CGTX

Our net losses were $23.5 million and $34.0 million for the years ended December 31, 2025, and 2024, respectively.
As of December 31, 2025, we had an accumulated deficit of $198.6 million. We have devoted substantially all of our financial resources and efforts to the development of our product candidates, including conducting preclinical studies and clinical trials.
We have limited experience conducting and completing clinical trials and have not yet demonstrated our ability to successfully complete pivotal clinical trials, obtain regulatory approvals, manufacture a product on a commercial scale, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful commercialization.
As of December 31, 2025, we had 37.0 million in cash, cash equivalents, and restricted cash equivalents and have not generated positive cash flows from operations.
Based on our current business plans, we believe that our existing cash, cash equivalents and restricted cash, income from our non-dilutive grants, will be sufficient for us to fund our operating expenses and capital expenditures requirements through the second quarter of 2027.
Our future capital requirements will depend on many factors, including, but not limited to : ● the scope, progress, costs and results of our ongoing and planned clinical trials of zervimesine, as well as the associated costs, including any unforeseen costs we may incur as a result of preclinical study or clinical trial delays due to supply chain disruptions or other delays ; ● the scope, progress, costs and results of preclinical development, laboratory testing and clinical trials for any future product candidates we may decide to pursue; ● the extent to which we develop, in-license or acquire other product candidates and technologies; ● the costs and timing of process development and manufacturing scale-up activities associated with our product candidates and other programs we advance them through preclinical and clinical development; ● the availability, timing and receipt of any future non-dilutive grants from the NIA, or NIA Grants, or any changes made to existing grants as a result of political or regulatory pressures; ● the number and development requirements of other product candidates that we may pursue; ● the costs, timing and outcome of regulatory review of our product candidates; ● the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval; ● the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; ● our ability to establish collaborations to commercialize zervimesine or any of our other product candidates outside the United States; ● macroeconomic factors such as inflationary pressures, rising interest rates, liquidity constraints, tariffs and other trade disputes, failures and instability in U.S. and international financial banking systems, supply disruptions due to political unrest, conflict and war or other factors, and pandemics such as the COVID-19 pandemic; ● the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and ● the additional costs we may incur as a result of operating as a public company, including our efforts to enhance operational systems and hire additional personnel, including enhanced internal controls over financial reporting. We believe our existing cash and cash equivalents and income from our non-dilutive grants will not be sufficient to fund any of our product candidates through regulatory approval, and we will need to raise substantial additional capital to complete the development and commercialization of zervimesine and our product candidates.
In addition to our existing cash and cash equivalents and income from our non-dilutive grants.
In December 2025, we entered into a sales agreement with Jefferies LLC, or the Sales Agent, providing for the offering, issuance and sale by us of up to $75 million of our common stock from time to time in “at-the-market” offerings, or the 2025 ATM.
There can be no assurance that we will be able to sell all of the shares under the 2025 ATM.
There can be no assurances of our traded price per share and volumes being at sufficient levels to provide adequate funding from the 2025 ATM.
Clinical trials can be delayed or terminated for a variety of reasons, including delays or failures related to: ● supply chain disruptions, which may result in clinical site closures, delays to patient enrollment or changes to trial protocols; ● the FDA or comparable foreign regulatory authorities disagreeing as to the design or implementation of our clinical trials; ● delays in obtaining, or failure to obtain, regulatory authorization to commence a trial; ● imposition of a temporary or permanent clinical hold by the FDA or comparable foreign regulatory authorities; ● reaching agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; ● identifying, recruiting and training suitable clinical investigators; ● obtaining institutional review board, or IRB, approval at each trial site; ● new safety findings that present unreasonable risk to clinical trial participants; ● a negative finding from an inspection of our clinical trial operations or study sites; ● recruiting an adequate number of suitable patients to participate in a trial; ● having subjects complete a trial or return for post-treatment follow-up; ● clinical sites deviating from trial protocol or dropping out of a trial; ● addressing subject safety concerns that arise during the course of a trial; ● adding a sufficient number of clinical trial sites; or ● obtaining sufficient supply of product candidates for use in preclinical studies or clinical trials from third-party suppliers. We may experience numerous adverse or unforeseen events during, or as a result of, preclinical studies and clinical trials which could delay or prevent our ability to receive marketing approval or commercialize our product candidates, including: ● we may receive feedback from regulatory authorities that requires us to modify the design of our clinical trials or require that we submit additional data or information before allowing a clinical trial to be initiated or continue; ● clinical studies of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon drug development programs; ● the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate; ● our third-party contractors may fail to comply with regulatory requirements, fail to maintain adequate quality controls or be unable to provide us with sufficient product supply to conduct and complete preclinical studies or clinical trials of our product candidates in a timely manner, or at all; ● we or our investigators might have to suspend or terminate clinical trials or expanded access of our product candidates for various reasons, including non-compliance with regulatory requirements, a finding that our product candidates have undesirable side effects or other unexpected characteristics or a finding that the participants are being exposed to unacceptable health risks; ● the cost of clinical trials of our product candidates may be greater than we anticipate; ● the quality of our product candidates or other materials necessary to conduct preclinical studies or clinical trials of our product candidates may be insufficient or inadequate; ● regulators may revise the requirements for approving our product candidates or such requirements may not be as we anticipate; and ● any future collaborators may conduct clinical trials in ways they view as advantageous to them but that are suboptimal for us. If we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently contemplate, if we are unable to successfully complete clinical trials of our product candidates or other testing, if the results of these trials or tests are not positive or are only moderately positive or if there are safety concerns, we may: ● incur unplanned costs; ● be delayed in obtaining marketing approval for our product candidates or not obtain marketing approval at all; ● obtain marketing approval in some countries and not in others; ● obtain marketing approval for indications or patient populations that are not as broad as intended or desired; ● obtain marketing approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings; ● be subject to additional post-marketing testing requirements; or ● have the product removed from the market after obtaining marketing approval . If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
Adverse events or other undesirable side effects caused by our product candidates or related to procedures conducted as part of the clinical trials or expanded access could cause us or regulatory authorities to interrupt, delay or halt clinical trials or expanded access and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or comparable foreign regulatory authorities.
Results of our planned clinical trials or learnings through our ongoing expanded access program for zervimesine in DLB patients could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics.
If unacceptable side effects arise in the development of our product candidates, we, the FDA, the IRBs at the institutions in which our studies are conducted or the data safety monitoring board, or DSMB, could suspend or terminate our clinical trials or expanded access or the FDA or comparable foreign regulatory authorities could order us to cease clinical trials or deny approval of our product candidates for any or all targeted indications.
In addition, changes to the design of our current or future clinical trials may be necessary if there are new developments in the field of Alzheimer’s or DLB research.
Several disease-modifying therapeutic options have been approved by the FDA for AD, and none have been approved for DLB.
Specifically, Biogen’s Aduhelm received accelerated approval on June 7, 2021 (and was later discontinued in January 2024); the FDA granted accelerated approval to Eisai’s Leqembi on January 6, 2023; and Eli Lilly’s Kisunla was approved in July 2024.
Leqembi and Kisunla are monoclonal antibodies administered via infusion reported to reduce Aβ plaques and protofibrils.
Leqembi and Kisunla are the only currently marketed drugs approved by the FDA to treat patients with AD.
Changes in funding for, or disruptions to the staffing and operations of the FDA and other government agencies 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.
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 federal agencies, including substantial leadership departures, personnel cuts, and policy changes, may also slow the time necessary for new drugs to be reviewed and/or approved, which would harm our business.
Changes and cuts in FDA staffing have been reported within the pharmaceutical industry as creating instances of delays in the FDA’s responsiveness or in its ability to review IND submissions or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion or at all. A prolonged government shutdown or significant leadership, personnel, and/or policy changes, or other substantial modification in agency activities (including due to global health concerns or geopolitical factors) 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.
Future shutdowns or other disruptions could also affect other government agencies such as the SEC, which may also impact our business by delaying review of our public filings, to the extent such review is necessary, and our ability to access the public markets. With the change in the U.S. presidential administration in 2025, there is substantial uncertainty as to whether and how the Trump administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates and any products for which we obtain approval.
This uncertainty could present new challenges and/or opportunities as we navigate development and approval of our product candidates.
Additionally, the new administration could issue or promulgate executive orders, regulations, policies or guidance that adversely affect us or create a more challenging or costly environment to pursue the development of new therapeutic candidates.
We have conducted, and in the future plan to conduct, clinical trials for product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
In cases where data from foreign clinical trials are intended to serve as the basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless: ● the data are applicable to the U.S. population and U.S. medical practice; ● the trials were performed by clinical investigators of recognized competence, or in line with GCP requirements; and ● the data may be considered valid without the need for an on-site inspection by the FDA or, if the FDA considers such as inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. Many foreign regulatory authorities have similar requirements.
As of March 1, 2026, we had 14 full-time employees.
If such an event were to occur, it could result in legal claims or proceedings, liability or financial loss under laws that protect the privacy of personal information, damage to our reputation, and interruptions in our operations, which could result in a material disruption of our product development programs.
In the United States, numerous federal and state laws and regulations, including the U.S. federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and its implementing regulations, or HITECH, state data breach notification laws, state privacy and health information privacy laws and federal and state consumer protection laws, including Section 5 of the Federal Trade Commission Act, which govern the collection, use, disclosure and protection of health-related and other personal information, may apply to our operations and the operations of any future collaborators.
Further, 20 states have now passed comprehensive privacy laws and regulations.
For example, California enacted the California Consumer Privacy Act, or CCPA, which gives California residents expanded rights to access and delete their personal information, opt out of certain personal information sharing and receive detailed information about how their personal information is used.
The CCPA also provides for civil penalties for violations, enforcement by the state Attorney General and by a dedicated agency called CapPrivacy, and a private right of action for data breaches.
Similar privacy laws have been proposed at the federal level and in other states, Creating a complicated national patchwork.
Furthermre, some states have proposed or enacted legislation specifically focused on health privacy, such as Washington’s My Health My Data Act, with similar statutes in Nevada and Connecticut.
The effects of state privacy laws are significant and may require us to modify our data processing practies and policies and to incur substantial costs and potential liability in an effort to comply with such legislation. Foreign data protection laws, including Regulation 2016/679, known as the General Data Protection Regulation, or GDPR, and its United Kingdom equivalent, also apply to health-related and other personal information of data subjects in the European Union and the United Kingdom.
The GDPR and UK GDPR impose numerous requirements for the collection, use, storage and disclosure of personal information of European Union or United Kingdom data subjects, including requirements relating to providing notice to and obtaining consent from data subjects, personal data breach notification, cross-border transfers of personal information, and honoring and providing for the rights of European Union or United Kingdom individuals in relation to their personal information, including the right to access, correct and delete their data. In addition, we may be unable to transfer personal data from Europe and other jurisdictions to the United States or other countries due to data localization requirements or limitations on cross-border data flows.
Europe and other jurisdictions have enacted laws requiring data to be localized or limiting the transfer of personal data to other countries.
In particular, the EEA and the UK have significantly restricted the transfer of personal data to countries whose privacy laws it believes are inadequate, including the United States in certain circumstances, unless a derogation exists or adequate international transfer safeguards are put in place (for example, the European Commission-approved Standard Contractual Clauses and the UK International Data Transfer Agreement/Addendum) and transfer impact assessments are carried out.

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Gone since FY2024

Our net losses were $34.0 million and $25.8 million for the years ended December 31, 2024 and 2023, respectively.
As of December 31, 2024, we had an accumulated deficit of $175.2 million. We have devoted substantially all of our financial resources and efforts to the development of our product candidates, including conducting preclinical studies and clinical trials.
There is substantial doubt about our ability to continue as a going concern.
Our management has concluded that, based on our current operating plan, there is substantial doubt as to whether we can continue as a going concern for the twelve months following the issuance of this Annual Report.
To date, we have not generated any revenues from product sales and have incurred significant operating losses in each year since our inception and we anticipate that losses may continue for the next several years or until such time as we can generate substantial revenues and achieve profitability.
As of December 31, 2024, we had $25.0 million in cash and cash equivalents and have not generated positive cash flows from operations.
Based on our current business plans, we believe that our existing cash and cash equivalents, income from non-dilutive grants, will be sufficient for us to fund our operating expenses and capital expenditures into the fourth quarter of 2025, which assumes no usage from the remaining ATM Facility (defined below) nor the equity line of credit with Lincoln Park Capital Fund, LLC, or Lincoln Park.
Our ability to continue as a going concern is dependent upon raising capital to maintain current operations and continue research and development efforts.
We plan to raise additional capital to fund our operations through public or private equity offerings, debt financings, and/or potential collaborations and license arrangement or other sources.
There is no assurance, however, that any additional financing or any revenue-generating collaboration will be available when needed or that we will be able to obtain financing or enter into a collaboration on terms acceptable to us or at all.
If such additional capital is not available on satisfactory terms, or is not available in sufficient amounts, or if we are unable to enter into a collaboration, we may be required to delay, limit or eliminate the development of zervimesine and our ability to achieve our business objectives, our competitiveness, and our business, financial condition and results of operations will be materially adversely affected.
If we fail to comply or regain compliance with the continued listing standards of the Nasdaq Capital Market, or Nasdaq, we may be delisted and the price of our common stock, or ability to access the capital markets and our financial condition could be negatively impacted.
Our common stock is currently listed on the Nasdaq Stock Market LLC, which has minimum requirements that a company must meet in order to remain listed.
These requirements include maintaining a minimum closing bid price of $1.00 per share, which closing bid cannot fall below $1.00 per share for a period of more than 30 consecutive trading days.
On September 12, 2024, we received a deficiency letter from the Staff of the Nasdaq Stock Market LLC notifying us that, for the last 30 consecutive business days, the closing bid price for our common stock has been below the minimum $1.00 per share required for continued listing on The Nasdaq Global Market pursuant to Rule 5450(a)(1).
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we were given 180 calendar days, or until March 11, 2025, to regain compliance with Rule 5450(a)(1).
We did not come into compliance by March 11, 2025.
On March 12, 2025, we received approval from the Listing Qualifications Department of Nasdaq Stock Market LLC to transfer the listing of our stock to the Nasdaq Capital Market.
Following the transfer of the listing, we have been granted an additional 180 calendar day period to regain compliance with Nasdaq's $1.00 minimum bid price requirement.
The additional 180-day grace period will end on September 8, 2025.
If we do not regain compliance within the allotted compliance period(s), including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that our common stock will be subject to delisting.
At that time, we may appeal the Nasdaq staff's determination to a Hearings Panel.
We intend to actively monitor the closing bid price for our common stock and will consider available options to resolve the deficiency and regain compliance with Rule 5450(a)(1), including effecting a reverse stock split.
However, there can be no assurance that the Company will regain compliance with the minimum bid price requirement.
If Nasdaq delists our securities from trading on its exchange for failure to meet the listing standards, we and our stockholders could face negative consequences including the reduction of liquidity and market price of our common stock, our ability to obtain sufficient additional capital to fund our operations, and our ability to operate as a going concern would be substantially impaired.
We have limited experience conducting and completing clinical trials and not yet demonstrated our ability to successfully complete pivotal clinical trials, obtain regulatory approvals, manufacture a product on a commercial scale, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful commercialization.
Based on our current business plans, we believe that our existing cash and cash equivalents, income from our non-dilutive grants, will be sufficient for us to fund our operating expenses and capital expenditures requirements into the fourth quarter of 2025.
Our future capital requirements will depend on many factors, including, but not limited to : ● the scope, progress, costs and results of our ongoing and planned clinical trials of zervimesine, as well as the associated costs, including any unforeseen costs we may incur as a result of preclinical study or clinical trial delays due to supply chain disruptions or other delays ; ● the scope, progress, costs and results of preclinical development, laboratory testing and clinical trials for any future product candidates we may decide to pursue; ● the extent to which we develop, in-license or acquire other product candidates and technologies; ● the costs and timing of process development and manufacturing scale-up activities associated with our product candidates and other programs we advance them through preclinical and clinical development; ● the availability, timing and receipt of any future non-dilutive grants from the NIA, or NIA Grants, or any changes made to existing grants as a result of political or regulatory pressures; ● the number and development requirements of other product candidates that we may pursue; ● the costs, timing and outcome of regulatory review of our product candidates; ● the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval; ● the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; ● our ability to establish collaborations to commercialize zervimesine or any of our other product candidates outside the United States; ● macroeconomic factors such as inflationary pressures, rising interest rates, liquidity constraints, failures and instability in U.S. and international financial banking systems, supply disruptions due to political unrest, conflict and war or other factors, and pandemics such as the COVID-19 pandemic; ● the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and ● the additional costs we may incur as a result of operating as a public company, including our efforts to enhance operational systems and hire additional personnel, including enhanced internal controls over financial reporting. We believe our existing cash and cash equivalents and income from our non-dilutive grants will not be sufficient to fund any of our product candidates through regulatory approval, and we will need to raise substantial additional capital to complete the development and commercialization of zervimesine and our product candidates.
In addition to our existing cash and cash equivalents and income from our non-dilutive grans, in March 2023, we entered into a Purchase Agreement with Lincoln Park, providing for the sale of up to $35 million worth of shares of our common stock.
In addition, in December 2022, we entered into a sales agreement with Cantor Fitzgerald & Co. and B.
Riley Securities, Inc., or the Sales Agents, providing for the offering, issuance and sale by us of up to $40 million of our common stock from time to time in “at-the-market” offerings, or the ATM Facility, subject to the limitations of General Instruction I.B.6 of Form S-3.
There can be no assurance that we will be able to sell all of the shares under the equity line with Lincoln Park or the ATM Facility.
Amounts available under the equity line with Lincoln Park have a strong and direct correlation to the Company’s publicly traded price per share and volumes.
There can be no assurances of our traded price per share and volumes being at sufficient levels to provide adequate funding from the equity line with Lincoln Park or the ATM Facility.
Clinical trials can be delayed or terminated for a variety of reasons, including delays or failures related to: ● supply chain disruptions, which may result in clinical site closures, delays to patient enrollment or changes to trial protocols; ● the FDA or comparable foreign regulatory authorities disagreeing as to the design or implementation of our clinical trials; ● delays in obtaining, or failure to obtain, regulatory authorization to commence a trial; ● imposition of a temporary or permanent clinical hold by the FDA or comparable foreign regulatory authorities; ● reaching agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; ● identifying, recruiting and training suitable clinical investigators; ● obtaining institutional review board, or IRB, approval at each trial site; ● new safety findings that present unreasonable risk to clinical trial participants; ● a negative finding from an inspection of our clinical trial operations or study sites; ● recruiting an adequate number of suitable patients to participate in a trial; ● having subjects complete a trial or return for post-treatment follow-up; ● clinical sites deviating from trial protocol or dropping out of a trial; ● addressing subject safety concerns that arise during the course of a trial; ● adding a sufficient number of clinical trial sites; or ● obtaining sufficient supply of product candidates for use in preclinical studies or clinical trials from third-party suppliers. We may experience numerous adverse or unforeseen events during, or as a result of, preclinical studies and clinical trials which could delay or prevent our ability to receive marketing approval or commercialize our product candidates, including: ● we may receive feedback from regulatory authorities that requires us to modify the design of our clinical trials or require that we submit additional data or information before allowing a clinical trial to be initiated or continue; ● clinical studies of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon drug development programs; ● the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate; ● our third-party contractors may fail to comply with regulatory requirements, fail to maintain adequate quality controls or be unable to provide us with sufficient product supply to conduct and complete preclinical studies or clinical trials of our product candidates in a timely manner, or at all; ● we or our investigators might have to suspend or terminate clinical trials of our product candidates for various reasons, including non-compliance with regulatory requirements, a finding that our product candidates have undesirable side effects or other unexpected characteristics or a finding that the participants are being exposed to unacceptable health risks; ● the cost of clinical trials of our product candidates may be greater than we anticipate; ● the quality of our product candidates or other materials necessary to conduct preclinical studies or clinical trials of our product candidates may be insufficient or inadequate; ● regulators may revise the requirements for approving our product candidates or such requirements may not be as we anticipate; and ● any future collaborators may conduct clinical trials in ways they view as advantageous to them but that are suboptimal for us. If we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently contemplate, if we are unable to successfully complete clinical trials of our product candidates or other testing, if the results of these trials or tests are not positive or are only moderately positive or if there are safety concerns, we may: ● incur unplanned costs; ● be delayed in obtaining marketing approval for our product candidates or not obtain marketing approval at all; ● obtain marketing approval in some countries and not in others; ● obtain marketing approval for indications or patient populations that are not as broad as intended or desired; ● obtain marketing approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings; ● be subject to additional post-marketing testing requirements; or ● have the product removed from the market after obtaining marketing approval . If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
Adverse events or other undesirable side effects caused by our product candidates or related to procedures conducted as part of the clinical trials could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or comparable foreign regulatory authorities.
Results of our planned clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics.
If unacceptable side effects arise in the development of our product candidates, we, the FDA, the IRBs at the institutions in which our studies are conducted or the data safety monitoring board, or DSMB could suspend or terminate our clinical trials or the FDA or comparable foreign regulatory authorities could order us to cease clinical trials or deny approval of our product candidates for any or all targeted indications.
In addition, changes to the design of our current or future clinical trials may be necessary if there are new developments in the field of Alzheimer’s research.
Only two disease-modifying therapeutic options have been approved by the FDA for AD, and none have been approved for DLB.

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