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 notes thereto included elsewhere in this Quarterly Report, and the consolidated financial statements and accompanying notes, as well as Management's Discussion and Analysis of Financial Condition and Results of Operations contained in our Annual Report on Form 10-K for the year endedDecember 31, 2020 . Certain of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the section entitled "Risk Factors," our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. You should carefully read the section entitled "Risk Factors" to gain an understanding of the material and other risks that could cause actual results to differ materially from our forward-looking statements. Please also see the section entitled "Cautionary Note Regarding Forward-Looking Statements."
Overview
Introduction
We are a clinical-stage biopharmaceutical company pursuing a targeted approach to neuroscience that combines a deep understanding of disease-related biology and neurocircuitry of the brain with advanced chemistry and central nervous system, or CNS, target receptor selective pharmacology to discover and design new therapies. We seek to transform the lives of patients through the development of new therapies for neuroscience diseases, including schizophrenia, epilepsy and Parkinson's disease. Our "ready-made" pipeline of 11 small molecule programs, which includes five clinical-stage product candidates, was developed through over a decade of research and investment by Pfizer Inc., or Pfizer, and was supported by an initial capital commitment from an affiliate ofBain Capital and a keystone equity position from Pfizer. We are advancing our extensive and diverse pipeline with numerous clinical trials underway, including three Phase 3 trials and an open-label safety extension trial for tavapadon in Parkinson's as well as a Phase 2 trial in focal epilepsy and a Phase 1 trial in acute anxiety for darigabat. In addition, we recently announced positive topline results for CVL-231 in our Phase 1b trial in schizophrenia. See "-Our Pipeline" below. We have built a highly experienced team of senior leaders and neuroscience drug developerswho combine a nimble, results-driven biotech mindset with the proven expertise of large pharmaceutical company experience and capabilities in drug discovery and development. Our portfolio of product candidates is based on a differentiated understanding of the neurocircuitry of CNS diseases, as well as the key pillars of our targeted approach to neuroscience: (i) receptor-drug interactions at the atomic level to achieve targeted receptor subtype selectivity, (ii) orthosteric and allosteric chemistry to achieve ideal receptor pharmacology and (iii) robust packages of preclinical and clinical data that elucidate the key points of differentiation for our compounds. Our rational design approach uses measured and calculated structural and surface charge information from the target protein combined with high-resolution crystallography data, computational homology models, screening of single-residue mutant proteins, indirect solution-phase imaging techniques and other biophysical measurements to glean key molecular-level information about the interaction between a target protein and our product candidates. These insights then drive structure-informed design of subsequent molecules. Due to our understanding of the specificity and dynamic range of neural networks and how to modulate them, we believe that our product candidates have the potential to achieve optimal therapeutic activity while minimizing unintended side effects of currently available therapies.
Key Pipeline and Business Developments
OnJuly 7, 2021 , we completed a follow-on public offering of our common stock pursuant to which we issued and sold 14,000,000 shares of our common stock at a price to the public of$25.00 per share. The aggregate net proceeds from this offering totaled approximately$328.2 million , after deducting underwriting discounts and commissions of$21.0 million and offering expenses of approximately$0.8 million .
CVL-231 Positive Phase 1b Data
OnJune 29, 2021 , we announced positive topline results for CVL-231 in our Phase 1b clinical trial in schizophrenia. Both doses of CVL-231 demonstrated a clinically meaningful and statistically significant improvement in Positive and Negative Syndrome Scale, or PANSS, total score at six weeks and were generally well-tolerated compared with placebo. 22 --------------------------------------------------------------------------------
Funding Agreements
OnApril 12, 2021 , we entered into funding agreements, or the Funding Agreements, withNovaQuest Co-Investment Fund XVI, L.P. , or NovaQuest, andBC Pinnacle Holdings, LP , or Bain, pursuant to which NovaQuest and Bain will provide up to$125.0 million , or the Total Funding Commitment, to support our development of tavapadon for the treatment of Parkinson's disease over four years, of which approximately$31.1 million (25% of the Total Funding Commitment, net of$0.2 million of fees incurred by Bain and NovaQuest) was received inApril 2021 .
For additional information on our funding agreements, please read Note 5, Financing Liabilities, to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report.
Our Pipeline
The following table summarizes our current portfolio of product candidates. This table does not include two additional preclinical programs with disease-modifying potential that have not yet been disclosed.
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Below are our five most advanced product candidates:
1.
CVL-231 is a positive allosteric modulator, or PAM, that selectively targets the muscarinic acetylcholine 4 receptor subtype, or M4. We conducted a Phase 1b trial of CVL-231 in schizophrenia, consisting of Part A, a multiple ascending dose, or MAD, study and Part B, a pharmacodynamic, or PD, assessment. InJune 2021 , we announced positive topline results for the Phase 1b trial. Both doses of CVL-231 demonstrated a clinically meaningful and statistically significant improvement in PANSS total score at six weeks and were generally well-tolerated compared with placebo. We plan to rapidly advance CVL-231 with a comprehensive Phase 2 development program for schizophrenia and to evaluate the potential of this mechanism in other populations, including dementia-related psychosis. 2. Darigabat (formerly known as CVL-865) is a PAM that selectively targets the alpha-2/3/5 subunits of the GABAA receptor. In the second half of 2020, we initiated a Phase 2 proof-of-concept trial, known as REALIZE, in patients with drug-resistant focal onset seizures in epilepsy, or focal epilepsy. Data is expected in the second half of 2022 for the Phase 2 focal epilepsy trial. We are also conducting a Phase 1 proof-of-principle trial of darigabat in acute anxiety. The Phase 1 acute anxiety trial is being conducted at theCentre for Human Drug Research , a single specialized site inthe Netherlands . InJuly 2021 , Dutch government authorities reimposed restrictions due to the ongoing COVID-19 pandemic, now driven primarily by Delta variant cases in 23 --------------------------------------------------------------------------------
3.
young unvaccinated adults following relaxation measures that ended inJune 2021 . We will continue to closely monitor the rapidly evolving regulatory landscape inthe Netherlands and its impact on the clinical trial timeline. While this trial remains ongoing and actively recruiting, as a result of recent COVID-19 guidance by the Dutch authorities, data for the acute anxiety trial are now expected in the first half of 2022. 3. Tavapadon is a selective dopamine D1/D5 partial agonist that we are developing for the treatment of early- and late-stage Parkinson's disease. We initiated a registration-directed Phase 3 program for tavapadon beginning inJanuary 2020 , which includes two trials in early-stage Parkinson's, known as TEMPO-1 and TEMPO-2, one trial in late-stage Parkinson's, known as TEMPO-3, and an open-label safety extension trial, known as TEMPO-4. We expect initial data from our Phase 3 program to be available beginning in the first half of 2023. 4. CVL-871 is a selective dopamine D1/D5 partial agonist specifically designed to achieve a modest level of partial agonism, which we believe may be useful in modulating the complex neural networks that govern cognition, motivation and apathy behaviors in neurodegenerative diseases. In the second quarter of 2021, theU.S. Food and Drug Administration , or FDA, granted Fast Track Designation for CVL-871 for the treatment of dementia-related apathy. We initiated screening in a Phase 2a exploratory trial in dementia-related apathy, with data expected in the second half of 2022. 5. CVL-936 is a selective dopamine D3-preferring antagonist that we are developing for the treatment of substance use disorder, or SUD. We have received a notice of award for cooperative grant funding from theNational Institute on Drug Abuse , or NIDA, to support the development of this compound in opioid use disorder, or OUD. We initiated a Phase 1 single ascending dose, or SAD, trial inJanuary 2020 . We concluded dosing of Cohort 1 of the Phase 1 SAD trial after receiving sufficient clinical data for the intended purposes for this trial. We intend to conduct a multiple dose non-clinical safety pharmacology study before additional Phase 1 SAD and MAD evaluations. We believe that all five of our most advanced product candidates have target product profiles that may enable them to become backbone therapies in their respective lead indications, either replacing standards of care as monotherapies or enhancing treatment regimens as adjunct to existing therapies. Results from the clinical trials mentioned above will guide the potential development of our product candidates in additional indications with similar neurocircuitry deficits. We plan to advance the development of the remainder of our broad portfolio across multiple neuroscience indications, including CVL-354, our selective kappa opioid receptor antagonist, which we refer to as KORA, that we are developing in major depressive disorder, or MDD, and SUD. We submitted an Investigational New Drug, or IND, for CVL-354 in the second quarter of 2021 and expect to initiate a Phase 1 SAD and MAD trial in the third quarter of 2021. We are also developing CVL-047, our selective PDE4 inhibitor that spares the PDE4D subtype, for the treatment of MDD and schizophrenia, and we plan to submit an IND in the fourth quarter of 2021. We are also deploying the latest technologies, such as artificial intelligence and DNA-encoded chemical libraries, to efficiently identify new therapeutic molecules, including those with disease-modifying potential. We believe that our targeted approach to neuroscience will enable us to create a leading drug discovery and development platform to transform the lives of patients living with neuroscience diseases. Behind our portfolio stands a team with a multi-decade track record of drug approvals and commercial success. This track record has been driven by their extensive experience with empirically-driven clinical trial design and implementation, a history of successful interactions with regulatory agencies and relationships with global key opinion leaders. We believe that the distinctive combination of our management team and our existing pipeline has the potential to bring to patients the next generation of transformative neuroscience therapies.
Business Environment
The biopharmaceutical industry is extremely competitive. We are subject to risks and uncertainties common to clinical-stage companies in the biopharmaceutical industry. These risks include, but are not limited to, the introduction of new products, therapies, standards of care or technological innovations, our ability to obtain and maintain adequate protection for our licensed technology, data or other intellectual property and proprietary rights and compliance with extensive government regulation and oversight. We are also dependent upon the services of key personnel, including our Chief Executive Officer, executive team and other highly skilled employees. Demand for experienced personnel in the pharmaceutical and biotechnology industries is high and competition for talent is intense. Please read the section entitled "Risk Factors" for additional information. We face potential competition from many different sources, including pharmaceutical and biotechnology companies, academic institutions and governmental agencies as well as public and private research institutions. Many of our competitors are working to develop or have commercialized products similar to those we are developing and have considerable experience in undertaking clinical trials and in obtaining regulatory approval to market pharmaceutical products. Our competitors may also have significantly greater financial resources, established presence in the market, expertise in research and development, manufacturing, preclinical and clinical testing, obtaining regulatory approvals and reimbursement and marketing approved products. Other smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties also compete with us in recruiting and retaining qualified scientific and management personnel, establishing 24 --------------------------------------------------------------------------------
clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.
Risks and Liquidity
Product development is very expensive and involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. We will not generate revenue from product sales unless and until we successfully complete clinical development, are able to obtain regulatory approval for and successfully commercialize the product candidates we are developing or may develop. We currently do not have any product candidates approved for commercial sale. In addition, we operate in an environment of rapid change in technology. We are also dependent upon the services of our employees, consultants, third-party CROs, CMOs and other third-party organizations. Our product candidates, currently under development or that we may develop, will require significant additional research and development efforts, including extensive clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance and reporting capabilities. There can be no assurance that our research and development activities will be successfully completed, that adequate protection for our licensed or developed technology will be obtained and maintained, that products developed will obtain necessary regulatory approval or that any approved products will be commercially viable. Until such time, if ever, as we can generate substantial product revenue, we will need substantial additional funding to support our continuing operations and pursue our growth strategy, and we may finance our operations through a combination of additional private or public equity offerings, debt financings, collaborations, strategic alliances, marketing, distribution or licensing arrangements with third parties or through other sources of financing. To the extent that we raise additional capital through the sale of private or public equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. 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 raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or drug candidates, or grant licenses on terms that may not be favorable to us. 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 research, product development or future commercialization efforts, grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves, obtain funds through arrangement with collaborators on terms unfavorable to us or pursue merger or acquisition strategies, all of which could adversely affect the holdings or the rights of our stockholders. We have incurred significant operating losses since our inception and, as ofJune 30, 2021 , we had an accumulated deficit of$495.1 million and had not yet generated revenues. We believe that our available cash resources as ofJune 30, 2021 , of$327.1 million , will enable us to fund our operating expense and capital expenditure requirements through at least twelve months from the issuance date of the unaudited condensed consolidated financial statements included in this Quarterly Report.
We anticipate that our expenses will increase significantly in connection with our ongoing activities, as we:
? advance our clinical-stage product candidates CVL-231, darigabat, tavapadon, CVL-871 and CVL-936 through clinical development, including as we advance these candidates into later-stage clinical trials; ? advance our preclinical stage product candidates into clinical development including CVL-354 and CVL-047; ? seek to identify, acquire and develop additional product candidates, including through business development efforts to invest in or in-license other technologies or product candidates; ? hire additional clinical, quality control, medical, scientific and other technical personnel to support our clinical operations; ? expand our operational, financial and management systems and increase personnel to support our operations; ? meet the requirements and demands of being a public company; ? maintain, expand and protect our intellectual property portfolio; ? make milestone, royalty or other payments due under the Pfizer License Agreement and any future in-license or collaboration agreements; ? seek regulatory approvals for any product candidates that successfully complete clinical trials; and ? undertake any pre-commercialization activities to establish sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products on our own or jointly with third parties. 25 --------------------------------------------------------------------------------
Business Combination Transaction
OnOctober 27, 2020 ,ARYA Sciences Acquisition Corp II , or ARYA, completed the acquisition ofCerevel Therapeutics, Inc. , or Old Cerevel, a private company, pursuant to the Business Combination Agreement datedJuly 29, 2020 , as amended onOctober 2, 2020 , or the Business Combination Agreement. ARYA was incorporated as aCayman Islands exempted company onFebruary 20, 2020 and was formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses.Cerevel Therapeutics, Inc. was incorporated inDelaware onJuly 23, 2018 under the namePerception Holdco, Inc. , which was subsequently changed toCerevel Therapeutics, Inc. onOctober 23, 2018 . Upon the closing of the transactions contemplated by the Business Combination Agreement, which we refer to as the Business Combination or the Business Combination Transaction, Old Cerevel became a wholly owned subsidiary of ARYA and ARYA was renamedCerevel Therapeutics Holdings, Inc. Upon completion of the Business Combination Transaction, and pursuant to the terms of the Business Combination Agreement, the existing shareholders of Old Cerevel exchanged their interests for shares of common stock ofCerevel Therapeutics Holdings, Inc. , or New Cerevel. We accounted for the Business Combination Transaction as a reverse recapitalization, which is the equivalent of Old Cerevel issuing stock for the net assets of ARYA, with ARYA treated as the acquired company for accounting purposes. The net assets of ARYA were stated at historical cost with no goodwill or other intangible assets recorded. Reported results from operations included herein prior to the Business Combination are those of Old Cerevel. The shares and corresponding capital amounts and loss per share related to Old Cerevel's outstanding redeemable convertible preferred stock, redeemable convertible common stock, and common stock prior to the Business Combination Transaction have been retroactively restated to reflect the exchange ratio established in the Business Combination Agreement (1.00 share of Old Cerevel for 2.854 shares of New Cerevel), or the Exchange Ratio. For additional information on our operations, please read Note 1, Nature of Operations, to our audited consolidated financial statements included in our Annual Report on Form 10-K for the year endedDecember 31, 2020 , or our Annual Report. For additional information on the Business Combination Transaction, please read Note 3, Business Combination, to our audited consolidated financial statements included in our Annual Report.
Pfizer License Agreement
InAugust 2018 we entered into a license agreement with Pfizer, or the Pfizer License Agreement, pursuant to which we were granted an exclusive, sublicensable, worldwide license under certain Pfizer patent rights, and a non-exclusive, sublicensable, worldwide license under certain Pfizer know-how to develop, manufacture and commercialize certain compounds and products, which currently constitute the entirety of our asset portfolio, in the field of treatment, prevention, diagnosis, control and maintenance of all diseases and disorders in humans, subject to the terms and conditions of the Pfizer License Agreement. Under the Pfizer License Agreement, we are solely responsible for the development, manufacture, regulatory approval and commercialization of compounds and products in the field and we will pay Pfizer tiered royalties on the aggregate net sales during each calendar year, determined on a product-by-product basis, with respect to products under the Pfizer License Agreement, and we may pay potential milestone payments to Pfizer, based on the successful achievement of certain regulatory and commercial milestones. To date, no regulatory or commercial approval milestone payments or royalty payments were made or became due under this agreement.
For additional information on our Pfizer License Agreement, please read Note 6, Pfizer License Agreement, to our audited consolidated financial statements included in our Annual Report.
Impact of the COVID-19 Pandemic
InMarch 2020 , theWorld Health Organization declared the COVID-19 outbreak a pandemic. The COVID-19 pandemic is evolving, and to date has led to the implementation of various responses, including government-imposed quarantines, travel restrictions and other public health safety measures. We are closely monitoring the impact of the pandemic of COVID-19 on all aspects of our business, including how it has impacted and may continue to impact our operations and the operations of our suppliers, vendors and business partners. We have taken steps to identify and mitigate the adverse impacts on, and risks to, our business posed by its spread and actions taken by governmental and health authorities to address this pandemic; however, the spread of COVID-19 has caused us to modify our business practices, including implementing a temporary work-from-home policy for all employeeswho are able to perform their duties remotely and temporarily restricting all non-essential travel and discouraging employee attendance at industry events and in-person work-related meetings. We expect to continue to take actions as may be required or recommended by government authorities or as we determine are in the best interests of our employees and other business partners in light of COVID-19. More specifically, the onset of the COVID-19 pandemic caused brief pauses in patient screening and enrollment in our Phase 3 trials of tavapadon for the treatment of Parkinson's (which we subsequently resumed in the second half of 2020), and we remain particularly vigilant about patient safety given the elderly nature of this population. In addition, our Phase 1 trial of darigabat in acute 26
-------------------------------------------------------------------------------- anxiety is being conducted at theCentre for Human Drug Research , a single specialized site inthe Netherlands . InJuly 2021 , Dutch government authorities reimposed restrictions due to the ongoing COVID-19 pandemic, now driven primarily by Delta variant cases in young unvaccinated adults following relaxation measures that ended inJune 2021 . We will continue to closely monitor the rapidly evolving regulatory landscape inthe Netherlands and its impact on the clinical trial timeline. While this trial remains ongoing and actively recruiting, as a result of recent COVID-19 guidance by the Dutch authorities, data for the acute anxiety trial are now expected in the first half of 2022. While we have taken measures to revise clinical trial protocols, the extent to which COVID-19 impacts our business, results of operations and financial condition will depend on future developments, which, despite progress in vaccination efforts, are highly uncertain and cannot be predicted with confidence, including the duration of the outbreak, new information that may emerge concerning the severity of COVID-19, such as new strains of the virus, including the Delta variant, which may impact rates of infection and vaccination efforts, developments or perceptions regarding the safety of vaccines and the effectiveness of any additional preventative and protective actions to contain COVID-19 or treat its impact, including vaccination campaigns, among others. In addition, recurrences or additional waves of COVID-19 cases could cause other widespread or more severe impacts depending on where infection rates are highest. We cannot presently predict the scope and severity of any potential business shutdowns or disruptions, but if we or any of the third parties with whom we engage were to experience prolonged business shutdowns or other disruptions, our ability to conduct our business in the manner and on the timelines presently planned could be materially and negatively affected, which could have a material adverse impact on our business, results of operations and financial condition. The estimates of the impact on our business may change based on new information that may emerge concerning COVID-19 and the actions to contain it or treat its impact and the economic impact on local, regional, national and international markets.
We have not incurred any significant impairment losses in the carrying values of our assets as a result of the pandemic and we are not aware of any specific related event or circumstance that would require us to revise our estimates reflected in our audited consolidated financial statements.
Components of Operating Results
Revenues
We have not generated any revenues since our inception and do not expect to generate any revenues from the sale of products in the near future, if at all. If our development efforts for our current product candidates or additional product candidates that we may develop in the future are successful and can be commercialized, we may generate revenue in the future from product sales. Additionally, we may enter into collaboration and license agreements from time to time that provide for certain payments due to us. Accordingly, we may generate revenue from payments from such collaboration or license agreements in the future. Research and Development We support our drug discovery and development efforts through the commitment of significant resources to our preclinical and clinical development activities. Our research and development expense includes: ? employee-related expenses, consisting of salaries, benefits and equity-based compensation for personnel engaged in our research and development activities; ? expenses incurred in connection with the preclinical and clinical development of our product candidates, including costs incurred under agreements with clinical research organizations, or CROs, investigative clinical trial sites and consultants and other third-party organizations that conduct research and development activities on our behalf; ? costs associated with preclinical studies and clinical trials, including research materials; ? materials and supply costs associated with the manufacture of drug substance and drug product for preclinical testing and clinical trials; ? costs related to regulatory compliance requirements; and ? certain indirect costs incurred in support of overall research and development activities, including facilities, depreciation and technology expenses. We expense research and development expenses as incurred. Payments we make for research and development services prior to the services being rendered are recorded as prepaid assets in our consolidated balance sheets and are expensed as the services are provided. We estimate and accrue the value of goods and services received from CROs, CMOs and other third parties each reporting period based on estimates of the level of services performed and progress in the period when we have not received an invoice from such organizations. When evaluating the adequacy of accrued liabilities, we analyze progress of the studies or clinical trials, including the phase of completion of events, invoices received and contracted costs. We reassess and adjust our accruals as actual costs become 27 --------------------------------------------------------------------------------
known or as additional information becomes available. Our historical accrued estimates have not been materially different from actual costs.
Our external research and development expenses for our clinical stage product candidates are tracked on a program-by-program basis and consist primarily of fees, reimbursed materials and other costs paid to consultants, contractors, CROs and CMOs. External research and developments costs that directly support our discovery activities and preclinical programs are classified within other research and development programs. Program costs for the periods presented do not reflect an allocation of expenses associated with personnel costs, equity-based compensation expense, activities that benefit multiple programs or indirect costs incurred in support of overall research and development, such as technology and facilities-related costs. We expect that our research and development expenses will increase substantially in connection with our planned preclinical and clinical development activities both in the near-term and beyond as we continue to invest in activities to develop our product candidates and preclinical programs and as certain product candidates advance into later stages of development. 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, scope and duration of later-stage clinical trials. Furthermore, the process of conducting the necessary clinical trials to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. As a result, we cannot accurately estimate or know the nature, timing and costs that will be necessary to complete the preclinical and clinical development for any of our product candidates or when and to what extent we may generate revenue from the commercialization and sale of any of our product candidates or achieve profitability.
The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors that include:
? per patient trial costs; ? the number of patients that participate in the trials; ? the number of sites included in the trials; ? the countries in which the trials are conducted; ? the length of time required to enroll eligible patients; ? the number of doses that patients receive; ? the drop-out or discontinuation rates of patients; ? potential additional safety monitoring or other studies requested by regulatory agencies; ? the duration of patient follow-up; and ? the efficacy and safety profile of our product candidates. Changes in any of these assumptions could significantly impact the cost and timing associated with the development of our product candidates. Additionally, future competition and commercial and regulatory factors beyond our control may also impact our clinical development programs and plans.
General and Administrative
We expense general and administrative costs as incurred. General and administrative expenses consist primarily of salaries, benefits, equity-based compensation and outsourced labor for personnel in executive, finance, human resources, legal and other corporate administrative functions. General and administrative expenses also include legal fees incurred relating to corporate and patent matters, professional fees incurred for accounting, auditing, tax and administrative consulting services, insurance costs, facilities and depreciation expenses. We estimate and accrue for services provided by third parties related to the above expenses by monitoring the status of services provided and receiving estimates from our service providers. We reassess and adjust our accruals as actual costs become known or as additional information becomes available. We expect that our general and administrative expenses will increase both in the near-term and beyond as we continue to build general corporate infrastructure to support organization; however, we expect that the rate at which these expenses grow will moderate throughout 2021.
Interest Income, Net
Interest income, net primarily consists of interest earned on our cash, cash equivalents and restricted cash.
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Other Income (Expense), Net
Other income (expense), net primarily consists gains (losses) on the fair value remeasurement of our financing liabilities and private placement warrants and, prior to their termination upon completion of the Business Combination Transaction inOctober 2020 , gains (losses) on the fair value remeasurement of the Equity Commitment and Share Purchase Option. Other income (expense), net also includes amounts for other miscellaneous income and expense unrelated to our core operations. The private placement warrants are free-standing financial instruments that were reclassified from equity to other long-term liabilities onMarch 31, 2021 . We revalue our private placement warrants each reporting period with increases or decreases in the fair value of these warrants recognized as an adjustment to other income (expense), net in our consolidated statements of operations and comprehensive loss. Changes in the fair value of our private placement warrants result from changes to one or multiple inputs, including adjustments to the discount rate, expected volatility and dividend yield as well as changes in the fair value of our common stock and public warrants. As permitted under ASC 825, Financial Instruments, we elected the Fair Value Option for our financing liabilities, wherein the financial instruments were initially measured at their issue-date estimated fair value and subsequently remeasured at estimated fair value on a recurring basis at each reporting period date. Changes in the fair value of our financing liabilities can result from changes to one or multiple inputs, including adjustments to the discount rate and achievement and timing of any cumulative sales-based and regulatory milestones or changes in the probability of certain clinical events and changes in the assumed probability associated with regulatory approval. The estimated fair value adjustment for our financing liabilities, as required by ASC 825-10-45-5, is recognized as a component of other comprehensive income with respect to the portion of the fair value adjustment attributed to a change in the instrument-specific credit risk, with the remaining amount of the fair value adjustment recognized as other income (expense), net, in the consolidated statement of operations. As there were no material instrument specific credit risk changes during the period, the change in fair value was recorded as a single line item in our consolidated statement of operations. The Equity Commitment and Share Purchase Option were free-standing financial instruments that were recorded at their fair value on the Formation Transaction Date. We revalued these instruments each reporting period and recorded increases or decreases in their respective fair value as an adjustment to other income (expense), net in our consolidated statements of operations and comprehensive loss. Changes in the fair value of these financial instruments resulted from changes to one or multiple inputs, including adjustments to the discount rates and expected volatility and dividend yield as well as changes in the amount and timing of the anticipated future funding required to settle these instruments and the fair value of our preferred and common stock that were expected to be exchanged to complete that additional funding. Discount rates in our valuation models represent a measure of the credit risk associated with settling the financial instruments. The expected dividend yield was assumed to be zero as we have never paid dividends, nor do we have current plans to do so in the future.
Significant judgment is employed in determining the appropriateness of the assumptions underlying the initial fair value determination for each of these instruments and for each subsequent period.
Income Tax Benefit (Provision), Net
To date, we have not recorded any significant amounts related to income tax expense, we have not recognized any reserves related to uncertain tax positions, nor have we recorded any income tax benefits for net operating losses incurred to date or for our research and development tax credits. We account for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements or our tax returns. Deferred tax assets and liabilities are determined based on difference between the financial statement carrying amounts and tax bases of existing assets and liabilities and for loss and credit carryforwards, which are measured using the enacted tax rates and laws in effect in the years in which the differences are expected to reverse. The realization of our deferred tax assets is dependent upon the generation of future taxable income, the amount and timing of which are uncertain. Valuation allowances are provided, if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. As ofJune 30, 2021 , we continue to maintain a full valuation allowance against all of our deferred tax assets based on our evaluation of all available evidence. We file income tax returns in theU.S. federal tax jurisdiction and state jurisdictions and may become subject to income tax audit and adjustments by related tax authorities. Our initial tax return period forU.S. federal income taxes was the 2018 period. We currently remain open to examination under the statute of limitations by the Internal Revenue Service and state jurisdictions for the 2019 and 2018 tax years. We record reserves for potential tax payments to various tax authorities related to uncertain tax positions. The nature of uncertain tax positions is subject to significant judgment by management and subject to change, which may be substantial. These reserves are based on a determination of whether and how much a tax benefit taken by us in our tax filings or positions is more likely than not to be realized following the resolution of any potential contingencies related to the tax benefit. We develop our assessment of uncertain tax positions, and the associated cumulative probabilities, using internal expertise and assistance from third-party experts. As additional information becomes available, estimates are revised and refined. Differences between 29
-------------------------------------------------------------------------------- estimates and final settlement may occur resulting in additional tax expense. Potential interest and penalties associated with such uncertain tax positions is recorded as a component of our income tax benefit (provision), net. To date, no amounts are being presented as an uncertain tax position.
Results of Operations
The following table summarizes our results of operations:
For the Three Months For the Six Months Ended June 30, Ended June 30, 2021 2020 Change 2021 2020 Change Operating expenses: Research and development$ 37,294 $ 22,183 68 %$ 73,855 $ 49,142 50 % General and administrative 13,216 12,973 2 % 27,226 23,716 15 % Total operating expenses 50,510 35,156 44 % 101,081 72,858 39 % Loss from operations (50,510 ) (35,156 ) 44 % (101,081 ) (72,858 ) 39 % Interest income, net 10 5 100 % 25 209 (88 )% Other income (expense), net (2,739 ) 8,418 (133 )% (3,164 ) (7,292 ) (57 )% Loss before income taxes (53,239 ) (26,733 ) 99 % (104,220 ) (79,941 ) 30 % Income tax benefit (provision), net - 16 (100 )% - 16 (100 )% Net loss$ (53,239 ) $ (26,717 ) 99 %$ (104,220 ) $ (79,925 ) 30 % Research and Development The following table summarizes the components of research and development expense: For the Three Months For the Six Months Ended June 30, Ended June 30, 2021 2020 2021 2020 (In thousands) Change Change Tavapadon$ 12,351 $ 5,589 121 %$ 23,222 $ 14,773 57 % CVL-231 4,092 3,289 24 % 11,207 6,895 63 % Darigabat 4,936 1,773 178 % 10,000 5,100 96 % CVL-871 1,286 89 1345 % 2,453 488 403 % CVL-936 298 633 (53 )% 318 1,671 (81 )% Other research and development programs 2,585 2,014 28 % 4,731 3,087 53 % Unallocated 2,512 2,275 10 % 4,266 4,479 (5 )% Personnel costs 7,112 5,606 27 % 13,739 10,824 27 % Equity-based compensation 2,122 915 132 % 3,919 1,825 115 % Total research and development$ 37,294 $ 22,183 68 %$ 73,855 $ 49,142 50 % For the three and six months endedJune 30, 2021 , compared to the same periods in 2020, the increase in research and development expense was primarily due to the continued advancement of our tavapadon, CVL-231, darigabat and CVL-871 programs as well as increased investment in our preclinical and discovery research efforts. The increase in research and development expense for the comparative periods also reflects higher personnel costs, including equity-based compensation, as we continue to develop our organizational infrastructure to advance our pipeline. These increases were partially offset by a reduction in costs for the development of CVL-936 as we concluded dosing of Cohort 1 of the Phase 1 SAD trial in the first quarter of 2020 after receiving sufficient clinical data for the intended purposes for this trial. General and Administrative For the Three Months For the Six Months Ended June 30, Ended June 30, 2021 2020 2021 2020 (In thousands) Change Change General and administrative$ 13,216 $ 12,973 2 %$ 27,226 $ 23,716 15 % 30
-------------------------------------------------------------------------------- For the three and six months endedJune 30, 2021 , compared to the same periods in 2020, the increase in general and administrative expense was primarily due to increased public company costs and higher personnel costs, including equity-based compensation as we continued to grow our organization. These increases were partially offset by a reduction in outsourced labor and the write-off of approximately$2.5 million of deferred financing costs inJune 2020 upon signing of the term sheet for the Business Combination Transaction. General and administrative expense for the six months endedJune 30, 2021 , also includes a$2.2 million net charge associated with the departure of certain executives. Interest Income, Net For the Three Months For the Six Months Ended June 30, Ended June 30, 2021 2020 2021 2020 (In thousands) Change Change Interest income, net$ 10 $ 5 100 %$ 25 $ 209 (88 )% Interest income, net primarily consists of interest earned on our cash, cash equivalents and restricted cash. The changes in the three and six month periods endedJune 30, 2021 compared to the same period in 2020 are driven by changes in our cash balances and market interest rates.
Other Income (Expense), Net
The following table summarizes other income (expense), net:
For the Three Months For the Six Months Ended June 30, Ended June 30, 2021 2020 2021 2020 (In thousands) Change Change Gain (loss) on fair value remeasurement of Equity Commitment $ -$ 9,110 (100 )% $ -$ (6,650 ) (100 )% Loss on fair value remeasurement of Share Purchase Option - (690 ) (100 )% - (640 ) (100 )% Loss on fair value remeasurement of financing liability, related party (496 ) - ** (496 ) - ** Loss on fair value remeasurement of financing liability (496 ) - ** (496 ) - ** Loss on fair value remeasurement of private placement warrants (1,746 ) - ** (2,170 ) - ** Other, net (1 ) (2 ) (50 )% (2 ) (2 ) 0 % Other income (expense), net$ (2,739 ) $ 8,418 (133 )%$ (3,164 ) $ (7,292 ) (57 )% ** - Not meaningful For the three and six months endedJune 30, 2021 , other income (expense), net primarily reflects net losses recognized on fair value remeasurement of our financing liabilities and private placement warrants. The changes in fair value remeasurement of our financing liabilities were primarily due to changes in our discount rate and the passage of time. The changes in fair value remeasurement of our private placement warrants were primarily due to changes in the fair values of our common stock and public warrants, as well as changes in the volatility implied by the market price of our public warrants. For additional information on our warrants, please read Note 6, Fair Value Measurements, and Note 8, Stockholders' Equity, to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report. For the three and six months endedJune 30, 2020 , other income (expense), net primarily reflects the net changes in fair value remeasurement of the Equity Commitment and Share Purchase Option resulting from changes in the timing of the anticipated future funding required in settlement of the Equity Commitment and Share Purchase Option, as well as increases in the fair value of our preferred and common stock expected to be exchanged for that additional funding. The Equity Commitment and Share Purchase Option were free-standing financial instruments that were recorded at fair value on the Formation Transaction Date. We revalued these financial instruments each reporting period until their termination upon the completion of our Business Combination Transaction in 2020. For additional information on our Equity Commitment and Share Purchase Option, please read Note 7, Equity Commitment and Share Purchase Option, to our audited consolidated financial statements included in our Annual Report. 31 --------------------------------------------------------------------------------
Liquidity and Capital Resources
Sources of Liquidity and Capital
We have incurred significant operating losses since our inception, and we expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future. Our net losses totaled$104.2 million and$79.9 million for the six months endedJune 30, 2021 and 2020, respectively, and as ofJune 30, 2021 , we had an accumulated deficit of$495.1 million . We have not yet generated revenues. Our cash and cash equivalents totaled$327.1 million as ofJune 30, 2021 . Until required for use in our business, we typically invest our cash in investments that are highly liquid, readily convertible to cash with original maturities of 90 days or less at the date of purchase. We attempt to minimize the risks related to our cash and cash equivalents by maintaining balances in accounts only with accredited financial institutions and, consequently, we do not believe we are subject to unusual credit risk beyond the normal credit risk associated with ordinary commercial banking relationships. Prior to the Business Combination, our operations were funded primarily from the issuance of convertible preferred stock, convertible common stock and common stock. Upon the closing of the Business Combination Transaction inOctober 2020 , we received net proceeds totaling approximately$439.5 million . OnApril 12, 2021 , we entered into the Funding Agreements, pursuant to which NovaQuest and Bain will provide up to$125.0 million in funding to support our development of tavapadon for the treatment of Parkinson's disease over four years, of which approximately$31.1 million (25% of the Total Funding Commitment, net of$0.2 million of fees incurred by Bain and NovaQuest) was received inApril 2021 . OnJuly 7, 2021 , we completed a follow-on public offering of our common stock pursuant to which we issued and sold 14,000,000 shares of our common stock at a price to the public of$25.00 per share. The aggregate net proceeds from this offering totaled approximately$328.2 million , after deducting underwriting discounts and commissions of$21.0 million and offering expenses of approximately$0.8 million .
Future Funding Requirements
Our primary use of cash is to fund operating expenses, primarily related to our research and development activities. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable, accrued expenses and prepaid expenses. We have incurred significant operating expenses since our inception, and we expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future. In the future, we will require additional capital to meet operational needs and capital requirements for clinical trials, other research and development expenditures, and business development activities.
Our future funding requirements will depend on many factors, including:
? the scope, progress, results and costs of researching and developing our current product candidates, as well as other additional product candidates we may develop and pursue in the future; ? the timing of, and the costs involved in, obtaining marketing approvals for our product candidates and any other additional product candidates we may develop and pursue in the future; ? the number of future product candidates that we may pursue and their development requirements; ? subject to receipt of regulatory approval, the costs of commercialization activities for our product candidates, to the extent such costs are not the responsibility of any future collaborators, including the costs and timing of establishing product sales, marketing, distribution and manufacturing capabilities; ? subject to receipt of regulatory approval, revenue, if any, received from commercial sales of our product candidates or any other additional product candidates we may develop and pursue in the future; ? the achievement of milestones that trigger payments under the Pfizer License Agreement and the Funding Agreements; ? the royalty payments due under the Pfizer License Agreement and the Funding Agreements; ? the extent to which we in-license or acquire rights to other products, product candidates or technologies; ? our ability to establish collaboration arrangements for the development of our product candidates on favorable terms, if at all; ? our headcount growth and associated costs as we expand our research and development and establish a commercial infrastructure; 32 -------------------------------------------------------------------------------- ? the costs of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights, including enforcing and defending intellectual property related claims; and ? the costs of operating as a public company. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the total amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical trials and preclinical studies. Our expectations with respect to our ability to fund current planned operations is based on estimates that are subject to risks and uncertainties. Our operating plan may change as a result of many factors currently unknown to us and there can be no assurance that the current operating plan will be achieved in the time frame anticipated by us, and we may need to seek additional funds sooner than planned. If adequate funds are not available to us on a timely basis, we may be required to delay, limit, reduce or terminate certain of our research, product development or future commercialization efforts, obtain funds through arrangements with collaborators on terms unfavorable to us, or pursue other merger or acquisition strategies, all of which could adversely affect the holdings or the rights of our stockholders.
For additional information on risks associated with our substantial capital requirements, please read the section entitled "Risk Factors" included elsewhere in this Quarterly Report.
Warrants
ARYA issued public warrants and private placement warrants, or collectively, the warrants, in its IPO inJune 2020 . The warrants became exercisable beginning onJune 9, 2021 . Warrants may only be exercised for a whole number of shares. No fractional shares will be issued upon exercise of the warrants. Each whole warrant entitles the holder to purchase one share of common stock at an exercise price of$11.50 per share. We will use our commercially reasonable efforts to maintain the effectiveness of our registration statement and a current prospectus relating to those common shares issuable upon exercise of the warrants until the warrants expire or are redeemed, as specified in the warrant agreement. If our common stock at the time of any exercise of a warrant is not listed on a national securities exchange, we may, at our option, require holders of the warrantswho exercise their warrants to do so on a "cashless basis." We are not required to file or maintain in effect a registration statement. In no event will we be required to net cash settle any warrant. Except as described in the warrant agreement, the private placement warrants have terms and provisions that are identical to those of the public warrants. If the private placement warrants are held by holders other than the Sponsor or its permitted transferees, the private placement warrants will be redeemable by us and exercisable by the holders on the same basis as the public warrants.
We may call the public warrants for redemption:
? in whole and not in part; ? at a price of$0.01 per warrant; ? upon not less than 30 days' prior written notice of redemption to each warrant holder; and ? if, and only if, the closing price of our common stock equals or exceeds$18.00 per share (as adjusted for share splits, share capitalizations, reorganizations, recapitalizations and the like) for any 20 trading days within a 30-trading day period ending on the third trading day prior to the date on which notice of the redemption is given to the warrant holder. We may exercise our redemption right even if we are unable to register or qualify the underlying securities for sale under all applicable state securities laws. If we call the public warrants for redemption, as described above, we will have the option to require any holder that wishes to exercise the public warrants to do so on a "cashless basis," as described in the warrant agreement. OnJuly 30, 2021 , we announced the redemption of all of our outstanding public warrants. Public warrants may be exercised by the holders thereof untilAugust 30, 2021 to purchase shares of our common stock at the exercise price of$11.50 per share. Any public warrants that remain outstanding as ofAugust 30, 2021 will be void and no longer exercisable, and the holders of those public warrants will be entitled to receive the redemption price of$0.01 per warrant. The private placement warrants are not subject to this redemption. As ofAugust 6, 2021 , an aggregate of 3,037,950 public warrants have been exercised, which resulted in proceeds of approximately$34.9 million and the issuance of 3,037,950 shares of common stock.
Commencing on
? in whole and not in part; ? at$0.10 per warrant upon a minimum of 30 days' prior written notice of redemption, provided that holders will be able to exercise their warrants on a cashless basis prior to redemption and receive that number of shares determined by reference to 33
-------------------------------------------------------------------------------- ? the table included in the warrant agreement, based on the redemption date and the "fair market value" of our shares of common stock, except as otherwise described below; ? if, and only if, the closing price of the shares of common stock equals or exceeds$10.00 per share (as adjusted for share subdivisions, share dividends, reorganizations, reclassifications, recapitalizations and the like) on the trading day before we send the notice of redemption to the warrant holders; ? if, and only if, the private placement warrants are also concurrently called for redemption on the same terms as the outstanding public warrants, as described above; and ? if, and only if, there is an effective registration statement covering the issuance of common stock issuable upon exercise of the warrants and a current prospectus relating thereto available throughout the 30-day period after written notice of redemption is given.
The warrants will expire on
Working Capital
The following table summarizes our total working capital, defined as current assets less current liabilities:
As of June 30, December 31, (In thousands) 2021 2020 Change Current assets$ 331,782 $ 390,560 (15 )% Current liabilities (29,257 ) (29,548 ) (1 )% Total working capital$ 302,525 $ 361,012 (16 )% The change in working capital atJune 30, 2021 fromDecember 31, 2020 , reflects a net decrease in total current assets of$58.8 million , partially offset by a net increase in total current liabilities of$0.3 million . The net decrease in total current assets was primarily driven by a net decrease in our cash and cash equivalents reflecting$82.0 million of net cash flows used in operating activities and$8.2 million of net cash flows used for the purchase of property and equipment, partially offset by the receipt of$31.1 million in connection with the Funding Agreements and$2.6 million of proceeds received from the exercise of stock options and purchases of stock under our employee stock purchase plan (ESPP).
The net decrease in current liabilities was primarily driven by a net decrease in accrued expenses and other current liabilities related to employee compensation and personnel costs and accruals for purchases of property and equipment, partially offset by increases in accruals related to external research and development services.
Cash Flows
The following table summarizes our cash flow activity:
For the Six Months Ended June 30, (In thousands) 2021 2020 Change
Net cash flows used in operating activities
46 % Net cash flows used in investing activities (8,243 ) (4,042 ) 104 % Net cash flows provided by (used in) financing activities 33,706 (1,524 )
**
Net decrease in cash, cash equivalents and restricted cash$ (56,563 ) $ (61,583 )
(8 )%
Cash flows used in Operating Activities
Net cash flows used in operating activities represent the cash receipts and disbursements related to all of our activities other than investing and financing activities. We expect cash provided by financing activities will continue to be our primary source of funds to finance operating needs and capital expenditures for the foreseeable future.
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Net cash flows used in operating activities is derived by adjusting our net loss for:
? non-cash operating items such as depreciation and amortization, non-cash rent expense, equity-based compensation, impairments and write-offs of deferred charges; ? changes in operating assets and liabilities reflect timing differences between the receipt and payment of cash associated with transactions and when they are recognized in results of operations; and ? changes in the fair value remeasurement of the Equity Commitment and Share Purchase Option, the financial liability, related party, the financial liability, and the private placement warrants. For the six months endedJune 30, 2021 , cash used in operating activities primarily reflects our net loss for the period of$104.2 million , adjusted for net non-cash charges totaling$14.7 million and a net change of$7.4 million in our net operating assets and liabilities. Our non-cash charges primarily consisted of$11.3 million of equity-based compensation expense,$2.2 million related to the fair value remeasurement of private placement warrants and$1.0 million related to the fair value remeasurement of our financing liabilities. The net change in our operating assets and liabilities was primarily due to an increase in operating lease liabilities resulting from landlord reimbursement for tenant improvements, an increase in accounts payable and accrued expenses related to operating activities and a decrease in prepaids and other current assets primarily resulting from the recognition of insurance premiums paid in advance. For the six months endedJune 30, 2020 , net cash used in operating activities primarily reflected our net loss for the period of$79.9 million , adjusted by non-cash charges totaling$17.5 million and a net change of$6.4 million in relation to our net operating assets and liabilities. Our non-cash charges primarily consisted of net losses totaling$7.3 million recognized related to the Equity Commitment and Share Purchase Option,$6.4 million of equity-based compensation expense, the$2.5 million write-off of deferred costs related to our abandoned initial public offering and other financing activities and$1.0 million of non-cash rent expense. The net change in our operating assets and liabilities was primarily due to an increase in accounts payable and accrued expenses and other current liabilities, and a decrease in prepaid expenses and other current assets.
Cash flows used in Investing Activities
For the six months ended
For the six months ended
Cash flows provided by Financing Activities
For the six months endedJune 30, 2021 , net cash provided by financing activities totaled$33.7 million , primarily consisting of$31.3 million related to the Funding Agreements, described in Note 5, Financing Liabilities, to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report, and$2.6 million of proceeds received from stock option exercises and purchases of stock under our ESPP. For the six months endedJune 30, 2020 , net cash used in financing activities totaled$1.5 million , reflecting deferred costs related to our abandoned initial public offering and other financing activities.
Contractual Obligations and Other Commitments
Our contractual obligations primarily consist of our obligations under
non-cancellable operating leases, contracts and other purchase obligations. We
did not have any debt obligations as of
Our most significant contracts relate to agreements with CROs for clinical trials and preclinical studies, CMOs and other service providers for operating purposes, which we enter into in the normal course of business. These contracts are generally cancelable at any time by us following a certain period after notice and therefore, we believe that our non-cancelable obligations under these agreements are not material. In addition, we have obligations with respect to potential future royalties payable, contingent development, regulatory and commercial milestone payments and amounts related to uncertain tax positions. The timing and amount of such obligations are unknown or uncertain as ofJune 30, 2021 . For additional information on potential royalties and milestone payments payable to Pfizer, see "Our Agreements with Licensors and Stockholders-Pfizer License Agreement" in our Annual Report. We completed the build-out and took occupancy of our corporate headquarters inCambridge, Massachusetts in the second quarter of 2021. As ofJune 30, 2021 , our remaining obligations related to the build-out of our corporate headquarters were insignificant. 35
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Funding Agreements
OnApril 12, 2021 , we entered into the Funding Agreements, pursuant to which we will receive up to a combined total of up to$125.0 million , to support our development of tavapadon for the treatment of Parkinson's disease. In return, we agreed to pay to NovaQuest and Bain significant regulatory milestone, sales milestone and royalty payments upon approval of tavapadon by the FDA that collectively will not exceed$531.3 million . In addition, we have the option to satisfy our payment obligations to NovaQuest and Bain upon the earlier of FDA approval orMay 1, 2025 , by paying an amount equal to the Total Funding Commitment multiplied by an initial factor of 3.00x. This factor will increase ratably over time up to a maximum of 4.25x, less amounts previously paid to NovaQuest and Bain.
For additional information on our funding agreements, please read Note 5, Financing Liabilities, to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report.
As of
Tax Related Obligations
To date, we have not recognized any reserves related to uncertain tax positions.
As of
Off-balance sheet arrangements
We have not entered into any off-balance sheet arrangements and do not have holdings in any variable interest entities.
Critical Accounting Policies and Estimates
This management's discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted inthe United States of America , or GAAP. The preparation of the consolidated financial statements in conformity with GAAP requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. Our most critical accounting policies and estimates were described under the heading "Management's Discussion and Analysis of Financial Condition and Results of Operations-Critical Accounting Policies and Estimates" in our Annual Report. There have been no material changes to our critical accounting policies and estimates described in our Annual Report except as described as follows:
Fair Value Option for Funding Agreements
We elected to account for our funding agreements and related financial liabilities described in Note 5, Financing Liabilities, in accordance with the fair value option permitted under ASC 825-10, Financial Instruments. A liability associated with each of our funding agreements was initially recognized at their estimated fair value within our condensed consolidated balance sheets. We revalue these financial instruments on a recurring basis each reporting period with subsequent changes in fair value, excluding the impact of the change in fair value related to instrument-specific credit risk, separately presented as a component of other income (expense), net in our condensed consolidated statements of operations and comprehensive income. The portion of the fair value adjustment attributed to a change in the instrument-specific credit risk will be recognized and separately presented as a component of other comprehensive income. Changes in the fair value of our financing liabilities can result from changes to one or multiple inputs, including adjustments to the discount rate and achievement and timing of any cumulative sales-based and regulatory milestones or changes in the probability of certain clinical events and changes in the assumed probability associated with regulatory approval. These fair value measurements represent Level 3 measurements as they are based on significant inputs not observable in the market.
Up-front, direct costs and fees related to the instruments for which we have elected the fair value option were recognized in general and administrative expense in earnings as incurred.
The decision to elect the fair value option is determined on an instrument-by-instrument basis, must be applied to an entire instrument and is irrevocable once elected, but need not be applied to all similar instruments. Assets and liabilities measured at fair 36 --------------------------------------------------------------------------------
value pursuant to ASC 825-10 are required to be reported separately from those instruments measured using another accounting method.
For additional information related to our qualifying instruments that we have elected to account for under the fair value option, please read Note 5, Financing Liabilities, and Note 6, Fair Value Measurements to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report.
Emerging Growth Company and Smaller Reporting Company Status
We are currently an "emerging growth company" as defined in Section 2(a)(19) of the Securities Act of 1933, or the Securities Act, as modified by the Jumpstart Our Business Startups Act, or the JOBS Act, and a "smaller reporting company" as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended, or the Exchange Act. As such, we are eligible for, have taken and intend to take advantage of certain exemptions from various reporting requirements applicable to other public companies that are not emerging growth companies and/or smaller reporting companies for as long as we continue to be an emerging growth company and/or a smaller reporting company, including (i) the exemption from the auditor attestation requirements with respect to internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, (ii) the exemptions from say-on-pay, say-on-frequency and say-on-golden parachute voting requirements and (iii) reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements. In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an emerging growth company to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of this extended transition period and, as a result, we may adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for non-public companies instead of the dates required for other public companies. As ofJune 30, 2021 , the last business day of our most recently completed second fiscal quarter, the market value of our common stock that was held by non-affiliates exceeded$700.0 million , and as ofDecember 31, 2021 , we will have been public for more than one year and filed at least one annual report. As a result, we will lose our emerging growth company status and our smaller reporting company status as of the end of the current fiscal year endingDecember 31, 2021 , and we will be subject to certain requirements that apply to other public companies but did not previously apply to us due to our status as an emerging growth company, including the provisions of Section 404(b) of the Sarbanes-Oxley Act, which require that our independent registered public accounting firm provides an attestation report on the effectiveness of our internal control over financial reporting.
Recent Accounting Pronouncements
For a discussion of new accounting standards and their expected impact on our consolidated financial statements or disclosures, please read Note 3, Recent Accounting Guidance, to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report. 37
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