What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2020-10-01 compared with 2019-10-15 · 138 added, 102 removed, 1075 unchanged (18% of the section changed)

7 unchanged sentences

RELATED TO OUR FINANCIAL CONDITION AND OUR NEED FOR ADDITIONAL CAPITAL

independent registered public accounting firm has expressed concerns about our ability to continue as a going concern.

to continue as a going concern is in substantial doubt absent obtaining adequate new debt or equity financings.

report of our independent registered public accounting firm expresses concern about our ability to continue as a going concern

based on the absence of revenues, recurring losses from operations and our need for additional financing to fund all of our operations.

Working capital limitations continue to impinge on our day-to-day operations, thus contributing to continued operating losses.

For the fiscal years ended June 30, 2019 and June 30, 2018, we had net losses of $5,758,369 and $7,039,155, respectively.

as of June 30, 2019, we had $2,394 in cash and had an accumulated deficit of $51,041,047.

ability to continue as a going concern is in substantial doubt absent obtaining adequate new debt or equity financings.

We have concerns about

our ability to continue as a going concern based on the absence of revenues, recurring losses from operations and our need for

additional financing to fund all of our operations.

Working capital limitations continue to impinge on our day-to-day operations,

thus contributing to continued operating losses.

For the fiscal years ended June 30, 2020 and June 30, 2019, we had net losses

of $4,740,723 and $5,758,369, respectively and used cash in operations of $1,849,589 and $2,060,037.

Further, as of June

30, 2020, we had $67,007 in cash and had an accumulated deficit and a stockholders’

deficit of $55,781,770

and $3,641,425 respectively.

upon our current business plan, we will need considerable cash investments to have the opportunity to be successful.

7 unchanged sentences

of your investment in our common stock.

face risks related to Novel Coronavirus (COVID-19) which could significantly disrupt our research and development, operations,

sales, and financial results.

business will be adversely impacted by the effects of the Novel Coronavirus (COVID-19).

In addition to global macroeconomic effects,

the Novel Coronavirus (COVID-19) outbreak and any other related adverse public health developments will cause disruption to our

operations, research and development, and sales activities.

Our third-party manufacturers, third-party distributors, and our customers

have been and will be disrupted by worker absenteeism, quarantines and restrictions on employees’

ability to work, office

and factory closures, disruptions to ports and other shipping infrastructure, border closures, or other travel or health-related

restrictions.

Depending on the magnitude of such effects on our activities or the operations of our third-party manufacturers

and third-party distributors, the supply of our products will be delayed, which could adversely affect our business, operations

and customer relationships.

In addition, the Novel Coronavirus (COVID-19) or other disease outbreak will in the short-run and

may over the longer term adversely affect the economies and financial markets of many countries, resulting in an economic downturn

that will affect demand for our products and impact our operating results.

There can be no assurance that any decrease in sales

resulting from the Novel Coronavirus (COVID-19) will be offset by increased sales in subsequent periods.

Although the magnitude

of the impact of the Novel Coronavirus (COVID-19) outbreak on our business and operations remains uncertain, the continued spread

of the Novel Coronavirus (COVID-19) or the occurrence of other epidemics and the imposition of related public health measures

and travel and business restrictions will adversely impact our business, financial condition, operating results and cash flows.

In addition, we have experienced and will experience disruptions to our business operations resulting from quarantines, self-isolations,

or other movement and restrictions on the ability of our employees to perform their jobs that may impact our ability to develop

and design our products in a timely manner or meet required milestones or customer commitments.

have incurred significant losses since our inception.

2 unchanged sentences

inception, we have incurred significant operating losses.

Our net loss was $5,758,369 and $7,039,155, respectively, for the fiscal

years ended June 30, 2019 and June 30, 2018.

As of June 30, 2019, we had a deficit accumulated during the development phase of

To date, we have not generated any revenues and have financed most of our operations with funds obtained from private

Our net loss was $4,740,723 and $5,758,369, respectively, for

the fiscal years ended June 30, 2020 and June 30, 2019.

As of June 30, 2020, we had a deficit accumulated of $55,781,770.

we have not generated any revenues and have financed most of our operations with funds obtained from private financings.

October 2007, we have devoted substantially all of our efforts to research and development of our product candidates, particularly

60 unchanged sentences

on a favorable basis or is eliminated.

of June 30, 2019, the total amount of debt outstanding under these convertible notes, including interest, is approximately $1,177,000

(not including redemption premium).

Please see the section captioned “Management’s Discussion of Financial Condition

and Results of Operations - Recent Developments”

As of June 30, 2020, the

total amount of debt outstanding under these convertible notes, including interest, is approximately $1,100,000 (not including

redemption premium).

Please see the section captioned “Management’s Discussion of Financial Condition and Results

of Operations - Recent Developments”

for further information

52 unchanged sentences

interests of existing stockholders.

As of June 30, 2019, we had 10 outstanding notes convertible into up 1,810,347 shares of our

common stock (based on then applicable conversion prices).

Each holder of the notes has agreed to a 4.99% beneficial ownership

conversion limitation (subject to certain noteholders’

As of June 30, 2020, we had 11 outstanding notes convertible into approximately 439,113,000

shares of our common stock (based on then applicable conversion prices).

Each holder of the notes has agreed to a 4.99% beneficial

ownership conversion limitation (subject to certain noteholders’

ability to increase such limitation to 9.99% upon 60 days’

343 unchanged sentences

and released for clinical trials.

We have spent a total of $1,689,146 as of June 30, 2019 under the MSA.

The MSA shall continue

for a term of three years unless extended by mutual agreement in writing.

Either party to the MSA has the right to terminate the

MSA by written notice to the other party if the other party commits a material breach of the MSA (subject to a 30-day cure period).

If we are not current with payments to Amatsigroup and Amatsigroup terminates the MSA or suspends its manufacturing services to

us, this adversely affect our supply of PRP and result in harm to our business and results of operations.

The Company has spent a total of $1,689,146 of costs to date under this contract of which

$49,854 was expensed in fiscal 2019, $701,973 in fiscal 2018 and $937,319 in fiscal 2017.

The MSA shall continue for a term

of three years unless extended by mutual agreement in writing.

Either party to the MSA has the right to terminate.

MSA expired in 2019 and may be extended by mutual agreement in writing with a possible extension currently under consideration.

If we are not current with payments to Amatsigroup and Amatsigroup terminates the MSA or suspends its manufacturing services

to us, this adversely affect our supply of PRP and result in harm to our business and results of operations.

reliance on a third party increases the risk that we will not have sufficient quantities of PRP on hand at any given time, which

43 unchanged sentences

similar or identical to ours, and our ability to successfully commercialize our technology and products may be adversely affected.

have obtained patent protection for PRP in twenty-nine countries, and have a patent application either pending or under examination

in two others, Brazil and Canada.

Our future success depends in large part on our and, as applicable, our licensors’, ability

to obtain and maintain patent protection in the United States and other countries with respect to our proprietary technology.

have obtained patent protection for PRP in thirty-two countries and have a further thirty-three patent applications either pending

or under examination in major global jurisdictions.

Our future success depends in large part on our and, as applicable, our licensors’,

ability to obtain and maintain patent protection in the United States and other countries with respect to our proprietary technology.

We cannot be certain that patents will be issued in those countries where our applications are still under examination.

282 unchanged sentences

within the UK.

March 29, 2017, the UK invoked Article 50 of Lisbon Treaty to initiate complete withdrawal from the European Union to a date yet

to be determined, and therefore, the regulatory drug approval process in that country may be significantly different from the

current drug regulatory policies in the European Union.

We currently are considering holding our clinical trials in the UK, among

other countries, and therefore this event could significantly impact our efforts to successfully bring PRP to market.

yet possible for us to determine the impact of the UK’s withdrawal from the European Union, but any additional costs or

delays in obtaining approvals may hinder our ability to conduct clinical trials or market PRP in the UK.

March 29, 2017, the UK invoked Article 50 of Lisbon Treaty to initiate complete withdrawal from the European Union which was

effected on January 31, 2020, and therefore, the regulatory drug approval process in that country may be significantly different

from the current drug regulatory policies in the European Union.

We currently are considering holding our clinical trials in the

UK, among other countries, and therefore this event could significantly impact our efforts to successfully bring PRP to market.

It is not yet possible for us to determine the impact of the UK’s withdrawal from the European Union, but any additional

costs or delays in obtaining approvals may hinder our ability to conduct clinical trials or market PRP in the UK.

RELATING TO EMPLOYEE MATTERS AND MANAGING GROWTH

2 unchanged sentences

are highly dependent on our management team, specifically Mr.

James Nathanielsz, our Chief Executive Officer, Chief Financial

Officer, Acting Chairman, Secretary, Treasurer and a director, and Dr.

Julian Kenyon, our director who also serves as our chief

scientific officer in a non-executive officer capacity.

While we have a current employment agreement with Mr.

Nathanielsz and

a director agreement with Dr.

Kenyon, both such employment agreement and director agreement permit each of the respective parties

thereto to terminate such agreements upon notice.

If we lose this key employee and/or the services of our other director, our

business will suffer and we may have to cease operations.

James Nathanielsz, our Chief Executive Officer, Acting Chairman,

Secretary, Treasurer and a director;

Julian Kenyon, our director who also serves as our chief scientific officer in

a non-executive officer capacity, and Mr Carlo Campiciano our Chief Financial Officer.

While we have a current employment

agreement with Mr.

Nathanielsz and a director agreement with Dr.

Kenyon, both such employment agreement and director agreement

permit each of the respective parties thereto to terminate such agreements upon notice.

If we lose this key employee and/or the

services of our other director, our business will suffer and we may have to cease operations.

and retaining qualified scientific, clinical, manufacturing and sales and marketing personnel will also be critical to our future

24 unchanged sentences

in material misstatements in our consolidated financial statements in future periods.

connection with the audits of our consolidated financial statements for the fiscal years ended June 30, 2019 and 2018, we identified

certain deficiencies relating to our internal control over financial reporting that constitute a material weakness under standards

established by the Public Company Accounting Oversight Board (the “PCAOB”).

The PCAOB defines a material weakness

as a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable

possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or

detected on a timely basis.

A deficiency in internal control exists when the design or operation of a control does not allow management

or employees, in the normal course of performing their assigned functions, to prevent or detect misstatements on a timely basis.

connection with the audits of our consolidated financial statements for the fiscal years ended June 30, 2020 and 2019,

we identified certain deficiencies relating to our internal control over financial reporting that constitute a material weakness

under standards established by the Public Company Accounting Oversight Board (the “PCAOB”).

The PCAOB defines a material

weakness as a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a

reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be

prevented or detected on a timely basis.

A deficiency in internal control exists when the design or operation of a control does

not allow management or employees, in the normal course of performing their assigned functions, to prevent or detect misstatements

on a timely basis.

following material weaknesses in our internal control over financial reporting continued to exist at June 30, 2020:

11 unchanged sentences

knowledge of U.S.

outsource the functions that would normally be performed by a principal financial officer to assist us in implementing the necessary

financial controls over the financial reporting and the utilization of internal management and staff to effectuate these controls.

outsource certain functions that would normally be performed by a principal financial officer to assist us in implementing

the necessary financial controls over the financial reporting and the utilization of internal management and staff to effectuate

these controls.

believe that these material weaknesses primarily relate, in part, to our lack of sufficient staff with appropriate training in

4 unchanged sentences

plan to take a number of actions in the future to correct these material weaknesses including, but not limited to, establishing

an audit committee of our board of directors comprised of at least two independent directors, adding experienced accounting and

financial personnel and retaining third-party consultants to review our internal controls and recommend improvements, subject

to receiving sufficient additional capital.

If we receive sufficient capital, we hope to hire a part- or full-time chief financial

officer as the first step in building out our accounting department.

We will need to take additional measures to fully mitigate

these issues, and the measures we have taken, and expect to take, to improve our internal controls may not be sufficient to (1)

address the issues identified, (2) ensure that our internal controls are effective or (3) ensure that the identified material

weakness or other material weaknesses will not result in a material misstatement of our annual or interim financial statements.

an audit committee of our board of directors comprised of at least two independent directors, adding additional experienced

accounting and financial personnel and retaining third-party consultants to review our internal controls and recommend improvements,

subject to receiving sufficient additional capital.

If we receive sufficient capital, we hope to increase the chief financial

officer’s role from part-time to full-time as the next step in building out our accounting department.

need to take additional measures to fully mitigate these issues, and the measures we have taken, and expect to take, to improve

our internal controls may not be sufficient to (1) address the issues identified, (2) ensure that our internal controls are effective

or (3) ensure that the identified material weakness or other material weaknesses will not result in a material misstatement of

our annual or interim financial statements.

In addition, other material weaknesses may be identified in the future.

If we are unable to correct deficiencies in internal controls

in a timely manner, our ability to record, process, summarize and report financial information accurately and within the time

periods specified in the rules and forms of the SEC will be adversely affected.

This failure could negatively affect the market

price and trading liquidity of our common stock, cause investors to lose confidence in our reported financial information, subject

us to civil and criminal investigations and penalties, and generally materially and adversely impact our business and financial

unable to correct deficiencies in internal controls in a timely manner, our ability to record, process, summarize and report financial

information accurately and within the time periods specified in the rules and forms of the SEC will be adversely affected.

failure could negatively affect the market price and trading liquidity of our common stock, cause investors to lose confidence

in our reported financial information, subject us to civil and criminal investigations and penalties, and generally materially

and adversely impact our business and financial condition.

do not have any independent directors, which represents a potential conflict of interest, and helps create a material weakness

69 unchanged sentences

all of our assets are located outside of the United States.

In addition, our Chief Executive Officer, James Nathanielsz, resides

in Australia and our other director, Dr.

Julian Kenyon, resides in the UK.

As a result, it may be difficult for you to effect

service of process within the United States upon these persons.

It is uncertain whether the courts of Australia or the UK would

recognize or enforce judgments of the United States or state courts against us or such persons predicated upon the civil liability

provisions of the laws of the United States or any state.

In addition, our Chief Executive Officer, James Nathanielsz, and

our Chief Financial Officer, Carlo Campiciano, reside in Australia and our other director, Dr.

Julian Kenyon, resides in the

As a result, it may be difficult for you to effect service of process within the United States upon these persons.

It is uncertain

whether the courts of Australia or the UK would recognize or enforce judgments of the United States or state courts against us

or such persons predicated upon the civil liability provisions of the laws of the United States or any state.

RELATED TO OUR COMMON STOCK

2 unchanged sentences

trading price of our common stock may continue to be highly volatile.

For example, the closing price of our stock during a short

period of time from August 24, 2018 to September 5, 2018, fluctuated between a low of $2.00 and a high of $129.95.

Our stock price

could continue to be subject to wide fluctuations in response to a variety of factors, including the following:

Our stock price could continue to be subject to wide fluctuations

in response to a variety of factors, including the following:

or anticipated results of our clinical trials;

52 unchanged sentences

calendar days.

On May 14, 2019, the OTCQB informed us that the bid price for our common stock has closed below $0.01 for more

than 30 consecutive calendar days, and therefore, our common stock no longer meets the Standards for Continued Eligibility for

The OTCQB has granted us a cure period of 90 calendar days from such date during which the minimum closing bid price of

our common stock must be $0.01 or greater for ten consecutive trading days in order for our common stock to continue trading on

On July 2, 2020, the OTCQB informed us that the bid price for our common stock has closed below $0.01 for

more than 30 consecutive calendar days, and therefore, our common stock no longer meets the Standards for Continued Eligibility

The OTCQB has granted us a cure period of 90 calendar days from such date (being September 29, 2020) during

which the minimum closing bid price of our common stock must be $0.01 or greater for ten consecutive trading days in order for

our common stock to continue trading on the OTCQB.

management determined that a Reverse Stock Split would allow us to satisfy such minimum closing price requirement for the duration

of the required period.

Our Reverse Stock Split occurred on June 24, 2019, within the 90 calendar day cure period allowing the

Company to meet the minimum closing bid test of $0.01 per share following the Reverse Stock Split.

On August 22, 2020 we submitted a Form 14C to Finra to affect a 1:1000 reverse split of the Company’s

The application has progressed and there are no matters outstanding that have not been addressed by the Company and as

such we believe that the application is in the final stages of approval by Finra.

At the date of this report it is unlikely that

the reverse split will be affected by the deadline of September 29, 2020, as such it is likely that the Company’s stock

will be removed from the OTCQB marketplace and will move to the Pink market.

In the event that the Company’s stock is removed

from the OTCQB market, the Company will reapply for quotation on the OTCQB market as soon as the reverse split is affected.

our directors and officers currently and for the foreseeable future will continue to control our Company, it is not likely that

19 unchanged sentences

are authorized to issue up to 1,000,000,000 shares of our common stock, $0.001 par value per share.

We have the right to raise additional

capital or incur borrowings from third parties to finance our business.

The board of directors has the authority, without the

consent of any of the shareholders, to cause us to issue more shares of our common stock and/or securities convertible into our

common stock.

We have the right to raise

additional capital or incur borrowings from third parties to finance our business.

The board of directors has the authority, without

the consent of any of the shareholders, to cause us to issue more shares of our common stock and/or securities convertible into

our common stock.

We will likely issue additional shares of our common stock and/or such securities in the future and such future

52 unchanged sentences

financial prospects.

will remain a smaller reporting company until the beginning of a fiscal year in which we had a public float of $250 million held

by non-affiliates as of the last business day of the second quarter of the prior fiscal year, assuming our common stock is registered

under Section 12 of the Exchange Act on the applicable evaluation date.

Even if we remain a smaller reporting company, if our

public float exceeds $75, we will become subject to the provisions of Section 404(b) of the Sarbanes-Oxley Act.

We will remain a smaller

reporting company until we have a public float of $250 million held by non-affiliates or our annual revenues are

greater than $100 million.

risks above do not necessarily comprise of all those associated with an investment in our Company.

7 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