Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 03, 2022 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
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 Address, Postal Zip Code | 92120 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Interactive Data Current | Yes | |
Entity Common Stock, Shares Outstanding | 94,025,441 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
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 Brossolette | |
Entity Address, City or Town | Montrouge | |
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 | |
No Trading Symbol Flag | true | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Financial Position - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 212,670 | $ 77,301 |
Other current assets | 13,025 | 37,085 |
Total current assets | 225,695 | 114,386 |
Non-Current assets: | ||
Property, plant, and equipment, net | 14,429 | 18,146 |
Right-of-use assets related to operating leases | 2,614 | 7,336 |
Intangible assets | 11 | 22 |
Other non-current assets | 5,368 | 6,833 |
Total non-current assets | 22,422 | 32,338 |
Total Assets | 248,117 | 146,723 |
Current liabilities: | ||
Trade payables | 15,369 | 11,429 |
Short-term operating leases | 1,381 | 3,003 |
Short-term financial debt | 0 | 510 |
Current contingencies | 3,026 | 4,095 |
Other current liabilities | 8,615 | 12,361 |
Total current liabilities | 28,391 | 31,397 |
Non-Current liabilities | ||
Long-term operating leases | 1,423 | 7,147 |
Non-current contingencies | 5,272 | 6,758 |
Other non-current liabilities | 979 | 2,147 |
Total non-current liabilities | 7,674 | 16,052 |
Total Liabilities | 36,065 | 47,449 |
Shareholders' equity: | ||
Ordinary shares, €0.10 par value; 94,025,441 and 55,095,762 shares authorized, and issued as at September 30, 2022 and December 31, 2021, respectively | 10,709 | 6,538 |
Additional paid-in capital | 456,884 | 358,115 |
Treasury stock, 137,101 and 153,631 ordinary shares as of September 30, 2022 and December 31, 2021, respectively, at cost | (1,083) | (1,232) |
Accumulated deficit | (220,337) | (258,528) |
Accumulated other comprehensive income | 783 | 519 |
Accumulated currency translation effect | (34,904) | (6,137) |
Total Shareholders' equity | 212,052 | 99,274 |
Total Liabilities and Shareholders' equity | $ 248,117 | $ 146,723 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Financial Position (Parenthetical) - Common Shares [Member] - € / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Common stock shares par value | € 0.1 | € 0.1 |
Common stock shares authorized | 94,025,441 | 94,025,441 |
Common stock shares issued | 55,095,762 | 55,095,762 |
Treasury stock, common, shares | 137,101 | 153,631 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenues | ||||
Operating income | $ 2,074 | $ 1,323 | $ 6,148 | $ 2,776 |
Operating expenses | ||||
Research and development expenses | (15,096) | (16,320) | (45,930) | (58,663) |
Sales and marketing expenses | (159) | (1,072) | (1,659) | (2,999) |
General and administrative expenses | (4,839) | (8,299) | (17,173) | (26,250) |
Total Operating expenses | (20,094) | (25,691) | (64,762) | (87,912) |
Loss from operations | (18,020) | (24,368) | (58,614) | (85,137) |
Other Income (expenses) | ||||
Financial income | 732 | 336 | 1,668 | 597 |
Loss before taxes | (17,287) | (24,033) | (56,946) | (84,540) |
Income tax (expense) | 0 | 0 | (87) | 404 |
Net loss | (17,287) | (24,033) | (57,033) | (84,136) |
Foreign currency translation differences, net of taxes | (15,425) | (3,728) | (28,752) | (9,684) |
Actuarial gains (losses) on employee benefits, net of taxes | 41 | 28 | 264 | (10) |
Total comprehensive loss | $ (32,672) | $ (27,733) | $ (85,520) | $ (93,830) |
Basic net loss per share attributable to shareholders | $ (0.18) | $ (0.44) | $ (0.79) | $ (1.53) |
Weighted average shares outstanding used in computing per share amounts: | 93,905,050 | 54,947,354 | 71,779,572 | 54,911,278 |
Diluted net loss per share attributable to shareholders | $ (0.18) | $ (0.44) | $ (0.79) | $ (1.53) |
Weighted average shares outstanding used in computing per share amounts: | 93,905,050 | 54,947,354 | 71,779,572 | 54,911,278 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Statement of Cash Flows [Abstract] | ||
Net loss for the period | $ (57,033) | $ (84,136) |
Cash flows used in operating activities: | ||
Depreciation, amortization and accrued contingencies | 1,140 | 9,705 |
Retirement pension obligations | 58 | 127 |
Expenses related to share-based payments | 3,416 | 4,078 |
Other elements | (3) | 1,214 |
Changes in operating assets and liabilities: | ||
Decrease (increase) in trade receivables | 0 | 2,174 |
Decrease (increase) in other current assets | 20,900 | (9,036) |
(Decrease) increase in trade payables | 5,699 | (7,135) |
(Decrease) increase in other current and non-current liabilities | (3,405) | (5,497) |
Change in operating lease liabilities and right of use assets | (2,554) | (946) |
Net cash flow used in operating activities | (31,781) | (89,452) |
Cash flows used in investing activities: | ||
Acquisitions of property, plant, and equipment, net from proceeds | (742) | 0 |
Proceeds from property, plant, and equipment dispositions | 3 | 46 |
Acquisition of intangible assets | 0 | (8) |
Acquisitions of non-current financial assets | (149) | 0 |
Proceeds from non-current financial assets | 822 | 3 |
Net cash flows used in investing activities | (66) | 41 |
Cash flows provided by financing activities: | ||
Decrease in conditional advances | (479) | (518) |
Treasury shares | 149 | (359) |
Capital increases, net of transaction costs | 194,732 | 794 |
Other cash flows related to financing activities | 0 | (21) |
Net cash flows provided by financing activities | 194,403 | (103) |
Effect of exchange rate changes on cash and cash equivalents | (27,186) | (8,643) |
Net increase (decrease) in cash and cash equivalents | 135,369 | (98,157) |
Net Cash and cash equivalents at the beginning of the period | 77,301 | 196,352 |
Net cash and cash equivalents at the end of the period | $ 212,670 | $ 98,195 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Changes in Shareholders' Equity $ in Thousands | USD ($) | EUR (€) | Common Shares [Member] USD ($) shares | Additional Paid-in Capital [Member] USD ($) | Treasury Stock [Member] USD ($) | Accumulated Deficit [Member] USD ($) | Accumulated Other Comprehensive income (loss) [Member] USD ($) | Accumulated Currency Translation Effect [Member] USD ($) |
Beginning balance at Dec. 31, 2020 | $ 205,491 | $ 6,518 | $ 1,152,042 | $ (1,169) | $ (958,543) | $ 484 | $ 6,158 | |
Beginning balance (Shares) at Dec. 31, 2020 | shares | 54,929,187 | |||||||
Net (loss) | (29,449) | (29,449) | ||||||
Other comprehensive income (loss) | (8,829) | (85) | (8,744) | |||||
Issuance of ordinary shares | 42 | $ 1 | 42 | |||||
Issuance of ordinary shares (Shares) | shares | 7,500 | |||||||
Treasury shares | 488 | 488 | ||||||
Share-based payments | 1,433 | 1,433 | ||||||
Ending balance at Mar. 31, 2021 | 169,176 | $ 6,519 | 1,153,516 | (681) | (987,992) | 399 | (2,586) | |
Ending balance (Shares) at Mar. 31, 2021 | shares | 54,936,687 | |||||||
Beginning balance at Dec. 31, 2020 | 205,491 | $ 6,518 | 1,152,042 | (1,169) | (958,543) | 484 | 6,158 | |
Beginning balance (Shares) at Dec. 31, 2020 | shares | 54,929,187 | |||||||
Net (loss) | (84,136) | |||||||
Ending balance at Sep. 30, 2021 | 116,892 | $ 6,529 | 359,081 | (810) | (244,856) | 474 | (3,526) | |
Ending balance (Shares) at Sep. 30, 2021 | shares | 55,011,687 | |||||||
Beginning balance at Mar. 31, 2021 | 169,176 | $ 6,519 | 1,153,516 | (681) | (987,992) | 399 | (2,586) | |
Beginning balance (Shares) at Mar. 31, 2021 | shares | 54,936,687 | |||||||
Net (loss) | (30,654) | (30,654) | ||||||
Other comprehensive income (loss) | 2,836 | 48 | 2,788 | |||||
Issuance of ordinary shares | 473 | $ 9 | 464 | |||||
Issuance of ordinary shares (Shares) | shares | 75,000 | |||||||
Issuance of warrants | 279 | 279 | ||||||
Treasury shares | (185) | (185) | ||||||
Share-based payments | 1,094 | 1,094 | ||||||
Allocation of accumulated net losses | (797,823) | 797,823 | ||||||
Ending balance at Jun. 30, 2021 | 143,019 | $ 6,529 | 357,530 | (866) | (220,823) | 446 | 203 | |
Ending balance (Shares) at Jun. 30, 2021 | shares | 55,011,687 | |||||||
Net (loss) | (24,033) | (24,033) | ||||||
Other comprehensive income (loss) | (3,701) | 28 | (3,728) | |||||
Treasury shares | 56 | 56 | ||||||
Share-based payments | 1,551 | 1,551 | ||||||
Ending balance at Sep. 30, 2021 | 116,892 | $ 6,529 | 359,081 | (810) | (244,856) | 474 | (3,526) | |
Ending balance (Shares) at Sep. 30, 2021 | shares | 55,011,687 | |||||||
Beginning balance at Dec. 31, 2021 | 99,274 | $ 6,538 | 358,115 | (1,232) | (258,528) | 519 | (6,137) | |
Beginning balance (Shares) at Dec. 31, 2021 | shares | 55,095,762 | |||||||
Net (loss) | (16,706) | (16,706) | ||||||
Other comprehensive income (loss) | (1,909) | 24 | (1,933) | |||||
Issuance of ordinary shares | 1 | $ 1 | ||||||
Issuance of ordinary shares (Shares) | shares | 775 | |||||||
Treasury shares | 40 | 40 | ||||||
Share-based payments | 1,363 | 1,363 | ||||||
Other changes | 15 | (15) | ||||||
Ending balance at Mar. 31, 2022 | 82,062 | $ 6,539 | 359,478 | (1,193) | (275,219) | 543 | (8,086) | |
Ending balance (Shares) at Mar. 31, 2022 | shares | 55,096,537 | |||||||
Beginning balance at Dec. 31, 2021 | 99,274 | $ 6,538 | 358,115 | (1,232) | (258,528) | 519 | (6,137) | |
Beginning balance (Shares) at Dec. 31, 2021 | shares | 55,095,762 | |||||||
Net (loss) | (57,033) | |||||||
Issuance of ordinary shares | € | € 3,285,566,900 | |||||||
Share-based payments | € | € 95,281,440,100 | |||||||
Ending balance at Sep. 30, 2022 | 212,052 | $ 10,709 | 456,884 | (1,083) | (220,337) | 783 | (34,904) | |
Ending balance (Shares) at Sep. 30, 2022 | shares | 94,025,441 | |||||||
Beginning balance at Mar. 31, 2022 | 82,062 | $ 6,539 | 359,478 | (1,193) | (275,219) | 543 | (8,086) | |
Beginning balance (Shares) at Mar. 31, 2022 | shares | 55,096,537 | |||||||
Net (loss) | (23,039) | (23,039) | ||||||
Other comprehensive income (loss) | (11,194) | 200 | (11,394) | |||||
Issuance of ordinary shares | 107,176 | $ 4,170 | 103,007 | |||||
Issuance of ordinary shares (Shares) | shares | 38,926,142 | |||||||
Issuance of warrants | 88,094 | 88,094 | ||||||
Treasury shares | 240 | 240 | ||||||
Share-based payments | 1,078 | 1,078 | ||||||
Allocation of accumulated net losses | (95,209) | 95,209 | ||||||
Ending balance at Jun. 30, 2022 | 244,416 | $ 10,708 | 456,447 | (953) | (203,050) | 743 | (19,480) | |
Ending balance (Shares) at Jun. 30, 2022 | shares | 94,022,679 | |||||||
Net (loss) | (17,287) | (17,287) | ||||||
Other comprehensive income (loss) | (15,384) | 41 | (15,425) | |||||
Issuance of ordinary shares | (539) | $ 1 | (540) | |||||
Issuance of ordinary shares (Shares) | shares | 2,762 | |||||||
Treasury shares | (130) | (130) | ||||||
Share-based payments | 976 | 976 | ||||||
Ending balance at Sep. 30, 2022 | $ 212,052 | $ 10,709 | $ 456,884 | $ (1,083) | $ (220,337) | $ 783 | $ (34,904) | |
Ending balance (Shares) at Sep. 30, 2022 | shares | 94,025,441 |
The Company
The Company | 9 Months Ended |
Sep. 30, 2022 | |
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”, or the “group”) 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 filed with the SEC on March 9, 2022 (the “Annual Report”). The condensed consolidated statement of financial position as of December 31, 2021 was derived from the audited consolidated financial statements but does not include all disclosures required by U.S. GAAP. The Company’s critical accounting policies are detailed in the Annual Report. The Company’s critical accounting policies have not changed materially since December 31, 2021. 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, 2022, 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 basis, management evaluates its estimates, primarily those related to: (1) evaluation of costs and measure of progress of the development activities conducted as part of the collaboration agreement with Nestlé Health Science, (2) research tax credits, (3) assumptions used in the valuation of right of use assets - operating lease, (4) impairment of right-of-use assets related to leases and property, plant and equipment, (5) recoverability of the Company's net deferred tax assets and related valuation allowance, (6) assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan, and (7) estimate of contingencies. Accounting Pronouncements adopted in 2022 The Company has not adopted any new accounting pronouncements in 2022 to date. Accounting Pronouncements issued not yet adopted In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-13 - Financial Instruments - Credit losses, which replaces the incurred loss impairment methodology for financial instruments in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The FASB has issued ASU 2019-10 which has resulted in the postponement of the effective date of the new guidance for eligible smaller reporting companies to the fiscal year beginning January 1, 2023. The guidance must be adopted using a modified-retrospective approach and a prospective transition approach is required for debt securities for which an other-than-temporary impairment had been recognized before the effective date. The Company is currently evaluating the impact of the guidance on its Consolidated Financial Statements. The Company does not expect this new standard will have a material impact on its consolidated financial statements. 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 | 9 Months Ended |
Sep. 30, 2022 | |
Significant Events And Transactions Disclosure [Abstract] | |
Significant Events and Transactions | Note 2: Significant Events and Transactions Clinical programs Viaskin TM 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 Complete Response Letter received in August 2020. The FDA agreed with its position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 µg (approximately 1/1000 of one peanut) remains unchanged and performs in the same way it has performed previously. In order to confirm the consistency of efficacy data between the existing and a modified patch, FDA requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4-11. The Company named that assessment EQUAL, which stands for Equivalence in Uptake of ALlergen. The FDA also recommended conducting a 6-month, well-controlled safety and adhesion trial to assess a modified Viaskin Peanut patch in the intended patient population. The Company later named this study STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches. Based on the January 2021 FDA feedback, the Company defined three parallel workstreams: 1. Identify a modified Viaskin patch (“mVP”). 2. Generate the 6-month safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan. The Company prioritized the STAMP protocol submission so the Company could begin the study as soon as possible. 3. Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL. The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch. To support those exchanges, the Company outlined its proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional studies: a. PREQUAL, a Phase I study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays the Company intends to use in EQUAL b. ‘EQUAL in adults’—a second Phase I study with adult healthy volunteers to compare the allergen uptake of cVP and mVP; In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches, to identify the one or two best-performing patches, which the Company completed in the second quarter of 2021. Based on the adhesion parameters studied, the Company selected the modified patch to advance to further clinical testing in the intended patient population. 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 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 in October 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. After careful review of the FDA’s information requests, in December 2021, the Company decided not to pursue the stepwise approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 letter. The Company estimated that the FDA’s newly proposed stepwise approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, the 6-month safety and adhesion study. As such, in December 2021, the Company announced its plan to initiate a pivotal Phase III placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The clinical trial will also include updates to the Instructions for Use (IFU). The Company considers this approach the most straightforward to potentially demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. The FDA confirmed the Company’s change in strategy is agreeable via oral and written exchanges. The new Phase 3 pivotal study for modified Viaskin Peanut has been named VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy), which means “speed” in French. In May 2022, the Company announced that the FDA granted it a Type C meeting to align on the protocol and the study protocol was submitted to the FDA as part of Type C meeting briefing package. On September 9, 2022, the Company announced the initiation of the Phase 3 study, using the modified Viaskin™ Peanut Patch, in peanut-allergic children ages 4 to 7 years. On September 21, 2022, the Company announced it received feedback from the U.S. FDA in the form of a partial clinical hold on its VITESSE Phase 3 clinical study. In the partial clinical hold letter, the FDA specifies changes to elements of the VITESSE protocol with the intent for the trial to support a future BLA submission. The modifications noted within the FDA’s communication 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. The Company has not yet begun the screening or recruitment of subjects in the VITESSE study. The partial clinical hold is specific to VITESSE and does not impact any other ongoing its clinical studies. The Company expects to provide additional updates following consultation with the FDA. Viaskin Peanut for children ages 4-11 - European Union Regulatory History and Current Status In August 2021, the Company announced its receipt from the EMA of 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. In December 2021, the Company announced it had withdrawn the Marketing Authorization Application for Viaskin Peanut and formally notified the EMA of our decision. The initial filing was supported by positive data from a single, placebo-controlled Phase 3 pivotal trial known as PEPITES (V712-301). The decision to withdraw was based on the view of EMA Committee for Medicinal Products for Human Use (CHMP) that the data available to date from a single pivotal study were not sufficient to preclude a Major Objection at Day 180 in the review cycle. The Company believes data from a second Viaskin Peanut pivotal study will support a more robust path for licensure of Viaskin Peanut in the EU. The Company intends to resubmit the MAA when that data set is available. Viaskin Peanut for children ages 1-3 In June 2020, the Company announced that in Part A, patients 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 Pg dose in this age group, which is the dose being studied in Part B of the study. Enrollment for Part B of EPITOPE was completed in the first quarter of 2022. In June 2022, the Company announced that its pivotal Phase III trial EPITOPE, assessing the safety and efficacy of Viaskin™ Peanut 250 µg for the treatment of peanut-allergic toddlers ages 1 to 3 years, met its primary endpoint. Viaskin Peanut demonstrated a statistically significant treatment effect (p<0.001), with 67.0% of subjects in the Viaskin Peanut arm meeting the treatment responder criteria after 12 months, as compared to 33.5% of subjects in the placebo arm (difference in response rates = 33.4 %, 95 % CI = 22.4% - 44.5 %). The Company intends to further analyze the data from EPITOPE and explore regulatory pathways for Viaskin Peanut in children ages 1 to 3 years, given the high unmet need and absence of approved treatments for this vulnerable population. Financing In May 2022, the Company announced that pursuant to the Company’s At-The-Market one-half In June 2022, the Company announced an aggregate $194 million private investment in public equity (PIPE) financing (corresponding to €181 million on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022) from the sale of 32,855,669 ordinary shares, as well as pre-funded pre-funded pre-funded pre-funded pre-funded The ordinary shares, including the ordinary shares issuable upon exercise of the pre-funded warrants from the PIPE financing, have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. In connection with the PIPE financing, the Company entered into a registration rights agreement (the “Registration Rights Agreement”), pursuant to which the Company filed has a registration statement with the Securities and Exchange Commission (the “SEC”) registering the resale of 59,269,629 ordinary shares issued in the PIPE financing, including ordinary shares underlying the pre-funded warrants. COVID-19 On March 11, 2020, the World Health Organization declared COVID-19 The Company has assessed the impact of the uncertainties created by the pandemic. As of September 30, 2022, those uncertainties were taken into account in the assumptions underlying the estimates and judgments used by the Company. The Company continues to update these estimates and assumptions as the situation evolves. The effects of the COVID-19 pandemic are presented in the relevant line items of the condensed consolidated statement of financial position and the condensed consolidated statement of operations according to the function or nature of the income or expense, and Comprehensive Loss. Legal Proceedings A class action complaint was filed on January 15, 2019 in the United States District Court for the District of New Jersey, entitled Travis Ito-Stone v. DBV Technologies, et al., Case No. 2:19-cv-00525. The complaint alleged that the Company and its former Chief Executive Officer, its current Chief Executive Officer, and its former Deputy Chief Executive Officer violated certain federal securities laws, specifically under Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder. The plaintiffs seek unspecified damages on behalf of a purported class of purchasers of the Company’s securities between February 14, 2018 and August 4, 2020 and also held the Company’s securities on December 20, 2018 and/or March 16, 2020 and/or August 4, 2020. A hearing was held on July 29, 2021 in the U.S. District Court for the District of New Jersey where the Court entered an order granting the Company’s Motion to Dismiss the Second Amended Class Action Complaint without prejudice. As the dismissal was without prejudice, the Plaintiffs replead their case by filing a Third Amended Class Action Complaint on September 30, 2021 in the same Court. The company moved to dismiss third amended complaint on December 10, 2021. On July 29, 2022 the Court entered an order granting the Company’s Motion to Dismiss the Plaintiff’s Third Amended Complaint with prejudice. The Court indicated that the Third Amended Complaint was deficient in a number of ways, failing to allege a violation of the Securities Exchange Act of 1934, and ordered the matter closed. Per court procedural rules, the Plaintiffs have 30 days to appeal the dismissal of the Third Amended Complaint. The Plaintiffs failed to file an appeal of the dismissal of the Third Amended Complaint within the 30-day period and this matter is resolved with finality. |
Cash and Cash Equivalents
Cash and Cash Equivalents | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, 2022 and December 31, 2021: September 30, December 31, 2022 2021 Cash 167,916 31,427 Cash equivalents 44,754 45,874 Total cash and cash equivalents as reported in the statements of financial position 212,670 77,301 Cash equivalents are immediately convertible into cash at no or insignificant cost, on demand. They are measured using level 1 fair value measurements. |
Other Current Assets
Other Current Assets | 9 Months Ended |
Sep. 30, 2022 | |
Other Current Assets [Abstract] | |
Other Current Assets | Note 4 Other Current Assets Other current assets consisted of the following: September 30, December 31, 2022 2021 Research tax credit 4,094 28,092 Other tax claims 3,636 3,561 Prepaid expenses 4,107 4,149 Other receivables 1,188 1,283 Total 13,025 37,085 Research tax credit In the fiscal year ended December 31, 2021, the Company recovered its Small and Medium-sized During the nine months period ended September 30, 2022, the Company received the reimbursement of the 2019, 2020 and 2021 fiscal year research tax credit. The variance in Research Tax Credit is presented as follows: Amount in Opening research tax credit receivable as of January 1, 2022 28,092 + Operating revenue 4,467 - Payment received (26,386 ) - Adjustment and currency translation effect (2,079 ) Closing research tax credit receivable as of September 30, 2022 4,094 Of which - Non-current — Of which - Current portion 4,094 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 | 9 Months Ended |
Sep. 30, 2022 | |
Lessee Disclosure [Abstract] | |
Lease contracts | Note 5 Lease contracts Future minimum lease payments under the Company's operating leases’ right of use as of September 30, 2022 and December 31, 2021, are as follows: September 30, 2022 December 31, 2021 Real estate Other Total Real estate Other Total Current portion 1,504 34 1,538 3,361 77 3,438 Year 2 1,874 18 1,891 3,124 23 3,147 Year 3 103 6 109 2,299 18 2,317 Year 4 — — — 771 1 773 Year 5 — — — 790 — 790 Thereafter — — — 1,220 — 1,220 Total minimum lease payments 3,481 58 3,538 11,565 119 11,684 Less: Effects of discounting (729 ) (5 ) (734 ) (1,526 ) (8 ) (1,534 ) Present value of operating lease 2,752 52 2,804 10,039 111 10,150 Less: current portion (1,350 ) (31 ) (1,381 ) (2,929 ) (74 ) (3,003 ) Long-term operating lease 1,402 22 1,423 7,110 37 7,147 Weighted average remaining lease term (years) 1.80 — 4.14 2.01 Weighted average discount rate 3.50 % 0.9 % 4.84 % 3.32 % 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: September 30, 2022 2021 Operating lease expense 1,373 2,480 Net termination impact (1,657 ) — In January 2022, the company entered into a termination agreement for its U.S. office in Summit, NJ, following the resizing of its facility use. The Company recognized an income of $1.2 million as of June 30, 2022 due to the early termination of its Summit, NJ lease, offset by the payment of a one-time On March 28, 2022, the Company entered into a binding office lease agreement in New Jersey for a lease term of 3 years and 2 months. The lease commencement was based upon delivery of possession of the premises by the Landlord and occurred on April 1, 2022. Right of use and related lease debt have been recorded starting April 1, 2022 for a gross amount of $ Supplemental cash flow information related to operating leases is as follows for the period September 30, 2022 and 2021: September 30, 2022 2021 Cash paid for amounts included in the measurement of lease liabilities — — Operating cash flows from operating leases 1,533 2,845 |
Trade Payables and Other Curren
Trade Payables and Other Current Liabilities | 9 Months Ended |
Sep. 30, 2022 | |
Payables and Accruals [Abstract] | |
Trade Payables and Other Current Liabilities | Note 6: Trade Payables and Other Current 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 Liabilities The following tables summarize the other liabilities as of September 30, 2022 and December 31, 2021: September 30, December 31, 2022 2021 Other current Other non- current Total Other current Other non- Total Employee related liabilities 4,666 54 4,719 6,708 247 6,954 Deferred income 2,911 926 3,836 4,146 1,900 6,046 Tax liabilities 405 — 405 182 — 182 Other debts 634 — 634 1,325 — 1,325 Total 8,615 979 9,594 12,361 2,147 14,508 The other current liabilities include short-term debt to employees including social welfare and tax agency obligations. Deferred income primarily includes deferred income from the collaboration agreement with Nestlé Health Science, which amounted to $3.8 million as of September 30, 2022. |
Shareholders' equity
Shareholders' equity | 9 Months Ended |
Sep. 30, 2022 | |
Stockholders' Equity Note [Abstract] | |
Shareholders' equity | Note 7: Shareholders’ equity The share capital as of September 30, 2022 is set at the sum of €9,402,544 ($10,708,725 converted at historical rates). It is divided into 94,025,441 fully authorized, subscribed and paid-up Pursuant to the authorization granted by the General Meeting of the Shareholders held on May 12, 2022 (the “SH General Meeting”), the accumulated net losses of DBV Technologies S.A. after appropriation of the net result for the year ended December 31, 2021 have been allocated to additional paid-in Pursuant to the authorization granted by the SH General Meeting, the Board of Directors, at its meeting of June 9, 2022 (the “Board General Meeting”): • decided, within the framework of the PIPE financing the principle of a capital increase in cash with cancellation th nd • granted a number of authorizations for the purpose of carrying out the i • sub-delegated The Chief Executive Officer, acting pursuant to the sub-delegations of authority granted by the Board of Directors of the Company on June 8, 2022, after receiving the favorable opinion of the Pricing Committee established by the Board of Directors, has, on June 9, 2022 : • decided, making use of the 18 th 225-128 • decided to set the maximum nominal amount of the capital increase resulting from the full exercise of the prefunded warrants at € 2,827,633.10, by issuing a maximum of 28,276,331 ordinary shares, with a value of € 0.10 to be subscribed in cash at the price of € 0.10 euro (without share premium), and to be fully paid up at the time of subscription, i.e. a capital increase of a maximum nominal amount of € 2,827,633.10 (and a share premium corresponding to the amount of the pre-financed • determined the list of beneficiaries (designated within each of the categories of persons defined in the 18 th resolution of the Board General Meeting) and the number of New Ordinary Shares and warrants allocated to each of them under the conditions defined in the 18th resolution of the Board General Meeting beneficiaries under the conditions defined in section 5 of the offering circular relating to the PIPE financing. The Company has assessed the pre-funded pre-funded The 2022 Warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. In addition, the 2022 Warrants do not provide any guarantee of value or return. Accordingly, the pre-funded paid-in The changes in number of outstanding prefunded warrants are as follows: Prefunded Balance as of December 31, 2021 — Granted during the period 28,276,331 Forfeited during the period — Exercised/released during the period — Expired during the period — Balance as of September 30, 2022 28,276,331 |
Share-Based Payments
Share-Based Payments | 9 Months Ended |
Sep. 30, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Share-Based Payments | Note 8: Share-Based Payments The Board of Directors has been authorized by the SH General Meeting to grant restricted stock units (“RSU”), stock options plan (“SO”) and non-employee Bons de Souscription d’Actions During the nine months ended September 30, 2022, the Company granted 154,500 stock options and 69,900 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 13 to the consolidated financial statements included in the Annual Report. Stock option fair value assumptions during the nine months ended September 30, 2022 Weighted average share price at grant date in € 4.3 Weighted average expected volatility 93.6 % Weighted average risk-free interest rate 0.89 % Weighted average expected term (in years) 6 Dividend yield — Weighted average fair value of stock options in € 3.3 Change in Number of BSA/SO/RSU: Number of outstanding BSA SO RSUs Balance as of December 31, 2021 256,693 3,631,210 1,240,520 Granted during the period — 154,500 69,900 Forfeited during the period — (238,715 ) (92,326 ) Exercised/released during the period — (5,613 ) (32,159 ) Expired during the period (5,000 ) — — Balance as of September 30, 2022 251,693 3,541,383 1,185,936 Share-based payments exp e follows: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Research & development SO (337 ) (273 ) (1,002 ) (952 ) RSU (201 ) (660 ) (594 ) (795 ) Sales & marketing SO 30 (60 ) (3 ) (172 ) RSU 20 (27 ) 4 (75 ) General & administrative SO (423 ) (439 ) (1,599 ) (1,791 ) RSU (66 ) (92 ) (223 ) (293 ) Total share-based compensation (expense) (976 ) (1,551 ) (3,416 ) (4,078 ) |
Contingencies
Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Loss Contingency [Abstract] | |
Contingencies | Note 9: Contingencies The following tables summarize the contingencies as of September 30, 2022 and December 31, 2021: September 30, December 31, 2022 2021 Current contingencies 3,026 4,095 Non-current contingencies 5,272 6,758 Total contingencies 8,298 10,853 The changes in contingencies are as follows: Pension Collaboration Other Total At January 1, 2022 1,008 9,800 45 10,853 Increases in liabilities 58 — — 58 Used liabilities — (889 ) (43 ) (932 ) Reversals of unused liabilities — — — — Net interest related to employee benefits, and unwinding of discount — — — — Actuarial gains and losses on defined-benefit plans (264 ) — — (264 ) Currency translation effect (123 ) (1,291 ) (3 ) (1,417 ) At September 30, 2022 678 7,620 — 8,298 Of which Current — 3,026 — 3,026 Of which Non-current 678 4,594 — 5,272 In 2021 and during the first nine months of 2022, the Company updated its measurement of progress of the Phase 2 clinical trial (“PII”) conducted as part of the collaboration and license agreement with Nestlé and updated the cumulative income recognized. The Company has recorded an accrual in the amount of the excess between the Company’s current best estimates of costs yet to be incurred and incomes yet to be recognized for the completion of the PII. 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 | 9 Months Ended |
Sep. 30, 2022 | |
Other Income and Expenses [Abstract] | |
Operating Income | Note 10: Operating income The following table summarizes the operating income during the three and six months ended September 30, 2022 and 2021: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Research tax credit 1,407 1,647 4,467 5,324 Other operating income 668 (324 ) 1,681 (2,549 ) Total 2,074 1,323 6,148 2,776 As of September 30, 2022, the Company recorded its collaboration agreement’s revenue based on its updated measurement of progress of the Phase II clinical trial conducted as part of the agreement. The accrual recorded in the amount of the difference between the Company’s current best estimates of costs yet to be incurred and revenues yet to be recognized for the completion of the Phase II clinical trial has been updated accordingly. |
Allocation of Personnel Expense
Allocation of Personnel Expenses | 9 Months Ended |
Sep. 30, 2022 | |
Operating Expenses [Abstract] | |
Allocation of Personnel Expenses | Note 11: Allocation of Personnel Expenses The Company had an average of 85 employees during the nine months ended September 30, 2022, in comparison with an average of 105 employees during the nine months ended September 30, 2021. The following table summarizes the allocation of personnel expenses by function during the three and nine months ended September 30, 2022 and 2021: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Research and Development expenses 3,186 4,161 9,357 12,272 Sales and Marketing expenses 138 492 727 1,528 General and Administrative expenses 1,598 2,583 6,961 9,347 Total personnel expenses 4,922 7,236 17,045 23,148 The following table summarizes the allocation of personnel expenses by nature during the three and nine months ended September 30, 2022 and 2021: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Wages and salaries 3,505 3,793 11,001 12,629 Social security contributions 634 1,110 2,141 3,505 Expenses for pension commitments 214 286 723 981 Employer contribution to bonus shares (406 ) 497 (236 ) 1,955 Share-based payments 976 1,551 3,416 4,078 Total 4,922 7,236 17,045 23,148 The decrease in personnel expenses is mainly due to a decrease in headcount following the full implementation of the new organization. |
Commitments
Commitments | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | Note 12: Commitments There have been no significant changes in other commitments from those disclosed in Note 18 to the consolidated financial statements included in the Annual Report. |
Relationships with Related Part
Relationships with Related Parties | 9 Months Ended |
Sep. 30, 2022 | |
Related Party Transactions [Abstract] | |
Relationships with Related Parties | Note 13: Relationships with Related Parties The Company’s related parties consist exclusively of the members of the Board of Directors and the members of the Executive Committee. As of September 30, 2022, the total amount of remuneration granted to the members of the Board of Directors and Executive Committee has not changed significantly since December 31, 2021. 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 19 to the consolidated financial statements included in the Annual Report. |
Loss Per Share
Loss Per Share | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Loss Per Share | Note 14: 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 and nine months periods ended September 30, 2022 and 2021, 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 and six months ended September 30, 2022 and 2021 indicated in number of potential shares: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Non-employee warrants 251,693 256,693 251,693 256,693 Stock options 3,541,383 2,585,710 3,541,383 2,585,710 Restricted stock units 1,185,936 1,104,145 1,185,936 1,104,145 Prefunded warrants 28,276,331 — 28,276,331 — |
Events After The Close Of The P
Events After The Close Of The Period | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events [Abstract] | |
Events after the Close of the Period | Note 15: Events after the Close of the Period The Company evaluated subsequent events that occurred after September 30, 2022, through the date the condensed consolidated financial statements were issued after their approval by the Board of Directors on November 3, 2022 and determined that there are no significant events that require adjustments or disclosure in such condensed consolidated financial statements. |
The Company (Policies)
The Company (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
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 filed with the SEC on March 9, 2022 (the “Annual Report”). The condensed consolidated statement of financial position as of December 31, 2021 was derived from the audited consolidated financial statements but does not include all disclosures required by U.S. GAAP. The Company’s critical accounting policies are detailed in the Annual Report. The Company’s critical accounting policies have not changed materially since December 31, 2021. 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, 2022, 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 basis, management evaluates its estimates, primarily those related to: (1) evaluation of costs and measure of progress of the development activities conducted as part of the collaboration agreement with Nestlé Health Science, (2) research tax credits, (3) assumptions used in the valuation of right of use assets - operating lease, (4) impairment of right-of-use assets related to leases and property, plant and equipment, (5) recoverability of the Company's net deferred tax assets and related valuation allowance, (6) assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan, and (7) estimate of contingencies. |
Accounting Pronouncements adopted in 2022 | Accounting Pronouncements adopted in 2022 The Company has not adopted any new accounting pronouncements in 2022 to date. |
Accounting Pronouncements issued not yet adopted | Accounting Pronouncements issued not yet adopted In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-13 - Financial Instruments - Credit losses, which replaces the incurred loss impairment methodology for financial instruments in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The FASB has issued ASU 2019-10 which has resulted in the postponement of the effective date of the new guidance for eligible smaller reporting companies to the fiscal year beginning January 1, 2023. The guidance must be adopted using a modified-retrospective approach and a prospective transition approach is required for debt securities for which an other-than-temporary impairment had been recognized before the effective date. The Company is currently evaluating the impact of the guidance on its Consolidated Financial Statements. The Company does not expect this new standard will have a material impact on its consolidated financial statements. 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) | 9 Months Ended |
Sep. 30, 2022 | |
Cash and Cash Equivalents [Abstract] | |
Summary of breakdown of cash and cash equivalents | The following tables summarize the cash and cash equivalents as of September 30, 2022 and December 31, 2021: September 30, December 31, 2022 2021 Cash 167,916 31,427 Cash equivalents 44,754 45,874 Total cash and cash equivalents as reported in the statements of financial position 212,670 77,301 |
Other Current Assets (Tables)
Other Current Assets (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Other Current Assets [Abstract] | |
Summary of Other Current Asset | Other current assets consisted of the following: September 30, December 31, 2022 2021 Research tax credit 4,094 28,092 Other tax claims 3,636 3,561 Prepaid expenses 4,107 4,149 Other receivables 1,188 1,283 Total 13,025 37,085 |
Summary of Research Tax Credi | The variance in Research Tax Credit is presented as follows: Amount in Opening research tax credit receivable as of January 1, 2022 28,092 + Operating revenue 4,467 - Payment received (26,386 ) - Adjustment and currency translation effect (2,079 ) Closing research tax credit receivable as of September 30, 2022 4,094 Of which - Non-current — Of which - Current portion 4,094 |
Lease contracts (Tables)
Lease contracts (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Lessee Disclosure [Abstract] | |
Summary of Operating Leases Future Minimum Payments Receivable | Future minimum lease payments under the Company's operating leases’ right of use as of September 30, 2022 and December 31, 2021, are as follows: September 30, 2022 December 31, 2021 Real estate Other Total Real estate Other Total Current portion 1,504 34 1,538 3,361 77 3,438 Year 2 1,874 18 1,891 3,124 23 3,147 Year 3 103 6 109 2,299 18 2,317 Year 4 — — — 771 1 773 Year 5 — — — 790 — 790 Thereafter — — — 1,220 — 1,220 Total minimum lease payments 3,481 58 3,538 11,565 119 11,684 Less: Effects of discounting (729 ) (5 ) (734 ) (1,526 ) (8 ) (1,534 ) Present value of operating lease 2,752 52 2,804 10,039 111 10,150 Less: current portion (1,350 ) (31 ) (1,381 ) (2,929 ) (74 ) (3,003 ) Long-term operating lease 1,402 22 1,423 7,110 37 7,147 Weighted average remaining lease term (years) 1.80 — 4.14 2.01 Weighted average discount rate 3.50 % 0.9 % 4.84 % 3.32 % |
Summary of Rent expenses | Rent expense presented in the condensed consolidated statement of operations and comprehensive loss was: September 30, 2022 2021 Operating lease expense 1,373 2,480 Net termination impact (1,657 ) — |
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 September 30, 2022 and 2021: September 30, 2022 2021 Cash paid for amounts included in the measurement of lease liabilities — — Operating cash flows from operating leases 1,533 2,845 |
Trade Payables and Other Curr_2
Trade Payables and Other Current Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Other Liabilities [Abstract] | |
Summary of Other Liabilities | The following tables summarize the other liabilities as of September 30, 2022 and December 31, 2021: September 30, December 31, 2022 2021 Other current Other non- current Total Other current Other non- Total Employee related liabilities 4,666 54 4,719 6,708 247 6,954 Deferred income 2,911 926 3,836 4,146 1,900 6,046 Tax liabilities 405 — 405 182 — 182 Other debts 634 — 634 1,325 — 1,325 Total 8,615 979 9,594 12,361 2,147 14,508 |
Shareholders' equity (Tables)
Shareholders' equity (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Nonvested Share Activity | The changes in number of outstanding prefunded warrants are as follows: Prefunded Balance as of December 31, 2021 — Granted during the period 28,276,331 Forfeited during the period — Exercised/released during the period — Expired during the period — Balance as of September 30, 2022 28,276,331 |
Share-Based Payments (Tables)
Share-Based Payments (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Summary of Stock Options Valuation Assumptions | Stock option fair value assumptions during the nine months ended September 30, 2022 Weighted average share price at grant date in € 4.3 Weighted average expected volatility 93.6 % Weighted average risk-free interest rate 0.89 % Weighted average expected term (in years) 6 Dividend yield — Weighted average fair value of stock options in € 3.3 |
Summary of RSU Activity | Change in Number of BSA/SO/RSU: Number of outstanding BSA SO RSUs Balance as of December 31, 2021 256,693 3,631,210 1,240,520 Granted during the period — 154,500 69,900 Forfeited during the period — (238,715 ) (92,326 ) Exercised/released during the period — (5,613 ) (32,159 ) Expired during the period (5,000 ) — — Balance as of September 30, 2022 251,693 3,541,383 1,185,936 |
Summary of Share-Based Payments Expenses | Share-based payments exp e follows: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Research & development SO (337 ) (273 ) (1,002 ) (952 ) RSU (201 ) (660 ) (594 ) (795 ) Sales & marketing SO 30 (60 ) (3 ) (172 ) RSU 20 (27 ) 4 (75 ) General & administrative SO (423 ) (439 ) (1,599 ) (1,791 ) RSU (66 ) (92 ) (223 ) (293 ) Total share-based compensation (expense) (976 ) (1,551 ) (3,416 ) (4,078 ) |
Contingencies (Tables)
Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Loss Contingency [Abstract] | |
Summary of Current Contingencies and Non-current Contingencies | The following tables summarize the contingencies as of September 30, 2022 and December 31, 2021: September 30, December 31, 2022 2021 Current contingencies 3,026 4,095 Non-current contingencies 5,272 6,758 Total contingencies 8,298 10,853 |
Summary of Movement in Provisions | The changes in contingencies are as follows: Pension Collaboration Other Total At January 1, 2022 1,008 9,800 45 10,853 Increases in liabilities 58 — — 58 Used liabilities — (889 ) (43 ) (932 ) Reversals of unused liabilities — — — — Net interest related to employee benefits, and unwinding of discount — — — — Actuarial gains and losses on defined-benefit plans (264 ) — — (264 ) Currency translation effect (123 ) (1,291 ) (3 ) (1,417 ) At September 30, 2022 678 7,620 — 8,298 Of which Current — 3,026 — 3,026 Of which Non-current 678 4,594 — 5,272 |
Operating Income (Tables)
Operating Income (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Other Income and Expenses [Abstract] | |
Schedule of operating income | The following table summarizes the operating income during the three and six months ended September 30, 2022 and 2021: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Research tax credit 1,407 1,647 4,467 5,324 Other operating income 668 (324 ) 1,681 (2,549 ) Total 2,074 1,323 6,148 2,776 |
Allocation of Personnel Expen_2
Allocation of Personnel Expenses (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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 and nine months ended September 30, 2022 and 2021: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Research and Development expenses 3,186 4,161 9,357 12,272 Sales and Marketing expenses 138 492 727 1,528 General and Administrative expenses 1,598 2,583 6,961 9,347 Total personnel expenses 4,922 7,236 17,045 23,148 |
Summary of Allocation of Personnel Expenses By Nature | The following table summarizes the allocation of personnel expenses by nature during the three and nine months ended September 30, 2022 and 2021: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Wages and salaries 3,505 3,793 11,001 12,629 Social security contributions 634 1,110 2,141 3,505 Expenses for pension commitments 214 286 723 981 Employer contribution to bonus shares (406 ) 497 (236 ) 1,955 Share-based payments 976 1,551 3,416 4,078 Total 4,922 7,236 17,045 23,148 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share, Basic [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | 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 and six months ended September 30, 2022 and 2021 indicated in number of potential shares: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Non-employee warrants 251,693 256,693 251,693 256,693 Stock options 3,541,383 2,585,710 3,541,383 2,585,710 Restricted stock units 1,185,936 1,104,145 1,185,936 1,104,145 Prefunded warrants 28,276,331 — 28,276,331 — |
Significant Events and Transa_2
Significant Events and Transactions - Additional Information (Detail) € / shares in Units, $ / shares in Units, € in Thousands, $ in Millions | 1 Months Ended | 6 Months Ended | 9 Months Ended | ||||
Jan. 31, 2020 | May 31, 2022 USD ($) $ / shares shares | Jun. 30, 2022 USD ($) $ / shares shares | Jun. 30, 2022 EUR (€) shares | Sep. 30, 2022 EUR (€) € / shares shares | Jun. 30, 2022 € / shares shares | May 31, 2022 € / shares | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Stock Issued During Period, Shares, New Issues | 59,269,629 | ||||||
Shares Issued, Price Per Share | € / shares | € 2.9 | ||||||
Proceeds From Issuance Of Common Stock | € | € 98,567,007 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | (per share) | $ 3.11 | € 2.9 | |||||
Class of Warrant or Right, Issue price | € / shares | 0.1 | ||||||
American Depositary Shares | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Stock Issued During Period, Shares, New Issues | 6,036,238 | ||||||
Shares Issued, Price Per Share | (per share) | $ 1.27 | € 2.41 | |||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 1.0531 | ||||||
Proceeds From Issuance Of Common Stock | $ | $ 15.3 | ||||||
private investment in public equity [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Stock Issued During Period, Shares, New Issues | 32,855,669 | 32,855,669 | |||||
Shares Issued, Price Per Share | (per share) | $ 3.22 | € 3 | |||||
Proceeds From Issuance Of Common Stock | $ 194 | € 181,000 | |||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 28,276,331 | 28,276,331 | |||||
Private Placement [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 1.0739 | 1.0739 | |||||
ViaskinTM Clinical Program For Children Aged Between Four to Eleven [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Clinical Program Trial Period | 6 months |
Cash and Cash Equivalents - Sum
Cash and Cash Equivalents - Summary of breakdown of cash and cash equivalents (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Cash and Cash Equivalents, at Carrying Value [Abstract] | ||
Cash | $ 167,916 | $ 31,427 |
Cash equivalents | 44,754 | 45,874 |
Total cash and cash equivalents as reported in the statements of financial position | $ 212,670 | $ 77,301 |
Other Current Assets - Summary
Other Current Assets - Summary of Other Current Asset (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Other Assets [Abstract] | ||
Research tax credit | $ 4,094 | $ 28,092 |
Other tax claims | 3,636 | 3,561 |
Prepaid expenses | 4,107 | 4,149 |
Other receivables | 1,188 | 1,283 |
Total | $ 13,025 | $ 37,085 |
Other Current Assets - Summar_2
Other Current Assets - Summary of Research Tax Credit (Detail) $ in Thousands | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Tax Credit Carryforward [Line Items] | |
Opening balance | $ 28,092 |
Operating revenue | 4,467 |
Payment received | (26,386) |
Adjustment and currency translation effect | (2,079) |
Closing balance | 4,094 |
Of which - Non-current portion | 0 |
Of which - Current portion | $ 4,094 |
Lease contracts - Summary of Op
Lease contracts - Summary of Operating Leases Future Minimum Payments Receivable (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current portion | $ 1,538 | $ 3,438 |
Year 2 | 1,891 | 3,147 |
Year 3 | 109 | 2,317 |
Year 4 | 773 | |
Year 5 | 790 | |
Thereafter | 1,220 | |
Total minimum lease payments | 3,538 | 11,684 |
Less: Effects of discounting | (734) | (1,534) |
Present value of operating lease | 2,804 | 10,150 |
Less: current portion | (1,381) | (3,003) |
Long-term operating leases | 1,423 | 7,147 |
Real Estate [Member] | ||
Current portion | 1,504 | 3,361 |
Year 2 | 1,874 | 3,124 |
Year 3 | 103 | 2,299 |
Year 4 | 771 | |
Year 5 | 790 | |
Thereafter | 1,220 | |
Total minimum lease payments | 3,481 | 11,565 |
Less: Effects of discounting | (729) | (1,526) |
Present value of operating lease | 2,752 | 10,039 |
Less: current portion | (1,350) | (2,929) |
Long-term operating leases | $ 1,402 | $ 7,110 |
Weighted average remaining lease term (years) | 1 year 9 months 18 days | 4 years 1 month 20 days |
Weighted average discount rate | 3.50% | 4.84% |
Other Asset [Member] | ||
Current portion | $ 34 | $ 77 |
Year 2 | 18 | 23 |
Year 3 | 6 | 18 |
Year 4 | 1 | |
Total minimum lease payments | 58 | 119 |
Less: Effects of discounting | (5) | (8) |
Present value of operating lease | 52 | 111 |
Less: current portion | (31) | (74) |
Long-term operating leases | $ 22 | $ 37 |
Weighted average remaining lease term (years) | 2 years 3 days | |
Weighted average discount rate | 0.90% | 3.32% |
Lease contracts - Summary of Re
Lease contracts - Summary of Rent expenses (Detail) - Rent Expenses [Member] - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Operating lease expense | $ 1,373 | $ 2,480 |
Net termination impact | $ (1,657) |
Lease contracts - Summary of Su
Lease contracts - Summary of Supplemental cash flow information related to our operating leases (Detail) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash Flow, Operating Activities, Lessee [Abstract] | ||
Operating cash flows from operating leases | $ 1,533 | $ 2,845 |
Lease contracts - Additional In
Lease contracts - Additional Information (Detail) - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2022 | Sep. 30, 2022 | Dec. 31, 2021 | |
Operating Lease, Right-of-Use Asset | $ 2,614 | $ 7,336 | |
NEW JERSEY | |||
Gain on termination of lease | $ 1,200 | ||
Early Termination of Lease Offset By The Payment Of A One Time Lump Sum Early Termination Fee | $ 1,500 | ||
Operating Lease, Right-of-Use Asset | $ 400 | ||
lease agreement for lease term | 3 years 2 months |
Trade Payables and Other Curr_3
Trade Payables and Other Current Liabilities - Additional Information (Detail) $ in Millions | Sep. 30, 2022 USD ($) |
Nestl Health Science [Member] | |
Deferred revenues | $ 3.8 |
Trade Payables and Other Curr_4
Trade Payables and Other Current Liabilities - Summary of Other Liabilities by Nature (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Schedule Of Other Liabilities, By Nature [Line Items] | ||
Other current liabilities | $ 8,615 | $ 12,361 |
Other non-current liabilities | 979 | 2,147 |
Total | 9,594 | 14,508 |
Employee related liabilities [Member] | ||
Schedule Of Other Liabilities, By Nature [Line Items] | ||
Other current liabilities | 4,666 | 6,708 |
Other non-current liabilities | 54 | 247 |
Total | 4,719 | 6,954 |
Deferred income [Member] | ||
Schedule Of Other Liabilities, By Nature [Line Items] | ||
Other current liabilities | 2,911 | 4,146 |
Other non-current liabilities | 926 | 1,900 |
Total | 3,836 | 6,046 |
Tax Liabilities [Member] | ||
Schedule Of Other Liabilities, By Nature [Line Items] | ||
Other current liabilities | 405 | 182 |
Other non-current liabilities | 0 | 0 |
Total | 405 | 182 |
Other Debts [Member] | ||
Schedule Of Other Liabilities, By Nature [Line Items] | ||
Other current liabilities | 634 | 1,325 |
Other non-current liabilities | 0 | 0 |
Total | $ 634 | $ 1,325 |
Shareholders' equity - Addition
Shareholders' equity - Additional Information (Detail) € / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||||
Sep. 30, 2022 USD ($) shares | Jun. 30, 2022 USD ($) | Mar. 31, 2022 USD ($) | Sep. 30, 2021 USD ($) | Jun. 30, 2021 USD ($) | Mar. 31, 2021 USD ($) | Sep. 30, 2022 EUR (€) | Sep. 30, 2022 EUR (€) € / shares shares | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Class of Stock [Line Items] | ||||||||||
Share capital | $ | $ 212,052 | $ 244,416 | $ 82,062 | $ 116,892 | $ 143,019 | $ 169,176 | $ 99,274 | $ 205,491 | ||
Deferred Compensation Arrangement with Individual, Shares Authorized for Issuance | 6,113,200 | 6,113,200 | ||||||||
Stock Issued During Period, Value, New Issues | $ (539) | 107,176 | 1 | 473 | 42 | € 3,285,566,900 | ||||
Common Stock, Shares Subscribed but Unissued | 32,855,669 | 32,855,669 | ||||||||
Shares Issued, Price Per Share | € / shares | € 2.9 | |||||||||
APIC, Share-based Payment Arrangement, Increase for Cost Recognition | $ 976 | $ 1,078 | $ 1,363 | $ 1,551 | $ 1,094 | $ 1,433 | 95,281,440,100 | |||
Proceeds From Issuance Of Common Stock | € | 98,567,007,000 | |||||||||
Class of Warrant or Right, Unissued | 28,276,331 | 28,276,331 | ||||||||
Warrants and Rights Outstanding | € | € 82,001,359,900 | |||||||||
Prefunded Warrants [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Stock Issued During Period, Value, New Issues | € | 2,827,633,100 | |||||||||
Shares Issued, Price Per Share | € / shares | € 0.1 | |||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 28,276,331 | 28,276,331 | ||||||||
APIC, Share-based Payment Arrangement, Restricted Stock Unit, Increase for Cost Recognition | € | € 100 | |||||||||
Share Capital | ||||||||||
Class of Stock [Line Items] | ||||||||||
Share capital | $ 10,708,725 | € 9,402,544,000 | ||||||||
Nominal value | € / shares | € 0.1 | |||||||||
Share capital authorized | 94,025,441 | 94,025,441 |
Shareholders' equity - Schedule
Shareholders' equity - Schedule of Nonvested Share Activity (Detail) - Prefunded Warrants [Member] | 9 Months Ended |
Sep. 30, 2022 shares | |
Class of Stock [Line Items] | |
Balance as of December 31, 2021 | 0 |
Granted during the period | 28,276,331 |
Forfeited during the period | 0 |
Exercised/released during the period | 0 |
Expired during the period | 0 |
Balance as of September 30, 2022 | 28,276,331 |
Share-Based Payments - Summary
Share-Based Payments - Summary of Stock Options Valuation Assumptions (Detail) | 9 Months Ended |
Sep. 30, 2022 € / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Weighted average share price at grant date in € | € 4.3 |
Weighted average risk-free interest rate | 0.89% |
Weighted average expected term (in years) | 6 years |
Dividend yield | 0% |
Weighted average fair value of stock options in € | € 3.3 |
Weighted average expected volatility | 93.60% |
Share-Based Payments - Summar_2
Share-Based Payments - Summary of RSU Activity (Detail) | 9 Months Ended |
Sep. 30, 2022 shares | |
BSA Warrants [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of warrants outstanding, Beginning Balance | 256,693 |
Number of warrants outstanding, Exercised/released during the period | 0 |
Number of warrants outstanding, Expired during the period | (5,000) |
Number of warrants outstanding, Ending Balance | 251,693 |
Restricted Stock Units [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of RSU outstanding, Beginning Balance | 1,240,520 |
Number of RSU outstanding, Granted during the period | 69,900 |
Number of RSU outstanding, Forfeited during the period | (92,326) |
Number of RSU outstanding, Exercised during the period | (32,159) |
Number of RSU outstanding, Expired during the period | 0 |
Number of RSU outstanding, Ending Balance | 1,185,936 |
Employee Stock Option Member | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of stock options outstanding, Beginning Balance | 3,631,210 |
Number of stock options outstanding, Granted during the period | 154,500 |
Number of stock options outstanding, Forfeited during the period | (238,715) |
Number of stock options outstanding, Exercised during the period | (5,613) |
Number of stock options outstanding, Ending Balance | 3,541,383 |
Share-Based Payments - Summar_3
Share-Based Payments - Summary of Share-Based Payments Expenses (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based payments | $ (976) | $ (1,551) | $ (3,416) | $ (4,078) |
Research & Development expenses [Member] | Employee Stock Option Member | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based payments | (337) | (273) | (1,002) | (952) |
Research & Development expenses [Member] | Restricted Stock Units [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based payments | (201) | (660) | (594) | (795) |
Sales & Marketing expenses [Member] | Employee Stock Option Member | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based payments | 30 | (60) | (3) | (172) |
Sales & Marketing expenses [Member] | Restricted Stock Units [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based payments | 20 | (27) | 4 | (75) |
General & Administrative expenses [Member] | Employee Stock Option Member | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based payments | (423) | (439) | (1,599) | (1,791) |
General & Administrative expenses [Member] | Restricted Stock Units [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based payments | $ (66) | $ (92) | $ (223) | $ (293) |
Share-Based Payments - Addition
Share-Based Payments - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2022 shares | |
Share options [Member] | |
Share-Based Payments [Line iteam] | |
Number of stock options outstanding, Granted during the period | 154,500 |
Restricted stock units [Member] | |
Share-Based Payments [Line iteam] | |
Number of RSU outstanding, Granted during the period | 69,900 |
Contingencies - Summary of Curr
Contingencies - Summary of Current Contingencies and Non-current Contingencies (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Liability, Defined Benefit Plan [Abstract] | ||
Current contingencies | $ 3,026 | $ 4,095 |
Non-current contingencies | 5,272 | 6,758 |
Total contingencies | $ 8,298 | $ 10,853 |
Contingencies - Summary of Move
Contingencies - Summary of Movement in Contingencies (Detail) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Dec. 31, 2021 | |
Contingencies, Beginning balance | $ 10,853 | |
Increases in liabilities | 58 | |
Used liabilities | (932) | |
Reversals of unused liabilities | 0 | |
Net interest related to employee benefits, and unwinding of discount | 0 | |
Actuarial gains and losses on defined-benefit plans | (264) | |
Currency translation effect | (1,417) | |
Contingencies, Ending balance | 8,298 | |
Of which current | 3,026 | $ 4,095 |
Of which non-current | 5,272 | $ 6,758 |
Pension retirement obligations [Member] | ||
Contingencies, Beginning balance | 1,008 | |
Increases in liabilities | 58 | |
Reversals of unused liabilities | 0 | |
Actuarial gains and losses on defined-benefit plans | (264) | |
Currency translation effect | (123) | |
Contingencies, Ending balance | 678 | |
Of which non-current | 678 | |
Collaboration agreement -Loss at completion [Member] | ||
Contingencies, Beginning balance | 9,800 | |
Increases in liabilities | 0 | |
Used liabilities | (889) | |
Currency translation effect | (1,291) | |
Contingencies, Ending balance | 7,620 | |
Of which current | 3,026 | |
Of which non-current | 4,594 | |
Other provisions incl. restructuring [Member] | ||
Contingencies, Beginning balance | 45 | |
Increases in liabilities | 0 | |
Used liabilities | (43) | |
Currency translation effect | (3) | |
Contingencies, Ending balance | $ 0 |
Operating Income - Summary of O
Operating Income - Summary of Operating Income (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Other Income and Expenses [Abstract] | ||||
Research Tax Credit | $ 1,407 | $ 1,647 | $ 4,467 | $ 5,324 |
Other operating income | 668 | (324) | 1,681 | (2,549) |
Total | $ 2,074 | $ 1,323 | $ 6,148 | $ 2,776 |
Allocation of Personnel Expen_3
Allocation of Personnel Expenses - Summary of Allocation of Personnel Expenses By Function (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Research and development expenses | $ 15,096 | $ 16,320 | $ 45,930 | $ 58,663 |
General and administrative expenses | 4,839 | 8,299 | 17,173 | 26,250 |
Total Operating expenses | 20,094 | 25,691 | 64,762 | 87,912 |
Expenses by Function [Member] | ||||
Research and development expenses | 3,186 | 4,161 | 9,357 | 12,272 |
Sales and marketing expenses | 138 | 492 | 727 | 1,528 |
General and administrative expenses | 1,598 | 2,583 | 6,961 | 9,347 |
Total Operating expenses | $ 4,922 | $ 7,236 | $ 17,045 | $ 23,148 |
Allocation of Personnel Expen_4
Allocation of Personnel Expenses -Summary of Allocation of Personnel Expenses By Nature (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based payments | $ (976) | $ (1,551) | $ (3,416) | $ (4,078) |
Total Operating expenses | 20,094 | 25,691 | 64,762 | 87,912 |
Expenses by Nature [Member] | ||||
Wages and salaries | 3,505 | 3,793 | 11,001 | 12,629 |
Social security contributions | 634 | 1,110 | 2,141 | 3,505 |
Expenses for pension commitments | 214 | 286 | 723 | 981 |
Employer contribution to bonus shares | (406) | 497 | (236) | 1,955 |
Share-based payments | 976 | 1,551 | 3,416 | 4,078 |
Total Operating expenses | $ 4,922 | $ 7,236 | $ 17,045 | $ 23,148 |
Commitments - Additional Inform
Commitments - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2022 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 | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Deferred Compensation Arrangement with Individual, Excluding Share-based Payments and Postretirement Benefits [Line Items] | |
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 | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
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 | 251,693 | 256,693 | 251,693 | 256,693 |
Stock options [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 3,541,383 | 2,585,710 | 3,541,383 | 2,585,710 |
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 | 1,185,936 | 1,104,145 | 1,185,936 | 1,104,145 |
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 | 0 | 28,276,331 | 0 |