What changed in this filing

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Item 1. Business

2024-09-30 compared with 2023-09-28 · 39 added, 40 removed, 906 unchanged (8% of the section changed)

13 unchanged sentences

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

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

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 patients.

Subject to us receiving sufficient financing,

we plan to begin our Investigational Medicinal Product Dossier, study proposal and Investigator’s Brochure in 2023.

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 third calendar quarter of

2023 and complete the CTA compilation and submit the CTA in the second half of the 2023 calendar year.

In the fourth calendar quarter

of 2023, 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 first half of the 2024 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.

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.

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

345 unchanged sentences

costs and expenses.

We received a refund of $192,872 AUD ($129,841) and $75,800 AUD ($ 54,977

USD) for the years ended June 30, 2023 and 2022, 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 received a refund of $196,937 AUD ($129,132) and $192,872 AUD ($129,841) for the years ended June 30, 2024 and

2023, 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

3 unchanged sentences

be driven by the need to increase our internal resources in order to effectively manage our research and development activities.

fourth calendar quarter of 2023, we anticipate the submission of the CTA for PRP.

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

We anticipate receiving approval of the CTA in the

7 unchanged sentences

Visits and complete our CTA review.

Commencing in the first half of the 2024 calendar year, we intend to initiate a Phase Ib study in

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.

1 unchanged sentence

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

2023 – February 2024

2024 – April 2025

Investigational

2 unchanged sentences

Investigator’s

2023 – February 2024

2023 – April 2024

2025 – June 2025

2025 – August 2025

Research Organization and Contracts

2023 – February 2024

2024 – June 2025

Laboratory Selection and Contracts

Site Selection and Contracts

2024 – June 2024

2025 – September 2025

Site Initiation Visits

172 unchanged sentences

property rights.

second collaborative research project commenced on July 27, 2022, 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 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

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 is 24 months.

second collaborative research project commenced on July 27, 2022, 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 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.

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

346 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