What changed in this filing

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Item 1. Business

2020-10-01 compared with 2019-10-15 · 172 added, 93 removed, 1188 unchanged (18% of the section changed)

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Report except as the context otherwise requires.

prepare our financial statements in United States dollars and in accordance with generally accepted accounting principles as applied

in the United States, (“U.S.

prepare our consolidated financial statements in United States dollars and in accordance with generally accepted accounting

principles as applied in the United States, (“U.S.

GAAP”).

In this Annual Report, references to “$”

and “dollars”

“dollars”

are to United States dollars.

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of our technology, over the last year we have conducted successful pre-clinical studies on PRP and subject to us receiving adequate

financing, hope to submit a clinical trial application in the fourth calendar quarter of 2019.

We intend to develop our PRP to

treat early-stage cancer and pre-cancerous diseases and as a preventative measure for patients at risk of developing cancer based

on genetic screening.

financing, hope to submit a clinical trial application in the first half of 2021.

We intend to develop our PRP to treat early-stage

cancer and pre-cancerous diseases and as a preventative measure for patients at risk of developing cancer based on genetic screening.

Research and Development Highlights:

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Medicinal Product Dossier to be submitted in connection with our anticipated first clinical trial for PRP, which we expect

will be conducted in the UK, Europe or Australia.

will be conducted in Australia.

Drug Designation :

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several of which have been granted while others remain pending.

In the U.S., we have been issued one patent to date (No.

Our most recent notification of allowance was allowed in the United States in March 2019.

Our patent protection extends to

both PRP’s mechanism of action and the new compositions of proenzymes.

In the U.S., we have been issued two patents to date

9,636,359 and 10,350,239).

A further application has been filed and an Examiner’s first report expected by May

Our patent protection extends to both PRP’s mechanism of action and the new compositions of proenzymes.

and development expenses:

During the fiscal years ended June 30, 2019 and 2018, we have spent $260,335 and $1,825,728,

respectively, on research and development expenses.

Historically, we have assumed all of the costs associated with research

and development.

In September 2018, we entered into a two-year joint collaboration agreement with the Jaén University,

which is based in Andalucía, Spain, to assist us in expanding our product pipeline by discovering new compounds based

on trypsinogen and chymotrypsinogen.

During the fiscal years ended June 30, 2020 and 2019, we have spent $179,987 and $260,335, respectively,

on research and development expenses.

Historically, we have assumed all of the costs associated with research and development.

In September 2018, the Company entered into a two-year collaboration agreement with the University of Jaén (the “University”)

to provide certain research services to the Company.

In consideration of such services, the Company agreed to pay the University

approximately 52,000 Euros ($59,508 USD) in year one of which 31,754 Euros ($36,117 USD) was paid in fiscal 2019

and 15,410 Euros ($17,331 USD) was accrued in fiscal 2020;

and a maximum of 40,000 Euros ($45,775 USD) in year two.

Additionally, in exchange for full ownership of the intellectual property the Company agreed to pay royalties of 2% of net

revenues to the University.

In August 2019, we announced that we have

developed a method to quantify the active ingredients of our lead product candidate, PRP, in preparation for the

company’s First-In-Human (“FIH”) study, planned for the second half of 2021 calendar year.

was conducted by Propanc’s research partner based in Berlin, Germany, who has extensive experience in the development

of functional assays for unique bio-therapeutics.

This bioanalytical method development and validation plays a significant

role in evaluation and interpretation of the systemic absorption of PRP in clinical studies including its distribution, and

clinical effects throughout the body.

The development of the bioanalytical assay is also an important step for the clinical

development of PRP, as Propanc evaluates sites to conduct the FIH study in advanced cancer patients, such as the Peter Mac

Center, Australia’s largest cancer hospital, which has significant experience in early stage clinical development.

Validation of the bioanalytical method will be undertaken in 2021.

November 2019, we announced today that our POP1 research and drug discovery program has made significant advancements towards

producing synthetic versions of the two proenzymes, trypsinogen and chymotrypsinogen.

With the aim of producing large quantities

of trypsinogen and chymotrypsinogen for commercial use, exhibiting minimal variation between lots and without sourcing the proenzymes

from animals, the Company is undertaking a challenging research project in collaboration with the universities of Jaén

The two active ingredients are currently naturally derived from animal sources, which combine to form our lead product

candidate, PRP.

Our vision is to produce a backup product candidate to PRP which can further stabilize and enhance the effects

of the proenzymes when administered to patients.

At the research laboratories at the universities of Jaén and Granada,

scientific researchers are in the process of optimizing conditions to achieve high titers of recombinant trypsinogen and chymotrypsinogen

with this expression system.

January 2020, we announced that a Certificate for Advance Overseas Finding was received from the Board of Innovation and Science

Australia to receive up to a 43.5% “cash back”

benefit from overseas R&D expenses.

The finding relates to the

planned Phase 1 clinical trial –

Multiple Ascending Dose Studies of proteolytic proenzymes for the treatment of pancreatic

Overseas activities to be undertaken include the development of an analytical assay for the quantification of active pharmaceutical

ingredients in the Company’s lead product candidate, PRP, and its manufacture of the finished product for the Phase 1 clinical

were originally incorporated in Melbourne, Victoria Australia on October 15, 2007 as Propanc PTY LTD and continue to be based

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that occurred on June 24, 2019.

February 4, 2020, we filed a Certificate of Amendment to our Certificate of Incorporation to increase the number of

authorized shares of our common stock from 100,000,000 to 1,000,000,000 which was effected on March 13,

Milestones for Propanc

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trials, and in the future targeting other cancer types as our product candidate progresses to commercialization.

early 2008, a research collaborative partnership was established with Professor David Tosh at the Center for Regenerative

Medicine, Department of Biology and Biochemistry at Bath University, to investigate the molecular mechanisms by which the

proenzyme formulation is acting, which resulted in us filing two provisional patents a year later.

We undertook additional

scientific research with Professor Tosh, Dr.

Macarena Perán, Department of Health Sciences at Jaén University,

Juan Antonio Marchal, Biopathology and Regenerative Medicine Institute at Granada University.

Important anti-cancer

effects of the proenzymes were discovered, including triggering cell necrosis (cell death) and apoptosis (programmed cell

death) and significantly, the induction of cell differentiation (i.e.

In early 2008, a research collaborative partnership

was established with Professor David Tosh at the Center for Regenerative Medicine, Department of Biology and Biochemistry

at Bath University, to investigate the molecular mechanisms by which the proenzyme formulation is acting, which resulted in

us filing two provisional patents a year later.

We undertook additional scientific research with Professor Tosh, Dr.

Perán, Department of Health Sciences at Jaén University, and Dr.

Juan Antonio Marchal, Biopathology and Regenerative

Medicine Institute at Granada University.

Important anti-cancer effects of the proenzymes were discovered, including triggering

cell necrosis (cell death) and apoptosis (programmed cell death) and significantly, the induction of cell differentiation

inducing cancer cells to exhibit normal cell behavior).

This led to us increasing our intellectual property base and patent new pharmaceutical compositions designed to enhance the

effects of proenzymes.

Subsequently, two provisional patents were combined into one Patent Cooperation Treaty (“PCT”)

Application, filed on October 22, 2010 (PCT Application), and then a year later, we completed a 30 month national phase filing

deadline for an international patent and commenced entering the national phase in countries around the world.

have received grant status in Australia, China, Japan, Indonesia, Israel, New Zealand, Singapore and South Africa and our

application remains under examination in Brazil, Canada, the European Union, Malaysia, Mexico and the Republic of Korea.

the United States, one patent has been issued to date by the United States Patent and Trademark Office (No.

9,636,359) while

another remains pending.

We also have a second PCT application for our proenzyme composition that is pending as well two other

applications filed and pending in Spain.

This led to us increasing our intellectual property base and

patent new pharmaceutical compositions designed to enhance the effects of proenzymes.

Subsequently, two provisional patents

were combined into one Patent Cooperation Treaty (“PCT”) Application, filed on October 22, 2010 (PCT Application),

and then a year later, we completed a 30 month national phase filing deadline for an international patent and commenced entering

the national phase in countries around the world.

Thus far, we have received grant status in Australia, China, Japan, Indonesia,

Israel, New Zealand, Singapore and South Africa and our application remains under examination in Brazil, Canada, the European

Union, Malaysia, Mexico and the Republic of Korea.

In the United States, two patents have been issued

to date by the United States Patent and Trademark Office (No.

9,636,359 and No.

10,350,239) while another remains pending.

We also have another 3 PCT applications for proenzyme compositions that have entered national phase in major global jurisdictions.

late 2010, we made important discoveries and scientific observations, resulting in additional composition claims, which were

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country, according to where intellectual property protection is sought.

September 2018, we entered into a two-year collaboration agreement with the University of Jaén to provide certain research

services to us.

In consideration of such services, we agreed to pay the university approximately 52,000 Euros ($60,762 USD)

in year one and a maximum of 40,000 Euros ($46,740 USD) in year two.

Additionally, in exchange for full ownership of the intellectual

property we agreed to pay royalties of 2% of net revenues to the University.

September 2018, we entered into a two-year collaboration agreement with the University

of Jaén to provide certain research services to us.

In consideration of such services,

we agreed to pay the university approximately 52,000 Euros ($59,508 USD) in year

one and a maximum of 40,000 Euros ($45,775 USD) in year two.

Additionally, in

exchange for full ownership of the intellectual property we agreed to pay royalties of

2% of net revenues to the University.

December 2018, we announced that our foundation patent application has been granted by the Office of the Controller General

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discovery of a pharmaceutical composition for treating cancer via a combination of trypsinogen and/or chymotrypsinogen pancreatic

As of June 30, 2019, the foundation patent has been granted in the United States, Belgium, Czech Republic, Denmark,

France, Germany, Ireland, Italy, Netherlands, Portugal, Spain, Sweden, Switzerland, Liechtenstein, Turkey, United Kingdom,

Australia, China, Japan, Indonesia, Israel, New Zealand, Singapore, Malaysia, South Africa, Mexico, Republic of Korea and

As of June 30, 2020, the foundation patent has been granted in the United States, Belgium, Czech Republic,

Denmark, France, Germany, Ireland, Italy, Netherlands, Portugal, Spain, Sweden, Switzerland, Liechtenstein, Turkey, United

Kingdom, Australia, China, Japan, Indonesia, Israel, New Zealand, Singapore, Malaysia, South Africa, Mexico, Republic of Korea

It is presently under examination in Brazil and Canada.

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that PRP’s patent application is complete and meets all relevant statutory requirements.

March 2019, we announced that we have initiated development of a bio-analytical assay intended to quantify the active ingredients

of RPR in preparation for human trails planned for 2019.

The necessary work performed in connection with this development

will be conducted by a specialist Contract Research Organization with extensive knowledge in the development of functional

March 2019, we announced that we have initiated development of a bio-analytical assay

intended to quantify the active ingredients of RPR in preparation for human trails.

necessary work performed in connection with this development will be conducted by a specialist

Contract Research Organization with extensive knowledge in the development of functional

assays for different bio-therapeutics.

after deepening our scientific knowledge of the anti-cancer effects of proenzymes through our ongoing efforts with our research

partners and strengthening our intellectual property portfolio by filing our patents in countries around the world, we believe

we are ready to undertake human clinical trials and subject to receiving adequate financing, we hope to submit a clinical

trial application in the fourth quarter of 2019 calendar year.

July 2019, we appointed Mr.

Carlo Campiciano as Chief Financial Officer.

Campiciano brings significant experience

to the Company across a broad range of financial disciplines in the healthcare sector, including taxation, finance, operations,

planning and financial strategy.

Campiciano will assist with the transformational stage into a clinical development company,

along with the goal of up-listing to a U.S.

national stock exchange.

November 2019, we announced that the POP1 research and drug discovery program has made significant advancements towards

producing synthetic versions of the two proenzymes, trypsinogen and chymotrypsinogen.

With the aim of producing large quantities

of trypsinogen and chymotrypsinogen for commercial use, exhibiting minimal variation between lots and without sourcing the

proenzymes from animals, the Company is undertaking a challenging research project in collaboration with the universities

of Jaén and Granada.

So far, the Company’s scientific researchers have developed a novel expression system.

the research laboratories at the universities of Jaén and Granada, scientific researchers are in the process of optimizing

conditions to achieve high titers of recombinant trypsinogen and chymotrypsinogen with this expression system.

January 2020, we announced that a Certificate for Advance Overseas Finding was received from the Board of Innovation and Science

Australia to receive up to a 43.5% “cash back”

benefit from overseas R&D expenses.

The finding relates to

the planned Phase 1 clinical trial –

Multiple Ascending Dose Studies of proteolytic proenzymes for the treatment of

pancreatic cancer, for 2018/19 and the two following financial years.

Overseas activities to be undertaken include the development

of an analytical assay for the quantification of active pharmaceutical ingredients in the Company’s lead product candidate,

PRP, and its manufacture of the finished product for the Phase 1 clinical trial.

The finding from the Board agreed there is

a significant link between the two supporting activities and the planned Phase 1 clinical trial, and the two activities cannot

be conducted solely in Australia.

The Phase 1 clinical trial is planned to be conducted at the Peter Mac Center, one of the

world’s leading cancer research, education and treatment centers, globally and is Australia’s only public hospital

solely dedicated to caring for people affected by cancer.

after deepening our scientific knowledge of the anti-cancer effects of proenzymes through

our ongoing efforts with our research partners and strengthening our intellectual property

portfolio by filing our patents in countries around the world, we believe we are ready

to undertake human clinical trials and subject to receiving adequate financing, we hope

to submit a clinical trial application in the second quarter of 2021 calendar

the early phases of tumor progression, cancer cells multiply near the site where their predecessors first began uncontrolled proliferation.

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invasive ability.

carcinoma cells may invade into lymphatic or blood microvessels.

The latter may then transport these cancer cells to distant sites

in the body where they may be trapped and subsequently form new metastases.

carcinoma cells may invade into lymphatic or blood micro vessels.

The latter may then transport these cancer cells to distant

sites in the body where they may be trapped and subsequently form new metastases.

is important to note, that even before cells penetrate the basement membrane, they often stimulate angiogenesis (blood

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the cancer cell’s morphology (structure) from a malignant to a benign state.

Up to four pathways related to cancer spread

and metastasis, including TGFΒ, Hippo, Wnt and Notch pathways were regulated by proenzymes.

Clinical Development

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A First-In-Human (FIH), Phase Ib study in patients with advanced solid tumors, evaluating

the safety, pharmacokinetics and anti-tumor efficacy of PRP is planned to commence in the first half of 2020 calendar year in

the safety, pharmacokinetics and anti-tumor efficacy of PRP is planned to commence in the second half of 2021 calendar year in

a jurisdiction to be selected by us, subject to us receiving adequate financing, and is hoped to be completed within twelve months.

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mg and 957.3 respectively, ranging in a 50% tumor inhibition (52% - 46%).

PRP Formulation

pancreatic enzymes have been administered previously in a variety of circumstances and are in current clinical use in conditions

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we are closely evaluating Australia because of its research and development tax incentives, as well as a simplified regulatory

As part of such incentives, eligible companies conducting clinical trials in Australia may receive up to 43.5% “cash-back”

As part of such incentives, eligible companies conducting clinical trials in Australia receive up to 43.5% “cash-back”

benefit in the form of a refund of their qualified research and development costs and expenses.

We are evaluating all options

to conduct our planned clinical trials in the most cost-efficient manner, while striving to minimize dilution to our stockholders.

The Company received a refund

of $199,834 AUD ($134,728 USD) and $161,383 AUD ($115,437 USD) in the years ended June 30, 2020 and 2019 respectively.

are continuing to evaluate all options to conduct our planned clinical trials in the most cost-efficient manner, while

striving to minimize dilution to our stockholders.

anticipate reaching the Phase IIa proof of concept milestone in approximately three to four years, subject to regulatory approval

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planned Phase Ib clinical trial.

fourth quarter of 2019 calendar year, we anticipate the submission of the Clinical Trial Application for PRP in a jurisdiction

first quarter of 2021 calendar year, we anticipate the submission of the Clinical Trial Application for PRP in a jurisdiction

to be determined by us that would suit the best interests of the trial and our Company.

We anticipate receiving approval of such

application in the first calendar quarter of 2020.

Following the clinical trial application, we plan to commence our Study Preparation,

including CRO Selection and Contracts, Analytical Lab Selection Contracts and Trial Sites Selection and Contracts.

In connection

with the Clinical Trial Application, this product will be part of our Investigation Medicinal Product Dossier, Study Protocol

and Investigator’s Brochure.

In the first half of 2020 calendar year, we hope to complete the Study Preparation with the

Preparation of Logistics and Trial Sites Initiation Visits and complete our clinical trial application review.

in the first half of 2020 calendar year, we intend to initiate a Phase Ib study in advanced cancer patients with solid tumors

application in the first half of 2021.

Following the clinical trial application, we plan to commence our Study Preparation, including

CRO Selection and Contracts, Analytical Lab Selection Contracts and Trial Sites Selection and Contracts.

In connection with the

Clinical Trial Application, this product will be part of our Investigation Medicinal Product Dossier, Study Protocol and Investigator’s

In the first half of 2021 calendar year, we hope to complete the Study Preparation with the Preparation of Logistics

and Trial Sites Initiation Visits and complete our clinical trial application review.

in the second half of 2021 calendar year, we intend to initiate a Phase Ib study in advanced cancer patients with solid tumors

and the anticipated costs will be approximately $6.5 million.

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each of the countries listed in the table below.

This application has been granted and remains in force in the United States,

This patent has been granted and remains in force in the United States,

Belgium, Czech Republic, Denmark, France, Germany, Ireland, Italy, Netherlands, Portugal, Spain, Sweden, Switzerland, Liechtenstein,

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Mexico, Republic of Korea and India

applications filed and under examination in USA, Mexico and China

Canada, China, Europe, Hong Kong, India, Indonesia, Israel, Japan, Malaysia, New Zealand, Singapore, South Africa and USA

divisional applications granted and also under examination in Mexico and China

China, Europe, Hong Kong, India, Indonesia, Israel, Japan, Malaysia, New Zealand, Singapore, South Africa and USA

filed and pending

Canada, China, Europe, Hong Kong, Israel, Japan, Malaysia, New Zealand, Singapore and USA

China, Europe, Hong Kong, Israel, Japan, Malaysia, New Zealand, Singapore and USA

filed and pending

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of medicines that are to be assessed via the centralized procedure.

June 23, 2016, the UK government held a referendum to gauge voters’

On June 23, 2016, the

UK government held a referendum to gauge voters’

support to remain or leave the European Union.

The referendum

resulted in 51.9% of UK voters in favor of leaving the European Union, commonly referred to as “Brexit.”

29, 2017, the UK invoked Article 50 of Lisbon Treaty to initiate complete withdrawal from the European Union by March 30, 2019.

Currently, the center for the EMA is based in London but the European Union intends to relocate the center to another city.

The referendum resulted

in 51.9% of UK voters in favor of leaving the European Union, commonly referred to as “Brexit.”

On March 29, 2017,

the UK invoked Article 50 of Lisbon Treaty to initiate complete withdrawal from the European Union, which was effected on January

The center for the EMA was based in London but the European Union has relocated the center

to The Netherlands.

impact of Brexit on the drug approval process in the UK is uncertain, which could significantly impact Propanc as we may elect

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to, or necessary for, our programs.

of October 2, 2019, we have one full-time employee and two part-time employees.

In addition to our employees, we engage key consultants

and utilize the services of independent contractors to perform various services on our behalf.

Some of our executive officers

and directors are engaged in outside business activities that we do not believe conflict with our business.

Over time, we may

be required to hire additional employees or engage independent contractors to execute various projects that are necessary to grow

and develop our business.

of September 14, 2020, we have one full-time employee and two part-time employees.

In addition to our employees, we engage

key consultants and utilize the services of independent contractors to perform various services on our behalf.

Some of our executive

officers and directors are engaged in outside business activities that we do not believe conflict with our business.

we may be required to hire additional employees or engage independent contractors to execute various projects that are necessary

to grow and develop our business.

These decisions will be made by our officers and directors, if and when appropriate.

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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