What changed in this filing

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Item 1. Business

2023-03-16 compared with 2022-03-16 · 252 added, 303 removed, 361 unchanged (61% of the section changed)

are a pharmaceutical company focused on developing, acquiring, and commercializing innovative pharmaceutical products that fulfill an

unmet patient need.

Since the formation of our company in 2017, we have used our expertise in business development, regulatory, and product

development to assemble a diversified portfolio of eleven products and product candidates.

Six of our products have been approved

Food & Drug Administration (“FDA”) and commercially launched, and an additional four product candidates have

been submitted to the FDA.

We plan to continue growing our business through the acquisition of additional late-stage, high-value

product candidates.

product portfolio is comprised of three categories:

Orphan Drugs, Hospital Products, and Royalty Products.

orphan drug product category is focused on commercializing products that treat the unmet needs of patients suffering from rare diseases.

As defined by the FDA, orphan drugs typically address diseases that impact fewer than 200,000 patients in the United States.

small patient populations, products are typically promoted with small, targeted sales forces and distributed through high-touch specialty

pharmacies that provide comprehensive services to patients or caregivers.

We expect to continue to grow our orphan drug product category.

Some of our orphan drug products include:

is an innovative pharmaceutical company focused on developing, acquiring, and commercializing innovative products to address unmet needs

in patients suffering from rare diseases.

Company currently has three commercial rare disease products, ALKINDI SPRINKLE® for the treatment of adrenocortical insufficiency,

Carglumic Acid for the treatment of hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency, and Betaine Anhydrous for the

treatment of homocystinuria and has three additional product candidates in late-stage development.

The Company is developing dehydrated

alcohol injection, which has received Orphan Drug Designation for the treatment of methanol poisoning, ZENEO® hydrocortisone autoinjector

for the treatment of adrenal crisis, and ET-400.

SPRINKLE® (hydrocortisone granules) - This product was approved by the FDA in September 2020 as a replacement therapy for Adrenocortical

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launched ALKINDI SPRINKLE® in December 2020 with a sales force targeting pediatric endocrinologists.

In November 2021, we entered into

a co-promotion agreement with Tolmar Pharmaceuticals, Inc.

(“Tolmar”) to use their 60+ person salesforce to promote Alkindi

Tolmar’s sales force will promote Alkindi Sprinkle to pediatric endocrinology healthcare professionals and Tolmar will

receive a royalty on net sales growth above the product’s baseline sales level at the time of the transaction.

Eton retains ownership

of the product and will maintain responsibility for all non-sales force related commercial activities.

We believe there are approximately

10,000 children currently suffering from AI in the United States.

Alkindi Sprinkle is protected by four issued patents that extend to

In January 2021, we announced the acquisition of Canadian rights to Alkindi Sprinkle and we expect to pursue regulatory approval

of the product in Canada in the near future.

Acid tablets - Our Carglumic Acid product is the first and only FDA-approved generic version of Carbaglu®.

Our product is approved

for the treatment of acute and chronic hyperammonemia due to N-acetylglutamate Synthase (NAGS) deficiency.

We acquired marketing rights

to the product in October 2021 and launched the product in December 2021.

ALKINDI SPRINKLE® is protected by three issued patents that extend

In January 2021, we announced the acquisition of Canadian rights to ALKINDI SPRINKLE®.

Acid tablets - Our Carglumic Acid product is an FDA-approved generic version of Carbaglu®.

Our product is approved for the treatment

of acute and chronic hyperammonemia due to N-acetylglutamate Synthase (NAGS) deficiency.

We acquired marketing rights to the product

in October 2021 and launched the product in December 2021.

We promote the product with our internal sales force.

was awarded Competitive Generic Therapy (CGT) designation by the FDA, which provides us with 180 days of generic exclusivity.

that the Carbaglu® market is more than $50 million annually and our goal is to capture 25% to 35% of the market.

Alcohol Injection.

Our dehydrated alcohol injection product candidate for the treatment of methanol poisoning was submitted to the

FDA and was granted Orphan Drug Exclusivity in late 2020.

In May 2021, we received a Complete Response Letter (“CRL”) from

We believe all of the items raised by the CRL are addressable, and we plan to submit our response to the FDA in the near future.

Anhydrous for Oral Solution - Our Betaine Anhydrous product is an FDA-approved generic version of Cystadane® for the treatment

of homocystinuria, a rare inherited condition that is estimated to impact less than 2,000 patients in the United States.

the product in September 2022 and expect to relaunch in early 2023.

Alcohol Injection - Our dehydrated alcohol injection product candidate is currently under review with the FDA for the treatment of

methanol poisoning.

The application has been assigned a Target Action Date of June 27, 2023.

The product was granted Orphan Drug Designation

We believe the dehydrated alcohol injection market is more than $70 million annually.

Hydrocortisone Autoinjector.

Our Zeneo hydrocortisone autoinjector product candidate is a proprietary needle-free autoinjector under

development for the treatment of adrenal crisis.

We acquired the product candidate from Crossject in June 2021.

Currently patients suffering

from adrenal crisis typically use Solu-Cortef, a lyophilized hydrocortisone injection kit that must be reconstituted prior to delivery.

- Eton expects to submit a new drug application for the adrenal insufficiency product by the end of 2023, which could allow for an

approval and launch of the product in 2024.

Hydrocortisone Autoinjector - Our ZENEO® hydrocortisone autoinjector product candidate is a proprietary needle-free autoinjector

under development for the treatment of adrenal crisis.

We acquired U.S.

marketing rights to the product candidate from Crossject in June

Currently patients suffering from adrenal crisis typically use Solu-Cortef, a lyophilized hydrocortisone injection kit that must

be reconstituted prior to delivery.

The current market for Solu-Cortef is more than $85 million annually based on IQVIA data.

We believe our needle-free autoinjector will

be preferred by patients.

We expect to submit a New Drug Application (“NDA”) for the product in 2023, which could

allow for FDA approval in 2024.

hospital products category consists of injectable products that are used in the hospital setting.

These include:

(phenylephrine HCl).

Biorphen is the first and only FDA-approved formulation of ready-to-use phenylephrine injection.

indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.

acquired U.S.

marketing rights to the product in February 2019.

The product was approved in October 2019 and launched in December 2019.

We estimate the current addressable market for ready-to-use phenylephrine to be more than twenty million units of Biorphen annually.

Biorphen primarily competes with FDA-approved formulations of concentrated phenylephrine injection, which must be diluted prior to administration

to patients, and with unapproved formulations of ready-to-use phenylephrine sold by 503B compounding pharmacies.

Eton owns the Biorphen

NDA, but the product is currently promoted by Xellia Pharmaceuticals’ (“Xellia”) hospital sales force under a co-promotion

Eton pays Xellia a commission on sales of the product in certain channels.

Eton retains the right to exit the co-promotion

agreement under certain conditions.

We are actively working on converting this product from its current ampule container to a vial.

expect to launch the vial presentation in 2022, which is expected to drastically increase the adoption of the product.

(ephedrine HCl) .

Rezipres is an innovative ready-to-use formulation of a molecule that is indicated for the treatment of clinically

important hypotension occurring in the setting of anesthesia.

Our product will compete against Emerphed® and non-FDA approved ready-to-use

products from compounding facilities.

Rezipres® provides a ready-to-use strength that can be immediately administered to patients,

eliminating the need for calculations and additional dilution steps.

Our product is also preservative free and does not contain any sulfites.

This product was launched in March 2022.

We have partnered with XGen Pharmaceuticals DJB (“XGen”) for commercialization

of the product.

XGen’s sales force is responsible for promoting the product to hospitals.

We are actively working on converting

the product from its current ampule container to a vial.

We expect to launch the vial presentation in 2022.

Our cysteine injection product candidate is a generic form of EXELA Pharma Sciences’ Elcys® product for which

we have submitted an Abbreviated New Drug Application (“ANDA”) to the FDA.

We are actively engaged in the Paragraph IV litigation

associated with the innovator company’s patent.

Given our first-to-file status, we expect to be entitled to 180 days of generic

exclusivity if we are successful in challenging the patent.

The trial is expected to begin in March of 2022.

We believe the current market

for Cysteine injection is more than $50 million annually.

royalty products category is comprised of products that Eton does not commercialize.

In most cases, these are products that Eton initiated

development of, or licensed at an early stage, and advanced development to an FDA submission before selling the product rights to a third

These products are now owned and commercialized partners that pay Eton milestones and royalties on commercial sales.

products category strategy allows us to monetize our vast experience and talent in business development, regulatory activities, and product

development to generate high returns on our financial investments without being restricted by commercial organization limitations and

it does not require significant ongoing overhead support costs.

We currently have four royalty products:

Alway Preservative Free, which

is owned and marketed by Bausch Health, and our three neurology oral liquid products, EPRONTIA™, Zonisamide oral suspension

and Lamotrigine oral suspension, which are owned and marketed by Azurity Pharmaceuticals (“Azurity”).

Preservative Free (ketotifen fumarate) .

Alaway Preservative Free is the first and only preservative-free ophthalmic product

approved for the treatment of allergic conjunctivitis.

The preservative-free formulation is designed to deliver an improved comfort profile

to patients compared to currently available ketotifen ophthalmic products that contain preservatives.

The product is sold via the over-the-counter

Currently, the market for ketotifen ophthalmic products is estimated to be more than $75 million annually based on data from

IRI and IQVIA.

We sold the product rights to Bausch Health in February 2019.

Bausch Health is responsible for commercialization of the

product which was launched in February 2021.

We received a $1.5 million milestone payment in conjunction with the launch of the product

and receive a twelve percent royalty on the product’s net sales.

Oral Liquids.

Starting in 2018, we assembled a portfolio of three neurology oral liquid products through in-licensing and

internal development.

All three products are molecules that are widely used in oral solid forms to treat epilepsy, but were not

FDA-approved in liquid formulations.

We believe the formulations will be beneficial to patients suffering from dysphagia, which

is prevalent among pediatric and geriatric patients.

In addition, the liquid formulations offer precision dosing, which can provide patients

and caregivers with accurate doses that are lower than or in between the limited strength doses available from oral solid products.

sold these three products to Azurity in February 2021.

Under terms of the agreement, Azurity has paid us $17 million

and will pay up to $25 million in additional milestone payments plus a single digit royalty on net sales of the products.

taken over ownership of the products and is responsible for all development, regulatory, and commercial activities.

The three neurology

oral liquid products are:

(topiramate oral solution).

the only FDA-approved liquid formulation of topiramate.

The product is approved for three indications, including:

monotherapy for treatment

of partial-onset or primary general tonic-clonic seizures in patients two years of age and older;

adjunctive therapy for treatment of

partial-onset seizures, including seizures associated with Lennox-Gastaut syndrome in patients two year of age and older;

and as a preventive

treatment of migraine in patients 12 years of age and older.

The product was approved in November 2021 and launched by Azurity in December

The current market for topiramate in oral form is more than $800 million annually according to IQVIA.

Oral Suspension.

The product is an innovative liquid formulation of zonisamide under FDA review for the treatment of partial seizures

in patients with epilepsy.

The product application was originally assigned a PDUFA date of May 29, 2021 and the FDA issued a Complete

Response Letter because it was unable to inspect the manufacturing site due to COVID-related travel restrictions.

The FDA inspected the

facility in January 2022, and we believe the application could be approved in the near future.

The current market for zonisamide in oral

form is more than $65 million annually according to IQVIA.

for Oral Suspension .

The product is an innovative liquid formulation of lamotrigine under FDA review for the treatment of partial

on-set seizures, primary generalized tonic-clonic seizures, and seizures of Lennox-Gastaut syndrome in patients two year of age and older.

The product has been issued a patent, which is now owned by Azurity.

The product’s NDA application received a Complete Response

Letter in March 2020 and the FDA requested changes to the Dosage and Administration section of the product’s Prescribing Information

to simplify the dosing information for intended users.

The FDA requested a human factors validation study with the revised labeling to

demonstrate that the intended users can prepare and administer the oral suspension safely and effectively.

Our development partner completed

the study and submitted the report to the FDA in November 2021.

The application has been assigned a PDUFA date of May 30, 2022.

market for lamotrigine in oral form is more than $600 million annually according to IQVIA.

our needle-free autoinjector will be preferred by patients.

We expect to submit a New Drug Application (“NDA”) for the product

in 2024, which could allow for FDA approval in 2025.

addition, the Company is entitled to royalties or milestone payments from five FDA-approved products and one product candidate under

development that the Company developed and out-licensed.

The products are Alaway® Preservative Free, EPRONTIA®, Cysteine

Hydrochloride, ZONISADE™, Biorphen®, and Lamotrigine for Oral Suspension.

Preservative Free (ketotifen fumarate) - Alaway Preservative Free is the first and only preservative-free ophthalmic

product FDA-approved for the treatment of allergic conjunctivitis.

The Company sold the product rights to Bausch Health in February 2019.

Bausch Health is responsible for commercialization of the product which was launched in February 2021 and we receive a twelve

percent royalty on the product’s net sales.

(topiramate oral solution) - EPRONTIA® is the only FDA-approved liquid formulation of topiramate.

It is approved for three

indications, including:

monotherapy for treatment of partial-onset or primary general tonic-clonic seizures in patients two years of

age and older;

adjunctive therapy for treatment of partial-onset seizures, including seizures associated with Lennox-Gastaut syndrome

in patients two years of age and older;

and as a preventive treatment of migraine in patients 12 years of age and older.

The product was

approved in November 2021 and launched by Azurity Pharmaceuticals, Inc.

(“Azurity”) in December 2021.

Hydrochloride - Cysteine hydrochloride is an FDA-approved generic form of EXELA Pharma Sciences’ Elcys® product indicated

for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infants.

The product is now owned by Dr.

Reddy’s Laboratories S.A.

(zonisamide oral suspension) - The product is an FDA-approved innovative liquid formulation of zonisamide for the treatment of partial

seizures in patients with epilepsy.

The product was approved in July 2022.

Biorphen® - Biorphen is

the first and only FDA-approved formulation of ready-to-use phenylephrine injection.

Biorphen is indicated for the treatment of clinically

important hypotension resulting primarily from vasodilation in the setting of anesthesia.

The product was approved in October 2019 and

launched in December 2019.

The product is marketed by Dr.

for Oral Suspension - The product is an innovative liquid formulation of lamotrigine under development for the treatment of epilepsy.

The product’s NDA was previously submitted to the FDA and received a Complete Response Letter (“CRL”) in May 2022.

Azurity is working on addressing the items identified in the CRL in order to resubmit the product’s NDA.

Pharmaceuticals

Insufficiency

Preservative Free

Conjunctivitis

Homocystinuria

Alcohol Injection

SPRINKLE (Canada)

Insufficiency

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and Strengths

goal is to become a leading profitable pharmaceutical company that brings innovative treatments to patients.

We believe we are unique

in the pharmaceutical industry in our ability to identify, acquire, and advance products through the development and regulatory process.

goal is to become a leading profitable pharmaceutical company that brings innovative treatments to rare disease patients.

we are unique in the pharmaceutical industry in our ability to identify, acquire, and advance products through the development and regulatory

Our biggest competitive strengths are:

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provide the company with proprietary deal flow.

We avoid participating in broker led transactions of auction processes.

We typically avoid participating in broker led transactions of auction processes.

expertise – our knowledge and experience gaining FDA approval, and particularly our knowledge within the 505(b)(2) regulatory

pathway, which provides drug sponsors with the opportunity to leverage existing data or literature to drastically expedite drug development

pathway, provides drug sponsors with the opportunity to leverage existing data or literature to drastically expedite drug development

timelines and reduce investment.

and Marketing

currently own or have economic interests in six commercial products.

We typically commercialize our orphan products under our own label

with our internal infrastructure and sales force, however, we may at times supplement our efforts with a co-promotion arrangement as

we have with Tolmar Pharmaceuticals on Alkindi Sprinkle.

In our orphan product category, we currently commercialize Alkindi Sprinkle

and Carglumic Acid in the United States.

These products are distributed to patients via a specialty pharmacy, which supports customer

service and reimbursement activities.

our hospital category, we have entered into short-term co-promotion agreements for the ampule format of both Biorphen and Rezipres.

retain ownership of the products and have no commercial arrangements relating to the vial formats of both products.

For each future product

launch we will assess if it is more advantageous to promote internally with our own sales force or partner with a company with an existing

hospital sales force.

currently commercialize three orphan products under our own label with our internal infrastructure and sales force.

We currently commercialize

ALKINDI SPRINKLE®, Carglumic Acid, and Betaine Anhydrous in the United States.

These products are distributed to patients via specialty

pharmacies, which support customer service and reimbursement activities.

our royalty product category, the products are commercialized by our partners.

Bausch Health is responsible for all sale and marketing

activities related to Alaway Preservative Free, and Azurity is responsible for all sales and marketing activities related

to Eprontia, zonisamide oral suspension, and lamotrigine suspension.

activities related to Alaway Preservative Free, and Azurity is responsible for all sales and marketing activities related to EPRONTIA®,

ZONISADE™, and lamotrigine suspension.

In all cases we receive a royalty on net sales of the products.

January 2020 we signed a co-promotion agreement with Xellia for the promotion of Biorphen.

Under terms of the agreement, Xellia’s

U.S.-based hospital sales force will promote Biorphen in certain customer channels in exchange for a commission based on net sales realized

at certain customer accounts.

Eton owns the Biorphen NDA and the product is sold under Eton’s brand name.

The agreement has a five-year

term, but allows Eton to exit under various scenarios, including a change of control, and after 2021 if Biorphen net sales from Xellia

designated accounts do not exceed $29.4 million in 2021, or $42.0 million in 2022 and the following years.

In July 2021 we signed a co-promotion

agreement with XGen whereby XGen’s salesforce will promote Rezipres for a three-year

term, in exchange for a profit share on the Rezipres product.

In November 2021 we signed a co-promotion agreement with Tolmar whereby

Tolmar will promote Alkindi Sprinkle® through its 60+ person salesforce in exchange for a royalty on net sales.

and Development

currently have seven employees that support our product research and development activities.

currently have eight employees that support our product research and development activities.

In addition, we utilize external sources

for various product development activities, including the resources of our product development partners for certain product candidates

and also through the use of contract laboratory services on a fee for service model.

and through the use of contract laboratory services on a fee for service model.

Manufacturing

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rely on third-party contract manufacturing organizations (“CMOs”) to manufacture our products.

All our manufacturing partners

are based in the United States or Europe.

We seek to work with CMOs that have a long history of quality and FDA compliance.

are manufactured in compliance with current Good Manufacturing Processes (“cGMP”), and our internal quality system requires

us to enter quality agreements with and audit all of our manufacturers prior to commercializing the product.

Our choice to rely on external

manufacturers significantly reduces the amount of capital invested in our business and allows us the flexibility to pursue a broad range

of opportunities beyond the specific capabilities of a single facility.

All of our finished product

manufacturing partners are based in the United States or Europe.

We seek to work with CMOs that have a long history of quality and FDA

All products are manufactured in compliance with current Good Manufacturing Processes (“cGMP”), and our internal

quality system requires us to enter quality agreements with and audit all of our manufacturers prior to commercializing the product.

Our choice to rely on external manufacturers significantly reduces the amount of capital invested in our business and allows us the flexibility

to pursue a broad range of opportunities beyond the specific capabilities of a single facility.

policy is to seek to protect our proprietary position by, among other methods, filing U.S.

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upon any single patent, trademark or contract.

Sprinkle is protected by four issued patents that extend to 2034.

We intend to seek patent protection on our internally developed products

as circumstances warrant.

development partners for zonisamide and topiramate have filed patent applications on those products and our development partner for lamotrigine

was granted a patent by the United States Patent and Trademark Office for the product’s unique formulation.

We expect the lamotrigine

patent to be Orange Book listed after product approval.

These patents were assigned to Azurity in February 2021.

SPRINKLE® is protected by three issued patents that extend to 2034.

We intend to seek patent protection on our internally developed

products as circumstances warrant.

Regulations and Funding

Pharmaceutical

companies are subject to extensive regulation by foreign, federal, state and local agencies, such as the FDA, and various European regulatory

The manufacture, distribution, marketing and sale of pharmaceutical products are subject to government regulation in the

United States and various foreign countries.

Additionally, in the United States, we must follow rules and regulations established by

the FDA requiring the presentation of data indicating that our products are safe and efficacious and are manufactured in accordance with

cGMP regulations.

If we do not comply with applicable requirements, we may be fined, the government may refuse to approve our marketing

applications or allow us to manufacture or market our products, and we may be criminally prosecuted.

We, our manufacturers and contract

research organizations (“CROs”) may also be subject to regulations under other foreign, federal, state and local laws, including,

but not limited to, the U.S.

Occupational Safety and Health Act, the Resource Conservation and Recovery Act, the Clean Air Act and import,

export and customs regulations as well as the laws and regulations of other countries.

government has increased its enforcement

activity regarding illegal marketing practices domestically and internationally.

As a result, pharmaceutical companies must ensure their

compliance with the Foreign Corrupt Practices Act and federal healthcare fraud and abuse laws, including the False Claims Act.

companies are subject to extensive regulation by foreign, federal, state and local agencies, such as the FDA, and various European

regulatory authorities.

The manufacture, distribution, marketing and sale of pharmaceutical products are subject to government

regulation in the United States and various foreign countries.

Additionally, in the United States, we must follow rules and

regulations established by the FDA requiring the presentation of data indicating that our products are safe and efficacious and are

manufactured in accordance with cGMP regulations.

If we do not comply with applicable requirements, we may be fined, the government

may refuse to approve our marketing applications or allow us to manufacture or market our products, and we may be criminally

We, and our manufacturers and contract research organizations (“CROs”), may also be subject to regulations

under other foreign, federal, state and local laws, including, but not limited to, the U.S.

Occupational Safety and Health Act, the

Resource Conservation and Recovery Act, the Clean Air Act and import, export and customs regulations as well as the laws and

regulations of other countries.

government has increased its enforcement activity regarding illegal marketing practices

domestically and internationally.

As a result, pharmaceutical companies must ensure their compliance with the Foreign Corrupt

Practices Act and federal healthcare fraud and abuse laws, including the False Claims Act.

regulatory requirements impact our operations and differ from one country to another, so that securing the applicable regulatory approvals

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numbers of subjects at various sites to assess as fully as possible both the safety and effectiveness of the drug.

trials must be conducted in accordance with the FDA’s good clinical practices (“GCP”) requirements.

trials must be conducted in accordance with the FDA’s Good Clinical Practices (“cGCP”) requirements.

The FDA may order

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An institutional review board (“IRB”) generally must approve the clinical trial design and patient informed consent

at study sites that the IRB oversees and also may halt a study, either temporarily or permanently, for failure to comply with the IRB’s

at study sites that the IRB oversees and may halt a study, either temporarily or permanently, for failure to comply with the IRB’s

requirements, or may impose other conditions.

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should be approved.

The FDA is not bound by the recommendation of an advisory committee, but it typically follows such recommendations.

The FDA is not bound by the recommendation of the advisory committee, but it typically follows such recommendations.

Data from clinical studies are not always conclusive and the FDA and/or any advisory committee it appoints may interpret data differently

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For example, if we change the manufacturer of a product or our API, the FDA may require stability or other

data from the new manufacturer, and such data will take time and are costly to generate, and the delay associated with generating these

data from the new manufacturer.

Such data will take time and are costly to generate, and the delay associated with generating these

data may cause interruptions in our ability to meet commercial demand, if any.

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FDA may also require post-marketing testing or Phase 4 testing, as well as risk minimization action plans and surveillance to monitor

the effects of an approved product or place conditions or an approval that could otherwise restrict the distribution or use of the product.

the effects of an approved product or place conditions on an approval that could otherwise restrict the distribution or use of the product.

505(b)(2) New Drug Applications

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the extent that the Section 505(b)(2) applicant is relying on the FDA’s conclusions regarding studies conducted for an already

approved product, the applicant is required to certify to the FDA concerning any patents listed for the approved product in the FDA’s

Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.

Specifically, the applicant must certify that:

required patent information has not been filed;

(ii) the listed patent has expired;

(iii) the listed patent has not expired, but will

expire on a particular date and approval is sought after patent expiration;

or (iv) the listed patent is invalid or will not be infringed

by the new product.

The Section 505(b)(2) application also will not be approved until any non-patent exclusivity, such as exclusivity

for obtaining approval of a new chemical entity, listed in the Orange Book for the reference product has expired.

If the Orange Book

certifications outlined above are not accomplished, the Section 505(b)(2) applicant may invest a significant amount of time and expense

in the development of its products only to be subject to significant delay and patent litigation before its products may be commercialized.

approved product, the applicant must provide the patent number and certify to the FDA in its opinion and to the best of its

knowledge, one of the following circumstances:

(i) the required patent information has not been filed;

(ii) the listed patent has

(iii) the listed patent has not expired, but will expire on a particular date and approval is sought after patent

or (iv) the listed patent is invalid or will not be infringed by the new product.

The Section 505(b)(2) application also

will not be approved until any non-patent exclusivity, such as exclusivity for obtaining approval of a new chemical entity, listed

in the Orange Book for the reference product has expired.

If the Orange Book certifications outlined above are not accomplished, the

Section 505(b)(2) applicant may invest a significant amount of time and expense in the development of its products only to be

subject to significant delay and patent litigation before its products may be commercialized.

505(j) Abbreviated New Drug Applications

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A product candidate utilizing the 505(j) pathway requires an abbreviated new drug application,

or ANDA, which relies on the FDA’s finding that the previously approved drug candidate is safe and effective.

(“ANDA”), which relies on the FDA’s finding that the previously approved drug candidate is safe and effective.

An ANDA generally

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false or fraudulent or making a false statement to avoid, decrease, or conceal an obligation to pay money to the federal government;

Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which prohibits, among other things, executing

a scheme to defraud any healthcare benefit program and knowingly and willfully falsifying, concealing or covering up a material fact

or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items, or services;

The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which prohibits, among other things, executing

a scheme to defraud any healthcare benefit program, including private third-party payors, and knowingly and willfully falsifying, concealing

or covering up a material fact or making any materially false, fictitious, or fraudulent statement in connection with the delivery of

or payment for healthcare benefits, items, or services;

as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, imposes

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identifiable health information;

Physician Payments Sunshine Act which requires certain manufacturers of drugs, devices, biologics and medical supplies for which

payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report

annually to the Centers for Medicare & Medicaid Services (“CMS”) information related to payments or other transfers

of value made to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate

family members;

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

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branded prescription drugs, and established a Medicare Part D coverage gap discount program.

of the provisions of the Health Care Reform Law have yet to be implemented, and there have been judicial and Congressional challenges

to certain aspects of the Health Care Reform Law.

In addition, Congress has considered legislation that would repeal or repeal and replace

all or part of the Health Care Reform Law.

While Congress has not passed comprehensive repeal legislation, two bills affecting the implementation

of certain taxes under the Health Care Reform Law have been signed into law.

The Tax Cuts and Jobs Act of 2017 (the “Tax Act”)

included a provision which repealed, effective January 1, 2019, the tax-based shared responsibility payment imposed by the Health Care

Reform Law on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred

to as the “individual mandate.” The Bipartisan Budget Act of 2018, among other things, amended the Health Care Reform, effective

January 1, 2019, to increase from 50 percent to 70 percent the point-of-sale discount that is owed by pharmaceutical manufacturers who

participate in Medicare Part D and to close the coverage gap in most Medicare drug plans, commonly referred to as the “donut hole”.

of the provisions of the Health Care Reform Law have yet to be implemented, and there have been judicial and Congressional

challenges to certain aspects of the Health Care Reform Law.

In addition, Congress has considered legislation that would repeal or

repeal and replace all or part of the Health Care Reform Law.

While Congress has not passed comprehensive repeal legislation, two

bills affecting the implementation of certain taxes under the Health Care Reform Law have been signed into law.

The Tax Cuts and

Jobs Act of 2017 (the “Tax Act”) included a provision which repealed, effective January 1, 2019, the tax-based shared

responsibility payment imposed by the Health Care Reform Law on certain individuals who fail to maintain qualifying health coverage

for all or part of a year that is commonly referred to as the “individual mandate.” The Bipartisan Budget Act of 2018,

among other things, amended the Health Care Reform Law, effective January 1, 2019, to increase from 50 percent to 70 percent the

point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part D and to close the coverage gap

in most Medicare drug plans, commonly referred to as the “donut hole”.

In 2018, a Texas U.S.

District Court Judge ruled that the Health Care Reform Law is unconstitutional in its entirety because the “individual

mandate” was repealed by Congress as part of the Tax Act.

While the ruling has no immediate effect pending appeal of the decision,

it is unclear how this decision, subsequent appeals, and other efforts to repeal and replace the Health Care Reform will impact the Health

Care Reform Law.

District Court Judge ruled

that the Health Care Reform Law is unconstitutional in its entirety because the “individual mandate” was repealed by

Congress as part of the Tax Act.

On June 17, 2021, the U.S.

Supreme Court overturned the 2018 Texas U.S.

District Court decision.

is unclear how subsequent appeals and other efforts to repeal and replace the Health Care Reform will impact our

addition, other legislative changes have been proposed and adopted in the United States since the Health Care Reform Law was enacted,

These changes include, among others, aggregate reductions of Medicare payments to providers of up to 2% per fiscal year and an increase

in the statute of limitations period for the government to recover overpayments to providers from three to five years.

In August 2011, President Obama signed into law the Budget Control Act of 2011, which, among other things, created the Joint Select Committee

on Deficit Reduction to recommend to Congress proposals for deficit reduction of at least $1.2 trillion for the years 2013 through 2021.

The Joint Select Committee on Deficit Reduction did not achieve a targeted deficit reduction, which triggered the legislation’s

automatic reduction to several government programs.

This includes aggregate reductions to Medicare payments to providers of, up to 2%

per fiscal year, and, due to subsequent legislative amendments, will remain in effect through 2030 unless Congress takes additional action.

These reductions went into effect in April 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through

2030 unless additional action is taken by Congress.

On April 13, 2017, CMS published a final rule that gives states greater flexibility in setting benchmarks for insurers in the individual

and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the Health Care Reform Law for plans sold

through such marketplaces.

On May 30, 2018, the Right to Try Act, was signed into law.

The law, among other things, provides a federal framework for certain patients

to access certain investigational new drug products that have completed a Phase 1 clinical trial and that are undergoing investigation

for FDA approval.

Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without

obtaining FDA permission under the FDA expanded access program.

There is no obligation for a pharmaceutical manufacturer to make its

drug products available to eligible patients as a result of the Right to Try Act.

On May 23, 2019, CMS published a final rule to allow Medicare Advantage Plans the option of using step therapy for Part B drugs beginning

January 1, 2020.

there has been heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost

of prescription drugs and biologics.

Such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal

and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing

and manufacturer patient programs, and reform government program reimbursement methodologies for products.

For example, in President

Biden’s 2022 State of the Union Speech, President Biden again called for Congress to take action to combat high prices of prescription

In 2019, the Health and Human Services (“HHS”) Office of Inspector General proposed modifications to the U.S.

Anti-Kickback

Statute discount safe harbor for the purpose of reducing the cost of drug products to consumers which, among other things, if finalized,

will affect discounts paid by manufacturers to Medicare Part D plans, Medicaid managed care organizations and pharmacy benefit managers

working with these organizations.

While some of these and other proposed measures may require additional authorization to become effective,

Congress and government administration officials have each indicated that they will continue to seek new legislative and/or administrative

measures to control drug costs.

currently have 17 full-time employees, seven of whom are engaged in research and development activities, six are engaged in sales/marketing

Such scrutiny has resulted in several recent U.S.

Congressional Inquiries and proposed and enacted

federal and state legislation designed to, among other things, bring more transparency to product pricing, reduce the cost of prescription

drugs under Medicare, review the relationship between pricing and manufacturer and patient programs, and reform government program reimbursement

methodologies for products.

At a federal level, President Biden signed an Executive Order on July 9, 2021, affirming the administration’s

policy to (i) support legislative reforms that would lower the prices of prescription drug and biologics, including by allowing Medicare

to negotiate drug prices, by imposing inflation caps, and, by supporting the development and market entry of lower-cost generic drugs

and biosimilars;

and (ii) support the enactment of a public health insurance option.

Among other things, the Executive Order also directs

Department of Health & Human Services (“HHS”) to provide a report on actions to combat excessive pricing of prescription drugs, enhance the domestic drug supply chain, reduce

the price that the Federal government pays for drugs, and address price gouging in the industry;

and directs the FDA to work with states

and Indian Tribes that propose to develop section 804 Importation Programs in accordance with the Medicare Prescription Drug, Improvement,

and Modernization Act of 2003, and the FDA’s implementing regulations.

FDA released such implementing regulations on September

24, 2020, which went into effect on November 30, 2020, providing guidance for states to build and submit importation plans for drugs

On September 25, 2020, CMS stated drugs imported by states under this rule will not be eligible for federal rebates under

Section 1927 of the Social Security Act and manufacturers would not report these drugs for “best price” or Average Manufacturer

Price purposes.

Since these drugs are not considered covered outpatient drugs, CMS further stated it will not publish a National Average

Drug Acquisition Cost for these drugs.

If implemented, importation of drugs from Canada may materially and adversely affect the price

we receive for any of our product candidates.

Additionally, on November 30, 2020, HHS published a regulation removing safe harbor protection

for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers,

unless the price reduction is required by law.

The rule also creates a new safe harbor for price reductions reflected at the point-of-sale,

as well as a safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers.

Pursuant to court order,

the removal and addition of the aforementioned safe harbors were delayed and recent legislation imposed a moratorium on implementation

of the rule until January 1, 2032.

Although a number of these and other proposed measures may require authorization through additional

legislation to become effective, and the Biden administration may reverse or otherwise change these measures, both the Biden administration

and Congress have indicated that they will continue to seek new legislative measures to control drug costs.

recently, on August 16, 2022, President Biden signed the Inflation Reduction Act (“IRA”) which provides for (i) the government

to set or negotiate prices for select high-cost Medicare Part D (beginning in 2026) and Medicare Part B drugs (beginning in 2028) that

are more than nine years (for small-molecule drugs) or 13 years (for biological products) from their FDA approval, (ii) manufacturers

to pay a rebate for Medicare Part B and Part D drugs when prices increase faster than inflation beginning in 2022 for Medicare Part D

and 2023 for Medicare Part B drugs, and (iii) Medicare Part D redesign which replaces the current coverage gap provisions and establishes

a $2,000 cap for out-of-pocket limits costs for Medicare beneficiaries beginning in 2025, with manufacturers being responsible for 10%

of costs up to the $2,000 cap and 20% after that cap is reached.

Implementation of the IRA is expected to be carried out through upcoming

actions by regulatory authorities, the outcome of which is uncertain.

the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and

biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and

marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk

expect that the healthcare reform measures that have been adopted and may be adopted in the future, may result in more rigorous coverage

criteria and in additional downward pressure on the price that we receive for any approved product and could seriously harm our future

Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from

private third-party payors.

June 2016, the electorate in the UK voted in favor of leaving the EU (commonly referred to as “Brexit”), and the UK formally

left the EU on January 31, 2020.

There was a transition period during which EU pharmaceutical laws continued to apply to the UK, which

expired on December 31, 2020.

However, the EU and the UK have concluded a trade and cooperation agreement, or TCA, which was provisionally

applicable since January 1, 2021, and has been formally applicable since May 1, 2021.

The TCA includes specific provisions concerning

pharmaceuticals, which include the mutual recognition of GMP, inspections of manufacturing facilities for medicinal products and GMP

documents issued but does not foresee wholesale mutual recognition of UK and EU pharmaceutical regulations.

At present, Great Britain

has implemented EU legislation on the marketing, promotion, and sale of medicinal products through the Human Medicines Regulations 2012

(as amended) (under the Northern Ireland Protocol, the EU regulatory framework will continue to apply in Northern Ireland).

The regulatory

regime in Great Britain therefore largely aligns with current EU regulations, however it is possible that these regimes will diverge

in future now that Great Britain’s regulatory system is independent from the EU and the TCA does not provide for mutual recognition

of UK and EU pharmaceutical legislation.

have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal, and state levels directed at

broadening the availability of healthcare and containing or lowering the cost of healthcare.

The implementation of cost containment measures

or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product.

reforms could have an adverse effect on anticipated revenue from product candidates that we may successfully develop and for which we

may obtain regulatory approval and may affect our overall financial condition and ability to develop product candidates.

currently have 28 full-time employees, eight of whom are engaged in research and development activities, 16 are engaged in sales/marketing

operations and four of whom are engaged in general corporate and strategy roles.

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Interested persons can subscribe

on our website to email alerts that are sent automatically when we issues press releases, file reports with the SEC or post certain other

on our website to email alerts that are sent automatically when we issue press releases, file reports with the SEC or post certain other

information to our website.

12 unchanged sentences

our business.

business is adversely affected by the ongoing coronavirus pandemic and the impact could be material.

may have significant research, regulatory and development expenses as we advance our product candidates.

45 unchanged sentences

financial condition and results of operations.

Chief Executive Officer holds ownership interest in some of the third parties we have entered into agreements with.

The terms and

fee arrangements of these agreements, we believe, approximate the terms and fee arrangements of an agreement that would have been

obtained in an arm’s length and unaffiliated transaction.

Nonetheless, this may expose us to claims of interested transactions

and other fiduciary suits.

termination or suspension of, or delays in the commencement or completion of, any necessary studies of any of our product candidates

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

What changed 10-K

Item 1. Business