What changed in this filing

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Item 1. Business

2025-09-29 compared with 2024-09-30 · 390 added, 257 removed, 688 unchanged (48% of the section changed)

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These pancreatic enzymes could represent the body’s primary defense against cancer.

Our lead product candidate, PRP, is a variation upon our novel formulation

and involves proenzymes, the inactive precursors of enzymes.

As a result of positive early indications of the anti-cancer effects of our

technology, we have conducted successful pre-clinical studies on PRP and also commenced preparation for a clinical study in advanced cancer

Subject to us receiving sufficient financing, we plan to begin our Investigational Medicinal Product Dossier, study proposal

and Investigator’s Brochure in 2024.

Our plan is to then commence our study preparation process with the contract research organization

(“CRO”), analytical lab and trial site(s) selection and to begin our clinical trial application for PRP (“CTA”)

compilation in the first calendar quarter of 2025 and complete the CTA compilation and submit the CTA in the first half of the 2025 calendar

In the second calendar quarter of 2025, we plan to begin the preparation of logistics and trial site initiation visits.

to raising additional sufficient capital, we subsequently plan to commence a First-In-Human (“FIH”), Phase Ib study in patients

with advanced solid tumors, evaluating the safety, pharmacokinetics and anti-tumor efficacy of PRP in the second half of the 2025 calendar

year, which study we hope to complete within twelve months thereafter.

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.

lead product candidate, PRP, is a variation upon our novel formulation and involves proenzymes, the inactive precursors of enzymes.

As a result of positive early indications of the anti-cancer effects of our technology, we have conducted successful pre-clinical

studies on PRP and commenced preparation for a clinical study in advanced cancer patients.

Subject to us receiving sufficient

financing, we plan to begin our Investigational Medicinal Product Dossier, study proposal and Investigator’s Brochure in 2025.

Our plan is to then commence our study preparation process with the contract research organization (“CRO”), analytical

lab and trial site(s) selection and to begin our clinical trial application for PRP (“CTA”) compilation in the first

calendar quarter of 2026 and complete the CTA compilation and submit the CTA in the first half of the 2026 calendar year.

second calendar quarter of 2026, we plan to begin the preparation of logistics and trial site initiation visits.

Subject to raising

additional sufficient capital, we subsequently plan to commence a First-In-Human (“FIH”), Phase Ib study in patients

with advanced solid tumors, evaluating the safety, pharmacokinetics and anti-tumor efficacy of PRP in the second half of the 2026

calendar year, which study we hope to complete within twelve months thereafter.

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

is an intravenous injection proenzyme treatment designed as a therapeutic option in cancer treatment and prevention.

PRP is a combination

of the pancreatic proenzymes, trypsinogen and chymotrypsinogen.

of pancreatic proenzymes, trypsinogen and chymotrypsinogen.

PRP produces multiple effects on cancerous cells intended to inhibit

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We entered into a second two-year joint research and collaboration agreement with the University of Jaén,

which is undertaking the research activities for the POP1 Program.

occurs when cells in the body start to divide quickly and uncontrollably with an ability to migrate from one location and spread to distant

which concluded successfully late 2024.

A third agreement is planned for the

next three years for future joint drug discovery research activities designed to produce a new compound which enhances the anti-cancer

effects of proenzymes and consequently introduces a new therapeutic drug class for the treatment and prevention of metastatic cancer.

occurs when cells in the body start to divide quickly and uncontrollably with an ability to migrate from one location and spread to

distant sites.

A cell becomes cancerous when it becomes undifferentiated.

The cell forgets to do its job and invests all its energy to proliferating.

The cell forgets to do its job and invests all its energy

in proliferating.

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

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

This is known as differentiation therapy.

This is known as differentiation

The key focus is to convince the malignant cells to stop proliferating and return to do their work as a specific cell type.

Differentiation

therapy does not target cell death, so healthy cells within the patient will not be compromised, unlike chemotherapeutic drugs or gamma

Differentiation therapy does not target cell death, so healthy cells within the patient will not be compromised, unlike

chemotherapeutic drugs or gamma irradiation.

Differentiation

therapy induces the cancer cells into the pathway of terminal differentiation and eventual senescence ( i.e.

, a non-proliferative

Differentiation therapy acts not only against cancer cells, but interestingly can turn cancer stem cells (undifferentiated cells)

towards completely differentiated ( i.e.

non-proliferative state).

Differentiation therapy acts not only against cancer cells but interestingly can turn cancer stem cells

(undifferentiated cells) towards completely differentiated ( i.e.

, normal) cells.

are natural elements within our body that could help us fight against cancer.

Enzymes are natural proteins that stimulate and accelerate

biological reactions in the body.

Particularly, enzymes secreted by the exocrine pancreas that are essential for the digestion of proteins

More than one hundred years ago, Professor John Beard first proposed that pancreatic enzymes represent the body’s primary

defense against cancer and would be useful as a cancer treatment.

Since then, several scientists have endorsed Professor Beard´s

hypothesis with encouraging data from patient treatment.

Enzymes are natural proteins that stimulate and

accelerate biological reactions in the body.

Particularly, enzymes secreted by the exocrine pancreas are essential for the digestion

of proteins and fats.

More than one hundred years ago, Professor John Beard first proposed that pancreatic enzymes represent the

body’s primary defense against cancer and would be useful as a cancer treatment.

Since then, several scientists have endorsed

Professor Beard´s hypothesis with encouraging data from patient treatment.

are developing a long-term therapy based on a pancreatic proenzyme formulation to prevent tumor recurrence and metastasis, the main cause

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like advanced pancreatic adenocarcinoma and advanced epithelial ovarian cancer.

carcinoma (n = 4)

Cancer (n = 7)

Cancer (n = 6)

Rectal Cancer (n = 5)

Cancer (n = 2)

Cancer (n = 8)

Lymphoma (n = 1)

Neuro-endocrine

Tumor (n = 1)

Cell Carcinoma (n = 1)

Cancer (n = 1)

unknown primary (n = 1)

Life Expectation

Pancreatic carcinoma (n = 4)

Ovarian Cancer (n = 7)

Breast Cancer (n = 6)

Colon Rectal Cancer (n = 5)

Gastric Cancer (n = 2)

Prostate Cancer (n = 8)

Non-Hodgkin Lymphoma (n = 1)

Mesothelioma (n = 1)

Melanoma (n = 2)

Neuro-endocrine Tumor (n = 1)

Bladder (n = 2)

NSCLS (n = 2)

Bowel (n = 2)

Small Cell Carcinoma (n = 1)

Renal Cancer (n = 1)

Abdomen unknown primary (n = 1)

overview of clinical results.

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Whereas 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 PRP offers to 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 in Vienna, Austria, and are working towards full scale manufacture

of a synthetic recombinant formulation to PRP.

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 PRP offers to cancer sufferers.

For example, both

proenzymes are 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 in Vienna, Austria, and are working towards full scale manufacture of a synthetic recombinant formulation to

Target Indications

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While the hope is that such procedures are curative,

in many instances the tumor returns, and second-line treatment strategies are chosen in an effort to achieve a degree of control over

in many instances the tumor returns, and second-line treatment strategies are chosen to achieve a degree of control over

In most instances, the benefit is temporary, and eventually the point is reached where the patient’s tumor either fails

to respond to treatment adequately, or the treatment has unacceptable toxicity that severely limits its usefulness.

the planned Phase I, II and III clinical trials confirm the efficacy of PRP, along with the favorable safety and tolerability profile

suggested by pre-clinical studies conducted to date, we believe our product will have utility in a number of clinical situations including:

the planned Phase I, II and III clinical trials confirm the efficacy of PRP, along with the favorable safety and tolerability

profile suggested by pre-clinical studies conducted to date, we believe our product will have utility in several clinical situations

the early-stage management of solid tumors, most likely as part of a multi-pronged treatment strategy in combination with existing

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a product that can be administered long term for patients following standard treatment approaches, such as surgery, or chemotherapy,

in order to prevent or delay recurrence;

to prevent or delay recurrence;

a preventative measure for patients at risk of developing cancer based on genetic screening.

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leading cause of cancer-related mortality.

pancreatic cancer is an essentially fatal condition, disease duration is roughly equivalent with survival time.

The median time of survival

of patients with pancreatic cancer depends on the extend of disease at the time of diagnosis and ranges from 11 to 20 months for patients

who qualified for surgical resection (Stage I/II), to 6-11 months for patients with locally advanced disease (Stage III), and only two

to six months for patients with metastatic disease (Stage IV) (Amikura 1995, Richter 2003).

Taking these low survival times into consideration,

the yearly incidence rates for pancreatic cancer are considered the more relevant measure for this disease.

pancreatic cancer is an essentially fatal condition, disease duration is roughly equivalent to survival time.

The median time

of survival of patients with pancreatic cancer depends on the extend of disease at the time of diagnosis and ranges from 11 to 20

months for patients who qualified for surgical resection (Stage I/II), to 6-11 months for patients with locally advanced disease

(Stage III), and only two to six months for patients with metastatic disease (Stage IV) (Amikura 1995, Richter 2003).

low survival times into consideration, yearly incidence rates for pancreatic cancer are considered the more relevant measure for

this disease.

year the American Cancer Society estimates the numbers of new cancer cases and deaths that will occur in the United States in the current

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therapeutic options for the treatment of cancer offer, at most, a few months of extra life or tumor stabilization.

Some experts believe

that drugs that kill most tumor cells do not affect cancer stem cells, which can regenerate the tumor (e.g., chemotherapy).

revealing the genetic changes in cells that cause cancer and spur its growth.

This research is providing scientific researchers with

many potential targets for drugs.

believe that drugs that kill most tumor cells do not affect cancer stem cells, which can regenerate the tumor (e.g., chemotherapy).

Studies reveal the genetic changes in cells that cause cancer and spur its growth.

This research is providing scientific researchers

with many potential targets for drugs.

Tumor cells, however, can develop resistance to drugs.

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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

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

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costs and expenses.

We received a refund of $196,937 AUD ($129,132) and $192,872 AUD ($129,841) for the years ended June 30, 2024 and

We received a refund of $0 and $196,937 AUD ($129,132) for the years ended June 30, 2025, and

2024, 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.

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

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second calendar quarter of 2025, we anticipate the submission of the CTA for PRP.

We anticipate receiving approval of the CTA in the

second half of the 2025 calendar year.

Following the CTA, we plan to commence our study preparation process, including CRO Selection

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

We anticipate receiving approval in the second

half of the 2025 calendar year.

Following the CTA approval, we plan to commence our study preparation process, including CRO Selection and

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

In connection with the CTA, this product will

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In the second half of the

calendar year, we hope to complete the study preparation process together with the Preparation of Logistics and Trial Sites Initiation

Visits and complete our CTA review.

Commencing in the second half of the 2025 calendar year, we intend to initiate a Phase Ib study in

advanced cancer patients with solid tumors and we anticipate costs to be approximately $6.5 million.

We will need to raise additional

financing to fund our planned Phase I, II and III clinical trials and for working capital.

2025 calendar year, we hope to complete the study preparation process together with the Preparation of Logistics and Trial Sites

Initiation Visits and complete our CTA review.

Commencing in the second half of the 2025 calendar year, we intend to initiate a

Phase Ib study in advanced cancer patients with solid tumors and we anticipate costs to be approximately $6.5 million.

to raise additional financing to fund our planned Phase I, II and III clinical trials and for working capital.

2025 – April 2026

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POP1 Program has been established with our collaborators at the universities of Jaén and Granada to investigate the changes in

genetic and protein expression that occur in cancer cells as a consequence of being exposed to our proenzyme formulation.

genetic and protein expression that occur in cancer cells because of being exposed to our proenzyme formulation.

The objective

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initial focus is to organize, coordinate and finance the various parts of our drug development pipeline.

We intend to carefully introduce

new personnel into our Company over time as our R&D activities expand.

We plan for such personnel to have specific expertise in product

development, manufacture and formulation, regulatory affairs, toxicology, clinical operations and business development (including intellectual

property management, licensing and other corporate activities).

Additional clinical management and development expertise will likely

be required at the outset to assist with the development of PRP.

Therefore, we anticipate hiring additional employees in order to effectively

manage our contractors as our development activities progress.

We intend to carefully

introduce new personnel into our Company over time as our R&D activities expand.

We plan for such personnel to have specific

expertise in product development, manufacture and formulation, regulatory affairs, toxicology, clinical operations and business

development (including intellectual property management, licensing and other corporate activities).

Additional clinical management

and development expertise will likely be required at the outset to assist with the development of PRP.

Therefore, we anticipate

hiring additional employees to effectively manage our contractors as our development activities progress.

outsourcing strategy is common in the biotechnology sector and is an efficient way to obtain access to the necessary skills required

to progress a project, in particular as the required skills change as the project progresses from discovery, through manufacturing and

to progress a project, as the required skills change as the project progresses from discovery, through manufacturing and

non-clinical development and into clinical trials.

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could reduce the size and threat of metastases to a more manageable level for late-stage cancer patients.

believe these potential treatment approaches will be complementary to existing treatment regimens and PRP.

believe such potential treatment approaches will be complementary to existing treatment regimens and PRP.

No formal approaches regarding

such other products have currently been made and it is unknown whether we will engage in any such discussion in the near future.

such other products have currently been made and it is unknown whether we will engage in any such discussion soon.

as we further develop PRP within the development pathway, we intend to assess future opportunities that may arise to use the expertise

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mortality rate, a substantial unmet medical need exists for new treatments.

Once the efficacy and safety of PRP has been demonstrated

Once the efficacy and safety of PRP is demonstrated

in late-stage patient populations, we plan to undertake exploration of the utility of the drug in earlier stage disease, together with

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with an effective date of July 18, 2008, will continue in force;

agreed to pay to the University of Bath a royalty of two percent of any and all net revenues;

agreed to pay to the University of Bath a royalty of two percent of all net revenues;

agreed to use all reasonable endeavors to develop and commercially exploit the patents for the mutual benefit of us and the University

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we agreed to pay five percent of each, and every license agreement subscribed for.

The contract is cancellable at any time by either party.

The contract may be cancelled at any time by

either party.

To date, no amounts are owed under the agreement.

of Jaén Collaboration Agreement

have established a collaboration with the University of Jaén to carry out a research project aimed at the synthetic development

of PRP and its subsequent validation.

The University of Jaén is providing scientific research activities the Department of Health

Sciences, which provides the necessary technical and human resources in order to carry out the programmed works.

A Collaboration Agreement

(the “Collaboration Agreement”), dated October 1, 2020, was entered into with the main objective for the synthetic development

of PRP and its subsequent validation.

Pursuant to the Collaboration Agreement, a pre-clinical protocol of safety evaluation was established

relating to the antitumor efficacy on cancer stem cells and in orthotopic xenotransplantations derived from cancer stem cells isolated

from tumor cell lines, and newly developed synthetic formulation based on the two pancreatic zymogens.

ownership of potential intellectual property rights that may arise as a result of the knowledge obtained through such research project

have established a collaboration with the University of Jaén to carry out a research project aimed at the synthetic

development of PRP and its subsequent validation.

The University of Jaén is providing scientific research activities, the

Department of Health Sciences, which provides the necessary technical and human resources to carry out the programmed

A Collaboration Agreement (the “Collaboration Agreement”), dated October 1, 2020, was entered into with the main

objective for the synthetic development of PRP and its subsequent validation.

Pursuant to the Collaboration Agreement, a

pre-clinical protocol of safety evaluation was established relating to the antitumor efficacy on cancer stem cells and in orthotopic

xenotransplantations derived from cancer stem cells isolated from tumor cell lines, and newly developed synthetic formulation based

on the two pancreatic zymogens.

ownership of potential intellectual property rights that may arise because of the knowledge obtained through such research project

will belong to us.

In consideration for payment of the compensation, the University of Jaén assigned and agreed to do all things

In consideration for payment of compensation, the University of Jaén assigned and agreed to do all things

reasonably required to assign to the contracting entity all industrial property rights arising from such research project.

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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 universities 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.

Professor Macarena Perán from the University of Jaén and Professor Marchal from the University of Granada will receive

one percent of the net revenue to us from sales of any products sold by us, or on our behalf, which fall within the scope of protection

of such industrial property rights.

The commencement date for the experiments was September 1, 2022, and the estimated length of time

for completion was 24 months.

The specific tasks developed under this

collaboration focused 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 universities

of Jaén and Granada whose work has contributed to the creation of knowledge that gives rise to industrial property rights

should be listed as inventors.

Further, Professor Macarena Perán from the University of Jaén and Professor Marchal

from the University of Granada will receive one percent of the net revenue to us from sales of any products sold by us, or on our

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

The commencement date for the experiments was

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

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

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Initially targeting the oncology sector, our focus is to identify and develop novel treatments that are highly effective

targeted therapies, with few side effects as a result of toxicity to healthy cells.

targeted therapies, with few side effects because of toxicity to healthy cells.

Company has filed multiple patent applications relating to PRP.

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A third PCT application entered national phase in October 2018.

of September 25, 2024, we have 84 granted, allowed, or accepted patents and 6 patent applications filed, or under examination in key

global jurisdictions, relating to the use of proenzymes against solid tumors, covering PRP.

of June 30, 2025, we have 85 granted, allowed, or accepted patents and 5 patent applications filed, or under examination in key global

jurisdictions, relating to the use of proenzymes against solid tumors, covering PRP.

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

field of technology relating to pharmaceutical compositions of proenzymes for treating cancer.

list of the Company’s patents are as follows:

pharmaceutical composition for treating cancer comprising trypsinogen and/or chymotrypsinogen and an active agent selected from a

selenium compound, a vanilloid compound and a cytoplasmic glycolysis reduction agent

BR112012009521-8

pharmaceutical composition and use of chymotrypsinogen or tripsinogen

ZL201710885368.4

pharmaceutical composition for treating cancer comprising trypsinogen and chymotrypsinogen

ZL201080054056.5

pharmaceutical composition for treating cancer comprising trypsinogen and/or chymotrypsinogen and an active agent selected from a

selenium compound, a vanilloid compound and a cytoplasmic glycolysis reduction agent

pharmaceutical composition for treating cancer comprising trypsinogen and/or chymotrypsinogen and an active agent selected from a

selenium compound, a vanilloid compound and a cytoplasmic glycolysis reduction agent

Patent Convention

Pharmaceutical