What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2021-06-29 compared with 2020-06-29 · 222 added, 186 removed, 639 unchanged (39% of the section changed)

We are a developmental stage

medical device company and have a history of significant operating losses;

we expect to continue to incur operating losses, and

we may never achieve or maintain profitability.

a developmental stage medical device company and have a history of significant operating losses;

we expect to continue to incur

operating losses, and we may never achieve or maintain profitability.

As a development-stage

28 unchanged sentences

However, we cannot assure you that our plans will be successful.

In light of the foregoing, there is

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

If we cannot continue as a viable entity, our stockholders

would likely lose most or all of their investment in us.

In light of the foregoing, there is substantial

doubt about our ability to continue as a going concern.

If we cannot continue as a viable entity, our stockholders would likely

lose most or all of their investment in us.

We have no revenues and substantial

indebtedness, which could adversely affect our business and financial position and, among other things, our ability to raise additional

capital and our ability to satisfy our financial obligations.

Because we are

a development stage company, we have not and do not anticipate generating any revenues for the foreseeable future.

we are dependent upon our ability to raise capital through sales of our debt and equity securities.

In connection

with our private placement completed in May 2021 (the 2021 Placement), we issued $6,560,000 aggregate principal amount of our

12% unsecured convertible promissory notes (the 2021 Notes), with each 2021 Note due 12 months from the issuance date.

we have substantial outstanding debt, which could adversely affect our business and financial position, and, among other things,

our ability to raise additional capital and our ability to satisfy our financial obligations, including interest and principal

payments on the 2021 Notes.

The impact of the indebtedness may include, but may not be limited to, the following:

our ability to borrow additional funds for working capital, capital expenditures, acquisitions,

or other general business purposes;

us to use a substantial portion of any future cash flow from operations and/or capital

raised to make debt service payments instead of other business purposes, thereby reducing

the amount of any future cash flow and/or capital raised available for future working

capital, capital expenditures, acquisitions, or other general business purposes;

our flexibility to plan for, or react to, changes in our business and industry;

us at a competitive disadvantage compared with our less-leveraged competitors;

our vulnerability to the impact of adverse economic, competitive, and industry conditions;

our cost of borrowing.

full effects of COVID-19 and other potential future public health crises, epidemics, pandemics or similar events are uncertain

9 unchanged sentences

and foreign government agencies to prevent disease spread, all of which are uncertain, out of our control and cannot be predicted.

In accordance

with applicable U.S.

governmental ordinances generally exempting essential businesses and/or critical infrastructure workforces

from mandated closures and orders to “shelter-in-place,”

we are operating in support of essential products and services,

subject to limitations and requirements in applicable state and county orders.

We have been complying with county and state orders

and have implemented a teleworking policy for our employees and contractors and significantly minimized the number of employees

who visit our office.

However, a facility closure, work slowdowns or temporary stoppage at one of our manufacturing suppliers

could occur, which could have a longer-term impact and could delay our prototype production and ability to conduct business.

been complying with county and state orders and, until May 2021, had implemented a teleworking policy for our employees and contractors

and significantly minimized the number of employees who visit our office.

However, a facility closure, work slowdowns or temporary

stoppage at one of our manufacturing suppliers could occur, which could have a longer-term impact and could delay our prototype

production and ability to conduct business.

workforce is unable to work effectively, including because of illness, quarantines, absenteeism, government actions, facility

13 unchanged sentences

We were recently able to raise additional

capital in a private placement that commenced in March 2020, however, we will need to raise additional capital to support our

capital in a private placement that commenced in February 2021, however, we will need to raise additional capital to support our

operations in the future.

11 unchanged sentences

business, we will need to raise substantial additional capital and/or enter into strategic partnerships or joint ventures to enable

clinical studies and seek regulatory approvals;

or access manufacturing and commercialization capabilities;

test, and, if approved, market our product;

or license additional internal systems and other infrastructure;

and support additional management, engineering and scientific personnel.

· fund clinical studies and

seek regulatory approvals;

· build or access manufacturing

and commercialization capabilities;

· develop, test, and, if approved,

market our product;

· acquire or license additional

internal systems and other infrastructure;

· hire and support additional

management, engineering and scientific personnel.

generate a sufficient amount of product revenue to finance our cash requirements, which we may never achieve, we expect to finance

38 unchanged sentences

Any equity financings will result in dilution and may contain other terms that are not favorable to our then-existing stockholders.

Although we currently do not have any debt financing, any sources of debt financing that we may obtain in the future may result

in a high interest expense.

We currently have debt financing, and any additional sources of debt financing that we may obtain in the future may result in

a high interest expense.

Any financing, if available, may be on unfavorable terms.

6 unchanged sentences

requirements will depend on many factors, including, but not limited to:

costs of our tests for our insulin pump product and other development activities conducted

by us directly, and our ability to successfully conclude the studies and activities and

achieve favorable results;

ability to attract future strategic partners to pay for or share costs related to our

product development efforts;

costs and timing of seeking and obtaining regulatory clearance and approvals for our

costs of filing, prosecuting, maintaining and enforcing any patents and other intellectual

property rights that we may have and defending against potential claims of infringement;

to hire additional scientific, engineering or administrative personnel or consultants;

ability to manage administrative and other costs of our operations;

presence or absence of adverse developments in our research program.

· the testing costs for our

insulin pump product and other development activities conducted by us directly, and our ability to successfully conclude the studies

and activities and achieve favorable results;

· our ability to attract future

strategic partners to pay for or share costs related to our product development efforts;

· the costs and timing of seeking

and obtaining regulatory clearance and approvals for our product;

· the costs of filing, prosecuting,

maintaining and enforcing any patents and other intellectual property rights that we may have and defending against potential

claims of infringement;

· decisions to hire additional

scientific, engineering or administrative personnel or consultants;

· our ability to manage administrative

and other costs of our operations;

· the presence or absence of

adverse developments in our research program.

If any of these

9 unchanged sentences

costs of compliance with laws, regulations, or judicial decisions applicable to us;

costs of general and administrative infrastructure required to manage our business and

protect corporate assets and shareholder interests

the costs of general and

administrative infrastructure required to manage our business and protect corporate assets and shareholder interests.

If we fail to

1 unchanged sentence

financial condition, and stock price, and we may even be forced to discontinue our operations and liquidate our assets.

See “Our

Business –

Keep costs low during our design and development process,”

Technological

21 unchanged sentences

conducting our business, which would adversely affect our operations and financial condition.

See “Our Business –

Employ experienced engineers, recruited, supervised and led by Mr.

DiPerna, a highly experienced respected engineer and executive

in the insulin pump industry.”

limited internal research and development personnel, making us dependent on consulting relationships.

56 unchanged sentences

not receive the necessary regulatory clearance or approvals for our insulin pump, and failure to timely obtain necessary clearances

and/or approvals could harm our then operations, including to commercialize our product.

and/or approvals could harm our then operations, including our ability to commercialize our product.

Before we can

10 unchanged sentences

To be “substantially equivalent,”

device must have the same intended use as the predicate device, and either have the same technological characteristics as the

predicate device or have different technological characteristics and not raise different questions of safety or effectiveness

than the predicate device.

the proposed device

must have the same intended use as the predicate device, and either have the same technological characteristics as the predicate

device or have different technological characteristics and not raise different questions of safety or effectiveness than the predicate

Certain future

13 unchanged sentences

delay, limit or deny clearance or approval for our insulin pump medical device for many reasons, including:

inability to demonstrate to the satisfaction of the FDA that our product is safe or effective

for its intended use;

disagreement of the FDA with the design or implementation of our clinical studies or

the interpretation of data from our clinical studies;

and unexpected adverse device effects experienced by participants in our clinical studies;

data from clinical studies may be insufficient to support clearance or approval, where

inability to demonstrate that the benefits of our pump outweigh the risks;

manufacturing process or facilities we intend to use may not meet applicable requirements;

potential for approval policies or regulations of the FDA to change significantly in

a manner rendering our data or regulatory filings insufficient for clearance or approval.

· our inability to demonstrate

to the satisfaction of the FDA that our product is safe or effective for its intended use;

· the disagreement of the FDA

with the design or implementation of our clinical studies or the interpretation of data from our clinical studies;

· serious and unexpected adverse

device effects experienced by participants in our clinical studies;

· the data from clinical studies

may be insufficient to support clearance or approval, where required;

· our inability to demonstrate

that the benefits of our pump outweigh the risks;

· the manufacturing process

or facilities we intend to use may not meet applicable requirements;

· the potential for approval

policies or regulations of the FDA to change significantly in a manner rendering our data or regulatory filings insufficient for

clearance or approval.

the FDA may change its clearance and approval policies, adopt additional regulations or revise existing regulations, or take other

34 unchanged sentences

Our competitors

product candidates and market products that increase the levels of safety or efficacy

that our product candidates will need to show in order to obtain regulatory approval;

product candidates and market products that are less expensive or more effective than

· commercialize

competing products before we can launch any products we are working to develop;

or obtain proprietary rights that could prevent us from commercializing our products;

therapies or market medical products that render our potential product candidates obsolete.

· develop product candidates

and market products that increase the levels of safety or efficacy that our product candidates will need to show in order to obtain

regulatory approval;

· develop product candidates

and market products that are less expensive or more effective than ours;

· commercialize competing products

before we can launch any products we are working to develop;

· hold or obtain proprietary

rights that could prevent us from commercializing our products;

· introduce therapies or market

medical products that render our potential product candidates obsolete.

compete against large medical device companies, such as Medtronic, Inc., Tandem Diabetes Care, Inc.

6 unchanged sentences

significantly greater experience in:

medical device and other product candidates;

· undertaking

testing and clinical studies;

relationships with key customers and opinion-leading physicians;

and maintaining FDA and other regulatory approvals;

· formulating

and manufacturing medical devices;

marketing and selling medical devices;

management oversight for all of the above-listed operational functions.

· developing medical device

and other product candidates;

· undertaking testing and clinical

· building relationships with

key customers and opinion-leading physicians;

· obtaining and maintaining

FDA and other regulatory approvals;

· formulating and manufacturing

medical devices;

· launching, marketing and

selling medical devices;

· providing management oversight

for all of the above-listed operational functions.

If we fail to

18 unchanged sentences

costs and loss of potential revenues.

See “Our Business –

Keep costs low during design and development process”

not be able to successfully scale-up manufacturing of our product in sufficient quality and quantity, which would delay or prevent

35 unchanged sentences

effect on our projected future operating results and our ability to raise capital, commercialize products, and remain in business.

See “Our Business –

Government Regulations”

subject to extensive regulation by the U.S.

18 unchanged sentences

which may include any of the following sanctions:

letters, warning letters, fines, injunctions, consent decrees and civil penalties;

notification, or orders for repair, replacement or refunds

or mandatory recall or seizure of our current or future products;

· administrative

detention by the FDA of medical devices believed to be adulterated or misbranded;

operating restrictions, suspension or shutdown of production;

our requests for 510(k) clearance or pre-market approval of any new products, new intended

uses or modifications to our insulin pump;

510(k) clearance that has already been granted;

· untitled letters, warning

letters, fines, injunctions, consent decrees and civil penalties;

· customer notification, or

orders for repair, replacement or refunds

· voluntary or mandatory recall

or seizure of our current or future products;

· administrative detention

by the FDA of medical devices believed to be adulterated or misbranded;

· imposing operating restrictions,

suspension or shutdown of production;

· refusing our requests for

510(k) clearance or pre-market approval of any new products, new intended uses or modifications to our insulin pump;

· rescinding 510(k) clearance

that has already been granted;

· criminal prosecution.

The occurrence

24 unchanged sentences

extensive testing required of us to obtain FDA approval.

See “Our Business –

Patents,”

are sued for infringing on third-party intellectual property rights, it will be costly and time-consuming, and an unfavorable

10 unchanged sentences

harm our competitive position, including, but not limited to:

· infringement

and other intellectual property claims that, even if meritless, can be costly and time-consuming,

delay the regulatory approval process and divert management’s attention from our

core business operations;

· substantial

damages for infringement, including consequential damages for lost of profits or market

share, if a court determines that our products or technologies infringe on a third party’s

patent or other proprietary rights;

court prohibiting us from selling or licensing our products or technologies unless the

holder licenses the patent or other proprietary rights to us, which it is not required

if a license is available from a holder, we may have to pay substantial royalties or

grant cross-licenses to our patents or other proprietary rights.

· infringement and other intellectual

property claims that, even if meritless, can be costly and time-consuming, delay the regulatory approval process and divert management’s

attention from our core business operations;

· substantial damages for infringement,

including consequential damages for lost of profits or market share, if a court determines that our products or technologies infringe

on a third party’s patent or other proprietary rights;

· a court prohibiting us from

selling or licensing our products or technologies unless the holder licenses the patent or other proprietary rights to us, which

it is not required to do;

· even if a license is available

from a holder, we may have to pay substantial royalties or grant cross-licenses to our patents or other proprietary rights.

If any of these

146 unchanged sentences

have a material adverse effect on our business.

See “Our Business –

Government Regulation”

are a “smaller reporting company”

and, as a result of the reduced disclosure and governance requirements applicable

to smaller reporting companies, our common stock may be less attractive to investors.

“smaller reporting company,”

and are subject to lesser disclosure obligations in our SEC filings compared to other

Specifically, “smaller reporting companies”

are able to provide simplified executive compensation disclosures

in their filings, are exempt from the provisions of Section 404(b) of the Sarbanes-Oxley Act requiring that independent registered

public accounting firms provide an attestation report on the effectiveness of internal control over financial reporting and have

certain other decreased disclosure obligations in their SEC filings, including, among other things, only being required to provide

two years of audited financial statements in annual reports.

Decreased disclosures in our SEC filings due to our status as a “smaller

a “smaller reporting company”

and, as a result of the reduced disclosure and governance requirements applicable to

smaller reporting companies, our common stock may be less attractive to investors.

We are a “smaller

reporting company,”

and are subject to lesser disclosure obligations in our SEC filings compared to other issuers.

Specifically,

“smaller reporting companies”

are able to provide simplified executive compensation disclosures in their filings,

are exempt from the provisions of Section 404(b) of the Sarbanes-Oxley Act requiring that independent registered public accounting

firms provide an attestation report on the effectiveness of internal control over financial reporting and have certain other decreased

disclosure obligations in their SEC filings, including, among other things, only being required to provide two years of audited

financial statements in annual reports.

Decreased disclosures in our SEC filings due to our status as a “smaller reporting

company”

may make it harder for investors to analyze our operating results and financial prospects.

shares of common stock are quoted on the OTC Pink Open Market, and there is no active trading market for our common stock.

of common stock are traded on the OTC Pink Open Market.

There is currently no trading market, and for over three years there has

not been any active trading market for our common stock.

There can be no assurance that an active trading market for our common

stock will develop, or, even if one develops, it will be sustained.

do not expect any cash dividends to be paid on our shares of common stock for the foreseeable future.

never declared or paid a cash dividend and we do not anticipate declaring or paying dividends on our common stock for the foreseeable

of common stock are quoted on the OTCQB Venture Market, and the trading market for our common stock is limited.

Our shares of

common stock are traded on the OTCQB Venture Market.

There is currently a limited trading market for our common stock, and, prior

to 2021, there had been no active trading market for our common stock.

While we believe an active trading market for our common

stock is developing, there can be no assurance that an active trading market for our common stock will develop, or, even if one

develops, it will be sustained.

not expect any cash dividends to be paid on our shares of common stock for the foreseeable future.

We have never

declared or paid a cash dividend and we do not anticipate declaring or paying dividends on our common stock for the foreseeable

We expect to use future financing proceeds and earnings, if any, to fund operating expenses.

1 unchanged sentence

only opportunity to achieve a return on their investment is if the price of our stock appreciates and they sell their shares at

We cannot assure stockholders of a positive return on their investment when they sell their shares or that stockholders

We cannot assure shareholders of a positive return on their investment when they sell their shares or that shareholders

will not lose the entire amount of their investment.

In addition, no dividend is permitted to be declared and/or paid on our shares

of common stock unless and until we have made all required dividend payments on the then-outstanding Series A Preferred Stock.

the beneficial ownership of our common stock continues to be highly concentrated, it may prevent our shareholders from influencing

beneficial ownership of our common stock continues to be highly concentrated, it may prevent our shareholders from influencing

significant corporate decisions.

agreement to elect directors.

31, 2021, our executive officers, directors and certain persons who may be deemed their affiliates beneficially owned substantially

1 unchanged sentence

As a result, such persons may exercise substantial influence over

the outcome of corporate actions requiring stockholder approval including, without limitation, the election of directors, certain

the outcome of corporate actions requiring shareholder approval including, without limitation, the election of directors, certain

mergers, consolidations and sales of all or substantially all of our assets or any other significant corporate transactions.

persons may also vote against a change of control, even if such a change of control would benefit our other shareholders.

pursuant to the July 2017 Acquisition Agreement, until July 24, 2022, our board of directors will consist of no less than two

and no more than five directors, of which Mr.

DiPerna, in addition to being our chairman, has the right to appoint two additional

directors, which Manchester has the right to appoint two directors, of which Mr.

DiPerna approved William Febbo and Liam Burns

and Manchester approved Mr.

Frank and Carmen Volkart.

As a result of such agreement, until July 24, 2022, other shareholders will

not have the ability to elect any directors either at the annual meeting or by written consent, even if such other shareholders

believe that our board of directors is taking actions to which the shareholders object.

of our common stock by shareholders could encourage short sales by third parties, which could contribute to the further decline

19 unchanged sentences

filer, which requires the market value of our common stock that is held by non-affiliates to exceed $700.0 million as of the prior

June 30 th , and (ii) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior

three-year period.

September 30 th , and (ii) the date on which we have issued more than $1.0 billion in non-convertible debt during the

prior three-year period.

common stock may be classified as “penny stock”

1 unchanged sentence

stock regulations.

stock is traded on the OTC Pink Open Market.

stock is traded on the OTCQB Venture Market.

Rules 15g-1 through 15g-9 promulgated under the Securities Exchange Act impose sales

41 unchanged sentences

of directors has the authority to designate and issue up to 5,000,000 shares of our preferred stock without further shareholder

approval, of which 2,000,000 of such shares have been authorized by our board of directors to be designated as Series A Preferred

Stock and are being offered for sale in our ongoing preferred stock public offering.

In the future, our board of directors could

authorize the issuance of one or more additional series of preferred stock that would grant to holders the preferred right to

our assets upon liquidation, the right to receive dividend payments before dividends are distributed to the holders of common

stock and the right to the redemption of the shares, together with a premium, prior to the redemption of our common stock.

addition, our board of directors could authorize the issuance of a series of preferred stock that has greater voting power than

our common stock or that is convertible into our common stock, which could decrease the relative voting power of our common stock

or result in dilution to our existing shareholders.

we are unable to effectively implement or maintain a system of internal control over financial reporting, we may not be able to

accurately or timely report our financial results and our stock price could be adversely affected.

404 of the Sarbanes-Oxley Act of 2002 and related regulations require our management to evaluate the effectiveness of our internal

In the future, our board of directors could authorize the issuance of one or more series of preferred stock that would

grant to holders, among other rights, the preferred right to our assets upon liquidation, the right to receive dividend payments

before dividends are distributed to the holders of common stock and the right to the redemption of our preferred shares acquired

by such persons, together with a premium, prior to the redemption of our common stock.

In addition, our board of directors could

authorize the issuance of a series of preferred stock that has greater voting power than our common stock or that is convertible

into our common stock, which could decrease the relative voting power of our common stock or result in dilution to our existing

shareholders.

have not held regular annual meetings of shareholders in the past, and if we are required by the Nevada District Court to hold

an annual meeting pursuant to Nevada Revised Statutes §78.345(1), it could result in the unanticipated expenditure of funds,

time and other Company resources.

2.01 of our Amended Bylaws provides that an annual meeting of shareholders shall be held each year on a date and at a time designated

by our board of directors.

Section 78.345(1) of the Nevada Revised Statutes provides that, if there is a failure to hold the annual

meeting for a period of 18 months after the last election of directors, shareholders owning at least 15% of the voting power of

the outstanding common stock may apply to the Nevada district court to order the election of directors.

We have not held regular

annual meetings of shareholders in the past because approximately 75% of our voting stock is owned by our largest shareholders,

thereby making it easy to obtain written consent in lieu of a meeting when necessary.

Moreover, handling matters by written consent

allows us to save on financial and administrative resources required to prepare for and hold such annual meetings.

To our knowledge,

no shareholder or director has requested our management to hold such an annual meeting and no shareholder or director has applied

to the Nevada district court seeking an order directing us to hold such an annual meeting of shareholders.

However, if one or

more shareholders or directors were to apply to the Nevada district court seeking such an order, and if the Nevada district court

were to order an annual meeting before we were prepared to hold one, the preparation for an annual meeting of shareholders and

the meeting itself could result in the unanticipated expenditure of funds, time, and other resources of ours.

we fail to establish and maintain an effective system of internal controls, we may not be able to report our financial results

accurately or prevent fraud.

Any inability to report and file our financial results accurately and timely could harm our reputation

and adversely affect the trading price of our common stock.

internal controls are necessary for us to provide reliable financial reports and prevent fraud.

If we cannot provide reliable

financial reports or prevent fraud, we may not be able to manage our business as effectively as we would if an effective control

environment existed, and our business and reputation with investors may be harmed.

If we are unable to maintain effective internal controls, we may not have adequate, accurate or timely financial information,

and we may be unable to meet our reporting obligations as a public company, including the requirements of the Sarbanes-Oxley

Act of 2002 (the Sarbanes-Oxley Act).

In addition, we may be unable to accurately report our financial results in future periods,

or report them within the timeframes required by the requirements of the SEC or the Sarbanes-Oxley Act.

Failure to comply

with the Sarbanes-Oxley Act, when and as applicable, could also potentially subject us to sanctions or investigations by

the SEC or other regulatory authorities.

Any failure to maintain or implement required new or improved controls, or any difficulties

we encounter in their implementation, could result in identification of additional material weaknesses or significant deficiencies,

cause us to fail to meet our reporting obligations or result in material misstatements in our financial statements.

Section 404 of the Sarbanes-Oxley Act and related regulations require our management to evaluate the effectiveness of our internal

control over financial reporting as of the end of each fiscal year.

Based on its evaluations, our management concluded that there

were material weaknesses in our internal control over financial reporting and management concluded that our internal controls

over financial reporting were not effective as of March 31, 2019.

Such material weaknesses related to inadequate internal controls

over financial reporting, and the lack of segregation of duties in our financial reporting process.

Specifically, management noted

that we do not have a separately designated audit committee or an independent director.

Thereafter, during fiscal 2020, we implemented

remediation activities to address such weaknesses, including appointing new independent directors to our board of directors and

forming an audit committee.

While we believe we have remediated these material weaknesses, such that management determined that

our internal controls over financial reporting were effective as of March 31, 2020, we cannot assure that, in the future, a material

weakness or significant deficiency will not exist or otherwise be discovered.

If that were to happen, it could harm our operating

results and cause shareholders to lose confidence in our reported financial information.

Any such loss of confidence would have

a negative effect on the trading price of our securities.

Based on its evaluation, our management concluded that our

internal controls over financial reporting were effective as of March 31, 2021.

We cannot provide assurance that, in the future,

a material weakness or significant deficiency will not exist or otherwise be discovered.

If that were to happen, it could harm

our operating results and cause shareholders to lose confidence in our reported financial information.

Any such loss of confidence

would have a negative effect on the trading price of our securities.

board of directors is able to adopt recapitalizations through forward or reverse splits of our outstanding shares of common stock

6 unchanged sentences

effect on them.

Series A Preferred Stock has required annual dividend payments and senior liquidation rights to our common stock.

we will escrow at each closing of our preferred stock public offering, three years of 13% dividend payments for each share of

Series A Preferred Stock sold therein, which escrow funds will be used to pay three years of dividend payments on outstanding

shares of our Series A Preferred Stock, following such three-year period, we will be required to make such dividend payments from

funds then available to us.

Additionally, we may elect in our discretion to redeem a portion or all of any then outstanding Series

A Preferred Stock following the date three years from the closing of such offering to the extent we have funds available to use

for such purposes.

Our failure to make required dividend payments would result in a breach of our obligations to the holders thereof.

Moreover, upon any liquidation and/or similar events of us, we are required to make liquidation payments of $25.00 plus any accrued,

but unpaid, dividends to holders of the then-outstanding Series A Preferred Stock prior to making any such payments to the holders

of then outstanding shares of our common stock.

UNRESOLVED STAFF COMMENTS

4 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