DBV Technologies SA
For the period ended Sep 30, 2024. Filed Nov 6, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 6, 2024
DBVT$10.45+6.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-07-30.
0001193125-24-188853
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-06.
0001613780-24-000007
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 93 previous paragraphs and 102 current paragraphs.
47 unchanged; 42 reworded; 12 added; 4 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 11 previous and 11 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (12)
Current report
On July 30, 2024, the Company announced that it and the FDA had been engaged in ongoing dialogue since May 2023 on the COMFORT Toddlers supplemental safety study in 1 – 3-years-old with a peanut allergy. The study protocol was submitted on November 9, 2023, with comments provided by FDA on March 11, 2024. Since March, much of the dialogue between DBV and FDA regarding the COMFORT Toddlers supplemental study had focused on patch wear-time experience, including how prescribers would advise parents and caregivers to manage day-to-day variability in patch wear time. The Company proposed an approach, informed by the EPITOPE efficacy data, that focuses on the user experience during the first 90-days of treatment. The Company submitted to the FDA draft labeling for Section 2 – Dosing and Administration, for a potential Viaskin Peanut Prescribing Information (PI), along with comprehensive supportive data and analyses. Within the first 90-days of treatment (excluding the lead-in dosing period) it is possible to identify those patients who are very likely to have a robust clinical efficacy response based on patch wear time experience (i.e., “Label-in” patients). The proposed PI recommends continuation of treatment for these patients. With the same 90-day approach, patients less likely to have a robust clinical efficacy response, identified by their patch wear-time experience, would be identified as “Label-out” patients. In these instances, the PI would recommend a shared decision-making process, between the health care provider and the parent or caregiver, to determine whether treatment should be discontinued.
Current report
On October 22, 2024, the Company announced positive regulatory updates for the Viaskin Peanut patch in the United States and Europe. The Company has agreed to guidance provided by the FDA on a potential pathway under the Accelerated Approval program for the Viaskin Peanut patch in toddlers ages 1 – 3 years-old.
Current report
FDA guidance for Accelerated Approval include three qualifying criteria: 1) that the product candidate treats a serious condition, 2) that the product candidate generally provides a meaningful advantage over available therapies, and 3) that the product candidate demonstrates an effect on an intermediate clinical endpoint that is reasonably likely to predict clinical benefit. FDA confirmed that DBV has met criterion 1 and 2. Regarding criterion 3, FDA has provided guidance and suggestion regarding the intermediate clinical endpoint, which DBV has agreed to in informal discussions with the FDA. The Company intends to formalize the Accelerated Approval guidance provided by FDA via submission of a meeting request to confirm the general elements of the two study components: the COMFORT Toddlers safety study, to be completed before BLA submission, and the confirmatory effectiveness study, including the third Accelerated Approval criterion regarding the intermediate clinical endpoint. DBV expects that the confirmatory study will be initiated by the time of BLA submission and would run in parallel to commercialization in the United States, if Viaskin Peanut is approved.
Current report
The Company announced further that it has aligned with FDA on a wear time collection methodology in COMFORT Toddlers that provides a practical approach for subjects and families, is intended to generate sufficient data to support a BLA submission, and places wear time into an acceptable clinical hierarchy relative to other study endpoints. DBV has initiated study start-up activities and plans to screen the first subject in the second quarter of 2025. The Company anticipates enrolling approximately 300 – 350 subjects on active treatment into the safety study, which would bring the total Viaskin Peanut patch safety database in toddlers to approximately 600 subjects, consistent with prior FDA guidance. With this path forward, the BLA submission for Viaskin Peanut patch in 1 – 3 years-old under the Accelerated Approval program is anticipated to be supported by:
Current report
The Company announced further that the COMFORT Children safety study is expected to be initiated in the second quarter of 2025. This study plans to enroll approximately 250 subjects to raise the total number of 4 – 7 years-old on active treatment across the development program to approximately 600, consistent with prior FDA guidance. The VITESSE phase 3 efficacy trial of the Viaskin Peanut patch in peanut allergic children ages 4 – 7 years-old and the COMFORT Children safety study will constitute the core studies for a BLA submission in 4 – 7 years-old.
Current report
The Company announced further that it sought scientific advice from the EMA regarding the components of a MAA for the Viaskin Peanut patch. Previous advice obtained from two local country regulatory health authorities indicated a potential path for a 1 – 7 year-old registration with one patch, the modified patch. The EMA recently confirmed through scientific advice that the completed EPITOPE study in 1 – 3 years-old, and a positive VITESSE study in 4 – 7 years-old, could constitute an MAA submission for a 1 – 7 year-old indication for peanut allergy patients using the modified patch, along with a new safety study in 1 – 3 years-old with the modified patch. Timing for the initiation of this new safety study to satisfy the important EU market is currently being planned.
Current report
General and Administrative expenses increased by $1.0 million for the three months ended September 30, 2024, compared to the three months ended September 30, 2023.
Current report
External professional services increased by $1.7 million for the three months ended September 30, 2024, compared to the three months ended September 30, 2023 mainly due to (1) one-time costs associated with financing activities, and trademark and patent activities and (2) an accrual reversal that occurred last year and had the effect of reducing the corresponding last year expenses.
Current report
Comparison of the Nine Months Ended September 30, 2024 and 2023
Current report
Depreciation, amortization and other costs increased by $3.9 million for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023, due to (1) l the termination of the Collaboration Agreement with NESTEC, (2) accruals on CRO activities and (3) Medical, Quality and Regulatory Affairs activities.
Current report
General and Administrative expenses increased by $1.4 million for nine months ended September 30, 2024, compared to the nine months ended September 30, 2023.
Current report
External professional services increased by $1.8 million for nine months ended September 30, 2024, compared to the nine months ended September 30, 2023, primarily due to one-time costs associated with (1) office moves in France and the U.S, (2) financing activities and (3) trademark and patent activities.
Removed paragraphs (4)
Previous report
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 report
These were partially offset by an increase of $0.8 million in employee-related costs (excluding share-based payment) related to the hiring of 7 internal resources to support recruitment, project management, information solutions and legal and intellectual property activities.
Previous report
Comparison of the Six Months Ended June 30, 2024 and 2023
Previous report
Employee-related costs (excluding share-based payment) increased by $0.7 million for the six months ended June 30, 2024, compared to the six months ended June 30, 2023 mainly due to the hiring of 7 employees to support recruitments, project management, information solutions and legal and intellectual property activities.
Reworded paragraphs (42)
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 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.
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 (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
Currently, we have an ongoing Phase 3 efficacy and safety trial (VITESSE) to evaluate the modified Viaskin Peanut patch in children ages four through seven with peanut allergy. Screening of the last subject is anticipated by the end of the third quarter of 2024 with topline results anticipated in the third quarter of 2025. We also have an ongoing Phase 3 open-label extension to the EPITOPE trial (our completed Phase 3 efficacy and safety trial conducted in peanut-allergic toddlers which met its clinical endpoints), with 3-year results anticipated later this year, 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 The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1-through-3-year-olds to the FDA on November 9, 2023. The Company received comments and queries to the protocol from the FDA on March 11, 2024. Since March, the Company and the FDA have been engaged in ongoing dialogue related to the program. Much of the ongoing dialogue has focused on patch wear-time experience. To address the FDA’s protocol queries, the Company submitted to the FDA on June 28, 2024, a proposed labeling approach, informed by the EPITOPE efficacy data. The proposed labeling approach focuses on the user experience during the first 90 days on treatment. The Company is awaiting feedback on the labeling proposal following FDA review.
Current wording
Currently, we have an ongoing Phase 3 efficacy and safety trial (VITESSE) to evaluate the modified Viaskin Peanut patch in children ages four through seven with peanut allergy. On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study. The Company announced on September 23, 2024 that subject screening was completed in the third quarter of 2024 and that topline results are anticipated by fourth quarter of 2025. We also have an ongoing Phase 3 open-label extension to the EPITOPE trial (our completed Phase 3 efficacy and safety trial conducted in peanut-allergic toddlers which met its clinical endpoints), with 3-year results anticipated later this year, 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. The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1 – 3 years-old to the FDA on November 9, 2023. The Company received comments and queries to the protocol from the FDA on March 11, 2024.
Previous 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.
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(“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
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.
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 September 30, 2024 compared to $1.1 million for the three months ended September 30, 2023.
Previous wording
Research tax credit decreased by $0.8 million for the three months ended June 30, 2024, compared to the three months ended June 30, 2023 primarily due to a greater proportion of studies activities carried out in North America and therefore not eligible to the French Research tax credit.
Current wording
Research tax credit decreased by $0.2 million for the three months ended September 30, 2024, compared to the three months ended September 30, 2023 primarily due to a greater proportion of studies activities carried out in North America and therefore not eligible to the French Research tax credit.
Previous 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.
Current wording
Research and Development expenses increased by $9.9 million for the three months ended September 30, 2024, compared to the three months ended September 30, 2023, due to an increase in external clinical-related expenses of $4.9 million, primarily reflecting progress on subject enrollment in VITESSE Phase 3 clinical trial after the initiation of the study with the first patient screened in March 2023.
Previous 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.
Current wording
Employee-related costs, excluding share-based payments, increased by $1.1 million for the three months ended September 30, 2024, compared to the three months ended September 30, 2023 due to the recruitment of 13 internal resources in Medical, Quality and Regulatory Affairs mostly based in the U.S.
Previous wording
Depreciation, amortization and other costs decreased by $0.5 million for the three months ended June 30, 2024, compared to the three months ended June 30, 2023, due to no longer requiring onerous contract provisioning following the termination of the Collaboration Agreement with NESTEC.
Current wording
Depreciation, amortization and other costs increased by $3.6 million for the three months ended September 30, 2024, compared to the three months ended September 30, 2023, due to (1) the termination of the Collaboration Agreement with NESTEC no longer requiring onerous contract provisioning, (2) accruals on CRO activities and (3) Medical, Quality and Regulatory Affairs activities.
Previous wording
General and Administrative expenses remain flat thanks to the optimization of External professional services.
Current wording
Sales and marketing expenses have decreased by $0.1 million during the three months ended September 30, 2024, compared to the three months ended September 30, 2023 mainly due to the optimization of external professional services.
Previous wording
General and Administrative expenses decreased by $0.6 million for the three months ended June 30, 2024, compared to the three months ended June 30, 2023 as a result of (1) an optimization and rationalization of external professional services and (2) the decrease of depreciation, amortization and other costs primarily explained by the provision reversal on the Montrouge office revamping following thenon-renewal of the related lease agreement.
Current wording
These increases are partially offset by a decrease in depreciation, amortization and other costs for $1.0 million for the three months ended September 30, 2024, compared to the three months ended September 30, 2023 primarily due to the provision reversal on the Montrouge office revamping following the non-renewal of the related lease agreement.
Previous 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.
Current wording
Our financial expense was $(0.1) million for the three months ended September 30, 2024, compared to a financial income of $1.5 million for the three months ended September 30, 2023. This item mainly includes the financial income on our financial assets and foreign exchange result.
Previous wording
Our income tax expense was nil for the three months ended June 30, 2024 compared to $13 thousand for the three months ended June 30, 2023.
Current wording
Our income tax expense was nil for the three months ended September 30, 2024 compared to nil for the three months ended September 30, 2023.
Previous 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.
Current wording
Net loss was $30.4 million for the three months ended September 30, 2024, compared to $16.7 million for the three months ended September 30, 2023. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.32 and $0.17 for the three months ended September 30, 2024 and 2023, respectively.
Previous 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 six months ended June 30, 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 nine months ended September 30, 2024 and 2023.
Previous wording
The following table summarizes our operating income during the six months ended June 30, 2024 and 2023:
Current wording
The following table summarizes our operating income during the nine months ended September 30, 2024 and 2023:
Previous wording
During the six months ended June 30, 2024 we generated an Operating Income of $2.6 million compared to $4.5 million during the six months ended June 30, 2023.
Current wording
During the nine months ended September 30, 2024 we generated an Operating Income of $3.6 million compared to $6.9 million during the nine months ended September 30, 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 composed of the French research tax credit. Other operating income was nil for the six months ended June 30, 2024 compared to $0.7 million for the six months ended June 30, 2023.
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 composed of the French research tax credit. Other operating income was nil for the nine months ended September 30, 2024 compared to $1.9 million for the nine months ended September 30, 2023.
Previous wording
Research tax credit decreased by $1.2 million for the six months ended June 30, 2024, compared to the six months ended June 30, 2023 primarily due to the fact that a greater proportion of clinical studies activities were carried out in North America and were therefore not eligible to the French Research tax credit.
Current wording
Research tax credit decreased by $1.3 million for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023 primarily due to the fact that a greater proportion of clinical studies activities were carried out in North America and were therefore not eligible to the French Research tax credit.
Previous wording
The following table summarizes our R&D expenses incurred during the six months ended June 30, 2024 and 2023:
Current wording
The following table summarizes our R&D expenses incurred during the nine months ended September 30, 2024 and 2023:
Previous wording
Research and Development expenses increased by $13.1 million for the six months ended June 30, 2024, compared to the six months ended June 30, 2023, essentially due to external clinical-related expenses surging by $10.6 million from both patient enrollment in VITESSE Phase 3 clinical trial sustainable increase 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.
Current wording
Research and Development expenses increased by $23.0 million for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023, essentially due to external clinical-related expenses increasing by $15.5 million from both patient enrollment in VITESSE Phase 3 clinical trial sustainable increase 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 $2.2 million for the six months ended June 30, 2024, compared to the six 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.
Current wording
Employee-related costs, excluding share-based payments, increased by $3.3 million for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023 due to the recruitment of 13 internal resources in Medical, Quality and Regulatory Affairs, mostly based in the U.S.
Previous wording
The following table summarizes our sales and marketing expenses incurred during the six months ended June 30, 2024 and 2023:
Current wording
The following table summarizes our sales and marketing expenses incurred during the nine months ended September 30, 2024 and 2023:
Previous wording
Sales and marketing expenses increased by $0.8 million for the six months ended June 30, 2024, compared to the six months ended June 30, 2023, primarily to supportpre-commercialization activities for Viaskin Peanut in North America.
Current wording
Sales and marketing expenses increased by $0.6 million for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023, primarily to support pre-commercialization activities for Viaskin Peanut in North America.
Previous wording
The following table summarizes our general and administrative expenses incurred during the six months ended June 30, 2024 and 2023:
Current wording
The following table summarizes our general and administrative expenses incurred during the nine months ended September 30, 2024 and 2023:
Previous wording
This increase is partially offset by a decrease in Depreciation, amortization and other costs for $0.4 million for the six months ended June 30, 2024, compared to the six months ended June 30, 2023 primarily due to the provision reversal on the Montrouge office revamping.
Current wording
This increase is partially offset by a decrease in depreciation, amortization and other costs for $1.4 million for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023 primarily due to the provision reversal on the Montrouge office revamping.
Previous wording
Our financial income was $2.0 million for the six months ended June 30, 2024, compared to a financial income of $1.5 million for the six months ended June 30, 2023. This item mainly includes financial income on our financial assets and a favorable foreign exchange result..
Current wording
Our financial income was $1.9 million for the nine months ended September 30, 2024, compared to a financial income of $3.0 million for the nine months ended September 30, 2023. This item mainly includes financial income on our financial assets and an unfavorable foreign exchange result.
Previous 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.
Current wording
Our income tax expense was $48 thousand for the nine months ended September 30, 2024 compared to $13 thousand for the nine months ended September 30, 2023.
Previous wording
Net loss was $60.5 million for the six months ended June 30, 2024, compared to $44.8 million for the six months ended June 30, 2023. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.63 and $0.48 for the six months ended June 30, 2024 and 2023, respectively.
Current wording
Net loss was $90.9 million for the nine months ended September 30, 2024, compared to $61.5 million for the nine months ended September 30, 2023. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.95 and $0.65 for the nine months ended September 30, 2024 and 2023, respectively.
Previous wording
On June 30, 2024, we had $66.2 million in cash and cash equivalents compared to $141.4 million of cash and cash equivalents on December 31, 2023.
Current wording
On September 30, 2024, we had $46.4 million in cash and cash equivalents compared to $141.4 million of cash and cash equivalents on December 31, 2023.
Previous wording
As of the date of filing, our available cash is not projected to be sufficient to support our operating plan for at least the next 12 months. As such, there is substantial doubt regarding our ability to continue as a going concern.
Current wording
As of the date of filing, our available cash and cash equivalents will not be sufficient to support our operating plan for at least the next 12 months. As such, there is substantial doubt regarding our ability to continue as a going concern.
Previous 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.
Current wording
We have incurred operating losses and negative cash flows from operations since our inception. Net cash used for operating activities was $92.2 million and $66.0 million for the nine months ended September 30, 2024 and 2023, respectively. For the nine months ended September 30, 2024, we recorded a net loss of $90.9 million. Our net cash flows provided by financing activities decreased to $(0.1) million during the nine months ended September 30, 2024 from $7.0 million during the nine months ended September 30, 2023 yielded by our ATM.
Previous wording
We intend to seek additional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts. We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms ofnon-dilutive financings.
Current wording
We intend to seek additional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts. We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings.
Previous 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.
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 $5.7 million cash requirement as of September 30, 2024. The lease term ends in 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, 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.
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.
Previous 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.
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 $1.9 million cash requirement as of September 30, 2024 which expires December 31, 2029.
Previous wording
We also have facilities in North America that were intended to support our U.S. operations. We lease 5,799 square feet in Basking Ridge, New Jersey, which commenced on April 1, 2022 and is effective for 38 months.
Current wording
We also have facilities in North America that were intended to support our U.S. operations. We lease 5,799 square feet in Basking Ridge, New Jersey, which commenced on April 1, 2022 and is effective for 38 months.The Basking Ridge office represents a $0.1 million cash requirement as of September 30, 2024 which expires April 30, 2025.
Previous wording
The table below summarizes our sources and uses of cash for the six months ended June 30, 2024 and 2023.
Current wording
The table below summarizes our sources and uses of cash for the nine months ended September 30, 2024 and 2023.
Previous 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.
Current wording
Our net cash flows used in operating activities were $92.2 million and $66.0 million during the nine months ended September 30, 2024 and 2023, respectively. Our net cash flows used in operating activities increased by $26.3 million . The variance is mainly driven by the increase in (1) external clinical related expenses by $10.2 million, (2) Regulatory and Manufacturing activities by $9.9 million and (3) internal employees’ compensation increase by $4.8 million as a result of the hiring of 16 additional internal resources.
Previous wording
Our net cash flows used in investing activities were $1.4 million and $0.3 million during the six months ended June 30, 2024 and 2023 respectively. The variance includes capitalized costs for the headquarters move to Châtillon in April 2024 which amounted to $1.8 million.
Current wording
Our net cash flows used in investing activities were $1.5 million and $0.6 million during the nine months ended September 30, 2024 and 2023 respectively. The variance includes capitalized costs for the headquarters move to Châtillon in April 2024 which amounted to $1.8 million.
Previous wording
Our net cash flows from financing activities were $95 thousand for the six months ended June 30, 2024 compared to $7.8 million for the six months ended June 30, 2023 from the ATM.
Current wording
Our net cash flows from financing activities were $(88) thousand for the nine months ended September 30, 2024 compared to $7.0 million for the nine months ended September 30, 2023 from the ATM.
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Current report — wording carried from elsewhere
There have been no material changes in our purchase obligations from those disclosed in our Annual Report.