Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2024 | May 07, 2024 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2024 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | DBV TECHNOLOGIES S.A. | |
Entity Central Index Key | 0001613780 | |
Entity File Number | 001-36697 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Interactive Data Current | Yes | |
Entity Common Stock, Shares Outstanding | 96,434,369 | |
Document Transition Report | false | |
Document Quarterly Report | true | |
Entity Shell Company | false | |
Entity Emerging Growth Company | false | |
Entity Address, Country | FR | |
Entity Small Business | true | |
Entity Incorporation, State or Country Code | I0 | |
Entity Address, Address Line One | 177-181 avenue Pierre | |
Entity Address, Address Line Two | Brossolette | |
Entity Address, City or Town | Montrouge | |
Entity Address, Postal Zip Code | 92120 | |
City Area Code | 33 | |
Local Phone Number | 1 55 42 78 78 | |
Entity Tax Identification Number | 00-0000000 | |
American Depositary Share [Member] | ||
Document Information [Line Items] | ||
Title of 12(b) Security | American Depositary Shares, each representing one-half of one ordinary share, nominal value €0.10 per share | |
Trading Symbol | DBVT | |
Security Exchange Name | NASDAQ | |
Ordinary Shares [Member] | ||
Document Information [Line Items] | ||
Title of 12(b) Security | Ordinary shares, nominal value €0.10 per share | |
Security Exchange Name | NASDAQ | |
No Trading Symbol Flag | true |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Financial Position - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 101,525 | $ 141,367 |
Other current assets | 18,037 | 17,548 |
Total current assets | 119,562 | 158,915 |
Non-Current assets | ||
Property, plant, and equipment, net | 12,913 | 12,623 |
Right-of-use assets related to operating leases | 6,551 | 5,247 |
Intangible assets | 52 | 58 |
Other non-current assets | 6,818 | 6,144 |
Total non-current assets | 26,334 | 24,071 |
Total Assets | 145,895 | 182,986 |
Current liabilities | ||
Trade payables | 18,076 | 23,302 |
Short-term operating leases | 232 | 1,144 |
Current contingencies | 3,153 | 3,959 |
Other current liabilities | 5,023 | 8,934 |
Total current liabilities | 26,483 | 37,339 |
Non-Current liabilities | ||
Long-term operating leases | 6,793 | 4,526 |
Non-current contingencies | 965 | 935 |
Other non-current liabilities | 0 | 0 |
Total non-current liabilities | 7,758 | 5,461 |
Total Liabilities | 34,241 | 42,799 |
Shareholders' equity: | ||
Ordinary shares, €0.10 par value; 96,434,369 and 96,431,770 shares authorized, and issued as of March 31, 2024 and December 31, 2023, respectively | 10,972 | 10,972 |
Additional paid-in capital | 379,426 | 377,468 |
Treasury stock, 262,644 and 222,988 ordinary shares as of March 31, 2024 and December 31, 2023, respectively, at cost | (1,325) | (1,263) |
Accumulated deficit | (266,207) | (238,862) |
Accumulated other comprehensive income | 683 | 742 |
Accumulated currency translation effect | (11,897) | (8,871) |
Total Shareholders' equity | 111,654 | 140,187 |
Total Liabilities and Shareholders' equity | $ 145,895 | $ 182,986 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Financial Position (Parenthetical) - € / shares | Mar. 31, 2024 | Mar. 31, 2023 |
Treasury stock, common, shares | 262,644 | 222,988 |
Common Shares [Member] | ||
Common stock shares par value | € 0.1 | € 0.1 |
Common stock shares authorized | 96,434,369 | 96,431,770 |
Common stock shares issued | 96,434,369 | 96,431,770 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating income | $ 1,407 | $ 2,194 |
Operating expenses | ||
Research and development expenses | (21,403) | (16,037) |
Sales and marketing expenses | (758) | (434) |
General and administrative expenses | (7,804) | (6,889) |
Total Operating expenses | (29,964) | (23,359) |
Loss from operations | (28,558) | (21,165) |
Financial income(expenses) | 1,261 | 605 |
Loss before taxes | (27,297) | (20,561) |
Income tax (expense) | (48) | 0 |
Net loss | (27,345) | (20,561) |
Foreign currency translation differences, net of taxes | (3,026) | 3,666 |
Actuarial gains (losses) on employee benefits, net of taxes | (59) | (82) |
Total comprehensive loss | $ (30,429) | $ (16,977) |
Basic Net loss per share attributable to shareholders | $ (0.28) | $ (0.22) |
Weighted average shares outstanding used in computing per share amounts: | 96,176,057 | 93,970,598 |
Diluted Net loss per share attributable to shareholders | $ (0.28) | $ (0.22) |
Weighted average shares outstanding used in computing per share amounts: | 96,176,057 | 93,970,598 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Statement of Cash Flows [Abstract] | ||
Net loss for the period | $ (27,345) | $ (20,561) |
Cash flows used in operating activities: | ||
Depreciation, amortization and accrued contingencies | 53 | (228) |
Retirement pension obligations | (8) | (35) |
Expenses related to share-based payments | 1,958 | 1,632 |
Other elements | 0 | 0 |
Changes in operating assets and liabilities: | ||
Decrease (increase) in other current assets | (835) | (3,098) |
(Decrease) increase in trade payables | (4,805) | 4,478 |
(Decrease) increase in other current and non-current liabilities | (3,765) | (2,989) |
Change in operating lease liabilities and right of use assets | 56 | (42) |
Net cash flow provided by (used in) operating activities | (34,692) | (20,841) |
Cash flows provided by (used in) investing activities: | ||
Acquisitions of property, plant, and equipment | (1,335) | (111) |
Proceeds from property, plant, and equipment dispositions | 0 | 0 |
Acquisitions of non-current financial assets | (858) | 0 |
Proceeds from non-current financial assets dispositions | 62 | 153 |
Net cash flows provided by (used in) investing activities | (2,132) | 42 |
Cash flows provided by (used in) financing activities: | ||
(Decrease) increase in conditional advances | 0 | 0 |
Treasury shares | (62) | (14) |
Net cash flows provided by (used in) financing activities | (62) | (14) |
Effect of exchange rate changes on cash and cash equivalents | (2,957) | 3,909 |
Net increase (decrease) in cash and cash equivalents | (39,842) | (16,905) |
Net Cash and cash equivalents at the beginning of the period | 101,525 | 192,289 |
Net cash and cash equivalents at the end of the period | $ 141,367 | $ 209,194 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Changes in Shareholders' Equity - USD ($) $ in Thousands | Total | Common Shares [Member] | Additional Paid-in Capital [Member] | Treasury Stock [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive income (loss) [Member] | Accumulated Currency Translation Effect [Member] |
Beginning balance at Dec. 31, 2022 | $ 194,453 | $ 10,720 | $ 458,221 | $ (1,109) | $ (259,578) | $ 781 | $ (14,581) |
Beginning balance (Shares) at Dec. 31, 2022 | 94,137,145 | ||||||
Net (loss) | (20,561) | (20,561) | |||||
Other comprehensive income (loss) | 3,584 | (82) | 3,666 | ||||
Issuance of ordinary shares | 0 | $ 1 | (1) | ||||
Issuance of ordinary shares (Shares) | 10,174 | ||||||
Treasury shares | (14) | (14) | |||||
Share-based payments | 1,632 | 1,632 | |||||
Ending balance at Mar. 31, 2023 | 179,094 | $ 10,721 | 459,852 | (1,123) | (280,138) | 698 | (10,915) |
Ending balance (Shares) at Mar. 31, 2023 | 94,147,319 | ||||||
Beginning balance at Dec. 31, 2023 | 140,187 | $ 10,972 | 377,468 | (1,263) | (238,862) | 742 | (8,871) |
Beginning balance (Shares) at Dec. 31, 2023 | 96,431,770 | ||||||
Net (loss) | (27,345) | (27,345) | |||||
Other comprehensive income (loss) | (3,084) | (59) | (3,026) | ||||
Issuance of ordinary shares | 0 | $ 3 | (3) | ||||
Issuance of ordinary shares (Shares) | 2,599 | ||||||
Treasury shares | (62) | (62) | |||||
Share-based payments | 1,958 | 1,958 | |||||
Ending balance at Mar. 31, 2024 | $ 111,654 | $ 10,972 | $ 379,426 | $ (1,325) | $ (266,207) | $ 683 | $ (11,897) |
Ending balance (Shares) at Mar. 31, 2024 | 96,434,369 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (27,345) | $ (20,561) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
The Company
The Company | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
The Company | Note 1: The Company Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies” or the “Company”) is a clinical-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, or EPIT, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin. Basis of Presentation 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. The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from these interim financial statements. However, these condensed consolidated financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year ending December 31, 2024, or any other future period. Use of estimates The preparation of the Company’s condensed consolidated financial statements requires the use of estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, and disclosures of contingent assets and liabilities at the date of the consolidated financial statements and the reported amount of income and expenses during the period. The Company bases its estimates and assumptions on historical experience and other factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The actual results may differ from these estimates. On an on-going right-of-use , Going Concern These Condensed Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. However, substantial doubt about the Company’s ability to continue as a going concern exists. Since its inception, the Company has primarily funded its operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credits (Crédit d’Impôt Recherche). The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved. Following receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) in connection with its BLA for Viaskin Peanut, in August 2020, the Company scaled down its other clinical programs and pre-clinical In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following the CRL. In order to respond to the FDA’s requests and recommendations, the Company defined parallel workstreams primarily in order to generate the 6-month Following the submission of the adhesion study’s protocol to the FDA, the Company received an Advice/ Information Request letter from the FDA in October 2021, requesting a stepwise approach to the modified Viaskin patch development program and provided partial feedback on this protocol. In December 2021, the Company decided not to pursue the sequential approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 feedback and announced its plan to initiate a pivotal Phase 3 clinical study for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The Company considers this approach as the most straightforward approach to demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. After receiving approval from the FDA for its change in strategy, the protocol for the new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch was completed at the end of February 2022 and has been prepared for FDA submission. In May 2022, the Company established an At-The-Market In June 2022, the Company announced that its pivotal Phase 3 trial EPITOPE, assessing the safety and efficacy of Viaskin Peanut treatment of peanut-allergic toddlers ages 1 to 3 years, met its primary endpoint, with a statistically significant treatment effect. The Company also indicated continuing productive dialogue with the FDA on the protocol design of VITESSE, a pivotal Phase 3 trial of the modified Viaskin Peanut patch in peanut- allergic children ages 4 to 7 years. During the same month, the Company announced private placement financing (“PIPE”) amounting to $194 million. In September 2022, after announcing the initiation of the VITESSE clinical trial, the Company received a partial clinical hold letter from the FDA on its VITESSE Phase 3 clinical study. Within the FDA’s communication, the modifications address design elements, including the statistical analysis of adhesion, minimum daily wear time and technical alignments in methods of categorizing data, to meet study objectives as well as the total number of trial participants on active treatment. On December 23, 2022, the Company announced the FDA lifted the partial clinical hold and confirmed the Company satisfactorily addressed all clinical hold issues. The FDA stated that the VITESSE phase 3 clinical study may proceed with the revised trial protocol. On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study. Screening of the last patient is anticipated by Q3 2024. The company has incurred operating losses and negative cash flows from operations since inception. As of the date of the filing, the Company’s available cash and cash equivalents are not projected to be sufficient to support its operating plan for at least the next 12 months. As such, there is substantial doubt regarding the Company’s ability to continue as a going concern. Based on our current operations, as well as our plans and assumptions, we expect that our balance of cash and cash equivalents of $101.5 million as of March 31, 2024 will be sufficient to fund our operations until December 31, 2024. The Company intends to seek additional capital as it prepares for the launch of Viaskin Peanut, if approved, and continues other research and development efforts. The Company will require substantial additional capital to fund its research and development and ongoing operating expenses. These capital requirements are expected to be funded through debt and equity offerings prior to December 31, 2024. The Company may seek to finance its 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 The Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due to any future pandemics, epidemics or global health crises and conflict in Ukraine or other global political or military crises. The COVID-19 If the Company is not successful in its financing objectives, the Company could have to scale back its operations, notably by delaying or reducing the scope of its research and development efforts or obtain financing through arrangements with collaborators or others that may require the Company to relinquish rights to its product candidates that the Company might otherwise seek to develop or commercialize independently. These Condensed Consolidated Financial Statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company was unable to continue as a going concern. Accounting Pronouncements recently adopted There have been no recently issued accounting standards adopted during the period which had a material impact on the Company’s financial statements. There are no recently issued accounting standards that are expected to have a material impact on our results of operations, financial condition, or cash flows. Accounting Pronouncements issued not yet adopted Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s Consolidated Financial Statements upon adoption. |
Significant Events and Transact
Significant Events and Transactions | 3 Months Ended |
Mar. 31, 2024 | |
Significant Events And Transactions of the Period Disclsure [Abstract] | |
Significant Events and Transactions | Note 2: Significant Events and Transactions Clinical programs United States Regulatory History and Current Status In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following receipt of the 4-11. 6-month, In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a Phase 1 trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches. The Company completed CHAMP in the second quarter of 2021. All modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the then-current Viaskin Peanut patch, and the Company then selected two modified patches that performed the best out of the five modified patches studied for further development. The Company then selected the circular patch for further development, which is larger in size relative to the current patch and circular in shape. In May 2021, the Company submitted its proposed STAMP protocol to the FDA, and on October 14, 2021, the Company received an Advice/Information Request letter from the FDA. In this letter, the FDA requested a stepwise approach to the modified Viaskin patch development program and provided partial feedback on the STAMP protocol. Specifically, the FDA requested that the Company conduct allergen uptake comparison studies (i.e., ‘EQUAL in Adults’, EQUAL), and submit the allergen uptake comparison data for FDA review and feedback prior to starting the STAMP study. The FDA’s explanation was that the results from the allergen uptake studies might affect the design of the STAMP study. After careful review of the FDA’s information requests, in December 2021, the Company decided not to pursue the sequential approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 feedback. The Company estimated that the FDA’s newly proposed sequential approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, the 6-month On September 7, 2022, the Company announced the initiation of VITESSE, a new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch in children ages 4-7 On September 21, 2022, the Company announced it received feedback from the U.S. FDA in the form of a partial clinical hold on VITESSE. In the partial clinical hold letter, the FDA specified changes to elements of the VITESSE protocol, acknowledging the intent for the trial to support a future BLA submission. In the following months, we engaged with the FDA to address the feedback provided in the partial clinical hold letter and to finalize the VITESSE protocol. In addition, we continued internal preparations for VITESSE and conducted certain site assessment and start-up On December 23, 2022, the Company announced the FDA lifted the partial clinical hold and confirmed the Company satisfactorily addressed all clinical hold issues. The FDA stated that VITESSE phase 3 clinical study may proceed with the revised trial protocol. On March 2, 2023, the Company announced the completion of EVOLVE, a 12-week 4–11-years On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study. Screening of the last patient is anticipated by the third quarter of 2024. On April 19, 2023, the Company outlined the regulatory pathway for Viaskin Peanut in children 1-3 pre-specified On July 31, 2023, the Company announced receipt of feedback from FDA on the two supplemental safety studies, COMFORT Children and COMFORT Toddlers. The COMFORT Toddlers safety study will enroll peanut allergic toddlers ages 1 – 3-years 7-years 6-month The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1-through-3-year-olds to FDA on November 9, 2023, and the Company and FDA are still engaged in ongoing dialogue related to the program. Viaskin Peanut for children ages 4-11— On August 2, 2021, the Company announced it received from the European Medicines Agency (EMA) the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process. It is a letter that is meant to include any remaining questions or objections at that stage in the process. The EMA indicated many of their objections and major objections from the Day 120 list of questions had been answered. One major objection remained at Day 180. The Major Objection questioned the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study. On December 20, 2021, the Company announced it withdrew the Marketing Authorization Application (MAA) for Viaskin Peanut and formally notified the EMA of our decision. The initial filing was supported by data from a single, placebo-controlled Phase 3 pivotal trial known as PEPITES (V712-301). Viaskin Peanut for children ages 1-3 In June 2020, the Company announced that in Part A of the EPITOPE phase 3 clinical study, subjects in both treatment arms showed consistent treatment effects after 12 months of therapy, as assessed by a double-blind placebo-controlled food challenge and biomarker results. Part A subjects were not included in Part B and the efficacy analyses from Part A were not statistically powered to demonstrate superiority of either dose versus placebo. These results validate the ongoing investigation of the 250 µg dose in this age group, which is the dose being studied in Part B of the EPITOPE phase 3 clinical study. Enrollment for Part B of EPITOPE was completed in the first quarter of 2021. In June 2022, the Company announced positive topline results from Part B of EPITOPE, which enrolled 362 subjects ages 1 to 3 years, of which 244 and 118 were in the active and placebo arms respectively. Enrollment was balance for age and baseline disease characteristics between the active and placebo treatment arms. The Company intends to further analyze the data from EPITOPE and explore regulatory pathways for Viaskin Peanut in children ages 1 3 On April 19, 2023, the Company outlined the regulatory pathway for Viaskin Peanut in children 1-3 pre-specified On May 10, 2023, the New England Journal of Medicine (NEJM) published results that demonstrated epicutaneous immunotherapy (EPIT) with VP was statistically superior to placebo in desensitizing children to peanut exposure by increasing the peanut dose that triggers allergic symptoms. As stated in an accompanying editorial piece, these data are seen as “very good news” for toddlers with peanut allergy, as there are currently no approved treatment options for peanut-allergic children under the age of 4 years. Following this publication, the Company confirmed it is advancing regulatory efforts for VP in toddlers ages 1-3 In November 2023, the Company announced the interim analyses from the first year of the open-label extension of EPITOPE. These data were presented at the annual American College of Allergy, Asthma and Immunology (ACAAI) in November 2023. The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1-through-3-year-olds to FDA on November 9, 2023, and the Company and FDA are still engaged in ongoing dialogue related to the program. Viaskin Peanut for Children ages 4-7 On September 7, 2022, the Company announced the initiation of VITESSE, a new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch in children ages 4-7 The Company On September 21, 2022, the Company announced we had received feedback from the FDA in the form of a partial clinical hold on VITESSE. In the partial clinical hold letter, the FDA specified changes to elements of the VITESSE protocol, acknowledging the intent for the trial to support a future BLA submission. In the following months, the Company the Company start-up On December 23, 2022, the Company announced the FDA lifted the partial clinical hold and confirmed we satisfactorily addressed all clinical hold issues. The FDA stated that VITESSE may proceed with the revised trial protocol. On March 7, 2023, the Company announced that the first patient was screened in the VITESSE trial. Screening of the last patient is anticipated by the third quarter of 2024. In July 2023, the Company received Type C Meeting Written Responses from the FDA regarding key study design elements for COMFORT Children. In summary, there was an agreement with the Agency that COMFORT Children will be a Double-Blind, Placebo-Controlled study involving approximately 270 children, randomized at a 3:1 ratio (active to placebo). Participation will not necessitate a food challenge, and patch adhesion data will be generated using the same approach as previously agreed upon with the FDA for the VITESSE phase 3 study. Subsequently, in October 2023, the Company received feedback from the FDA addressing the remaining protocol design elements for COMFORT Children. This feedback included language simplification for how Viaskin should be used. Furthermore, the key inclusion criteria for the COMFORT Children study will be based on a physician-diagnosed peanut allergy, peanut-specific IgE and a Skin Prick Test (with no requirement for a DBPCFC). The revised protocol design of the safety study was submitted to the FDA in Q4 2023. COMFORT Children is anticipated to be initiated towards the end of VITESSE enrollment. The Company intends that enrollment of the COMFORT Children safety study will be strategically timed to avoid competition with the VITESSE study for the same subjects. Legal Proceedings From time to time, the Company may become subject to various legal proceedings and claims that arise in the ordinary course of our business activities. The Company is not currently subject to any material legal proceedings. |
Cash and Cash Equivalents
Cash and Cash Equivalents | 3 Months Ended |
Mar. 31, 2024 | |
Cash and Cash Equivalents [Abstract] | |
Cash and Cash Equivalents | Note 3: Cash and Cash Equivalents The following tables summarize the cash and cash equivalents as of March 31, 2024 and December 31, 2023: March 31, December 31, 2024 2023 Cash 15,725 10,530 Cash equivalents 85,800 130,836 Total cash and cash equivalents as reported in the statements of financial position 101,525 141,367 March 31, December 31, 2024 2023 Bank overdrafts — — Total cash and cash equivalents as reported in the statements 101,525 141,367 Cash equivalents are immediately convertible into cash at no or insignificant cost, on |
Other Current Assets
Other Current Assets | 3 Months Ended |
Mar. 31, 2024 | |
Other Current Assets [Abstract] | |
Other Current Assets | Note 4 : Other current assets consisted of the following: March 31, December 31, 2024 2023 Research tax credit 10,066 8,857 Other tax claims 5,725 5,236 Prepaid expenses 1,727 2,103 Other receivables 518 1,353 Total 18,037 17,548 Research tax credit The variance in Research Tax Credit is presented as follows: Amount in thousands of US Dollars Opening research tax credit receivable as of January 1, 2024 8,857 + Operating revenue 1,407 - Payment received — - Adjustment and currency translation effect (198 ) Closing research tax credit receivable as of March 31, 2024 10,066 Of which - Non-current — Of which - Current portion 10,066 The other tax claims are primarily related to the VAT as well as the reimbursement of VAT that has been requested. Prepaid expenses are comprised primarily of insurance expenses, as well as legal and scientific consulting fees. Prepaid expenses also include upfront payments which are recognized over the term of the ongoing clinical studies. |
Lease contracts
Lease contracts | 3 Months Ended |
Mar. 31, 2024 | |
Lessee Disclosure [Abstract] | |
Lease contracts | Note 5 : Future minimum lease payments under the Company’s operating leas March 31, 2024 December 31, 2023 Real estate Other assets Total Real estate Other assets Total Current portion 344 61 405 1,205 71 1,275 Year 2 1,014 — 1,014 65 11 75 Year 3 1,259 — 1,259 421 — 421 Thereafter 6,256 — 6,256 5,515 — 5,515 Total minimum lease payments 8,873 61 8,934 7,205 81 7,295 Less: Effects of discounting (1,902 ) (7 ) (1,909 ) (1,617 ) (9 ) (1,626 ) Present value of operating lease 6,971 54 7,025 5 ,588 73 5,670 Less: current portion (178 ) (54 ) (232 ) (1,072 (72 (1,144 Long-term operating lease 6,793 — 6,793 4,516 1 4,526 Weighted average remaining lease term (years) 7.52 0.01 7.95 — Weighted average discount rate 5.00 % 0.03 4.53 % 2.50 The Company recognizes rent expense, calculated as the remaining cost of the lease allocated over the remaining lease term on a straight-line basis. Rent expense presented in the condensed consolidated statement of operations and comprehensive loss was: March 31, 2024 2023 Operating lease expense / (income) 586 446 Net termination impact (12 ) (81 ) Supplemental cash flow information related to operating leases is as follows for the period March 31, 2024 and 2023: March 31 2024 2023 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows for operating leases 501 496 |
Trade payables and Other Liabil
Trade payables and Other Liabilities | 3 Months Ended |
Mar. 31, 2024 | |
Payables and Accruals [Abstract] | |
Trade payables and Other Liabilities | Note 6: Trade Payables and Other Liabilities 6.1 Trade Payables No discounting was performed on the trade payables to the extent that the amounts did not present payment terms longer than one year at the end of each fiscal period presented. 6.2 Other Current Liabilities The following tables summarize the other current liabilities as of March 31, 2024 and December 31, 2023: March 31 December 31, 2024 2023 Other current liabilities Other non- current liabilities Total Other current liabilities Other non- current liabilities Total Employee related liabilities 4,629 — 4,629 7,828 — 7,828 Tax liabilities 180 — 180 223 — 223 Other debts 214 — 214 883 — 883 Total 5,023 — 5,023 8,934 — 8,934 The Employee related liabilities include short-term debt to employees including social welfare and tax agency obligations as of March 31, 2024. The Employee related liabilities included short-term debt to employees including social welfare, tax agency obligations and bonus provision (paid during first quarter 2024) as |
Shareholders' equity
Shareholders' equity | 3 Months Ended |
Mar. 31, 2024 | |
Stockholders' Equity Note [Abstract] | |
Shareholders' equity | Note 7: Shareholders’ equity The share capital as of March 31, 2024 is set at the sum of €9,643,437 ($10,972 thousands converted at historical rates). It is divided into 96,434,369 fully authorized, subscribed and paid-up ordinary |
Share-Based Payments
Share-Based Payments | 3 Months Ended |
Mar. 31, 2024 | |
Share-based Payment Arrangement [Abstract] | |
Share-Based Payments | Note 8: Share-Based Payments The Board of Directors has been authorized by the Shareholders General Meeting to grant restricted stock units (“RSU”), stock options (“SO”) and non-employee Bons de Souscription d’Actions During the three months ended March 31, 2024, the Company granted 262,000 stock options and 59,000 restricted stock units to employees. There have been no changes in the vesting conditions and method of valuation of the SO and RSUs from that disclosed in Note 12 to the consolidated financial statements included in the Annual Report. Change in Number of BSA/SO/RSU: Number of outstanding BSA SO RSUs Balance as of December 31, 2023 244,693 7,129,541 2,021,370 Granted during the period — 262,000 59,000 Forfeited during the period — 3,525 13,738 Exercised/released duri n — — 2,598 Expired during the period — — — Balance as of March 31, 2024 244,693 7,388,016 2,064,035 Share-based payments expenses reflected in the condensed consolidated statements of operations is as follows: Three Months Ended March 31, 2024 2023 Research & development SO (513 ) (429 ) RSU (256 ) (258 ) Sales & marketing SO (23 ) (27 ) RSU (9 ) (8 ) General & administrative SO (1,030 ) (797 ) RSU (126 ) (113 ) Total share-based compensation (expense) (1,958 ) (1,632 ) The $0.3 million increase in share-based compensation expenses is notably due to the increase of number of ordinary share equivalents granted in 2023 impacting the three months ended March 31, 2024, in comparison to the number granted in 2022 impacting the three months ended March 31, 2023. |
Contingencies
Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
Loss Contingency [Abstract] | |
Contingencies | Note 9: Contingencies The following tables summarize the contingencies as of March 31, 2024 and December 31, 2023: March 31, December 31, 2024 2023 Current contingencies 3,153 3,959 Non-current 965 935 Total contingencies 4,118 4,894 The changes in contingencies are as follows: Pension retirement obligations Other contingencies Total At January 1, 2024 935 3,959 4,894 Increases in liabilities — — — Used liabilities — (723 ) (723 ) Reversals of unused liabilities (8 ) — (8 ) Net interest related to employee benefits, and unwinding of discount — — — Actuarial gains and losses on defined-benefit plans 59 — 59 Currency translation effect (20 ) (82 ) (103 ) At March 31, 2024 965 3,153 4,118 Pension retirement obligations Other contingencies Total Of which Current — 3,153 3,153 Of which Non-current 965 — 965 In May 2016, the Company entered into a Development Collaboration and License Agreement (the “Collaboration Agreement”) with Société des Produits Nestlé S.A. (formerly NESTEC S.A.) (“NESTEC”) under which the Company was responsible for leading the development activities of MAG1C up through a pivotal phase 3 clinical program. On October 30, 2023, the Company signed and NESTEC entered into a Mutual Termination Letter Agreement terminating the Collaboration Agreement. As of March 31, 2024, the accrual for ongoing Clinical study completion totals $1.3 million (vs. $2.3 million as of December 31, 2023) representing our best estimate of the remaining expenses related to the ongoing clinical study. The Company does not hold any plan assets related to long-term employee benefit for any of the periods presented. There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 14 to the consolidated financial statements included in the Annual Report. |
Operating Income
Operating Income | 3 Months Ended |
Mar. 31, 2024 | |
Other Income and Expenses [Abstract] | |
Operating Income | Note 10: Operating income The following table summarizes the operating income during the three months ended March 31, 2024 and 2023: Three Months Ended March 31, 2024 2023 Research tax credit 1,407 1,765 Other operating income — 429 Total 1,407 2,194 As of March 31, 2023, other income were recorded according the Collaboration Agreement between the Company and NESTEC. On October 30, 2023, the Company and NESTEC entered into a Mutual Termination Letter Agreement terminating the Collaboration Agreement, explaining the lack of other income as of March 31, 2024. |
Operating Expenses
Operating Expenses | 3 Months Ended |
Mar. 31, 2024 | |
Operating Expenses [Abstract] | |
Operating expenses | Note 11: Operating expenses The Company had an average of 105 employees during the three months ended March 31, 2024, in comparison with an average of 87 employees during the three months ended March 31, 2023. This increase is mainly due to hiring to support clinical development activities related to ongoing and anticipated clinical trials and to support quality activities. The following table summarizes the allocation of personnel expenses by function during the three months ended March 31, 2024 and 2023: Three Months Ended March 31, 2024 2023 Research and Development expenses 5,048 4,006 Sales and Marketing expenses 334 165 General and Administrative expenses 3,236 3,100 Total personnel expenses 8,618 7,272 The following table summarizes the allocation of personnel expenses by nature during the three months ended March 31, 2024 and 2023: Three Months Ended March 31, 2024 2023 Wages and salaries 5,144 4,438 Social security contributions 1,207 699 Expenses for pension commitments 309 258 Employer contribution to bonus shares — 244 Share-based payments 1,958 1,632 Total 8,618 7,272 The increase in personnel expenses is mainly due to the recruitment of US employees. |
Financial Income (Expense)
Financial Income (Expense) | 3 Months Ended |
Mar. 31, 2024 | |
Financial Income Expense [Abstract] | |
Financial income (expense) | Note 12: Financial income (expense) Our financial income was $1.3 million for the three months ended March 31, 2024, compared to $0.6 million for the three months |
Commitments
Commitments | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | Note 13: Commitments There has been no significant change in other commitments from those disclosed in Note 17 to the consolidated financial statements included in the Annual Report. |
Relationships with Related Part
Relationships with Related Parties | 3 Months Ended |
Mar. 31, 2024 | |
Related Party Transactions [Abstract] | |
Relationships with Related Parties | Note 14: Relationships with Related Parties There were no new significant related-party transactions during the period nor any change in the nature of the transactions from those described in Note 18 to the consolidated financial statements included in the Annual Report. |
Loss Per Share
Loss Per Share | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
Loss Per Share | Note 15: Loss Per Share Basic loss per share is calculated by dividing the net loss attributable to the shareholders of the Company by the weighted average number of ordinary shares outstanding during the period. As the Company was in a loss position for each of the three months ended March 31, 2024 and 2023, the diluted loss per share is equal to basic loss per share because the effects of potentially dilutive shares were anti-dilutive as a result of the Company’s net loss. The following is a summary of the ordinary share equivalents that were excluded from the calculation of diluted net loss per share for each of the three months ended March 31, 2024 and 2023 indicated in number of potential shares: Three Months Ended March 31, 2024 2023 Non-employee 244,693 251,693 Stock options 7,388,016 5,318,569 Restricted stock units 2,064,035 1,583,938 Prefunded warrants 28,276,331 28,276,331 |
Events After the Close of the P
Events After the Close of the Period | 3 Months Ended |
Mar. 31, 2024 | |
Subsequent Events [Abstract] | |
Events after the Close of the Period | Note 16: Events after the Close of the Period The Company evaluated subsequent events that occurred after March 31, 2024, through the date the condensed consolidated financial statements were issued after their approval by the Board of Directors on May 7, 2024 and determined that there are no significant events that require adjustments or disclosure in such condensed consolidated financial statements. On April 22, 2024, the Company moved its headquarters to 107 Avenue de la République in Châtillon in France, which is subject to ratification by the shareholders of the Company at the annual general meeting on May 16, 2024. |
The Company (Policies)
The Company (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation 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. The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from these interim financial statements. However, these condensed consolidated financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year ending December 31, 2024, or any other future period. |
Use of estimates | Use of estimates The preparation of the Company’s condensed consolidated financial statements requires the use of estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, and disclosures of contingent assets and liabilities at the date of the consolidated financial statements and the reported amount of income and expenses during the period. The Company bases its estimates and assumptions on historical experience and other factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The actual results may differ from these estimates. On an on-going right-of-use , |
Going concern | Going Concern These Condensed Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. However, substantial doubt about the Company’s ability to continue as a going concern exists. Since its inception, the Company has primarily funded its operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credits (Crédit d’Impôt Recherche). The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved. Following receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) in connection with its BLA for Viaskin Peanut, in August 2020, the Company scaled down its other clinical programs and pre-clinical In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following the CRL. In order to respond to the FDA’s requests and recommendations, the Company defined parallel workstreams primarily in order to generate the 6-month Following the submission of the adhesion study’s protocol to the FDA, the Company received an Advice/ Information Request letter from the FDA in October 2021, requesting a stepwise approach to the modified Viaskin patch development program and provided partial feedback on this protocol. In December 2021, the Company decided not to pursue the sequential approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 feedback and announced its plan to initiate a pivotal Phase 3 clinical study for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The Company considers this approach as the most straightforward approach to demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. After receiving approval from the FDA for its change in strategy, the protocol for the new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch was completed at the end of February 2022 and has been prepared for FDA submission. In May 2022, the Company established an At-The-Market In June 2022, the Company announced that its pivotal Phase 3 trial EPITOPE, assessing the safety and efficacy of Viaskin Peanut treatment of peanut-allergic toddlers ages 1 to 3 years, met its primary endpoint, with a statistically significant treatment effect. The Company also indicated continuing productive dialogue with the FDA on the protocol design of VITESSE, a pivotal Phase 3 trial of the modified Viaskin Peanut patch in peanut- allergic children ages 4 to 7 years. During the same month, the Company announced private placement financing (“PIPE”) amounting to $194 million. In September 2022, after announcing the initiation of the VITESSE clinical trial, the Company received a partial clinical hold letter from the FDA on its VITESSE Phase 3 clinical study. Within the FDA’s communication, the modifications address design elements, including the statistical analysis of adhesion, minimum daily wear time and technical alignments in methods of categorizing data, to meet study objectives as well as the total number of trial participants on active treatment. On December 23, 2022, the Company announced the FDA lifted the partial clinical hold and confirmed the Company satisfactorily addressed all clinical hold issues. The FDA stated that the VITESSE phase 3 clinical study may proceed with the revised trial protocol. On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study. Screening of the last patient is anticipated by Q3 2024. The company has incurred operating losses and negative cash flows from operations since inception. As of the date of the filing, the Company’s available cash and cash equivalents are not projected to be sufficient to support its operating plan for at least the next 12 months. As such, there is substantial doubt regarding the Company’s ability to continue as a going concern. Based on our current operations, as well as our plans and assumptions, we expect that our balance of cash and cash equivalents of $101.5 million as of March 31, 2024 will be sufficient to fund our operations until December 31, 2024. The Company intends to seek additional capital as it prepares for the launch of Viaskin Peanut, if approved, and continues other research and development efforts. The Company will require substantial additional capital to fund its research and development and ongoing operating expenses. These capital requirements are expected to be funded through debt and equity offerings prior to December 31, 2024. The Company may seek to finance its 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 The Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due to any future pandemics, epidemics or global health crises and conflict in Ukraine or other global political or military crises. The COVID-19 If the Company is not successful in its financing objectives, the Company could have to scale back its operations, notably by delaying or reducing the scope of its research and development efforts or obtain financing through arrangements with collaborators or others that may require the Company to relinquish rights to its product candidates that the Company might otherwise seek to develop or commercialize independently. These Condensed Consolidated Financial Statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company was unable to continue as a going concern. |
Accounting Pronouncements recently adopted | Accounting Pronouncements recently adopted There have been no recently issued accounting standards adopted during the period which had a material impact on the Company’s financial statements. There are no recently issued accounting standards that are expected to have a material impact on our results of operations, financial condition, or cash flows. |
Accounting Pronouncements issued not yet adopted | Accounting Pronouncements issued not yet adopted Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s Consolidated Financial Statements upon adoption. |
Cash and Cash Equivalents (Tabl
Cash and Cash Equivalents (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Cash and Cash Equivalents [Abstract] | |
Summary of breakdown of cash and cash equivalents | The following tables summarize the cash and cash equivalents as of March 31, 2024 and December 31, 2023: March 31, December 31, 2024 2023 Cash 15,725 10,530 Cash equivalents 85,800 130,836 Total cash and cash equivalents as reported in the statements of financial position 101,525 141,367 March 31, December 31, 2024 2023 Bank overdrafts — — Total cash and cash equivalents as reported in the statements 101,525 141,367 |
Other Current Assets (Tables)
Other Current Assets (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Other Current Assets [Abstract] | |
Summary of Other Current Asset | Other current assets consisted of the following: March 31, December 31, 2024 2023 Research tax credit 10,066 8,857 Other tax claims 5,725 5,236 Prepaid expenses 1,727 2,103 Other receivables 518 1,353 Total 18,037 17,548 |
Summary of Research Tax Credit | The variance in Research Tax Credit is presented as follows: Amount in thousands of US Dollars Opening research tax credit receivable as of January 1, 2024 8,857 + Operating revenue 1,407 - Payment received — - Adjustment and currency translation effect (198 ) Closing research tax credit receivable as of March 31, 2024 10,066 Of which - Non-current — Of which - Current portion 10,066 |
Lease contracts (Tables)
Lease contracts (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Lessee Disclosure [Abstract] | |
Summary of Operating Leases Future Minimum Payments Receivable | Future minimum lease payments under the Company’s operating leas March 31, 2024 December 31, 2023 Real estate Other assets Total Real estate Other assets Total Current portion 344 61 405 1,205 71 1,275 Year 2 1,014 — 1,014 65 11 75 Year 3 1,259 — 1,259 421 — 421 Thereafter 6,256 — 6,256 5,515 — 5,515 Total minimum lease payments 8,873 61 8,934 7,205 81 7,295 Less: Effects of discounting (1,902 ) (7 ) (1,909 ) (1,617 ) (9 ) (1,626 ) Present value of operating lease 6,971 54 7,025 5 ,588 73 5,670 Less: current portion (178 ) (54 ) (232 ) (1,072 (72 (1,144 Long-term operating lease 6,793 — 6,793 4,516 1 4,526 Weighted average remaining lease term (years) 7.52 0.01 7.95 — Weighted average discount rate 5.00 % 0.03 4.53 % 2.50 |
Summary of Rent expenses | Rent expense presented in the condensed consolidated statement of operations and comprehensive loss was: March 31, 2024 2023 Operating lease expense / (income) 586 446 Net termination impact (12 ) (81 ) |
Summary of Supplemental cash flow information related to our operating leases | Supplemental cash flow information related to operating leases is as follows for the period March 31, 2024 and 2023: March 31 2024 2023 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows for operating leases 501 496 |
Trade payables and Other Liab_2
Trade payables and Other Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Other Liabilities, Current [Abstract] | |
Summary of Other Current Liabilities | The following tables summarize the other current liabilities as of March 31, 2024 and December 31, 2023: March 31 December 31, 2024 2023 Other current liabilities Other non- current liabilities Total Other current liabilities Other non- current liabilities Total Employee related liabilities 4,629 — 4,629 7,828 — 7,828 Tax liabilities 180 — 180 223 — 223 Other debts 214 — 214 883 — 883 Total 5,023 — 5,023 8,934 — 8,934 |
Share-Based Payments (Tables)
Share-Based Payments (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Summary of RSU Activity | Change in Number of BSA/SO/RSU: Number of outstanding BSA SO RSUs Balance as of December 31, 2023 244,693 7,129,541 2,021,370 Granted during the period — 262,000 59,000 Forfeited during the period — 3,525 13,738 Exercised/released duri n — — 2,598 Expired during the period — — — Balance as of March 31, 2024 244,693 7,388,016 2,064,035 |
Summary of Share-Based Payments Expenses | Share-based payments expenses reflected in the condensed consolidated statements of operations is as follows: Three Months Ended March 31, 2024 2023 Research & development SO (513 ) (429 ) RSU (256 ) (258 ) Sales & marketing SO (23 ) (27 ) RSU (9 ) (8 ) General & administrative SO (1,030 ) (797 ) RSU (126 ) (113 ) Total share-based compensation (expense) (1,958 ) (1,632 ) |
Contingencies (Tables)
Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Loss Contingency [Abstract] | |
Summary of Non-current Contingencies and Current Contingencies | The following tables summarize the contingencies as of March 31, 2024 and December 31, 2023: March 31, December 31, 2024 2023 Current contingencies 3,153 3,959 Non-current 965 935 Total contingencies 4,118 4,894 |
Summary of Movement in Provisions | The changes in contingencies are as follows: Pension retirement obligations Other contingencies Total At January 1, 2024 935 3,959 4,894 Increases in liabilities — — — Used liabilities — (723 ) (723 ) Reversals of unused liabilities (8 ) — (8 ) Net interest related to employee benefits, and unwinding of discount — — — Actuarial gains and losses on defined-benefit plans 59 — 59 Currency translation effect (20 ) (82 ) (103 ) At March 31, 2024 965 3,153 4,118 Pension retirement obligations Other contingencies Total Of which Current — 3,153 3,153 Of which Non-current 965 — 965 |
Operating Income (Tables)
Operating Income (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Other Income and Expenses [Abstract] | |
Schedule of operating income | The following table summarizes the operating income during the three months ended March 31, 2024 and 2023: Three Months Ended March 31, 2024 2023 Research tax credit 1,407 1,765 Other operating income — 429 Total 1,407 2,194 |
Operating Expenses (Tables)
Operating Expenses (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Operating Expenses [Abstract] | |
Summary of Allocation of Personnel Expenses By Function | The following table summarizes the allocation of personnel expenses by function during the three months ended March 31, 2024 and 2023: Three Months Ended March 31, 2024 2023 Research and Development expenses 5,048 4,006 Sales and Marketing expenses 334 165 General and Administrative expenses 3,236 3,100 Total personnel expenses 8,618 7,272 |
Summary of Allocation of Personnel Expenses By Nature | The following table summarizes the allocation of personnel expenses by nature during the three months ended March 31, 2024 and 2023: Three Months Ended March 31, 2024 2023 Wages and salaries 5,144 4,438 Social security contributions 1,207 699 Expenses for pension commitments 309 258 Employer contribution to bonus shares — 244 Share-based payments 1,958 1,632 Total 8,618 7,272 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share, Basic [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following is a summary of the ordinary share equivalents that were excluded from the calculation of diluted net loss per share for each of the three months ended March 31, 2024 and 2023 indicated in number of potential shares: Three Months Ended March 31, 2024 2023 Non-employee 244,693 251,693 Stock options 7,388,016 5,318,569 Restricted stock units 2,064,035 1,583,938 Prefunded warrants 28,276,331 28,276,331 |
The Company - Additional Inform
The Company - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 6 Months Ended | ||
May 31, 2022 | Jun. 30, 2022 | Mar. 31, 2024 | Dec. 31, 2023 | |
Subsidiary or Equity Method Investee [Line Items] | ||||
Cash and cash equivalents | $ 101,525 | $ 141,367 | ||
American Depositary Shares [Member] | At The Market [Member] | ||||
Subsidiary or Equity Method Investee [Line Items] | ||||
Proceeds From Issuance Of Common Stock | $ 100,000 | |||
Private Investment In Public Equity [Member] | ||||
Subsidiary or Equity Method Investee [Line Items] | ||||
Proceeds From Issuance Of Common Stock | $ 194,000 |
Significant Events and Transa_2
Significant Events and Transactions - Additional Information (Detail) - ViaskinTM Clinical Program For Children Aged Between Four to Eleven [Member] - Candidates | Jul. 31, 2023 | Jan. 31, 2020 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Clinical Program Trial Period | 6 months | |
Comfort Toddlers Safety Study [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total number of additional candidates covered by the study | 400 | |
Period for which the study shall be carried out | 6 months | |
Comfort Children Safety Study [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Period for which the study shall be carried out | 6 months | |
Minimum [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Age Of Child | 4 years | |
Minimum [Member] | Comfort Toddlers Safety Study [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Age Of Child | 1 year | |
Minimum [Member] | Comfort Children Safety Study [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Age Of Child | 4 years | |
Maximum [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Age Of Child | 11 years | |
Maximum [Member] | Comfort Toddlers Safety Study [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Age Of Child | 3 years | |
Maximum [Member] | Comfort Children Safety Study [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Age Of Child | 7 years |
Cash and Cash Equivalents - Sum
Cash and Cash Equivalents - Summary of breakdown of cash and cash equivalents (Detail) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Cash and Cash Equivalents, at Carrying Value [Abstract] | ||
Cash | $ 15,725 | $ 10,530 |
Cash equivalents | 85,800 | 130,836 |
Total cash and cash equivalents as reported in the statements of financial position | 101,525 | 141,367 |
Bank overdrafts | 0 | 0 |
Total cash and cash equivalents as reported in the statements of cash flows | $ 101,525 | $ 141,367 |
Other Current Assets - Summary
Other Current Assets - Summary of Other Current Asset (Detail) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Other Assets [Abstract] | ||
Research tax credit | $ 10,066 | $ 8,857 |
Other tax claims | 5,725 | 5,236 |
Prepaid expenses | 1,727 | 2,103 |
Other receivables | 518 | 1,353 |
Total | $ 18,037 | $ 17,548 |
Other Current Assets - Summar_2
Other Current Assets - Summary Of Research Tax Credit (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Tax Credit Carryforward [Line Items] | |
Opening balance | $ 8,857 |
+ Operating revenue | 1,407 |
- Payment received | 0 |
- Adjustment and currency translation effect | (198) |
Closing balance | 10,066 |
Of which - Non-current portion | 0 |
Of which - Current portion | $ 10,066 |
Lease contracts - Summary of Op
Lease contracts - Summary of Operating Leases Future Minimum Payments Receivable (Detail) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current portion | $ 405 | $ 1,275 |
Year 2 | 1,014 | 75 |
Year 3 | 1,259 | 421 |
Thereafter | 6,256 | 5,515 |
Total minimum lease payments | 8,934 | 7,295 |
Less: Effects of discounting | (1,909) | (1,626) |
Present value of operating lease | 7,025 | 5,670 |
Less: current portion | (232) | (1,144) |
Long-term operating lease | 6,793 | 4,526 |
Real Estate [Member] | ||
Current portion | 344 | 1,205 |
Year 2 | 1,014 | 65 |
Year 3 | 1,259 | 421 |
Thereafter | 6,256 | 5,515 |
Total minimum lease payments | 8,873 | 7,205 |
Less: Effects of discounting | (1,902) | (1,617) |
Present value of operating lease | 6,971 | 5,588 |
Less: current portion | (178) | (1,072) |
Long-term operating lease | $ 6,793 | $ 4,516 |
Weighted average remaining lease term (years) | 7 years 6 months 7 days | 7 years 11 months 12 days |
Weighted average discount rate | 5% | 4.53% |
Other Asset [Member] | ||
Current portion | $ 61 | $ 71 |
Year 2 | 0 | 11 |
Year 3 | 0 | 0 |
Thereafter | 0 | 0 |
Total minimum lease payments | 61 | 81 |
Less: Effects of discounting | (7) | (9) |
Present value of operating lease | 54 | 73 |
Less: current portion | (54) | (72) |
Long-term operating lease | $ 0 | $ 1 |
Weighted average remaining lease term (years) | 3 days | |
Weighted average discount rate | 0.03% | 2.50% |
Lease contracts - Summary of Re
Lease contracts - Summary of Rent expenses (Detail) - Rent Expenses [Member] - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating lease expense / (income) | $ 586 | $ 446 |
Net termination impact | $ (12) | $ (81) |
Lease contracts - Summary of Su
Lease contracts - Summary of Supplemental cash flow information related to our operating leases (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash Flow, Operating Activities, Lessee [Abstract] | ||
Operating cash flows from operating leases | $ 501 | $ 496 |
Trade payables and Other Liab_3
Trade payables and Other Liabilities - Summary of Other Current Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Other current liabilities | $ 5,023 | $ 8,934 |
Other non-current liabilities | 0 | 0 |
Total | 5,023 | 8,934 |
Employee Related Liabilities [Member] | ||
Other current liabilities | 4,629 | 7,828 |
Other non-current liabilities | 0 | 0 |
Total | 4,629 | 7,828 |
Tax Liabilities [Member] | ||
Other current liabilities | 180 | 223 |
Other non-current liabilities | 0 | 0 |
Total | 180 | 223 |
Other Debts [Member] | ||
Other current liabilities | 214 | 883 |
Other non-current liabilities | 0 | 0 |
Total | $ 214 | $ 883 |
Shareholders' equity - Addition
Shareholders' equity - Additional Information (Detail) € / shares in Units, € in Thousands, $ in Thousands | Mar. 31, 2024 USD ($) shares | Mar. 31, 2024 EUR (€) € / shares shares | Dec. 31, 2023 USD ($) | Mar. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) |
Class of Stock [Line Items] | |||||
Share capital | $ | $ 111,654 | $ 140,187 | $ 179,094 | $ 194,453 | |
Share capital [Member] | |||||
Class of Stock [Line Items] | |||||
Share capital authorized | shares | 96,434,369 | 96,434,369 | |||
Nominal value | € / shares | € 0.1 | ||||
Share capital | $ 10,972 | € 9,643,437 |
Share-Based Payments - Summary
Share-Based Payments - Summary of RSU Activity (Detail) | 3 Months Ended |
Mar. 31, 2024 shares | |
BSA Warrants [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of warrants outstanding, Beginning Balance | 244,693 |
Number of warrants outstanding, Ending Balance | 244,693 |
Restricted Stock Units [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of RSU outstanding, Beginning Balance | 2,021,370 |
Number of RSU outstanding, Granted during the period | 59,000 |
Number of RSU outstanding, Forfeited during the period | 13,738 |
Number of RSU outstanding, Released during the period | 2,598 |
Number of RSU outstanding, Ending Balance | 2,064,035 |
Share-based Payment Arrangement, Option [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of stock options outstanding, Beginning Balance | 7,129,541 |
Number of stock options outstanding, Granted during the period | 262,000 |
Number of stock options outstanding, Forfeited during the period | 3,525 |
Number of stock options outstanding, Ending Balance | 7,388,016 |
Share-Based Payments - Summar_2
Share-Based Payments - Summary of Share-Based Payments Expenses (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based payments | $ (1,958) | $ (1,632) |
Research and Development expenses [Member] | Share options [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based payments | (513) | (429) |
Research and Development expenses [Member] | Restricted Stock Units [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based payments | (256) | (258) |
Sales and Marketing expenses [Member] | Share options [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based payments | (23) | (27) |
Sales and Marketing expenses [Member] | Restricted Stock Units [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based payments | (9) | (8) |
General and Administrative expenses [Member] | Share options [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based payments | (1,030) | (797) |
General and Administrative expenses [Member] | Restricted Stock Units [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based payments | $ (126) | $ (113) |
Share-Based Payments - Addition
Share-Based Payments - Additional Information (Detail) $ in Millions | 3 Months Ended |
Mar. 31, 2024 USD ($) shares | |
Share-Based Payments [Line iteam] | |
Increase in sharebased compensation expense | $ | $ 0.3 |
Share options [Member] | |
Share-Based Payments [Line iteam] | |
Number of stock options outstanding, Granted during the period | 262,000 |
Restricted Stock Units [Member] | |
Share-Based Payments [Line iteam] | |
Number of RSU outstanding, Granted during the period | 59,000 |
Contingencies - Summary of Non
Contingencies - Summary of Non Current Contingencies and Current Contingencies (Detail) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Liability, Defined Benefit Plan [Abstract] | ||
Current contingencies | $ 3,153 | $ 3,959 |
Non-current contingencies | 965 | 935 |
Total contingencies | $ 4,118 | $ 4,894 |
Contingencies - Summary of Move
Contingencies - Summary of Movement in Contingencies (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Dec. 31, 2023 | |
Of which Current | $ 3,153 | $ 3,959 |
Of which Non-current | 965 | $ 935 |
Pension retirement obligations [Member] | ||
Contingencies, Beginning balance | 935 | |
Increases in liabilities | 0 | |
Reversals of unused liabilities | (8) | |
Actuarial gains and losses on defined-benefit plans | 59 | |
Currency translation effect | (20) | |
Contingencies, Ending balance | 965 | |
Of which Non-current | 965 | |
Collaboration agreement -Loss at completion [Member] | ||
Contingencies, Beginning balance | 3,959 | |
Increases in liabilities | 0 | |
Used liabilities | (723) | |
Reversals of unused liabilities | 0 | |
Currency translation effect | (82) | |
Contingencies, Ending balance | 3,153 | |
Of which Current | 3,153 | |
Of which Non-current | 0 | |
Other provisions incl. restructuring [Member] | ||
Contingencies, Beginning balance | 4,894 | |
Increases in liabilities | 0 | |
Used liabilities | (723) | |
Reversals of unused liabilities | (8) | |
Net interest related to employee benefits, and unwinding of discount | 0 | |
Actuarial gains and losses on defined-benefit plans | 59 | |
Currency translation effect | (103) | |
Contingencies, Ending balance | 4,118 | |
Of which Current | 3,153 | |
Of which Non-current | $ 965 |
Contingencies - Additional Info
Contingencies - Additional Information (Detail) - USD ($) $ in Millions | Mar. 31, 2024 | Dec. 31, 2023 |
Loss Contingency [Abstract] | ||
Accrued Contract Expenses | $ 1.3 | $ 2.3 |
Operating Income - Summary of O
Operating Income - Summary of Operating Income (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Other Income and Expenses [Abstract] | ||
Research tax credit | $ 1,407 | $ 1,765 |
Other operating income | 0 | 429 |
Total | $ 1,407 | $ 2,194 |
Operating Expenses - Summary of
Operating Expenses - Summary of Allocation of Personnel Expenses By Function (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Research and Development expenses | $ 21,403 | $ 16,037 |
Sales and Marketing expenses | 758 | 434 |
General and Administrative expenses | 7,804 | 6,889 |
Total Operating expenses | 29,964 | 23,359 |
Expenses by Function [Member] | ||
Research and Development expenses | 5,048 | 4,006 |
Sales and Marketing expenses | 334 | 165 |
General and Administrative expenses | 3,236 | 3,100 |
Total Operating expenses | $ 8,618 | $ 7,272 |
Operating Expenses - Summary _2
Operating Expenses - Summary of Allocation of Personnel Expenses By Nature (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based payments | $ (1,958) | $ (1,632) |
Total Operating expenses | 29,964 | 23,359 |
Expenses by Nature [Member] | ||
Wages and salaries | 5,144 | 4,438 |
Social security contributions | 1,207 | 699 |
Expenses for pension commitments | 309 | 258 |
Employer contribution to bonus shares | 0 | 244 |
Share-based payments | 1,958 | 1,632 |
Total Operating expenses | $ 8,618 | $ 7,272 |
Financial Income (Expense) - Ad
Financial Income (Expense) - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Financial Income Expense [Abstract] | ||
Financial income (expenses) | $ 1,261 | $ 605 |
Commitments - Additional Inform
Commitments - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Disclosure Of Commitments [Line Items] | |
Increase (decrease) in other commitments during the period | $ 0 |
Relationships with Related Pa_2
Relationships with Related Parties - Additional Information (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Related Party Transactions [Abstract] | |
Increase decrease in related party transactions and changes in nature of the transactions | $ 0 |
Loss Per Share - Summary of the
Loss Per Share - Summary of the Common Stock Equivalents Which Were Excluded From the Calculation of Diluted Net Loss Per Share (Detail) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Non-employee warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 244,693 | 251,693 |
Stock options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 7,388,016 | 5,318,569 |
Restricted stock units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 2,064,035 | 1,583,938 |
Prefunded warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 28,276,331 | 28,276,331 |