What changed in this filing

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Item 1A. Risk Factors

2025-03-10 compared with 2024-03-15 · 140 added, 297 removed, 1399 unchanged (24% of the section changed)

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

into the second quarter of 2025, while advancing our main product candidates such as, PF614 and PF614-MPAR and nafamostat through their

respective next phases of clinical development.

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

The issuances of common stock pursuant to the GEM

Agreement would result in dilution of existing stockholders and could have a negative impact on the market price of our common stock.

Additionally, the negative covenants under the GEM Agreement are onerous and any breach by us thereunder may entitle GEM Global and GYBL

to indemnification payments, reimbursements of legal and other expenses and other compensation thereby diverting our time and resources.

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 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

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

of additional shares of our common stock, would result in dilution of existing stockholders and have a negative impact on the market

price of our common stock and our ability to obtain equity financing.

addition, the negative covenants under the GEM Agreement are onerous and any breach thereof may trigger indemnification, reimbursement

of losses and other liability for us thereby diverting our time and resources.

To date, we have not used the GEM facility to raise capital.

business is highly dependent on the success of our product candidates.

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years, is dependent on our ability to successfully develop, obtain regulatory approval for and commercialize one or more of our product

A Phase 1b study of PF614 was initiated in 2021.

Part A of the study completed enrollment in December 2021 and Part B was

completed mid-year 2022.

A Phase 1b study of PF614 was completed mid-year 2022.

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.

An efficacy Phase 2 study of PF614 was completed in December 2023.

A Phase 1 trial for PF614-MPAR was completed in May 2023 and a Phase

1b trial for PF614-MPAR was initiated in December 2024.

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.

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

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

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we are pursuing.

These companies include, but are not limited to, Purdue Pharma, LP, and Collegium Pharmaceutical, Inc.

Potential competitors

include companies developing novel non-opioid pain drug candidates such as pharmaceutical companies and academic institutions, government

agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative

arrangements for research, development, manufacturing and commercialization.

These companies include, but are not limited to, Purdue Pharma, LP, Collegium Pharmaceutical, Inc.

and Vertex Pharmaceuticals

Incorporated.

Potential competitors include companies developing novel non-opioid pain drug candidates such as pharmaceutical companies

and academic institutions, government agencies and other public and private research organizations that conduct research, seek patent

protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

believe that a significant number of product candidates are currently under development for the same indications that we are currently

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have an adverse effect on our results of operations.

are exposed to the risk that we and our contract research organizations’ (“ CROs ”) employees and contractors,

including principal investigators, consultants, commercial collaborators, service providers and other vendors may engage in fraudulent

or other illegal activity.

Misconduct by these parties could include intentional, reckless and/or negligent conduct or other unauthorized

activities that violate the laws and regulations of the FDA and other similar regulatory bodies, including those laws that require the

reporting of true, complete and accurate information to such regulatory bodies;

are exposed to the risk that we and our CROs’ employees and contractors, including principal investigators, consultants, commercial

collaborators, service providers and other vendors may engage in fraudulent or other illegal activity.

Misconduct by these parties could

include intentional, reckless and/or negligent conduct or other unauthorized activities that violate the laws and regulations of the

FDA and other similar regulatory bodies, including those laws that require the reporting of true, complete and accurate information to

such regulatory bodies;

manufacturing standards;

federal and state healthcare

fraud and abuse and health regulatory laws and other similar foreign fraudulent misconduct laws;

or laws that require the true, complete

and accurate reporting of financial information or data.

Activities subject to these laws also involve the improper use or misrepresentation

of information obtained during clinical trials, which could result in regulatory sanctions and serious harm to our reputation.

not always possible to identify and deter third-party misconduct, and the precautions we take to detect and prevent this activity may

not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions

or lawsuits stemming from a failure to be in compliance with such laws or regulations.

If any such actions are instituted against us,

and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business

and financial results, including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines,

possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, reputational harm, diminished profits

and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business and our

results of operations

federal and state healthcare fraud and abuse and health regulatory laws and other similar

foreign fraudulent misconduct laws;

or laws that require the true, complete and accurate reporting of financial information or data.

Activities subject to these laws also involve the improper use or misrepresentation of information obtained during clinical trials, which

could result in regulatory sanctions and serious harm to our reputation.

It is not always possible to identify and deter third-party

misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged

risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance

with such laws or regulations.

If any such actions are instituted against us, and we are not successful in defending ourselves or asserting

our rights, those actions could have a significant impact on our business and financial results, including the imposition of significant

civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and

other federal healthcare programs, reputational harm, diminished profits and future earnings, and curtailment of our operations, any

of which could adversely affect our ability to operate our business and our results of operations

of our programs are partially supported by government grant awards, which may not be available to us in the future.

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output, we may not be able to reduce our costs over time.

we are unable to develop our sales, marketing and distribution capability on our own or through collaborations with marketing partners,

we will not be successful in commercializing our product candidates.

currently have no marketing, sales or distribution capabilities.

We intend to establish a sales and marketing organization, either on

our own or in collaboration with third parties, with technical expertise and supporting distribution capabilities to commercialize PF614

or one or more of our other product candidates that may receive regulatory approval in key territories.

These efforts will require substantial

additional resources, some or all of which may be incurred in advance of any approval of the product candidate.

Any failure or delay

in the development of our or third parties’ internal sales, marketing and distribution capabilities would adversely impact the

commercialization of PF614, our other product candidates and other future product candidates.

that may inhibit our efforts to commercialize our product candidates on our own include:

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candidates we develop, including:

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 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.

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:

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.

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.

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

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.

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.

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

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control of inventory through measures such as vaults and inventory reconciliations.

contract manufacturing organizations, or CMOs, who manufacture and distribute PF614 are required to be registered with DEA and relevant

state authorities and comply with all security, recordkeeping and reporting requirements.

Manufacturers and distributors are subject

to routine inspections and audits by the DEA related to compliance with security, recordkeeping and reporting requirements.

maintain the required registrations or to comply and follow these requirements can lead to significant civil and/or criminal penalties

and possibly even lead to a revocation of a DEA registration to manufacture or distribute such products.

CMOs, who manufacture and distribute PF614 are required to be registered with DEA and relevant state authorities and comply with all

security, recordkeeping and reporting requirements.

Manufacturers and distributors are subject to routine inspections and audits by the

DEA related to compliance with security, recordkeeping and reporting requirements.

Failure to maintain the required registrations or

to comply and follow these requirements can lead to significant civil and/or criminal penalties and possibly even lead to a revocation

of a DEA registration to manufacture or distribute such products.

Manufacturing

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The DEA has decreased the aggregate quota for certain narcotic drugs,

including oxycodone over the last five years.

Also, in October 2018, Congress passed the SUPPORT Act which requires the DEA to consider

potential diversion in establishing quotas for narcotic drugs which could lead to continued decreases in quota available to API manufacturers

and dosage form manufacturers of these substances.

including oxycodone from 2015 to 2024.

Also, in October 2018, Congress passed the SUPPORT Act, updated in 2019, which requires the DEA

to consider potential diversion in establishing quotas for narcotic drugs which could lead to continued decreases in quota available

to API manufacturers and dosage form manufacturers of these substances.

future years, we may need greater amounts of controlled substances that are subject to the DEA’s quota system to sustain our development

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to obtain a significant commercial advantage from the intellectual property that we own or license.

in European law have caused uncertainty about our European patent portfolio and may result in additional costs to us.

2012, the European Patent Package, or EU Patent Package, regulations were passed with the goal of providing for a single pan-European

Unitary Patent, and a new European Unified Patent Court, or UPC, for litigation of European patents.

The EU Patent Package was ratified

in February 2023 and currently covers 17 member states.

On June 1, 2023, all European patents, including those issued prior to ratification,

will by default automatically fall under the jurisdiction of the UPC and allow for the possibility of obtaining pan-European injunctions,

and further will be at risk of a central revocation proceeding at the UPC in participating UPC states.

Under the EU Patent Package, patent

holders are permitted to “opt out” of the UPC on a patent-by-patent basis during an initial seven year period after the EU

Patent Package is ratified, with the proviso that an “opt-out” is no longer available for EP patents for which a revocation

has been initiated before the UPC.

Owners of European patent applications who receive notice of grant after the EU Patent Package is

ratified could, for the UPC contracting states, either obtain a Unitary Patent or validate the patent nationally and file an opt-out

The EU Patent Package may increase the uncertainties and costs surrounding the enforcement or defense of our issued European

patents and pending applications.

The full impact on future European patent filing strategy and the enforcement or defense of our issued

European patents in member states and/or the UPC is not known.

may be subject to claims that we or our employees, consultants, contractors or advisors have infringed, misappropriated or otherwise

violated the intellectual property of a third party, or claiming ownership of what we regard as our own intellectual property.

of the contributors to our intellectual property, including patents and applications, were previously employed at universities or other

biotechnology or pharmaceutical companies, including our competitors or potential competitors.

Although we try to ensure that our employees

do not use the intellectual property and other proprietary information, know-how or trade secrets of others in their work for us, we

may be subject to claims that we or these employees have used or disclosed such intellectual property or other proprietary information.

Litigation may be necessary to defend against these claims.

addition, while we typically require our employees, consultants 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.

For example, we have not obtained assignments for certain

patent applications relating to abuse-resistant amphetamines.

To the extent that we fail to obtain such assignments, such assignments

do not contain a self-executing assignment of intellectual property rights or such assignments are breached, we may be forced to bring

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

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

which might adversely affect our ability to develop and market our product candidates.

the extent undertaken, we cannot guarantee that any of our patent searches or analyses, including the identification of relevant patents,

the scope of patent claims or the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified

each and every third-party patent and pending application in the United States and abroad that is or may be relevant to or necessary

for the commercialization of our product candidates in any jurisdiction.

Patent applications in the United States and elsewhere are not

published until approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being

commonly referred to as the priority date.

In addition, certain United States patent applications can remain confidential until patents

Therefore, patent applications covering our products could have been filed by others without our knowledge.

Additionally, pending

patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover our product

candidates or the use of our product candidates.

scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution

Our interpretation of the relevance or the scope of a patent or a pending application may be incorrect, which may negatively

impact our ability to market our product candidates.

We may incorrectly determine that our product candidates are not covered by a third-party

patent or may incorrectly predict whether a third party’s pending application will issue with claims of relevant scope.

Our determination

of the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect, and our failure to identify

and correctly interpret relevant patents may negatively impact our ability to develop and market our product candidates.

we fail to identify and correctly interpret relevant patents, we may be subject to infringement claims.

We cannot guarantee that we will

be able to successfully settle or otherwise resolve such infringement claims.

If we fail in any such dispute, in addition to being forced

to pay damages, we may be temporarily or permanently prohibited from commercializing any of our product candidates that are held to be

We might, if possible, also be forced to redesign product candidates or services so that we no longer infringe the third-party

intellectual property rights.

Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial

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

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

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are illustrative:

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.

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.

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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stock, restrict our operations or require us to relinquish rights to our technologies or product candidates.

expect our expenses to increase in connection with our planned operations.

Unless and until we can generate a substantial amount of revenue

from our product candidates, we expect to finance our future cash needs through public or private equity offerings, debt financings,

collaborations, licensing arrangements or other sources, or any combination of the foregoing.

In addition, we may seek additional capital

due to favorable market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or future

operating plans.

expenses have increased in connection with our planned operations.

Unless and until we can generate a substantial amount of revenue from

our product candidates, we expect to finance our future cash needs through public or private equity offerings, debt financings, collaborations,

licensing arrangements or other sources, or any combination of the foregoing.

In addition, we may seek additional capital due to favorable

market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or future operating plans.

the extent that we raise additional capital through the sale of common stock, convertible securities or other equity securities as we

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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.

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

to 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.

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

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

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

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;

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.

and global economic environments;

future accounting pronouncements

or changes in our accounting policies.

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.

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.

have issued a significant amount of 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.

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

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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

“penny stock” rules, which could have a material adverse effect on the liquidity of our common stock, the ability of investors

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

to “penny stock” rules, which could have a material adverse effect on the liquidity of our common stock, the ability of investors

to sell their shares and our ability to raise funding.

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.

November 14, 2024, we received notice from Nasdaq stating that we had demonstrated compliance with the $2.5 million stockholders’

equity requirement set forth in Nasdaq Listing Rule 5550(b)(1) as of September 30, 2024.

On December 20, 2024, we received notice from

Nasdaq that we had regained compliance with the bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2).

There can be no assurance

that we will be able to maintain compliance with such Nasdaq Listing Rules and our common stock could be delisted.

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

20 unchanged sentences

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