DBV Technologies SA

Previous wording

We are a clinical-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 epicutaneous immunotherapy, or EPIT, 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 antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen and migrate to the lymph node 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.

Current wording

We are a clinical-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 epicutaneous immunotherapy, or EPIT, 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 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 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.

Previous wording

Our most advanced product candidate is Viaskin Peanut, which has been evaluated as a potential therapy for children with peanut allergy in eleven clinical trials, including four Phase 2 trials and four completed Phase 3 trials. We also have an ongoing Phase 3 trial of Viaskin Peanut in children ages four to seven with peanut allergy, as well as two planned Phase 3 supplementary safety studies, one in peanut-allergic children ages four through seven, and one in peanut-allergic toddlers, ages one through three.

Current wording

Our most advanced product candidate is Viaskin Peanut, evaluated as a potential immunotherapy for children with peanut allergy in eleven clinical trials, including four Phase 2 trials and four completed Phase 3 trials. We are advancing two separate Viaskin Peanut product candidates in parallel to support two potential Biologics License Applications (BLAs) in two distinct age groups: one in toddlers ages one through three with the original (square) patch, and one in children ages four through seven with the modified (circular) patch.

Previous wording

Our management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, as well as the revenue, costs and expenses recognized during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Current wording

Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP. The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements, as well as the revenue, costs and expenses recognized during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Previous wording

The following table summarizes our results of operations, derived from our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars, for the three months ended March 31, 2024 and 2023.

Current wording

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 thousands of U.S. dollars, for the three months ended June 30, 2024 and 2023.

Previous wording

Until the end of 2023, our operating income was composed of both the French research tax credit (Crédit d’Impôt Recherche, or “CIR”) and the revenue recognized under the Collaboration Agreement with NESTEC. Following the termination of the Collaboration Agreement on October 30, 2023, our operating income is now exclusively generated by the French research tax credit.

Current wording

Until the end of 2023, our operating income was composed of both the French research tax credit (Crédit d’Impôt Recherche, or “CIR”) and the revenue recognized under the Collaboration Agreement with NESTEC. Following the termination of the Collaboration Agreement on October 30, 2023, our operating income is now exclusively generated by the French research tax credit which explains why Other operating income was nil for the three months ended June 30, 2024 compared to $.3 million for the three months ended June 30, 2023.

Previous wording

months ended March 31, 2023, primarily due to the increase in external clinical-related expenses for $3.6 million, driven by progress on patient enrollment in VITESSE Phase 3 clinical trial.

Current wording

Research and Development expenses increased by $7.8 million for the three months ended June 30, 2024, compared to the three months ended June 30, 2023, due to an increase in external clinical-related expenses by $7.0 million, reflecting the progress on patient enrollment in VITESSE Phase 3 clinical trial after the initiation of the study with the first patient screened in March 2023 and the preparatory activities for the COMFORT studies in preparation for and anticipation of initiation after FDA alignment.

Previous wording

Employee-related costs, excluding share-based payments, increased by $1.0 million for the three months ended March 31, 2024 compared to the three months ended March 31, 2023 due to the recruitment of employees to support research and development activities mainly on the VITESSE trial.

Current wording

Employee-related costs, excluding share-based payments, increased by $1.2 million for the three months ended June 30, 2024, compared to the three months ended June 30, 2023 due to the recruitment of 17 internal resources in Medical, Quality and Regulatory Affairs mostly based in the U.S.

Previous wording

Sales and marketing expenses have increased by $0.3 million during the three months ended March 31, 2024, compared the three months ended March 31, 2023 to supportpre-commercialization activities for Viaskin Peanut in North America.

Current wording

Sales and marketing expenses have increased by $0.5 million during the three months ended June 30, 2024, compared to the three months ended June 30, 2023 to supportpre-commercialization activities for Viaskin Peanut in North America.

Previous wording

Our financial income was $1.3 million for the three months ended March 31,2024, compared to a financial income of $0.6 million for the three months ended March 31,2023. This item mainly includes the financial income on our financial assets.

Current wording

Our financial income was $0.7 million for the three months ended June 30, 2024, compared to a financial income of $0.8 million for the three months ended June 30, 2023. This item mainly includes the financial income on our financial assets and foreign exchange result.

Previous wording

Net loss was $27.3 million for the three months ended March 31, 2024, compared to $20.6 million for the three months ended March 31, 2023. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.28 and $0.22 for the three months ended March 31, 2024 and 2023, respectively.

Current wording

Net loss was $33.1 million for the three months ended June 30, 2024, compared to $24.2 million for the three months ended June 30, 2023. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.34 and $0.26 for the three months ended June 30, 2024 and 2023, respectively.

Previous wording

Our income tax profit for the three months ended March 31, 2024 was $48 thousand. We did not have any income tax profit or expense for the three months ended March 31, 2023.

Current wording

Our income tax expense was $48 thousand for the six months ended June 30, 2024 compared to $13 thousand for the six months ended June 30, 2023.

Previous wording

On March 31, 2024, we had $101.5 million in cash and cash equivalents compared to $141.4 million of cash and cash equivalents on December 31, 2023. Based on its current operations, plans and assumptions, the Company expects that its balance of cash and cash equivalents will be sufficient to fund its operations until December 31, 2024.

Current wording

Based on its current operations, plans and assumptions, the Company expects that its balance of cash and cash equivalents will be sufficient to fund its operations into the first quarter 2025.

Previous wording

We have incurred operating losses and negative cash flows from operations since our inception. Net cash used for operating activities was $34.7 million and $20.8 million for the three months ended March 31, 2024 and 2023, respectively. For the three months ended March 31, 2024, we recorded a net loss of $27.3 million. Our net cash flows provided by financing activities was $(0.1) million during the three months ended March 31, 2024 compared to a nil amount during the three months ended March 31, 2023. Our net cash flows used in investing activities was $(2.1) million during the three months ended March 31, 2024, including revamping of the new headquarter for $(1.3) million, compared to $(0.1) million during the three months ended March 31, 2023.

Current wording

We have incurred operating losses and negative cash flows from operations since our inception. Net cash used for operating activities was $69.8 million and $46.4 million for the six months ended June 30, 2024 and 2023, respectively. For the six months ended June 30, 2024, we recorded a net loss of $60.5 million. Our net cash flows provided by financing activities decreased to $0.1 million during the six months ended June 30, 2024 from $7.8 million during the six months ended June 30, 2023 yielded by our ATM.

Previous wording

In May 2022, we established an At-The-Market (“ATM”) program to offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $100 million of American Depositary Shares (“ADSs”), each ADS representingone-half of one ordinary share of the Company. The ATM program is intended to be effective through the expiration of the Company’s existing registration statement registering the ADSs to be issued under the ATM program, i.e. until July 16, 2024, unless terminated prior to such date in accordance with the sales agreement or the maximum amount of the program has been reached. The Company’s intent is to use the net proceeds, if any, of sales of ADSs issued under the program, together with its existing cash and cash equivalents, primarily for activities associated with potential approval and launch of Viaskin Peanut, as well as to advance the development of the Company’s product candidates using its Viaskin Platform and for working capital and other general corporate purposes.

Current wording

In May 2022, we established an At-The-Market (“ATM”) program to offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $100 million of American Depositary Shares (“ADSs”), each ADS representing one ordinary share of the Company. The ATM program was intended to be effective through the expiration on July 16, 2024 of the Company’s existing registration statement registering the ADSs to be issued under the ATM program. The Company’s intent was to use the net proceeds, if any, of sales of ADSs issued under the program, together with its existing cash and cash equivalents, primarily for activities associated with potential approval and launch of Viaskin Peanut, as well as to advance the development of the Company’s product candidates using its Viaskin Peanut platform and for working capital and other general corporate purposes.

Previous wording

At the date of filing, our corporate headquarters are located in Châtillon, France. Our principal offices occupy a 2,447 square meter facility, pursuant to a lease agreement dated November, 2023 and represents a $4.5 million cash requirement as of March 31, 2024 until March, 2033. The move of the corporate headquarters to Châtillon, France is subject to ratification by the shareholders of the Company at the annual general meeting on May 16, 2024.

Current wording

Our corporate headquarters are located in Châtillon, France. Our principal offices occupy a 2,447 square meter facility, pursuant to a lease agreement dated November, 2023 and represents $0.8 million cash requirement as of June 30, 2024 until March, 2033.

Previous wording

The lease agreement for the office occupying 4,470 square meter facility in Montrouge, France, signed on March 3, 2015, with an effective date of August 1, 2025, expires on May, 2024. Associated lease termination costs were reflected in the Company’s financial accounts in the Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 7, 2024.

Current wording

The lease agreement for the office occupying 4,470 square meter facility in Montrouge, France, signed on March 3, 2015, with an effective date of August 1, 2025, expired on May 31, 2024. Associated lease termination costs were reflected in the Company’s financial accounts in the Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 7, 2024.

Previous wording

At the date of filing, our primary U.S. office is located in Warren, New Jersey. In February 2024, we entered into a sublease agreement, commencing on March 19, 2024 and effective for 70 months, for an office of 16,704 square feet in Warren, New Jersey. The Warren office represent a $1.8 million cash requirement as of March 31, 2024 which expires December 31, 2029.

Current wording

Our primary U.S. office is located in Warren, New Jersey. In February 2024, we entered into a sublease agreement, commencing on March 19, 2024 and effective for 70 months, for an office of 16,704 square feet in Warren, New Jersey. The Warren office represent a $0.1 million cash requirement as of June 30, 2024 which expires December 31, 2029.

Previous wording

The Company transitioned to its new offices location in Warren NJ and Châtillon France over the end of the first quarter of 2024. Leases from prior offices located in Basking Ridge NJ and Montrouge, France offices were still active at the time of filing.

Current wording

The Company transitioned to its new offices location in Warren NJ and Châtillon France in April 2024.

Previous wording

There have been no material changes in our operating leases from those disclosed in the Annual Report.

Current wording

There have been no material changes in our operating leases from those disclosed in the Annual Report except the impact of the new lease in Warren NJ for $1.7 million.

Previous wording

In connection with the launch of our clinical trials for Viaskin Peanut and Viaskin Milk, we signed agreements with several contract research organizations. As of December 31, 2023, expenses associated with the ongoing trials amounted globally to $114.4 millions, and we had non-cancellable contractual obligations with CRO until year ended 2025 amountingto $64.4 millions.

Current wording

In preparation of the launch of our clinical trials for Viaskin Peanut, we signed agreements with several contract research organizations. As of , June 30, 2024 expenses associated with the ongoing trials amounted globally to $162.4 million compared to $114.4 million as of December 31, 2023.

Previous wording

The table below summarizes our sources and uses of cash for the three months ended March 31, 2024 and 2023.

Current wording

The table below summarizes our sources and uses of cash for the six months ended June 30, 2024 and 2023.

Previous wording

Our net cash flows used in operating activities were $34.7 million and $20.8 million during the three months ended March 31, 2024 and 2023, respectively. The variance of $13.9 million is mainly driven by the increase in (1) external clinical-related expenses by $3.7 million, (2) R&D activities to support clinical trials progress through Regulatory Affairs, Medical Affairs, Manufacturing platform and Supply activities by $6.4 million and (3) internal employees’ compensation increase by $2.5 million with 18 additional employees.

Current wording

Our net cash flows used in operating activities were $69.8 million and $46.4 million during the six months ended June 30, 2024 and 2023, respectively. Our net cash flows used in operating activities increased by $23.4 million . The variance is mainly driven by the increase in (1) external clinical related expenses by $6.6 million, (2) R&D activities to support clinical trials progress through Regulatory Affairs, Medical Affairs and Operations activities by $8.2 million and (3) internal employees’ compensation increase by $3.1 million with the hiring of 24 additional internal resources.