Ataibeckley Inc.
A clinical-stage biopharmaceutical company developing psychedelic-inspired treatments for mental health, including BPL-003, a short-acting nasal spray for hard-to-treat depression. It was born in 2025 from the merger of atai Life Sciences and Beckley Psytech, the latter named after Beckley Park, the centuries-old English estate of the Feilding family. Its lead therapy is a synthetic form of a compound found in toad venom.
10-Q · Quarter ended Jun 30, 2026 · SEC filing ↗
The original filing sections are available below.
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and related notes thereto included in this Quarterly Report and our audited consolidated financial s…
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and related notes thereto included in this Quarterly Report and our audited consolidated financial statements and related notes thereto for the year ended December 31, 2025, included in our Form 10-K (the “Annual Report”) filed with the SEC on March 6, 2026. This discussion contains forward-looking statements based upon current plans, expectations, and beliefs involving risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth in the section titled “Risk Factors” in our Annual Report as may be updated from time to time in our other filings with the SEC. Proposed Acquisition by Eli Lilly and Company On July 15, 2026, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Eli Lilly and Company, an Indiana corporation (“Lilly”), and Albali Acquisition Corporation, a Delaware corporation and indirect wholly owned subsidiary of Lilly (“Merger Sub”), pursuant to which, subject to satisfaction or waiver of the conditions therein, Merger Sub will merge with and into the Company (the “Merger”), with the Company surviving as a wholly owned subsidiary of Lilly. Pursuant to the Merger Agreement, and upon the terms and subject to the conditions thereof, at the effective time of the Merger (the “Effective Time”) each share of AtaiBeckley’s common stock, par value $0.01 per share, issued and outstanding immediately prior to the Effective Time (other than (x) shares held in the treasury of the Company, owned by the Company or any of its subsidiaries, or owned by Lilly, Merger Sub or any of their wholly owned subsidiaries, and (y) Dissenting Shares (as defined in the Merger Agreement)) will be converted into the right to receive (i) $6.75 in cash, without interest and less applicable tax withholdings, plus (ii) one contingent value right (each, a “CVR” and collectively, the “CVRs”), representing the right to receive up to an aggregate of $2.50 in cash per CVR upon achievement, if any, of specified clinical and regulatory milestones, payable in accordance with the terms of a Contingent Value Rights Agreement to be entered into between Lilly and a rights agent selected by Lilly and reasonably acceptable to the Company, less any applicable tax withholding. Each CVR will entitle its holder to the following cash payments conditioned on achievement within specific time periods: (1) up to $1.00 per share upon initiation of a Phase 3 clinical trial of VLS-01 prior to the 4th anniversary of the Closing (as defined in the Merger Agreement), (2) up to $0.50 per share upon U.S. regulatory approval and Drug Enforcement Agency (“DEA”) rescheduling of BPL-003 prior to the 5th anniversary of the Closing and (3) up to $1.00 per share upon U.S. regulatory approval and DEA rescheduling of VLS-01 prior to the 7th anniversary of the Closing. There can be no assurance that any payments will be made with respect to the CVR. The transaction is not subject to any financing condition and is expected to close in the third quarter of 2026, subject to approval by AtaiBeckley stockholders and satisfaction of other customary closing conditions, including regulatory approvals. For additional information, see Note 26, Subsequent Events in our unaudited condensed consolidated financial statements appearing under Part I, Item 1 and Part II, Item 1A, Risk Factors. Business Overview Overview Founded in 2025 through the strategic combination of atai Life Sciences N.V. and Beckley Psytech Limited, AtaiBeckley is a clinical-stage biotechnology company on a mission to create breakthroughs for people with difficult-to-treat mental health conditions. Our work is grounded in rigorous science to deliver meaningful outcomes for the patients we serve. Mental health disorders are highly prevalent and estimated to affect more than one billion people globally. The economic burden of these disorders is substantial and is growing rapidly. Between 2009 and 2019, spending on mental health care in the United States increased by more than 50%, reaching $225 billion, and a Lancet Commission report estimates that the global economic cost will reach $16 trillion by 2030. While current treatments, such as selective serotonin reuptake inhibitors (“SSRIs”) and serotonin-norepinephrine reuptake inhibitors (“SNRIs”) are well established and effective for certain patients, approximately 65% of patients do not achieve remission of their symptoms after up to four antidepressant treatment trials, translating to a significant unmet medical need. On December 30, 2025, as part of the previously announced plan to change our corporate domicile from the Netherlands to the United States via Luxembourg (the “Redomiciliation Transaction”), as approved by our shareholders, we merged with and into atai Life Sciences Luxembourg S.A., a Luxembourg public limited liability company (“atai LuxCo”), which then immediately consummated the conversion of atai LuxCo into a corporation incorporated under the laws of the State of Delaware under the name AtaiBeckley Inc. As a result of the Redomiciliation Transaction, AtaiBeckley Inc. became the successor issuer to Atai Beckley N.V. pursuant to Rule 12g‑3(a) under the Exchange Act. Our Programs We aim to create breakthroughs in mental health by developing effective, rapid-acting and convenient treatments that could transform patient outcomes. We are committed to leading a new era of mental health treatment – one that not only offers relief from symptoms, but the possibility of an improved quality of life and lasting change. 40 We have built a diversified pipeline of investigational psychedelic-based neuroplastogens designed to address some of the most urgent unmet needs in mental health. Our programs include: •BPL-003: Mebufotenin (5-MeO-DMT) benzoate nasal spray; •VLS-01: Dimethyltryptamine (“DMT”) buccal film; •EMP-01: Oral R-enantiomer of 3,4-methylenedioxy-methamphetamine (“R-MDMA”); and •A drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists We believe psychedelics are emerging as novel breakthrough therapies for mental health disorders, such as depression, supported by growing scientific evidence, recent regulatory advancements and increasing patient and physician acceptance. Clinical studies have demonstrated the potential safety and efficacy profile of psychedelics, particularly their rapid onset of effect and sustained efficacy after a short course of administration. We believe these programs, which include both novel molecular entities and optimized variants of known compounds, have the potential to address significant unmet needs in mental health treatment. We are committed to innovation in the mental health space as exemplified by our drug discovery program and its focus on identifying new molecules with psychedelic-like pharmacology but without hallucinogenic potential. In addition to these investments in novel chemical entity ("NCE") discovery, intellectual property development has been a key strategic component since inception. Our Pipeline Our pipeline includes wholly owned psychedelic-based product candidates across multiple neuropsychiatric indications, including depression and anxiety. The following summarizes the status of our programs as of the date of this Quarterly Report: BPL-003: Mebufotenin benzoate nasal spray •BPL-003 Phase 3 activities in treatment-resistant depression (“TRD”) have been initiated •Phase 3 program consists of two pivotal studies: •ReConnection‑1 (approximately 350 patients) •ReConnection‑2 (approximately 230 patients) •Primary endpoint: change from baseline in MADRS total score at Week 4 •Both studies include a 52‑week open‑label extension, allowing individualized 8mg BPL-003 retreatment at 8-week or 12-week intervals with the aim of maintaining remission and evaluating durability and longer‑term safety •Phase 2a Part 4 (two‑dose induction and SSRIs) cohort initial data on track for Q4 2026 VLS-01: DMT buccal film •Elumina Phase 2b study in TRD advancing with last patient dosed; topline results anticipated in Q4 2026 EMP-01: Oral R-MDMA •EMP-01 Phase 2a study in SAD completed; topline and additional Phase 2a results previously reported Discovery •Novel, non-hallucinogenic 5-HT2A/2C agonist program received Notice of Award under NIDA-funded grant for opioid use disorder; enters second year of milestone-driven development Components of Our Results of Operations Revenue We have not and do not expect to generate any revenue from the sale of our core psychedelic product candidates or non-psychedelic product candidates unless and until such time that these product candidates have advanced through clinical development and regulatory approval, if ever. We expect that any revenue we may generate, if at all, will fluctuate from year-to-year as a result of the timing and amount of payments relating to such services and milestones and the extent to which any of our products are approved and successfully commercialized. Our ability to generate future revenues will also depend on our ability to complete preclinical and clinical development of product candidates or obtain regulatory approval for them. License revenue Nualtis Corp. (“Nualtis”), a wholly owned subsidiary, is a drug delivery company focused on the development and manufacturing of novel oral thin film products for the pharmaceutical market and for our development candidate, VLS-01. As a full service contract development and manufacturing organization, Nualtis offers services that include pharmaceutical research and development and the manufacturing of pharmaceutical products by leveraging its proprietary drug delivery technologies. Nualtis recognizes license revenue from the use of its proprietary drug delivery technologies in its customers' products. 41 Research and development services revenue Nualtis also recognizes revenue from various research and development agreements. In these agreements, Nualtis is responsible for performing research and development services for customers interested in leveraging Nualtis' novel oral thin film technology for drug delivery. Many of these agreements provide Nualtis either the option or the right to serve as the sole manufacturer of these drugs upon regulatory approval. Operating Expenses Research and development expenses Research and development expenses consist primarily of costs incurred for our research activities, including our discovery efforts and the development of our product candidates, which include: •employee-related expenses, including salaries, related benefits, and stock-based compensation, for employees engaged in research and development functions; •expenses incurred in connection with the preclinical and clinical development of our product candidates, including our agreements with third parties, such as consultants and contract research organizations ("CROs"); •expenses incurred under agreements with consultants who supplement our internal capabilities; •the cost of laboratory supplies and acquiring, developing, and manufacturing preclinical study materials and clinical trial materials; •costs related to compliance with regulatory requirements; •payments made in connection with third-party licensing agreements; and •depreciation, amortization, and other direct or allocated expenses, including rent, insurance, and other operating costs, incurred as a result of our research and development activities. Research and development costs are expensed as incurred. We account for non-refundable advance payments for goods and services that will be used in future research and development activities as expenses when the service has been performed or when the goods have been received. Qualifying research and development expenditures reimbursements under government grants are netted against research and development expenses as incurred. Our direct research and development expenses are tracked on a program-by-program basis for our product candidates and consist primarily of external costs, such as fees paid to outside consultants, CROs, contract manufacturing organizations (“CMOs”), and research laboratories in connection with our preclinical development, process development, manufacturing, and clinical development activities. Our direct research and development expenses by program also include fees incurred under third-party license agreements. Certain internal research and development expenses consisting of employee and contractor-related costs are not allocated to specific product candidate programs because these costs are deployed across multiple product candidate programs under research and development expense. Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. Assuming we continue to operate as an independent company, we expect that our research and development expenses will continue to increase for the foreseeable future in connection with our planned preclinical and clinical development activities in the near term and in the future. The successful development of our product candidates is highly uncertain. As such, at this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the remainder of the development of these product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from our product candidates. This is due to the numerous risks and uncertainties associated with developing products, including the uncertainty of whether (i) any clinical trials will be conducted or progress as planned or completed on schedule, if at all, (ii) we obtain regulatory approval for our product candidates, and (iii) we successfully commercialize product candidates. General and administrative expenses General and administrative expenses consist primarily of employee-related expenses, including salaries, related benefits, and stock-based compensation, for personnel in our executive, finance, legal, business development, and administrative functions. General and administrative expenses also include legal fees relating to corporate matters and intellectual property, professional fees for accounting, auditing, tax, human resources, administrative consulting services, insurance costs, information technology-related expenses, travel expenses, and facility-related expenses, which include direct depreciation costs and allocated expenses for office rent and other operating costs. General and administrative expenses also reflect sublease income that is used to offset the cost for facility rent and other operating costs. 42 Other income (expense), net Interest income Interest income consists of interest earned on cash balances held in interest-bearing accounts. We expect that our interest income will fluctuate based on the timing and ability to raise additional funds as well as the amount of expenditures for the research and development of our product candidates and ongoing business operations. Interest expense Interest expense consists of interest expense incurred in connection with our 2022 term loan facility with Hercules Capital, Inc. (the “2022 Term Loan Facility”), which was terminated in May 2025. Benefit from research and development tax credits Benefit from research and development tax credits consists of tax credits received in Australia, Canada, and the United Kingdom. Qualifying expenditures include employment costs for research staff, consumables, and relevant, permitted CRO costs incurred as part of research projects. Change in fair value of assets and liabilities, net: The Company carries various assets and liabilities at fair value and subsequent remeasurements are recorded as a Change in fair value of assets and liabilities, net as a component of Other expense, net. Assets held at fair value include securities held at fair value and investments held at fair value. Liabilities held at fair value include convertible promissory notes, contingent considerations, derivative liability, and pre-funded warrant liabilities. The components of change in fair value of assets and liabilities, net include: Change in fair value of securities carried at fair value Change in fair value of securities consists of changes in fair value of our available for sale securities, for which we have elected the fair value option. Change in fair value of other investments held at fair value Change in fair value of other current investment held at fair value consists of subsequent remeasurements of our investment in COMPASS Pathways plc (“COMPASS”), for which we have elected the fair value option, as well as additional contingent warrants held with Beckley Psytech prior to our acquisition of Beckley Psytech in November 2025. Change in fair value of short-term convertible promissory notes and derivative liability - related party Change in fair value of short-term convertible promissory notes and derivative liability consists of subsequent remeasurements of certain convertible notes issued in 2020 to a related party prior to their conversion in September 2025. Change in fair value of short-term convertible promissory notes and derivative liability Change in fair value of short-term convertible promissory notes and derivative liability consists of subsequent remeasurements of certain convertible notes issued in 2020 prior to their conversion in September 2025. Change in fair value of pre-funded warrant liabilities Change in fair value of pre-funded warrant liabilities consists of subsequent remeasurements of our pre-funded warrants issued pursuant to the June and July 2025 PIPE Financings, which we record at fair value. Gain on other investments Gain on other investments consists of a gain recognized on our additional investment in Beckley Psytech upon the issuance of deferred shares pursuant to the deferred payment escrow agreement, dated as of January 3, 2024, with Beckley Psytech (“Escrow Agreement”). Change in fair value of digital assets, net Change in fair value of digital assets, net consists of the subsequent remeasurement of our Bitcoin holding, as Bitcoin is measured at fair value based on quoted prices on active exchanges pursuant to ASC 350-60. Loss on extinguishment of debt Loss on extinguishment of debt represents the difference between the net carrying amount and the redemption amount related to our early repayment of all outstanding obligations under our 2022 Term Loan Facility pursuant to ASC 405-20. Foreign exchange gain (loss), net Foreign exchange gain, net consists of the impact of changes in foreign currency exchange rates on our foreign exchange denominated assets and liabilities, relative to the U.S. dollar. The impact of foreign currency exchange rates on our results of operations fluctuates 43 period over period based on our foreign currency exposures resulting from changes in applicable exchange rates associated with our foreign denominated assets and liabilities. Other income (expense), net Other expense, net consists principally of the changes in the carrying values of our assets and liabilities, issuance costs allocated to warrant liabilities, and net gains (losses) recognized on the sale of certain of our assets. Provision for income taxes Since our inception, we have not recorded any U.S. federal, foreign, or state income tax benefits for the net losses we have incurred in each year or for our earned research and development tax credits, as it is more likely-than-not that these benefits will not be realized. We have U.S. federal and state net operating loss carryforwards and research and development tax credit carryforwards to offset future taxable income. Income taxes are determined at the applicable tax rates adjusted for non-deductible expenses, research and development tax credits and other permanent differences. Our income tax provision may be significantly affected by changes to our estimates. Net Loss Attributable to Noncontrolling Interests Net loss attributable to noncontrolling interests consists of the portion of net loss that is allocated to the noncontrolling interests of certain consolidated variable interest entities (“VIEs”). Net losses in consolidated VIEs are attributed to noncontrolling interests considering the liquidation preferences of the different classes of equity held by the shareholders in the VIE and their respective interests in the net assets of the consolidated VIE in the event of liquidation, and their pro rata ownership. Changes in the amount of net loss attributable to noncontrolling interests are directly impacted by changes in the net loss of our VIEs and our ownership percentage changes. Results of Operations Comparison of the Three Months Ended June 30, 2026 and 2025 (unaudited) For the three months ended June 30, 2026 2025 $ Change % Change (in thousands, except percentages) License revenue $ 437 $ — $ 437 100 % Research and development services revenue 1,267 719 548 76 % Total revenue $ 1,704 $ 719 $ 985 137 % Operating expenses: Research and development 28,074 11,092 16,982 153 % General and administrative 17,771 14,900 2,871 19 % Total operating expenses 45,845 25,992 19,853 76 % Loss from operations (44,141 ) (25,273 ) (18,868 ) 75 % Other income (expense), net: Interest income 79 248 (169 ) (68 %) Interest expense — (264 ) 264 (100 %) Benefit from research and development tax credits 2,419 28 2,391 8539 % Change in fair value of assets and liabilities, net 10,039 (7,005 ) 17,044 (243 %) Gain on other investments — 3,794 (3,794 ) (100 %) Change in fair value of digital assets, net (904 ) 1,428 (2,332 ) (163 %) Loss on extinguishment of debt — (1,317 ) 1,317 (100 %) Foreign exchange gain (loss), net (52 ) 1,460 (1,512 ) (104 %) Other income (expense), net 76 (752 ) 828 (110 %) Total other income (expense), net: 11,657 (2,380 ) 14,037 (590 %) Net loss before income taxes (32,484 ) (27,653 ) (4,831 ) 17 % Provision for income taxes (64 ) (93 ) 29 (31 %) Net loss $ (32,548 ) $ (27,746 ) $ (4,802 ) 17 % Net loss attributable to noncontrolling interests (24 ) (17 ) (7 ) 40 % Net loss attributable to AtaiBeckley Inc. stockholders $ (32,524 ) $ (27,729 ) $ (4,795 ) 17 % 44 Revenue License Revenue We recognized $0.4 million of license revenue for the three months ended June 30, 2026, primarily related to Nualtis' license agreements with Rizafilm LLC. We did not recognize any license revenue for the three months ended June 30, 2025. Research and Development Services Revenue We recognized $1.3 million and $0.7 million of research and development services revenue for the three months ended June 30, 2026 and 2025, respectively, related to certain research and development services performed by Nualtis for its customers. Operating expenses Research and Development Expenses The table and discussion below present research and development expenses for the three months ended June 30, 2026 and 2025: For the three months ended June 30, 2026 2025 $ Change % Change (in thousands, except percentages) Direct research and development expenses by program: BPL-003 $ 10,060 $ — $ 10,060 100 % VLS-01 8,299 3,471 4,828 139 % EMP-01 1,051 1,783 (732 ) (41 %) Discovery 491 395 96 24 % Other Programs 394 2,536 (2,142 ) (84 %) Unallocated research and development expenses: Personnel expenses 7,009 2,543 4,466 176 % Professional and consulting services 82 94 (12 ) (13 %) Rent and facilities related costs 188 174 14 8 % Other 294 36 258 717 % Depreciation and amortization 206 60 146 243 % Total research and development expenses $ 28,074 $ 11,092 $ 16,982 153 % Research and development expenses were $28.1 million for the three months ended June 30, 2026, compared to $11.1 million for the three months ended June 30, 2025. The increase of $17.0 million was primarily attributable to a $12.1 million net increase in the direct costs of our programs as discussed below, a $4.5 million increase in personnel and related expenses (inclusive of a $2.1 million increase in stock-based compensation) primarily driven by increased headcount following our strategic combination with Beckley Psytech in November 2025, a $0.3 million increase in other expenses, and a $0.1 million increase in depreciation expense. BPL-003: Mebufotenin for TRD The costs attributed to BPL-003 represent direct costs related to the ongoing development activities of BPL-003, which have initiated Phase 3 activities in the second quarter of 2026. Direct costs include $8.3 million of clinical development and related costs, $1.5 million of manufacturing costs, and $0.3 million of preclinical development costs. VLS-01: DMT for TRD The $4.8 million increase in direct costs for our VLS-01 program was primarily due to a $4.4 million increase in clinical development and related costs for our Elumina trial, the randomized, double-blind, placebo-controlled Phase 2b clinical trial of VLS-01, a $0.3 million increase in manufacturing costs, and a $0.1 million increase in preclinical development costs. EMP-01: R-MDMA for SAD The $0.7 million decrease in direct costs for our EMP-01 program was primarily due to a $1.3 million decrease in clinical development costs relating to our completed exploratory, randomized, double-blind, placebo-controlled Phase 2a study in the United Kingdom that assessed the safety, tolerability and efficacy of EMP-01. These costs were partially offset by a $0.5 million increase in manufacturing costs, and a $0.1 million increase in preclinical development costs. Discovery The $0.1 million net increase in discovery costs was primarily due to a $0.9 million increase in preclinical development costs related to our novel 5-HT2A receptor agonists. These costs were partially offset by a $0.8 million decrease in our discovery program’s research and development expenses as certain expenses qualified for reimbursement under our National Institute on Drug Abuse, part of the National Institutes of Health. 45 Other Programs The $2.1 million decrease in direct costs for our other programs was primarily due to a $2.1 million decrease in direct costs for our RL-007 program, which is driven by a decrease in clinical development and related costs for our completed Phase 2b clinical trial for RL-007 in cognitive impairment associated with schizophrenia and a $0.3 million decrease in direct costs for Nualtis. These decreases were partially offset by a $0.3 million increase related to various other programs. General and Administrative Expenses General and administrative expenses were $17.8 million for the three months ended June 30, 2026 compared to $14.9 million for the three months ended June 30, 2025. The $2.9 million increase was largely attributable to a $2.7 million increase in personnel and related costs (inclusive of a $2.6 million increase in stock-based compensation) and a $0.2 million increase in legal, intellectual property, and professional service expenses. Other income (expense), net Interest income Interest income for the three months ended June 30, 2026 and 2025 primarily consisted of interest earned on our cash balances. We recognized interest income of $0.1 million and $0.2 million for the three months ended June 30, 2026 and 2025, respectively. Interest expense We did not recognize interest expense for the three months ended June 30, 2026. We recognized $0.3 million of interest expense for the three months ended June 30, 2025, which consisted of interest expense incurred in connection with our 2022 Term Loan Facility that was terminated in May 2025. Benefit from research and development tax credits We recognized, in total, $2.4 million in research and development tax credits from tax authorities in Canada, Australia, and the United Kingdom for the three months ended June 30, 2026. We recognized an immaterial benefit for research and development tax credits from tax authorities in Canada and Australia for the three months ended June 30, 2025. Change in fair value of assets and liabilities, net: Changes in fair value of assets and liabilities, net consisted of the following for the three months ended June 30, 2026 and 2025: Three months ended June 30, 2026 2025 Change on fair value of securities carried at fair value $ 1,620 $ 634 Change in fair value of other investments held at fair value 27,237 (2,381 ) Change in fair value of short-term convertible promissory notes - related party — (1,175 ) Change in fair value of short-term convertible promissory notes — (1,874 ) Change in fair value of pre-funded warrant liabilities (18,818 ) (2,209 ) Change in fair value of assets and liabilities, net $ 10,039 $ (7,005 ) Gain on other investments We did not recognize a gain on other investments for the three months ended June 30, 2026. Gain on other investments for the three months ended June 30, 2025 consists of a $3.8 million gain related to our investment in Beckley Psytech, which was recognized upon the issuance of the deferred shares pursuant to the Escrow Agreement. Change in fair value of digital assets, net We recognized a $0.9 million loss and a $1.4 million gain for the three months ended June 30, 2026 and 2025, respectively, related to the change in fair value of our digital assets. Loss on extinguishment of debt We did not recognize any loss on extinguishment of debt for the three months ended June 30, 2026. Loss on extinguishment of debt for the three months ended June 30, 2025 was $1.3 million, which is related to our early repayment of all outstanding obligations under the 2022 Term Loan Facility in May 2025. Foreign exchange gain (loss), net We recognized an immaterial loss related to foreign currency exchange rates for the three months ended June 30, 2026 and a $1.5 million gain related to foreign currency exchange rates for the three months ended June 30, 2025. This was due to the impact of fluctuations in the 46 foreign currency exchange rate between the Euro, Canadian Dollar, Australian Dollar, Pound Sterling, and the U.S. dollar on our foreign denominated balances. Other income (expense), net Other income, net for the three months ended June 30, 2026 was $0.1 million, which is driven by the change in our expected credit loss for certain notes receivable we hold with Amandala Neuro Limited. Other expense, net for the three months ended June 30, 2025 was $0.8 million, which was related to $0.7 million of issuance costs allocated to pre-funded warrant liabilities issued pursuant to the June 2025 PIPE Financing (see Note 15, Stockholders’ Equity in our unaudited condensed consolidated financial statements appearing under Part I, Item 1 for further information) (the “June 2025 PIPE Financing”) and $0.1 million from the disposal of certain fixed assets. Provision for income taxes We incurred a $0.1 million provision for income tax expense for both the three months ended June 30, 2026 and 2025. Our current income tax expense relates to tax expense of subsidiaries in the United States, Germany, and the United Kingdom. We recognized no deferred tax expense for three months ended June 30, 2026 and 2025, respectively. Given our early-stage development and lack of prior earnings history, we have a full valuation allowance primarily related to U.S. and foreign tax loss carryforwards, capitalized research and experimental costs, and stock-based compensation timing differences that we consider more-likely-than-not not to be realized. Comparison of the Six Months Ended June 30, 2026 and 2025 (unaudited) For the six months ended June 30, 2026 2025 $ Change % Change (in thousands, except percentages) License revenue $ 638 $ 202 $ 436 216 % Research and development services revenue 2,019 2,072 (53 ) (3 %) Total revenue $ 2,657 $ 2,274 $ 383 17 % Operating expenses: Research and development 45,488 22,420 23,068 103 % General and administrative 32,213 25,497 6,716 26 % Total operating expenses 77,701 47,917 29,784 62 % Loss from operations (75,044 ) (45,643 ) (29,401 ) 64 % Other income (expense), net: Interest income 157 434 (277 ) (64 %) Interest expense — (1,164 ) 1,164 (100 %) Benefit from research and development tax credits 3,160 56 3,104 5543 % Change in fair value of assets and liabilities, net 12,630 (12,502 ) 25,132 (201 %) Gain on other investments — 3,794 (3,794 ) (100 %) Change in fair value of digital assets, net (2,873 ) 1,216 (4,089 ) (336 %) Loss on extinguishment of debt — (1,317 ) 1,317 (100 %) Foreign exchange gain (loss), net (460 ) 1,916 (2,376 ) (124 %) Other income (expense), net 165 (752 ) 917 (122 %) Total other income (expense), net: 12,779 (8,319 ) 21,098 (254 %) Net loss before income taxes (62,265 ) (53,962 ) (8,303 ) 15 % Provision for income taxes (85 ) (249 ) 164 (66 %) Net loss $ (62,350 ) $ (54,211 ) $ (8,139 ) 15 % Net loss attributable to noncontrolling interests (44 ) (51 ) 7 (14 %) Net loss attributable to AtaiBeckley Inc. stockholders $ (62,306 ) $ (54,160 ) $ (8,146 ) 15 % Revenue License Revenue We recognized $0.6 million and $0.2 million of license revenue for the six months ended June 30, 2026 and 2025, respectively, primarily related to Nualtis' license agreements with Rizafilm LLC. Research and Development Services Revenue We recognized $2.0 million and $2.1 million of research and development services revenue for the six months ended June 30, 2026 and 2025, respectively, related to certain research and development services performed by Nualtis for its customers. 47 Operating expenses Research and Development Expenses The table and discussion below present research and development expenses for the six months ended June 30, 2026 and 2025: For the six months ended June 30, 2026 2025 $ Change % Change (in thousands, except percentages) Direct research and development expenses by program: BPL-003 $ 12,532 $ — $ 12,532 100 % VLS-01 13,805 5,812 7,993 138 % EMP-01 2,720 2,137 583 27 % Discovery 688 765 (77 ) (10 %) Other Programs 924 5,768 (4,844 ) (84 %) Unallocated research and development expenses: Personnel expenses 13,287 6,404 6,883 107 % Professional and consulting services 174 216 (42 ) (19 %) Rent and facilities related costs 428 349 79 23 % Other 570 850 (280 ) (33 %) Depreciation and amortization 360 119 241 203 % Total research and development expenses $ 45,488 $ 22,420 $ 23,068 103 % Research and development expenses were $45.5 million for the six months ended June 30, 2026, compared to $22.4 million for the six months ended June 30, 2025. The increase of $23.1 million was primarily attributable to a $16.2 million net increase in the direct costs of our programs as discussed below, a $6.9 million increase in personnel and related expenses (inclusive of a $3.3 million increase in stock-based compensation and a $0.4 million decrease in restructuring charges) primarily driven by increased headcount following our strategic combination with Beckley Psytech in November 2025, a $0.1 million increase in facility related costs, and a $0.2 million increase in depreciation expense. These increases were partially offset by a $0.3 million decrease in other expenses and professional and consulting services, which is driven by a $0.8 million milestone payment to Psilera, Inc. (“Psilera”) in February 2025 pursuant to an intellectual property assignment and license agreement. BPL-003: Mebufotenin for TRD The costs attributed to BPL-003 represent direct costs related to the ongoing development activities of BPL-003, which initiated Phase 3 activities in the second quarter of 2026. Direct costs include $10.2 million of clinical development and related costs, $1.9 million of manufacturing costs, and $0.4 million of preclinical development costs. VLS-01: DMT for TRD The $8.0 million increase in direct costs for our VLS-01 program was primarily due to a $7.1 million increase in clinical development and related costs for our Elumina trial, the randomized, double-blind, placebo-controlled Phase 2b clinical trial of VLS-01, a $0.7 million increase in related manufacturing costs, and a $0.2 million increase in preclinical development costs. EMP-01: R-MDMA for SAD The $0.6 million net increase in direct costs for our EMP-01 program was primarily due to a $1.0 million increase in manufacturing costs and a $0.2 million increase in preclinical development costs. These costs were partially offset by a $0.6 million decrease in clinical development costs relating to our completed exploratory, randomized, double-blind, placebo-controlled Phase 2a study in the United Kingdom that assessed the safety, tolerability and efficacy of EMP-01. Discovery The $0.1 million net decrease in discovery costs was primarily due to a $1.5 million reduction in our research and development expenses related to our discovery program as certain expenses qualified for reimbursement under our National Institute on Drug Abuse, part of the National Institutes of Health. This decrease was partially offset by a $1.4 million increase in preclinical development costs related to our novel 5-HT2A receptor agonists. Other Programs The $4.9 million decrease in direct costs for our other programs was primarily due to a $4.0 million decrease in direct costs for our RL-007 program as a result of a decrease in clinical development and related costs for our Phase 2b clinical trial for RL-007 in cognitive 48 impairment associated with schizophrenia. The decrease also includes a $0.5 million decrease in our direct costs for Nualtis and a $0.3 million decrease in various other programs. General and Administrative Expenses General and administrative expenses were $32.2 million for the six months ended June 30, 2026 compared to $25.5 million for the six months ended June 30, 2025. The $6.7 million increase was largely attributable to a $3.4 million increase in legal, intellectual property, and professional service expenses and a $3.3 million increase in personnel and related costs (inclusive of a $3.6 million increase in stock-based compensation and a $0.7 million decrease in restructuring charges). Other income (expense), net Interest income Interest income for the six months ended June 30, 2026 and 2025 primarily consisted of interest earned on our cash balances. We recognized interest income of $0.2 million and $0.4 million for the six months ended June 30, 2026 and 2025, respectively. Interest expense We did not recognize interest expense for the six months ended June 30, 2026. We recognized $1.2 million of interest expense for the six months ended June 30, 2025, which consisted of interest expense incurred in connection with our 2022 Term Loan Facility that was terminated in May 2025. Benefit from research and development tax credits We recognized, in total, $3.1 million in research and development tax credits from tax authorities in Canada, Australia, and the United Kingdom for the six months ended June 30, 2026. We recognized $0.1 million of research and development tax credits from tax authorities in Canada and Australia for the six months ended June 30, 2025. Change in fair value of assets and liabilities, net: Changes in fair value of assets and liabilities, net consisted of the following for the six months ended June 30, 2026 and 2025: For the six months ended June 30, 2026 2025 Change on fair value of securities carried at fair value $ 3,228 $ 1,093 Change in fair value of other investments held at fair value 22,238 (8,214 ) Change in fair value of short-term convertible promissory notes - related party — (1,224 ) Change in fair value of short-term convertible promissory notes — (1,947 ) Change in fair value of pre-funded warrant liabilities (12,835 ) (2,209 ) Change in fair value of assets and liabilities, net $ 12,630 $ (12,502 ) Gain on other investments We did not recognize a gain on other investments for the six months ended June 30, 2026. Gain on other investments for the six months ended June 30, 2025 consists of a $3.8 million gain related to our investment in Beckley Psytech which was recognized upon the issuance of the deferred shares pursuant to the Escrow Agreement. Change in fair value of digital assets, net We recognized a $2.9 million loss and a $1.2 million gain, respectively, for the six months ended June 30, 2026 and 2025 related to the change in fair value of our digital assets. Loss on extinguishment of debt We did not recognize any loss on extinguishment of debt for the six months ended June 30, 2026. Loss on extinguishment of debt for the six months ended June 30, 2025 was $1.3 million, which is related to our early repayment of all outstanding obligations under the 2022 Term Loan Facility in May 2025. Foreign exchange gain (loss), net We recognized a $0.5 million loss and $1.9 million gain related to foreign currency exchange rates for the six months ended June 30, 2026, and 2025, respectively. This was due to the impact of fluctuations in the foreign currency exchange rate between the Euro, Canadian Dollar, Pound Sterling, Australian Dollar, and the U.S. dollar on our foreign denominated balances. Other income (expense), net We recognized Other income, net of $0.2 million for the six months ended June 30, 2026, which is driven by the change in our expected credit loss for certain notes receivable we hold with Amandala Neuro Limited. Other expense, net for the six months ended June 30, 2025 49 was $0.8 million, which is related to $0.7 million of issuance costs allocated to pre-funded warrant liabilities issued pursuant to the June 2025 PIPE Financing and $0.1 million from the disposal of certain fixed assets. Provision for income taxes We incurred $0.1 million and a $0.2 million of current income tax expense for the six months ended June 30, 2026 and 2025, respectively. Our current income tax expense relates to tax expense of subsidiaries in the United States, Germany, and the United Kingdom. Given our early-stage development and lack of prior earnings history, we have a full valuation allowance primarily related to U.S. and foreign tax loss carryforwards, capitalized research and experimental costs, and stock-based compensation timing differences that we consider more-likely-than-not not to be realized. 50 Liquidity and Capital Resources Overview For the six months ended June 30, 2026 and 2025, we had net losses attributable to our stockholders of $62.3 million and $54.2 million, respectively. As of June 30, 2026 and December 31, 2025, our accumulated deficit was $1.4 billion and $1.4 billion, respectively. We expect to continue to incur losses and operating cash outflows for the foreseeable future as we continue advancing our product candidates through clinical development. Our primary sources of liquidity are our cash and cash equivalents, short-term securities, investments, digital assets and sales of common stock. We maintain cash balances with financial institutions in excess of insured limits. Our primary requirements for liquidity and capital are clinical trial costs, manufacturing costs, nonclinical and other research and development costs, funding of strategic investments (including integration process from our strategic combination with Beckley Psytech), public company compliance costs and general corporate needs. Because our product candidates are in various stages of clinical and preclinical development and the outcome of these efforts is uncertain, we cannot estimate the actual amounts necessary to successfully complete the development and commercialization of our product candidates or whether, or when, we may achieve profitability. Our ability to generate sufficient product revenue to achieve profitability will depend substantially on the successful development and eventual commercialization, if any, of product candidates. We expect to continue to incur significant expenses and increasing operating losses for at least the next several years. In the event the Merger is not completed, we expect to finance our cash needs through a combination of equity or debt financings, collaboration arrangements, license agreements, other business development opportunities with third parties and government grants. We recognize revenue from license and research and development arrangements through Nualtis. Sources of Liquidity Investments A potential source of non-dilutive funding resides in our investment in COMPASS's ADS, subject to market conditions. Based on quoted market prices, the market value of our ownership in COMPASS was $34.0 million as of June 30, 2026. Digital Assets A potential source of non-dilutive funding resides in our investment in digital assets, subject to market conditions, volatility, and price fluctuations. Based on quoted market prices, the market value of our ownership in Bitcoin was $5.9 million as of June 30, 2026. ATM Program On March 6, 2026, we entered into an Open Market Sale AgreementSM (the “Sales Agreement”) with Jefferies LLC (“Jefferies”), pursuant to which we could issue and sell our common stock from time to time through an “at the market” equity offering program under which Jefferies would act as sales agent. The common stock to be sold pursuant to the Sales Agreement, if any, was to be issued pursuant to our registration statement on Form S-3 (File No. 333-294124) and related prospectus supplement contained therein that were filed on March 9, 2026 with the Securities and Exchange Commission. The Sales Agreement was subsequently terminated pursuant to its terms in connection with the Company’s entry into the Merger Agreement. There were no sales under the Sales Agreement during the six months ended June 30, 2026. See Note 15, Stockholders’ Equity, in our unaudited condensed consolidated financial statements appearing under Part I, Item 1 for more information. Liquidity Risks As of June 30, 2026, we had cash and cash equivalents of $168.8 million and short-term securities of $23.0 million. Based on our current operating plan as a standalone entity, we believe our available cash and cash equivalents and marketable securities, will be sufficient to fund our planned level of operations for at least the next 12 months. As discussed above, we expect that our pending Merger will close in the third quarter of 2026. We expect to continue to incur substantial additional expenditures in the near term to support our ongoing activities. Additionally, we have incurred and expect to continue to incur additional costs as a result of operating as a public company. We expect to continue to incur net losses for the foreseeable future. In the event the Merger is not completed, our ability to fund our product development and clinical operations as well as commercialization of our product candidates, will depend on the amount and timing of cash received from planned financings. Our future capital requirements will depend on many factors, including: •our ability to complete the Merger; •the time and cost necessary to complete ongoing and planned clinical trials; •the outcome, timing and cost of meeting regulatory requirements established by the FDA, the EMA and other comparable foreign regulatory authorities; 51 •the progress, timing, scope and costs of our preclinical studies, clinical trials and other related activities for our ongoing and planned clinical trials, and potential future clinical trials; •the costs of commercialization activities for any of our product candidates that receive marketing approval, including the costs and timing of establishing product sales, marketing, distribution and manufacturing capabilities, or entering into strategic collaborations with third parties to leverage or access these capabilities; •the amount and timing of sales and other revenues from our product candidates, if approved, including the sales price and the availability of coverage and adequate third party reimbursement; •the cash requirements for developing our programs and our ability and willingness to finance their continued development; •the cash requirements for strategic transactions, including acquisitions and partnerships and integration process for our strategic combination with Beckley Psytech; •the cash requirements for discovering and developing product candidates; and •the time and cost necessary to respond to technological and market developments, including other products that may compete with one or more of our product candidates. A change in the outcome of any of these or other variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. Further, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plans. If we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development efforts. In the event the Merger is not completed, we expect to finance our operations through a combination of equity financings, debt financings, collaborations with other companies and other strategic transactions. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. Further, our operating plans may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development activities. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated product development programs. Cash Flows The following table summarizes our cash flows for the six months ended June 30, 2026 and 2025: June 30, 2026 2025 (in thousands) Net cash used in operating activities $ (56,363 ) $ (31,935 ) Net cash provided by (used in) investing activities 136,937 (1,230 ) Net cash provided by financing activities 3,457 67,362 Effect of foreign exchange rate changes on cash (524 ) 238 Net increase in cash, cash equivalents, and restricted cash $ 83,507 $ 34,435 Net Cash Used in Operating Activities Net cash used in operating activities was $56.4 million for the six months ended June 30, 2026, which consisted of a net loss of $62.4 million, adjusted by noncash charges adjustments of $6.8 million and $0.8 million net cash outflow related to the change in operating assets and liabilities. The noncash charges primarily consisted of $12.9 million related to stock-based compensation, $2.9 million noncash loss related to the change in fair value of digital assets, $0.4 million noncash loss related to unrealized foreign exchange revaluation, $0.3 million of depreciation and amortization, and $0.1 million of non-cash lease expense. These losses were partially offset by $9.7 million gain related to the change in fair value of assets and liabilities, net and $0.2 million of other noncash income. The $0.8 million net cash outflow from the change in operating assets and liabilities were primarily due to a $6.5 million increase in other assets, $0.9 million decrease in deferred revenue, $0.1 million decrease in accrued liabilities, and $0.1 million increase in prepaid expenses and other assets, offset by a $6.7 million increase in accounts payable. 52 Net cash used in operating activities was $31.9 million for the six months ended June 30, 2025, which consisted of a net loss of $54.2 million, adjusted by non-cash charges and other adjustments of $16.2 million and a net cash inflow of $6.1 million related to the change in operating assets and liabilities. The non-cash charges primarily consisted of a $13.4 million loss related to the change in fair value of assets and liabilities, net, $6.0 million related to stock-based compensation, $1.3 million related to non-cash loss on the extinguishment of debt, $0.9 million related to other non-cash expenses, $0.7 million related to issuance costs allocated to pre-funded warrant liabilities issued pursuant to the June 2025 PIPE Financing, $0.4 million of depreciation and amortization, $0.2 million of non-cash lease expense, and $0.2 million related to amortization of debt discount. These losses were partially offset by $3.8 million non-cash gain related to other investments, $1.9 million non-cash gain related to unrealized foreign exchange revaluation, and $1.2 million non-cash gain related to the change in fair value of digital assets. The net cash inflow of $6.1 million from the change in operating assets and liabilities were primarily due to a $4.0 million increase in accrued liabilities, $1.3 million decrease in prepaid expenses and other assets, and $0.8 million increase in accounts payable. Net Cash Provided by (Used in) Investing Activities Net cash provided by investing activities was $136.9 million for the six months ended June 30, 2026, primarily driven by $112.6 million of cash received from the sale of our UBS investments, $23.7 million of cash received for the sale of our COMPASS ADS, and $0.6 million for the proceeds from the repayment of our notes receivable. Net cash used in investing activities was $1.2 million for the six months ended June 30, 2025, primarily driven by $10.0 million of cash paid for our investment in Beckley Psytech, $5.0 million of cash paid for the acquisition of digital assets, $0.8 million of cash paid for Psilera asset acquisition, and $0.4 million of cash paid for property and equipment. These were partially offset by $11.1 million of proceeds from the sale and maturity of investments carried at fair value and $3.9 million of proceeds from the sale of our COMPASS Pathways plc. Net Cash Provided by Financing Activities Net cash provided by financing activities was $3.5 million for the six months ended June 30, 2026, driven by $3.5 million in proceeds from stock option exercises. Net cash provided by financing activities was $67.3 million for the six months ended June 30, 2025, primarily driven by the $78.2 million of net cash proceeds from the issuance of common stock related to our February 2025 equity offering and June 2025 PIPE Financing, $11.5 million of proceeds from the issuance of pre-funded warrants related to the June 2025 PIPE Financing, and $1.6 million in proceeds from stock option exercises. These were offset by $21.8 million paid for the extinguishment of our 2022 Term Loan Facility and $2.2 million paid for common stock and pre-funded warrant issuance costs related to our February 2025 equity offering and June 2025 PIPE Financing. Material Cash Requirements from Known Contractual and Other Obligations and Commitments Our material commitments and obligations were reported in our Annual Report. As of June 30, 2026, there has been no change in our material commitments and obligations that were previously reported in our Annual Report. Recently Adopted Accounting Pronouncements See Note 2, Basis of Presentation and Summary of significant Accounting Policies, to our unaudited condensed consolidated financial statements appearing under Part I, Item 1 for more information. Critical Accounting Policies and Estimates Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Estimates” in our Form 10-K and in Note 2, Basis of Presentation and Summary of significant Accounting Policies, to our audited consolidated financial statements included in our Form 10-K. As disclosed in Note 2, Basis of Presentation and Summary of significant Accounting Policies, to our audited consolidated financial statements included in our Form 10-K, the preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions about future events that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ significantly from those estimates. During the period covered by this Quarterly Report, there were no material changes to our critical accounting policies from those discussed in our Form 10-K other than those disclosed in Note 2, Basis of Presentation and Summary of significant Accounting Policies, of this Quarterly Report. 53
Read original filing text →We are exposed to market risks in the ordinary course of our business. Market risk represents the risk of loss that may impact our financial position due to adverse changes in financial market prices and rates. Our market risk exposure is primarily the result of fluctuations in…
We are exposed to market risks in the ordinary course of our business. Market risk represents the risk of loss that may impact our financial position due to adverse changes in financial market prices and rates. Our market risk exposure is primarily the result of fluctuations in interest rates and foreign currency exchange rates. In addition, our portfolio of notes receivables is exposed to credit risk in the form of non-payment or non-performance. In mitigating our credit risk, we consider multiple factors, including the duration and terms of the note and the nature of and our relationship with the counterparty. The following analysis provides quantitative information regarding these risks. Interest Rate Sensitivity Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates. As of June 30, 2026 we had cash and cash equivalents of $168.8 million and short-term securities of $23.0 million. We generally hold our cash in interest-bearing demand deposit accounts and short-term securities. Due to the nature of our cash and investment portfolio, a hypothetical 100 basis point change in interest rates would not have a material effect on the fair value of our cash. Our cash is held for working capital purposes. The Company purchases investment grade marketable debt securities which are rated by nationally recognized statistical credit rating organizations in accordance with its investment policy. This policy is designed to minimize the Company's exposure to credit losses and to ensure that the adequate liquidity is maintained at all times to meet anticipated cash flow needs. Foreign Currency Exchange Risk Our reporting and functional currency is the U.S. dollar, and the functional currency of our foreign subsidiaries is generally the respective local currency. The assets and liabilities of each of our foreign subsidiaries are translated into U.S. dollars at exchange rates in effect at each balance sheet date. Adjustments resulting from translating foreign functional currency financial statements into U.S. dollars are recorded as a separate component on the unaudited condensed consolidated statements of comprehensive loss. Equity transactions are translated using historical exchange rates. Expenses are translated using the average exchange rate during the previous month. Gains or losses due to transactions in foreign currencies are included in other expenses, net in our unaudited condensed consolidated statements of operations. The volatility of exchange rates depends on many factors that we cannot forecast with reliable accuracy. We have experienced and will continue to experience fluctuations in foreign exchange gains and losses related to changes in foreign currency exchange rates. In the event our foreign currency denominated assets, liabilities, revenue, or expenses increase, our results of operations may be more greatly affected by fluctuations in the exchange rates of the currencies in which we do business, resulting in unrealized foreign exchange gains or losses. We have not engaged in the hedging of foreign currency transactions to date, although we may choose to do so in the future. No strategy can completely insulate us from risks associated with such fluctuations and our currency exchange rate risk management activities could expose us to substantial losses if such rates move materially differently from our expectations. A hypothetical 10% change in the relative value of the U.S. dollar to other currencies during any of the periods presented would not have had a material effect on our consolidated financial statements, but could result in significant unrealized foreign exchange gains or losses for any given period. 54
We are, from time to time, party to various claims and legal proceedings arising in the ordinary course of our business. Given that such proceedings are subject to uncertainty, there can be no assurance that any such legal proceedings, either individually or in the aggregate, wi…
We are, from time to time, party to various claims and legal proceedings arising in the ordinary course of our business. Given that such proceedings are subject to uncertainty, there can be no assurance that any such legal proceedings, either individually or in the aggregate, will not have a material adverse effect on our business, results of operations, financial condition or cash flows. See Part I, Item I “Financial Statements (Unaudited) – Note 19, Commitments and Contingencies, in this Quarterly Report, which are incorporated herein by reference. Item lA. Risk Factors. Investing in our common stock involves a high degree of risk. In addition to the other information set forth in this Quarterly Report and in other documents that we file with the SEC, you should carefully consider the factors described in the section titled "Risk Factors" in our Form 10-K. Other than the below, there have been no material changes to the risk factors described in Part I, Item 1A of our Form 10-K. If any of the risk factors described in the Form 10-K actually materializes, our business, financial condition and results of operations could be materially adversely affected. In such an event, the market price of our common stock could decline and you may lose all or part of your investment. Additional risks that we currently do not know about or that we currently believe to be immaterial may also impair our business. We may disclose changes to such risk factors or disclose additional risk factors from time to time in our future filings with the SEC. Risks Related to the Merger The conditions to the consummation of the Merger may not be satisfied at all or in the anticipated timeframe. On July 15, 2026, we entered into the Merger Agreement with Lilly and Merger Sub, pursuant to which Merger Sub will merge with and into the Company, with the Company surviving the Merger as a wholly-owned subsidiary of Lilly. Consummation of the Merger is subject to a number of conditions, including: (i) approval of the Merger Agreement by holders of at least a majority of the outstanding stock entitled to vote; (ii) the expiration or termination of any applicable waiting period (and extensions thereof) under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended; (iii) the expiration or termination of the antitrust notices, approvals, clearances and waiting periods required under the antitrust laws of Australia and Germany, as well as the antitrust laws of the United Kingdom and another specified jurisdiction; (iv) the absence of any law or order by any governmental authority of competent jurisdiction that would prohibit or prevent the Merger; (v) the absence of any pending suit, action or proceeding by a governmental authority of competent jurisdiction (a) seeking to prohibit or impose material limitations on Lilly or Merger Sub’s ownership or operation of all or any material portion of their or our businesses or assets, or to compel a divestiture or hold separate of any material portion thereof, (b) seeking to prohibit or make illegal the consummation of the Merger, (c) seeking to impose material limitations on Lilly’s or Merger Sub’s ability to exercise full rights of ownership of our shares, or (d) seeking to require divestiture by Lilly of our shares; and (vii) other conditions specified in the Merger Agreement. As a result, there can be no assurance that the Merger will be consummated. These conditions are described in more detail in the Merger Agreement, which is filed as an exhibit to the Current Report on Form 8-K, filed with the SEC on July 16, 2026, and incorporated herein by reference. The Company intends to pursue all required approvals in accordance with the Merger Agreement. However, no assurance can be given that the required approvals will be obtained and, even if all such approvals are obtained, no assurance can be given to the terms, conditions and timing of the approvals or that they will satisfy the terms of the Merger Agreement. The announcement of, or a failure to consummate, the Merger could negatively impact our business, financial condition, results of operations or our stock price. Our announcement of having entered into the Merger Agreement could cause a material disruption to our business and there can be no assurance that the conditions to the consummation of the Merger will be satisfied. The Merger Agreement may also be terminated by us and/or Lilly in certain specified circumstances, as described below. We are subject to several risks as a result of the announcement of the Merger Agreement, including, but not limited to, the following: •if the Merger is not completed within the expected timeframe, or at all, the share price of our common stock will change to the extent that the current market price of our common stock reflects an assumption that the Merger will be consummated; •pursuant to the Merger Agreement, we are subject to certain restrictions on the conduct of our business prior to the completion of the Merger, which restrictions could adversely affect our ability to realize certain of our business strategies or take advantage of certain business opportunities; •the attention of our management may be directed towards the consummation of the Merger and related matters, and their focus may be diverted from the day-to-day business operations of our Company, including from other opportunities that might otherwise be beneficial to us; 56 •we may experience difficulty retaining existing key employees or hire new capable employees, given the uncertainty regarding our future, in order to execute on our continuing business operations; •a failure to complete the Merger within the proposed timeframe, or at all, may result in negative publicity and/or a negative impression of us in the investment community or business community generally; •we may experience difficulties maintaining relationships with collaborators, vendors, and other business partners; •third parties may determine to terminate and/or attempt to renegotiate their relationship with us as a result of the Merger, whether pursuant to the terms of their existing agreements with us or otherwise; •upon termination of the Merger Agreement by us or Lilly under specified circumstances, we would be required to pay a termination fee of $104,300,000; •we could be subject to litigation related to any failure to complete the Merger; and •if the Merger is not completed, we will have incurred significant transaction costs and expended significant management resources, and may need to seek additional financing to continue to develop our product candidates, which financing may not be available within the necessary timeframe, on acceptable terms, or at all. In addition, our executive officers and directors may have interests in the Merger that are different from, or are in addition to, those of our stockholders generally. These interests include without limitation the following: •each of our directors and executive officers hold outstanding Company equity awards; •our directors and officers are subject to a voting and support agreement in favor of the adoption and approval of the Merger Agreement; •each of our executive officers is a party to an employment agreement that provides for severance benefits upon a qualifying termination of employment in connection with a change in control, which includes the Merger; •all equity awards, whether vested or unvested (other than out-of-the-money options), held by our executive officers will be cancelled at the Effective Time in exchange for a cash payment, plus a certain number of CVRs, under the terms of the Merger Agreement; •all equity awards held by our non-employee directors will vest in full at the Effective Time, under the terms of the applicable award agreement underlying such equity award; and •certain executive officers may continue to provide employment or other services to Lilly after the Effective Time and may enter into new agreements, arrangements or understandings with Lilly to set forth the terms and compensation of such post-Effective Time service. The Merger Agreement contains provisions that could make it difficult for a third-party to acquire us prior to the completion of the Merger. The Merger Agreement contains restrictions on our ability to obtain a third-party proposal for an acquisition of our Company. These provisions include our agreement not to solicit or initiate any additional discussions with third parties regarding other proposals to acquire us, as well as restrictions on our ability to respond to such proposals, subject to fulfillment of certain fiduciary requirements of our Board of Directors. The Merger Agreement also contains certain termination rights, including, under certain circumstances, a requirement for us to pay Lilly a termination fee of $104,300,000. These provisions might discourage an otherwise-interested third party from considering or proposing an acquisition of our Company, even one that may be deemed of greater value to our stockholders than the Merger. Furthermore, even if a third party elects to propose an acquisition, the concept of a termination fee may result in that third party offering a lower value to our stockholders than such third-party might otherwise have offered. While the Merger Agreement is in effect, we are subject to restrictions on our business activities. The Merger Agreement includes restrictions on the conduct of our business prior to the completion of the Merger, generally requiring us to use commercially reasonable efforts to conduct our business in the ordinary course consistent with past practice, including using commercially reasonable efforts to preserve our business organization and goodwill and maintain existing relationships with customers, suppliers, officers, employees and creditors. In addition, we are subject to a variety of specified restrictions. Unless we obtain Lilly’s prior written consent (which consent may not be unreasonably withheld, conditioned or delayed), except as specifically required by the Merger Agreement or required by applicable law, we may not, among other things and subject to certain exceptions, limitations and qualifications, incur additional indebtedness, issue additional shares of our common stock outside of our equity incentive plans, pay distributions, acquire certain assets or securities, sell or dispose of certain material intellectual property, enter into material contracts other than in the ordinary course of business, or make certain capital expenditures. We may find that these and other contractual restrictions in the Merger Agreement 57 delay or prevent us from responding, or limit our ability to respond, effectively to competitive pressures, industry developments and future business opportunities that may arise during such period, even if our management believes they may be advisable. If any of these effects were to occur, it could materially and adversely impact our operating results, financial position, cash flows or the price of our common stock. Securities class action and derivative lawsuits in connection with the Merger could result in substantial costs and prevent or delay the consummation of the Merger. Securities class action lawsuits and derivative lawsuits are often brought against public companies that have entered into acquisition or merger agreements. Defending against and settling or otherwise resolving these types of claims can result in substantial costs, including costs associated with indemnification of directors and officers, and divert management time and resources. An adverse judgment in any such litigation relating to the Merger could result in monetary damages, which could have a negative impact on our financial condition. If a plaintiff is successful in obtaining an injunction prohibiting completion of the Merger, that injunction could delay or prevent the Merger from being completed, which could negatively impact our business, financial condition, results of operations or our stock price. Our stockholders may not receive any payment on the CVR and the CVR may expire valueless. If the Merger is completed, the holders of our common stock will be entitled to receive CVRs, subject to the terms and conditions of a Contingent Value Rights Agreement (the “CVR Agreement”). Each CVR will represent a contractual right to receive contingent cash payments upon achievement of specified development and regulatory milestones related to the BPL-003 and VLS-01 programs. There can be no assurance any payments will be made with respect to the CVRs. The CVRs will not be transferable, except in the limited circumstances specified in the CVR Agreement, will not have any voting or dividend rights, and will not represent any equity or ownership interest in Lilly or any constituent party to the Merger Agreement. Accordingly, the right of any of our stockholders to receive any future payment on or derive any value from the CVRs will be contingent solely upon the occurrence of certain events, as outlined in the CVR Agreement, and if no such events are achieved for any reason within the time periods specified in the CVR Agreement, no payments will be made under the CVRs, and the CVRs will expire valueless.