What changed in this filing

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Item 1A. Risk Factors

2026-04-03 compared with 2025-04-01 · 131 added, 166 removed, 335 unchanged (47% of the section changed)

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2022, as the global economy has recovered from the impact of the COVID-19 pandemic, it has also been experiencing additional macroeconomic

pressures such as rising inflation and disruptions to the global supply chain, in part resulting from the ongoing conflict between Russia

pressures such as rising inflation and disruptions to the global supply chain, in part resulting from ongoing conflicts and tariff escalations.

We may experience supply discontinuities due to macroeconomic issues, regulatory actions, including sanctions and trade restrictions,

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business include:

Current macroeconomic conditions are becoming increasingly less stable due to the war in Ukraine, and tensions in the Middle and Far East.

Current macroeconomic conditions are becoming increasingly less stable due to ongoing war in Ukraine, and the Middle East, and threats of war in various other areas around the world including South America, Greenland, and the Far East.

Destabilized macroeconomics conditions pose a serious threat to supply chains around the world including those for the generic pharmaceutical business.

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These adverse market forces would have a direct impact on our ability to achieve our sales projections.

A significant portion of Nora Pharma’s revenues are derived from relatively few key customers, and any financial difficulties experienced by a single key customer, or any delay in receiving payments from such a customer, could have a material adverse effect on Nora Pharma’s business, financial condition, and results of operations.

If Nora Pharma encounters difficulties in executing launches of new products, it may not be able to offset the increasing price erosion on existing products resulting from pricing pressures and accelerated generics approvals for competitors.

Such unsuccessful launches can be caused by many factors, including delays in regulatory approvals, lack of operational or clinical readiness or patent litigation.

Failure or delays to execute launches of new generic products could have a material adverse effect on Nora Pharma’s business and its ability to realize projected sales.

Nora Pharma’s sales of generic pharmaceutical products in Canada are heavily dependent on federal and provincial reimbursement frameworks, which determine pricing, formulary inclusion, and allowable markups.

Any changes to these government-controlled reimbursement policies, whether through cost-containment measures, reference pricing adjustments, or formulary restrictions, could adversely affect Nora Pharma’s revenues in this market.

Sales of our generic products may be adversely

affected by the drug regulatory environment in Canada

we sell our generic drugs only in Canada.

Our net sales may be affected by fluctuations in the buying patterns of our customers resulting

from government lead pricing pressures and other factors.

Our generic sales in Canada are done via retail pharmacies, pharmacy channels,

distributors, and wholesalers.

Pricing pressures in Canada represent the highest risk due to ongoing and unresolved negotiations between

the pharmaceutical industry and the federal government.

Any financial difficulties experienced by a single key customer, or any delay

in receiving payments from such a customer, could have a material adverse effect on our business, financial condition, and results of

from generic products may decline as a result of competition from other pharmaceutical companies and changes in regulatory policy

Currently we sell our generic drugs only in Canada.

Our net sales may be affected by fluctuations in the buying patterns of our customers resulting from government lead pricing pressures

and other factors.

Our generic sales in Canada are done via retail pharmacies, pharmacy channels, distributors, and wholesalers.

pressures in Canada represent the highest risk due to ongoing and unresolved negotiations between the pharmaceutical industry and the

federal government.

Any financial difficulties experienced by a single key customer, or any delay in receiving payments from such a customer,

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

Our revenues from generic

products may decline as a result of competition from other pharmaceutical companies and changes in regulatory policy

Our generic drugs face intense competition.

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of their approvals.

brand pharmaceutical companies continue to manage products in a challenging environment through marketing agreements with payers, pharmacy

benefits managers and generic manufacturers.

For example, brand companies often sell or license their own generic versions of their products,

either directly or through other generic pharmaceutical companies (so-called “authorized generics”).

No significant

regulatory approvals are required for authorized generics, and brand companies do not face any other significant barriers to entry into

Brand companies may seek to delay introduction of generic equivalents through a variety of commercial and regulatory tactics.

These actions may increase the costs and risks of our efforts to introduce generic products and may delay or prevent such introductions

Furthermore, brand pharmaceutical companies continue

to manage products in a challenging environment through marketing agreements with payers, pharmacy benefits managers and generic manufacturers.

For example, brand companies often sell or license their own generic versions of their products, either directly or through other generic

pharmaceutical companies (so-called “authorized generics”).

No significant regulatory approvals are required for

authorized generics, and brand companies do not face any other significant barriers to entry into such market.

Brand companies may seek

to delay introduction of generic equivalents through a variety of commercial and regulatory tactics.

These actions may increase the costs

and risks of our efforts to introduce generic products and may delay or prevent such introductions altogether.

We may experience delays in launching our new

generic products

we cannot execute timely launches of new products, we may not be able to offset the increasing price erosion on existing products resulting

from pricing pressures and accelerated generics approvals for competing products.

Such unsuccessful launches can be caused by many factors,

including delays in regulatory approvals, lack of operational or clinical readiness or patent litigation.

Failure or delays in executing

launches of new generic products could have a material adverse effect on our business, financial condition, and results of operations.

If we cannot execute timely launches of new products,

we may not be able to offset the increasing price erosion on existing products resulting from pricing pressures and approvals for competing products.

Such unsuccessful launches can be caused by many factors, including delays in regulatory approvals,

lack of operational or clinical readiness or patent litigation.

Failure or delays in executing launches of new generic products could

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

We may not receive required

regulatory approval for any of our non-generic pharmaceutical product candidates

have not received approval for any of our proprietary (non-generic) drug development operations product candidates from the FDA.

compounds we discover or in-license will require extensive and costly development, preclinical testing and clinical trials prior to seeking

regulatory approval for commercial sales.

Our most advanced product candidate, K1.1 mRNA and our potential Covid-19 treatment in development

may never be approved for commercial sale.

We have not received approval for any of our proprietary

(non-generic) drug development operations product candidates from the FDA or any other regulatory bodies in other jurisdictions.

Any compounds

we discover or in-license will require extensive and costly development, preclinical testing and clinical trials prior to seeking regulatory

approval for commercial sales.

Our most advanced product candidate, K1.1 mRNA and our potential Covid-19 treatment in development may

never be approved for commercial sale.

We have not made any filings to date with the FDA or other regulatory bodies in other jurisdictions.

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in the foreseeable future, if at all

date, we have no approved non-generic pharmaceutical products on the market and have generated product revenues largely from our

generic pharmaceutical product sales.

We have funded our operations primarily from sales of our securities.

We have not received,

and do not expect to receive, for the foreseeable future, if at all, any revenues from the commercialization of our non-generic

pharmaceutical product candidates.

To obtain revenues from sales of such pharmaceutical product candidates we must succeed, either

alone or with third parties, in developing, obtaining regulatory approval for manufacturing, marketing and distributing drugs with

commercial potential.

We may never succeed in these activities, and we may not generate sufficient revenues to continue our business

operations or achieve profitability.

To date, we have no approved non-generic pharmaceutical

products on the market and have generated product revenues largely from our generic pharmaceutical product sales.

We have funded our operations

primarily from sales of our securities.

We have not received, and do not expect to receive, for the foreseeable future, if at all, any

revenues from the commercialization of our non-generic pharmaceutical product candidates.

To obtain revenues from sales of such pharmaceutical

product candidates we must succeed, either alone or with third parties, in developing, obtaining regulatory approval for manufacturing,

marketing and distributing drugs with commercial potential.

We may never succeed in these activities, and we may not generate sufficient

revenues to continue our business operations or achieve profitability.

We will require additional

funding to satisfy our future capital needs, which may not be available

will require significant additional funding for our operations, including future preclinical and clinical testing costs, and insufficient

sales revenues in the near future.

We do not know whether additional financing will be available to us on favorable terms or at all.

If we cannot raise additional funds, we may be required to reduce our capital expenditures, scale back product development programs,

reduce our workforce and license to others products or technologies that we may otherwise be able to commercialize.

We are currently

unable to project when or whether our operations will generate positive cash flow.

additional equity securities we issue or issuances of debt we may enter into or undertake may have rights, preferences or privileges

senior to those of existing holders of common stock.

To the extent that we raise additional funds through collaboration and licensing

arrangements, we may be required to relinquish some rights to our technologies or product candidates or grant licenses on terms that

are not favorable to us.

We will require significant additional funding

for our operations, including future preclinical and clinical testing costs, and insufficient sales revenues in the near future.

not know whether additional financing will be available to us on favorable terms or at all.

If we cannot raise additional funds, we may

be required to reduce our capital expenditures, scale back product development programs, reduce our workforce and license to others products

or technologies that we may otherwise be able to commercialize.

We are currently unable to project when or whether our operations will

generate positive cash flow.

Any additional equity securities we issue or issuances

of debt we may enter into or undertake may have rights, preferences or privileges senior to those of existing holders of common stock.

To the extent that we raise additional funds through collaboration and licensing arrangements, we may be required to relinquish some rights

to our technologies or product candidates or grant licenses on terms that are not favorable to us.

We may be sued or become

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The loss of Dr.

Slilaty will also significantly

Slilaty would also significantly

delay or prevent the achievement of our business objectives.

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If we are able to reach an agreement with any collaborator or third-party manufacturer in the future, of which there can be

no assurance, these collaborators and/or third-party manufacturers may not be able to increase their

manufacturing capacity for any of our product candidates in a timely or economic manner, or at all.

Significant scale-up of manufacturing

may require additional validation studies, which the FDA must review and approve.

If we are unable to increase the manufacturing capacity

for a product candidate successfully, the regulatory approval or commercial launch of that product candidate may be delayed or there may

be a shortage in the supply of the product candidate.

no assurance, these collaborators and/or third-party manufacturers may not be able to increase their manufacturing capacity for any of

our product candidates in a timely or economic manner, or at all.

Significant scale-up of manufacturing may require additional validation

studies, which the FDA must review and approve.

If we are unable to increase the manufacturing capacity for a product candidate successfully,

the regulatory approval or commercial launch of that product candidate may be delayed or there may be a shortage in the supply of the

product candidate.

Our product candidates require precise, high-quality manufacturing.

of collaborators or third-party manufacturers to achieve and maintain these high manufacturing standards, including the incidence of manufacturing

errors, could result in patient injury or death, product recalls or withdrawals, delays or failures in product testing or delivery, cost

overruns or other problems that could seriously harm our business.

The failure of collaborators or third-party manufacturers

to achieve and maintain these high manufacturing standards, including the incidence of manufacturing errors, could result in patient injury

or death, product recalls or withdrawals, delays or failures in product testing or delivery, cost overruns or other problems that could

seriously harm our business.

If we are unable to establish

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ability to generate product revenues, and become profitable, would be severely limited.

Even if we obtain required US and foreign regulatory

Even if we obtain required U.S.

and foreign regulatory

approvals, as applicable, factors that may inhibit our efforts to commercialize our pharmaceutical product candidates without strategic

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revenues and may damage our reputation in the industry and in the investment community.

The future clinical testing

of our proprietary drug product candidates could be delayed, resulting in increased costs to us and a delay in our ability to generate

Our proprietary drug product candidates will require

additional preclinical testing and extensive clinical trials prior to submission of a regulatory application for commercial sales.

do not know whether clinical trials will begin on time, if at all.

Delays in the commencement of clinical testing could significantly

increase our product development costs and delay product commercialization.

In addition, many of the factors that may cause, or lead to,

a delay in the commencement of clinical trials may also ultimately lead to denial of regulatory approval of a product candidate.

of these results would adversely affect our ability to generate revenues.

The commencement of clinical trials can be delayed

for a variety of reasons, including delays in:

demonstrating sufficient safety to obtain regulatory approval to commence a clinical trial;

reaching agreement on acceptable terms with prospective research organizations and trial sites;

manufacturing sufficient quantities of a product candidate;

obtaining institutional review board approvals to conduct clinical trials at prospective sites;

procuring adequate financing to fund the work.

In addition, the commencement of clinical trials

may be delayed due to insufficient patient enrollment, which is a function of many factors, including the size of the patient population,

the nature of the protocol, the proximity of patients to clinical sites, the availability of effective treatments for the relevant disease,

and the eligibility criteria for the clinical trial.

If we are unable to enroll a sufficient number of evaluable patients, the clinical

trials for our product candidates could be delayed until sufficient numbers are achieved.

We face or will face

significant competition from other biotechnology and pharmaceutical companies, and our operating results will

suffer if we fail to compete effectively

We face or will face significant

competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively

Most of our pharmaceutical company competitors,

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protect our proprietary information will be impaired.

In addition, some of the technology we have developed or licensed relies on inventions

In addition, some of the technology we have licensed relies on inventions

developed using U.S.

and other governments’ resources.

government resources.

Under applicable law, the U.S.

government has the right to require us to

grant a nonexclusive, partially exclusive or exclusive license for such technology to a responsible applicant or applicants, upon terms

that are reasonable under the circumstances, if the government determines that such action is necessary.

government has the right to require us to grant a nonexclusive,

partially exclusive or exclusive license for such technology to a responsible applicant or applicants, upon terms that are reasonable

under the circumstances, if the government determines that such action is necessary.

Confidentiality agreements

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Our failure to successfully manage our growth will have a negative impact on our anticipated results of operations.

A significant or prolonged

economic downturn could have a material adverse effect on our results of operations

A significant or prolonged economic downturn may

adversely affect the disposable income of many consumers and may lower demand for some of our products.

Any decline in economic conditions

could negatively impact our business.

A significant decline in consumer demand, even if only due in part to general economic conditions

could have a material adverse effect on our revenues and profit margins.

The failure of our service

providers and suppliers to supply quality services and materials in sufficient quantities, at a favorable price, and in a timely fashion

The failure of our suppliers to supply quality materials in sufficient quantities, at a favorable price, and in a timely fashion

could adversely affect the results of our operations

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Increasing cost pricing pressures on

raw materials and other products occurred throughout fiscal 2023 as a result of limited supplies of various ingredients, the effects of

higher labor and transportation costs, and the impact of Covid-19.

raw materials and other products occurred throughout fiscal 2024 and 2025 as a result of limited supplies of various ingredients, and

the effects of higher labor and transportation costs.

We expect these upward pressures to continue through fiscal 2026.

we may be able to raise our prices in response to significant increases in the cost of raw materials, we may not be able to raise prices

sufficiently or quickly enough to offset the negative effects such cost increases could have on our results of operations or financial

Although we may

be able to raise our prices in response to significant increases in the cost of raw materials, we may not be able to raise prices sufficiently

or quickly enough to offset the negative effects such cost increases could have on our results of operations or financial condition.

There can be no assurance suppliers will provide

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The occurrence

of these or any other operational problems, including the improper installation or operation of equipment, terrorism, pandemics (including

COVID-19), natural or other disasters, intentional acts of violence, and the need to comply with the requirements or directives of governmental

agencies, including the FDA and Health Canada may have a material adverse effect on our business, financial condition and results of operations.

of these or any other operational problems, including the improper installation or operation of equipment, terrorism, pandemics, natural

or other disasters, intentional acts of violence, and the need to comply with the requirements or directives of governmental agencies,

including the FDA and Health Canada may have a material adverse effect on our business, financial condition and results of operations.

We are dependent on a concentrated

base of finished goods suppliers, which increases our risk of product interruption

Approximately 75% of the drugs in our products

portfolio are manufactured by three (3) suppliers overseas.

Reliance on a limited number of third-party suppliers for finished products

exposes us to material operational, regulatory, and financial risks.

Because these suppliers are responsible for manufacturing, packaging,

and releasing finished pharmaceuticals under stringent regulatory requirements, any disruption in their operations can directly affect

our ability to maintain continuous product supply.

Disruptions may arise from GMP non-compliance, regulatory inspection findings, quality

system failures, contamination events, batch deviations, or shortages of critical components such as active pharmaceutical ingredients,

excipients, or specialized packaging.

Regulatory actions, including FDA Form 483 observations, warning letters, import alerts, or license

suspensions can halt production or delay batch release.

These risks, individually or in the aggregate, could have a material adverse effect

on our business, financial condition, and results of operations.

Risks Related to Our Common

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to meet the listing requirements of Nasdaq, our common stock will be delisted

stock currently trades on Nasdaq, where it is subject to various listing requirements.

February 28, 2024, we received a notification letter from Nasdaq advising that Nasdaq’s staff had determined that as of February

27, 2024, our common stock had a closing bid price of $0.10 or less for ten consecutive trading days and accordingly, we were subject

to the provisions contemplated under Listing Rule 5810(c)(3)(A)(iii).

Accordingly, Nasdaq determined to remove our securities from listing

and registration on Nasdaq, subject to the procedures set forth in the Nasdaq Listing Rule 5800 Series which provides us with the opportunity

to appeal this determination.

June 7, 2024, we received a notification letter from Nasdaq, that based on further review of our public filings with the Securities and

Exchange Commission and supporting materials submitted to Nasdaq, its staff determined to delist our securities pursuant to its discretionary

authority under Listing Rule 5101.

Specifically, as set forth in the letter, Nasdaq’s staff determined that the “alternative

cashless exercise” provision of the Series A Warrants the Company issued on February 15, 2024, raised public interest and investor

protection concerns because the issuance of Series A Warrants resulted in substantial dilution for the stockholders of the Company to

date and could cause potential future dilution.

Accordingly, as set forth in the letter, this matter served as an additional basis for

delisting the Company’s securities from The Nasdaq Stock Market.

letter served as a formal notification that the Nasdaq Hearings Panel (the “Panel”) would consider this matter in their decision

regarding our continued listing on The Nasdaq Capital Market.

September 9, 2024, we received a letter from Nasdaq confirming that we had regained compliance with the bid price requirement in

Listing Rule 5550(a)(2) (the “Bid Price Rule”), as required by the Panel’s decision dated June 28, 2024.

letter further stated that the Company will be subject to a Mandatory Panel Monitor for a period of one year.

If, within that one-year

monitoring period, the Nasdaq Listing Qualifications staff (“Nasdaq Staff”) finds the Company again out of compliance with

the Bid Price Rule, the Company will not be permitted to provide the Staff with a plan of compliance with respect to that deficiency

and Staff will not be permitted to grant additional time for the Company to regain compliance with respect to that deficiency, nor will

the Company be afforded an applicable cure or compliance period pursuant to Rule 5810(c)(3).

Instead, the Nasdaq Staff will issue a Delist

Determination Letter and the Company will have an opportunity to request a new hearing with the initial Panel or a newly convened Hearings

Panel if the initial Panel is unavailable.

The Company will have the opportunity to respond/present to the Hearings Panel as provided

by Listing Rule 5815(d)(4)(C).

The Company’s securities may be delisted from Nasdaq at that time.

may be unable to maintain compliance with Nasdaq listing requirements.

If we are unable to maintain compliance with Nasdaq listing requirements,

we could be subject to suspension and delisting proceedings.

A delisting of our common stock and our inability to list on another national

securities market could negatively impact us by:

(i) reducing the liquidity and market price of our common stock;

(ii) reducing the number

of investors willing to hold or acquire our common stock, which could negatively impact our ability to raise equity financing;

limiting our ability to use certain registration statements to offer and sell freely tradeable securities, thereby limiting our ability

to access the public capital markets;

and (iv) impairing our ability to provide equity incentives to our employees.

common stock currently trades on Nasdaq, where it is subject to various listing requirements, including Nasdaq Rule 5500(a)(2), which

requires that our common stock maintain a minimum bid price of at least $1.00 to maintain its listing on Nasdaq (the “Bid Price

common stock has recently traded at prices slightly above the $1.00 Nasdaq required minimum bid price requirement.

In addition, though

we have obtained stockholder approval to authorize the board of directors to implement a reverse stock split in its discretion, in a

ratio of up to 1-for-10, there is no assurance that, even if we implement a reverse split, we will be able to maintain compliance with

the Bid Price Rule or other applicable requirements for continued listing on Nasdaq.

If we are unable to maintain compliance with Nasdaq

listing requirements, we could be subject to suspension and delisting proceedings.

A delisting of our common stock and our inability

to list on another national securities market could negatively impact us by:

(i) reducing the liquidity and market price of our common

(ii) reducing the number of investors willing to hold or acquire our common stock, which could negatively impact our ability to

raise equity financing;

(iii) limiting our ability to use certain registration statements to offer and sell freely tradeable securities,

thereby limiting our ability to access the public capital markets;

and (iv) impairing our ability to provide equity incentives to our

We do not intend to pay dividends

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in our Company

our plans and expectations that we will need additional capital and personnel, we anticipate that we will need to issue additional shares

of common stock or securities convertible or exercisable for shares of common stock, including convertible preferred stock, convertible

notes, stock options or warrants.

In addition, as of the date of filing of this report, we had 12,226,549 Series B Warrants issued and

outstanding, each exercisable to purchase one share of our common stock at an exercise price of $2.79 per warrant..

The issuance of additional

securities in the future will dilute the percentage ownership of our current stockholders.

Given our plans and expectations that we will need

additional capital and personnel, we anticipate that we will need to issue additional shares of common stock or securities convertible

or exercisable for shares of common stock, including convertible preferred stock, convertible notes, stock options or warrants.

as of the date of filing of this report, we had 15,227,962 Series B Warrants issued and outstanding, each exercisable to purchase one

share of our common stock at an exercise price of $2.07 per warrant.

The issuance of additional securities in the future will dilute the

percentage ownership of our current stockholders.

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