What changed in this filing

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Item 1A. Risk Factors

2024-03-15 compared with 2023-03-30 · 320 added, 569 removed, 1376 unchanged (39% of the section changed)

Related to Our Business, Financial Condition and Capital Requirements

report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2022

contains an explanatory paragraph relating to our ability to continue as a going concern.

auditor’s opinion on our audited financial statements for the year ended December 31, 2022 includes an explanatory paragraph stating

that the Company does not have revenue generating activities and is dependent on additional financing to fund operations.

These conditions raise substantial doubt about the Company’s ability to continue as a going concern.

While we believe that we will be able to raise the capital

we need to continue our operations, there can be no assurances that we will be successful in these efforts or will be able to resolve

our liquidity issues or eliminate our operating losses.

is substantial doubt about our ability to continue as a going concern.

Company does not have revenue generating activities and is dependent on additional financing to fund operations.

These conditions raise

substantial doubt about the Company’s ability to continue as a going concern.

While we believe that we will be able to raise the

capital we need to continue our operations, there can be no assurances that we will be successful in these efforts or will be able to

resolve our liquidity issues or eliminate our operating losses.

If we are unable to obtain sufficient funding, we would need to significantly

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to have, an adverse effect on our stockholders’ equity and working capital.

Our net loss was $24.2 million for the year ended December

31, 2022 and $29.1 million for the year ended December 31, 2021.

As of December 31, 2022, we had an accumulated deficit of $110.9 million.

We expect to continue to incur significant losses for the foreseeable future as we continue our research and development of, and seek

regulatory approvals for, our product candidates.

Net losses and negative cash flows have had, and will

continue to have, an adverse effect on our stockholders’ equity and working capital.

We expect to continue to incur significant

losses for the foreseeable future as we continue our research and development of, and seek regulatory approvals for, our product candidates.

we continue to suffer losses as we have since inception, investors may not receive any return on their investment and may lose their

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the requirements and demands of being a public company;

our operational, financial and management systems and increases personnel to support our operations;

our operational, financial and management systems and increase personnel to support our operations;

additional clinical, quality control, medical, scientific and other technical personnel to support our clinical operations;

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candidates, including our planned Phase 2 program for nafamostat and planned clinical trials for PF614 and PF614-MPAR.

need to raise additional capital to complete our currently planned clinical trials and any future clinical trials.

Other unanticipated

costs may arise during our development efforts.

If we can obtain marketing approval for product candidates that we develop, we would

require significant additional amounts of funding to launch and commercialize such product candidates.

We cannot reasonably estimate

the actual amounts necessary to successfully complete the development and commercialization of any product candidate we develop and we

will require substantial additional funding to complete the development and commercialization of our product candidates.

We will need to

raise additional capital to complete our currently planned clinical trials and any future clinical trials.

Other unanticipated costs

may arise during our development efforts.

If we can obtain marketing approval for product candidates that we develop, we would require

significant additional amounts of funding to launch and commercialize such product candidates.

We cannot reasonably estimate the actual

amounts necessary to successfully complete the development and commercialization of any product candidate we develop and we will require

substantial additional funding to complete the development and commercialization of our product candidates.

future need for additional funding depends on many factors, including:

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believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements

into the second quarter of 2023, while advancing our main product candidates such as, PF614 and PF614 MPAR™ and nafamostat through

their respective next phases of clinical development.

into the third quarter of 2024, while advancing our main product candidates such as, PF614 and PF614-MPAR and nafamostat through their

respective next phases of clinical development.

Our estimate may prove to be wrong, and we could use our available capital resources,

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reduce the scope of, suspend or eliminate one or more of our platforms, programs, planned clinical trials or future commercialization

may incur additional dilution upon repayment of the Investor Notes with common stock.

the terms of the Securities Purchase Agreement, we are permitted to repay principal and interest on the Investor Notes by issuing additional

shares of common stock.

In addition, the conversion price of the Investor Notes, and the exercise price of the Prior Warrants, are subject

to downward revision in the event we make certain issuances of our common stock at prices below the conversion price.

The conversion

price of the 2022 Notes and exercise price of the Prior Warrants have been reset, but not below a price of $2.006 for the Prior Warrants

issued in 2022, $15.60 for the Prior Warrants issued in 2021 and $2.006 for the 2022 Notes (temporarily reduced for the 2022 Notes to

$0.7512 for the period from January 12, 2023 until May 12, 2023).

In such case, stockholders will have dilution in amounts exceeding

the straight conversion of the Investor Notes or, with respect to the Prior Warrants, the Company will receive a reduced level of proceeds

from the exercise of the Prior Warrants.

Please see the discussion of conversion and exercise prices under “ Description of Capital

Stock—Convertible Promissory Notes” and “—Warrants.”

price of our common stock on Nasdaq and Public Warrants on the OTC Pink Open Market may be volatile.

price of our common stock on Nasdaq and our Public Warrants on the OTC Pink Open Market may fluctuate due to a variety of factors, including:

in the industries in which we and our customers operate;

in our operating performance and the performance of our competitors in general;

and adverse impact of the COVID-19 pandemic on the markets and the broader global economy;

or anticipated fluctuations in our quarterly or annual operating results;

of research reports by securities analysts about us, our competitors or our industry;

public’s reaction to our press releases, other public announcements and filings with the SEC;

failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may give to

and departures of key personnel;

in laws and regulations affecting our business;

of, or involvement in, litigation involving us;

about, among other things, the results of our clinical trials or other developments, or the use or abuse of opioids,

in our capital structure, such as future issuances of securities or the incurrence of additional debt;

or anticipated sales, of large blocks of our common stock;

volume of shares of our common stock available for public sale;

economic and political conditions such as recessions, interest rates, fuel prices, foreign currency fluctuations, international tariffs,

social, political and economic risks and acts of war or terrorism.

and other factors, many of which are beyond our control, may cause the market price and demand for our shares of common stock to fluctuate

substantially.

Low trading volume could increase the volatility of our share price in response to news in the market, could prevent investors

from readily selling their shares and may otherwise negatively affect the market price and liquidity of our shares.

In addition, in the

past, when the market price of a stock has been volatile, holders of that stock have sometimes instituted securities class action litigation

against the company that issued the stock.

If any of our stockholders brought a lawsuit against us, we could incur substantial costs

defending the lawsuit.

Such a lawsuit could also divert the time and attention of our management from our business, which could significantly

harm our profitability and reputation.

we are unable to regain compliance with the listing standards of Nasdaq, our common stock may become delisted, which could have a material

adverse effect on our ability to raise funding, which could negatively impact our business, capital and financial condition.

are not in compliance with Nasdaq listing standards for our common stock and have been granted an exception through June 12, 2023 to

meet a number of obligations before June 12, 2023 that have been imposed by Nasdaq and to meet all listing requirements no later than

June 12, 2023.

If we do not meet all of those obligations by the deadlines imposed, our common stock could be delisted by Nasdaq.

delisting occurs, it could be more difficult to buy or sell our securities and to obtain accurate quotations, and the price of our common

stock could suffer a material decline.

In addition, a delisting would impair our ability to raise capital through the public markets,

could deter broker-dealers from making a market in or otherwise seeking or generating interest in our securities and might deter certain

institutions and persons from investing in our securities.

Any of these could negatively impact our financial condition or our ability

to operate our business and maintain adequate capital.

may be no proceeds under the GEM Agreement or proceeds may be less than anticipated.

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we have raised capital from other sources, we have not used the GEM Facility to date.

Under a Share Purchase Agreement between us, GEM

Global Yield LLC SCS (“ GEM Global ”) and GEM Yield Bahamas Limited (“ GYBL ”), dated as of December

29, 2020, including a Registration Rights Agreement between the same parties and dated as of the same date (the “ GEM Agreement ”),

we are entitled to draw down up to $60 million of gross proceeds from GEM Global in exchange for shares of our common stock at a price

equal to 90% of the average closing bid price of the shares of our common stock on Nasdaq for a 30 day period, subject to meeting the

terms and conditions of the GEM Agreement.

This equity line facility is available for a period of 36 months from the closing date of

However, we have not been able to make use of the GEM Facility and we may not be able to do so before it expires.

see the section entitled “ Business ” for additional information.

The limitations on the amount and frequency of the

draws that we can make pursuant to the GEM Agreement, which include the requirement that (i) there be an effective registration statement

and (ii) size restrictions relating to our trading volume, may affect the ability to draw under the GEM Agreement and result in proceeds

that are less than anticipated.

Under a Share Purchase Agreement between us,

GEM Global Yield LLC SCS (“ GEM Global ”) and GEM Yield Bahamas Limited (“ GYBL ”), dated as of

December 29, 2020, including a Registration Rights Agreement between the same parties and dated as of the same date (the

“ GEM Agreement ”), we are entitled to draw down up to $60 million of gross proceeds from GEM Global in exchange

for shares of our common stock at a price equal to 90% of the average closing bid price of the shares of our common stock on Nasdaq

for a 30 day period, subject to meeting the terms and conditions of the GEM Agreement.

This equity line facility is available for a

period of 36 months from the closing date of the Merger.

However, we have not been able to make use of the GEM Facility and we may

not be able to do so before it expires.

Please see the section entitled “Item1.

Business ” for additional

The limitations on the amount and frequency of the draws that we can make pursuant to the GEM Agreement, which include

the requirement that (i) there be an effective registration statement and (ii) size restrictions relating to our trading volume, may

affect the ability to draw under the GEM Agreement and result in proceeds that are less than anticipated.

addition, the occurrence of the Merger triggered (i) payment of a commitment fee of $1.2 million to GEM Global payable in either our

common stock or cash, of which all has been satisfied with 3,838 shares of common stock transferred from related parties in July 2022

2022 and an additional 533,334 shares of common stock issued in January 2023 and (ii) the issuance of a warrant granting GYBL the

right to purchase 55,306 shares of our common stock, at a strike price per share of $0.7512 as of January 12, 2023.

The number of shares underlying the

warrant as well as the strike price is subject to adjustments for recapitalizations, reorganizations, change of control, stock

split, stock dividend, reverse stock splits and certain issuances of additional shares of our common stock.

and an additional 44,444 shares of common stock issued in January 2023 and (ii) the issuance of a warrant granting GYBL the right to

purchase 4,608 shares of our common stock, at a strike price per share reset to $1.5675.

The number of shares underlying the warrant

as well as the strike price is subject to adjustments for recapitalizations, reorganizations, change of control, stock split, stock dividend,

reverse stock splits and certain issuances of additional shares of our common stock.

issuances of shares at discount under the GEM Agreement and the anti-dilution protection granted to GEM Global in connection with issuances

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completed mid-year 2022.

A Phase 1 trial was also initiated for PF614-MPAR™ in December 2021 and the clinical portion of Part A

of that trial was completed in December 2022.

All of our other product candidates are in earlier stages of development and will require

substantial additional investment for manufacturing, preclinical testing, clinical development, regulatory review and approval in one

or more jurisdictions.

If any of our product candidates encounter safety or efficacy problems, development delays or regulatory issues

or other problems, our development plans and business would be materially harmed.

Two Human Abuse Potential clinical studies were completed in 2023.

An efficacy Phase 2 study of PF614 was completed

in December 2023.

A Phase 1 trial was also initiated for PF614-MPAR in December 2021 and the clinical portion of Part A of that trial

was completed in December 2022.

The clinical portion of Part B was initiated in January 2023 and enrollment completed in March 2023.

A Phase 1 safety study of nafamostat was completed in 2020.

All of our other product candidates are in earlier stages of development

and will require substantial additional investment for manufacturing, preclinical testing, clinical development, regulatory review and

approval in one or more jurisdictions.

If any of our product candidates encounter safety or efficacy problems, development delays or

regulatory issues or other problems, our development plans and business would be materially harmed.

may not have the financial resources to continue development of our product candidates.

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We seek to maintain a process of prioritization and resource allocation to maintain an optimal balance between aggressively

pursuing our more advanced clinical-stage product candidates, such [as nafamostat], PF614 and PF614-MPAR™, and ensuring the development

of additional potential product candidates.

pursuing our more advanced clinical-stage product candidates, such as PF614 and PF614-MPAR, and ensuring the development of additional

potential product candidates.

to the significant resources required for the development of our product candidates, we must focus on specific diseases and disease pathways

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safety upon commercialization.

are committing a substantial majority of our resources to the development of products utilizing our TAAP and MPAR TM .

are committing a substantial majority of our resources to the development of products utilizing our TAAP and MPAR ® .

can be no assurance that our products will perform as tested and limit or impede the actual abuse, overdose or misuse of such products

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acceptance for such products and on our financial condition and results of operations.

we fail to discover, develop and commercialize other product candidates, we may be unable to grow our business and our ability to achieve

our strategic objectives would be impaired.

In addition, we may also seek to commercialize certain treatments that may not be proprietary

the development and commercialization of our current product candidates are our initial focus, as part of our long-term growth strategy,

we plan to develop other product candidates.

We may also seek to commercialize treatments that may not be proprietary to us.

to evaluate internal opportunities from our existing product candidates or other potential product candidates.

While our technology platforms

have potential applicability to other uses, we have not conducted any clinical trials on these other uses and we may not be successful

in developing product candidates for other uses.

addition, we intend to devote capital and resources for basic research to discover and identify additional product candidates.

research programs require technical, financial and human resources, whether or not any product candidates are ultimately identified.

Our research programs may initially show promise in identifying potential product candidates, yet fail to yield product candidates for

clinical development for many reasons, including the following:

research methodology used may not be successful in identifying potential product candidates;

may develop alternatives that render our product candidates obsolete;

candidates that we develop may nevertheless be covered by third parties’ patents or other exclusive rights;

product candidate may, on further study, be shown to have harmful side effects or other characteristics that indicate it is unlikely

to be effective or otherwise does not meet applicable regulatory criteria;

product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all;

product candidate may not be accepted as safe and effective by patients, the medical community or third-party payors.

addition, future acquisitions may entail numerous operational and financial risks, including:

to unknown liabilities;

of our business and diversion of our management’s time and attention to develop acquired products or technologies;

of substantial debt, dilutive issuances of securities or depletion of cash to pay for acquisitions;

than expected acquisition and integration costs;

in combining the operations and personnel of any acquired businesses with our operations and personnel;

amortization expenses;

of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership;

to motivate key employees of any acquired businesses.

we are unsuccessful in identifying and developing additional product candidates, either through internal development or acquisition from

third parties, our potential for growth and achieving our strategic objectives may be impaired.

we do not achieve our projected development and commercialization goals within the timeframes we expect, the development and commercialization

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other qualified personnel in the future.

currently only have seven full-time employees and five consultants and we expect to add additional employees.

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.

currently only have seven full-time employees, one part-time employee and one consultant and we expect to add additional employees.

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.

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

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on the study being funded.

Also, the continued spread of COVID-19 could affect governmental priorities in the future or prospective funding

for our product candidates.

Therefore, we cannot provide any assurance that we will receive any future grant funding from any government

agencies, or, that if received, we will receive the full amount of the particular grant award.

agencies, or, if received, we will receive the full amount of the particular grant award.

Any such reductions could delay the development

of our product candidates and the introduction of new products.

on financing, we expect to expand our organization, and as a result, we may encounter difficulties in managing our growth, which could

disrupt our operations.

on financing, we expect to experience growth in the number of our employees and the scope of our operations.

To manage these growth activities,

we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit

and train additional qualified personnel.

Our management may need to devote a significant amount of their attention to managing these

growth activities.

Due to our limited financial resources and the limited experience of our management team in managing a company with

such anticipated growth, we may not be able to effectively manage the expansion of our operations, retain key employees, or identify,

recruit and train additional qualified personnel.

Our inability to manage the expansion of our operations effectively may result in weaknesses

in our infrastructure, give rise to operational mistakes, loss of business opportunities, loss of employees and reduced productivity

among remaining employees.

Our expected growth could also require significant capital expenditures and may divert financial resources

from other projects, such as the development of additional product candidates.

If we are unable to effectively manage our expected growth,

our expenses may increase more than expected, our ability to generate revenues could be reduced and we may not be able to implement our

business strategy, including the successful commercialization of our product candidates.

The failure of financial

institutions or transactional counterparties could adversely affect our current and projected business operations and our financial condition

and results of operations.

8, 2023, Silvergate Bank announced that it would self liquidate.

On March 10, 2023, Silicon Valley Bank was closed by the California

Department of Financial Protection and Innovation, with the Federal Deposit Insurance Corporation (“FDIC”) appointed as receiver.

On March 12, 2023, Signature Bank was closed by the New York State Department of Financial Services, with the FDIC appointed as

The standard deposit insurance amount is up to $250,000 per depositor, per insured bank, for specified account categories.

Although we do not have any funds deposited with the above-named banks, we regularly maintain cash balances with other financial institutions

in excess of the FDIC insurance limit.

A failure of a depository institution to return deposits could impact access to our invested cash

or cash equivalents and could adversely impact our liquidity and financial performance.

Related to Our Dependence on Third-Party Providers

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for use in our clinical trials or for commercial product, if any.

We have entered into a Manufacturing Agreement (the “ Recro

Agreement ”) with Recro Gainesville LLC (“ Recro ”) now known as Societal CDMO, (“ Societal ”)

for the production of PF614 capsules and other materials and services with respect to our clinical studies.

In addition, we do not have

the capability to encapsulate any of our product candidates as a finished product for commercial distribution.

As a result, we expect

to be obligated to rely on contract manufacturers, like Societal , if and when any of our product candidates are approved for commercialization.

In the event that Societal is unable to perform its obligations under the Recro Agreement, we may be unable to replace the Societal

Agreement on terms as favorable to us.

We have not entered into an agreement with any contract manufacturers for commercial supply

and may not be able to engage a contract manufacturer for commercial supply of any of our product candidates on favorable terms to us,

We have entered into an agreement with Purisys LLC (“Purisys”)

for production of PF614 drug substance and a Manufacturing Agreement (the “Recro Agreement”) with Recro Gainesville LLC (“Recro”)

now known as Societal CDMO, (“Societal”) for the production of PF614 capsules and other materials and services with respect

to our clinical studies.

In addition, we do not have the capability to encapsulate any of our product candidates as a finished product

for commercial distribution.

As a result, we expect to be obligated to rely on contract manufacturers, like Societal, if and when any

of our product candidates are approved for commercialization.

In the event that Societal is unable to perform its obligations under the

Recro Agreement, we may be unable to replace the Recro Agreement on terms as favorable to us.

We have not entered into an agreement with

any contract manufacturers for commercial supply and may not be able to engage a contract manufacturer for commercial supply of any of

our product candidates on favorable terms to us, or at all.

processes used by our contract manufacturers to manufacture our product candidates must be approved by the FDA or comparable foreign

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and record keeping relating to our product candidates.

If our contract manufacturers, including Societal , do not successfully

manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others, our product candidates

may not be approved.

If these facilities do not maintain a compliance status acceptable to the FDA, Drug Enforcement Agency, or DEA,

or comparable regulatory authorities, we may need to find alternative manufacturing facilities, which would significantly impact our

ability to develop, obtain regulatory approval for or market our product candidates, if approved.

contract manufacturers, including Societal , will be subject to ongoing periodic unannounced inspections by the FDA, DEA and corresponding

state and foreign agencies for compliance with cGMPs, security, recordkeeping and similar regulatory requirements.

Although we will not

have control over our contract manufacturers’ compliance with these regulations and standards, we are nonetheless responsible for

assuring such compliance.

If our contract manufacturers, including Societal, do not successfully manufacture

material that conforms to our specifications and the strict regulatory requirements of the FDA or others, our product candidates may

not be approved.

If these facilities do not maintain a compliance status acceptable to the FDA, Drug Enforcement Agency, or DEA, or comparable

regulatory authorities, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop,

obtain regulatory approval for or market our product candidates, if approved.

contract manufacturers, including Purisys and Societal, will be subject to ongoing periodic unannounced inspections by the FDA, DEA and

corresponding state and foreign agencies for compliance with cGMPs, security, recordkeeping and similar regulatory requirements.

we will not have control over our contract manufacturers’ compliance with these regulations and standards, we are nonetheless responsible

for assuring such compliance.

Failure by any of our contract manufacturers to comply with applicable regulations could result in sanctions

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standards could adversely affect our ability to develop, obtain regulatory approval for or market any of our product candidates.

for any reason, these third parties, including Societal , are unable or unwilling to perform, we may not be able to terminate our

agreements with them, and we may not be able to locate alternative manufacturers or formulators or enter into favorable agreements with

them and we cannot be certain that any such third parties will have the manufacturing capacity to meet future requirements.

manufacturers or any alternate manufacturer of finished drug product experiences any significant difficulties in its respective manufacturing

processes for our ingredients or finished products or should cease doing business with us, we could experience significant interruptions

in the supply of any of our product candidates or may not be able to create a supply of our product candidates at all.

Our inability

to coordinate the efforts of our third-party manufacturing partners, or the lack of capacity available at our third-party manufacturing

partners, could impair our ability to supply any of our product candidates at required levels.

Because of the significant regulatory

requirements that we would need to satisfy in order to qualify a new bulk or finished product manufacturer, if we face these or other

difficulties with our current manufacturing partners, we could experience significant interruptions in the supply of any of our product

candidates if we decide to transfer the manufacture of any of our product candidates to one or more alternative manufacturers in an effort

to deal with the difficulties.

manufacturing problem or the loss of a contract manufacturer, including Societal , could be disruptive to our operations and delay

development of our investigational products.

Additionally, we rely on third parties to supply the raw materials needed to manufacture

our potential products.

Any reliance on suppliers may involve several risks, including a potential inability to obtain critical materials

and reduced control over production costs, delivery schedules, reliability and quality.

Any unanticipated disruption to a future contract

manufacturer caused by problems at suppliers could delay shipment of any of our investigational products and, if approved, product candidates.

for any reason, these third parties, including Societal, are unable or unwilling to perform, we may not be able to terminate our agreements

with them, and we may not be able to locate alternative manufacturers or formulators or enter into favorable agreements with them and

we cannot be certain that any such third parties will have the manufacturing capacity to meet future requirements.

If these manufacturers

or any alternate manufacturer of finished drug product experiences any significant difficulties in its respective manufacturing processes

for our ingredients or finished products or should cease doing business with us, we could experience significant interruptions in the

supply of any of our product candidates or may not be able to create a supply of our product candidates at all.

Our inability to coordinate

the efforts of our third-party manufacturing partners, or the lack of capacity available at our third-party manufacturing partners, could

impair our ability to supply any of our product candidates at required levels.

Because of the significant regulatory requirements that

we would need to satisfy in order to qualify a new bulk or finished product manufacturer, if we face these or other difficulties with

our current manufacturing partners, we could experience significant interruptions in the supply of any of our product candidates if we

decide to transfer the manufacture of any of our product candidates to one or more alternative manufacturers in an effort to deal with

the difficulties.

manufacturing problem or the loss of a contract manufacturer, including Societal, could be disruptive to our operations and delay development

of our investigational products.

Additionally, we rely on third parties to supply the raw materials needed to manufacture our potential

Any reliance on suppliers may involve several risks, including a potential inability to obtain critical materials and reduced

control over production costs, delivery schedules, reliability and quality.

Any unanticipated disruption to a future contract manufacturer

caused by problems at suppliers could delay shipment of any of our investigational products and, if approved, product candidates.

cannot guarantee that our future manufacturing and supply partners will be able to reduce the costs of commercial scale manufacturing

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in whole or in part upon the efforts of these third parties, which may not be successful and are generally not within our control.

we are not successful in commercializing any approved products, our future product revenue will suffer and we may incur significant additional

we are not successful in commercializing any approved products, our future product revenue will suffer, and we may incur significant

additional losses.

we do not establish sales and marketing capabilities successfully, either on our own or in collaboration with third parties, we will

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In addition, approval policies,

regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s

clinical development and may vary among jurisdictions.

To date, we have not submitted an NDA to the FDA or similar drug approval submissions

to comparable foreign regulatory authorities for our most advanced product candidate, PF614, or any other product candidate.

complete additional preclinical studies and clinical trials to demonstrate the safety and efficacy of our product candidates in humans

before we will be able to obtain these approvals.

regulations, or the type and amount of clinical data necessary to gain approval may change during a product candidate’s clinical

development and may vary among jurisdictions.

To date, we have not submitted an NDA to the FDA or similar drug approval submissions to

comparable foreign regulatory authorities for our most advanced product candidate, PF614, or any other product candidate.

We must complete

additional preclinical studies and clinical trials to demonstrate the safety and efficacy of our product candidates in humans before

we will be able to obtain these approvals.

testing is expensive, difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome.

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It is possible that even if any of our product candidates has a beneficial effect, that effect will not be detected during

clinical evaluation as a result of one or more of a variety of factors, including the size, duration, design, measurements, conduct or

analysis of our clinical trials.

Conversely, as a result of the same factors, our clinical trials may indicate an apparent positive effect

of such product candidate that is greater than the actual positive effect, if any.

Similarly, in our clinical trials, we may fail to

detect toxicity of, or intolerability caused by, such product candidate, or mistakenly believe that our product candidates are toxic

or not well tolerated when that is not in fact the case.

Serious adverse events, or SAEs, or other adverse effects, as well as tolerability

issues, could hinder or prevent market acceptance of the product candidate at issue.

clinical evaluation because of one or more of a variety of factors, including the size, duration, design, measurements, conduct or analysis

of our clinical trials.

Conversely, because of the same factors, our clinical trials may indicate an apparent positive effect of such

product candidate that is greater than the actual positive effect, if any.

Similarly, in our clinical trials, we may fail to detect toxicity

of, or intolerability caused by, such product candidate, or mistakenly believe that our product candidates are toxic or not well tolerated

when that is not in fact the case.

Serious adverse events, or SAEs, or other adverse effects, as well as tolerability issues, could hinder

or prevent market acceptance of the product candidate at issue.

current and future product candidates could fail to receive regulatory approval for many reasons, including the following:

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In such event, prior to a product launch,

the DEA will need to determine the controlled substance schedule of the product, taking into account the recommendation of the FDA.

timing of the scheduling process is uncertain and may delay our ability to market any product candidate that we successfully developed

and approved.

the DEA will need to determine the controlled substance schedule of the product, considering the recommendation of the FDA.

of the scheduling process is uncertain and may delay our ability to market any product candidate that we successfully developed and approved.

our clinical trials fail to replicate positive results from earlier preclinical studies or clinical trials conducted by us or third parties,

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FDA, EMA or comparable foreign regulatory authorities may disagree with our regulatory plan for our product candidates.

have submitted IND applications for PF614 and nafamostat and completed a Phase 1 trial for each product candidate.

We have applied for

and received fast track designation for PF614.

However, fast track designation does not guaranty a faster development or regulatory review

or approval process and does not assure FDA approval.

We have received feedback from the FDA on requirements to achieve abuse deterrent

labeling claims for PF614.

We have submitted an IND for PF614-MPAR™ and have received feedback on required pre-clinical, manufacturing

and clinical studies that will be required for an NDA.

hold INDs for PF614 and nafamostat and completed a Phase 1 trial for each product candidate.

We have completed multiple human abuse potential

and efficacy studies for PF614.

We have applied for and received fast track designation for PF614.

However, fast track designation does

not guarantee a faster development or regulatory review or approval process and does not assure FDA approval.

We have received feedback

from the FDA on requirements to achieve abuse deterrent labeling claims for PF614.

We have also received an IND for PF614-MPAR and have

completed an initial Phase 1 study.

We have been granted Breakthrough Therapy designation by the FDA for PF614-MPAR.

For all INDs that

we hold we have received feedback on required pre-clinical, manufacturing and clinical studies that will be required for an NDA.

clinical trial results may not support approval of our product candidates.

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on feedback from regulatory agencies or those that have been used for the approval of similar drugs, will be acceptable for future approvals.

For example, while we have designed our Phase 2 clinical trials of nafamostat for coronaviral infections after receiving input and feedback

from the FDA, there can be no assurance that the design of our planned clinical trials will be satisfactory to the FDA, the FDA will

not require us to modify our trials, these trials will enable us to conduct the required Phase 3 studies or other testing or that completing

these trials will result in regulatory approval.

topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become

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candidates we develop, including:

or institutional review boards, or IRBs, or other reviewing bodies may not authorize us or our investigators to commence a clinical

trial, or to conduct or continue a clinical trial at a prospective or specific trial site;

may not reach agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to

extensive negotiation and may vary significantly among different CROs and trial sites;

may experience challenges or delays in recruiting principal investigators or study sites to lead our clinical trials;

number of subjects or patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment

in these clinical trials may be insufficient or slower than we anticipate, and the number of clinical trials being conducted at any

given time may be high and result in fewer available patients for any given clinical trial, or patients may drop out of these clinical

trials at a higher rate than we anticipate;

third-party contractors, including those manufacturing our product candidates or conducting clinical trials on our behalf, may fail

to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

may have to amend clinical trial protocols submitted to regulatory authorities or conduct additional studies to reflect changes in

regulatory requirements or guidance, which we may be required to resubmit to an IRB and regulatory authorities for re-examination;

or other reviewing bodies may find deficiencies with or subsequently find fault with the manufacturing processes or facilities of

third-party manufacturers with which we enter into agreement for clinical and commercial supplies, or the supply or quality of any

product candidate or other materials necessary to conduct clinical trials of our product candidates may be insufficient, inadequate

or not available at an acceptable cost, or we may experience interruptions in supply;

potential for approval policies or regulations of the FDA or the applicable foreign regulatory agencies to significantly change in

a manner rendering our clinical data insufficient for approval.

regulators, or institutional

review boards, or IRBs, or other reviewing bodies may not authorize us or our investigators to commence a clinical trial, or to conduct

or continue a clinical trial at a prospective or specific trial site;

we may not reach agreement

on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and

may vary significantly among different CROs and trial sites;

we may experience challenges

or delays in recruiting principal investigators or study sites to lead our clinical trials;

the number of subjects

or patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical

trials may be insufficient or slower than we anticipate, and the number of clinical trials being conducted at any given time may

be high and result in fewer available patients for any given clinical trial, or patients may drop out of these clinical trials at

a higher rate than we anticipate;

our third-party contractors,

including those manufacturing our product candidates or conducting clinical trials on our behalf, may fail to comply with regulatory

requirements or meet their contractual obligations to us in a timely manner, or at all;

we may have to amend clinical

trial protocols submitted to regulatory authorities or conduct additional studies to reflect changes in regulatory requirements or

guidance, which we may be required to resubmit to an IRB and regulatory authorities for re-examination;

regulators or other reviewing

bodies may find deficiencies with or subsequently find fault with the manufacturing processes or facilities of third-party manufacturers

with which we enter into agreement for clinical and commercial supplies, or the supply or quality of any product candidate or other

materials necessary to conduct clinical trials of our product candidates may be insufficient, inadequate or not available at an acceptable

cost, or we may experience interruptions in supply;

the potential for approval

policies or regulations of the FDA or the applicable foreign regulatory agencies to significantly change in a manner rendering our

clinical data insufficient for approval.

or IRBs of the institutions in which clinical trials are being conducted may suspend, limit or terminate a clinical trial, or data monitoring

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may experience difficulties in patient enrollment in our clinical trials for a variety of factors, including:

patient eligibility criteria defined in the protocol;

size of the patient population required for analysis of the trial’s primary endpoints;

proximity of patients to study sites;

design of the trial;

ability to recruit clinical trial investigators with the appropriate competencies and experience;

clinical trials and clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate

being studied in relation to other available therapies, including any new drugs that may be approved for the indications that we

are investigating;

ability to obtain and maintain patient consents;

risk that patients enrolled in clinical trials will drop out of the trials before completion.

the patient eligibility

criteria defined in the protocol;

the size of the patient

population required for analysis of the trial’s primary endpoints;

the proximity of patients

to study sites;

the design of the trial;

our ability to recruit

clinical trial investigators with the appropriate competencies and experience;

competing clinical trials

and clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate being studied

in relation to other available therapies, including any new drugs that may be approved for the indications that we are investigating;

our ability to obtain and

maintain patient consents;

the risk that patients

enrolled in clinical trials will drop out of the trials before completion.

addition, our clinical trials may compete with other clinical trials for product candidates that are in the same therapeutic areas as

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have obtained Fast Track designation for PF614 for management of moderate to severe chronic pain when a continuous, around-the-clock

analgesic is needed for an extended period of time.

We believe that fast track designation will enable us to facilitate the development

and expedite the review of PF614.

Fast track designation does not ensure that PF614 will receive marketing approval or that approval

will be granted within any particular timeframe.

As a result, we may not experience a faster development process, review or approval

compared to conventional FDA procedures.

In addition, the FDA may withdraw fast track designation if it believes that the designation

is no longer supported by data from our clinical development program.

Fast track designation does not guarantee that an NDA will obtain

priority review designation.

If any of these events occur, it could require us to conduct more extensive clinical trials and go through

more extensive FDA review, which could substantially increase expenses and delay the time for commercializing our products.

analgesic is needed for an extended period.

We believe that Fast Track designation will enable us to facilitate the development and expedite

the review of PF614.

Fast Track designation does not ensure that PF614 will receive marketing approval or that approval will be granted

within any timeframe.

As a result, we may not experience a faster development process, review or approval compared to conventional FDA

In addition, the FDA may withdraw Fast Track designation if it believes that the designation is no longer supported by data

from our clinical development program.

Fast Track designation does not guarantee that an NDA will obtain priority review designation.

If any of these events occur, it could require us to conduct more extensive clinical trials and go through more extensive FDA reviews,

which could substantially increase expenses and delay the time for commercializing our products.

the FDA does not conclude that certain of our product candidates satisfy the requirements for the Section 505(b)(2) regulatory approval

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Regardless of the merits or eventual outcome, liability claims may result in:

demand for any of our future approved products;

to our reputation;

of clinical trial participants;

of clinical trial sites or entire trial programs;

litigation costs;

monetary awards to, or costly settlements with, patients or other claimants;

recalls or a change in the indications for which they may be used;

of management and scientific resources from our business operations;

inability to commercialize our product candidates.

decreased demand for any

of our future approved products;

injury to our reputation;

withdrawal of clinical

trial participants;

termination of clinical

trial sites or entire trial programs;

significant litigation

substantial monetary awards

to, or costly settlements with, patients or other claimants;

product recalls or a change

in the indications for which they may be used;

loss of revenue;

diversion of management

and scientific resources from our business operations;

the inability to commercialize

our product candidates.

the clinical trial process is designed to identify and assess potential side effects, clinical development does not always fully characterize

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claims against third parties, or defend claims they may bring against us, to determine the ownership of what we regard as our intellectual

If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual

property rights or personnel.

Such intellectual property rights could be awarded to a third party, and we could be required to obtain

a license from such third party to commercialize our technology or products.

Such a license may not be available on commercially reasonable

terms or at all.

Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs

and be a distraction to our management and scientific personnel.

reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them

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could be compromised by disclosure during this type of litigation.

may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.

may be subject to claims that former employees, collaborators or other third parties have an ownership interest in the patents and intellectual

property that we own or that we may own or license in the future.

While it is our policy to require our employees and contractors who

may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, we may

be unsuccessful in executing such an agreement with each party who in fact develops intellectual property that we regard as our own;

our licensors may face similar obstacles.

In addition, we have not updated the records in the patent offices to reflect our ownership

of our patent filings relating to PF614 and other technologies.

Failure to update such ownership may result in an innocent purchaser

potentially acquiring rights in such patents that are adverse to our interests.

Furthermore, as noted above, we have not obtained assignments

for certain patent applications relating to abuse-resistant amphetamines.

We could be subject to ownership disputes arising, for example,

from conflicting obligations of consultants or others who are involved in developing our product candidates.

Litigation may be necessary

to defend against any claims challenging inventorship or ownership.

If we fail in defending any such claims, we may have to pay monetary

damages and may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, intellectual property, which

could adversely impact our business, results of operations and financial condition.

may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent,

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and management resources that we would otherwise be able to devote to our business.

intellectual property agreements with third parties may be subject to disagreements over contract interpretation, which could narrow

the scope of our rights to the relevant intellectual property or technology or increase our financial or other obligations to our licensors.

provisions in our intellectual property agreements may be susceptible to multiple interpretations.

Disputes may arise between us and

any of these counterparties regarding intellectual property rights that are subject to such agreements, including, but not limited to:

scope of rights granted under the agreement and other interpretation-related issues;

and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the

right to sublicense patent and other rights to third parties;

diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of

our product candidates, and what activities satisfy those diligence obligations;

ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and

our partners;

right to transfer or assign our license;

effects of termination.

resolution of any contract interpretation disagreement that may arise could affect the scope of our rights to the relevant intellectual

property or technology, or affect financial or other obligations under the relevant agreement, either of which could have a material

adverse effect on our business, financial condition, results of operations and prospects.

we fail to comply with our obligations under any agreements, we may be required to pay damages and could lose intellectual property rights

that are necessary or useful for developing and protecting our product candidates.

have acquired all intellectual property rights from Signature and Mucokinetica, Ltd.

(“ Mucokinetica ”), with the exception

of our pending application directed to the use of orally administered nafamostat to treat coronaviruses.

Any future collaboration agreements

or license agreements we enter into are likely to impose various development, commercialization, funding, milestone, royalty, diligence,

sublicensing, insurance, patent prosecution and enforcement or other obligations on us.

If we breach any such material obligations, or

use the intellectual property licensed to us in an unauthorized manner, we may be required to pay damages and the licensor may have the

right to terminate the license, which could result in us being unable to develop, manufacture and sell products that are covered by the

licensed technology, or having to negotiate new or reinstated licenses on less favorable terms, or enable a competitor to gain access

to the licensed technology.

property rights do not necessarily address all potential threats to our business.

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are illustrative:

may be able to make formulations that are similar to our product candidates or other formulations but that are not covered by the

claims of our patent rights;

patents of third parties may have an adverse effect on our business;

or any future strategic partners might not have been the first to conceive or reduce to practice the inventions covered by the issued

patent or pending patent application that we own;

or any future strategic partners might not have been the first to file patent applications covering certain of our inventions;

may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual

property rights;

is possible that our pending patent applications will not lead to issued patents;

patents that we may own or that we exclusively license in the future may not provide us with any competitive advantage, or may be

held invalid or unenforceable, as a result of legal challenges by our competitors;

competitors might conduct research and development activities in countries where we do not have patent rights and then use the information

learned from such activities to develop competitive products for sale in our major commercial markets;

parties performing manufacturing or testing for us using our product candidates or technologies could use the intellectual property

of others without obtaining a proper license;

may not develop additional proprietary technologies that are patentable;

patents of others may have an adverse effect on our business.

others may be able to make

formulations that are similar to our product candidates or other formulations but that are not covered by the claims of our patent

the patents of third parties

may have an adverse effect on our business;

we or any future strategic

partners might not have been the first to conceive or reduce to practice the inventions covered by the issued patent or pending patent

application that we own;

we or any future strategic

partners might not have been the first to file patent applications covering certain of our inventions;

others may independently

develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;

it is possible that our

pending patent applications will not lead to issued patents;

issued patents that we

may own or that we exclusively license in the future may not provide us with any competitive advantage, or may be held invalid or

unenforceable, as a result of legal challenges by our competitors;

our competitors might conduct

research and development activities in countries where we do not have patent rights and then use the information learned from such

activities to develop competitive products for sale in our major commercial markets;

third parties performing

manufacturing or testing for us using our product candidates or technologies could use the intellectual property of others without

obtaining a proper license;

we may not develop additional

proprietary technologies that are patentable;

the patents of others may

have an adverse effect on our business.

any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations and

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which may adversely affect our management’s ability to oversee the development of our product candidates.

The possible issuance

of additional shares of common stock at lower conversion prices in repayment of the 2022 Notes or obligations arising under the 2022

Notes could have a negative impact on the price of our common stock.

Also, we will receive reduced proceeds if the exercise price of

the Prior Warrants is reduced.

The conversion price of the 2022 Notes and exercise price of the Prior Warrants issued in 2022 were reset

to a price of $2.006 and we have, from time to time, temporarily lowered the conversion price such that a greater amount of principal

on the 2022 Notes could be extinguished for shares.

The conversion price of the 2022 Notes is $0.7512 for the period from January 12,

2023 until May 12, 2023.

In the future, to conserve cash necessary for us to conduct operations, we may do similarly for amounts owed

in connection with the 2022 Notes or other notes.

The exercise price of the Prior Warrants issued in 2021 were reset to a price of $15.60.

Because of a decline in the price of our common stock since issuance of the 2022 Notes and the ability of holders of the 2022 Notes to

convert amounts payable under the 2022 Notes into additional shares of our common stock, we are required to register for resale with

the SEC additional shares of common stock.

We are obligated to register a sufficient number of shares of common stock for resale and

our failure to timely register sufficient additional shares of common stock could cause us to default in our payments and result in our

payment of additional shares and/or cash to the holders of the 2022 Notes.

addition, we may sell securities in the public or private equity markets if and when conditions are favorable, or at prices per share

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and execute our business plan.

The Investor Notes contain such restrictions.

The Investor Notes contain such restrictions including a pledge of substantially all of our tangible and

intangible assets, including our intellectual property.

we raise additional funds through upfront payments or milestone payments pursuant to strategic collaborations, strategic alliances or

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that we would otherwise prefer to develop and market ourselves.

addition, any issuances of common stock pursuant to the GEM Agreement would result in dilution of the ownership interest of our shareholders.

Any such issuances may also have a negative impact on the market price of our common stock because of the discount at issuance.

price resets of the GEM Warrants would also dilute our shareholders.

See “— We require substantial additional funding.

If we are unable raise capital when needed, we could be forced to delay, reduce or terminate our product discovery and development programs

or commercialization efforts ” for description of risks related to additional funding.

internal controls over financial reporting currently do not meet all of the standards contemplated by Section 404 of Sarbanes-Oxley Act,

and failure to achieve and maintain effective internal controls over financial reporting in accordance with Section 404 of the Sarbanes-Oxley

are a smaller reporting company within the meaning of the Securities Act, and if we take advantage of certain exemptions from disclosure

requirements available to “smaller reporting companies,” this could make our securities less attractive to investors and

may make it more difficult to compare our performance with other public companies.

are a “ smaller reporting company ” as defined in Item 10(f)(1) of Regulation S-K.

Smaller reporting companies may take

advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements.

We will remain a smaller reporting company until the last day of the fiscal year in which (i) the market value of our common stock held

by non-affiliates is greater than or equal to $250 million as of the end of that fiscal year’s second fiscal quarter, and (ii)

our annual revenues are greater than or equal to $100 million during the last completed fiscal year and the market value of our common

stock held by non-affiliates exceeds $700 million as of the end of that fiscal year’s second fiscal quarter.

To the extent we take

advantage of such reduced disclosure obligations, it may also make comparison of our financial statements with other public companies

difficult or impossible.

internal controls over financial reporting currently may not meet all of the standards contemplated by Section 404 of Sarbanes-Oxley

Act, and failure to achieve and maintain effective internal controls over financial reporting in accordance with Section 404 of the Sarbanes-Oxley

Act could impair our ability to produce timely and accurate financial statements or comply with applicable regulations and have a material

adverse effect on our business.

previously operated as a private company.

In connection with the preparation of our consolidated financial statements for the years ended

December 31, 2020 and 2019, we concluded that there were material weaknesses in our internal controls over financial reporting.

weakness is a significant deficiency, or a combination of significant deficiencies, in internal controls over financial reporting such

that it is reasonably possible that a material misstatement of the annual or interim financial statements will not be prevented or detected

on a timely basis.

The material weaknesses identified are insufficient internal controls because of inadequate technical accounting expertise

and inappropriate level of supervision and review due to the limited number of accounting personnel.

While we are taking steps to remediate

the material weaknesses in our internal controls over financial reporting, including hiring a Chief Financial Officer in February 2021,

we may not be successful in remediating such weaknesses.

the Business Combination, our management has significant requirements for enhanced financial reporting and internal controls as a public

The process of designing and implementing effective internal controls is a continuous effort that will require us to anticipate

and react to changes in our business and the economic and regulatory environments and to expend significant resources to maintain a system

of internal controls that is adequate to satisfy our reporting obligations as a public company.

If we are unable to establish or maintain

appropriate internal financial reporting controls and procedures, it could cause us to fail to meet our reporting obligations on a timely

basis or result in material misstatements in our consolidated financial statements, which could harm our operating results.

we are required, pursuant to Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness

of our internal controls over financial reporting.

This assessment needs to include disclosure of any material weaknesses identified

by our management in our internal control over financial reporting.

The rules governing the standards that must be met for our management

to assess our internal control over financial reporting are complex and require significant documentation, testing, and possible remediation.

Testing and maintaining internal controls may divert management’s attention from other matters that are important to our business.

Our independent registered public accounting firm is required to attest to the effectiveness of our internal control over financial reporting

on an annual basis.

However, while we remain an emerging growth company, we are not required to include an attestation report on internal

control over financial reporting issued by our independent registered public accounting firm.

If we are not able to complete an initial

assessment of our internal controls and otherwise implement the requirements of Section 404 of the Sarbanes-Oxley Act in a timely manner

or with adequate compliance, our independent registered public accounting firm may not be able to certify as to the adequacy of our internal

controls over financial reporting.

management has significant requirements for enhanced financial reporting and internal controls as a public company.

The process of designing

and implementing effective internal controls is a continuous effort that will require us to anticipate and react to changes in our business

and the economic and regulatory environments and to expend significant resources to maintain a system of internal controls that is adequate

to satisfy our reporting obligations as a public company.

If we are unable to maintain appropriate internal financial reporting controls

and procedures, it could cause us to fail to meet our reporting obligations on a timely basis or result in material misstatements in

our consolidated financial statements, which could harm our operating results.

In addition, we are required, pursuant to Section 404

of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of our internal controls over

financial reporting.

This assessment needs to include disclosure of any material weaknesses identified by our management in our internal

control over financial reporting.

The rules governing the standards that must be met for our management to assess our internal control

over financial reporting are complex and require significant documentation, testing, and possible remediation.

impacting our internal controls may cause us to be unable to report our financial information on a timely basis and thereby subject us

to adverse regulatory consequences, including sanctions by the Securities and Exchange Commission, or SEC, or violations of applicable

stock exchange listing rules, which may result in a breach of the covenants under existing or future financing arrangements.

could be a negative reaction in the financial markets due to a loss of investor confidence in us and the reliability of our financial

Confidence in the reliability of our financial statements also could suffer if we or our independent registered public accounting

firm continue to report a material weakness in our internal controls over financial reporting.

to adverse regulatory consequences, including sanctions by the SEC, or violations of applicable stock exchange listing rules, which may

result in a breach of the covenants under existing or future financing arrangements.

There also could be a negative reaction in the financial

markets due to a loss of investor confidence in us and the reliability of our financial statements.

This could materially adversely affect

us and lead to a decline in the market price of our common stock.

are an emerging growth company and a smaller reporting company within the meaning of the Securities Act, and if we take advantage of

certain exemptions from disclosure requirements available to “emerging growth companies” or “smaller reporting companies,”

this could make our securities less attractive to investors and may make it more difficult to compare our performance with other public

are an “ emerging growth company ” within the meaning of the Securities Act, as modified by the JOBS Act, and we may

take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging

growth companies including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404

of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements,

and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any

golden parachute payments not previously approved.

As a result, our stockholders may not have access to certain information they may

deem important.

We could be an emerging growth company for up to five years, although circumstances could cause us to lose that status

earlier, including if the market value of our common stock held by non-affiliates exceeds $700 million as of the end of any second quarter

of a fiscal year, in which case we would no longer be an emerging growth company as of the last day of such fiscal year.

We cannot predict

whether investors will find our securities less attractive because we will rely on these exemptions.

If some investors find our securities

less attractive as a result of our reliance on these exemptions, the trading prices of our securities may be lower than they otherwise

would be, there may be a less active trading market for our securities and the trading prices of our securities may be more volatile.

Section 102(b)(1) of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting

standards until private companies (that is, those that have not had a registration statement under the Securities Act declared effective

or do not have a class of securities registered under the Exchange Act) are required to comply with the new or revised financial accounting

The JOBS Act provides that a company can elect to opt out of the extended transition period and comply with the requirements

that apply to non-emerging growth companies but any such election to opt out is irrevocable.

We have elected not to opt out of such extended

transition period, which means that when a standard is issued or revised and it has different application dates for public or private

companies, we, as an emerging growth company, can adopt the new or revised standard at the time private companies adopt the new or revised

This may make comparison of our financial statements with another public company that is not an emerging growth company or

is an emerging growth company which has opted out of using the extended transition period difficult or impossible because of the potential

differences in accounting standards used.

Additionally,

we are a “ smaller reporting company ” as defined in Item 10(f)(1) of Regulation S-K.

Smaller reporting companies may

take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial

We will remain a smaller reporting company until the last day of the fiscal year in which (i) the market value of our common

stock held by non-affiliates is greater than or equal to $250 million as of the end of that fiscal year’s second fiscal quarter,

and (ii) our annual revenues are greater than or equal to $100 million during the last completed fiscal year and the market value of

our common stock held by non-affiliates exceeds $700 million as of the end of that fiscal year’s second fiscal quarter.

extent we take advantage of such reduced disclosure obligations, it may also make comparison of our financial statements with other public

companies difficult or impossible.

amount of our future losses is uncertain and our quarterly and annual operating results may fluctuate significantly or fall below the

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of our control and may be difficult to predict, including the following:

timing and success or failure of clinical trials for our product candidates or competing product candidates, or any other change

in the competitive landscape of our industry,

ability to successfully recruit and retain subjects for clinical trials, and any delays caused by difficulties in such efforts, including

as a result of COVID-19;

risk/benefit profile, cost and reimbursement policies with respect to our product candidates, if approved, and existing and potential

future therapeutics that compete with our product candidates;

ability to obtain marketing approval for our product candidates and the timing and scope of any such approvals we may receive;

timing and cost of, and level of investment in, research and development activities relating to our product candidates, which may

change from time to time;

cost of manufacturing our product candidates, which may vary depending on the quantity of production and the terms of our agreements

with manufacturers;

ability to attract, hire and retain qualified personnel;

that we will or may incur to develop additional product candidates;

level of demand for our product candidates should they receive approval, which may vary significantly;

changing and volatile U.S.

the timing and success

or failure of clinical trials for our product candidates or competing product candidates, or any other change in the competitive

landscape of our industry,

our ability to successfully

recruit and retain subjects for clinical trials, and any delays caused by difficulties in such efforts;

the risk/benefit profile,

cost and reimbursement policies with respect to our product candidates, if approved, and existing and potential future therapeutics

that compete with our product candidates;

our ability to obtain marketing

approval for our product candidates and the timing and scope of any such approvals we may receive;

the timing and cost of,

and level of investment in, research and development activities relating to our product candidates, which may change from time to

the cost of manufacturing

our product candidates, which may vary depending on the quantity of production and the terms of our agreements with manufacturers;

our ability to attract,

hire and retain qualified personnel;

expenditures that we will

or may incur to develop additional product candidates;

the level of demand for

our product candidates should they receive approval, which may vary significantly;

the changing and volatile

and global economic environments;

accounting pronouncements or changes in our accounting policies.

future accounting pronouncements

or changes in our accounting policies.

cumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results.

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result in dilution to our stockholders.

are Public Warrants exercisable for an aggregate of approximately 500,000 shares of our common stock with an exercise price of $230.00

There are LACQ Warrants exercisable for an aggregate of approximately 351,663 shares of our common stock with a weighted average

exercise price of $227.87 per share.

In addition, there are GEM Warrants exercisable for 55,306 shares of our common stock (subject to

possible adjustment for anti-dilution events) with an exercise price of $0.7512 per share as of January 12, 2023.

There are also Prior

Warrants from 2021 exercisable for an aggregate of 54,174 shares of our common stock (subject to possible adjustment for anti-dilution

events) with an exercise price of $15.60 per share.

In addition, Prior Warrants from 2022 are exercisable for an aggregate of 466,788

shares of our common stock (subject to possible adjustment for anti-dilution events) with an exercise price of $14.17 per share.

exercise price of the Prior Warrants issued in 2022 were reset to a price of $2.006.

To the extent such warrants are exercised, additional

shares of our common stock will be issued, which will result in dilution to the holders of shares of our common stock and increase the

number of shares of common stock eligible for resale in the public market.

Sales of substantial numbers of such shares of common stock

in the public market or the fact that such Warrants may be exercised could adversely affect the market price of our common stock.

blocks of our total outstanding shares may be sold into the market.

If there are substantial sales of shares of our common stock, the

price of our common stock could decline.

price of our common stock could decline if there are substantial sales of shares of our common stock by our directors, executive officers,

or significant stockholders, if there is a large number of shares of our common stock available for sale, or if there is the perception

that these sales could occur.

Immediately after the Merger, a significant portion of our shares of common stock or Warrants exercisable

for our shares of common stock were held by persons who had been affiliated with LACQ prior to the Merger but did not remain so with

respect to us after the Merger.

In addition, we have registered shares of common stock that we may issue under our 2021 Omnibus Incentive

Shares held by our directors, executive officers and other affiliates are subject to restrictions on resale under the Securities

Act, lock up agreements and may be subject to various vesting agreements.

In addition, the rights of holders of the 2022 Notes to convert

amounts payable under the 2022 Notes into shares of our common stock has required us to register a substantial number of shares of common

stock and we are required to register an additional substantial amount of shares of common stock for possible resale by holders of those

market price of the shares of our common stock could decline as a result of the sale of a substantial number of our shares of common

stock in the public market or the perception in the market that the holders of a large number of such shares intend to sell their shares.

issuance of additional capital stock in connection with financings, acquisitions, investments, our 2021 Omnibus Incentive Plan and to

repay interest or principal on the Investor Notes or otherwise will dilute all other stockholders.

have issued warrants to purchase shares of our common stock in connection with various financing transactions.

To the extent these warrants

are exercised, additional shares of our common stock will be issued, which will result in dilution to the holders of shares of our common

stock and increase the number of shares of common stock eligible for resale in the public market.

Sales of substantial numbers of such

shares of common stock in the public market or the fact that such warrants may be exercised could adversely affect the market price of

our common stock.

issuance of additional capital stock in connection with financings, acquisitions, investments and our 2021 Omnibus Incentive Plan will

dilute all other stockholders.

expect to issue additional capital stock in the future that will result in dilution to all other stockholders.

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awards to employees, directors, and consultants under our 2021 Omnibus Incentive Plan and plan to do so in the future.

We have used,

and may in the future use, our common stock to make repayment of some or all of the principal and interest on the Investor Notes.

may also raise capital through equity financings in the future.

As part of our business strategy, we may acquire or make investments

in complementary companies, products, or technologies and issue equity securities to pay for any such acquisition or investment.

such issuances of additional capital stock may cause stockholders to experience significant dilution of their ownership interests and

the per share value of our common stock to decline.

on the OTC Pink Open Market is volatile and sporadic, which could depress the market price of the Public Warrants and make it difficult

for the Public Warrant holders to resell their Public Warrants.

Public Warrants are quoted on the OTC Pink Open Market.

Trading in securities quoted on the OTC Pink Open Market is often thin and characterized

by wide fluctuations in trading prices, due to many factors, some of which may have little to do with our operations or business prospects.

This volatility could depress the market price of the Public Warrants for reasons unrelated to operating performance.

Moreover, the OTC

Pink Open Market is not a stock exchange, and trading of securities on the OTC Pink Open Market is often more sporadic than the trading

of securities listed on Nasdaq.

These factors may result in investors having difficulty reselling any Public Warrants.

We may also raise

capital through equity financings in the future.

As part of our business strategy, we may acquire or make investments in complementary

companies, products, or technologies and issue equity securities to pay for any such acquisition or investment.

Any such issuances of

additional capital stock may cause stockholders to experience significant dilution of their ownership interests and the per share value

of our common stock to decline.

we are unable to regain compliance with the listing standards of Nasdaq, our common stock could be delisted and may become subject to

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to sell their shares and our ability to raise funding.

January 27, 2023, we received a notice in the form of a letter (the “Deficiency Letter”) from the listing qualifications

department staff of The Nasdaq Stock Market (“Nasdaq”) stating that the Company was not in compliance with Nasdaq Listing

Rule 5550(a)(2) because the bid price for the Company’s common stock had closed below $1.00 per share (the Minimum Bid Price”)

for the previous 30 consecutive business days.

Company’s Minimum Value of Listed Securities (“MVLS”) is below the minimum of $35 million required for continued listing

Because we did not regain compliance by the deadline set forth in a June 16, 2022 Notice we received from Nasdaq we requested

a hearing before a Nasdaq Hearings Panel (the “Panel”).

That hearing was held on January 26, 2023 and on February 14, 2023,

our request for continued listing by means of exception was granted through June 12, 2023, subject to, at various dates in the interim,

obtaining shareholder approval for a reverse split, eliminating outstanding convertible notes, meeting the Minimum Bid Price requirement

for at least 10 consecutive trading days, filing a registration statement with the SEC for a public offering to raise additional capital

and regaining compliance with the MVLS.

There can be no assurance that the Company will be able to meet these requirements or be able

to maintain compliance thereafter with Nasdaq listing standards.

November 13, 2023, we received notice from the Listing Qualifications department of Nasdaq stating that, due to our non-compliance with

the $2.5 million stockholders’ equity requirement set forth in Nasdaq Listing Rule 5550(b)(1) as of September 30, 2023, we were

subject to delisting unless we timely request a hearing before the Nasdaq Hearings Panel (the “Panel”), which we did, resulting

in a hearing before the Panel in early February 2024.

The Panel granted our request for continued listing until May 13, 2024.

to actively explore options to regain compliance with Nasdaq listing requirements;

however, there can be no assurance that we will be

able to evidence compliance prior to the expiration of the extension granted to us by the Panel.

de-listing of our common stock on Nasdaq could have a material adverse effect on us, including on our ability to raise capital through

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common stock in the secondary market.

Unresolved Staff Comments

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