What changed in this filing

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Item 1A. Risk Factors

2025-03-20 compared with 2024-03-26 · 189 added, 138 removed, 1186 unchanged (22% of the section changed)

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As of December 31, 2024, we had an accumulated deficit of $175.2 million.

Our clinical trials have been funded by approximately $171.0 million in cumulative nondilutive grants, awarded primarily by the National Institute of Aging, or NIA, a division of the National Institutes of Health.

On October 13, 2021, we completed our initial public offering, or IPO, whereby we received net proceeds of $37.9 million.

On November 12, 2021, we received an additional $6.3 million in net proceeds resulting from the exercise of the overallotment option held by the underwriters in our IPO.

On November 15, 2022, we completed a follow-on public offering whereby we received net proceeds of $5.2 million.

On March 14, 2024, we completed a follow-on public offering whereby we received net proceeds of approximately $10.4 million.

We have no products approved for commercialization and have never generated any revenue from product sales.

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.

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We anticipate that our expenses will increase substantially for the foreseeable future as we:

● conduct our ongoing and planned clinical trials of CT1812, as well as initiate and complete additional clinical trials;

● pursue regulatory approval of CT1812 for the treatment of mild-to-moderate Alzheimer’s disease, or AD, dry age-related macular degeneration, or GA secondary to dry AMD, and Parkinson’s disease, or PD, and dementia with Lewy bodies, or DLB, and other age-related degenerative diseases and disorders of the central nervous system, or CNS, and retina;

● conduct our ongoing and planned clinical trials of zervimesine, as well as initiate and complete additional clinical trials;

● pursue regulatory approval of zervimesine for the treatment of mild-to-moderate Alzheimer’s disease, or AD, and Parkinson’s disease, or PD, and dementia with Lewy bodies, or DLB, and other age-related degenerative diseases and disorders of the central nervous system, or CNS, and retina;

● seek to discover and develop additional clinical and preclinical product candidates from libraries generated using Novel Improved Conditioned Extraction, or NICE, screening platform, as well as other molecule generating and screening strategies;

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● scale up our clinical and regulatory capabilities;

● establish a commercialization infrastructure and scale up external manufacturing and distribution capabilities to commercialize any product candidates for which we may obtain regulatory approval, including CT1812.

To become and remain profitable, we must succeed in developing and eventually commercializing product candidates that generate significant revenue.

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A decline in the value of our company could also cause you to lose all or part of your investment.

We are conducting Phase 2 clinical trials and have no history of commercializing products, which may make it difficult for an investor to evaluate the success of our business to date and to assess our future viability.

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 completed, Phase 2 clinical trials, but have no history of commercializing products, which may make it difficult for an investor to evaluate the success of our business to date and to assess our future viability.

We commenced operations in 2007, and our operations to date have been largely focused on developing our clinical and preclinical product candidates and our NICE screening platform.

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Our operations have required substantial amounts of capital since inception, and we expect our expenses to increase significantly in the foreseeable future.

Identifying potential product candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never

generate the necessary data or results required to obtain regulatory approval and achieve product sales.

We expect to continue to incur significant expenses and operating losses over the next several years as we complete our ongoing clinical trials of our product candidates, initiate future clinical trials of our product candidates, seek marketing approval for CT1812 for the treatment of age-related degenerative diseases and disorders of the CNS and retina, such as AD, GA secondary to dry AMD, PD and DLB, and advance any of our other product candidates we may develop or otherwise acquire.

Identifying potential product candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and achieve product sales.

We expect to continue to incur significant expenses and operating losses over the next several years as we complete our ongoing clinical trials of our product candidates, initiate future clinical trials of our product candidates, seek marketing approval for zervimesine for the treatment of age-related degenerative diseases and disorders of the CNS and retina, such as AD, PD and DLB, and advance any of our other product candidates we may develop or otherwise acquire.

In addition, our product candidates, if approved, may not achieve commercial success.

Our revenue, if any, will be derived from sales of products that we do not expect to be commercially available for the foreseeable future, if at all.

If we obtain marketing approval for CT1812 or any other product candidates that we develop or otherwise acquire, we expect to incur significant commercialization expenses related to product sales, marketing, distribution and manufacturing.

If we obtain marketing approval for zervimesine or any other product candidates that we develop or otherwise acquire, we expect to incur significant commercialization expenses related to product sales, marketing, distribution and manufacturing.

We also expect an increase in our expenses associated with creating additional infrastructure to support operations as a public company.

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 our non-dilutive grants, and net proceeds received from our March 2024 follow-on public offering will be sufficient for us to fund our operating expenses and capital expenditures requirements through May of 2025.

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.

We have based these estimates on assumptions that may prove to be incorrect or require adjustment as a result of business decisions, and we could utilize our available capital resources sooner than we currently expect.

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 CT1812, 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 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;

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● 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;

● 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;

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● 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 CT1812 or any of our other product candidates outside the United States;

● 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.

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● 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 C1812 and our product candidates.

If we receive regulatory approval for any of these product candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize.

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 Capital Fund, LLC, or 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.

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.

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.

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.

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If adequate funds are not available on commercially acceptable terms when needed, we may be forced to delay, reduce or terminate the development or commercialization of all or part of our research programs or our product candidates or any future therapeutic candidate, or we may be unable to take advantage of future business opportunities.

Market volatility, liquidity constraints, failures and instability in United States and international financial banking systems, geopolitical tensions resulting from the ongoing conflicts between Ukraine and Russia and Israel and Hamas, heightened or fluctuating inflation and interest rates and the related impact on U.S.

Market volatility, liquidity constraints, failures and instability in United States and international financial banking systems, geopolitical tensions resulting from the ongoing conflicts between Ukraine and Russia and in the Middle East, heightened or fluctuating inflation and interest rates and the related impact on U.S.

and global economies or other economic or other factors could also adversely impact our ability to access capital as and when needed or increase our costs in order to raise capital.

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Although we have applied for and currently anticipate receiving additional NIA Grants, we cannot be certain that our grant applications will be successful, that additional NIA Grants will be made available to support our clinical trials or that we will continue to satisfy the award criteria of prior NIA Grants that have already been awarded to us.

If we fail to continue to receive NIA Grants, our ability to continue our clinical programs for CT1812 may be impaired and delayed, and we may otherwise need to seek additional financing through dilutive methods, such as through equity or debt financings.

If we fail to continue to receive NIA Grants, or fail to adhere to the terms of those grant agreements, our ability to continue our clinical programs for zervimesine may be impaired and delayed, and we may otherwise need to seek additional financing through dilutive methods, such as through equity or debt financings.

Such dilutive financings could have an adverse effect on the price of our common stock.

In addition, government funding is subject to the political process, which is inherently fluid and unpredictable.

Under the Trump administration, the U.S.

National Institutes of Health, or NIH, announced on February 7, 2025, a policy significantly reducing research grants by limiting payments for indirect costs.

Indirect costs represented more than 25% of total grant dollars awarded by the NIH in 2023.

While, as of the date of this filing, the order has been temporarily stayed, there can be no assurance that it will not take effect or that other adverse actions will not be taken.

We could be subject to audit and repayment of our non-dilutive NIA Grants.

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Any audit by the NIA could require significant financial and management resources and may result in a material adjustment to our results of operations and financial condition and harm our ability to operate in accordance with our business plan.

Additionally, negative results in any of our ongoing and planned clinical trials of CT1812 that are funded with NIA Grants may result in our failure to receive additional NIA Grants to fund future clinical trials.

Additionally, negative results in any of our ongoing and planned clinical trials of zervimesine that are funded with NIA Grants may result in our failure to receive additional NIA Grants to fund future clinical trials.

Due to the significant resources required for the development of our product candidates, we must prioritize development of certain product candidates and/or certain disease indications.

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We are currently focused on developing product candidates to address age-related degenerative diseases and disorders of the CNS and retina.

We seek to maintain a process of prioritization and resource allocation among our programs to maintain a balance between aggressively advancing our lead product candidate, CT1812, in identified indications and exploring additional indications or mechanisms as well as developing future product candidates.

We seek to maintain a process of prioritization and resource allocation among our programs to maintain a balance between aggressively advancing our lead product candidate, zervimesine, in identified indications and exploring additional indications or mechanisms as well as developing future product candidates.

However, due to the significant resources required for the development of our product candidates, we must focus on specific diseases and disease pathways and decide which product candidates to pursue from time to time and the amount of time and resources to allocate to each such product candidate.

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Risks Related to Discovery, Development and Regulatory Approval of Our Product Candidates

Our business is heavily dependent on the successful development, regulatory approval and commercialization of CT1812 and any future product candidates that we may develop or acquire.

Our business is heavily dependent on the successful development, regulatory approval and commercialization of zervimesine and any future product candidates that we may develop or acquire.

We currently have no products approved for sale, and our lead product candidate is in early stages of clinical development.

The success of our business, including our ability to finance our company and generate revenue in the future, will primarily depend on the successful development, regulatory approval and commercialization of our product candidates and, in particular, the advancement of CT1812, currently our only clinical-stage product candidate.

The success of our business, including our ability to finance our company and generate revenue in the future, will primarily depend on the successful development, regulatory approval and commercialization of our product candidates and, in particular, the advancement of zervimesine, currently our only clinical-stage product candidate.

However, given our stage of development, it may be many years, if we succeed at all, before we have demonstrated the safety and efficacy of a product candidate sufficient to warrant approval for commercialization.

We cannot be certain that our product candidates will receive regulatory approval or be successfully commercialized even if we receive regulatory approval.

The clinical and commercial success of CT1812 and any future product candidates that we may develop or acquire will depend on a number of factors, including the following:

The clinical and commercial success of zervimesine and any future product candidates that we may develop or acquire will depend on a number of factors, including the following:

● our ability to raise any additional required capital on acceptable terms, or at all;

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In addition, the FDA or other regulatory agencies may not agree with our clinical development plan and require that we conduct additional clinical trials to support our regulatory submissions.

We have not yet conducted an end of Phase 2 meeting with the FDA to discuss the registration pathway for CT1812, and our current clinical development plans for CT1812 in mild-to-moderate AD may change as a result of future interactions with the FDA.

For example, the FDA may not accept the results of the ongoing CT1812 clinical trials and may require that we conduct additional trials, including more than one pivotal trial, in order to gain approval in AD.

Furthermore, any approval of CT1812 for AD may be limited to CT1812 in combination with the existing standard of care.

We have not yet conducted an end of Phase 2 meeting with the FDA to discuss the registration pathway for zervimesine, and our current clinical development plans for zervimesine in mild-to-moderate AD may change as a result of future interactions with the FDA.

For example, the FDA may not accept the results of the ongoing zervimesine clinical trials and may require that we conduct additional trials, including more than one pivotal trial, in order to gain approval in AD.

Furthermore, any approval of zervimesine for AD may be limited to zervimesine in combination with the existing standard of care.

These factors, many of which are beyond our control, could cause us to experience significant delays or an inability to obtain regulatory approvals or commercialize our product candidates.

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Accordingly, we cannot provide assurances that we will be able to generate sufficient revenue through the sale of our product candidates or any future product candidates to continue our business or achieve profitability .

We may not successfully expand our pipeline of product candidates, including by pursuing additional indications for CT1812 or by in-licensing or acquiring additional product candidates for other diseases.

A key element of our strategy is to build and expand our pipeline of product candidates, including by developing CT1812 for the treatment of GA secondary to dry AMD and age-related degenerative diseases and disorders of the CNS beyond indications in AD, and by identifying other product candidates from libraries created using our NICE platform as well as new molecule and screening strategies.

We may not successfully expand our pipeline of product candidates, including by pursuing additional indications for zervimesine or by in-licensing or acquiring additional product candidates for other diseases.

A key element of our strategy is to build and expand our pipeline of product candidates, including by developing zervimesine for the treatment of age-related degenerative diseases and disorders of the CNS beyond indications in AD, and by identifying other product candidates from libraries created using our NICE platform as well as new molecule and screening strategies.

In addition, we may in-license or acquire additional product candidates for other diseases.

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We cannot give any assurance that any of our product candidates will receive regulatory approval.

We are at an early stage of clinical development of our only clinical stage product candidate, CT1812.

We are at an early stage of clinical development of our only clinical stage product candidate, zervimesine.

Our future success is dependent on our ability to successfully develop, obtain regulatory approval for and then successfully commercialize our product candidates, and we may fail to do so for many reasons, including the following:

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In addition, early clinical trials may only include a limited number of subjects and limited duration of exposure to our product candidates.

In particular, we are pursuing a new approach to inhibiting the synaptic binding and signaling of soluble Aβ oligomers through the use of small molecule receptor antagonists, like CT1812.

In particular, we are pursuing a new approach to inhibiting the synaptic binding and signaling of soluble Aβ oligomers through the use of small molecule receptor antagonists, like zervimesine.

As a result, our product candidates may cause unforeseen safety events when evaluated in larger patient populations.

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Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy characteristics despite having progressed through preclinical studies and initial clinical trials.

In particular, while we have conducted certain Phase 2 clinical trials of CT1812 targeting mild-to-moderate AD, we do not know whether CT1812 will perform in future clinical trials as it has performed in these prior trials.

The positive results we have observed for CT1812 in past clinical trials may not be predictive of our ongoing and future clinical trials in humans.

In particular, while we have conducted certain Phase 2 clinical trials of zervimesine targeting mild-to-moderate AD and DLB, we do not know whether zervimesine will perform in future clinical trials as it has performed in these prior trials.

The positive results we have observed for zervimesine in past clinical trials may not be predictive of our ongoing and future clinical trials in humans.

It is not uncommon to observe results in clinical trials that are unexpected based on preclinical studies and early clinical trials, and many product candidates fail in clinical trials despite very promising early results.

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Open-label clinical trials may be subject to a “patient bias” where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment.

In addition, open-label clinical trials may be subject to an “investigator bias” where those assessing and reviewing the

physiological outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably given this knowledge.

In addition, open-label clinical trials may be subject to an “investigator bias” where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably given this knowledge.

The results from an open-label trial may not be predictive of future clinical trial results with any of our product candidates when studied in a controlled environment with a placebo or active control.

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If the top-line data that we report differ from final results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, product candidates may be harmed, which could significantly harm our business, financial condition, results of operations and prospects .

We have initially concentrated our research and development efforts on the treatment of AD, a disease that has seen limited success in drug development.

Efforts by biopharmaceutical and pharmaceutical companies in treating AD have seen limited success in drug development.

Only two disease-modifying therapeutic options have been approved by the FDA.

Specifically, Biogen’s Aduhelm received accelerated approval on June 7, 2021 and the FDA granted accelerated approval to Eisai’s Leqembi on January 6, 2023.

Aduhelm and Leqembi are monoclonal antibodies administered via infusion reported to reduce Aβ plaques and protofibrils.

We have initially concentrated our research and development efforts on the treatment of AD and DLB, diseases that have seen limited success in drug development.

Efforts by biopharmaceutical and pharmaceutical companies in treating AD and DLB have seen limited success in drug development.

Only two 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) and the FDA granted accelerated approval to Eisai’s Leqembi on January 6, 2023.

Leqembi is monoclonal antibodies administered via infusion reported to reduce Aβ plaques and protofibrils.

We cannot be certain that our oral, small-molecule approach will lead to the development of approvable or marketable products.

With the exception of Aduhelm and Leqembi, the only drugs approved by the FDA to treat patients with AD address the symptoms of the disease.

As a result, the FDA has a limited set of products to rely on in evaluating CT1812.

This could result in a longer than expected regulatory review process, increased expected development costs or the delay or prevention of commercialization of CT1812 for the treatment of AD .

With the exception of Leqembi, the only currently marketed drug approved by the FDA to treat patients with AD address the symptoms of the disease.

As a result, the FDA has a limited set of products to rely on in evaluating zervimesine.

This could result in a longer than expected regulatory review process, increased expected development costs or the delay or prevention of commercialization of zervimesine for the treatment of AD or DLB .

We have never conducted pivotal clinical trials, and we may be unable to do so for any product candidates we may develop.

We will need to successfully initiate and complete pivotal clinical trials in order to obtain the approval of the FDA, the European Medicines Agency, or EMA, or other regulatory agencies to market CT1812 or any future product candidate.

Carrying out pivotal clinical trials is a complicated process that requires significant financial resources.

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We also expect to continue to rely on third parties to conduct our pivotal clinical trials.

Consequently, we may be unable to successfully and efficiently execute and complete necessary clinical trials in a way that leads to NDA submission and approval of CT1812 or future product candidates.

Consequently, we may be unable to successfully and efficiently execute and complete necessary clinical trials in a way that leads to NDA submission and approval of zervimesine or future product candidates.

We may require more time and incur greater costs than our competitors and may not succeed in obtaining regulatory approvals of product candidates that we develop.

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A Fast Track designation by the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive marketing approval.

The FDA granted CT1812 Fast Track designation in October 2017 for the treatment of mild-to- moderate AD, and, in the future, we may seek Fast Track designation for other of our product candidates.

The FDA granted zervimesine Fast Track designation in October 2017 for the treatment of mild-to- moderate AD, and, in the future, we may seek Fast Track designation for other of our product candidates.

If a drug is intended for the treatment of a serious or life-threatening condition and the drug demonstrates the potential to address unmet medical needs for this condition, the drug sponsor may apply for Fast Track designation.

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Many small molecule product candidates that have received Fast Track designation have failed to obtain marketing approval.

Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns 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.

Changes in funding for, or disruptions to the 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.

Currently, federal agencies in the U.S.

are operating under a continuing resolution that is set to expire on September 30, 2025.

Without appropriation of additional funding to federal agencies, our business operations related to our product development activities for the U.S.

market could be impacted.

The ability of the FDA to review and/or approve new products can be affected by a variety of factors, including government budget and funding levels, 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.

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Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business.

If a prolonged government shutdown occurs, or if global health concerns continue to prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it 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.

In addition, government funding of other agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

A prolonged government shutdown 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.

In addition, government funding of other agencies on which our operations may rely, including those that fund research and development activities and clinical trials, is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at agencies that fund our research and development activities and our clinical trials, or changes to such agencies’ budgets, may negatively impact our operations and ongoing clinical trials and may limit our ability to seek additional funding in the future.

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 .

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We have conducted clinical trials of our product candidates outside the United States, and plan to continue to do so in the future.

For example, we initially conducted our Phase 1b SNAP clinical trial of CT1812 in collaboration with the Karolinska Institute in Sweden.

In addition, the Phase 1 single and multiple ascending dose studies of CT1812 in healthy volunteers (COG0101) as well as the first-in-patient study (COG0102) were conducted in Australia.

For example, we initially conducted our Phase 1b SNAP clinical trial of zervimesine in collaboration with the Karolinska Institute in Sweden.

In addition, the Phase 1 single and multiple ascending dose studies of zervimesine in healthy volunteers (COG0101) as well as the first-in-patient study (COG0102) were conducted in Australia.

We opened additional clinical trial site in the Netherlands, Czech Republic and Spain for our SHINE study.

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There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from trials conducted outside of the United States or the applicable jurisdiction.

If the FDA or any comparable foreign regulatory authority does not accept such data, it would result in the need for additional trials, which would be costly and time-consuming and delay aspects

of our business plan, and which may result in product candidates that we may develop not receiving approval or clearance for commercialization in the applicable jurisdiction .

If the FDA or any comparable foreign regulatory authority does not accept such data, it would result in the need for additional trials, which would be costly and time-consuming and delay aspects of our business plan, and which may result in product candidates that we may develop not receiving approval or clearance for commercialization in the applicable jurisdiction .

If we are not successful in identifying, developing and commercializing additional product candidates, our ability to expand our business and achieve our strategic objectives would be impaired.

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A component of our strategy is to evaluate our product candidates in multiple indications based, in part, on our evaluation of certain biomarkers in a disease area.

For example, we intend to evaluate CT1812 and other product candidates discovered through our NICE platform in other diseases beyond indications in AD, such as GA secondary to dry AMD, and synucleinopathies, including PD and DLB.

For example, we intend to evaluate zervimesine and other product candidates discovered through our NICE platform in other diseases beyond indications in AD, such as synucleinopathies, including PD and DLB.

However, we may find that while we have seen promising results in one neurodegenerative disease, that effect is not replicated across other indications with promising similarities.

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Further, while regulatory approval of a product candidate in one country does not ensure approval in any other country, a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory approval process in others.

If we or any future collaborators fail to comply with the

regulatory requirements in international markets or to obtain all required marketing approvals, the target market for a particular potential product will be reduced, which would limit our ability to realize the full market potential for the product and adversely affect our business.

If we or any future collaborators fail to comply with the regulatory requirements in international markets or to obtain all required marketing approvals, the target market for a particular potential product will be reduced, which would limit our ability to realize the full market potential for the product and adversely affect our business.

Risks Related to Our Business and Industry

We are heavily dependent on the success of CT1812, our lead product candidate, which is still under clinical development, and if CT1812 does not receive regulatory approval or is not successfully commercialized, our business may be harmed.

The success of our business, including our ability to finance our company and generate revenue in the future, will primarily depend on the successful development, regulatory approval and commercialization of CT1812, currently our only clinical-stage product candidate.

To date, we have invested a significant portion of our efforts and financial resources in the development of CT1812 for the treatment of AD.

Our future success is substantially dependent on our ability to successfully complete clinical development for, obtain regulatory approval for and successfully commercialize CT1812, which may never occur.

We expect that a substantial portion of our efforts and expenditures over the next few years will be devoted to CT1812, which will require additional clinical development, management of clinical and manufacturing activities, regulatory approval in multiple jurisdictions, obtaining manufacturing supply, building of a commercial organization, substantial investment and significant marketing efforts before we can generate any revenues from any commercial sales.

We are heavily dependent on the success of zervimesine, our lead product candidate, which is still under clinical development, and if zervimesine does not receive regulatory approval or is not successfully commercialized, our business may be harmed.

The success of our business, including our ability to finance our company and generate revenue in the future, will primarily depend on the successful development, regulatory approval and commercialization of zervimesine, currently our only clinical-stage product candidate.

To date, we have invested a significant portion of our efforts and financial resources in the development of zervimesine for the treatment of AD and DLB.

We expect that a substantial portion of our efforts and expenditures over the next few years will be devoted to zervimesine, which will require additional clinical development, management of clinical and manufacturing activities, regulatory approval in multiple jurisdictions, obtaining manufacturing supply, building of a commercial organization, substantial investment and significant marketing efforts before we can generate any revenues from any commercial sales.

We cannot be certain that we will be able to successfully complete any of these activities.

Furthermore, while inhibition of Aβ oligomers has been validated as a therapeutic approach, the use of small molecule receptor antagonists, such as CT1812, to inhibit the synaptic binding and signaling of soluble Aβ oligomers is an innovative therapeutic approach, which exposes us to certain risks.

For example, we may discover unforeseen safety events or that CT1812 does not possess certain properties required for therapeutic effectiveness.

Even if found to be effective in one type of disease, CT1812, or the associated therapeutic approach, may not be effective in other diseases.

Furthermore, while inhibition of Aβ oligomers has been validated as a therapeutic approach, the use of small molecule receptor antagonists, such as zervimesine, to inhibit the synaptic binding and signaling of soluble Aβ oligomers is an innovative therapeutic approach, which exposes us to certain risks.

For example, we may discover unforeseen safety events or that zervimesine does not possess certain properties required for therapeutic effectiveness.

Even if found to be effective in one type of disease, zervimesine, or the associated therapeutic approach, may not be effective in other diseases.

In addition, given our therapeutic approach, designing preclinical studies and clinical trials to demonstrate its effect is complex and exposes us to risks.

The research, testing, manufacturing, labeling, approval, sale, marketing and distribution of drug products are subject to extensive regulation by the FDA and comparable regulatory authorities in other countries.

We are not permitted to market CT1812 in the United States until we receive approval of an NDA from the FDA, or in any foreign countries until we receive the requisite approval from such countries.

We have not submitted an NDA to the FDA or comparable applications to other regulatory authorities for CT1812 and may not be in a position to do so for several years, if ever.

If we are unable to obtain the necessary regulatory approvals for CT1812, we will not be able to commercialize CT1812 in AD, GA secondary to dry AMD, PD and DLB or other age-related degenerative diseases and disorders of the CNS and retina, and our financial position will be materially adversely affected and we may not be able to generate sufficient revenue to continue our business .

We are not permitted to market zervimesine in the United States until we receive approval of an NDA from the FDA, or in any foreign countries until we receive the requisite approval from such countries.

We have not submitted an NDA to the FDA or comparable applications to other regulatory authorities for zervimesine and may not be in a position to do so for several years, if ever.

If we are unable to obtain the necessary regulatory approvals for zervimesine, we will not be able to commercialize zervimesine in AD, PD and DLB or other age-related degenerative diseases and disorders of the CNS and retina, and our financial position will be materially adversely affected and we may not be able to generate sufficient revenue to continue our business .

We will need to increase the size of our organization, and we may experience difficulties in managing growth.

As of March 1, 2025, we had 25 full-time and 3 part-time employees.

We will need to continue to expand our managerial, operational, finance and other resources in order to manage our operations and clinical trials, continue our development activities and commercialize CT1812, our lead product candidate, or any future product candidates.

We will need to continue to expand our managerial, operational, finance and other resources in order to manage our operations and clinical trials, continue our development activities and commercialize zervimesine, our lead product candidate, or any future product candidates.

Our management and personnel, systems and facilities currently in place may not be adequate to support this future growth and we expect will lead to increasing costs.

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● continue to improve our operational, financial and management controls, reports systems and procedures.

Our future financial performance and our ability to develop, manufacture and commercialize CT1812 and our product candidates, if approved, will depend, in part, on our ability to effectively manage any future growth, and our management may also have to divert financial and other resources, and a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial amount of time, to managing these growth activities.

If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors, we may not be able to successfully implement the tasks necessary to further develop and commercialize CT1812, if approved, and our product candidates and, accordingly, may not achieve our research, development and commercialization goals .

Our future financial performance and our ability to develop, manufacture and commercialize zervimesine and our product candidates, if approved, will depend, in part, on our ability to effectively manage any future growth, and our management may also have to divert financial and other resources, and a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial amount of time, to managing these growth activities.

If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors, we may not be able to successfully implement the tasks necessary to further develop and commercialize zervimesine, if approved, and our product candidates and, accordingly, may not achieve our research, development and commercialization goals .

If we fail to attract and retain senior management and key scientific personnel, our business may be materially and adversely affected.

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Our potential inability to integrate any business, products or technologies effectively may adversely affect our business, results of operations and financial condition .

Significant disruptions of information technology systems and infrastructure, breaches of data security and other incidents could materially adversely affect our business, results of operations and financial condition.

Significant disruptions of information technology systems and infrastructure, data breaches and other cybersecurity incidents could materially adversely affect our business, results of operations and financial condition.

We collect and maintain information in digital and other forms that is necessary to conduct our business, and we are increasingly dependent on information technology systems and infrastructure to operate our business.

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We have also outsourced elements of our information technology infrastructure, and as a result a number of third-party vendors may have access to our confidential information.

Our internal information technology systems and infrastructure, and those of any future collaborators and our contractors, consultants, vendors and other third parties on which we rely, are vulnerable to damage, disruption, security compromise or incident, or other unauthorized access or use resulting from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the Internet, denial or degradation of service attacks, ransomware, hacking, phishing schemes intended to cause an unauthorized transfer of funds and other social engineering attacks, attachments to emails, persons inside our organization or persons with access to systems and data inside our organization.

Our internal information technology systems and infrastructure, and those of any future collaborators and our contractors, consultants, vendors and other third parties on which we rely, are vulnerable to damage, disruption, security compromise or incident, or other unauthorized access or use resulting from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions, malicious internet-based activity, online and offline fraud, phishing attacks and other social engineering schemes, denial or degradation of service attacks, ransomware, hacking, wrongful conduct by insider employees or vendors, data breaches, and other similar activities.

Such threats are prevalent and continue to rise, are increasingly difficult to detect, and come from a variety of sources.

The risk of a security compromise, incident, breach or disruption, particularly through cyber-attacks or cyber intrusion, including by computer hackers, foreign governments and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased.

The prevalent use of mobile devices that access confidential information also increases the risk of lost or stolen devices, security incidents and data security compromises or breaches, which could lead to the loss of confidential information, including intellectual property, proprietary business information and personal information.

We may face increased risks of a security compromise, incident, breach or disruption due to our reliance on internet technology and the number of our employees who work on a hybrid basis, at home and in the office.

This may create additional opportunities for cybercriminals to exploit vulnerabilities.

The costs to us to investigate, mitigate and remediate security incidents, compromises, breaches, disruptions, network security problems, bugs, viruses, worms, malicious software programs and security vulnerabilities could be significant.

We have in the past experienced threats related to our data and systems, including phishing attacks, and we may in the future experience other threats, compromises or breaches affecting confidential information.

The prevalent use of mobile devices that access confidential information also increases the risk of lost or stolen devices, security incidents and data breaches, which could lead to the loss of confidential information, including intellectual property, proprietary business information and personal information.

Like other companies in our industry, we, and our third party vendors, have experienced and will continue to experience threats and cybersecurity incidents relating to our information technology systems and infrastructure.

Further, and due to our reliance on internet technology and based on the number of our employees who work on a hybrid basis, at home and in the office, there may be increased opportunities for bad actors to exploit security vulnerabilities.

The costs to us to investigate, mitigate and remediate security incidents, compromises, data breaches, disruptions, network security problems, bugs, viruses, worms, malicious software programs and security vulnerabilities could be significant.

Additionally, our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages, or claims related to our privacy and data security obligations.

Further, although we maintain cyber liability insurance, this insurance may not provide adequate coverage against potential liabilities related to any experienced cybersecurity incident or breach.

We have in the past experienced threats related to our data and systems, including phishing attacks, and we will in the future experience such threats and cybersecurity incidents.

While we have implemented security measures designed to protect our data security and information technology systems and infrastructure, our efforts to address these problems may not be successful, and these problems could result in unexpected interruptions, delays, cessation of service, negative publicity and other harm to our business and our competitive position.

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Any security compromise affecting us, our partners or our industry, whether real or perceived, could harm our reputation, erode confidence in the effectiveness of our security measures and lead to regulatory scrutiny.

Moreover, if a computer security compromise or breach affects our systems or infrastructure or results in the unauthorized access to or unauthorized use, disclosure, release or other processing of personal information or clinical trial data, it may be necessary to notify individuals, governmental authorities, supervisory bodies, the media and other parties pursuant to privacy and security laws, and our reputation could be materially damaged.

Moreover, if a computer security compromise or breach affects our systems or infrastructure or results in the unauthorized access to or unauthorized use, disclosure, release or other processing of personal information or clinical trial data, it may be necessary to notify affected individuals, governmental authorities, regulatory agencies, the media and other parties pursuant to privacy and security laws, and our reputation could be materially damaged.

We would also be exposed to a risk of loss, governmental investigations or enforcement, litigation, fines, penalties, and other potential legal and financial exposure and liability, which could materially adversely affect our business, results of operations and financial condition .

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healthcare programs, other sanctions, imprisonment, contractual damages, reputational harm, diminished profits and future earnings and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

Environmental, social and governance matters may impact our business and reputation.

In addition to the changing rules and regulations related to environmental, social and governance, or ESG, matters imposed by governmental and self-regulatory organizations, a variety of third-party organizations, institutional investors and customers evaluate the performance of companies on ESG topics, and the results of these assessments are widely publicized.

These changing rules, regulations and stakeholder expectations have resulted in, and are likely to continue to result in, increased general and administrative expenses and increased management time and attention spent complying with or meeting such regulations and expectations.

Reduced access to or increased cost of capital may occur as financial institutions and investors increase expectations related to ESG matters.

Developing and acting on initiatives within the scope of ESG, and collecting, measuring and reporting ESG-related information and metrics can be costly, difficult and time consuming and is subject to evolving reporting standards.

We may also communicate certain initiatives and goals, regarding environmental matters, social investments and other ESG-related matters, in our SEC filings or in other public disclosures.

These initiatives and goals within the scope of ESG could be difficult and expensive to implement, the technologies needed to implement them may not be cost effective and may not advance at a sufficient pace, and we could be criticized for the accuracy, adequacy or completeness of the disclosure.

Furthermore, statements about our ESG-related initiatives and goals, and progress against those goals, may be based on standards for measuring progress that are still developing, internal controls and processes that continue to evolve and assumptions that are subject to change in the future.

In addition, we could be criticized for the scope or nature of such initiatives or goals, or for any revisions to these goals.

If our ESG-related data, processes and reporting are incomplete or inaccurate, or if we fail to achieve progress with respect to our goals, including our previously announced commitments to reduce greenhouse gas emissions, within the scope of ESG on a timely basis, or at all, our reputation, business, financial performance and growth could be adversely affected.

In addition, in recent years “anti-ESG” sentiment has gained momentum across the U.S., with several states and Congress having proposed or enacted “anti-ESG” policies, legislation, or initiatives or issued related legal opinions.

Such anti-ESG policies, legislation, initiatives, litigation, legal opinions, and scrutiny could result in the Company facing additional compliance obligations, becoming the subject of investigations and enforcement actions, or sustaining reputational harm.

Risks Related to Our Intellectual Property

If we are unable to obtain and maintain patent protection for our technology and product candidates including our lead product candidate, CT1812, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.

If we are unable to obtain and maintain patent protection for our technology and product candidates including our lead product candidate, zervimesine, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.

We rely, and will continue to rely, upon a combination of patents, trademarks, trade secret protection and confidentiality agreements with employees, consultants, collaborators, advisors and other third parties to protect the intellectual property related to our current and future drug development programs and product candidates.

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If we fail to timely file a patent application in any such country, we may be precluded from doing so at a later date.

The patent applications that we own may fail to result in issued patents with claims that cover any of our product candidates in the United

States or in other foreign countries.

The patent applications that we own may fail to result in issued patents with claims that cover any of our product candidates in the United States or in other foreign countries.

We may also inadvertently make statements to regulatory agencies during the regulatory approval process that may be inconsistent with positions that have been taken during prosecution of our patents, which may result in such patents being narrowed, invalidated or held unenforceable, and vice versa that may affect the regulatory approval process.

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The Leahy-Smith Act was signed into law on September 16, 2011 and includes a number of significant changes to U.S.

These include provisions that affect the way patent

applications are prosecuted, redefine prior art and provide more efficient and cost-effective avenues for competitors to challenge the validity of patents.

These include provisions that affect the way patent applications are prosecuted, redefine prior art and provide more efficient and cost-effective avenues for competitors to challenge the validity of patents.

These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review, and derivation proceedings.

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Additionally, such proceedings could provoke third parties to assert claims against us.

We may not prevail in any lawsuits that we initiate and the damages

or other remedies awarded, if any, may not be commercially meaningful.

We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful.

Thus, we may not be able to stop a competitor from marketing and selling in foreign countries products and services that are the same as or similar to our products and services, and our competitive position in the international market would be harmed.

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Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop .

Patent terms may be inadequate to protect our competitive position on our product candidates including our lead product candidate, CT1812, for an adequate amount of time.

Patent terms may be inadequate to protect our competitive position on our product candidates including our lead product candidate, zervimesine, for an adequate amount of time.

Patents have a limited lifespan.

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Even if we are able to obtain an extension, the patent term may still expire before or shortly after we receive FDA marketing approval.

referencing our clinical and preclinical data to obtain approval of competing products following our patent expiration and launch their product earlier than might otherwise be the case .

If we are unable to extend the expiration date of our existing patents or obtain new patents with longer expiry dates, our competitors may be able to take advantage of our investment in development and clinical trials by referencing our clinical and preclinical data to obtain approval of competing products following our patent expiration and launch their product earlier than might otherwise be the case .

If we do not obtain protection under the Hatch-Waxman Amendments by obtaining data exclusivity, our business may be harmed.

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If we are unable to obtain such marketing exclusivity for our product candidates, our competitors may be able to take advantage of our investment in development and clinical trials by referencing our clinical and preclinical data to obtain approval of competing products and launch their product earlier than might otherwise be the case .

The validity, scope and enforceability of any patents listed in the Orange Book that cover our product candidates including our lead product candidate CT1812 can be challenged by third parties.

The validity, scope and enforceability of any patents listed in the Orange Book that cover our product candidates including our lead product candidate zervimesine can be challenged by third parties.

If one of our product candidates is approved by the FDA, one or more third parties may challenge the current patents, or patents that may issue in the future, within our portfolio which could result in the invalidation of, or render unenforceable, some or all of the relevant patent claims or a finding of non- infringement.

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The filing of a patent infringement lawsuit within 45 days of receipt of the notice automatically prevents the FDA from approving the third party’s ANDA until the earliest of 30 months or the date on which the patent expires, the lawsuit is settled, or the court reaches a decision in the infringement lawsuit in favor of the third party.

file a patent infringement lawsuit within the required 45-day period, the third party’s ANDA will not be subject to the 30-month stay of FDA approval.

If we do not file a patent infringement lawsuit within the required 45-day period, the third party’s ANDA will not be subject to the 30-month stay of FDA approval.

Moreover, a third party may challenge the current patents, or patents that may issue in the future, within our portfolio which could result in the invalidation of some or all of the patents that might otherwise be eligible for listing in the Orange Book for one of our products.

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In some cases we may not have control over the prosecution, maintenance or enforcement of the patents that we may license, and may not have sufficient ability to provide input into the patent prosecution, maintenance and defense process with respect to such patents, and our potential licensors may fail to take the steps that we believe are necessary or desirable in order to obtain, maintain, defend and enforce the licensed patents .

Third-party claims or litigation alleging infringement of patents or other proprietary rights, or seeking to invalidate patents or other proprietary rights, may delay or prevent the development and commercialization of any of our product candidates including our lead product candidate, CT1812.

Our commercial success depends in part on our avoiding infringement and other violations of the patents and proprietary rights of third parties.

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Some of our competitors may be able to sustain the costs of complex intellectual property litigation more effectively than we can because they have substantially greater resources.

In addition, intellectual property litigation, regardless of its outcome, may cause negative publicity, adversely impact prospective customers, cause product

shipment delays, or prohibit us from manufacturing, marketing or otherwise commercializing our products, services and technology.

In addition, intellectual property litigation, regardless of its outcome, may cause negative publicity, adversely impact prospective customers, cause product shipment delays, or prohibit us from manufacturing, marketing or otherwise commercializing our products, services and technology.

Any uncertainties resulting from the initiation and continuation of any litigation could adversely impact our ability to raise additional funds or otherwise harm our business, results of operation, financial condition or cash flows.

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To counter infringement or unauthorized use, we may be required to file legal claims, which can be expensive and time-consuming.

In addition, in an infringement proceeding, a court may decide that a patent of ours is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our

patents do not cover the technology in question.

As a result, we cannot predict with certainty how much protection, if any, will be given to our patents if we attempt to enforce them and they are challenged in court.

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Changes in U.S.

patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protects our product including our lead product candidate, CT1812.

The United States has recently enacted and implemented wide-ranging patent reform legislation.

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In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained.

Depending on actions by the United States

Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce patents that we own or that we might obtain in the future.

Depending on actions by the United States Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce patents that we own or that we might obtain in the future.

Similarly, changes in patent law and regulations in other countries or jurisdictions or changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces patent laws or regulations may weaken our ability to obtain new patents or to enforce patents that we own or that we may obtain in the future.

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These agreements typically limit the rights of the third parties to use or disclose our confidential information, including our trade secrets.

our competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements.

Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by our competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements.

Any disclosure, either intentional or unintentional, by our employees, the employees of third parties with whom we share our facilities or third-party consultants and vendors that we engage to perform research, clinical trials or manufacturing activities, or misappropriation by third parties (such as through a cybersecurity breach) of our trade secrets or proprietary information could enable competitors to duplicate or surpass our technological achievements, thus eroding our competitive position in our market.

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For example, the NIA has provided grants to fund certain of our preclinical activities and clinical trials.

If the United States or another jurisdiction decides that the NIA grant bestows rights to our patent applications, that could affect our ability to obtain valid and enforceable patent claims protecting our rights as they relate to our lead product candidate, CT1812, our other product candidates and our NICE platform.

If the United States or another jurisdiction decides that the NIA grant bestows rights to our patent applications, that could affect our ability to obtain valid and enforceable patent claims protecting our rights as they relate to our lead product candidate, zervimesine, our other product candidates and our NICE platform.

As a consequence of these and other factors, our patent applications may fail to result in issued patents with claims that cover our product candidates in the United States or in other countries.

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Any failure by our product candidates that obtain regulatory approval to achieve market acceptance or commercial success would adversely affect our reputation, ability to raise additional capital, financial condition, results of operations and business prospects .

The market opportunities for CT1812, if approved, may be smaller than we anticipate.

We expect to initially seek approval for CT1812 for AD, GA secondary to dry AMD, PD and DLB and other age-related degenerative diseases and disorders of the CNS and retina.

The market opportunities for zervimesine, if approved, may be smaller than we anticipate.

We expect to initially seek approval for zervimesine for AD, PD and DLB and other age-related degenerative diseases and disorders of the CNS and retina.

Our estimates of market potential have been derived from a variety of sources, including scientific literature, patient foundations and market research and may prove to be incorrect.

Even if we obtain significant market share for CT1812 after FDA approval, the potential target populations may be too small to consistently generate revenue, and we may never achieve profitability without obtaining marketing approval for additional indications .

Even if we obtain significant market share for zervimesine after FDA approval, the potential target populations may be too small to consistently generate revenue, and we may never achieve profitability without obtaining marketing approval for additional indications .

We rely on third-party suppliers to manufacture our product candidates, and we intend to rely on third parties to produce commercial supplies of any approved product.

The loss of these suppliers, or their failure to comply with applicable regulatory requirements or to provide us with sufficient quantities at acceptable quality levels or prices, or at all, would materially and adversely affect our business, financial condition, results of operations and prospects.

We do not currently have nor do we plan to build or acquire the infrastructure or capability internally to manufacture supplies of our product candidates or the materials necessary to produce our product candidates for use in the conduct of our preclinical studies or clinical trials, and we lack the internal resources and the capability to manufacture any of our product candidates on a preclinical, clinical or commercial scale.

We do not currently have, nor do we plan to build or acquire the infrastructure or internal capability to manufacture supplies of our product candidates or the materials necessary to produce our product candidates for use in conducting our preclinical studies or clinical trials, and we lack the internal resources and the capability to manufacture any of our product candidates on a preclinical, clinical or commercial scale.

The facilities used by our contract manufacturers to manufacture our product candidates are subject to various regulatory requirements and may be subject to the inspection of the FDA or other regulatory authorities.

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In some cases, the technical skills required to manufacture our product candidates may be unique or proprietary to the original manufacturer and we may have difficulty, or there may be contractual restrictions prohibiting us from, transferring such skills to a back-up or alternate supplier, or we may be unable to transfer such skills at all.

In addition, if we are required to change CMOs for any reason, we will be required to verify that the new manufacturer maintains facilities

and procedures that comply with quality standards and with all applicable regulations.

In addition, if we are required to change CMOs for any reason, we will be required to verify that the new manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations.

The delays associated with the verification of a new manufacturer could negatively affect our ability to develop product candidates in a timely manner or within budget.

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For instance, the supply chains for our lead product candidate involves several manufacturers that specialize in specific operations of the manufacturing process, specifically, raw materials manufacturing, drug substance manufacturing and drug product manufacturing.

As a result, the supply chain for the manufacturing of our product candidates is complicated, and we expect the logistical challenges associated with our supply chain to grow more complex as our product candidates are further developed.

We do not have any control over the process or timing of the acquisition or manufacture of materials by our manufacturers.

We generally do not begin preclinical or clinical trials unless we believe we have access to a sufficient supply of a product candidate to complete such study.

As a result, the supply chain for the manufacturing of our product candidates is complicated, but not atypical, and we expect the logistical challenges associated with our supply chain to grow more complex as our product candidates are further developed.

We do not have complete control over the process or timing of the acquisition or manufacture of materials by our manufacturers.

We generally do not begin preclinical studies or clinical trials unless we believe we have access to a sufficient supply of a product candidate to complete such study.

In addition, any significant delay in, or quality control problems with respect to, the supply of a product candidate, or the raw material components thereof, for an ongoing study could considerably delay completion of our preclinical or clinical trials, product testing and potential regulatory approval of our product candidates.

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Potential competitors also include academic institutions, government agencies, and other public and private research organizations that conduct research, seek patent protection, and establish collaborative arrangements for research, development, manufacturing, and commercialization.

There are a number of large pharmaceutical and biotechnology companies that are currently pursuing the development of product candidates for the treatment of the diseases and disorders for which we have research programs, including AD, dry AMD, PD and DLB.

Companies developing therapeutics for similar indications include large companies with significant financial resources, such as AbbVie, AstraZeneca, Biogen, Celgene, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Novartis, Pfizer, Roche, Sanofi and Takeda.

Companies developing therapeutics for similar indications include large companies with significant financial resources, such as AbbVie, AstraZeneca, Biogen, Celgene (as acquired by Bristol Myers Squibb), Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Novartis, Pfizer, Roche, Sanofi and Takeda.

In addition to competition from other companies targeting neurodegenerative indications, any products we may develop may also face competition from other types of therapies.

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The holder of an approved application must submit new or supplemental applications and obtain approval for certain changes to the approved product, product labeling or manufacturing process.

We could also be asked to conduct post-marketing clinical trials to verify

the safety and efficacy of our products in general or in specific patient subsets.

We could also be asked to conduct post-marketing clinical trials to verify the safety and efficacy of our products in general or in specific patient subsets.

An unsuccessful post-marketing study or failure to complete such a study could result in the withdrawal of marketing approval.

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The legislation also extended Medicaid rebates, previously due only on fee-for-service Medicaid utilization, to include the utilization of Medicaid managed care organizations as well and created an alternative rebate formula for certain new formulations of certain existing products that is intended to increase the amount of rebates due on those products.

There have been significant ongoing efforts to modify or eliminate the

Affordable Care Act.

There have been significant ongoing efforts to modify or eliminate the Affordable Care Act.

For example, the Tax Act, enacted on December 22, 2017, repealed the shared responsibility payment for individuals who fail to maintain minimum essential coverage under section 5000A of the Internal Revenue Code of 1986, as amended, or the Code or the individual mandate.

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A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the U.S.

False Claims Act (which can be enforced through “qui tam,” or whistleblower actions, by private citizens on behalf of the federal government), prohibits any person from, among other things, knowingly presenting, or causing to be presented false or fraudulent claims for payment of government funds or knowingly making, using or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the U.S.

federal government ;

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Moreover, government entities and private litigants have asserted claims under state consumer protection statutes against pharmaceutical companies for alleged false or misleading statements in connection with the marketing, promotion and/or sale of pharmaceutical products.

Further, defending against any such actions can be costly and

time-consuming and may require significant personnel resources.

Further, defending against any such actions can be costly and time-consuming and may require significant personnel resources.

Even if we are successful in defending against any such actions that may be brought against us, our business may be impaired .

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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.

Existing regulatory policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates.

In June 2024, the U.S.

Supreme Court overruled the Chevron doctrine, which gives deference to regulatory agencies’ statutory interpretations in litigation against federal government agencies, such as the FDA, where the law is ambiguous.

This decision may result in more lawsuits against the FDA to challenge longstanding decisions and policies of the FDA, which could undermine the FDA’s authority, lead to uncertainties in the industry, and disrupt the FDA’s normal operations, any of which could delay the FDA’s review of our regulatory submissions.

We cannot predict the full impact of this decision, future judicial challenges brought against the FDA, or the nature or extent of government regulation that may arise from future legislation or administrative action.

If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, and we may not achieve or sustain profitability.

Congress, the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business.

In 2017, the U.S.

Congress and the Trump administration made substantial changes to U.S.

policies, which included comprehensive corporate and individual tax reform.

In addition, the Trump administration called for significant changes to U.S.

trade, healthcare, immigration and government regulatory policy.

With the transition to the Biden administration in early 2021, changes to U.

policy occurred and since the start of the Trump Administration in 2025, U.S.

policy changes have been implemented at a rapid pace and additional changes are likely.

Changes to U.S.

policy implemented by the U.S.

Congress, the Trump administration or any new administration have impacted and may in the future impact, among other things, the U.S.

and global economy, international trade relations, unemployment, immigration, healthcare, taxation, the U.S.

regulatory environment, inflation and other areas.

Although we cannot predict the impact, if any, of these changes to our business, they could adversely affect our business.

Until we know what policy changes are made, whether those policy changes are challenged and subsequently upheld by the court system and how those changes impact our business and the business of our competitors over the long term, we will not know if, overall, we will benefit from them or be negatively affected by them.

Risks Related to Our Common Stock

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The trading price of our common stock could be highly volatile and could be subject to wide fluctuations in response to various factors, some of which are beyond our control.

Since our common stock began trading on the Nasdaq Global Market on October 8, 2021, our stock has traded at prices as low as $0.90 per share and as high as $13.80 per share through March 22, 2024.

Our common stock began trading on the Nasdaq Global Market on October 8, 2021 and was transferred to a listing on Nasdaq Capital Market on March 14, 2025;

since its initial listing, our stock has traded at prices as low as $0.34 per share and as high as $13.80 per share through March 13, 2025.

In particular, the trading prices for biopharmaceutical companies have been highly volatile as a result of supply chain disruptions and the COVID-19 pandemic.

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● additions or departures of key personnel;

● our ability to maintain our listing on the Nasdaq Capital Market;

● intellectual property, product liability, or other litigation against us;

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If we sell shares of our common stock in future financings, stockholders may experience dilution and, as a result, our stock price may decline.

Because we expect our expenses to increase significantly in the foreseeable future and because, based on our current business plans, we believe that our cash, cash equivalents, income from our non-dilutive grants, and net proceeds received from our March 2024 follow-on public offering will be sufficient for us to fund our operating and capital expenditures through May of 2025.

Because we expect our expenses to increase significantly in the foreseeable future and because, based on our current business plans, we believe that our cash, cash equivalents and income from our non-dilutive grants will be sufficient for us to fund our operating and capital expenditures into the fourth quarter of 2025.

As a result, we may from time to time issue additional shares of common stock or other securities to raise capital.

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In December 2022, we filed a registration statement on Form S-3 relating to the registration of our common stock, preferred stock, debt securities, warrants, units and subscription rights or any combination thereof.

Concurrently with the filing of such registration statement, we entered into an "at-the-market" offering program, or ATM, which provides for the offering, issuance and sale by us of up shares of our common stock from time to time for aggregate gross proceeds of up to $40 million in sales deemed to be “at-the-market” as defined by the Securities Act of 1933, as amended.

For the period ended December 31, 2023, we sold 2,859,074 shares of its common stock pursuant to the ATM for gross proceeds of approximately $5.3 million.

For the period ended December 31, 2023, the Company sold 125,000 shares of common stock to Lincoln Park for proceeds of $0.2 million, as part of the equity line financing arrangement.

Concurrently with the filing of such registration statement, we entered into the ATM Facility, which provides for the offering, issuance and sale by us of up shares of our common stock from time to time for aggregate gross proceeds of up to $40 million in sales deemed to be “at-the-market” as defined by the Securities Act of 1933, as amended.

For the year ended December 31, 2024, we sold 19,913,189 shares of our common stock pursuant to the ATM for gross proceeds of approximately $12.8 million, subject to the limitations of General Instruction I.B.6 of Form S-3.

For the period ended December 31, 2024, the Company did not sell any shares of common stock to Lincoln Park pursuant to the equity line financing arrangement.

As of December 31, 2024, $34.8 million was available to draw pursuant to the Purchase Agreement.

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We may experience an ownership change in the future as a result of subsequent shifts in our stock ownership, some of which may be outside of our control.

Such ownership changes could result in the expiration of

our NOL carryforwards and other tax attributes before they can be utilized and, if we are profitable, our future cash flows could be adversely affected due to our increased tax liability.

Such ownership changes could result in the expiration of our NOL carryforwards and other tax attributes before they can be utilized and, if we are profitable, our future cash flows could be adversely affected due to our increased tax liability.

In 2023, we completed an analysis covering the periods from inception through December 31, 2022 to determine whether there may have been a Section 382 ownership change.

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Our business is susceptible to general conditions in the global economy and in the global financial markets.

Further, the impacts of political unrest, including as a result geopolitical tension, such as a deterioration in the relationship between the United States and China or the conflicts between Russia and Ukraine and Israel and Hamas, including any additional sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries against governmental or other entities in, for example, Russia, also has in the past and could in the future lead to disruption, instability and volatility in the global markets, which may have an adverse impact on our business or ability to access the capital markets.

A severe or prolonged economic downturn, including rises in interest rates, liquidity constraints, failures and instability in the United States and international financial banking systems, inflation, recession or depression, or political disruption has and could result in a variety of risks to our business, including weakened demand for our product candidates or any future product candidates, if approved, and our ability to raise additional capital when needed on acceptable terms, if at all.

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Any of the foregoing could materially and adversely affect our business, financial condition, results of operations and prospects, and we cannot anticipate all of the ways in which the political or economic climate and financial market conditions could adversely impact our business .

Further, the impacts of political unrest, including as a result geopolitical tension, such as a deterioration in the relationship between the United States and China or the conflicts between Russia and Ukraine and in the Middle East, including any additional sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries against governmental or other entities in, for example, Russia, also has in the past and could in the future lead to disruption, instability and volatility in the global markets, which may have an adverse impact on our business or ability to access the capital markets.

Additionally, significant political, trade, or regulatory developments, such as those stemming from the change in U.S.

federal administration, are difficult to predict and may have a material adverse effect on us.

Similarly, changes in U.S.

federal policy that affect the geopolitical landscape could give rise to circumstances outside our control that could have negative impacts on our business operations.

Political developments impacting government spending and international trade, including changes in trade agreements, potential government shutdowns and trade disputes and tariffs, including tariffs that have been or may in the future be imposed by the United States or other countries and future legislation or actions taken by the United States or other countries that restrict trade, and protectionist or retaliatory measures taken by the United States or other countries, may negatively impact markets and cause weaker macroeconomic conditions.

Adverse developments affecting the financial services industry, including events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our business, financial condition or results of operations.

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or international financial systems could result in less favorable commercial financing terms, including higher interest rates or costs and tighter financial and operating covenants, or systemic limitations on access to credit and liquidity sources, thereby making it more difficult for us to acquire financing on acceptable terms or at all.

obligations, result in breaches of our contractual obligations or result in violations of federal or state wage and hour laws.

Any decline in available funding or access to our cash and liquidity resources could, among other risks, adversely impact our ability to meet our operating expenses, financial obligations or fulfill our other obligations, result in breaches of our contractual obligations or result in violations of federal or state wage and hour laws.

Any of these impacts, or any other impacts resulting from the factors described above or other related or similar factors not described above, could have material adverse impacts on our liquidity and our business, financial condition or results of operations.

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We have incurred, and will continue to incur, significant legal, accounting and other expenses as a public company, including costs resulting from public company reporting obligations under the Exchange Act and regulations regarding corporate governance practices.

The listing requirements of the Nasdaq Global Market and the rules of the SEC require that we satisfy certain corporate governance requirements relating to director independence, filing annual and interim reports, stockholder meetings, approvals and voting, soliciting proxies, conflicts of interest and a code of conduct.

The listing requirements of the Nasdaq Capital Market and the rules of the SEC require that we satisfy certain corporate governance requirements relating to director independence, filing annual and interim reports, stockholder meetings, approvals and voting, soliciting proxies, conflicts of interest and a code of conduct.

Our management and other personnel will need to devote a substantial amount of time to ensure that we comply with all of these requirements.

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In order to report our results of operations and financial statements on an accurate and timely basis, we will depend in part on CROs and other third parties to provide timely and accurate notice of their costs to us.

Any failure to report our financial results on an accurate and timely basis could result in sanctions, lawsuits, delisting of our shares from the Nasdaq Global Market or other adverse consequences that would materially and adversely affect our business, financial condition, results of operations and prospects .

Any failure to report our financial results on an accurate and timely basis could result in sanctions, lawsuits, delisting of our shares from the Nasdaq Capital Market or other adverse consequences that would materially and adversely affect our business, financial condition, results of operations and prospects .

We have incurred, and will continue to incur, increased costs and demands upon management as a result of being a public company.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors