NMRA 10-K & 10-Q changes, risk factors and insider trading
Neumora Therapeutics, Inc. · Nasdaq · Biological Products, (No Diagnostic Substances) · CIK 1885522 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “If we are unable to maintain the listing of our common stock on the Nasdaq Global Select Market or another reputable stock exchange, the trading price and/or trading volume of our common stock may decline and it may be more difficult for our stockholders to sell their shares.”
New heading “We are a smaller reporting company and the reduced reporting requirements applicable to smaller reporting companies may make our common stock less attractive to investors.”
Removed heading “We were an emerging growth company and a smaller reporting company until December 31, 2024, and any decision on our part to comply only with certain reduced reporting and disclosure requirements applicable to emerging growth companies and smaller reporting companies could make our common stock less attractive to investors. The loss of emerging growth company and smaller reporting company status and compliance with additional disclosure requirements will increase our legal and financial compliance costs.”
Largest changes
Already, certain existing legal regimes (e.g., relating to data privacy) regulate certain aspects of AI Technologies, and new laws regulating AI Technologiessee in full comparisonarehaveexpectedeitherto enterentered into force in the United States and the EU or are expected to enter into force in2024.2026. In the United States, theBidenTrump administrationissuedhasarescindedbroadanExecutiveexecutiveOrderorderonrelating to theSafe, Secure,safe andTrustworthy Development and Use of Artificial Intelligence (2023 AI Order), that sets out principles intended to guide AI design and deployment for the public and private sector and signals the increase in governmental involvement and regulation over AI Technologies. The 2023 AI Order established certain new requirements for the training, testing and cybersecurity of sophisticated AI models and large scale computer centers used to train AI models. The 2023 AI Order also instructed several other federal agencies to promulgate additional regulations within specific timeframes from the date of the 2023 AI Order regarding the use andsecure development of AITechnologies.TechnologiesAgenciesthat was previously implemented by the Biden administration. The Trump administration then issued a new executive order that, among other things, requires certain agencies to develop and submit to the president action plans to “sustain and enhance America’s global AI dominance,” and to specifically review and, if possible, rescind rulemaking taken pursuant to the rescinded Biden executive order. Thus, the Trump administration may continue to rescind other existing federal orders and/or administrative policies relating to AI Technologies, or may implement new executive orders and/or other rule making relating to AI Technologies in the future. Any suchaschanges at theDepartmentfederaloflevelCommercecouldandrequiretheusFederaltoTradeexpendCommissionsignificanthaveresourcesissuedtoproposedmodifyrulesourgoverningproducts,theservices,useorandoperationsdevelopmenttoofensureAIcomplianceTechnologies.orLegislationremain competitive. U.S. legislation related to AI Technologies has also been introduced at the federal level and is advancing at the state level. For instance, California enacted a number of new laws that further regulate use of AI Technologies and provide consumers with additional protections around companies’ use of AI Technologies, such as requiring companies to disclose certain uses of generative AI. Other states have also passed AI-focused legislation. For example, on March 13, 2024, Utah passed the Utah AI Policy Act, which took effect in May 2024, imposing certain disclosure requirements on the use of AI, and on May 17, 2024, Colorado enacted the Colorado AI Act, which will take effect in February 2026. Further, the California Privacy Protection Agencyisrecentlycurrently in the process of finalizingfinalized regulations under the CCPA regarding the use of automated decision-making. Such additional regulations may impact our ability to develop,useuse, procure and commercialize AI Technologies in the future.
“In addition, the Trump administration is pursuing a two-fold strategy to reduce drug costs in the U.S. While it is unclear whether and how the Trump proposals will be implemented, the Trump policies are likely to have a negative impact on the pharmaceutical industry and on our ability to receive adequate revenues for investigational products, if approved. On the one hand, President Trump has threatened to impose significant tariffs on pharmaceutical manufacturers that do not adopt pricing policies such as most favored nation pricing, which would tie the price for drugs in the U.S. …”see in full comparison
Among other requirements, the GDPRsee in full comparisonregulatesand UK GDPR regulate transfers of personal data subject to the GDPR or UK GDPR to third countries that have not been found to provide adequate protection to such personal data, including the United States, and the efficacy and longevity of current transfer mechanisms between the EEA or UK and the United States remains uncertain. Case law from the Court of Justice of the European Union (“CJEU”) states that reliance on the standard contractual clauses‑– a standard form of contract approved by the European Commission as an adequate personal data transfer mechanism‑– alone may not necessarily be sufficient in all circumstances and that transfers must be assessed on a case‑by‑case basis.OnWeJuly 10, 2023,expect theEuropeanexistingCommissionlegaladoptedcomplexityitsandAdequacyuncertaintyDecisionregardingininternationalrelationpersonal data transfers to continue and international transfers to thenewUnitedEU-USStatesData Privacy Framework (DPF) rendering the DPF effective as an EU GDPR transfer mechanismand toU.S.otherentitiesjurisdictionsself‑certifiedmoreunder the DPF. On October 12, 2023, the UK Extensiongenerally tothecontinueDPFtoalsobecamesubjectintotoeffectenhanced(as approvedscrutiny bythe UK Government), as data transfer mechanism to U.S. entities self-certified under the DPF.regulators. As the regulatory guidance and enforcement landscape in relation to data transfers continue to develop, we could suffer additional costs, complaints, and/or regulatory investigations or fines, and/ or if we are otherwise unable to transfer personal data between and among countries and regions in which we operate, it could affect the manner in which weprovideoperate ourservices,business, the geographical location or segregation of our relevant systems and operations, and could adversely affect our financial results.These laws and regulations may apply, not only to us, but also to vendors that store or otherwise process data on our behalf, such as information technology vendors. If such a vendor misuses data we have provided to it, or fails to safeguard such data, we may be subject to litigation, regulatory investigations, enforcement notices, and/or enforcement actions, as well as adverse publicity and a potential loss of business.
We are also or may become subject to rapidly evolving data protection laws, rules and regulations in foreign jurisdictions. Any clinical trial programs and research collaborations that we engage in outside the United States may implicate international data protection laws, including, in the European Economic Area (“EEA”), the General Data Protection Regulation (“GDPR”), which became effective in 2018. The GDPR imposes stringent operational requirements for processors and controllers of the personal data of individuals within the EEA. Among other things, the GDPR requires detailed information to be given to data subjects regarding our processing of their personal data, including, for example, notices for clinical trial subjects and investigators, as well as requirements regarding the security of personal data and notification of data processing obligations or security incidents to appropriate data protection authorities or data subjects. If our privacy or data security measures fail to comply with the GDPR requirements, we may be subject to litigation, regulatory investigations, enforcement notices, enforcement actions requiring us to change the way we use personal data and/or fines. In addition to statutory enforcement, a personal data breach can lead to adverse publicity and a potential loss of business. Further, from January 1, 2021, companies have had to comply with both the GDPR and the United Kingdom GDPR (“UK GDPR”), which, together with the amended UK Data Protection Act 2018, imposes separate but similar obligations to those under the GDPR. The UK GDPR mirrors the fines under the GDPR, imposing fines up to the greater of €20 million (£17.5 million) or 4% of global turnover. These laws and regulations may apply, not only to us, but also to vendors that store or otherwise process data on our behalf, such as information technology vendors. If such a vendor misuses data we have provided to it, or fails to safeguard such data, we may be subject to litigation, regulatory investigations, enforcement notices, and/or enforcement actions, as well as adverse publicity and a potential loss of business.see in full comparison
“We currently and may in the future rely on foreign CROs and CMOs. Such foreign CROs and CMOs may be subject to U.S. legislation, sanctions, trade restrictions and other foreign regulatory requirements which could increase the cost or reduce the supply of material available to us, delay the procurement or supply of such material or have an adverse effect on our ability to secure significant commitments from governments to purchase our potential therapies. For example, the U.S. …”see in full comparison
“We were an emerging growth company and a smaller reporting company until December 31, 2024, and any decision on our part to comply only with certain reduced reporting and disclosure requirements applicable to emerging growth companies and smaller reporting companies could make our common stock less attractive to investors. The loss of emerging growth company and smaller reporting company status and compliance with additional disclosure requirements will increase our legal and financial compliance costs.”see in full comparison
Full comparison: every changed paragraph (100)
Investing in shares of our common stock involves a high degree of risk. You should carefully consider the following risks and uncertainties, together with all of the other information contained in this Annual Report on Form 10-K, including our audited consolidated financial statements and related notes and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” before making an investment decision. The risks described below are not the only ones facing us. Many of the following risks and uncertainties are, and will be, exacerbated by any worsening of the global business and economic environment. The occurrence of any of the following risks, or of additional risks and uncertainties not presently known to us or that we currently believe to be immaterial, could materially and adversely affect our business, financial condition, reputation, or results of operations. In such case, the trading price of shares of our common stock could decline, and you may lose all or part of your investment. These disclosures reflect our beliefs and opinions as to factors that could materially and adversely affect our company and our securities in the future. References to past events are provided by way of example only and are not intended to be a complete listing or a representation as to whether or not such factors have occurred in the past or their likelihood of occurring in the future.
We were founded withto confront the greatest medical challenges of our generation by taking a missionfundamentally different approach to redefinethe neuroscienceway drugtreatments development,for abrain fielddiseases are developed, fields that hashave seen very limited success. The ability to successfully develop drugs in thisthese fieldfields is extremely difficult and is subject to a number of unique challenges.
Because of the numerous risks and uncertainties associated with biopharmaceutical and biotechnology products and drug development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. If we are required by the U.S. Food and Drug Administration (FDA) or comparable foreign regulatory authorities to perform studies in addition to those we currently anticipate, or if there are any delays in commencing or completing our clinical trials or the development of any of our product candidates, our expenses could increase and commercial revenue could be further delayed and become more uncertain, which will have a material adverse impact on our business.
In connection with our acquisitions of assets in late 2020, we entered into arrangements whereby the former stockholders of those companies are entitled to substantial contingent consideration payments upon the occurrence of certain events. For example, in connection with our acquisition of BlackThorn Therapeutics, Inc. (“BlackThorn”), a privately held company, the former BlackThorn stockholders are entitled to contingent consideration (i) with respect to navacaprant (NMRA‑140), in the form of development and regulatory approval milestones of up to an aggregate amount of $365.0 million, which includes a milestone payment that became due in October 2023 upon dosing the first patient in the Phase 3 clinical trial for navacaprant, which was primarily settled by issuing unregistered shares of our common stock in December 2023, and sales‑based milestones of up to an aggregate amount of $450.0 million and (ii) with respect to NMRA‑511, in the form of development and regulatory approval milestones of up to an aggregate amount of $100.0 million and sales‑based milestones of up to an aggregate amount of $100.0 million (the “BlackThorn Milestone Payments”). With the exception of one development milestone in the amount of $10.0 million that is required to be settled in cash, the remaining BlackThorn Milestone Payments may be settled in cash or shares of our equity, or a combination of both, at our sole discretion. In connection with the BlackThorn acquisition, we also became obligated under its license agreement with The Scripps Research Institute (“TSRI”) for, among other obligations, development and regulatory milestone payments of up to $1.5 million in aggregate for the first product from each of the TSRI programs and commercial milestone payments of up to $3.5 million in aggregate for each occurrence.
Under the terms of our September 2021 license agreements with Amgen, we are obligated to pay Amgen up to an aggregate of $720.0 million in commercial milestone payments upon the achievement of certain sales thresholds and single digit royalties on potential annual worldwide net sales related to the CK1δ or glucocerebrosidase (“GCase”) programs. In addition, under the collaboration agreement with Amgen, we committed to making quarterly payments to Amgen for their collaboration activities over three years totaling $62.5 million.
Under the terms of our license agreement, as amended, with Vanderbilt University (“Vanderbilt”), we are obligated to pay Vanderbilt up to an aggregate of $422.4 million in development and commercial milestone payments upon the achievement of certain development milestones, which includes a milestone paymentpayments of $2.0 million and $5.0 million that became due in October 2023,2023 and July 2025, respectively, and sales thresholds, and mid‑single digit royalties on potential future net sales.
We are a clinical‑stage biopharmaceutical company with a limited operating history upon which you can evaluate our business and prospects. Since our inception in November 2019, we have devoted substantially all of our resources and efforts to building our organization, acquiring technologies and companies, executing preclinical studies and clinical trials, conducting research and development, identifying and developing potential product candidates, building our precision neuroscience tools, organizing and staffing our company, business planning, establishing, maintaining and protecting our intellectual property portfolio, raising capital and providing general and administrative support for these operations. All of our product candidates are in either clinical development or in preclinical stages of development, and we have not yet demonstrated our ability to successfully complete any late‑stage or registrational/pivotal clinical trials, obtain regulatory approvals, manufacture a commercial scale product or arrange for a third party to do so on our behalfbehalf, or conduct sales and marketing activities necessary for successful product commercialization. Additionally, we expect our financial condition and operating results to continue to fluctuate significantly from period to period due to a variety of factors, many of which are beyond our control. Consequently, any predictions you may make about our future success or viability may not be as accurate as they could be if we had a longer operating history.
the effect of macroeconomic trends including inflation, tariffs, trade controls, and interest rates;
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations with our existing cash, cash equivalents and marketable securities, the net proceeds from our initial public offering, any future equity or debt financings and upfront and milestone and royalties payments, if any, received under any future licenses or collaborations. If we raise additional capital through the sale of equity or convertible debt securities, or issue any equity or convertible debt securities in connection with a collaboration agreement or other contractual arrangement, 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 holder of our common stock. In addition, the possibility of such issuance may cause the market price of our common stock to decline. For example, in October 2024 we entered into a sales agreement with Leerink Partners LLC (“Leerink”) to sell shares of our common stock, from time to time, with aggregate gross sales proceeds of up to $300.0 million, through an at-the-market equity offering program (ATM) with Leerink as the sales agent. During the yearyears ended December 31, 2025 and 2024, we received aggregate net proceeds of $19.7 million and $13.7 millionmillion, respectively, through sales of shares of our common stock under the ATM after deducting commissions and offering expenses of $0.8 million.expenses. In December 2023, we settled a Phase 3 navacaprant milestone owed to BlackthornBlackThorn stockholders by primarily issuing shares of our common stock. Debt financing, if available, may result in increased fixed payment obligations and involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends or acquiring, selling or licensing intellectual property rights or assets, which could adversely impact our ability to conduct our business. For example, in May 2025, we entered into a loan and security agreement (as amended, the “Loan Agreement”) with K2 HealthVentures LLC (“K2HV”), which includes certain affirmative and restrictive covenants that may, among other things, limit our ability to incur additional debt. Additionally, pursuant to the terms of the Loan Agreement, K2HV has the right to convert up to an aggregate of $12.5 million of the outstanding principal of the term loans into shares of our common stock. As of March 30, 2026, K2HV has the right to convert up to an aggregate of $6.5 million of the remaining outstanding principal into shares of common stock, which right, if exercised, could have a dilutive impact on our stockholders’ ownership interests.
Our ability to generate revenue from sales of any of our approved product candidates, which we do not expect will occur for at least the next several years, if at all, depends heavily on the successful identification, development, regulatory approval and eventual commercialization of any product candidates, any of which may never occur. We have never generated revenue from sales of any products, and we may never be able to develop, obtain regulatory approval for, or commercialize, a marketable product. All of our product candidates will require significant clinical development, regulatory approval, establishment of sufficient manufacturing supply, including commercial manufacturing supply, and may require us to build a commercial organization and make substantial investment and significant marketing efforts before we generate any revenue from product sales. We are not permitted to market or promote any of our product candidates before we receive regulatory approval from the FDA or comparable foreign regulatory authorities, and we may never receive such regulatory approval for any of our product candidates.
We were founded withto confront the greatest medical challenges of our generation by taking a missionfundamentally different approach to redefinethe neuroscienceway drugtreatments development,for abrain fielddiseases are developed, fields that hashave seen very limited success. The ability to successfully develop drugs in thisthese fieldfields is extremely difficult and is subject to a number of unique challenges.
Drug development in the fieldfields of brain diseases, andincluding neuropsychiatric disorders and neurodegenerative diseases in particular, has seen very limited success historically. We estimate over $110 billion has been spent on neuroscience research and development since 2019 in the United States alone, representing approximately 33% of all disease‑specific spending. However, only approximately 12% of all new therapies approved during this time period have been for the treatment of brain diseases. From 2011 to 2020, clinical development success rates for new drug candidates that employed patient selection biomarkers were approximately 16% compared to approximately 8% for patients without patient selection biomarkers according to the BIO; however, clinicalClinical success depends on a number of factorsfactors, and employing a patient selection biomarker approach does not guarantee that our product candidates will be approved and commercialized. Developingdeveloping a product candidate for treatment of these and other brain diseases is extremely difficult and subjects us to a number of unique challenges, including obtaining regulatory approval from the FDA and other regulatory authorities who have only a limited set of precedents to rely on.
We intend to work closely with the FDA and comparable foreign regulatory authorities to perform the requisite scientific analyses and evaluation in an effort to obtain regulatory approval for our product candidates for brain or centrally mediated diseases; however, the process of developing our product candidates may be more complex and time‑consumingtime-consuming relative to other more well‑knownwell-known approaches to drug development. We cannot be certain that our approach will lead to the development of product candidates that effectively and safely address the underlying brain or centrally mediated diseases.
Moreover, given the history of clinical failures in thisthese field,fields, future clinical or regulatory failures by us or others may result in further negative perception of the likelihood of success in thisthese field,fields, which may significantly and adversely affect the market price of our common stock.
Our approach represents an aggregation of innovation and assets from multiple companies and academic institutions, including BlackThorn, Amgen, TSRI and Vanderbilt. Further, a key component of our strategy is to acquire and in‑license assets and technologies to support the growth of our product pipeline and to enhance our Precision Toolbox.Toolbox of translational neuroscience tools, methods, and data science capabilities. As such, we actively evaluate various strategic transactions on an ongoing basis. We may acquire other assets, businesses, products or technologies, as well as pursue joint ventures or investments in complementary businesses. The success of our strategic transactions and any future strategic transactions depends on the risks and uncertainties involved including:
If any of these risks or uncertainties occur, we may not realize the anticipated benefit of any acquisition or strategic transaction. For example, less than one year following the acquisition of Propellex, we terminated and are no longer developing the program we acquired from Propellex. Additionally, foreign acquisitions and joint ventures are subject to additional risks, including those related to integration of operations across different cultures and languages, currency risks, potentially adverse tax consequences of overseas operations and the particular economic, political and regulatory risks associated with specific countries.
Our ability to execute on our drug development strategy depends in part on our ability to enhance and improve our precision neuroscience approach. As part of this approach, we interrogate public, partnered and proprietary datasets across neuropsychiatric and neurodegenerative diseases, currently encompassing genetic, imaging, electroencephalogram (EEG),electroencephalogram, digital and clinical data. We rely on these datasets and data analytics for identifying or validating some of our biomarker‑target relationships. The success of our precision neuroscience approach and any enhancement to our approach depends on several factors, including access to and generation of additional multimodal patient datasets, whether public, partnered or proprietary, development of more advanced proprietary machine learning capabilities and increased computational storage and processing capacity. If we are unable to access additional datasets or they are not available on acceptable terms, or if we are otherwise unsuccessful in enhancing our approach, we may be limited in our precision neuroscience capabilities and not be able to fully utilize a precision neuroscience drug development strategy.
We outsource substantially all of the technological infrastructure relating to our hosted platformplatforms to third‑party hosting services, such as Amazon Web Services. We have no control over any of these third parties, and while we attempt to reduce risk by minimizing reliance on any single third party or its operations, we cannot guarantee that such third‑party providers will not experience system interruptions, outages or delays, or deterioration in their performance. We need to be able to access our computational platform at any time, without interruption or degradation of performance. Our hosted platform depends on protecting the virtual cloud infrastructure hosted by third‑party hosting services by maintaining its configuration, architecture, features, and interconnection specifications, as well as protecting the information stored in these virtual data centers, which is transmitted by third‑party Internet service providers. We have experienced and expect that in the future we may again experience interruptions, delays and outages in service and availability from time to time due to a variety of factors, including infrastructure changes, human or software errors, website hosting disruptions and capacity constraints. Any limitation on the capacity of our third‑party hosting services could adversely affect our business, financial condition, and results of operations. In addition, any incident affecting our third‑party hosting services’ infrastructure that may be caused by cyber‑attacks, natural disasters, fire, flood, severe storm, earthquake, power loss, telecommunications failures, terrorist or other attacks, and other disruptive events beyond our control could negatively affect our cloud‑basedhosted solutions.platforms. A prolonged service disruption affecting our cloud‑basedhosted solutionsplatforms could damage our reputation or otherwise harm our business. We may also incur significant costs for using alternative equipment or taking other actions in preparation for, or in reaction to, events that damage the third‑party hosting services we use.
In the event that our service agreements with our third‑party hosting services are terminated, or there is a lapse of service, elimination of services or features that we utilize, interruption of internet service provider connectivity, or damage to such facilities, we could experience interruptions in access to our platformplatforms as well as significant delays and additional expense in arranging or creating new facilities and services and/or re‑architecting our hosted software solutionsplatforms for deployment on a different cloud infrastructure service provider, which could adversely affect our business, financial condition, and results of operations.
timely completion of preclinical laboratory tests, animal studies and formulation studies in accordance with FDA’s Good Laboratory Practice (“GLP”) requirements and other applicable regulations;
approval by an independent Institutional Review Board (“IRB”) or ethics committee at each clinical site before each trial may be initiated;
delays in reaching a consensus with regulatory agencies on study design and obtaining regulatory authorization to commence clinical trials; delays in reaching agreement on acceptable terms with prospective contract research organizations (“CROs”), and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites;
failure by our CROs, other third parties or us to adhere to clinical trial protocols; failure to perform in accordance with the FDA’s or any other regulatory authority’s good clinical practice (“GCP”) requirements, or applicable regulatory guidelines in other countries;
transfer of manufacturing processes to larger‑scale facilities operated by a contract manufacturing organization (“CMO”) and delays or failure by our CMOs or us to make any necessary changes to such manufacturing process; and third parties being unwilling or unable to satisfy their contractual obligations to us.
Clinical trials must be conducted in accordance with the FDA'sFDA’s and other applicable regulatory authorities’ legal requirements, regulations or guidelines, and are subject to oversight by these governmental agencies and ethics committees or IRBs at the medical institutions where the clinical trials are conducted. We could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs of the institutions in which such trials are being conducted, by a Data Safety Monitoring Board for such trial or by the FDA or comparable foreign regulatory authorities. Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or comparable foreign regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. For example, in April 2024, our Phase 1 trial of NMRA-266 was placed on clinical hold by the FDA after data from nonclinical studies showed convulsions in rabbits. Although we are in discussions with the FDA regarding the potential to remove the clinical hold, there is no guarantee that we will be able to successfully resolve the clinical hold issues or resume clinical studies of NMRA-266 in the time and manner that we expect. In addition, changes in regulatory requirements and policies may occur, and we may need to amend clinical trial protocols to comply with these changes. Amendments may require us to resubmit our clinical trial protocols to IRBs for reexamination, which may impact the costs, timing or successful completion of a clinical trial.
In addition, the FDA’s and other regulatory authorities’ policies with respect to clinical trials may change and additional government regulations may be enacted. For example the EU Clinical Trials Regulation (“CTR”) which was adopted in April 2014 and repeals the EU Clinical Trials Directive, became applicable on January 31, 2022. While the Clinical Trials Directive required a separate clinical trial application (“CTA”), to be submitted in each member state in which the clinical trial takes place, to both the competent national health authority and an independent ethics committee, the CTR introduces a centralized process and only requires the submission of a single application for multi-center trials. The CTR allows sponsors to make a single submission to both the competent authority and an ethics committee in each member state, leading to a single decision per member state. The assessment procedure of the CTA has been harmonized as well, including a joint assessment by all member states concerned, and a separate assessment by each member state with respect to specific requirements related to its own territory, including ethics rules. Each member state’s decision is communicated to the sponsor via the centralized EU portal. Once the CTA is approved, clinical study development may proceed. The CTR transition period ended on January 31, 2025, and all clinical trials (and related applications) are now fully subject to the provisions of the CTR. Compliance with the CTR requirements by us and our third-party service providers, such as Contract research organizations (CRO),CROs, may impact our developments plans.
It is currently unclear to what extent the United Kingdom (“UK”) will seek to align its regulations with the EU.European Union (“EU”). The UK regulatory framework in relation to clinical trials is derived from existing EU legislation (as implemented into UK law, through secondary legislation).
On January 17, 2022, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”), launched an eight-week consultation on reframing the UK legislation for clinical trials which aimed to streamline clinical trials approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality, and promote patient and public involvement in clinical trials. The MHRA published its consultation outcome on March 21, 2023 confirming that it would bring forward changes to the legislation. These resulting legislative amendments, which are yet to be published, will ultimately determine the extent to which the UK regulations align with the (EU) CTR. A decision by the UK not to closely align its regulations with the new approach adopted in the EU may have an effect on the cost of conducting clinical trials in the UK as opposed to other countries.
To obtain the requisite regulatory approvals to market and sell any of our product candidates, we or any collaborator for such product candidate must demonstrate through extensive preclinical studies and clinical trials that the product candidate is safe and effective in humans. Before an investigational new drug application (“IND”) can be submitted to the FDA and become effective, which is a prerequisite for conducting clinical trials on human subjects in the United States, a product candidate must successfully progress through extensive preclinical studies, which include preclinical laboratory testing, animal studies, and formulation studies, certain of which must be conducted in accordance with GLP. We cannot be certain of the timely completion or outcome of any preclinical studies. We also cannot predict if the FDA or comparable foreign regulatory authorities will allow our proposed clinical programs to proceed or if the outcome of our preclinical studies will ultimately support further development of our programs. Additionally, we cannot be sure that we will be able to submit INDs or similar applications with respect to our product candidates on the timelines we expect, if at all, and we cannot be sure that submission of IND or similar applications will result in the FDA or other regulatory authorities allowing clinical trials to begin.
Moreover, success in preclinical studies or early clinical trials does not ensure that later preclinical studies or clinical trials will be successful. A number of companies in the biotechnology and biopharmaceutical industries have suffered significant setbacks in clinical trials, even after positive results in earlier preclinical studies. These setbacks have been caused by, among other things, preclinical findings made while clinical trials were underway and safety or efficacy observations made in clinical trials, including previously unreported adverse events. The design of a clinical trial can determine whether its results will support approval of a product, and flaws in the design of a clinical trial may not become apparent until the clinical trial is well advanced. In addition, clinical and preclinical data are often susceptible to varying interpretations and analyses. Notwithstanding any potential promising results in earlier studies, we cannot be certain that we will not face similar setbacks. For example, in January 2025, we announced that our KOASTAL-1 study did not demonstrate a statistically significant improvement on the primary endpoint of change from baseline in the Montgomery-Åsberg Depression Rating Scale (“MADRS”) total score at Week 6 or the key secondary endpoint of a change from baseline in the Snaith-Hamilton Pleasure Scale (“SHAPS”) scale. In addition, the results of our preclinical animal studies, including our non‑human primate studies, may not be predictive of the results of outcomes in subsequent clinical trials on human subjects. Product candidates in clinical trials may fail to show the desired pharmacological properties or safety and efficacy traits despite having progressed through preclinical studies.
regulatory authorities may require a medication guide outlining the risks of such side effects for distribution to patients, or that we implement a risk evaluation and mitigation strategy (“REMS”), plan to ensure that the benefits of the product outweigh its risks;
Although the clinical trial process is designed to identify and assess potential side effects, it is always possible that a drug, even after regulatory approval, may exhibit unforeseen side effects. If any of our product candidates were to cause adverse side effects during clinical trials or after approval of the product candidate, we may be exposed to substantial liabilities. Physicians and patients may not comply with any warnings that identify known potential adverse effects andor patients who should not use our product candidates.
The clinical development, manufacturing, labeling, packaging, storage, recordkeeping, advertising, promotion, export, import, marketing, distribution, adverse event reporting, including the submission of safety and other post‑marketing information and reports, and other possible activities relating to our product candidates are subject to extensive regulation. In the United States, obtaining marketing approval for a new drug requires the submission of a New Drug Application (“NDA”) to the FDA, and we are not permitted to market any product candidate in the United States until we obtain approval from the FDA of the NDA for that product candidate. An NDA must be supported by extensive clinical and preclinical data, as well as extensive information regarding pharmacology, chemistry, manufacturing, and controls. Outside the United States, many comparable foreign regulatory authorities employ similar approval processes.
the results of clinical trials may not meet the level of statistical significance or persuasiveness required by the FDA or comparable foreign regulatory authorities for approval;
If the FDA or a comparable foreign regulatory authority approves any of our product candidates, the manufacturing processes, testing, safety, efficacy, labeling, packaging, distribution, import, export, adverse event reporting, storage, advertising, promotion, and recordkeeping for the product will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post‑marketing information and reports, and registration, as well as continued compliance with current good manufacturing practices (“cGMPs”) and similar foreign requirements, and GCPs for any clinical trials that we conduct post‑approval, all of which may result in significant expense and limit our ability to commercialize such products. In addition, any regulatory approvals that we receive for our product candidates may also be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post‑marketing testing, including Phase 4 clinical trials, and additional surveillance to monitor the safety and efficacy of the product candidate.
Disruptions at the FDA and other government agencies caused by funding shortages, staffing reductions or globalpolicy health concernschanges could hinder their ability to hire, retain, or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved, or commercialized in a timely manner or at all, which could negatively impact our business.
The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, reductions in staffing, statutory, regulatory, and policy changes, the FDA’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s ability to perform routine functions. Average review times at the FDA have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies may also slow the time necessary for new drugs or modifications to approved drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, in recent years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. In addition, duringthe current U.S. Presidential administration has issued certain policies and Executive Orders directed towards reducing the COVID‑19employee pandemic,headcount and costs associated with U.S. administrative agencies, including the FDA postponed most inspections of domesticFDA, and foreignit manufacturingremains facilities at various points, and more recently there have been FDA staff cuts underunclear the Trumpdegree administration.to Ifwhich athese prolongedefforts governmentmay shutdown occurs,limit or ifotherwise staffingadversely reductions or global health concerns preventaffect the FDA or other regulatory authorities from conducting their regular activities, it could significantly impact theFDA’s ability of the FDA or other regulatory authorities to timelyconduct reviewroutine and process our regulatory submissions, which could have a material adverse effect on our business.activities.
If a prolonged government shutdown occurs, or if funding shortages, staffing reductions or similar constraints or events prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews or other activities, such events or circumstances could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
We are subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations, various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Controls, the U.S. Foreign Corrupt Practices Act of 1977, as amended (the “FCPA”), the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, the USA PATRIOT Act, and other state and national anti‑bribery and anti‑money laundering laws in the countries in which we conduct activities. Anti‑corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and other collaborators from authorizing, promising, offering, or providing, directly or indirectly, improper payments or anything else of value to recipients in the public or private sector. We may engage third parties to sell our products outside the United States, to conduct clinical trials, and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals. We have direct or indirect interactions with officials and employees of government agencies or government‑affiliated hospitals, universities, and other organizations. We can be held liable for the corrupt or other illegal activities of our employees, agents, contractors, and other collaborators, even if we do not explicitly authorize or have actual knowledge of such activities. Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences.
the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing, or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for, healthcare benefits, items, or services. Similar to the federal Anti‑Kickback Statute, a person or entity does not need to have actual knowledge of the healthcare fraud statute implemented under HIPAA or specific intent to violate it in order to have committed a violation;
the U.S. Physician Payments Sunshine Act and its implementing regulations, which requires, among other things, certain manufacturers of drugs and devices that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare and Medicaid Services,Services or CMS,(“CMS”), information related to certain payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals, as well as ownership and investment interests held by such physicians and their immediate family members;
In the United States and other jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes and proposed changes to the healthcare system that could affect our future results of operations. In particular, there have been and continue to be a number of initiatives at the U.S. federal and state levels that seek to reduce healthcare costs and improve the quality of healthcare. For example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the “ACA”), was enacted, which substantially changed the way healthcare is financed by both governmental and private payors. Among the provisions of the ACA of importance to the biopharmaceutical and biotechnology industries are the following:
Since its enactment, there have been judicial and Congressional challenges to certain aspects of the ACA. On June 17, 2021, the U.S. Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA. Thus, the ACA remains in effect in its current form. On August 16, 2022, President Biden signed the Inflation Reduction Act of 2022 (the “IRA”) was signed into law, which, among other things, extendsextended enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. It is unclear how other healthcare reform measures of the Trump administration or other efforts, if any, to challenge, repeal or replace the ACA, will impact our business.
In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted. For example, on March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 was signed into law, which eliminated the statutory Medicaid drug rebate cap, beginning January 1, 2024. The rebate was previously capped at 100% of a drug’s average manufacturer price. Further, in August 2011, the Budget Control Act of 2011, among other things, included aggregate reductions of Medicare payments to providers. These reductions went into effect in April 2013 and, due to subsequent legislative amendments to the statute, will remain in effect until 2032, with the exception of a temporary suspension from May 1, 2020 through March 31, 2022, unless additional action is taken by Congress.
Moreover, heightened governmental scrutiny is likely to continue over the manner in which manufacturers set prices for their marketed products, which already has resulted in several Congressional inquiries, proposed and enacted legislation and executive orders issued by the President designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. Most recently, the IRA marks the most significant action by Congress with respect to the biopharmaceutical industry since adoption of the ACA in 2010. Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023), and replaces the Part D coverage gap discount program with a new discounting program (which began on January 1,in 2025). Manufacturers that fail to comply with the IRA may be subject to various penalties, including civil monetary penalties. The IRA permits the Secretary of the Department of Health and Human Services (“HHS”) to implement many of these provisions through guidance, as opposed to regulation, for the initial years. OnCMS Augusthas 15, 2024, HHS announcedpublished the agreed uponnegotiated prices for the firstinitial ten drugs that are subject to price negotiations,drugs, which takewent into effect in January 2026.2026, HHSand the subsequent 15 drugs, which will selectfirst upbe to fifteen additional products covered under Part D for negotiationeffective in 2025. Each year thereafter, more Part B and Part D products will become subject to the HHS price negotiation program,2027, although the program is currently subject to legal challenges. For that and other reasons, it is currently unclear how the IRA will be effectuated, and while the impact of the IRA on the biopharmaceutical industry cannot yet be fully determined, it is likely to be significant.
The OBBBA also included significant reforms to Medicaid, including an estimated $1 trillion in reduced federal Medicaid spending from 2025 through 2034, the imposition of work requirements for certain adult enrollees, more frequent eligibility redeterminations, and increased cost-sharing for beneficiaries. These changes are expected to reduce overall Medicaid enrollment and access to care. Although the effect on our business is currently unknown, any decrease in the number of insured patients or reimbursement levels for our products could adversely affect our revenue and commercial prospects.
In addition, the Trump administration is pursuing a two-fold strategy to reduce drug costs in the U.S. While it is unclear whether and how the Trump proposals will be implemented, the Trump policies are likely to have a negative impact on the pharmaceutical industry and on our ability to receive adequate revenues for investigational products, if approved. On the one hand, President Trump has threatened to impose significant tariffs on pharmaceutical manufacturers that do not adopt pricing policies such as most favored nation pricing, which would tie the price for drugs in the U.S. to the lowest price in a group of other countries. In response, multiple manufacturers have reportedly entered into confidential pricing agreements with the federal government. On the other hand, the Trump administration is pursuing traditional regulatory pathways to impose drug pricing policies, although final regulations have not yet been published. Even regulatory proposals or executive actions that are ultimately deemed unlawful could negatively impact the U.S. pharmaceutical sector and our business. In addition, pharmaceutical pricing and marketing has long been the subject of considerable discussion in Congress and among policymakers.
Additionally, individual states in the United States have passed legislation and implemented regulations designed to control biopharmaceutical product pricing and costs. Similar developments have occurred outside of the United States, including in the European UnionEU where healthcare budgetary constraints have resulted in restrictions on the pricing and reimbursement of medicines by relevant health service providers. To obtain reimbursement or pricing approval in some European UnionEU member states, we may be required to conduct studies that compare the cost‑effectiveness of our product candidates to other therapies that are considered the local standard of care.
Our ability to commercialize any products successfully also will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from third‑party payors, such as government authorities, private health insurers, and other organizations. Even if we succeed in bringing one or more products to the market, these products may not be considered cost‑effective, and the amount reimbursed for any products may be insufficient to allow us to sell our products on a competitive basis. Because our programs are in the relatively early stages of development, we are unable at this time to determine their cost effectiveness or the likely level or method of coverage and reimbursement. Increasingly, the third‑party payors who reimburse patients or healthcare providers are requiring that drug companies provide them with predetermined discounts from list prices, and are seeking to reduce the prices charged or the amounts reimbursed for drug products. If the price we are able to charge for any products we develop, or the coverage and reimbursement provided for such products, is inadequate in light of our development and other costs, our return on investment could be affectedadversely adversely.affected.
Furthermore, the Federal Trade Commission (“FTC”) also has authority to initiate enforcement actions against entities that mislead customers about HIPAA compliance, make deceptive statements about privacy and data sharing in privacy policies, fail to limit third-party use of personal health information, fail to implement policies to protect personal health information or engage in other unfair practices that harm customers or that may violate Section 5 of the Federal Trade Commission Act (“FTC Act.Act”). Even when HIPAA does not apply, according to the FTC violating consumers’ privacy rights or failing to take appropriate steps to keep consumers’ personal information secure may constitute a violation of the FTC Act. The FTC expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities. Additionally, federal and state consumer protection laws are increasingly being applied by FTC and states’ attorneys general to regulate the collection, use, storage, and disclosure of personal or personally identifiable information, through websites or otherwise, and to regulate the presentation of website content.
We may maintain certain sensitive information about individuals, including health-related information, that we receive throughout the clinical trial process, in the course of our research collaborations, and directly from individuals (or their healthcare providers) who enroll in our patient assistance programs. As such, we may be subject to state laws and regulations governing the privacy and security of personal information or requiring notification of affected individuals and state regulators in the event of a breach of personal information. Such laws and regulations will be subject to interpretation by various courts and other governmental authorities, thus creating potentially complex compliance issues for us and our future customers and strategic partners. For example, the California Consumer Privacy Act, as amended by the California Privacy Rights Act (collectively, the “CCPA”) requires covered businesses that process the personal information of California residents to, among other things: (i) provide certain disclosures to California residents regarding the business’s collection, use, and disclosure of their personal information; (ii) receive and respond to requests from California residents to access, delete, and correct their personal information, or to opt out of certain disclosures of their personal information; and (iii) enter into specific contractual provisions with service providers that process California resident personal information on the business’s behalf. Although there are limited exemptions for health‑related information, including clinical trial data, the CCPA may increase our compliance costs and potential liability. Similar laws have been passed in other states, and are continuing to be proposed at the state and federal level, reflecting a trend toward more stringent privacy legislation in the United States. The enactment of such laws could have potentially conflicting requirements that would make compliance challenging.
We are also or may become subject to rapidly evolving data protection laws, rules and regulations in foreign jurisdictions. Any clinical trial programs and research collaborations that we engage in outside the United States may implicate international data protection laws, including, in the European Economic Area (“EEA”), the General Data Protection Regulation (“GDPR”), which became effective in 2018. The GDPR imposes stringent operational requirements for processors and controllers of the personal data of individuals within the EEA. Among other things, the GDPR requires detailed information to be given to data subjects regarding our processing of their personal data, including, for example, notices for clinical trial subjects and investigators, as well as requirements regarding the security of personal data and notification of data processing obligations or security incidents to appropriate data protection authorities or data subjects. If our privacy or data security measures fail to comply with the GDPR requirements, we may be subject to litigation, regulatory investigations, enforcement notices, enforcement actions requiring us to change the way we use personal data and/or fines. In addition to statutory enforcement, a personal data breach can lead to adverse publicity and a potential loss of business. Further, from January 1, 2021, companies have had to comply with both the GDPR and the United Kingdom GDPR (“UK GDPR”), which, together with the amended UK Data Protection Act 2018, imposes separate but similar obligations to those under the GDPR. The UK GDPR mirrors the fines under the GDPR, imposing fines up to the greater of €20 million (£17.5 million) or 4% of global turnover. These laws and regulations may apply, not only to us, but also to vendors that store or otherwise process data on our behalf, such as information technology vendors. If such a vendor misuses data we have provided to it, or fails to safeguard such data, we may be subject to litigation, regulatory investigations, enforcement notices, and/or enforcement actions, as well as adverse publicity and a potential loss of business.
Among other requirements, the GDPR regulatesand UK GDPR regulate transfers of personal data subject to the GDPR or UK GDPR to third countries that have not been found to provide adequate protection to such personal data, including the United States, and the efficacy and longevity of current transfer mechanisms between the EEA or UK and the United States remains uncertain. Case law from the Court of Justice of the European Union (“CJEU”) states that reliance on the standard contractual clauses ‑– a standard form of contract approved by the European Commission as an adequate personal data transfer mechanism ‑– alone may not necessarily be sufficient in all circumstances and that transfers must be assessed on a case‑by‑case basis. OnWe July 10, 2023,expect the Europeanexisting Commissionlegal adoptedcomplexity itsand Adequacyuncertainty Decisionregarding ininternational relationpersonal data transfers to continue and international transfers to the newUnited EU-USStates Data Privacy Framework (DPF) rendering the DPF effective as an EU GDPR transfer mechanismand to U.S.other entitiesjurisdictions self‑certifiedmore under the DPF. On October 12, 2023, the UK Extensiongenerally to thecontinue DPFto alsobe camesubject intoto effectenhanced (as approvedscrutiny by the UK Government), as data transfer mechanism to U.S. entities self-certified under the DPF.regulators. As the regulatory guidance and enforcement landscape in relation to data transfers continue to develop, we could suffer additional costs, complaints, and/or regulatory investigations or fines, and/ or if we are otherwise unable to transfer personal data between and among countries and regions in which we operate, it could affect the manner in which we provideoperate our services,business, the geographical location or segregation of our relevant systems and operations, and could adversely affect our financial results. These laws and regulations may apply, not only to us, but also to vendors that store or otherwise process data on our behalf, such as information technology vendors. If such a vendor misuses data we have provided to it, or fails to safeguard such data, we may be subject to litigation, regulatory investigations, enforcement notices, and/or enforcement actions, as well as adverse publicity and a potential loss of business.
Further, we use artificial intelligence (“AI”), machine learning, and automated decision-making technologies (collectively, “AI Technologies”) throughout our business. The regulatory framework for AI Technologies is rapidly evolving as many federal, state and foreign government bodies and agencies have introduced or are currently considering additional laws and regulations. Additionally, existing laws and regulations may be interpreted in ways that would affect the operation of our AI Technologies. As a result, implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future, and we cannot yet determine the impact future laws, regulations, standards, or market perception of their requirements may have on our business and may not always be able to anticipate how to respond to these laws or regulations.
Already, certain existing legal regimes (e.g., relating to data privacy) regulate certain aspects of AI Technologies, and new laws regulating AI Technologies arehave expectedeither to enterentered into force in the United States and the EU or are expected to enter into force in 2024.2026. In the United States, the BidenTrump administration issuedhas arescinded broadan Executiveexecutive Orderorder onrelating to the Safe, Secure,safe and Trustworthy Development and Use of Artificial Intelligence (2023 AI Order), that sets out principles intended to guide AI design and deployment for the public and private sector and signals the increase in governmental involvement and regulation over AI Technologies. The 2023 AI Order established certain new requirements for the training, testing and cybersecurity of sophisticated AI models and large scale computer centers used to train AI models. The 2023 AI Order also instructed several other federal agencies to promulgate additional regulations within specific timeframes from the date of the 2023 AI Order regarding the use andsecure development of AI Technologies.Technologies Agenciesthat was previously implemented by the Biden administration. The Trump administration then issued a new executive order that, among other things, requires certain agencies to develop and submit to the president action plans to “sustain and enhance America’s global AI dominance,” and to specifically review and, if possible, rescind rulemaking taken pursuant to the rescinded Biden executive order. Thus, the Trump administration may continue to rescind other existing federal orders and/or administrative policies relating to AI Technologies, or may implement new executive orders and/or other rule making relating to AI Technologies in the future. Any such aschanges at the Departmentfederal oflevel Commercecould andrequire theus Federalto Tradeexpend Commissionsignificant haveresources issuedto proposedmodify rulesour governingproducts, theservices, useor andoperations developmentto ofensure AIcompliance Technologies.or Legislationremain competitive. U.S. legislation related to AI Technologies has also been introduced at the federal level and is advancing at the state level. For instance, California enacted a number of new laws that further regulate use of AI Technologies and provide consumers with additional protections around companies’ use of AI Technologies, such as requiring companies to disclose certain uses of generative AI. Other states have also passed AI-focused legislation. For example, on March 13, 2024, Utah passed the Utah AI Policy Act, which took effect in May 2024, imposing certain disclosure requirements on the use of AI, and on May 17, 2024, Colorado enacted the Colorado AI Act, which will take effect in February 2026. Further, the California Privacy Protection Agency isrecently currently in the process of finalizingfinalized regulations under the CCPA regarding the use of automated decision-making. Such additional regulations may impact our ability to develop, useuse, procure and commercialize AI Technologies in the future.
In Europe, on May 21, 2024, the European UnionEU legislators approved the EU Artificial Intelligence Act (the “EU AI Act”), which establishes a comprehensive, risk-based governance framework for artificial intelligence in the EU market. The EU AI Act entered into force on August 2,1, 2024 and the majority of the substantive requirements will apply from August 2, 2026. The EU AI Act will apply to companies that develop, use and/or provide AI in the EU and includes requirements around transparency, conformity assessments and monitoring, risk assessments, human oversight, security, accuracy, general purpose AI and foundation models, and proposes fines for breach of up to 7% of worldwide annual turnover. In addition, onthe Septemberrevised 28,EU 2022,Product Liability Directive came into force in December 2024, to be implemented into EU member state national law by December 2026. This directive extends the EuropeanEU’s Commissionexisting proposedstrict two Directives seeking to establish a harmonized civilproduct liability regime forto AI inTechnologies theand EUAI-enabled inproducts, orderand to facilitatefacilitates civil claims in respect of harm caused by AI and to include AI-enabled products within the scope of the EU’s existing strict product liability regime.AI. Once fully applicable, the EU AI Act and the EU Product Liability DirectivesDirective will have a material impact on the way AI is regulated in the EU. Recent case law from the CJEU has taken an expansive view of the scope of the GDPR’s requirements around automated decision making and introduced uncertainty in the interpretation of these rules. The EU AI Act, and developing interpretation and application of the GDPR in respect of automated decision making, together with developing guidance and/or decisions in this area, may affect our use of AI Technologies and our ability to provide, improve or commercialize our business, require additional compliance measures and changes to our operations and processes, result in increased compliance costs and potential increases in civil claims against us, and could adversely affect our business, operations and financial condition.
We currently and may in the future rely on foreign CROs and CMOs. Such foreign CROs and CMOs may be subject to U.S. legislation, sanctions, trade restrictions and other foreign regulatory requirements which could increase the cost or reduce the supply of material available to us, delay the procurement or supply of such material or have an adverse effect on our ability to secure significant commitments from governments to purchase our potential therapies. For example, the U.S. BIOSECURE Act, which was enacted in December 2025, prohibits federal agencies from procuring or using any biotechnology equipment or services from “biotechnology companies of concern”, or entering into, extending, or renewing any contracts with entities that use such biotechnology equipment or services from “biotechnology companies of concern”. Congress has interpreted a “biotechnology company of concern” as an entity that is under the control of a foreign adversary and that poses a risk to national security based on its research or multiomic data collection (e.g., collection of genomic information). While the U.S. BIOSECURE Act has a grandfathering period of five years for existing contracts, and has carveouts for manufacture of drugs for supply under Medicaid and Medicare Part B, subject to the Secretary of Veteran Affairs’ discretion, the impact of the U.S. BIOSECURE Act on the biotechnology industry is uncertain. This and similar laws could have the potential to restrict the ability of biopharmaceutical companies like us to purchase services or products from, or otherwise collaborate with, certain biotechnology companies “of concern” without losing the ability to contract with, or otherwise receive funding from, the U.S. government. It is possible some of our contractual counterparties could be impacted by this or future legislation.
In January 2024, there was congressional activity, including the introduction of the BIOSECURE Act (H.R. 7085) in the House of Representatives and a substantially similar Senate bill (S.3558). The BIOSECURE Act was passed by the House of Representatives in September 2024. If these bills become law, or similar laws are passed, they would have the potential to severely restrict the ability of U.S. biopharmaceutical companies like us to purchase products or services from, or otherwise collaborate with, certain Chinese biotechnology companies “of concern” without losing the ability to contract with, or otherwise receive funding from, the U.S. government. It is possible some of our contractual counterparties, including WuXi AppTech and WuXi Biologics and other Chinese vendors, could be impacted by the legislation.
There is a limited number of third‑party service providers that specialize or have the expertise required to achieve our business objectives. Many of the third parties with whom we contract may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other drug development activities that could harm our competitive position. If any of our relationships with these third‑party laboratories, CROs or clinical investigators terminate, we may not be able to enter into arrangements with alternative laboratories, CROs, or investigators or to do so in a timely manner or on commercially reasonable terms. If laboratories, CROs, or clinical investigators do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our preclinical or clinical protocols, regulatory requirements or for other reasons, our preclinical or clinical trials may be extended, delayed, or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. As a result, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase, and our ability to generate revenues could be delayed. Switching or adding additional laboratories or CROs (or “investigators”) involves additional cost and requires management time and focus. In addition, there is a natural transition period when a new laboratory or CRO commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. Additionally, CROs may lack the capacity to absorb higher workloads or take on additional capacity to support our needs. Though we carefully manage our relationships with our contracted laboratories and CROs, there can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition, and prospects.
Given the breadth of the application of our precision neuroscience approach, in order to increase our ability to exploit our technologies, we may enter into collaborations and/or strategic partnerships in the future, and we may not realize the anticipated benefits of such collaborations or partnerships. WeIf maywe not beare able to doenter sointo such transactions or to realize the potential benefits of such transactions, whichwe may causebe usforced to alter or delay our development and commercialization plans.
Management's Discussion & Analysis (MD&A)
New heading “Interest Expense”
New heading “Interest Expense”
Largest changes
“Research and development expenses increased by $58.2 million, or 41%, to $200.9 million for the year ended December 31, 2024 from $142.7 million for the year ended December 31, 2023 as we advanced our clinical trials. Direct external program expenses increased by $62.8 million, of which $67.5 million was related to the advancement our Phase 3 and Phase 2 clinical trials for navacaprant, partially offset by a decrease of $4.8 million to preclinical program research. …”see in full comparison
“lower personnel-related costs of $11.0 million due to a reduction in stock based compensation expense primarily driven by one time stock option modification expense of $3.6 million recorded in 2024 that did not recur, as well as departures of certain key executive, and lower overall headcount, and a decrease in other costs of $8.9 million primarily due to a reduction in expense incurred under our research and collaboration agreements with Amgen of $6.3 million. …”see in full comparison
“We were an “emerging growth company,” as defined in the JOBS Act until December 31, 2024. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until those standards apply to private companies.”see in full comparison
“We were also a “smaller reporting company,” as defined in the Exchange Act until December 31, 2024, and we have elected to take advantage of certain of the scaled disclosures available to smaller reporting companies.”see in full comparison
Full comparison: every changed paragraph (43)
We are a clinical-stage biopharmaceutical company founded to confront the globalgreatest brainmedical diseasechallenges crisisof our generation by takingbringing a fundamentally different approach toforward the waynext treatmentsgeneration of novel therapies with brain-penetrant chemistry that offer improved treatment outcomes and quality of life for brainpatients. diseases are developed. We have rapidly scaled ourOur therapeutic pipeline, whichpipeline currently consists of seven neuroscience programs, including two clinical programs,programs that target novel mechanisms of action for a broad range of underservedunderserved, neuropsychiatric disorders and neurodegenerativeprevalent diseases. OurWe mostare advancedadvancing producta candidate,Phase navacaprant3 (NMRA-140),program isfor navacaprant, a novel once-daily oral kappa opioid receptor (“KOR”) antagonist that is being developed for the treatment of major depressive disorder (“MDD”), which we believe has the potential to provide significant advantages relative to the standard of care, if approved. NavacaprantWe isare beingalso investigated in the KOASTAL program, a pivotal Phase 3 program, evaluating navacaprant monotherapy in patients with moderate to severe MDD. Neumora expects to report topline data from KOASTAL-3 in the first quarter of 2026 and KOASTAL-2 in the second quarter of 2026. Our next most advanced product candidate isadvancing NMRA-511, a highly selective, novel antagonist of the vasopressin 1a receptor (“V1aR”) being developed for the treatment of agitation associated with dementia due to Alzheimer'sAlzheimer’s disease (“AD”). WeBeyond arenavacaprant and NMRA-511, Neumora is advancing NMRA-898, a Phasenovel 1bM4 signal-seekingPAM studywith investigatingpotential NMRA-511 initiallybest in healthyclass elderlypharmacology adultfor participantsthe andtreatment thenof peopleschizophrenia. withAdditionally, agitationNeumora associatedis withdeveloping dementiaNMRA-215, duea, tohighly AD,brain-penetrant, andoral weNLRP3 inhibitor for the treatment of obesity. We expect several updates from these programs throughout 2026, including to report Phase 3 KOASTAL-2 and -3 topline data from this study in bythe second quarter of 2026, report MAD extension data with NMRA-511 in the endsecond half of 2025.2026, Ourand M4to positive allosteric modular (PAM) franchise comprisesreport multiple novelascending compoundsdose that(“MAD”) eachdata havewith different chemical composition but optimal pharmacological properties, which have demonstrated robust activityNMRA-898 in preclinical efficacy models and high selectivity for the M4second receptorhalf subtype.of We expect to progress our next M4 PAM into the clinic by mid-2025.2026.
As of December 31, 2025, we had $182.5 million in cash and cash equivalents. Based upon our current operating plan, we believe that our existing cash and cash equivalents, will enable us to fund our operating expenses and capital expenditure requirements through at least the next 12 months following the issuance of the consolidated financial statements.
In September 2023, we completed our initial public offering (IPO) pursuant to which we issued and sold an aggregate of 14,710,000 shares of our common stock at a price to the public of $17.00 per share. We received aggregate net proceeds of $226.5 million after deducting underwriting discounts and commissions of $17.5 million and other offering expenses of $6.0 million. Since our IPO, in October 2024 we entered into a sales agreement with Leerink Partners LLC (Leerink) to sell shares of our common stock, from time to time, with aggregate gross sales proceeds of up to $300.0 million, through an at-the-market equity offering program (ATM) with Leerink as the sales agent. During the year ended December 31, 2024, we received aggregate net proceeds of $13.7 million after deducting commissions and offering expenses of $0.8 million. As of December 31, 2024, we had $307.6 million in cash, cash equivalents and marketable securities. Based upon our current operating plan, we believe that our existing cash, cash equivalents and marketable securities, will enable us to fund our operating expenses and capital expenditure requirements through at least the next 12 months following the issuance of the consolidated financial statements.
Since our inception, we have incurred significant operating losses and we expect to continue to incur significant losses for the foreseeable future as we continue to advance the development of our product candidates and approach, and incur additional costs associated with being a public company. Our net losses were $236.9 million and $243.8 million, $235.9 million, $130.9 million for the years ended December 31, 2024, 2023,2025 and 2022,2024, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $947.2$1,184.1 million. Our primary use of our capital resources is to fund our operating expenses, which consist primarily of expenditures related to identifying, acquiring, developing, and in-licensing our precision neuroscience approach and product candidates, and conducting preclinical studies and clinical trials, and to a lesser extent, general and administrative expenditures. Our net losses may fluctuate significantly from period to period, depending on the timing of our clinical trials and our expenditures on research and development activities.
We have assumed license arrangements with certain third parties as a result of our acquisitions and have entered into several additional agreements with various parties. For details regarding these agreements, see Note 89 – Strategic License and Research and Collaboration Agreements to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K.
Pursuant to the terms of the BlackThorn Merger Agreement, we are required to pay the former stockholders of BlackThorn contingent consideration (i) with respect to navacaprant, in the form of development and regulatory approval milestones of up to an aggregate amount of $365.0 million, which includes a milestone payment that became due and was paid in the fourth quarter of 2023 upon dosing the first patient in the Phase 3 clinical trial for navacaprant, and sales-based milestones of up to an aggregate amount of $450.0 million and (ii) with respect to NMRA-511, in the form of development and regulatory approval milestones of up to an aggregate amount of $100.0 million, and sales-based milestones of up to an aggregate amount of $100.0 million (“BlackThorn Milestones”). At the Company’s sole discretion, the BlackThorn Milestone payments may be settled in cash or shares of the Company, or a combination of both, subject to the provisions of the BlackThorn Merger Agreement, other than one development milestone in the amount of $10.0 million, which must be settled in cash. In December 2023, we issued 6,072,445 shares of common stock based on the volume weighted average price per share prior to the date the milestone was met and paid $2.3 million in cash in satisfaction of the Phase 3 navacaprant milestone to the former stockholders of BlackThorn and participants in the carveout plan. As of December 31, 2024,2025, none of the other BlackThorn Milestones have been achieved and no such related amounts were deemed due or payable.
Pursuant to the terms of the Vanderbilt License Agreement, we are required to pay Vanderbilt contingent consideration payable in cash up to an aggregate of $42.4$42.0 million upon the achievement of specified development milestones and up to an aggregate of $380.0 million upon the achievement of commercial milestone events as well as tiered royalties at mid-single digit percentages on potential future net sales. We achieved a $2.0 million development milestone in October 2023, which was paid in cash in November 2023. Additionally, in July 2025, we achieved and settled in cash a $5.0 million development milestone. As of December 31, 2024,2025, none of the other Vanderbilt milestones have been achieved and no such related amounts were deemed due or payable.
Research and development expenses consist of external and internal expenses, and primarily relate to our discovery efforts and development of our precision neuroscience approach, programs, and product candidates. We account for acquired in-process research and development (“IPR&D”) expenses from our strategic acquisitions, which accounted for a significant portion of our operating expenses during the years ended December 31, 2023 and 2022,acquisitions separately from research and development expenses. There was no IPR&D expense recognized during the year ended December 31, 2024.
External research and development expenses include, among others, amounts incurred with contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), preclinical testing organizations and other vendors that conduct research and development activities on our behalf. Internal research and development expenses include, among others, personnel-related costs, including salaries, benefits and stock-based compensation for employees engaged in research and development functions, laboratory supplies and other non-capital equipment utilized for in-house research, software development costs and allocated expenses including facilities costs and depreciation and amortization.
Interest Expense
Interest expense consists of interest expense related to our Loan Agreement, as well as amortization of debt discount and debt issuance costs.
For discussion of our 2023 results and a comparison with 2022 results please refer to “Management’s Discussion and Analysis of Financial Conditions and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 that was filed with the SEC on March 7, 2024.
Research and development expenses decreased by $24.9 million, or 12%, to $176.1 million for the year ended December 31, 2025 from $200.9 million for the year ended December 31, 2024.
Direct external program expenses decreased by $4.9 million primarily driven by:
a $12.2 million reduction in navacaprant program expenses following the completion of the KOASTAL-1 Phase-3 trial in 2024, and partially offset by a $5.2 million increase in preclinical research and manufacturing, and increased clinical trial related costs to both the M4 PAM and NMRA-511 programs of $1.2 million and $0.9 million, respectively.
Internal and unallocated expenses decreased by $19.9 million, which were primarily due to:
lower personnel-related costs of $11.0 million due to a reduction in stock based compensation expense primarily driven by one time stock option modification expense of $3.6 million recorded in 2024 that did not recur, as well as departures of certain key executive, and lower overall headcount, and a decrease in other costs of $8.9 million primarily due to a reduction in expense incurred under our research and collaboration agreements with Amgen of $6.3 million. The Amgen Collaboration Agreement automatically terminated upon its third anniversary in September 2024 and a final payment was made to Amgen in May 2025. Additionally, facilities-related expenses decreased by $2.2 million, reflecting the Company’s relocation from a combined office and laboratory facility to a smaller office-only footprint.
Research and development expenses increased by $58.2 million, or 41%, to $200.9 million for the year ended December 31, 2024 from $142.7 million for the year ended December 31, 2023 as we advanced our clinical trials. Direct external program expenses increased by $62.8 million, of which $67.5 million was related to the advancement our Phase 3 and Phase 2 clinical trials for navacaprant, partially offset by a decrease of $4.8 million to preclinical program research. Internal and unallocated expenses decreased by $4.6 million, primarily attributable to decreased activities under our research and collaboration agreements with Amgen and with other vendors, which was partially offset by an increase in personnel related costs of $10.2 million, including $9.6 million related to stock-based compensation. Stock-based compensation primarily increased due to stock modification expense of $4.1 million and the increased value of stock awards issued.
Acquired in-process research and development expenses decreasedof to nil for the year ended December 31, 2024 from $63.9$5.0 million for the year ended December 31, 2023.2025 For the year ended December 31, 2023, acquired in-process research and development expenses consisted of $61.1 millionwas related to the achievement of thea Phase 3 navacaprant1 development milestone andunder $2.8the millionVanderbilt relatedLicense to our in-license from Vanderbilt, as these assets had not yet reached technological feasibility and had no alternative future use.Agreement.
General and administrative (“G&A”) expenses decreased by $2.4 million, or 4%, to $60.1 million for the year ended December 31, 2025 from $62.5 million for the year ended December 31, 2024. The decrease was primarily attributable to reduced consulting and personnel related costs.
General and administrative (G&A) expenses increased by $17.1 million, or 38%, to $62.5 million for the year ended December 31, 2024 from $45.5 million for the year ended December 31, 2023. The increase was primarily attributable to higher personnel-related costs, including $13.2 million related to stock-based compensation due to the increased value of stock awards issued, a $2.6 million increase in professional services for legal, accounting and advisory services, a $1.0 million increase in business insurance, and a $1.0 million increase in facilities cost due to a higher allocation of G&A costs.
Interest income increaseddecreased by $3.3$11.6 million to $8.3 million for the year ended December 31, 2025 from $19.9 million for the year ended December 31, 2024 from $16.6 million for the year ended December 31, 2023,2024, which was attributable to less interest earned on our higherlower balances in cash equivalents and marketable securities.
Interest Expense
Interest expense of $3.2 million for the year ended December 31, 2025 consisted of interest expense related to our Loan Agreement, amortization of debt issuance costs and accretion of the final payment fee.
As of December 31, 2024, we had $307.6 million of cash, cash equivalents and marketable securities. Prior to our IPO we primarily funded our operations with the net proceeds from the sale and issuance of our convertible preferred stock and convertible promissory notes and raised gross cash proceeds of over $600 million including from the sale of convertible preferred stock, borrowings pursuant to convertible promissory notes and cash acquired in our acquisitions of assets. In September, 2023, we completed our IPO pursuant to which we issued and sold an aggregate of 14,710,000 shares of common stock at a price to the public of $17.00 per share. We received aggregate net proceeds of $226.5 million after deducting underwriting discounts and commissions of $17.5 million and other offering expenses of $6.0 million. Since our IPO, in October 2024 we entered into a sales agreement with Leerink to sell shares of our common stock, from time to time, with aggregate gross sales proceeds of up to $300.0 million, through an ATM with Leerink as the sales agent. We received aggregate net proceeds of $13.7 million after deducting commissions and offering expenses of $0.8 million during the three months ended December 31, 2024.
Since our inception, we have not generated any revenue from the sale of products and we have incurred significant net losses and negative cash flows from operations. Our primary use of our capital resources is to fund our operating expenses, which consist primarily of expenditures related to identifying, acquiring, developing, and in-licensing our precision neuroscience approach, programs, and product candidates, and conducting preclinical studies and clinical trials, and to a lesser extent, general and administrative expenditures. We have not yet commercialized any products and we do not expect to generate revenue from sales of any product candidates for a number of years, if ever. As of December 31, 2024, we had an accumulated deficit of $947.2 million.
As of December 31, 2025, we had $182.5 million of cash and cash equivalents.
Prior to our Initial Public Offering (“IPO”) we primarily funded our operations with the net proceeds from the sale and issuance of our convertible preferred stock and convertible promissory notes. In September, 2023, we completed our IPO pursuant to which we issued and sold an aggregate of 14,710,000 shares of common stock at a price to the public of $17.00 per share. We received aggregate net proceeds of $226.5 million after deducting underwriting discounts and commissions of $17.5 million and other offering expenses of $6.0 million.
In October 2024 we entered into a sales agreement with Leerink to sell shares of our common stock, from time to time, with aggregate gross sales proceeds of up to $300.0 million, through an at-the-market equity offering program (“ATM”) with Leerink as the sales agent. During the years ended December 31, 2025 and 2024, we received aggregate net proceeds of $19.7 million and $13.7 million, respectively, through sales of shares of our common stock under the ATM after deducting commissions and offering expenses.
In May 2025, we entered into a loan and security agreement, (as amended, the “Loan Agreement”) with K2 HealthVentures LLC (“K2HV”). The Loan Agreement provides us with a term loan facility in the aggregate principal amount of up to $125.0 million, of which we have borrowed $60.0 million. The remaining $65.0 million is available for borrowing upon our request, subject to certain clinical and regulatory milestones or discretionary approval by the lenders. The term loan facility matures on May 1, 2029 and can be extended to May 1, 2029, subject to our achievement of certain clinical milestones.
Based upon our current operating plan, we believe that our existing cash,cash and cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements through at least the next 12 months following the issuance of the consolidated financial statements. However, we anticipate that we will need to raise additional financing in the future to fund our operations, including the commercialization of any approved product candidates. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. We may also raise additional financing on an opportunistic basis in the future. We expect to continue to expend significant resources for the foreseeable future.
Net cash used in operating activities for the twelve months ended December 31, 2025 was $206.4 million, which consisted of a net loss of $236.9 million, partially offset by non cash charges of $30.9 million and a change in our net operating assets and liabilities of $0.4 million. The noncash charges primarily consisted of $29.9 million of stock-based compensation and $1.9 million of noncash operating lease expense, partially offset by $2.9 million of net accretion of discounts on marketable securities. The change in our net operating assets and liabilities primarily resulted from an increase accrued liabilities of $4.2 million primarily related to our clinical programs, partially offset by an increase in prepaid assets and other current assets of $2.8 million due to the timing of payments related to clinical trials and a decrease in operating lease liabilities of $1.9 million due to the Company’s move to a smaller office footprint.
Net cash used in operating activities for the year ended December 31, 2023 was $163.3 million, which consisted of a net loss of $235.9 million and a change in our net operating assets and liabilities of $8.9 million, which was partially offset by $17.6 million in noncash charges and $63.9 million IPR&D expense related to achievement of the Phase 3 navacaprant development milestone and a milestone payment under our Vanderbilt in-license agreement. The change in our net operating assets and liabilities primarily resulted from and an increase of $11.4 million in prepaid expenses and other current assets related to our clinical programs and a decrease of $3.4 million in operating lease liabilities, partially offset by an increase of $5.9 million in accounts payable and accrued liabilities due to increased activities and the timing of our accounts payable. The noncash charges primarily consisted of $17.2 million of stock-based compensation, $3.4 million of noncash operating lease expense and $0.7 million of depreciation and amortization, partially offset by $3.7 million of net accretion of discounts on marketable securities.
Net cash used in investing activities for the twelve months ended December 31, 2025 was $168.5 million, which primarily consisted of $82.9 million in purchases of marketable securities, partially offset by $251.2 million in proceeds from sales and maturities of marketable securities.
Net cash provided by investing activities for the year ended December 31, 2023 was $64.4 million, which primarily consisted of $178.2 million in proceeds from sales and maturities of marketable securities, partially offset by $109.1 million in purchases of marketable securities and $4.6 million cash paid for acquisition of assets, including upon achievement of milestones.
Net cash provided by financing activities for the twelve months ended December 31, 2025 was $77.1 million, which primarily consisted of net proceeds from our term loan with K2HV of $57.2 million and net proceeds from the ATM offering of $19.7 million Net cash provided by financing activities for the twelve months ended December 31, 2024 was $21.6 million, which primarily consisted of proceeds from the exercise of stock options of $7.5 million and net proceeds from the ATM offering of $13.7 million.
Net cash provided by financing activities for the year ended December 31, 2023 was $231.9 million, which primarily consisted of $232.6 million in proceeds from the issuance of common stock upon the completion of our IPO, net of underwriting commissions and discounts and $2.9 million in proceeds from exercise of stock options, partially offset by $3.8 million in payments of issuance costs in connection with our IPO.
Our contractual obligations and commitments relate primarily to our operating lease for our office and laboratory facilities located in Massachusetts with a noncancelable lease term expiring in JuneAugust 2025.2027. As of December 31, 2024,2025, undiscounted future minimum lease payments of $1.9$0.5 million remain on our operating lease. See Note 78 – Commitments and Contingencies to our consolidated financial statements for further information.
JOBS Act Accounting Smaller Reporting Company Elections
We are a smaller reporting company, which allows us to take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not smaller reporting companies, including not being required to comply with the auditor attestation requirements of Section 404 of Sarbanes-Oxley, reduced disclosure obligations regarding executive compensation in our Annual Report and our periodic reports and proxy statements and providing only two years of audited financial statements in our Annual Report and our periodic reports. We will remain a smaller reporting company so long as (a) the aggregate market value of our outstanding common stock held by non-affiliates as of the last business day our most recently completed second fiscal quarter is less than $250 million or (b) (1) we have less than $100 million in annual revenues during our most recently completed fiscal year and (2) the aggregate market value of our outstanding common stock held by non-affiliates as of the last business day our most recently completed second fiscal quarter is less than $700 million.
We were an “emerging growth company,” as defined in the JOBS Act until December 31, 2024. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until those standards apply to private companies.
We have elected to use this extended transition period for complying with certain new or revised accounting standards that have different effective dates for public and private companies until the date we lost emerging growth company status. As a result, our consolidated financial statements may or may not be comparable to companies that comply with new or revised accounting pronouncements as of public companies’ effective dates.
We were also a “smaller reporting company,” as defined in the Exchange Act until December 31, 2024, and we have elected to take advantage of certain of the scaled disclosures available to smaller reporting companies.
What changed in the latest 10-Q
Risk Factors
Largest changes
We are a clinical stage biopharmaceutical company and have incurred significant losses since our inception, and we expect to incur losses for the foreseeablesee in full comparisonfuture.future, which raises substantial doubt about our ability to continue as a going concern. We have no products approved for commercial sale and may never achieve or maintain profitability.
We are a clinical‑stage biopharmaceutical company with a limited operating history. Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. We have incurred significant losses since our inception in November 2019, have no products approved for commercialsee in full comparisonsale,sale and have not generated any revenue from productsales,sales. We have financed our operations principally through proceeds from sales of common stock, convertible preferred stock and convertible promissory notes and expect to incur significant losses for the foreseeablefuture.future, which raises substantial doubt about our ability to continue as going concern.. We expect that it will be several years before we have a commercialized product and generate revenue from product sales, if at all. Our net loss was$53.5$43.1 million and$68.0$52.7 million for three months endedMarchJune31,30, 2026 and 2025,respectively.respectively, and $96.5 million and $120.7 million for six months ended June 30, 2026 and 2025. As ofMarchJune31,30, 2026, we had an accumulated deficit of$1,237.6$1,280.7 million. Our losses have resulted principally from acquired in-process research and development from our acquisitions of assets, expenses incurred in the research and development of our product candidates, as well as from costs associated with our preclinical studies and clinical trials and management and administrative costs and other expenses that we have incurred while building our business infrastructure.
We are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception, and we expect to incur losses for the foreseeablesee in full comparisonfuture.future, which raises substantial doubt about our ability to continue as a going concern. We have no products approved for commercial sale and may never achieve or maintain profitability.
Moreover, if our product candidates are associated with undesirable side effects in clinical trials or have characteristics that are unexpected, we may elect to abandon their development or limit their development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk‑benefit perspective, which may limit the commercial expectations for the product candidate if approved. We may also be required to modify our study plans based on findings in our ongoing preclinical studies or clinical trials.see in full comparisonFor example, in a rat study, at its highest dose (100 mg/kg/day) navacaprant was observed to have skin‑related phototoxicity of erythema, edema and flaking additionally ocular phototoxicity (corneal edema). While no phototoxicity has been observed in our Phase 1 clinical trials, we monitored visual acuity and corneal integrity in our Phase 2 clinical trial to confirm there was no phototoxicity in humans. Though we did not observe any phototoxicity effects in our Phase 2 clinical trial, if phototoxicity is experienced in our later‑stage clinical trials, the labeling implications of such safety warnings may limit any future product sales, if navacaprant is approved.
Moreover, success in preclinical studies or early clinical trials does not ensure that later preclinical studies or clinical trials will be successful. A number of companies in the biotechnology and biopharmaceutical industries have suffered significant setbacks in clinical trials, even after positive results in earlier preclinical studies. These setbacks have been caused by, among other things, preclinical findings made while clinical trials were underway and safety or efficacy observations made in clinical trials, including previously unreported adverse events. The design of a clinical trial can determine whether its results will support approval of a product, and flaws in the design of a clinical trial may not become apparent until the clinical trial is well advanced. In addition, clinical and preclinical data are often susceptible to varying interpretations and analyses. Notwithstanding any potential promising results in earlier studies, we cannot be certain that we will not face similar setbacks. For example, in January 2025, we announced that our KOASTAL-1 study did not demonstrate a statistically significant improvement on the primary endpoint of change from baseline in the Montgomery-Åsberg Depression Rating Scale (“MADRS”) total score at Week 6 or the key secondary endpoint of a change from baseline in the Snaith-Hamilton Pleasure Scale (“SHAPS”) scale. Also, in June 2026, we announced that the Phase 3 KOASTAL-2 and -3 studies of navacaprant for the treatment of MDD did not achieve statistical significance on the primary or key secondary endpoints and that we were discontinuing development of navacaprant in MDD. In addition, the results of our preclinical animal studies, including our non‑human primate studies, may not be predictive of the results of outcomes in subsequent clinical trials on human subjects. Product candidates in clinical trials may fail to show the desired pharmacological properties or safety and efficacy traits despite having progressed through preclinical studies.see in full comparison
As ofsee in full comparisonMarchJune31,30, 2026 we had9263 full‑time employees.WeAlthough we announced a reduction in force of approximately 35% in connection with our discontinuation of the development of navacaprant in MDD in June 2026, we will continue to implement and improve our managerial, operational, and financial systems, expand our facilities, and continue to recruit and train additional qualifiedpersonnel.personnel as we develop our other product candidates. Due to the complexity in managing a company that has scaled very quickly, we may not be able to scale our headcount and operations effectively to manage the expansion of our product pipeline or recruit and train the necessary additional personnel. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.
Full comparison: every changed paragraph (10)
We are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception, and we expect to incur losses for the foreseeable future.future, which raises substantial doubt about our ability to continue as a going concern. We have no products approved for commercial sale and may never achieve or maintain profitability.
We are a clinical stage biopharmaceutical company and have incurred significant losses since our inception, and we expect to incur losses for the foreseeable future.future, which raises substantial doubt about our ability to continue as a going concern. We have no products approved for commercial sale and may never achieve or maintain profitability.
We are a clinical‑stage biopharmaceutical company with a limited operating history. Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. We have incurred significant losses since our inception in November 2019, have no products approved for commercial sale,sale and have not generated any revenue from product sales,sales. We have financed our operations principally through proceeds from sales of common stock, convertible preferred stock and convertible promissory notes and expect to incur significant losses for the foreseeable future.future, which raises substantial doubt about our ability to continue as going concern.. We expect that it will be several years before we have a commercialized product and generate revenue from product sales, if at all. Our net loss was $53.5$43.1 million and $68.0$52.7 million for three months ended MarchJune 31,30, 2026 and 2025, respectively.respectively, and $96.5 million and $120.7 million for six months ended June 30, 2026 and 2025. As of MarchJune 31,30, 2026, we had an accumulated deficit of $1,237.6$1,280.7 million. Our losses have resulted principally from acquired in-process research and development from our acquisitions of assets, expenses incurred in the research and development of our product candidates, as well as from costs associated with our preclinical studies and clinical trials and management and administrative costs and other expenses that we have incurred while building our business infrastructure.
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations with our existing cash, cash equivalents and marketable securities, the net proceeds from our initial public offering, any future equity or debt financings and upfront and milestone and royalties payments, if any, received under any future licenses or collaborations. If we raise additional capital through the sale of equity or convertible debt securities, or issue any equity or convertible debt securities in connection with a collaboration agreement or other contractual arrangement, 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 holder of our common stock. In addition, the possibility of such issuance may cause the market price of our common stock to decline. For example, in October 2024 we entered into a sales agreement with Leerink Partners LLC (“Leerink”) to sell shares of our common stock, from time to time, with aggregate gross sales proceeds of up to $300.0 million, through an ATM with Leerink as the sales agent. During the threesix months ended MarchJune 31,30, 2026,2026 we received aggregate net proceeds of $10.9$20.4 million through sales of shares of our common stock under the ATM after deducting commissions and offering expenses. Additionally, during the years ended December 31, 2025 and 2024, we received aggregate net proceeds of $19.7 million and $13.7 million, respectively, through sales of shares of our common stock under the ATM after deducting commissions and offering expenses. In December 2023, we settled a Phase 3 navacaprant milestone owed to BlackThorn stockholders by primarily issuing shares of our common stock. Debt financing, if available, may result in increased fixed payment obligations and involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends or acquiring, selling or licensing intellectual property rights or assets, which could adversely impact our ability to conduct our business. For example, in May 2025, we entered into a loan and security agreement (as amended, the “Loan Agreement”) with K2 HealthVentures LLC (“K2HV”), which includes certain affirmative and restrictive covenants that may, among other things, limit our ability to incur additional debt. Additionally, pursuant to the terms of the Loan Agreement, K2HV has the right to convert up to an aggregate of $12.5 million of the outstanding principal of the term loans into shares of our common stock. As of MarchJune 30, 2026, K2HV has the right to convert up to an aggregate of $6.5 million of the remaining outstanding principal into shares of common stock, which right, if exercised, could have a dilutive impact on our stockholders’ ownership interests.
As of MarchJune 31,30, 2026 we had 9263 full‑time employees. WeAlthough we announced a reduction in force of approximately 35% in connection with our discontinuation of the development of navacaprant in MDD in June 2026, we will continue to implement and improve our managerial, operational, and financial systems, expand our facilities, and continue to recruit and train additional qualified personnel.personnel as we develop our other product candidates. Due to the complexity in managing a company that has scaled very quickly, we may not be able to scale our headcount and operations effectively to manage the expansion of our product pipeline or recruit and train the necessary additional personnel. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.
Moreover, success in preclinical studies or early clinical trials does not ensure that later preclinical studies or clinical trials will be successful. A number of companies in the biotechnology and biopharmaceutical industries have suffered significant setbacks in clinical trials, even after positive results in earlier preclinical studies. These setbacks have been caused by, among other things, preclinical findings made while clinical trials were underway and safety or efficacy observations made in clinical trials, including previously unreported adverse events. The design of a clinical trial can determine whether its results will support approval of a product, and flaws in the design of a clinical trial may not become apparent until the clinical trial is well advanced. In addition, clinical and preclinical data are often susceptible to varying interpretations and analyses. Notwithstanding any potential promising results in earlier studies, we cannot be certain that we will not face similar setbacks. For example, in January 2025, we announced that our KOASTAL-1 study did not demonstrate a statistically significant improvement on the primary endpoint of change from baseline in the Montgomery-Åsberg Depression Rating Scale (“MADRS”) total score at Week 6 or the key secondary endpoint of a change from baseline in the Snaith-Hamilton Pleasure Scale (“SHAPS”) scale. Also, in June 2026, we announced that the Phase 3 KOASTAL-2 and -3 studies of navacaprant for the treatment of MDD did not achieve statistical significance on the primary or key secondary endpoints and that we were discontinuing development of navacaprant in MDD. In addition, the results of our preclinical animal studies, including our non‑human primate studies, may not be predictive of the results of outcomes in subsequent clinical trials on human subjects. Product candidates in clinical trials may fail to show the desired pharmacological properties or safety and efficacy traits despite having progressed through preclinical studies.
Moreover, if our product candidates are associated with undesirable side effects in clinical trials or have characteristics that are unexpected, we may elect to abandon their development or limit their development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk‑benefit perspective, which may limit the commercial expectations for the product candidate if approved. We may also be required to modify our study plans based on findings in our ongoing preclinical studies or clinical trials. For example, in a rat study, at its highest dose (100 mg/kg/day) navacaprant was observed to have skin‑related phototoxicity of erythema, edema and flaking additionally ocular phototoxicity (corneal edema). While no phototoxicity has been observed in our Phase 1 clinical trials, we monitored visual acuity and corneal integrity in our Phase 2 clinical trial to confirm there was no phototoxicity in humans. Though we did not observe any phototoxicity effects in our Phase 2 clinical trial, if phototoxicity is experienced in our later‑stage clinical trials, the labeling implications of such safety warnings may limit any future product sales, if navacaprant is approved.
As of DecemberJune 31,30, 2025,2026, our executive officers, directors, holders of 5% or more of our capital stock and their respective affiliates owned approximately 47% of our outstanding voting stock. Therefore, these stockholders will have the ability to influence us through this ownership position. These stockholders may be able to determine all matters requiring stockholder approval. For example, these stockholders may be able to control elections of directors, amendments of our organizational documents, or approval of any merger, sale of assets, or other major corporate transaction. In addition, certain members of our board of directors were originally designated by our principal stockholders, including Amgen and ARCH Venture Partners. This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders.
If our existing stockholders sell, or indicate an intention to sell, or if the market perceives that such existing stockholders might sell, substantial amounts of our common stock in the public market, the market price of our common stock could decline. As of MarchJune 31,30, 2026, we had outstanding a total of 182,157,466186,851,364 shares of common stock and approximately 46% of such shares were beneficially owned by our directors, officers, and holders of 5% or more of our common stock. In addition, approximately 57,959,60957,807,207 shares of common stock that are either subject to outstanding options or reserved for future issuance under our employee benefit plans will become eligible for sale in the public market to the extent permitted by the provisions of various vesting schedules and Rule 144 and Rule 701 under the Securities Act. If these additional shares of common stock are sold, or there is a perception that they will be sold, in the public market, the trading price of our common stock could decline. Further, certain holders of shares of our common stock are entitled to rights with respect to the registration of their shares under the Securities Act. Registration of these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act, except for shares held by affiliates, as defined in Rule 144 under the Securities Act. Any sales of securities by these stockholders could have a material adverse effect on the trading price of our common stock.
In addition, in the future, we may issue additional shares of common stock, or other equity or debt securities convertible into common stock, in connection with a financing, acquisition, employee arrangement, or otherwise. For example, in October 2024 we entered into a sales agreement with Leerink to sell shares of our common stock, from time to time, with aggregate gross sales proceeds of up to $300.0 million, through an ATM program with Leerink as the sales agent. During the threesix months ended MarchJune 31,30, 2026, we received aggregate net proceeds of $10.9$20.4 million through sales of shares of our common stock under the ATM after deducting commissions and offering expenses. Additionally, during the years ended December 31, 2025 and 2024, we received aggregate net proceeds of $19.7 million and $13.7 million, respectively, through sales of shares of our common stock under the ATM after deducting commissions and offering expenses. In December 2023, we settled a Phase 3 navacaprant milestone owed to BlackThorn stockholders by primarily issuing shares of our common stock. Any such issuance could result in substantial dilution to our existing stockholders and could cause the price of our common stock to decline.
Management's Discussion & Analysis (MD&A)
New heading “Results of Operations”
New heading “For the Six Months Ended June 30, 2026 and 2025”
New heading “Research and Development Expenses”
New heading “General and Administrative Expenses”
New heading “Interest Income”
New heading “Interest Expense”
Largest changes
“We have incurred significant losses and negative cash flows from operations since our inception. Given our recurring losses from operations and negative cash flows, and based on our current operating plan, we have concluded that there is substantial doubt about our ability to continue as a going concern within one year from the date of filing of this Form 10-Q. We expect to finance our future cash needs through equity or debt financings, collaborations or a combination of these approaches. …”see in full comparison
Full comparison: every changed paragraph (47)
We are a clinical-stage biopharmaceutical company founded to confront the greatest medical challenges of our generation by bringing forward the next generation of novel therapies with brain-penetrant chemistry that offer improved treatment outcomes and quality of life for patients. Our therapeutic pipeline currently consists of programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases. We are advancing a Phase 3 program for navacaprant, a novel once-daily oral kappa opioid receptor (“KOR”) antagonist that is being developed for the treatment of major depressive disorder (“MDD”), which we believe has the potential to provide significant advantages relative to the standard of care, if approved. We are also advancing NMRA-511, a highly selective, novel antagonist of the vasopressin 1a receptor (“V1aR”) being developed for the treatment of agitation associated with dementia due to Alzheimer’s disease (“AD”). BeyondWe navacaprantare and NMRA-511, Neumora isalso advancing NMRA-898, a novel muscarinic acetylcholine receptor subtype 4 (“M4”) positive allosteric modulator (“PAM”) with potential best in class pharmacology for the treatment of schizophrenia. Additionally, Neumora is developing NMRA-215, a highly brain-penetrant, oral NLRP3 inhibitor for the treatment of obesity. We expect several updates from these programs throughout 2026, including to report Phase 3 KOASTAL-2obesity and -3cardiovascular topline data in the second quarter of 2026, report multiple ascending dose (“MAD”) extension data with NMRA-511 in the second half of 2026, and to report MAD data with NMRA-898 in the second half of 2026.risk.
Our current pipeline isand shownexpected updates from these programs are detailed in the table below.
ALSCV = Amyotrophic lateral sclerosis; CK1δ= Casein Kinase I Isoform deltacardiovascular; GCase = Glucocerebrosidase; KOR = kappa opioid receptor; M4 = Muscarinic Acetylcholine Receptor M4; NLRP3 = Nucleotide-binding Domain, Leucine-rich–containing Family, Pyrin Domain–containing-3; V1aR = Vasopressin 1a Receptor; DIO = diet induced obesity mouse model.
Pursuant to the terms of the BlackThorn Merger Agreement, we are required to pay the former stockholders of BlackThorn contingent consideration (i) with respect to navacaprant, in the form of development and regulatory approval milestones of up to an aggregate amount of $365.0 million, which includes a milestone payment that became due and was paid in the fourth quarter of 2023 upon dosing the first patient in the Phase 3 clinical trial for navacaprant, and sales-based milestones of up to an aggregate amount of $450.0 million and (ii) with respect to NMRA-511, in the form of development and regulatory approval milestones of up to an aggregate amount of $100.0 million, and sales-based milestones of up to an aggregate amount of $100.0 million (“BlackThorn Milestones”). At our sole discretion, the BlackThorn Milestone payments may be settled in cash or shares of our common stock, or a combination of both, subject to the provisions of the BlackThorn Merger Agreement, other than one development milestone in the amount of $10.0 million, which must be settled in cash. In 2023, we issued 6,072,445 shares of common stock based on the volume weighted average price per share prior to the date the milestone was met and paid $2.3 million in cash in satisfaction of the Phase 3 navacaprant milestone to the former stockholders of BlackThorn and participants in the carveout plan. As of MarchJune 31,30, 2026, none of the other BlackThorn Milestones have been achieved and no such related amounts were deemed due or payable.
Pursuant to the terms of the Vanderbilt License Agreement, we are required to pay Vanderbilt contingent consideration payable in cash up to an aggregate of $42.0 million upon the achievement of specified development milestones and up to an aggregate of $380.0 million upon the achievement of commercial milestone events as well as tiered royalties at mid-single digit percentages on potential future net sales. We achieved a $2.0 million development milestone in October 2023, which was paid in cash in November 2023. Additionally, in July 2025, we achieved and settled in cash a $5.0 million development milestone. As of MarchJune 31,30, 2026, none of the other Vanderbilt milestones have been achieved and no such related amounts were deemed due or payable.
Interest income consists of interest earned on our cash equivalents and marketablecash securities and interest expense related to our Loan Agreement.equivalents.
For the Three Months Ended MarchJune 31,30, 2026 and 2025
Research and development expenses decreased by $13.6$9.4 million, or 26%,24%, to $38.6$29.3 million for the three months ended MarchJune 31,30, 2026, from $52.2$38.7 million for the three months ended MarchJune 31,30, 2025.
reduced navacaprant program costs of $3.6$8.9 million due to reducedthe manufacturingconclusion costsof incurred,our Phase 3 trial during the period, reduced NMRA-511 program costs of $1.4$1.2 million due to lower clinical trial costs with the completion of the Phase 1b study,study in 2025, partially offset by a $1.7$1.6 million increase in preclinical research and manufacturing.
Internal and unallocated expenses decreased $10.4$0.5 million, which were primarily duedriven toby:
a decrease in other costs of $1.6 million primarily due to lower consulting costs, partially offset by an increase in personnel-related costs of $1.2 million due severance-related costs incurred during the period.
a decrease in other costs of $7.4 million primarily due to no activity under our research and collaboration agreements with Amgen in the current period, compared to $6.3 million in the prior period. The Amgen Collaboration Agreement automatically terminated upon its third anniversary in September 2024. The final costs were incurred in the first quarter of 2025 and the final payment was made to Amgen in May 2025.
Lower personnel-related costs of $2.9 million primarily due to a reduction in stock based compensation expense driven by lower headcount, as well as a discretionary bonus payment made to a key executive in the prior period that did not recur.
General and administrative expenses decreased by $4.5$2.4 million, or 24%,16%, to $14.3$12.9 million for the three months ended MarchJune 31,30, 2026, from $18.8$15.3 million for the three months ended MarchJune 31,30, 2025 primarily due to lower personnel-related costs, driven by reduced headcount, which resulted inand decreased stock-basedconsulting compensationand expense,facilities as well as a discretionary bonus paid to a key executive in the prior period that did not recur.expenses.
Interest income decreased by $1.8$1.3 million to $1.2$0.9 million for the three months ended MarchJune 31,30, 20262026, from $3.1$2.3 million for the three months ended MarchJune 31,30, 2025, which was attributable to less interest earned on our lower balances in cash equivalents.
Interest expense increased by $1.4 million to $1.8 million for the three months ended June 30, 2026, from $0.4 million for the three months ended June 30, 2025, which was attributable to higher interest expense incurred on our higher term loan balance.
Results of Operations
For the Six Months Ended June 30, 2026 and 2025
The following table summarizes our result of operations for the periods presented:
Research and Development Expenses
The following table summarizes our research and development expenses by program for the periods presented:
Research and development expenses decreased by $23.0 million, or 25%, to $67.9 million for the six months ended June 30, 2026, from $90.9 million for the six months ended June 30, 2025.
Direct external program expenses decreased $12.2 million primarily driven by:
reduced navacaprant program costs of $12.5 million due to the conclusion of our Phase 3 trial during the period, reduced NMRA-511 program costs of $2.5 million due to lower clinical trial costs with the completion of the Phase 1b study in 2025, partially offset by a $3.2 million increase in preclinical research and manufacturing.
Internal and unallocated expenses decreased $10.8 million, primarily driven by:
a decrease in other costs of $9.1 million primarily due to lower consulting costs and no activity under our research and collaboration agreements with Amgen in the current period, compared to $6.3 million in the prior period. The Amgen Collaboration Agreement automatically terminated upon its third anniversary in September 2024. The final costs were incurred in the first quarter of 2025 and the final payment was made to Amgen in May 2025.
A decrease in personnel-related costs of $1.8 million due lower headcount and performance bonuses paid in the prior year period that did not recur, partially offset by one time severance related charges incurred during the six months ended June 30, 2026.
General and Administrative Expenses
General and administrative expenses decreased by $6.9 million, or 20%, to $27.2 million for the six months ended June 30, 2026, from $34.1 million for the six months ended June 30, 2025 primarily due to lower personnel-related costs, driven by reduced headcount, and decreased consulting and facilities expenses.
Interest Income
Interest income decreased by $3.2 million to $2.2 million for the six months ended June 30, 2026 from $5.3 million for the six months ended June 30, 2025, which was attributable to less interest earned on our lower balances in cash equivalents.
Interest Expense
Interest expense increased by $3.2 million to $3.7 million for the six months ended June 30, 2026, from $0.4 million for the six months ended June 30, 2025, which was attributable to higher interest expense incurred on our higher term loan balance.
Interest expense of $1.9 million for the three months ended March 31, 2026 consisted of interest expense related to our Loan Agreement, as well as amortization of debit issuance costs and accretion of the final payment fee.
As of MarchJune 31,30, 2026, we had $147.1$116.8 million of cash and cash equivalents.
In 2024, we entered into a sales agreement with Leerink to sell shares of our common stock, from time to time, with aggregate gross sales proceeds of up to $300.0 million, through an at-the-market equity offering program (“ATM”) with Leerink as the sales agent. During the years ended December 31, 2025 and 2024, we received aggregate net proceeds of $19.7 million and $13.7 million, respectively, through sales of shares of our common stock under the ATM after deducting commissions and offering expenses. Additionally, during the threesix months ended MarchJune 31,30, 2026 we received aggregate net proceeds of $10.9$20.4 million through sales of shares of our common stock under the ATM after deducting commissions and offering expenses.
In May 2025, we entered into a loan and security agreement, (as amended, the “Loan Agreement”) with K2 HealthVentures LLC (“K2HV”). The Loan Agreement provides us with a term loan facility in the aggregate principal amount of up to $125.0 million, of which we have borrowed $60.0 million. The remaining $65.0$20.0 million is available for borrowing upon our request, subject to certaindiscretionary approval by the lenders. The remaining $45.0 million is tied to clinical and regulatory milestones orthat discretionarywill approvalnot bybe met with the lenders.discontinuation of navacaprant in MDD. The term loan facility matures on May 1, 2029 and can be extended to May 1, 2030, subject to our achievement of certain clinical milestones.2029.
We have incurred significant losses and negative cash flows from operations since our inception. Given our recurring losses from operations and negative cash flows, and based on our current operating plan, we have concluded that there is substantial doubt about our ability to continue as a going concern within one year from the date of filing of this Form 10-Q. We expect to finance our future cash needs through equity or debt financings, collaborations or a combination of these approaches. See “Risk Factors—Risks Related to Our Limited Operating History, Financial Condition and Need for Additional Capital” for additional information.
We expect our expenses and operating losses will increase substantially over the foreseeable future as we continue our research and development efforts, advance our product candidates through clinical and preclinical development, enhance our precision neuroscience approach and programs, expand our product pipeline, seek regulatory approval, prepare for commercialization, as well as hire additional personnel and protect our intellectual property. Furthermore, since our IPO, we have incurred and will continue to incur additional costs associated with being a public company. Our net losses may fluctuate significantly from period to period, depending on the factors described below. We are subject to the risks typically related to the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business. The expected increase in expenses will be driven in large part by our ongoing activities, and our future capital requirements will depend on many factors, including:
Based upon our current operating plan, we believe that our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements through at least the next 12 months following the issuance of the condensed consolidated financial statements. However, we anticipate that we will need to raise additional financing in the future to fund our operations and pursue our long-term business plan, including the development and commercialization of our product candidates, if approved. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. We may also raise additional financing on an opportunistic basis in the future. We expect to continue to expend significant resources for the foreseeable future.
Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2026 was $46.4$85.9 million, which primarily consisted of a net loss of $53.5$43.1 million partially offset by noncash charges of $7.8$15.5 million. The noncash charges primarily consisted of $7.4$14.6 million of stock-based compensation and $0.4$0.8 million of amortization of debt issuance costs and accretion of the debt final payment fee. Our net operating assets and liabilities decreased by $0.8$4.9 million, primarily from a decrease in accrued liabilities of $4.0$5.5 million related to our ongoing and recently completed clinical trials, partially offset by an increase in accounts payable of $1.7$0.8 million due to the timing of our accounts payable and a decrease in prepaid expenses and other current assets of $1.6 million due to less interest receivable on our cash and cash equivalents.payable.
Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2025 was $59.4$111.9 million, which consisted of a net loss of $68.0$120.7 million and a change in our net operating assets and liabilities of $0.5$8.1 million, partially offset by noncash charges of $9.1$17.0 million. The change in our net operating assets and liabilities primarily resulted from ana decrease in accrued liabilities of $4.7 million primarily related to our clinical programs, a decrease in accounts payable of $2.3$2.7 million due to the timing of our accounts payable andpayable, a decrease in current operating lease liabilities of $0.9$1.9 million due to the upcoming expiration of ouran office and lab lease agreement, partially offset by a decrease in prepaid expenses and other current assets of $1.0 million due to less interest receivable on our cash and marketable securities and an increase in accruedprepaid liabilitiesexpenses of $1.7$1.1 million primarily due to deferred debt issuance costs related to ourthe ongoingterm clinicalloan trials.with K2HV. The noncash charges primarily consisted of $9.3$16.5 million of stock-based compensation, $0.9$1.8 million of noncash operating lease expense, partially offset by $1.3$2.2 million on of net accretion of discounts on marketable securities.
Net cash provided by investing activities for the threesix months ended MarchJune 31,30, 2026 was $0.1 million, which consisted of proceeds from the sale equipment.
Net cash provided by investing activities for the threesix months ended MarchJune 31,30, 2025 was $44.2$74.6 million, which primarily consisted of $88.6$157.3 million in proceeds from maturities of marketable securities, partially offset by $44.4$82.9 million in purchases of marketable securities.
Net cash provided by financing activities for the threesix months ended MarchJune 31,30, 2026 was $10.9$20.2 millionmillion, which primarily consisted of net proceeds received from the ATM offering.
Net cash provided by financing activities for the six months ended June 30, 2025 was $18.5 million, which primarily consisted of the net proceeds from the term loan with K2HV.
As of MarchJune 31,30, 2026, our contractual obligations and commitments relate primarily to our Loan Agreement with K2HV under which we had borrowed$54.0 $60.0million million.in principal outstanding as of June 30, 2026. The termCompany loanis maturesobligated to make interest-only payments through April 2029, with all outstanding principal, accrued and unpaid interest, and the final payment fee due at maturity on May 1, 2029, and we are obligated to make interest only payments until June 1, 2028.2029. Additional information about the Loan Agreement and our commitments under it can be found in Note 5 4– Debt to our condensed consolidated financial statements.
NMRA insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 2 filings (1 insider, 5 trade dates, 453,833 shares, about $701.5K). Net open-market shares: -453,833 (purchases minus sales); net value about -$701.5K.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-08-21 | Aurora Daljit Singh |
Option exercise | 20,553 | $0.72 | $14.8K |
| 2026-08-21 | Aurora Daljit Singh |
Open-market sale | 20,553 | $1.59 | $32.7K |
| 2026-08-21 | Aurora Daljit Singh |
Open-market sale | 21,055 | $1.60 | $33.7K |
| 2026-08-21 | Aurora Daljit Singh |
Option exercise | 21,055 | $0.72 | $15.2K |
| 2026-08-20 | Aurora Daljit Singh |
Option exercise | 67,741 | $0.72 | $48.8K |
| 2026-08-20 | Aurora Daljit Singh |
Open-market sale | 66,711 | $1.51 | $100.7K |
| 2026-08-20 | Aurora Daljit Singh |
Option exercise | 45,026 | $0.72 | $32.4K |
| 2026-08-20 | Aurora Daljit Singh |
Option exercise | 21,685 | $0.72 | $15.6K |
| 2026-08-20 | Aurora Daljit Singh |
Open-market sale | 67,741 | $1.51 | $102.3K |
| 2026-08-19 | Aurora Daljit Singh |
Open-market sale | 30,918 | $1.65 | $51.0K |
| 2026-08-19 | Aurora Daljit Singh |
Option exercise | 30,918 | $0.72 | $22.3K |
| 2026-08-19 | Aurora Daljit Singh |
Open-market sale | 31,000 | $1.65 | $51.1K |
| 2026-08-19 | Aurora Daljit Singh |
Option exercise | 17,732 | $0.72 | $12.8K |
| 2026-08-19 | Aurora Daljit Singh |
Option exercise | 13,268 | $0.72 | $9.6K |
| 2026-08-18 | Aurora Daljit Singh |
Open-market sale | 34,987 | $1.59 | $55.6K |
| 2026-08-18 | Aurora Daljit Singh |
Option exercise | 34,987 | $0.72 | $25.2K |
| 2026-08-18 | Aurora Daljit Singh |
Open-market sale | 34,162 | $1.58 | $54.0K |
| 2026-08-18 | Aurora Daljit Singh |
Option exercise | 34,162 | $0.72 | $24.6K |
| 2026-08-17 | Aurora Daljit Singh |
Option exercise | 40,890 | $0.72 | $29.4K |
| 2026-08-17 | Aurora Daljit Singh |
Option exercise | 15,355 | $0.72 | $11.1K |
| 2026-08-17 | Aurora Daljit Singh |
Open-market sale | 55,016 | $1.50 | $82.5K |
| 2026-08-17 | Aurora Daljit Singh |
Option exercise | 29,737 | $0.72 | $21.4K |
| 2026-08-17 | Aurora Daljit Singh |
Option exercise | 25,279 | $0.72 | $18.2K |
| 2026-08-17 | Aurora Daljit Singh |
Option exercise | 1,424 | $0.72 | $1.0K |
| 2026-08-17 | Aurora Daljit Singh |
Open-market sale | 57,670 | $1.51 | $87.1K |
| 2026-08-17 | Aurora Daljit Singh |
Open-market sale | 34,020 | $1.49 | $50.7K |
| 2026-08-17 | Aurora Daljit Singh |
Option exercise | 1 | $0.72 | $1 |
Well-known investors holding NMRA (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Two Sigma Investments | 2026-06-30 | 2,244,829 | $3.8M | 0.0% | Added 10% |
| Renaissance Technologies | 2026-06-30 | 1,262,304 | $2.1M | 0.0% | Reduced 9% |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 828,933 | $1.4M | 0.0% | Added 141% |
| Point72 Asset Management (Steve Cohen) | 2026-06-30 | 602,403 | $1.2M | — | Sold out |
| Millennium Management (Israel Englander) | 2026-06-30 | 509,210 | $865.7K | 0.0% | Reduced 82% |
| AQR Capital Management (Cliff Asness) | 2026-06-30 | 13,613 | $23.1K | 0.0% | Reduced 76% |