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Item 1A. Risk Factors

2025-03-27 compared with 2024-03-19 · 627 added, 488 removed, 921 unchanged (55% of the section changed)

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Summary of Risks

This section provides a summary of the risks that

may impact our performance in the future.

This section provides a summary of the risks

that may impact our performance in the future.

For details of our various risk factors and their impacts, see “Risk Factors Discussion.”

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Risks related to our business

Business risks include risks associated with

our products and regulatory approval, licensing agreements, historical losses, managing growth, and acquisitions.

In general, the risks

related to our business can cause variability in the future profits of the Company.

Business risks include risks associated with our products (including

as a result of pausing the development of our prior drug candidates and refocusing on new drug candidates) and regulatory approval, licensing

agreements, historical losses, managing growth, and acquisitions.

In general, the risks related to our business can cause variability

in the future profits of the Company.

Risks related to clinical and regulatory

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the trial will significantly increase our cost of doing business.

In addition, the active ingredient in our products is a controlled substance

which can affect the supply available for clinical trials, as well as commercial sales.

A limited supply could increase the time needed

to complete clinical trials and overall costs including product liability claims.

We could also face potential fines or reputational risk

if we do not comply.

Developments from competitors and the ability to obtain market exclusivity could also negatively impact future profits.

In addition, the active ingredient in some of our products is a controlled

substance which can affect the supply available for clinical trials, as well as commercial sales.

A limited supply could increase the

time needed to complete clinical trials and overall costs including product liability claims.

We could also face potential fines or reputational

risk if we do not comply.

Developments from competitors and the ability to obtain market exclusivity could also negatively impact future

Risks related to our intellectual property

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Infringing upon

patents or trade secrets could force us to cease or alter our product development efforts or obtain a license to continue to develop or

sale our products.

patents or trade secrets could force us to cease or alter our product development efforts or obtain a license to continue to develop

or sale our products.

These risks could not only impact the future profits of the company but also create adverse publicity for us.

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Litigation or investigations can increase costs, negatively affect our operating results and create adverse publicity

Risks related to our reliance on third parties

Risks related to our reliance on third

The Company relies on third parties to conduct

preclinical and clinical studies, as well as to manufacture our product candidates.

nonclinical and clinical studies, as well as to manufacture our product candidates.

Third parties’ failure to perform the trials

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Risks related to ownership of our common

Common stocks risks include risks associated with

the limited market for our common stock, a potential issuance of a substantial number of additional shares, stock price volatility, and

reporting requirements of federal securities laws.

Common stocks risks include risks associated

with the limited market for our common stock, a potential issuance of a substantial number of additional shares, stock price volatility,

and reporting requirements of federal securities laws.

The net effect of these risks can include reductions in future profits, additional

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Risks Related to Our Business

Our business depends on the success of esmethadone

(d-methadone, dextromethadone, REL-1017), our only product candidate currently in clinical development, which is in a pivotal clinical

trial for the adjunctive treatment of MDD.

If we are unable to obtain regulatory approval for and successfully commercialize REL-1017

or other future product candidates, or we experience significant delays in doing so, our business will be materially harmed.

To date, the primary focus of our product development

has been esmethadone (d-methadone, dextromethadone, REL-1017) for the adjunctive treatment of patients with MDD.

Currently, esmethadone

is our only product candidate under clinical development.

We intend, in 2024, to enter human studies of our proprietary, low dose modified-release

formulation of psilocybin (REL-P11) for metabolic indications, but there can be no assurance that such studies will be commenced or completed.

This may make an investment in our Company riskier than similar companies that have multiple product candidates in active development

and that therefore may be able to better sustain a setback of a lead candidate.

Successful continued development and ultimate regulatory

approval of esmethadone for the adjunctive treatment of MDD or other indications is critical to the future success of our business.

have invested, and will continue to invest, a significant portion of our time and financial resources in the clinical development of esmethadone.

If we cannot successfully develop, obtain regulatory approval for and commercialize esmethadone, we may not be able to continue our operations.

The future regulatory and commercial success of esmethadone is subject to a number of risks, including the following:

we may not be able to obtain adequate evidence from clinical trials

to support the efficacy and safety for esmethadone for the adjunctive treatment of MDD or other indications;

we may not be able to demonstrate that the benefits of esmethadone

for the adjunctive treatment of MDD or other indications outweigh the risks;

in our clinical trials for esmethadone, enrollment may be slower than anticipated and we may need additional clinical trial sites than originally planned, which could delay our clinical trial progress;

the results of our clinical trials may not meet the level of statistical or clinical significance required by the FDA or comparable foreign regulatory authorities for marketing approval;

patients in our clinical trials may suffer serious adverse effects for reasons that may or may not be related to esmethadone, which could delay or prevent further clinical development;

the standards implemented by clinical or regulatory agencies may change

at any time and we cannot be certain what efficacy endpoints the FDA or foreign clinical or regulatory agencies may require in pivotal

clinical trials with respect to the adjunctive treatment of MDD or any other indication for the approval of esmethadone;

the results of later stage clinical trials may not be as favorable as the results we have observed to date in our preclinical studies and Phase 1 and 2 clinical trials;

we cannot be certain of the number and type of clinical trials and

preclinical or toxicology studies that the FDA or other regulatory agencies will require in order to approve esmethadone for the adjunctive

treatment of MDD or any other indication;

we may not have sufficient financial and other resources to complete the necessary clinical trials for esmethadone, including, but not limited to, the clinical trials needed to obtain drug approval;

if approved for the adjunctive treatment of MDD, esmethadone will likely

compete with products that may reach approval prior to esmethadone, products that are currently approved for the adjunctive treatment

of MDD and the off-label use of currently marketed products for MDD;

we may not be able to obtain, maintain or enforce our patents and other intellectual property rights.

Esmethadone, psilocybin and any future product

candidates will be subject to rigorous and extensive clinical trials and extensive regulatory approval processes implemented by the FDA

and comparable foreign regulatory authorities before obtaining marketing approval, if at all, from these regulatory authorities.

development and approval process is lengthy and expensive, and approval is never certain.

Investigational new drugs, such as esmethadone,

may not prove to be safe and effective in clinical trials.

We have limited experience as a company in conducting later stage clinical

trials required to obtain regulatory approval.

We may be unable, if at all, to conduct future clinical trials at preferred sites, enlist

clinical investigators, enroll sufficient numbers of participants or begin or successfully complete clinical trials in a timely fashion.

In addition, the design of a clinical trial can determine whether its results will support approval of a product, and flaws in the design

of a clinical trial may not become apparent until the clinical trial is well advanced.

Because we have limited experience as a company

designing clinical trials, we may be unable to design and execute clinical trials to support regulatory approval.

Pausing of Our Former Primary Drug Candidate

May Adversely Affect Our Business and Financial Condition

We recently paused the development of our former

primary drug candidate, esmethadone (d-methadone, dextromethadone, or REL-1017) as a potential treatment for major depressive disorder

(MDD), which had been the cornerstone of our research and development efforts.

This decision was made due to an interim analysis indicating

that our Phase 3 study of esmethadone, Reliance II, was futile and unlikely to meet the primary efficacy endpoint with statistical significance.

We also recently paused development of REL-P11, a modified-release formulation of psilocybin, as an investigational agent for the treatment

of metabolic disease.

These determinations have resulted in the loss of significant time, resources and capital invested in the development

of esmethadone and REL-P11.

There can be no assurance that our refocusing on new drug candidates will successfully offset these setbacks.

Our Refocusing on New Drug Candidates Involves

Significant Uncertainty and Risk

We are now focusing our efforts on the development

of two new drug candidates, NDV-01 and Sepranolone.

These drug candidates are in early stages of development, and we have limited data

regarding their safety, efficacy or commercial viability.

The transition to these new candidates requires us to redirect resources, establish

new research protocols and secure additional regulatory approvals, all of which may increase our operational costs and extend our development

The mechanisms of action and therapeutic potential of our new drug candidates are different from those of our prior drug candidates.

There is no guarantee that our experience with the prior drug candidates will translate to success with the new ones.

Investors should

be aware that our refocused strategy is largely untested, and we may encounter unforeseen scientific, regulatory, or market challenges

that could materially impact our business prospects.

If either or both new drug candidates fail to demonstrate sufficient promise in

clinical trials, we may face further delays and/or an inability to sustain our operations.

Our business depends on the success of

our drug candidates.

If we are unable to obtain regulatory approval for and successfully commercialize our drug candidates or other future

product candidates, or we experience significant delays in doing so, our business will be materially harmed.

The primary focus of our product development is NDV-01 and Sepranolone.

This may make an investment in our Company riskier

than similar companies that have multiple product candidates in advanced stages of active development and that therefore may be able

to better sustain a setback of a product candidate.

Our operating history with our new drug candidates, NDV-01 and Sepranolone, is limited.

This lack of historical data and experience makes it difficult to predict the likelihood of success in development, regulatory approval,

or commercialization.

Successful continued development and ultimate regulatory approval of our drug candidates is critical to the future

success of our business.

We have invested, and will continue to invest, a significant portion of our time and financial resources in

the clinical development of our drug candidates.

If we cannot successfully develop, obtain regulatory approval for and commercialize

our drug candidates, we may not be able to continue our operations.

The future regulatory and commercial success of our drug candidates

is subject to a number of risks, including the following:

not be able to obtain adequate evidence from clinical trials to support the efficacy and safety products’ respective indications;

not be able to demonstrate the clinical benefits of our drug candidates for their respective indications;

clinical trials for our drug candidates, enrollment may be slower than anticipated and we may need additional clinical trial sites

than originally planned, which could delay our clinical trial progress;

of our clinical trials may not meet the level of statistical or clinical significance required by the FDA or comparable foreign regulatory

authorities for marketing approval;

in our clinical trials may suffer serious adverse effects for reasons that may or may not be related to our drug candidates, which

could delay or prevent further clinical development;

the standards

implemented by clinical or regulatory agencies may change at any time and we cannot be certain what efficacy endpoints the FDA or

foreign clinical or regulatory agencies may require in pivotal clinical trials;

of later stage clinical trials may not be as favorable as the results we have observed to date in our nonclinical studies and Phase

1 and 2 clinical trials;

be certain of the number and type of clinical trials and nonclinical or toxicology studies that the FDA or other regulatory agencies

will require in order to approve our drug candidates for their respective indications;

not have sufficient financial and other resources to complete the necessary clinical trials for our drug candidates, including, but

not limited to, the clinical trials needed to obtain drug approval;

our drug candidates will likely compete with products that may reach approval prior to these products, products that are currently approved

and the off-label use of currently marketed products;

not be able to obtain, maintain or enforce our patents and other intellectual property rights.

Our drug candidates and any future product candidates will be subject

to rigorous and extensive clinical trials and extensive regulatory approval processes implemented by the FDA and comparable foreign regulatory

authorities before obtaining marketing approval, if at all, from these regulatory authorities.

The drug development and approval process

is lengthy and expensive, and approval is never certain.

Investigational new drugs, such as our drug candidates may not prove to be safe

and effective in clinical trials.

We have limited experience as a company in conducting later stage clinical trials required to obtain

regulatory approval.

We may be unable, if at all, to conduct future clinical trials at preferred sites, enlist clinical investigators,

enroll sufficient numbers of participants or begin or successfully complete clinical trials in a timely fashion.

In addition, the design

of a clinical trial can determine whether its results will support approval of a product, and flaws in the design of a clinical trial

may not become apparent until the clinical trial is well advanced.

Because we have limited experience as a company designing clinical

trials, we may be unable to design and execute clinical trials to support regulatory approval.

There is a high failure rate for drugs and biological

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Failure can occur at any time during the clinical trial process.

The results of preclinical

studies and early clinical trials of esmethadone, psilocybin or any future product candidate may not be predictive of the results of later-stage

clinical studies or trials and the results of studies or trials in one set of patients or line of treatment may not be predictive of those

obtained in another.

In fact, many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in

late stage clinical trials even after achieving promising results in preclinical studies and earlier stage clinical trials.

data obtained from preclinical and clinical activities are subject to varying interpretations, which may delay, limit or prevent regulatory

Owing in part to the complexity of biological pathways, esmethadone, psilocybin or any future product candidate may not demonstrate

The results of nonclinical

studies and early clinical trials of our drug candidates or any future product candidate may not be predictive of the results of later-stage

clinical studies or trials and the results of studies or trials in one set of patients or line of treatment may not be predictive of

those obtained in another.

In fact, many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks

in late stage clinical trials even after achieving promising results in nonclinical studies and earlier stage clinical trials.

data obtained from nonclinical and clinical activities are subject to varying interpretations, which may delay, limit or prevent regulatory

Owing in part to the complexity of biological pathways, our drug candidates or any future product candidate may not demonstrate

in patients the biochemical and pharmacological properties we anticipate based on laboratory studies or earlier stage clinical trials,

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events or findings that may only be detected once a product candidate is administered to more patients and for greater periods of time.

Our Phase 2 clinical study of REL-1017 involved a small population of subjects with MDD, and, because of the small sample size in such

trial, the results of this clinical trial may be subject to substantial variability and may not be indicative of either future top-line

results or final results.

In addition, results from open-label trials, such as our open-label trial of REL-1017, may not predict results

in placebo-controlled trials for a number of reasons, including biases that may exaggerate therapeutic effect.

On October 13, 2022, we

announced that the RELIANCE III study, evaluating REL-1017 in the monotherapy setting for MDD, did not achieve its primary endpoint, which

was a statistically significant improvement in depression symptoms compared to placebo as measured by the MADRS on Day 28.

7, 2022, we announced that the RELIANCE I study, evaluating REL-1017 in the adjunctive setting for MDD, did not achieve its primary endpoint,

which was a statistically significant improvement in depression symptoms compared to placebo as measured by the MADRS on Day 28.

these findings, even if RELIANCE II, RELIGHT, or any additional Phase 3 studies achieve their primary endpoints, we may not have sufficient

evidence to demonstrate the efficacy of REL-1017 as an adjunctive treatment of MDD.

If we are unable to successfully demonstrate the safety

and efficacy of esmethadone, psilocybin or other future product candidates and receive the necessary regulatory approvals, our business

will be materially harmed.

Even if we do receive regulatory approval to market

esmethadone, psilocybin or other future product candidates, any such approval may be subject to limitations on the indicated uses or patient

populations for which we may market the products.

Accordingly, even if we are able to obtain the requisite financing to continue to fund

our development programs, we may be unable to successfully develop or commercialize esmethadone, psilocybin or other future product candidates.

If we or any of our future development collaborators are unable to develop, or obtain regulatory approval for, or, if approved, successfully

commercialize esmethadone, psilocybin or other future product candidates, we may not be able to generate sufficient revenue to continue

our business.

If we are unable to successfully demonstrate the safety and efficacy of our drug candidates or other future product candidates and receive

the necessary regulatory approvals, our business will be materially harmed.

Even if we do receive regulatory approval to market our drug candidates

or other future product candidates, any such approval may be subject to limitations on the indicated uses or patient populations for which

we may market the products.

Accordingly, even if we are able to obtain the requisite financing to continue to fund our development programs,

we may be unable to successfully develop or commercialize our drug candidates or other future product candidates.

If we or any of our

future development collaborators are unable to develop, or obtain regulatory approval for, or, if approved, successfully commercialize

our drug candidates or other future product candidates, we may not be able to generate sufficient revenue to continue our business.

Preliminary or top-line results may not

accurately reflect the complete results of the clinical study.

Preliminary or top-line data remain subject to audit and verification

procedures that may result in the final data being materially different from the preliminary or top-line data.

As a result, preliminary

or top-line data should be viewed with caution until the final data are available.

Our license agreement for esmethadone, our

only product candidate currently under clinical development, could terminate under certain circumstances, including if we terminate our

Chief Executive Officer except for cause, and we would be unable to conduct our business as planned.

Preliminary or top-line data remain subject to

audit and verification procedures that may result in the final data being materially different from the preliminary or top-line data.

As a result, preliminary or top-line data should be viewed with caution until the final data are available.

Our license agreement for NDV-01 or esmethadone

could terminate under certain circumstances, including if we terminate our Chief Executive Officer except for cause, and we would be

unable to conduct our business as planned.

In January 2018, we entered into an Intellectual

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The License Agreement also grants to us

rights in all future inventions developed by Licensor, whether or not in collaboration with us that relate in any way to esmethadone or

the use thereof.

rights in all future inventions developed by Licensor, whether or not in collaboration with us that relate in any way to esmethadone

or the use thereof.

The License Agreement was amended in December 2019 to modify certain termination rights relating to the Chief Executive

Officer, which are described further below.

If we develop any new inventions relating to esmethadone,

we are required to do so in collaboration with Licensor, and to file patents covering such inventions jointly in the name of the Company

and Licensor.

All such future inventions or patents shall be jointly owned by us and Licensor and, will be included in and subject to

the financial and other terms of the License Agreement.

If we develop any new inventions relating to

esmethadone, we are required to do so in collaboration with Licensor, and to file patents covering such inventions jointly in the name

of the Company and Licensor.

All such future inventions or patents shall be jointly owned by us and Licensor and, will be included in

and subject to the financial and other terms of the License Agreement.

The License Agreement includes standard termination

rights for Licensor in the event of our insolvency, challenge of the licensed patents and uncured material breach of our obligations under

the License Agreement.

In addition, the License Agreement contains certain “Key Man” provisions such that the Licensor may

terminate the License Agreement if we terminate the employment of our Chief Executive Officer, Mr.

Sergio Traversa, for any reason other

than for specified causes determined by a majority of our Board of Directors (including fraud, gross negligence, unauthorized use of our

confidential information, conduct including harassment or discrimination, breach of fiduciary duty or uncured material breach), or if

we (a) substantially modify Mr.

Traversa’s job responsibilities or decision-making rights in connection with the development and

commercialization of esmethadone, (b) remove him from the role of Chief Executive Officer other than in connection with a permitted change-of-control

transaction, (c) materially reduce his compensation, or (d) assign or transfer our rights under the License Agreement or the esmethadone

intellectual property without Mr.

Traversa’s consent, in each case (termination or the events in (a) through (d) during the period

commencing on the effective date and ending on the later of five years from the original effective date of the License Agreement on December

The December 2019 amendment to the License Agreement made certain clarifications to the nature of a termination for Cause, including

to clarify that termination due to Mr.

Traversa’s death or disability does not give Licensor the right to terminate the License

On December 27, 2022, the Licensor and the Company entered into a new amendment extending the “Key Man” provision

period until December 31, 2027.

rights for Licensor in the event of our insolvency, challenge of the licensed patents and uncured material breach of our obligations

under the License Agreement.

In addition, the License Agreement contains certain “Key Man” provisions such that the Licensor

may terminate the License Agreement if we terminate the employment of our Chief Executive Officer, Mr.

Sergio Traversa, for any reason

other than for specified causes determined by a majority of our Board of Directors (including fraud, gross negligence, unauthorized use

of our confidential information, conduct including harassment or discrimination, breach of fiduciary duty or uncured material breach),

or if we (a) substantially modify Mr.

Traversa’s job responsibilities or decision-making rights in connection with the development

and commercialization of esmethadone, (b) remove him from the role of Chief Executive Officer other than in connection with a permitted

change-of-control transaction, (c) materially reduce his compensation, or (d) assign or transfer our rights under the License Agreement

or the esmethadone intellectual property without Mr.

Traversa’s consent, in each case (termination or the events in (a) through

(d) during the period commencing on the effective date and ending on the later of five years from the original effective date of the

License Agreement on December 31, 2022.

The December 2019 amendment to the License Agreement made certain clarifications to the nature

of a termination for Cause, including to clarify that termination due to Mr.

Traversa’s death or disability does not give Licensor

the right to terminate the License Agreement.

On December 27, 2022, the Licensor and the Company entered into a new amendment extending

the “Key Man” provision period until December 31, 2027.

The License Agreement was not otherwise modified.

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Agreement, our rights to those patents may be terminated, and we will be unable to conduct our business.

We May Require Substantial Additional Funding,

Which May Not Be Available on Favorable Terms, or at All

The pause of our former drug candidates and the pivot to new candidates

may increase our need for additional capital to fund ongoing research, clinical trials and operational expenses.

There is no guarantee

that we will be able to secure additional funding on acceptable terms, or at all, particularly given the perceived risk associated with

our recent strategic shift.

Failure to obtain sufficient capital could force us to curtail operations, delay development or seek alternative

strategies, such as liquidation or bankruptcy.

We have generated no revenue from commercial

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since inception and generated no product revenues.

If we continue to incur operating losses and fail to become a profitable company, we

may be unable to continue our operations.

We expect to continue to operate at a net loss for at least the next several years as we continue

our research and development efforts, continue to conduct clinical trials and develop manufacturing, sales, marketing and distribution

If we continue to incur operating losses and fail to become a profitable company,

we may be unable to continue our operations.

We expect to continue to operate at a net loss for at least the next several years as we

continue our research and development efforts, continue to conduct clinical trials and develop manufacturing, sales, marketing and distribution

capabilities.

There can be no assurance that the products under development by us will be approved for sales in the US or elsewhere.

there can be no assurance that if such products are approved they will be successfully commercialized, and the extent of our future losses

and the timing of our profitability are highly uncertain.

International commercialization of our product

candidates faces significant obstacles.

Furthermore, there can be no assurance that if such products are approved they will be successfully commercialized, and the extent of

our future losses and the timing of our profitability are highly uncertain.

International commercialization of our

product candidates faces significant obstacles.

We may plan to commercialize some of our products

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Future partners are critical to our international success.

We may not be able to enter into collaboration agreements with appropriate

partners for important foreign markets on acceptable terms, or at all.

Future collaborations with foreign partners may not be effective

or profitable for us.

We will need to obtain approvals from the appropriate regulatory, pricing and reimbursement authorities to market

any of our proposed products internationally, and we may be unable to obtain foreign regulatory approvals.

Pursuing foreign regulatory

approvals will be time-consuming and expensive.

The regulations can vary among countries and foreign regulatory authorities may require

different or additional clinical trials than we conducted to obtain FDA approval for our product candidates.

In addition, adverse clinical

trial results, such as death or injury due to side effects, could jeopardize not only regulatory approval, but if approval is granted,

may also lead to marketing restrictions.

Our product candidates may also face foreign regulatory requirements applicable to controlled

We may not be able to enter into collaboration agreements with

appropriate partners for important foreign markets on acceptable terms, or at all.

Future collaborations with foreign partners may not

be effective or profitable for us.

We will need to obtain approval from the appropriate regulatory, pricing and reimbursement authorities

to market any of our proposed products internationally, and we may be unable to obtain foreign regulatory approvals.

Pursuing foreign

regulatory approvals will be time-consuming and expensive.

The regulations can vary among countries and foreign regulatory authorities

may require different or additional clinical trials than we conducted to obtain FDA approval for our product candidates.

adverse clinical trial results, such as death or injury due to side effects, could jeopardize not only regulatory approval, but if approval

is granted, may also lead to marketing restrictions.

Our product candidates may also face foreign regulatory requirements applicable

to controlled substances.

We have a history of losses and we may never achieve or sustain

profitability.

We have incurred substantial losses since our inception, and we may

not achieve profitability for the foreseeable future, if at all.

Since inception, we have an accumulated deficit of approximately $560.9

We have incurred substantial losses since our

inception, and we may not achieve profitability for the foreseeable future, if at all.

Since inception, we have an accumulated deficit

of approximately $640.8 million at December 31, 2024.

The Company had cash, cash equivalents and short-term investments of approximately

$44.9 million at December 31, 2024.

The Company had cash, cash equivalents and short-term investments of approximately $96.3 million at December

Even if we succeed in developing and commercializing one or more of our product candidates, we expect to incur substantial net

losses and negative cash flows for the foreseeable future due in part to increasing research and development expenses, including clinical

trials, and increasing expenses from leasing additional facilities and hiring additional personnel.

As a result, we will need to generate

significant revenues in order to achieve and maintain profitability.

We may not be able to generate these revenues or achieve profitability

in the future.

Even if we do achieve profitability, we may not be able to sustain or increase profitability.

Even if we succeed in developing and commercializing one or more of our product candidates, we expect

to incur substantial net losses and negative cash flows for the foreseeable future due in part to increasing research and development

expenses, including clinical trials, and increasing expenses from leasing additional facilities and hiring additional personnel.

result, we will need to generate significant revenues in order to achieve and maintain profitability.

We may not be able to generate

these revenues or achieve profitability in the future.

Even if we do achieve profitability, we may not be able to sustain or increase

profitability.

We have a limited operating history upon

which to base an investment decision.

Our limited operating history may limit your ability

to evaluate our prospects due to our limited historical financial data and our unproven potential to generate profits.

You should evaluate

the likelihood of financial and operational success in light of the risks, uncertainties, expenses and difficulties associated with an

early-stage business, many of which may be beyond our control, including:

our potential inability to continue to undertake preclinical studies, pharmaceutical development and clinical trials,

our potential inability to obtain regulatory approvals, and

our potential inability to manufacture, sell and market our products.

Our limited operating history may limit your

ability to evaluate our prospects due to our limited historical financial data and our unproven potential to generate profits.

evaluate the likelihood of financial and operational success in light of the risks, uncertainties, expenses and difficulties associated

with an early-stage business, many of which may be beyond our control, including:

our potential inability

to continue to undertake nonclinical studies, pharmaceutical development and clinical trials,

our potential inability

to obtain regulatory approvals, and

our potential inability

to manufacture, sell and market our products.

Our operations have been limited to organizing

and staffing, on a limited basis, our company, acquiring, developing and securing our proprietary technology and undertaking preclinical

and staffing, on a limited basis, our company, acquiring, developing and securing our proprietary technology and undertaking nonclinical

studies and clinical trials of our principal product candidates.

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carryforwards and certain other tax attributes may be limited.

As of December 31, 2023, we had Federal, New York

State and New York City net operating loss (NOL) carryforwards of approximately $100,077,000, $15,016,000 and $14,998,000, respectively,

of December 31, 2024, we had Federal, New York State and New York City net operating loss

(NOL) carryforwards of approximately $127,041,000, $1,068,000 and $1,068,000, respectively,

which begin expiring in 2027, 2032 and 2032, respectively.

federal tax legislation enacted in 2017, informally titled the Tax

Cuts and Jobs Act, or Tax Act, federal NOLs incurred in 2018 and in future years may be carried forward indefinitely, but the deductibility

of such federal NOLs is limited to 80% of taxable income in the year.

It is uncertain if and to what extent various states will conform

to the Tax Act.

Under Sections 382 and 383 of the U.S.

federal tax legislation

enacted in 2017, informally titled the Tax Cuts and Jobs Act, or Tax Act, federal NOLs incurred

in 2018 and in future years may be carried forward indefinitely, but the deductibility of

such federal NOLs is limited to 80% of taxable income in the year.

It is uncertain if and

to what extent various states will conform to the Tax Act.

Under Sections 382 and 383 of

Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership

change” (generally defined as a greater than 50 percentage-point cumulative change (by value) in the equity ownership of certain

stockholders over a rolling three-year period), the corporation’s ability to use its pre-change NOLs and other pre-change tax attributes

change” (generally defined as a greater than 50 percentage-point cumulative change

(by value) in the equity ownership of certain stockholders over a rolling three-year period),

the corporation’s ability to use its pre-change NOLs and other pre-change tax attributes

to offset its post-change taxable income or taxes may be limited.

We may also experience ownership changes as a result of stock offerings

or as a result of subsequent shifts in our stock ownership, some of which are outside our control.

We have not completed an analysis to

determine whether any such limitations have been triggered.

If any were determined to be triggered, our ability to use our current NOLs

and other pre-change tax attributes to offset post-change taxable income or taxes would be subject to limitation.

We will be unable to

use our NOLs if we do not attain profitability sufficient to offset our available NOLs prior to their expiration.

We may not be successful in hiring and retaining

key employees.

Our future operations and successes depend in

large part upon the continued service of key members of our senior management team whom we are highly dependent upon to manage our business,

specifically Dr.

Sergio Traversa, our Chief Executive Officer, and Dr.

Paolo Manfredi, Acting Chief Scientific Officer.

If either terminates

employment with us, such a departure would have a material adverse effect on our business.

We may also experience

ownership changes as a result of stock offerings or as a result of subsequent shifts in our

stock ownership, some of which are outside our control.

We have not completed an analysis

to determine whether any such limitations have been triggered.

If any were determined to

be triggered, our ability to use our current NOLs and other pre-change tax attributes to

offset post-change taxable income or taxes would be subject to limitation.

We will be unable

to use our NOLs if we do not attain profitability sufficient to offset our available NOLs

prior to their expiration.

We may not be successful in hiring and

retaining key employees.

Our future operations and successes depend in large part upon the continued

service of key members of our senior management team whom we are highly dependent upon to manage our business, specifically Dr.

Traversa, our Chief Executive Officer and our executive team.

If any terminates employment with us, such a departure would have a material

adverse effect on our business.

Our future success also depends on our ability

to identify, attract, hire or engage, retain and motivate other well-qualified managerial, technical, clinical and regulatory personnel.

We currently only have 16 full time employees and are likely to hire additional qualified personnel with expertise in nonclinical pharmacology

and toxicology, pharmaceutical development, clinical research, regulatory affairs, manufacturing, sales and marketing.

We compete for

qualified individuals with numerous biopharmaceutical companies, universities and other research institutions.

Our success depends heavily on the expertise of our management team and scientific personnel.

The pivot to new drug candidates may require

specialized knowledge or skills that our current team lacks.

If we lose key personnel or fail to attract and retain qualified replacements,

our ability to execute our revised strategy could be compromised, leading to delays or failure in our development program.

only have 17 full time employees and are likely to hire additional qualified personnel with expertise in nonclinical pharmacology and

toxicology, pharmaceutical development, clinical research, regulatory affairs, manufacturing, sales and marketing.

We compete for qualified

individuals with numerous biopharmaceutical companies, universities and other research institutions.

Competition for such individuals,

particularly in the United States, is intense, and we may not be able to hire sufficient personnel to support our efforts.

no assurance that these professionals will be available in the market, or that we will be able to retain existing professionals or to

meet or to continue to meet their compensation requirements.

Furthermore, the cost base in relation to such compensation, which may include

equity compensation, may increase significantly, which could have a material adverse effect on us.

Failure to establish and maintain an

effective management team and work force could adversely affect our ability to operate, grow and manage our business.

be no assurance that these professionals will be available in the market, or that we will be able to retain existing professionals or

to meet or to continue to meet their compensation requirements.

Furthermore, the cost base in relation to such compensation, which may

include equity compensation, may increase significantly, which could have a material adverse effect on us.

Failure to establish and maintain

an effective management team and work force could adversely affect our ability to operate, grow and manage our business.

Managing our growth as we expand operations

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to train, motivate and manage our employees.

We may expand our business through the acquisition

of rights to new drug candidates that could disrupt our business, harm our financial condition and may also dilute current stockholders’

ownership interests in our company.

Our business strategy includes expanding our products

and capabilities, and we may seek acquisitions of drug candidates or technologies to do so.

Acquisitions involve numerous risks, including

substantial cash expenditures;

We may expand our business through the

acquisition of rights to new drug candidates that could disrupt our business, harm our financial condition and may also dilute current

stockholders’ ownership interests in our company.

Our business strategy includes expanding our

products and capabilities, and we may seek acquisitions of drug candidates or technologies to do so.

Acquisitions involve numerous risks,

including substantial cash expenditures;

potentially dilutive issuance of equity securities;

incurrence of debt and contingent liabilities, some

of which may be difficult or impossible to identify at the time of acquisition;

incurrence of debt and contingent liabilities,

some of which may be difficult or impossible to identify at the time of acquisition;

difficulties in assimilating the acquired technologies

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work or be successful.

Furthermore, the development or expansion of our business or any acquired products, business or companies may require

a substantial capital investment by us.

We may not have these necessary funds or they might not be available to us on acceptable terms

We may also seek to raise funds by selling shares of our preferred or common stock, which could dilute each current stockholder’s

ownership interest in us.

Business interruptions could limit our ability

to operate our business.

Furthermore, the development or expansion of our business or any acquired products, business or companies may

require a substantial capital investment by us.

We may not have these necessary funds or they might not be available to us on acceptable

terms or at all.

We may also seek to raise funds by selling shares of our preferred or common stock, which could dilute each current

stockholder’s ownership interest in us.

Business interruptions could limit our

ability to operate our business.

Our operations as well as those of our collaborators

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could result in losses or damages incurred by us and require us to cease or curtail our operations.

There is doubt about our ability to continue

as a going concern.

As of December 31, 2024, the Company had an accumulated deficit of

$640,882,035.

Losses have principally occurred as a result of the substantial resources required for research and development of the Company’s

product candidates which included the general and administrative expenses associated with its organization and product development as

well as the lack of sources of revenues until such time as the Company’s products are commercialized.

These factors raise substantial

doubt about the Company’s ability to continue as a going concern for the 12 months from the issuance date of these audited consolidated

financial statements for the year ended December 31, 2024.

These financial statements do not include any adjustments to reflect the possible

future effect on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from

the outcome of these uncertainties.

Management intends to pursue additional funding and implement its strategic plan to allow the opportunity

for the Company to continue as a going concern.

However, there cannot be any assurance that we will be successful in doing so.

Risks Related to Clinical and Regulatory Matters

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regulatory approvals would:

delay commercialization of, and product revenues from, our drug candidates;

diminish the competitive advantages that we may have otherwise enjoyed, which would have an adverse effect on our operating results and financial condition.

delay commercialization

of, and product revenues from, our drug candidates;

diminish the competitive

advantages that we may have otherwise enjoyed, which would have an adverse effect on our operating results and financial condition.

Even if we or our collaborators comply with all

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Phase 3 clinical trials may not demonstrate the safety or efficacy of our drug

Success in preclinical studies and early clinical trials does not ensure that later clinical trials will be successful.

of later clinical trials may not replicate the results of prior clinical trials and preclinical studies.

For example, our RELIANCE I study

did not achieve its primary endpoint, statistically significant improvements in depression symptoms compared to placebo on Day 28, even

though our Phase 2 study was positive.

Further, our monotherapy Phase 3 study, RELIANCE III, also did not meet its primary endpoint, statistically

significant improvements in depression symptoms compared to placebo on Day 28.

Even if our RELIANCE II, RELIGHT or other potential Phase

3 clinical trials are positive, we or our collaborators may have to commit substantial time and additional resources to conducting further

preclinical studies and clinical trials before obtaining FDA approval for any of our drug candidates.

Clinical trial results from the study of depression

are inherently difficult to predict.

In addition, our clinical trials and our future clinical trials for esmethadone measure clinical

symptoms, such as depression that are not biologically measurable.

The primary measure of depression is subjective and can be influenced

by factors outside of our control, and can vary widely from day to day for a particular patient, and from patient to patient and site

to site within a clinical study.

The results we have obtained in completed animal studies or we have observed in our clinical trials

conducted to date may not be predictive of results from our future clinical trials.

For example, our RELIANCE III and RELIANCE I studies

did not achieve their primary endpoints, statistically significant improvements in depression symptoms compared to placebo on Day 28.

Success in nonclinical studies and early clinical trials does not ensure that later clinical trials will be successful.

of later clinical trials may not replicate the results of prior clinical trials and nonclinical studies.

We or our collaborators may have to commit substantial

time and additional resources to conducting further nonclinical studies and clinical trials before obtaining FDA approval for any of

our drug candidates.

Clinical trials are very expensive and difficult

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will determine that the data from our clinical trials support marketing approval.

The FDA’s and other regulatory agencies’

decisions to approve our product candidates will depend on our ability to demonstrate through adequate well-controlled clinical trials,

that the product candidate is effective.

For esmethadone product candidate, efficacy is measured statistically by comparing the overall

improvement in depression in actively-treated patients against improvement in depression in the control group (a placebo control).

there is a possibility that our data may fail to show a statistically significant difference from the placebo control or the active control.

For example, our RELIANCE III and RELIANCE I studies did not achieve their primary endpoints, statistically significant improvements in

depression symptoms compared to placebo on Day 28.

Alternatively, there is a possibility that our data may be statistically significant,

but that the actual clinical benefit of the product candidates may not be considered to be clinically significant, clinically relevant

or clinically meaningful.

Even if we believe that the data from our trials will support marketing approval in the United States or in

Europe, we cannot predict whether the agencies will agree with our analysis and approve our applications.

The FDA’s and other regulatory agencies’ decisions to approve

our product candidates will depend on our ability to demonstrate, through adequate well-controlled clinical trials, that the product candidate

is effective.

However, there is a possibility that our data may fail to show a statistically significant difference from the placebo control

or the active control.

Alternatively, there is a possibility that our data may be statistically significant, but that the actual clinical

benefit of the product candidates may not be considered to be clinically significant, clinically relevant or clinically meaningful.

if we believe that the data from our trials will support marketing approval in the United States or in Europe, we cannot predict whether

the agencies will agree with our analysis and approve our applications.

Developments by competitors may establish

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or regulatory review or approval process.

We have obtained Fast Track Designation for esmethadone

for the adjunctive treatment of MDD.

Fast Track Designation is granted 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.

Fast Track Designation does not

guarantee a faster development process, review or approval compared to conventional FDA procedures.

The FDA may withdraw Fast Track Designation

if it believes that the designation is no longer supported by data from our clinical development program.

We have obtained Fast Track Designation for esmethadone for the adjunctive

treatment of MDD.

Fast Track Designation is granted 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.

Fast Track Designation does not guarantee a

faster development process, review or approval compared to conventional FDA procedures.

The FDA may withdraw Fast Track Designation if

it believes that the designation is no longer supported by data from our clinical development program.

Our esmethadone development program

is currently paused and under evaluation.

Even though we have obtained orphan drug

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for the same disease for seven years.

Orphan drug exclusivity may be lost if the FDA determines that the request for designation was materially

defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease

or condition.

Orphan drug exclusivity may be lost if the FDA determines that the request for designation was

materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the

rare disease or condition.

We have obtained orphan drug designation for

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for other product candidates or indications, we may never receive such designations or obtain orphan drug exclusivity.

Our esmethadone development program is currently paused and under evaluation.

We may not be able to obtain marketing

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have not be considered the same active ingredient as methadone and therefore an NCE, we anticipate obtaining 5-year exclusivity.

were to determine that we do not meet the requirements to make the election, we may not be able to obtain 5-year exclusivity for the product.

were to determine that we do not meet the requirements to make the election, we may not be able to obtain 5-year exclusivity for the

In addition, under the statute, this election currently may only be made in an NDA submitted before October 1, 2027.

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in new therapeutic areas where we have little or no experience.

Although our primary strategic interest is in

the areas of depression, esmethadone has potential benefits in other therapeutic areas.

If our drug development efforts in depression

fail, or if the competitive landscape or investment climate for antidepressant drug development is less attractive, we may need to change

the company’s strategic focus to include development of our product candidates, or of newly acquired product candidates, for therapeutic

areas other than depression.

We have very limited drug development experience in other therapeutic areas and we may be unsuccessful in

making this change from a depression company to a company with a focus in areas other than depression, such as metabolic disorders with

psilocybin, or a company with a focus in multiple therapeutic areas including depression.

Our product candidates contain controlled

substances, the supply of which may be limited by U.S.

statutes and regulations, and the use of which may generate public controversy.

If our drug development efforts fail, or if the

competitive landscape or investment climate for antidepressant drug development is less attractive, we may need to change the company’s

strategic focus to include development of our product candidates, or of newly acquired product candidates.

We have very limited drug

development experience in therapeutic areas other than depression and we may be unsuccessful in making this change from a depression

focused company to a company with a focus in areas other areas, or a company with a focus in multiple therapeutic areas.

Some of our product candidates contain

controlled substances, the supply of which may be limited by U.S.

statutes and regulations, and the use of which may generate public

The active ingredients in esmethadone and psilocybin

are listed by the CSA and regulations promulgated by the DEA as controlled substances.

are stated in the CSA and regulations promulgated by the DEA as controlled substances.

The CSA and regulations promulgated by the DEA

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These product candidates are also subject to the CSA and DEA regulations relating

to their handling (i.e., manufacturing, storage, distribution, prescribing and dispensing procedures).

Furthermore, the amount of controlled

substances that can be obtained for clinical trials and commercial distribution is limited by the DEA through its quota system.

may not be sufficient to complete clinical trials or meet commercial demand.

There is a risk that federal statutes and DEA regulations

concerning applicable quotas may interfere with the supply of the drugs used in clinical trials for our product candidates and the ability

to manufacture and distribute our product candidates, if approved, in the volume needed to meet commercial demand.

to manufacturing, storage, distribution, prescribing and dispensing.

Furthermore, the amount of controlled substances that can be obtained

for clinical trials and commercial distribution is limited by the DEA through its quota system.

Quotas may not be sufficient to complete

clinical trials or meet commercial demand.

There is a risk that federal statutes and DEA regulations concerning applicable quotas may

interfere with the supply of the drugs used in clinical trials for our product candidates and the ability to manufacture and distribute

our product candidates, if approved, in the volume needed to meet commercial demand.

Products containing controlled substances may

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regulation by the DEA.

Although esmethadone is substantially devoid of opioid activity, and psychotomimetic effects, it is currently classified

as a Schedule II drug.

Upon approval, the DEA may continue to designate it as a controlled substance falling under a DEA controlled

substance schedule.

Esmethadone is produced by separation from racemic methadone, a scheduled drug subject to extensive regulation by

Any psilocybin-containing product candidate we develop is also subject to extensive regulation by the DEA as a Schedule I substance.

The manufacture, shipment, storage, sale and use

of controlled substances are highly regulated, including security, recordkeeping and reporting obligations enforced by the DEA.

I substances by definition have a high potential for abuse, have no currently “accepted medical use” in the United States,

lack accepted safety for use under medical supervision, and may not be prescribed, marketed or sold in the United States.

Schedule I and

II substances (as well as substances defined as narcotics in any Schedule) are subject to the strictest regulatory requirements and restrictions

involving registration, storage, security, recordkeeping and reporting.

In particular, distribution and dispensing of Schedule II drugs

are strictly controlled.

For example, all Schedule II drug prescriptions cannot be refilled and must contain a written or electronic signature

of a practitioner when presented to a pharmacy.

This high degree of regulation can result in significant costs in order to comply with

the required regulations, which may have an adverse effect on the development and commercialization of our product candidates.

Although esmethadone is substantially devoid of opioid activity, and psychotomimetic effects, it is currently

classified as a Schedule II drug.

Upon approval, the DEA may continue to designate it as a controlled substance falling under a

DEA controlled substance schedule.

Esmethadone is produced by separation from racemic methadone, a scheduled drug subject to extensive

regulation by the DEA.

Any psilocybin-containing product candidate we develop is also subject to extensive regulation by the DEA as a

Schedule I substance.

The manufacture, shipment, storage, sale and

use of controlled substances are highly regulated, including security, recordkeeping and reporting obligations enforced by the DEA and

state authorities.

Schedule I substances by definition have a high potential for abuse, have no currently “accepted medical use”

in the United States, lack accepted safety for use under medical supervision, and may not be prescribed, marketed or sold in the United

Schedule I and II substances (as well as substances defined as narcotics in any Schedule) are subject to the strictest regulatory

requirements and restrictions involving registration, storage, security, recordkeeping and reporting.

In particular, distribution and

dispensing of Schedule II drugs are strictly controlled.

For example, all Schedule II drug prescriptions cannot be refilled and must

contain a written or electronic signature of a practitioner when presented to a pharmacy.

This high degree of regulation can result in

significant costs in order to comply with the required regulations, which may have an adverse effect on the development and commercialization

of our product candidates.

The DEA limits the availability and production

of all scheduled substances, including esmethadone and psilocybin, through a quota system.

The DEA requires substantial evidence and documentation

of expected legitimate medical and scientific needs before assigning quotas to manufacturers.

In future years, we may need greater amounts

of controlled substances to sustain our development program, and we will need significantly greater amounts to implement our commercialization

plans if the FDA approves our proposed formulations.

Any delay or refusal by the DEA in establishing the procurement quota or a reduction

in our quota for scheduled controlled substances or a failure to increase it over time as we anticipate could delay or stop the clinical

development or commercial sale of some of our products or product candidates.

This could have a material adverse effect on our business,

results of operations, financial condition and prospects.

Psilocybin is currently classified as a Schedule I drug in the

United States, and any product containing this substance must be rescheduled to be marketed.

There can be no assurance that the DEA will

make a favorable scheduling decision.

Even assuming categorization as a Schedule II or lower controlled substance (i.e., Schedule III,

IV or V) at the federal level, such substances would also require scheduling determinations under state laws and regulations.

If approved by FDA, and if

the finished dosage form of a future psilocybin-containing drug product is listed by the DEA as a Schedule II, III, or IV controlled

substance, its manufacture, importation, exportation, domestic distribution, storage, sale, prescribing, and dispensing will continue

to be subject to a significant degree of regulation by the DEA.

In addition, the final scheduling process may take significantly longer

than the 90-day deadline set forth in the CSA, especially if there are objections to such scheduling, thereby delaying the launch of

our psilocybin-containing product candidate in the United States.

the FDA, DEA or any comparable foreign regulatory authority could require us to generate more clinical or other data than we currently

anticipate to establish whether or to what extent the substance has an abuse or misuse potential, which could increase the cost and/or

delay the launch of any future psilocybin-containing product candidates.

In addition, product candidates containing controlled substances

are subject to regulations relating to manufacturing, storage, distribution, prescribing, and dispensing, including:

of all Schedule I and II and some Schedule III controlled substances, including esmethadone and psilocybin, through a quota system.

DEA requires substantial evidence and documentation of expected legitimate medical and scientific needs before granting quotas to manufacturers.

In future years, we may need greater amounts of controlled substances to sustain our development program, and we will need significantly

greater amounts to implement our commercialization plans if the FDA approves our proposed formulations.

Any delay or refusal by the DEA

in establishing the procurement quota or a reduction in our quota for scheduled controlled substances or a failure to increase it over

time as we anticipate could delay or stop the clinical development or commercial sale of some of our products or product candidates.

This could have a material adverse effect on our business, results of operations, financial condition and prospects.

Psilocybin is currently classified as a

Schedule I drug in the United States, and any product containing this substance must be rescheduled to be marketed.

There can be no assurance

that the DEA will make a favorable rescheduling decision.

Even assuming categorization as a Schedule II or lower controlled substance

(i.e., Schedule III, IV or V) at the federal level, such substances would also require scheduling determinations under state laws and

If we determine to restart our psilocybin development program and a

future psilocybin-containing drug product is approved by FDA, and if the finished dosage form of that drug is listed by the DEA as a Schedule

II, III, or IV controlled substance, its manufacture, importation, exportation, domestic distribution, storage, sale, prescribing, and

dispensing will continue to be subject to a significant degree of regulation by the DEA.

In addition, the final scheduling process may

take significantly longer than the 90-day deadline set forth in the CSA, especially if there are objections to such scheduling, thereby

delaying the launch of our psilocybin-containing product candidate in the United States.

Furthermore, the FDA, DEA or any comparable foreign

regulatory authority could require us to generate more clinical or other data than we currently anticipate to establish whether or to

what extent the substance has an abuse or misuse potential, which could increase the cost and/or delay the launch of any future psilocybin-containing

product candidates.

In addition, product candidates containing controlled substances are subject to regulations relating to manufacturing,

storage, distribution, prescribing, and dispensing, including:

● State-controlled

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psilocybin or the psilocybin-containing product candidate in the United States.

potential reclassification of psilocybin in the United States could create additional regulatory burdens on our operations and nega tively

affect our results of operations.

If psilocybin, rather than

just a specific FDA-approved formulation, is rescheduled under the CSA as a Schedule II or lower controlled substance (i.e., Schedule

III, IV or V), the ability to conduct research on psilocybin would most likely be improved.

However, rescheduling psilocybin may materially

alter enforcement policies across many federal and state agencies, primarily FDA and DEA.

FDA’s responsibilities include regulating

the ingredients as well as the marketing and labeling of drugs sold in interstate commerce.

Because it is currently illegal under federal

law to produce and sell psilocybin, and because there are no federally recognized medical uses, FDA has historically deferred enforcement

related to psilocybin to the DEA.

If psilocybin were to be rescheduled to a federally controlled, yet legal, substance, FDA would likely

play a more active regulatory role.

The DEA would continue to be active in regulating manufacturing, distribution and dispensing of such

The potential for multi-agency enforcement post-rescheduling, including state agencies, e.g., Boards of Pharmacy, could threaten

or have a materially adverse effect on our business.

In addition, if the psilocybin-containing product candidate is scheduled as Schedule

II, III, IV or V, we would also need to identify wholesale distributors with the appropriate DEA registrations and authority to distribute

the psilocybin-containing product candidate.

The failure to obtain, or delay in obtaining, or the loss of any of those registrations could

result in increased costs to us.

If the psilocybin-containing product candidate is classified as a Schedule II drug, participants in our

supply chain may have to maintain enhanced security including specially constructed vaults at manufacturing and distribution facilities.

This additional security may also discourage some pharmacies from carrying the product.

we determine to restart our psilocybin development program, the potential reclassification of psilocybin in the United States could create

additional regulatory burdens on our operations and negatively affect our results of operations.

If we determine to restart our psilocybin development

program, and if psilocybin, rather than just a specific FDA-approved formulation, is rescheduled under the CSA as a Schedule II or lower

controlled substance (i.e., Schedule III, IV or V), the ability to conduct research on psilocybin would most likely be improved.

rescheduling psilocybin may materially alter enforcement policies across many federal and state agencies, primarily FDA and DEA.

responsibilities include regulating the ingredients as well as the marketing and labeling of drugs sold in interstate commerce.

it is currently illegal under federal law to produce and sell psilocybin, and because there are no federally recognized medical uses,

FDA has historically deferred enforcement related to psilocybin to the DEA.

If psilocybin were to be rescheduled to a federally controlled,

yet legal, substance, FDA would likely play a more active regulatory role.

The DEA would continue to be active in regulating manufacturing,

distribution and dispensing of such substances.

The potential for multi-agency enforcement post-rescheduling, including state agencies,

e.g., Boards of Pharmacy, could threaten or have a materially adverse effect on our business.

In addition, if the psilocybin-containing

product candidate is rescheduled as Schedule II, III, IV or V, we would also need to identify wholesale distributors with the appropriate

DEA registrations and authority to distribute the psilocybin-containing product candidate.

The failure to obtain, or delay in obtaining,

or the loss of any of those registrations could result in increased costs to us.

If the psilocybin-containing product candidate is classified

as a Schedule II drug, participants in our supply chain may have to maintain enhanced security including specially constructed vaults

at manufacturing and distribution facilities.

The additional regulatory requirements related to ordering, storing (e.g., security) and

dispensing may also discourage some pharmacies from carrying the product.

If a supplier of an active pharmaceutical

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A DMF is a submission to the FDA used to provide confidential

detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of drugs to

support drug development and approval.

detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of drugs

to support drug development and approval.

In addition, some of the countries for our multisource APIs may not be same as our drug manufacturing

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our business and prospects and could cause us to cease operations.

On November 29, 2006, the FDA required a boxed

warning to be added to the Prescribing Information related to cardiac death for racemic methadone, a parent compound to our esmethadone.

Although the decision was based on case reports and not on a controlled clinical trial, as part of the development of esmethadone, we

currently assess (and have actively assessed) the cardiac safety profile of esmethadone in our Phase 3 clinical trials.

On November 29, 2006, the FDA required a boxed warning to be added

to the Prescribing Information related to cardiac death for racemic methadone, a parent compound to our esmethadone.

Although the decision

was based on case reports and not on a controlled clinical trial, as part of any future development of esmethadone, we would have to assess

(and have previously assessed) the cardiac safety profile of esmethadone in any future Phase 3 clinical trials.

There is no assurance

that the results of our clinical studies will demonstrate an absence of cardiac adverse events with esmethadone.

An adverse safety outcome

could result in a similar bolded warning on the label of esmethadone or in a decision not to approve esmethadone, either one of which

could have serious consequences for our continued operation.

If approved, esmethadone and any psilocybin-containing

drug product we successfully develop may require Risk Evaluation and Mitigation Strategies (REMS).

Esmethadone and any psilocybin-containing drug

product we successfully develop, may require REMS.

The REMS may include requirements for special labeling or medication guides for patients,

special communication plans to health care professionals and restrictions on distribution and use.

We cannot predict the specific REMS

to be required as part of the FDA’s approval of any of our products.

Depending on the extent of the REMS requirements, our costs

to commercialize our products may increase significantly.

Furthermore, controlled substances risks that are not adequately addressed through

proposed REMS for our product candidates may also prevent or delay their approval for commercialization.

that the results of any future clinical studies will demonstrate an absence of cardiac adverse events with esmethadone.

An adverse safety

outcome could result in a similar bolded warning on the label of esmethadone or in a decision not to approve esmethadone, either one of

which could have serious consequences for our continued operation.

If approved, our drug candidates and any

psilocybin-containing drug product we successfully develop may require Risk Evaluation and Mitigation Strategies (REMS).

Our drug candidates and any psilocybin-containing

drug product we successfully develop, may require REMS.

The REMS may include requirements for special labeling or medication guides for

patients, special communication plans to health care professionals and restrictions on distribution and use.

Methadone indicated as an

analgesic is currently subject to a REMS that strongly encourages healthcare providers to complete a REMS-compliant education program,

counsel patients and/or their caregivers on safe use, serious risks, and proper storage and disposal using the drug’s Medication

Guide, and consider other tools to improve patient, household, and community safety.

We cannot predict the specific REMS to be required

as part of the FDA’s approval of any of our products.

Depending on the extent of the REMS requirements, our costs to commercialize

our products may increase significantly.

Furthermore, controlled substances risks that are not adequately addressed through proposed

REMS for our product candidates may also prevent or delay their approval for commercialization.

Our products will face significant competition

in the markets for such products, and if they are unable to compete successfully, our business will suffer.

Our products candidates face, and will continue

to face, intense competition from large pharmaceutical companies, specialty pharmaceutical and biotechnology companies as well as academic

and research institutions.

Our products candidates face, and will continue to face, intense competition

from large pharmaceutical companies, specialty pharmaceutical and biotechnology companies as well as academic and research institutions.

We compete in an industry that is characterized by:

(i) rapid technological change, (ii) evolving industry

standards, (iii) emerging competition and (iv) new product introductions.

Our competitors have existing products and technologies that

will compete with our products and technologies and may develop and commercialize additional products and technologies that will compete

with our products and technologies.

Because several competing companies and institutions have greater financial resources than us, they

may be able to:

(i) provide broader services and product lines, (ii) make greater investments in research and development, (R&D ) ,

and (iii) carry on larger R&D initiatives.

Our competitors also have greater development capabilities than we do and have substantially

greater experience in undertaking nonclinical and clinical testing of products, obtaining regulatory approvals, and manufacturing and

marketing pharmaceutical products.

They also have greater name recognition and better access to customers than us.

Our chief competitors

include companies such as Johnson and Johnson, Abbvie, Pfizer, Eli Lilly, Axsome Therapeutics, and Neumora Therapeutics, Inc.

among others.

(i) rapid technological change, (ii) evolving industry standards, (iii) emerging competition

and (iv) new product introductions.

Our competitors have existing products and technologies that will compete with our products and technologies

and may develop and commercialize additional products and technologies that will compete with our products and technologies.

Because several

competing companies and institutions have greater financial resources than us, they may be able to:

(i) provide broader services and product

lines, (ii) make greater investments in research and development, (R&D ) , and (iii) carry on larger R&D initiatives.

competitors also have greater development capabilities than we do and have substantially greater experience in undertaking nonclinical

and clinical testing of products, obtaining regulatory approvals, and manufacturing and marketing pharmaceutical products.

They also have

greater name recognition and better access to customers than us.

Our chief competitors include companies such as Johnson and Johnson,

CG Oncology, UroGen, Soleno Therapeutics, Aardvark Therapeutics, and Protara Therapeutics, among others.

We may be exposed to liability claims associated

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or other proceedings, it could consume a substantial portion of our financial resources and the efforts of our personnel.

Our ability to protect and enforce our patents

does not guarantee that we will secure the right to commercialize our patents.

Our ability to protect and enforce our

patents does not guarantee that we will secure the right to commercialize our patents.

A patent is a limited monopoly right conferred

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federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act;

HIPAA, as amended by HITECH, imposes criminal and civil liability for,

among other things, knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program or making

false statements relating to healthcare matters.

Similar to the federal Anti-Kickback Statute, 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;

HIPAA, as amended by HITECH,

imposes criminal and civil liability for, among other things, knowingly and willfully executing or attempting to execute a scheme

to defraud any healthcare benefit program or making false statements relating to healthcare matters.

Similar to the federal Anti-Kickback

Statute, 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;

the federal Physician Payment

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their immediate family, which includes annual data collection and reporting obligations;

analogous state and

foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and

claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers;

some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines

and the relevant compliance guidance promulgated by the federal government and may require drug manufacturers to report information

related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures or drug

analogous state and foreign

laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims

involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers;

and some state

laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the

relevant compliance guidance promulgated by the federal government and may require drug manufacturers to report information related

to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures or drug pricing.

Efforts to ensure that our business arrangements

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other things, affect our ability to profitably sell any products for which we obtain marketing approval.

The commercial potential for our products, if any, could also be affected

by changes in healthcare spending and policy in the United States and abroad.

New laws, regulations, or judicial decisions or new interpretations

of existing laws, regulations, or decisions, related to healthcare availability, the method of delivery, or payment for healthcare products

and services could adversely affect our business, operations, and financial condition, if and when we are able to obtain marketing approval

and commercialize our products.

For example, the ACA was enacted in 2010 with a goal, among others, of reducing the cost of healthcare

and substantially changing the way healthcare is financed by both government and private insurers.

The ACA, among other things, expanded

manufacturers’ rebate liability under the Medicaid Drug Rebate Program, imposed a significant annual, nondeductible fee on companies

that manufacture or import certain branded prescription drug products, and enacted substantial provisions affecting compliance, which

may affect our business practices with healthcare practitioners.

There have been and continue to be a number of initiatives at the U.S.

The commercial potential for our products, if

any, could also be affected by changes in healthcare spending and policy in the United States and abroad.

New laws, regulations, or judicial

decisions or new interpretations of existing laws, regulations, or decisions, related to healthcare availability, the method of delivery,

or payment for healthcare products and services could adversely affect our business, operations, and financial condition, if and when

we are able to obtain marketing approval and commercialize our products.

For example, the ACA was enacted in 2010 with a goal, among

others, of reducing the cost of healthcare and substantially changing the way healthcare is financed by both government and private insurers.

The ACA, among other things, expanded manufacturers’ rebate liability under the Medicaid Drug Rebate Program, imposed a significant

annual, nondeductible fee on companies that manufacture or import certain branded prescription drug products, and enacted substantial

provisions affecting compliance, which may affect our business practices with healthcare practitioners.

There have been and continue to be a number of

initiatives at the U.S.

federal and state levels that seek to reduce healthcare costs in general and the cost of pharmaceuticals in particular.

These initiatives

recently culminated in the enactment of the IRA in August 2022, which, among other things, allows HHS to directly negotiate the selling

price of a statutorily speficied number of drugs and biologics each year that CMS reimburses under Medicare Part B and Part D.

Only high-expenditure

single-source biologics that have been approved for at least 11 years (7 years for single-source drugs) can be selected by CMS for negotiation,

with the negotiated price taking effect two years after the selection year.

Negotiations for Medicare Part D products begin in 2024 with

the negotiated price taking effect in 2026, and negotiations for Medicare Part B products begin in 2026 with the negotiated price taking

effect in 2028.

In August 2023, HHS announced the ten Medicare Part D drugs and biologics that it selected for negotiations.

announce the negotiated maximum fair prices by September 1, 2024, and this price cap, which cannot exceed a statutory ceiling price, will

come into effect on January 1, 2026.

A drug or biological product that has an orphan drug designation for only one rare disease or condition

will be excluded from the IRA’s price negotiation requirements, but will lose that exclusion if it has designations for more than

one rare disease or condition, or if is approved for an indication that is not within that single designated rare disease or condition,

unless such additional designation or such disqualifying approvals are withdrawn by the time CMS evaluates the drug for selection for

The IRA also imposes rebates on Medicare Part D and Part B drugs whose prices have increased at a rate greater than the rate

of inflation.

In addition, the law eliminates, beginning in 2025, the coverage gap under Medicare Part D by significantly lowering the

beneficiary maximum out-of-pocket cost and requiring manufacturers to subsidize, through a newly established manufacturer discount program,

10% of Part D enrollees’ prescriptions costs for brand drugs below the out-of-pocket maximum, and 20% once the out-of-pocket maximum

has been reached.

The IRA also extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through

plan year 2025.

The IRA permits the Secretary of HHS to implement many of these provisions through guidance, as opposed to regulation,

for the initial years.

Manufacturers that fail to comply with the IRA may be subject to various penalties, including civil monetary penalties.

These provisions will take effect progressively starting in 2023, although they may be subject to legal challenges.

For example, the provisions

related to the negotiation of selling prices of high-expenditure single-source drugs and biologics have been challenged in multiple lawsuits

brought by pharmaceutical manufacturers.

Thus, while it is unclear how the IRA will implemented, it will likely have a significant impact

on the pharmaceutical industry.

These initiatives recently culminated in the enactment of the IRA in August 2022, which, among other things, allows HHS to directly negotiate

the selling price of a statutorily specified number of drugs and biologics each year that CMS reimburses under Medicare Part B and Part

The negotiated price may not exceed a statutory ceiling price.

Only high-expenditure single-source drug that have been approved for

at least 7 years (11 years for single-source biologics) can be selected by CMS for negotiation, with the negotiated price taking effect

two years after the selection year.

For 2026, the first year in which negotiated prices become effective, CMS selected 10 high-cost Medicare

Part D products in 2023, negotiations began in 2024, and the negotiated maximum fair price for each product has been announced.

selected 15 additional Medicare Part D drugs for negotiated maximum fair pricing in 2027.

For 2028, an additional 15 drugs, which may

be covered under either Medicare Part B or Part D, will be selected, and for 2029 and subsequent years, 20 Part B or Part D drugs will

A drug or biological product that has an orphan drug designation for only one rare disease or condition will be excluded

from the IRA’s price negotiation requirements, but will lose that exclusion if it has designations for more than one rare disease

or condition, or if is approved for an indication that is not within that single designated rare disease or condition, unless such additional

designation or such disqualifying approvals are withdrawn by the time CMS evaluates the drug for selection for negotiation.

imposes rebates on Medicare Part D and Part B drugs whose prices have increased at a rate greater than the rate of inflation and in November

2024, CMS finalized regulations for these inflation rebates.

In addition, the law eliminates, beginning in 2025, the coverage gap under

Medicare Part D by significantly lowering the beneficiary maximum out-of-pocket cost and requiring manufacturers to subsidize, through

a newly established manufacturer discount program, 10% of Part D enrollees’ prescriptions costs for brand drugs below the out-of-pocket

limit, and 20% once the out-of-pocket limit has been reached.

The IRA also extends enhanced subsidies for individuals purchasing health

insurance coverage in ACA marketplaces through plan year 2025.

The IRA permits the Secretary of HHS to implement many of these provisions

through guidance, as opposed to regulation, for the initial years.

Manufacturers that fail to comply with the IRA may be subject to various

penalties, including civil monetary penalties.

These provisions will take effect progressively starting in 2023, although they may be

subject to legal challenges.

For example, the provisions related to the negotiation of selling prices of high-expenditure single-source

drugs and biologics have been challenged in multiple lawsuits brought by pharmaceutical manufacturers.

Thus, while it is unclear how

the IRA will be implemented, it will likely have a significant impact on the pharmaceutical industry.

Further, at the U.S.

state level, legislatures are increasingly enacting

laws and implementing regulations designed to control pharmaceutical and biological product pricing, including price or reimbursement

constraints, discount requirements, marketing cost disclosure, price gouging prohibitions, and price transparency reporting.

that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that

federal and state governments will pay for healthcare products and services or otherwise negatively impact our business model.

state level, legislatures

are increasingly enacting laws and implementing regulations designed to control pharmaceutical and biological product pricing, including

price or reimbursement constraints, discount requirements, marketing cost disclosure, price gouging prohibitions, and price transparency

We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit

the amounts that federal and state governments will pay for healthcare products and services or otherwise negatively impact our business

Disruptions at the FDA, the SEC and other

government agencies or comparable regulatory authorities caused by funding shortages or global health concerns, in addition to substantial

uncertainty regarding the new Administration’s initiatives and how these might impact the FDA, its implementation of laws, regulations,

policies and guidance, and its personnel, could hinder government agencies’ ability to hire and retain key leadership and other

personnel, or otherwise prevent new products and services from being developed or commercialized in a timely manner, or otherwise prevent

those agencies from performing normal business functions on which our business operations rely, including timely reviews, which could

negatively impact our business.

The ability of the FDA or comparable foreign

regulatory authorities to review and approve new products can be affected by a variety of factors, including government budget and funding

levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes that

may otherwise affect the FDA’s or comparable foreign regulatory authorities’ ability to perform routine functions.

government funding of the SEC and other government agencies or comparable foreign regulatory authorities 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.

Disruptions at the FDA and other agencies, including

substantial leadership, personnel, and policy changes, may also slow the time necessary for new drugs to be reviewed and/or approved

by necessary government agencies, which would harm our business.

Changes in FDA staffing could result in delays in the FDA’s responsiveness

or in its ability to review submissions or applications, issue regulations or guidance, or implement or enforce regulatory requirements

in a timely fashion or at all.

Similar consequences would also result in the event of another significant shutdown of the federal government.

For example, over the last several years, the U.S.

government has shut down several times and certain regulatory agencies, such as the

FDA, have had to furlough critical FDA employees and stop critical activities.

If a prolonged government shutdown occurs, or if geopolitical

or global health concerns 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 to timely review and process our regulatory submissions,

which could materially adversely affect our business, financial condition, results of operations and prospects.

Such changes could significantly

impact the ability of the FDA to timely review and take action on our regulatory submissions, which could have a material adverse effect

on our business.

Further, in our operations as a public company, future government shutdowns or substantial leadership, personnel, and

policy changes could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and

continue our operations.

If the FDA is constrained in its ability to engage in oversight and implementation activities in the normal

course, our business may be negatively impacted.

With the change in the U.S.

Presidential Administration

in 2025, there is substantial uncertainty as to whether and how the new administration will seek to modify or revise the requirements

and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates.

This uncertainty could present new

challenges and/or opportunities as we navigate development of our product candidates.

Some of these efforts have manifested to date in

the form of personnel measures that could impact the FDA’s ability to hire and retain key personnel, which could result in delays

or limitations on our ability to obtain guidance from the FDA on our product candidates in development and obtain the requisite regulatory

approvals in the future.

Moreover, the new Administration has proposed action to freeze or reduce the budget of the National Institutes

of Health, or NIH, as related to its funding for medical research, which could decrease the ability of facilities that rely on NIH funding

to enroll and conduct clinical trials or increase the costs to us of conducting clinical trials.

There remains general uncertainty regarding

future activities.

The new Administration could issue or promulgate executive orders, regulations, policies or guidance that adversely

affect us or create a more challenging or costly environment to pursue the development of new therapeutic products.

Alternatively, state

governments may attempt to address or react to changes at the federal level with changes to their own regulatory frameworks in a manner

that is adverse to our operations.

If we become negatively impacted by future governmental orders, regulations, policies or guidance

as a result of the new Administration, there could be a material adverse effect on us and our business.

Risks Related to Our Reliance on Third Parties

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If our contract manufacturers

were to encounter difficulties, our ability to provide our product candidates to patients in preclinical and clinical trials, or to provide

were to encounter difficulties, our ability to provide our product candidates to patients in nonclinical and clinical trials, or to provide

product for treatment of patients once approved, would be jeopardized.

We intend to rely on third parties to conduct

our preclinical studies and clinical trials.

our nonclinical studies and clinical trials.

If these third parties do not perform as contractually required or otherwise expected, we

may not be able to obtain regulatory approval for our product candidates.

We do not currently conduct preclinical studies

We do not currently conduct nonclinical studies

or clinical trials on our own, and instead will rely on third parties, such as contract research organizations (CROs), medical institutions,

clinical investigators and contract laboratories, to assist us with our preclinical studies and clinical trials.

clinical investigators and contract laboratories, to assist us with our nonclinical studies and clinical trials.

Accordingly, we have

less control over the timing, quality and other aspects of preclinical studies and clinical trials than if we conducted them on our own.

less control over the timing, quality and other aspects of nonclinical studies and clinical trials than if we conducted them on our own.

These investigators, CROs and consultants are not our employees and we will have limited control over the amount of time and resources

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The third parties with which we may contract might not be diligent,

careful or timely in conducting our preclinical studies or clinical trials, resulting in the preclinical studies or clinical trials being

careful or timely in conducting our nonclinical studies or clinical trials, resulting in the nonclinical studies or clinical trials being

delayed or unsuccessful.

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on commercially reasonable terms, or at all, or if these third parties do not carry out their contractual duties, satisfy legal and regulatory

requirements for the conduct of preclinical studies or clinical trials or meet expected deadlines, our clinical development programs

requirements for the conduct of nonclinical studies or clinical trials or meet expected deadlines, our clinical development programs

could be delayed and otherwise adversely affected.

In all events, we will be responsible for ensuring that each of our preclinical studies

In all events, we will be responsible for ensuring that each of our nonclinical studies

and clinical trials are conducted in accordance with the general investigational plan and protocols for the trial as well as applicable

legal and regulatory requirements.

The FDA generally requires preclinical studies to be conducted in accordance with good laboratory

The FDA generally requires nonclinical studies to be conducted in accordance with good laboratory

practices and clinical trials to be conducted in accordance with good clinical practices, including for designing, conducting, recording

and reporting the results of preclinical studies and clinical trials to assure that data and reported results are credible and accurate

and reporting the results of nonclinical studies and clinical trials to assure that data and reported results are credible and accurate

and that the rights, integrity and confidentiality of clinical trial participants are protected.

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do not control will not relieve us of these responsibilities and requirements.

Any adverse development or delay in our preclinical studies

Any adverse development or delay in our nonclinical studies

or clinical trials as a result of our reliance on third parties could have a material and adverse effect on our business, financial condition,

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to sell shares of our common stock, or the prices at which holders may be able to sell their common stock.

We are not in compliance with The Nasdaq

Stock Market $1.00 minimum bid price requirement and failure to maintain compliance with this standard could result in delisting and

adversely affect the market price and liquidity of our common stock.

Our common stock is currently traded on The Nasdaq

Global Select Market under the symbol “RLMD”.

If we fail to meet any of the continued listing standards of The Nasdaq Stock

Market, our common stock will be delisted from The Nasdaq Global Select Market.

These continued listing standards include specifically

enumerated criteria, such as a $1.00 minimum closing bid price.

On January 21, 2025, we received a deficiency letter from the Listing

Qualifications Department (the “Staff”) of The Nasdaq Stock Market advising that, for 30 consecutive business days preceding

the notification letter, the Company did not meet the minimum $1.00 per share bid price requirement for continued inclusion on The Nasdaq

Global Select Market.

The deficiency letter does not result in the immediate delisting of our common stock from the Nasdaq Global Select

In accordance with Nasdaq Listing Rule 5810(c)(3)(A) (the “Compliance Period Rule”), we have been provided an initial

period of 180 calendar days, or until July 21, 2025 (the “Compliance Date”), to regain compliance with the minimum bid price

If, at any time before the Compliance Date, the bid price for our common stock closes at $1.00 per share or more for a minimum

of 10 consecutive business days, as required by the Compliance Period Rule, the Staff will provide written notification to us that we

comply with the minimum bid price requirement, unless the Staff exercises its discretion to extend this 10-day period pursuant to Nasdaq

Listing Rule 5810(c)(3)(H).

While we intend to regain compliance with the

minimum bid price requirement, there can be no assurance that we will be able to maintain continued compliance with this rule or the

other listing requirements of The Nasdaq Stock Market.

If we were unable to meet these requirements, we would receive another delisting

notice from the Nasdaq Stock Market for failure to comply with one or more of the continued listing requirements.

If our common stock

were to be delisted from The Nasdaq Global Select Market, trading of our common stock most likely will be conducted in the over-the-counter

market on an electronic bulletin board established for unlisted securities such as the OTC Markets or in the “pink sheets.”

Such a downgrading in our listing market may limit our ability to make a market in our common stock and which may impact purchases or

sales of our securities.

A sale of a substantial number of shares

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These market fluctuations may also materially and adversely affect the market price of our common stock.

Our Stock Price May Be Volatile Due to

Recent Developments

The pause of our primary drug candidate and our shift to new development

programs may contribute to significant volatility in the price of our common stock.

Negative perceptions of our strategic pivot, combined

with uncertainties surrounding the new drug candidates’ potential, could lead to sharp declines in our stock price.

The Nevada Revised Statutes and our articles

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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