/2026 Capital increase by employee Stock Option 2,768 24,200

29/07/2026 Capital increase by employee RSU 167 1,465

3/8/2026 Capital increase by ordinary shares 2,098,619 45.8 18,288,220

26/08/2026 Capital increase by employee Stock Option 1,530 13,425

1 unchanged paragraph

Total Equity Balance as of June 30, 2026 33,961,702 408.3 296,061,497

Net Issuance of warrants 65.1 65.2

Total Equity Balance as of September 30, 2026 36,064,786 459.2 314,388,807

Note 9: Fair Value Measurement 6 changes

5 unchanged paragraphs

The Company is exposed to increasing foreign exchange risk due to a portion of its procurement activities being conducted in the United States and invoiced in U.S. dollars, as well as through the activity of its subsidiary DBV Technologies Inc., in connection with the Company s preparation for the potential launch of the VIASKIN Peanut patch in the United States, if approved.

1 unchanged paragraph

In this context, since 2025, the Company has hedged the current account of its US subsidiary through the use of financial instruments (foreign exchange swaps entered into with banking counterparties), which are linked to the subsidiary s current account as of June September 30, 2026.

1 unchanged paragraph

(In Million of dollars) As of June September 30, 2026 As of December 31, 2025

3 unchanged paragraphs

Forward sale at maturity Non-qualified derivative 5.3 5.3 0.9 0.9 1.8 1.8

1 unchanged paragraph

The Company's foreign currency swap arrangements do not qualify for hedge accounting. Accordingly, gains and losses arising from changes in fair value are recognized immediately within Foreign exchange gains/(losses) (excluding operating activities) in financial income (expense). The Company recorded a loss of $ 32.2 thousand for the six months ended June 30, 2026, compared with a loss of $ 5 thousand for the year ended December 31, 2025.

The fair value liability was nil for the nine months ended September 30, 2026, compared with a loss of $ 5 thousand for the year ended December 31, 2025.

Note 10: Share-Based Payments 14 changes

2 unchanged paragraphs

During the six nine months ended June September 30, 2026, the Company granted two special performance-based stock unit awards to its Chief Executive Officer, representing an aggregate of up to 5,800,000 RSUs. The awards were granted in two tranches, consisting of 1,740,000 RSUs granted on May 5, 2026 and 4,060,000 RSUs granted on June 5, 2026. The RSUs are subject to a continued presence condition through July 1, 2028 and to performance conditions based on specified VIASKIN Peanut regulatory milestones. The May 5, 2026 grant is linked to FDA acceptance for review of the applicable VIASKIN Peanut BLA, with 870,000 RSUs allocated to children aged 4 to 7 years old and 870,000 RSUs allocated to the toddlers aged 1 to 3 years old, or 1,740,000 RSUs if a single BLA covering both age groups is accepted for review.

3 unchanged paragraphs

Balance as of December 31, 2025 107,008

1 unchanged paragraph

Forfeited during the period ( 20,000 )

1 unchanged paragraph

Forfeited during the period ( 20,000 )

1 unchanged paragraph

During the six months ended June 30, 2026, the Company granted 1.0 million SOs and 6.4 million RSUs. The increase in outstanding awards primarily reflects grants made during the period including CEO special grants, partially offset by routine forfeitures, exercises, releases and expirations.

Balance as of June September 30, 2026 87,008

During the nine months ended September 30, 2026, the Company granted 1.1 million SOs and 6.5 million RSUs, including CEO special grants as described above.

As a result, outstanding RSUs and SOs increased to 10.0 million and 15.0 million, respectively, as of September 30, 2026, partially offset by 90,752 exercises or releases, 210,775 forfeitures, and 59,500 expirations during the period.

1 unchanged paragraph

Three Months Ended June 30, Six Months Ended June 30,

General & administrative SO ( 0.9 )

Three Months Ended September 30, Nine Months Ended September 30,

Research & development SO ( 0.7 ) 0.3 2.0 1.0

Sales & marketing SO ( 0.2 ) 0.3 0.5

General & administrative SO 0.7 0.3 2.6 1.9

Note 11: Contingencies & Employee Benefits 12 changes

The following tables summarize contingencies as of June September 30, 2026 and December 31, 2025:

June September 30, 2026 December 31, 2025

Current contingencies & Employee Benefits 0.4 0.3 0.2

Non-current contingencies & Employee Benefits 1.6 1.5 1.5

Total contingencies & Employee Benefits 2.0 1.9 1.7

3 unchanged paragraphs

Reversals of unused liabilities

Increases in liabilities 0.1 0.2 0.1 0.2

Actuarial gains and losses on defined-benefit plans ( 0.1 ) ( 0.1 )

1 unchanged paragraph

At June 30, 2026 1.6 0.4 2.0

At September 30, 2026 1.5 0.3 1.9

Of which current 0.4 0.4 0.3 0.3

Of which non-current 1.6 1.6 1.5 1.5

1 unchanged paragraph

Note 12: Operating income 7 changes

Three Months Ended June 30, Six Months Ended June 30,

Total 0.7 1.5 1.6 2.2

The following table summarizes the operating income during the three and six nine months ended June September 30, 2026 and 2025:

Three Months Ended September 30, Nine Months Ended September 30,

Research tax credit 0.7 1.5 1.6 2.2 2.8 3.1 5.0

Total 1.6 2.8 3.1 5.0

During the six nine months ended June September 30, 2026, the Company accrued $ 1.6 3.1 million of research tax credit. The tax credit income accrual reflects the expected level on a full year basis of eligible experimental activities, as the Company s focus continues to shift from clinical development toward commercial readiness activities.

Note 13: Allocation of Personnel Expenses 28 changes

Three Months Ended June 30, Six Months Ended June 30,

Research and Development expenses 9.4 5.7 17.9 10.3

Sales & Marketing expenses 2.2 0.2 3.2 0.4

General & Administrative expenses 6.4 3.9 11.0 6.9

Total personnel expenses 18.0 9.8 32.0 17.6

Three Months Ended June 30, Six Months Ended June 30,

Wages and salaries 10.8 6.7 19.8 11.4

Social security contributions 3.5 1.8 6.2 3.2

Share-based payments 3.7 1.2 6.0 2.9

Total 18.0 9.8 32.0 17.6

Personnel expenses for the period ended June 30, 2026, increased by $ 14.4 million compared to the six months ended June 30, 2025 and by $ 8.2 million compared to the three months ended June 30, 2025. This increase reflects the Company's transition from a clinical-stage organization operating under regulatory uncertainty in early 2025 to a substantially expanded organization focused on BLA execution and commercial launch preparedness following the FDA alignment reached in March 2025 and the completion of the March 2025 PIPE Financing.

As a result, the Company accelerated investments across development, quality, regulatory and commercial functions. The increase in personnel expenses primarily reflects workforce expansion, particularly in the United States, to support COMFORT Toddlers, BLA readiness activities and preparations for the potential commercial launch of the VIASKIN Peanut patch, if approved.

The Company had an average of 170 179 employees during the six nine months ended June September 30, 2026, compared to an average of 109 117 employees during the six nine months ended June September 30, 2025.

The following table summarizes the allocation of personnel expenses by function during the six nine months ended June September 30, 2026 and 2025:

Three Months Ended September 30, Nine Months Ended September 30,

Research and Development expenses 8.3 5.2 26.2 15.5

Sales & Marketing expenses 2.1 0.2 5.3 0.6

General & Administrative expenses 6.6 2.3 17.6 9.2

Total personnel expenses 17.0 7.8 49.1 25.3

The following table summarizes the allocation of personnel expenses by nature during the six nine months ended June September 30, 2026 and 2025:

Three Months Ended September 30, Nine Months Ended September 30,

Wages and salaries 10.0 5.6 29.8 17.0

Social security contributions 2.0 1.6 8.3 4.8

Expenses for pension commitments 0.1 0.1 0.1

Share-based payments 5.0 0.5 10.9 3.5

Total 17.0 7.8 49.1 25.3

Personnel expenses for the period ended September 30, 2026, increased by $ 23.7 million compared to the nine months ended September 30, 2025 and by $ 9.3 million compared to the three months ended September 30, 2025.

The increase in personnel expenses reflected the Company's continued investment in advancing VIASKIN Peanut toward potential commercialization. Additional financing completed during 2026 enabled further organizational expansion and commercial readiness, including third-quarter interactions with the FDA, the submission of the BLA for VIASKIN Peanut in children ages 4 through 7 on September 29, 2026, and preparation for a potential commercial launch, if approved.

Note 14: Commitments 5 changes

In the ordinary course of business, the Company enters into agreements with Contract Research Organizations ("CROs"), Contract Manufacturing Organizations ("CMOs") and strategic manufacturing partners. Certain arrangements include non-cancellable purchase commitments and minimum purchase obligations extending beyond the current reporting period. These commitments are generally not recognized in the consolidated balance sheet until the related goods or services are received, unless recognition of a liability is required under applicable U.S. GAAP, including when a loss contingency is probable and reasonably estimable.

5 unchanged paragraphs

Total contractual commitments 41.1 46.5 42.1 13.1 142.7

Total contractual commitments 29.8 50.5 39.1 13.5 132.9

Clinical development commitments primarily represent remaining contractual obligations under agreements with contract research organizations and other service providers supporting the Company s clinical programs, including amounts committed under executed change orders.

Manufacturing and supply commitments include primarily represent obligations under the Company's Company s strategic manufacturing arrangements with Sanofi and Fareva supporting clinical, regulatory and potential commercial supply of VIASKIN Peanut. These commitments include the letter of intent entered into Company s arrangements with Fareva Amboise in support of future commercial related to manufacturing readiness and dedicated production capacity, for VIASKIN Peanut, as well including the Letter of Intent, as amended, and the amendment to the Services Agreement covering additional production batches. They also include the PDS Services Agreement and related Binding Commercial Term Sheet entered into with Fareva La Vall e relating to for the establishment of dedicated Peanut Drug Substance PDS manufacturing capabilities and associated transfer services, as well as the Company s other contractual manufacturing and supply obligations with Sanofi and Fareva.

2 unchanged paragraphs

Note 15: Relationships with Related Parties 9 changes

During the six nine months ended June September 30, 2026, the Company identified two significant related-party transactions.

3 unchanged paragraphs

Six Months Ended June 30,

The compensation amounts presented below, which were awarded to the Directors and Officers of the Company totaled $ 7.1 13.2 million.

Nine Months Ended September 30,

2 unchanged paragraphs

The methods for the valuation of the benefit related to share-based payments are presented in Note 10 Share-Based Payments.

Share-based payments to directors and officers are described in Note 10 Share-Based Payments. The valuation methods are described in Note 11 to the consolidated financial statements included in the Annual Report.

Amounts payable to related parties as of June September 30, 2026 and December 31, 2025 are as follows:

June September 30, 2026 December 31, 2025

1 unchanged paragraph

June September 30, 2026 December 31, 2025

Note 16: Loss Per Share 10 changes

2 unchanged paragraphs

Six Months Ended June 30,

Net loss ( 98.0 ) ( 69.0 )

Weighted average number of ordinary shares 424,587,737 118,545,638

Nine Months Ended September 30,

Net loss in Million of USD ( 162.5 ) ( 102.1 )

Weighted average number of ordinary shares 433,484,635 124,723,638

Net loss per share attributable to ordinary shareholders, basic and diluted ($/share) ( 0.23 0.37 ) ( 0.58 0.82 )

1 unchanged paragraph

June September 30, 2026 December 31, 2025

2 unchanged paragraphs

Stock-options 15,067,578 15,067,578 15,029,103 15,029,103 14,104,578 14,104,578

Restricted stock units 9,919,060 9,919,060 9,952,395 9,952,395 3,608,347 3,608,347

7 unchanged paragraphs

Note 17: Reportable segment disclosure 18 changes

Three Months Ended June 30, Six Months Ended June 30,

Clinical studies 9.9 16.3 21.3 23.1

BLA & Regulatory 5.6 2.3 11.9 3.7

Medical Affairs & Other Medical 5.1 2.0 10.0 4.0

Research & Innovation 0.8 0.3 1.1 1.1

Manufacturing & Supply and Quality 9.9 12.8 20.4 23.4

Sales & Marketing 5.5 0.4 10.4 0.7

General & Administrative 14.6 8.5 25.1 14.1

Total expenses 51.3 42.6 100.1 70.0

Three Months Ended September 30, Nine Months Ended September 30,

Clinical studies 16.8 10.1 38.0 33.2

BLA & Regulatory 11.2 3.3 23.1 7.0

Medical Affairs & Other Medical 6.3 2.3 16.3 6.2

Research & Innovation 0.5 0.4 1.6 1.4

Manufacturing & Supply and Quality 12.3 12.6 32.6 35.9

Sales & Marketing 5.3 1.2 15.7 1.9

General & Administrative 14.0 7.3 39.1 21.3

Total expenses 66.3 37.1 166.4 107.0

3 unchanged paragraphs

Note 18: Events after the Close of the Period 5 changes

Services Agreement with Fareva La Vall e - Peanut Drug Substance

On July 8, 2026, the Company entered into a PDS Services Agreement and Binding Commercial Term Sheet with FLV relating to the construction development, installation and qualification of a dedicated Peanut Drug Substance ( PDS ) manufacturing line, as well as related transfer services for technical and validation batches.

The PDS facility services are expected to be completed no later than September 30, 2027, and the transfer services no later than September 1, 2028. The Company s commitments under the agreement include PDS facility services fees capped at $ 4.0 million, excluding certain capital expenditures directly supported by the Company, and transfer services fees capped at $ 3.0 million. The Company will also directly order and pay for certain equipment required for the dedicated PDS line, which will be owned by the Company. The agreement also includes binding commercial terms expected to be incorporated into a future definitive manufacturing and supply agreement.

The Company concluded that this agreement represents a non-recognized subsequent event as of June 30, 2026.

The Company evaluated subsequent events through the date of issuance of the unaudited condensed consolidated financial statements and identified no subsequent events requiring recognition or disclosure.

MD&A 164 changes

1 unchanged paragraph

Our most advanced product candidate is Viaskin Peanut patch, which has been evaluated as a potential therapy for children with peanut allergy in twelve completed clinical trials, including five Phase 2 trials and five completed Phase 3 trials. The Company is planning for a BLA submission in the third quarter of 2026 for Viaskin Peanut patch as a potential treatment for children 4 through 7 years old. The Company also has an ongoing Phase 3 supplementary safety study of Viaskin Peanut patch in peanut-allergic toddlers ages one through three. Conditional on successful completion of this safety study, the Company is planning for a BLA submission in the second half of 2026 for children ages one to three.

We are a late-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. Our therapeutic approach is based on EPIT, epicutaneous immunotherapy, our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin, an epicutaneous patch (i.e., a skin patch). We have generated significant data demonstrating that Viaskin s mechanism of action is novel and differentiated. Viaskin targets specific specialized antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen that accumulates in the outer layer of the skin, and then migrate to the skin-draining lymph node nodes in order to activate the immune system without passage of the antigen into the bloodstream, minimizing systemic exposure in the body. We are advancing this unique technology to treat children suffering from food allergies, for whom safety is paramount, since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock. We believe Viaskin may offer convenient, self-administered, non-invasive immunotherapy to patients, if approved.

Our most advanced product candidate is Viaskin Peanut patch, evaluated as a potential immunotherapy for children with peanut allergy in twelve clinical trials, including four Phase 2 trials and five completed Phase 3 trials. We are advancing two separate Viaskin Peanut product candidates in parallel to support two potential BLAs in two distinct age groups: one in toddlers ages one through three with the original, or square, patch, and one in children ages four through seven with the modified, or circular, patch. We submitted the BLA for Viaskin Peanut patch as a potential treatment for children 4 through 7 years old in the third quarter of 2026 and requested Priority Review. We also have an ongoing Phase 3 supplementary safety study of Viaskin Peanut patch in peanut-allergic toddlers ages one through three. We have held discussions with the FDA on how to ensure a timely review of the BLA for Viaksin Peanut for toddlers aged 1 through 3 years following the recent submission of the BLA for Viaskin Peanut for children 4 through 7 years old, including a potential rolling submission of the 1-through-3 BLA. The same review team will review both BLAs. The FDA indicated to us that a review of the BLA for Viaskin Peanut for 1 through 3 year olds initiated shortly after the review of the 4-through-7 BLA would allow the FDA to build on the learnings from its review and the efficiencies expected from the meaningful content overlap of the two BLAs. It would provide us and FDA the opportunity to align on the form, content, and best timing of the components of the submission of the BLA for Viaskin Peanut for 1 through 3 year olds, in support of an efficient review of both BLAs. We will continue the regulatory dialogue with FDA over the next few months and expect to submit the BLA for Viaskin Peanut in toddlers 1 through 3 years old in 2027, and we expect to will provide further update once the regulatory pathway for our toddler program has been finalized.

1 unchanged paragraph

During the second quarter of 2026, the Company continued to advance the key elements supporting the potential commercialization of VIASKIN Peanut, including regulatory readiness, clinical development, manufacturing and supply-chain preparedness, commercial launch planning and institutional investor engagement.

During the third quarter of 2026, we made significant progress toward the potential commercialization of VIASKIN Peanut. Following extensive interactions with the FDA during the quarter, we submitted our BLA for VIASKIN Peanut in children ages 4 through 7 years old on September 29, 2026 and requested Priority Review.

In parallel, supported by our strengthened financial resources extended through the refresh of the ATM Program, we accelerated the build-out of our commercial capabilities and continued to advance clinical development, manufacturing and supply-chain readiness and institutional investor engagement, including preparations for FDA inspection, while progressing launch infrastructure.

We are actively working to advance launch infrastructure, including distribution and patient access capabilities to support the launch of VIASKIN Peanut patch in the United States, upon approval..

1 unchanged paragraph

BLA Submission Update for VIASKIN Peanut Patch for children aged 4 through7 years

Submission of BLA FDA for the VIASKIN Peanut Patch in Children Aged 4-7 Years

On June 29, 2026, the Company we announced that it has we had ongoing detailed iterative engagement with FDA with the goal of ensuring a complete, efficient, and timely review of the Company s tour BLA for children aged 4 through 7 years, and, through this process and based on FDA review, DBV we received valuable, actionable input from the FDA, specific to the organization, mapping, and formatting of existing data sets for the CMC and biostatistical elements of the BLA. The Company We announced further that it will we would take the required time to incorporate the FDA s feedback and anticipates that it anticipated the BLA filing to occur in the third quarter of 2026. The FDA did not request any additional data. .

On September 29, 2026, we announced the submission of a BLA to FDA seeking approval of the VIASKIN Peanut patch for the treatment of peanut allergy in children aged 4 through 7 years. The submission is supported by data from the Phase 3 VITESSE study, a randomized, double-blind, placebo-controlled trial, which enrolled 654 children. We requested Priority Review, which, if granted, would reduce the standard review period from ten to six months. The FDA has 60 days from the submission date to determine whether the BLA is sufficiently complete to permit substantive review, following which we anticipate receipt of a PDUFA target action date. The BLA filing represents a significant regulatory milestone and an important step toward the potential commercialization of VIASKIN Peanut in the United States. There can be no assurance that the FDA will accept the BLA for filing, grant Priority Review, or ultimately approve the VIASKIN Peanut patch.

1 unchanged paragraph

Initiation of Phase 2 THRIVE Study

On June 2, 2026, the Company we announced that the first participant had been screened in the Phase 2 THRIVE study evaluating the efficacy and safety of the VIASKIN Peanut patch in infants aged 6 through 12 months with peanut allergy. The study has since progressed to eight participating clinical sites and eight enrolled patients. THRIVE is a single-arm, open-label study designed to assess the ability of participants to achieve ad lib consumption of dietary peanut following 36 months of treatment with the VIASKIN Peanut patch. for 36 months. The Company believes We believe the THRIVE study may provide additional information regarding the potential use of the VIASKIN Peanut patch in younger patient populations.

Shelf Registration Statement, ATM Program Refresh and Sale of $50 million in gross proceeds under ATM Program

On July 27, 2026, we filed an automatically effective shelf registration statement on Form S-3ASR with the SEC. The shelf registration statement permits us to sell, from time to time, ADSs representing ordinary shares and warrants. At the time of filing the shelf registration statement, we also filed a prospectus supplement with the SEC authorizing the sale of up to $150.0 million of ADSs under our existing ATM Program. On August 3, 2026, we announced the sale of $50.0 million in gross proceeds of ADSs to RA Capital Management, L.P. under the ATM Program. In connection with this transaction, we issued 18,288,220 new ordinary shares, underlying 3,657,644 new ADSs, at an at-the-market price of $13.67 per ADS.

1 unchanged paragraph

The Company has We received the supplemental gross proceeds of $94 $94.7 million ( 81 million) resulting in the full exercise of the ABSA Warrants and BS Warrants issued on its our March 2025 PIPE Financing. See Note 2: Significant Events and Transactions - March 2025 PIPE Financing in the notes to the condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information.

1 unchanged paragraph

On June 25, 2026, the Company entered into a letter of intent with Fareva in connection with the planned commercial-scale manufacturing of the VIASKIN Peanut patch. Under the letter of intent, Fareva will undertake manufacturing readiness activities, infrastructure and equipment upgrades and workforce expansion intended to support commercial production of VIASKIN Peanut patch. The parties are currently negotiating a definitive commercial manufacturing and supply agreement. The planned investment for commercial manufacturing is estimated at $7.5 million, of which up to $5.2 million is expected to be supported by the Company through a combination of an FDA approval-contingent upfront payment and manufacturing-related pricing arrangements. The Company expects these activities to support preparedness for future commercialization of VIASKIN Peanut patch, if approved.

Amendment to the Letter of intent signed with Fareva Amboise

On September 30, 2026, the Company entered into Amendment No. 1 to its June 25, 2026 Letter of Intent with Fareva Amboise concerning manufacturing readiness activities supporting the future commercial-scale manufacture of the VIASKIN Peanut patch. The planned investment is estimated at $5.5 million (at the exchange rate of 1 = $1.14). Under the amendment, the Company's $1.1 million (at the exchange rate of 1 = $1.14) upfront contribution to this project was modified such that payment is no longer contingent upon FDA approval of the Company's Biologics License Application. Instead, payment is contingent upon the successful completion of an independent Mock Pre-Approval Inspection , including the absence of critical findings or repeat observations and remediation of all findings by February 1, 2027.

In addition, the amendment finalized and secured the workforce expansion component of the project, including training and extended readiness activities. These personnel are dedicated to supporting industrial ramp-up, execution of the remediation plan and commercial manufacturing preparedness. The parties continue to negotiate a definitive commercial manufacturing and supply agreement. The Company expects the amended arrangement to support the timely execution of manufacturing readiness activities and further prepares the Amboise facility for future commercial production of VIASKIN Peanut, if approved, including activities necessary to support a successful FDA pre-approval inspection.

Services Agreement with Fareva La Vall e - Peanut Drug Substance

On July 8, 2026, the Company entered into a PDS Services Agreement and Binding Commercial Term Sheet with FLV relating to the construction development, installation and qualification of a dedicated PDS manufacturing line, as well as related transfer services for technical and validation batches. The PDS facility services are expected to be completed no later than September 30, 2027, and the transfer services no later than September 1, 2028. The agreement also includes binding commercial terms expected to be incorporated into a future definitive manufacturing and supply agreement.

Letter of intent signed with ICS Integrated Commercialization Solutions

On June 5, 2026, the Company entered into a Letter of Intent with Integrated Commercialization Solutions, LLC ("ICS") in connection with future commercialization support and distribution services for the VIASKIN Peanut patch if approved, in the United States, if approved. Under the letter of intent, the parties agreed to undertake certain preliminary launch readiness and implementation planning activities while continuing negotiations toward a definitive commercial outsourcing services agreement. The contemplated activities include operational planning, systems readiness, distribution infrastructure preparation and other commercialization support services intended to facilitate a potential future product launch, if approved. Management expects execution of the definitive agreement by the end of 2026.

1 unchanged paragraph

On March 17, 2026, the Company entered into the MS Agreement with FLV, under which FLV will manufacture and supply the PSM exclusively for DBV Technologies S.A. during the agreement term. The term is effective for a period of eight (8) years and can be renewed for a period of two (2) years.

4 unchanged paragraphs

Comparison of the Three Months Ended June September 30, 2026 and 2025

The following table summarizes our results of operations, derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in millions of U.S. dollars, for the three months ended June September 30, 2026 and 2025.

Three Months Ended June September 30,

1 unchanged paragraph

Research and development expenses (31.2) (47.0)

Sales and marketing expenses (5.5) (5.3)

General and administrative expenses (14.6) (14.0)

Total Operating expenses (51.3) (66.3)

1 unchanged paragraph

The following table summarizes our operating income during the three months ended June September 30, 2026 and 2025:

Three Months Ended June September 30,

1 unchanged paragraph

Research tax credit 0.7 1.6

Other operating income

2 unchanged paragraphs

Research tax credit decreased by $0.7 $1.2 million for the three months ended June September 30, 2026, compared to the three months ended June 30, 2025. September 30,2025. The accrual is consistent with the prior quarter and reflects the lower level of eligible research activities, as the Company s focus continues to shift from clinical development toward commercial readiness activities.

1 unchanged paragraph

The following table summarizes our research and development expenses incurred during the three months ended June September 30, 2026 and 2025:

Research and Development expenses Three Months Ended June September 30,

4 unchanged paragraphs

Depreciation, amortization BLA fees and other costs

1 unchanged paragraph

External clinical-related expenses decreased by $(3.2) million for the three months ended ended June 30, 2026, compared to the three months ended June 30, 2025. The decrease was primarily driven by the completion of the EPOPEX study, while expenditures associated with the VITESSE and COMFORT Toddlers programs remained globally consistent.

Employee-related costs increased by $3.0 million for the three months ended ended June 30, 2026, compared to the three months ended June 30, 2025. This increase was mainly driven by hirings to support development, medical affairs, regulatory and quality capabilities.

Pre-commercial inventory continues to increase during the period by $2.6 million as June 30, 2026 as the Company progresses with its commercialization readiness activities. The Company expenses Pre-commercial inventory until BLA approval.

Total Research and Development expenses 31.2 47.0

External clinical-related expenses increased by $8.2 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. The increase was primarily driven by accelerated patient enrollment in COMFORT Toddlers study, with the last patient randomized in August 2026, the ramp-up of expenses associated to THRIVE study, initiated in 2026, and the acceleration of BLA readiness activities to prepare BLA submission. This increase was partially offset by the completion of EPOPEX study and the resulting reduction in associated expenses, as well as lower costs related to VITESSE study after the last patient last visit double-blind placebo-controlled end of 2025.

Employee-related costs and share based payment expenses respectively increased by $2.4 million and $0.8 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. This increase is consistent with the reinforcement of Medical Affairs, Quality and

Regulatory functions in the United States, representing 38 new hirings across these functions compared to September 30, 2025, to support a potential U.S. launch, if approved, and to ensure organizational readiness as the Company approaches commercialization.

Following extensive interactions with the FDA, the Company also submitted its BLA for children ages 4 through 7 on September 29, 2026 and requested Priority Review, resulting in the recognition of $4.7 million of previously deferred BLA-related costs, which accounted for the majority of $7.9 million recognized during the period.

Pre-commercial inventory expense increased by $0.9 million, or 24%, reflecting the continued build-up of potential commercial inventory as the Company advances launch readiness for VIASKIN Peanut. Following the manufacturing ramp-up initiated in the third quarter of 2025, the Company continued to receive inventory produced essentially by its contract manufacturing organizations, to support potential commercial launch requirements. Until BLA approval is obtained, the related manufacturing costs continue to be recognized as research and development expense.

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The following table summarizes our sales and marketing expenses incurred during the three months ended ended June September 30, 2026 and 2025:

Sales & Marketing expenses Three Months Ended June September 30,

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Total Sales & Marketing expenses 5.5 5.3

For the fourth consecutive quarter, sales and marketing expenses have increased, rising by $5.1 $4.2 million during the three months ended June September 30, 2026, compared to the three months ended June September 30, 2025. primarily reflecting This reflects the continued execution of the Company s commercial launch readiness strategy in the United States. The increase was primarily driven by higher personnel personnel-related and external costs associated with the expansion of the Company s commercial, market access and launch-support capabilities in preparation for a the potential U.S. launch of VIASKIN Peanut, if approved. This expansion included the hiring of 15 U.S.-based employees compared to September 30, 2025, across Market Access and Patient Services (5), Marketing and Market Insights (4), Sales and Commercial Operations (3), and Commercial Leadership and Transformation (3).

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The following table summarizes our general and administrative expenses incurred during the three months ended June September 30, 2026 and 2025:

General & Administrative expenses Three Months Ended June September 30,

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Total General & Administrative expenses 14.6 14.0

General and Administrative expenses increased by $6.1 $6.7 million for the three months ended June September 30, 2026, compared to the three months ended June September 30, 2025, primarily reflecting continued scaling of the Company s corporate infrastructure to support BLA readiness and commercial launch preparedness. The increase was driven by $3.3 million of higher share-based compensation expense, related to new CEO grants, together with higher employee-related costs associated with 11 additional employees compared to September 30, 2025.

Other operating expenses also increased mainly driven by the extension of the New Jersey office lease, D&O insurance as well as patents and licenses expenses.

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Six Months Ended June 30,

Our financial income was $0.4 $0.6 million for the three months ended June September 30, 2026, compared to a financial expense of $0.6 $1.1 million for the three months ended June September 30, 2025, primarily reflecting higher interest income generated from the investment of available cash. following the Company s 2025 financing transactions, in accordance with its treasury policy. The increase was partially offset by foreign exchange unfavorable effects.

Our income tax expense was $0.2 $0.3 million for the three months ended June September 30, 2026 and was $0.1 million 0 for the three months ended June September 30, 2025.

Net loss was $50.4 $64.5 million for the three months ended June September 30, 2026, compared to $41.9 $33.2 million for the three months ended June September 30, 2025. Net loss per share (based on the weighted average number of shares outstanding over the period) was $(0.12) $0.14 and $(0.31) $0.24 for the three months ended June September 30, 2026 and 2025, respectively. This improvement reflects a significantly strengthened equity base following recent financings.

Comparison of the Six Nine Months Ended June September 30, 2026 and 2025

The following table summarizes our results of operations, derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in millions of U.S. dollars, for the six nine months ended June September 30, 2026 and 2025.

Nine Months Ended September 30,

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Operating income 1.6 2.2 (0.6) (27)%

Research and development expenses (64.6) (55.2) (9.4) 17%

Sales and marketing expenses (10.4) (0.7) (9.7) 1426%

General and administrative expenses (25.1) (14.1) (11.0) 78%

Total Operating expenses (100.1) (69.9) (30.1) 43%

Financial income (expense) 0.9 (1.1) 2.0 (184)%

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and 93 more changes in the filing

Controls and procedures 2 changes

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Legal proceedings 2 changes

and 2 more changes in the filing

Risk factors 7 changes

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and 7 more changes in the filing

Other information 1 change

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Exhibits 6 changes

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and 6 more changes in the filing