What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2022-09-28 compared with 2021-09-28 · 79 added, 88 removed, 857 unchanged (16% of the section changed)

58 unchanged sentences

Unlike normal cells, cancer cells multiply, but do not differentiate.

cancer therapies take advantage of the uncontrolled proliferation of the cancer cells and kill these cells by targeting the cell division machinery.

These therapies are effective but affect healthy cells as well, particularly those with a high rate of cell

turnover, inducing undesirable side effects.

cancer therapies take advantage of the uncontrolled proliferation of the cancer cells and kill these cells by targeting the cell division

These therapies are effective but affect healthy cells as well, particularly those with a high rate of cell turnover, inducing

undesirable side effects.

goal is to stop cancer not by targeting tumor cell death, but inducing cell differentiation.

22 unchanged sentences

no observable serious side effects and improves patient survival

the external microenvironment of malignant tumors, preventing tumors from returning and spreading.

is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection.

41 unchanged sentences

to prepare the pre-metastatic niche.

Several assays, in vitro and in vivo studies confirm that PRP exerts an anti-tumor

effect and acts selectively against all malignant, or tumor elements without affecting the non-tumor microenvironment and preventing

its malignification.

Vivo Efficacy of PRP In Pancreatic and Ovarian Tumors

49 unchanged sentences

JOINT RESEARCH AND DRUG DISCOVERY PROGRAM

date, both proenzymes were synthesized and purified in the laboratory.

Once purified, the proenzymes were lyophilized (freeze dried)

and each formed a stable, dry white powder.

The sequence of proteins of each proenzyme were then determined by mass spectrometry.

quantities of the proenzymes were produced with the objective of establishing their combined anti-cancer effects against pancreatic and

colorectal cancers.

In addition, research activities were transferred to the MEDINA Foundation Research Center to investigate the potential

to scale up production of the recombinant proenzymes from the expression of the novel expression system, which is currently ongoing.

MEDINA is a Non-Profit Research Organization established in 2008 through a public-private alliance between the Regional Government of

Andalusia, Spain, the pharmaceutical company Merck Sharp & Dohme de España S.A.

(MSD), and the University of Granada.

scientific platforms support the development of multidisciplinary research programs in Microbiology, Natural Product Chemistry and Screening

& Target Validation.

are elucidating the molecular pathways involved in the proenzymes anti-tumor efficacy and study how proenzymes interact with the pre-metastatic

tumor niche, focusing on the interaction and suppression of tumor associated cells, like cancer-associated fibroblasts and macrophages.

A pre-metastatic tumor niche is an environment in a secondary organ conducive to the metastasis of a primary tumor.

Such a niche provides

favorable conditions for growth, and eventually metastasis, in an otherwise foreign and hostile environment for the primary tumor cells.

Metastasis remains the main cause of patient death from solid tumors for cancer sufferers.

achieve this, we are using integrated tumor models in a microfluidics chip by obtaining 3-dimensional bio-impression samples from patients

with advanced solid tumors, developed at the Centre for Biomedical Research, University of Granada, Granada, Spain.

As well as explaining

the mechanism of action by which proenzymes exert their anti-cancer effects, it also confirms whether proenzymes penetrate into the tumor

microenvironment and exert their effects.

At the same time, it confirms the selectivity of the drug on solid tumors, by targeting cancer

cells and leaving healthy cells alone.

date, our investigation has confirmed that proenzyme therapy is effective against cancer stem cells, which are the cells responsible

for the formation of secondary tumors through metastasis.

They were also observed to be effective against cancer cells within the primary

tumor, whilst also leaving non-tumor cells alone.

The final part of the investigation is to determine the effects of the proenzymes against

both these cancerous cell types within the tumor microenvironment.

Joint Research Team successfully published data confirming the anti-tumor potential of a mixture of trypsinogen and chymotrypsinogen.

Treatment with proenzymes sensitizes cancer stem cells, which may allow standard treatment approaches like chemotherapy and radiotherapy

to be more effective.

vision is to produce a backup product candidate to PRP which can further stabilize and enhance the effects of the proenzymes when administered

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

and chymotrypsinogen with this expression system.

POP1 Joint Research and Drug Discovery Program is designed to produce a backup clinical compound to PRP, which is targeting metastatic

cancer from solid tumors.

According to Emergen Research, the global metastatic cancer market is projected to be worth $111 Billion by

date, recombinant trypsinogen and chymotrypsinogen were synthesized and purified in the laboratory.

In the case of trypsinogen, the initial

success of producing trypsinogen synthetically has advanced to the stage where optimization of protein production is underway.

purification and yield of chymotrypsinogen is currently the focus of research.

synthetic version of trypsinogen and chymotrypsinogen could have additional benefits to the global healthcare system that could further

capitalize on the new therapeutic approach to treating cancer that the Company’s lead product candidate PRP offers cancer sufferers.

For example, both proenzymes synthesized by an in vivo (living organism) system to produce crystalized proteins that could be

maintained for long periods without suffering degradation, even in the absence of refrigeration.

This will be particularly useful for

a longer shelf life as well as global distribution of the drug product, particularly in warmer climates and developing regions where

refrigeration may not be available.

The program’s joint researchers at the Universities of Jaén and Granada are currently

collaborating with the Institute of Microbiology and Microbial Biotechnology, at the University of Natural Resources and Life Sciences,

Vienna, Austria, Europe, and are working towards full scale manufacture of a synthetic recombinant formulation to PRP.

TARGET INDICATIONS

109 unchanged sentences

in patients with advanced solid tumors is completed at the Peter Mac Cancer Center.

Australia, we receive up to 43.5% “cash-back” benefit in the form of a refund of their qualified research and development

costs and expenses.

Australia, we receive up to 43.5% “cash-back” benefit in the form of a refund of their qualified research and,

development costs and expenses.

The Company received a refund of $75,800 AUD ($54,977 USD) and $151,767 AUD ($113,415 USD) for the

years ended June 30, 2021 and 2020 respectively.

We 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.

year ended June 30, 2022 and 2021, respectively.

We 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 in

36 unchanged sentences

program utilizing the identified molecular target to search for novel anticancer agents.

specific objective of the project is to synthesize both proenzymes by an in vivo system to produce crystalized proteins that could be

maintained for long periods without suffering degradation, even in absence of refrigeration.

This will be particularly useful for a longer

shelf life as well as global distribution of the drug product, particularly in warmer climates and developing regions where refrigeration

may not be available.

POP1 joint research and drug discovery program has produced synthetic recombinant versions of the two proenzymes, trypsinogen and chymotrypsinogen.

80 unchanged sentences

was developed because of the limitation of current cancer therapies.

While surgery is often safe and effective for early-stage

cancer, many standard therapies for late-stage cancer urgently need improvement;

current treatments generally provide modest benefits,

and frequently cause significant adverse effects.

Our focus is to provide oncologists and their patients with therapies for metastatic

cancer which are more effective than current therapies, and which have a substantially reduced side effect profile.

While surgery is often safe and effective for early-stage cancer,

many standard therapies for late-stage cancer urgently need improvement;

current treatments generally provide modest benefits, and frequently

cause significant adverse effects.

Our focus is to provide oncologists and their patients with therapies for metastatic cancer which

are more effective than current therapies, and which have a substantially reduced side effect profile.

progress has been made within the oncology sector in developing new treatments, the overall cancer death rate has only improved by 7%

32 unchanged sentences

global metastatic cancer treatment market is predicted to reach $111 Billion by 2027 by Emergen Research.

Demand for new cancer

products can largely be attributed to a combination of a rapidly aging population in western countries and changing environmental factors,

which together are resulting in rising cancer incidence rates.

Worldwide, the World Health Organization estimated 19.3 million

new cancer cases and almost 10.0 million cancer deaths occurred in 2020.

As such, global demand for new cancer treatments which are effective,

safe and easy to administer is rapidly increasing.

Our treatment will potentially target many aggressive tumor types for which little

or few treatment options exist.

Demand for new cancer products

can largely be attributed to a combination of a rapidly aging population in western countries and changing environmental factors, which

together are resulting in rising cancer incidence rates.

Worldwide, the World Health Organization estimated 19.3 million new cancer cases

and almost 10.0 million cancer deaths occurred in 2020.

As such, global demand for new cancer treatments which are effective, safe and

easy to administer is rapidly increasing.

Our treatment will potentially target many aggressive tumor types for which little or few treatment

options exist.

plan to target patients with solid tumors, most likely pancreatic and ovarian tumors, for whom other treatment options have been exhausted.

12 unchanged sentences

Major players operating in the pancreatic cancer therapy market include Eli Lilly and Company, F.

Hoffmann-La Roche AG, Celgene

Corporation, Amgen Inc., Novartis AG, Pharmacyte Biotech Inc., Clovis Oncology, Teva Pharmaceutical Industries Ltd., Pfizer Inc.,

Merck & Co., Inc.

Hoffmann-La Roche AG, Celgene Corporation,

Amgen Inc., Novartis AG, Pharmacyte Biotech Inc., Clovis Oncology, Teva Pharmaceutical Industries Ltd., Pfizer Inc., Merck &

among others.

For instance, in May 2018, Eli Lilly and Company acquired AMRO BioSciences.

AMRO BioSciences

is engaged into number of drugs for cancer.

The clinical trial explores a drug (pegilodecakin) which is ongoing for the pancreatic

The developments performed by the companies are helping the market to grow in the coming years.

AMRO BioSciences is engaged into

number of drugs for cancer.

The clinical trial explores a drug (pegilodecakin) which is ongoing for the pancreatic cancer.

The developments

performed by the companies are helping the market to grow in the coming years.

global market for ovarian cancer drugs expected to reach $10.1 billion by 2027, according to iHealthcareAnalyst.

be driven by continued uptake and expected launches of the approved PARP (poly adenosine diphosphate-ribose polymerase) inhibitors.

Major competitors operating in the global ovarian cancer treatment market include AbbVie, Inc., AstraZeneca plc (Acerta Pharma),

Boehringer Ingelheim GmbH, Chugai Pharmaceutical Co., Ltd., Clovis Oncology, Five Prime Therapeutics, Inc., GlaxoSmithKline plc (Tesaro),

Gradalis, Inc., Incyte Corporation, MacroGenics, Inc., Mateon Therapeutics, Inc., Merck & Co., Inc., Novartis AG, Novogen Limited,

Oasmia Pharmaceuticals, Inc., Pfizer, Inc., PharmaMar S.A, and Roche Holding AG.

This will be driven

by continued uptake and expected launches of the approved PARP (poly adenosine diphosphate-ribose polymerase) inhibitors.

Major competitors

operating in the global ovarian cancer treatment market include AbbVie, Inc., AstraZeneca plc (Acerta Pharma), Boehringer Ingelheim

GmbH, Chugai Pharmaceutical Co., Ltd., Clovis Oncology, Five Prime Therapeutics, Inc., GlaxoSmithKline plc (Tesaro), Gradalis, Inc.,

Incyte Corporation, MacroGenics, Inc., Mateon Therapeutics, Inc., Merck & Co., Inc., Novartis AG, Novogen Limited, Oasmia Pharmaceuticals,

Inc., Pfizer, Inc., PharmaMar S.A, and Roche Holding AG.

products can be defined as addition-in-class, advance-in-class, or first-in-class, depending on their degree of innovation.

59 unchanged sentences

scope of the protection of such industrial property rights.

second collaborative research project is underway with the Universities of Jaén and Granada investigating the effect of pancreatic

proenzymes against the tumor microenvironment and premetastatic niche.

The specific tasks developed under this collaboration focuses

on the effects of PRP on cancer associated fibroblasts within the tumor microenvironment.

Consistent with existing rights, Propanc will

own any intellectual property developed.

The personnel of the investigation team of the University of Jaén and Granada whose work

has contributed to the creation of knowledge that give rise to industrial property rights should be listed as inventors.

Further, Professors

Macarena Perán from the University of Jaén and Marchal from the University of Granada should receive one percent (1%) of

the net revenue to Propanc Biopharma from sales of any products sold by the contracting entity, or on behalf of the contracting entity,

which fall within the scope of protection of such industrial property rights.

The commencement date for the experiments is September

1, 2022, and the estimated length of time for completion is 24 months.

continue to learn the properties of proenzymes with the long-term aim of screening new compounds for development.

9 unchanged sentences

Malaysia, South Africa, Mexico, Republic of Korea, India and Brazil.

In Canada, the patent application remains

under examination.

In Canada, the patent application remains under examination.

2016 and early 2017, we filed other patent applications.

8 unchanged sentences

entered national phase in October 2018.

Presently, there are 31 granted patents and 34

patents under examination in key global jurisdictions relating to the use of proenzymes against solid tumors, covering the lead product

candidate PRP.

there are 43 granted, allowed, or accepted patents and 22 patents filed, or under examination in key global jurisdictions relating to the use of proenzymes against solid

tumors, covering the lead product candidate PRP.

patent applications are expected to be filed to capture and protect additional patentable subject matter based on the Company’s

209 unchanged sentences

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

The impact of Brexit on the drug approval process

in the UK is uncertain.

Companies based in the UK and operating in the drug industry are urging the European Union and the UK to reach

an agreement to harmonize the regulatory process once the UK officially exits the European Union.

impact of Brexit on the drug approval process in the UK is uncertain.

Companies based in the UK and operating in the drug industry are

urging the European Union and the UK to reach an agreement to harmonize the regulatory process.

Australia, the relevant regulatory body responsible for the pharmaceutical industry is the Therapeutics Goods Administration (the “TGA”).

69 unchanged sentences

trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our

of September 28, 2021, we have one full-time and one part-time employee.

of September 26, 2022, we have one full-time and two part-time employees.

In addition to our employees, we engage key consultants and

32 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 1. Business