14 unchanged sentences
lead product candidate, PRP, is a variation upon our novel formulation and involves proenzymes, the inactive precursors of enzymes.
−Removed: As a result of positive early indications of the anti-cancer effects of our technology, we have conducted successful pre-clinical
−Removed: studies on PRP and commenced preparation for a clinical study in advanced cancer patients.
−Removed: Subject to us receiving sufficient
−Removed: financing, we plan to begin our Investigational Medicinal Product Dossier, study proposal and Investigator’s Brochure in 2025.
−Removed: Our plan is to then commence our study preparation process with the contract research organization (“CRO”), analytical
−Removed: lab and trial site(s) selection and to begin our clinical trial application for PRP (“CTA”) compilation in the first
−Removed: calendar quarter of 2026 and complete the CTA compilation and submit the CTA in the first half of the 2026 calendar year.
−Removed: second calendar quarter of 2026, we plan to begin the preparation of logistics and trial site initiation visits.
−Removed: Subject to raising
−Removed: additional sufficient capital, we subsequently plan to commence a First-In-Human (“FIH”), Phase Ib study in patients
−Removed: with advanced solid tumors, evaluating the safety, pharmacokinetics and anti-tumor efficacy of PRP in the second half of the 2026
−Removed: calendar year, which study we hope to complete within twelve months thereafter.
−Removed: We intend to develop our PRP to treat early-stage
−Removed: cancer and pre-cancerous diseases and as a preventative measure for patients at risk of developing cancer based on genetic
+Added: a result of positive early indications of the anti-cancer effects of our technology, we have conducted successful pre-clinical studies
+Added: on PRP and commenced preparation for a clinical study in advanced cancer patients.
+Added: We have commenced preparation of our Clinical Study
+Added: Protocol and Investigator’s Brochure.
+Added: We have commenced our study preparation process with the contract research organization (“CRO”),
+Added: analytical lab and trial site(s) selection and begun our clinical trial application for PRP (“CTA”) compilation and plan
+Added: to submit the CTA in the fourth quarter of the 2026 calendar year.
+Added: In the first calendar quarter of 2027, we plan to begin the preparation
+Added: of logistics and trial site initiation visits.
+Added: Subject to raising additional sufficient capital, we subsequently plan to commence a First-In-Human
+Added: (“FIH”), Phase Ib study in patients with advanced solid tumors, evaluating the safety, pharmacokinetics and anti-tumor efficacy
+Added: of PRP in the first half of the 2027 calendar year, which study we hope to complete within twenty-four months thereafter.
+Added: develop our PRP to treat early-stage cancer and pre-cancerous diseases and as a preventative measure for patients at risk of developing
+Added: cancer based on genetic screening.
is an intravenous injection proenzyme treatment designed as a therapeutic option in cancer treatment and prevention.
1 unchanged sentence
of pancreatic proenzymes, trypsinogen and chymotrypsinogen.
−Removed: PRP produces multiple effects on cancerous cells intended to inhibit
−Removed: tumor growth and potentially stop a tumor from spreading through the body.
+Added: PRP produces multiple effects on cancerous cells intended to inhibit tumor
+Added: growth and potentially stop a tumor from spreading through the body.
received notification from the U.S.
11 unchanged sentences
and its manufacture of the finished product for the Phase Ib clinical trial.
−Removed: POP1 joint research and drug discovery program (“POP1 Program”) is designed to produce a backup clinical compound to PRP.
−Removed: With the aim of producing large quantities of trypsinogen and chymotrypsinogen for commercial use, exhibiting minimal variation between
−Removed: lots and without sourcing the proenzymes from animals, we are undertaking a research project in collaboration with the universities of
−Removed: Jaén and Granada.
−Removed: We entered into a second two-year joint research and collaboration agreement with the University of Jaén,
−Removed: which concluded successfully late 2024.
−Removed: A third agreement is planned for the
−Removed: next three years for future joint drug discovery research activities designed to produce a new compound which enhances the anti-cancer
−Removed: effects of proenzymes and consequently introduces a new therapeutic drug class for the treatment and prevention of metastatic cancer.
−Removed: occurs when cells in the body start to divide quickly and uncontrollably with an ability to migrate from one location and spread to
−Removed: distant sites.
+Added: POP1 joint research and drug discovery program (“POP1 Program”) is designed to produce a backup clinical compound to
+Added: With the aim of producing large quantities of trypsinogen and chymotrypsinogen for commercial use, exhibiting minimal variation
+Added: between lots and without sourcing the proenzymes from animals, we are undertaking a research project in collaboration with the
+Added: universities of Jaén and Granada.
+Added: We entered into a second two-year joint research and collaboration agreement with the
+Added: University of Jaén, which concluded successfully in late 2024.
+Added: A third agreement is planned for the next two years for
+Added: future joint drug discovery research activities designed to produce a new compound which enhances the anti-cancer effects of
+Added: proenzymes and consequently introduces a new therapeutic drug class for the treatment and prevention of metastatic
+Added: occurs when cells in the body start to divide quickly and uncontrollably with an ability to migrate from one location and spread to distant
A cell becomes cancerous when it becomes undifferentiated.
−Removed: The cell forgets to do its job and invests all its energy
−Removed: in proliferating.
+Added: 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.
−Removed: This is known as differentiation
+Added: This is known as differentiation therapy.
The key focus is to convince the malignant cells to stop proliferating and return to do their work as a specific cell type.
−Removed: Differentiation therapy does not target cell death, so healthy cells within the patient will not be compromised, unlike
−Removed: chemotherapeutic drugs or gamma irradiation.
Differentiation
+Added: therapy does not target cell death, so healthy cells within the patient will not be compromised, unlike chemotherapeutic drugs or gamma
+Added: Differentiation
therapy induces the cancer cells into the pathway of terminal differentiation and eventual senescence ( i.e.
−Removed: non-proliferative state).
−Removed: Differentiation therapy acts not only against cancer cells but interestingly can turn cancer stem cells
−Removed: (undifferentiated cells) towards completely differentiated ( i.e.
+Added: , a non-proliferative
+Added: Differentiation therapy acts not only against cancer cells but interestingly can turn cancer stem cells (undifferentiated cells)
+Added: towards completely differentiated ( i.e.
, normal) cells.
are natural elements within our body that could help us fight against cancer.
−Removed: Enzymes are natural proteins that stimulate and
−Removed: accelerate biological reactions in the body.
−Removed: Particularly, enzymes secreted by the exocrine pancreas are essential for the digestion
−Removed: of proteins and fats.
−Removed: More than one hundred years ago, Professor John Beard first proposed that pancreatic enzymes represent the
−Removed: body’s primary defense against cancer and would be useful as a cancer treatment.
−Removed: Since then, several scientists have endorsed
−Removed: Professor Beard´s hypothesis with encouraging data from patient treatment.
+Added: Enzymes are natural proteins that stimulate and accelerate
+Added: biological reactions in the body.
+Added: Particularly, enzymes secreted by the exocrine pancreas are essential for the digestion of proteins
+Added: More than one hundred years ago, Professor John Beard first proposed that pancreatic enzymes represent the body’s primary
+Added: defense against cancer and would be useful as a cancer treatment.
+Added: Since then, several scientists have endorsed Professor Beard´s
+Added: 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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epithelial cancer cells to become invasive and stem cell-like, features which then allow these cancer cells to spread and metastasize.
−Removed: PRP reverses the conversion from an epithelial to a mesenchymal phenotype and, as such, may reduce the metastatic potential of the tumor
+Added: PRP reverses the conversion from an epithelial to a mesenchymal phenotype and, as such, reduces the metastatic potential of the tumor
PRP also promotes the acquisition of a less malignant phenotype, in addition to a decrease in proliferation due to lineage (i.e.,
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Of Clinical Studies
−Removed: clinical efficacy of a suppository formulation containing bovine pancreatic pro-enzymes trypsinogen and chymotrypsinogen was evaluated
−Removed: in the context of a UK Pharmaceuticals Special Scheme at the Dove Clinic in Hampshire, UK by Dr.
−Removed: Julian Kenyon, the Company’s Chief
−Removed: Scientific Officer, and the results were published by the Company in a peer-reviewed journal, Scientific Reports, on behalf of Dr.
−Removed: Clinical effects were studied in 46 patients with advanced metastatic cancers of different origin (prostate, breast, ovarian, pancreatic,
−Removed: colorectal, stomach, non-small cell lung, bowel cancer and melanoma) after treatment with a rectal formulation of both pancreatic pro-enzymes.
−Removed: Patients were treated daily with a rectal formulation containing 8.92 mg of each of the two pancreatic pro-enzymes and 1.78 mg α-Amylase
−Removed: (A) per suppository.
−Removed: The study was carried out under a UK “Specials” License at the Dove Clinic, Hampshire, UK for periods
−Removed: up to 14 months.
+Added: clinical efficacy of a suppository formulation containing bovine pancreatic pro-enzymes trypsinogen and chymotrypsinogen was
+Added: evaluated in the context of a UK Pharmaceuticals Special Scheme at the Dove Clinic in Hampshire, UK by Dr.
+Added: Julian Kenyon, the
+Added: Company’s former Chief Scientific Officer, and the results were published by the Company in a peer-reviewed journal,
+Added: Scientific Reports, on behalf of Dr.
+Added: Kenyon in 2008.
+Added: Clinical effects were studied in 46 patients with advanced metastatic cancers
+Added: of different origin (prostate, breast, ovarian, pancreatic, colorectal, stomach, non-small cell lung, bowel cancer and melanoma)
+Added: after treatment with a rectal formulation of both pancreatic pro-enzymes.
+Added: Patients were treated daily with a rectal formulation
+Added: containing 8.92 mg of each of the two pancreatic pro-enzymes and 1.78 mg α-Amylase (A) per suppository.
+Added: The study was carried
+Added: out under a UK “Specials” License at the Dove Clinic, Hampshire, UK for periods up to 14 months.
severe or serious adverse events related to the rectal administration were observed.
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Whereas purification and yield of chymotrypsinogen is currently the focus of research.
−Removed: synthetic version of trypsinogen and chymotrypsinogen could have additional benefits to the global healthcare system that could
−Removed: further capitalize on the new therapeutic approach to treating cancer that PRP offers to cancer sufferers.
−Removed: For example, both
−Removed: proenzymes are synthesized by an in vivo (living organism) system to produce crystalized proteins that could be maintained for long
−Removed: periods without suffering degradation, even in the absence of refrigeration.
−Removed: 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
−Removed: may not be available.
−Removed: The program’s joint researchers at the universities of Jaén and Granada are currently
−Removed: collaborating with the Institute of Microbiology and Microbial Biotechnology, at the University of Natural Resources and Life
−Removed: Sciences in Vienna, Austria, and are working towards full scale manufacture of a synthetic recombinant formulation to
+Added: synthetic version of trypsinogen and chymotrypsinogen could have additional benefits to the global healthcare system that could further
+Added: capitalize on the new therapeutic approach to treating cancer that PRP offers to cancer sufferers.
+Added: For example, both proenzymes are synthesized
+Added: by an in vivo (living organism) system to produce crystalized proteins that could be maintained for long periods without suffering degradation,
+Added: even in the absence of refrigeration.
+Added: This will be particularly useful for a longer shelf-life as well as global distribution of the
+Added: drug product, particularly in warmer climates and developing regions where refrigeration may not be available.
+Added: The program’s joint
+Added: researchers at the universities of Jaén and Granada are currently collaborating with the Institute of Microbiology and Microbial
+Added: Biotechnology, at the University of Natural Resources and Life Sciences in Vienna, Austria, and are working towards full scale manufacture
+Added: of a synthetic recombinant formulation to PRP.
Target Indications
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While the hope is that such procedures are curative,
−Removed: in many instances the tumor returns, and second-line treatment strategies are chosen to achieve a degree of control over
−Removed: In most instances, the benefit is temporary, and eventually the point is reached where the patient’s tumor either fails
−Removed: to respond to treatment adequately, or the treatment has unacceptable toxicity that severely limits its usefulness.
−Removed: the planned Phase I, II and III clinical trials confirm the efficacy of PRP, along with the favorable safety and tolerability
−Removed: profile suggested by pre-clinical studies conducted to date, we believe our product will have utility in several clinical situations
+Added: in many instances the tumor returns, and second-line treatment strategies are chosen to achieve a degree of control over the tumor.
+Added: most instances, the benefit is temporary, and eventually the point is reached where the patient’s tumor either fails to respond
+Added: to treatment adequately, or the treatment has unacceptable toxicity that severely limits its usefulness.
+Added: the planned Phase I, II and III clinical trials confirm the efficacy of PRP, along with the favorable safety and tolerability profile
+Added: suggested by pre-clinical studies conducted to date, we believe our product will have utility in several clinical situations including:
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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pancreatic cancer is an essentially fatal condition, disease duration is roughly equivalent to survival time.
−Removed: The median time
−Removed: of survival of patients with pancreatic cancer depends on the extend of disease at the time of diagnosis and ranges from 11 to 20
−Removed: months for patients who qualified for surgical resection (Stage I/II), to 6-11 months for patients with locally advanced disease
−Removed: (Stage III), and only two to six months for patients with metastatic disease (Stage IV) (Amikura 1995, Richter 2003).
−Removed: low survival times into consideration, yearly incidence rates for pancreatic cancer are considered the more relevant measure for
−Removed: this disease.
−Removed: year the American Cancer Society estimates the numbers of new cancer cases and deaths that will occur in the United States in the current
−Removed: year and compiles the most recent data on cancer incidence, mortality, and survival.
−Removed: Incidence data are collected by the National Cancer
−Removed: Institute (NCI), the Centers for Disease Control and Prevention (CDC), and the North American Association of Central Cancer Registries
−Removed: In 2020, it was estimated that a total of more than 1,806,590 new cancer cases and more than 606,520 cancer deaths occurred
−Removed: in the United States according to the National Cancer Institute.
−Removed: Amongst these, a total of almost 50,000 new cases of pancreatic cancer
−Removed: (3.2% of new cancer cases) were estimated, which resulted in more than 40,000 deaths (8.2% of cancer deaths).
−Removed: This means only 20% survival
−Removed: rate of patients diagnosed with pancreatic cancer.
+Added: The median time of survival
+Added: 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
+Added: who qualified for surgical resection (Stage I/II), to 6-11 months for patients with locally advanced disease (Stage III), and only two
+Added: to six months for patients with metastatic disease (Stage IV) (Amikura 1995, Richter 2003).
+Added: Taking these low survival times into consideration,
+Added: yearly incidence rates for pancreatic cancer are considered the more relevant measure for this disease.
+Added: year the American Cancer Society estimates the numbers of new cancer cases and deaths that will occur in the United States in the
+Added: current year and compiles the most recent data on cancer incidence, mortality, and survival.
+Added: Incidence data are collected by the
+Added: National Cancer Institute (NCI), the Centers for Disease Control and Prevention (CDC), and the North American Association of Central
+Added: Cancer Registries (NAACCR).
+Added: In 2025, it was estimated that a total of more than 2,041,910 new cancer cases were diagnosed and more
+Added: than 618,120 cancer deaths occurred in the United States according to the National Cancer Institute.
+Added: Amongst these, a total of
+Added: almost 67,530 new cases of pancreatic cancer (3.2% of new cancer cases) were estimated, which resulted in more than 52,740 deaths
+Added: (8.4% of cancer deaths).
+Added: This means only 21% survival rate of patients diagnosed with pancreatic cancer.
cancer is a generic term that can be used for any cancer involving the ovaries, arising from one of the several different cell types
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This heterogeneity of the disease has impeded progress in the prevention, early detection, treatment and management of ovarian cancer.
−Removed: 2020, ovarian cancer is the eighth most diagnosed cancer among women in the world and accounts for an estimated 313,959 new cases and
−Removed: 207,252 deaths worldwide (World Cancer Research Fund International)., In the USA, 19,880 new cases (2015 – 2019) and 12,810 related
−Removed: deaths (2016 – 2020) are estimated to occur (National Cancer Institute).
−Removed: The disease typically presents at late stage when the
−Removed: five-year relative survival rate is only 29%.
−Removed: Few cases (15%) are diagnosed with localized tumor (stage 1), when the five-year survival
−Removed: Strikingly, the overall five-year relative survival rate generally ranges between 30% to 40% across the globe and has seen
−Removed: only very modest increases since 1995.
+Added: 2022, ovarian cancer was the eighth most diagnosed cancer among women in the world and accounts for an estimated 324,603 new cases and
+Added: 206,956 deaths worldwide (World Cancer Research Fund International).
+Added: In the United States, 21,010 new cases and 12,450 related deaths
+Added: are estimated to occur in 2026 (National Cancer Institute).
+Added: The disease typically presents at late stage when the five-year relative
+Added: survival rate is only 52%.
+Added: The earlier ovarian cancer is caught, the better chance a person has of surviving five years after being
+Added: For ovarian cancer, 21.7% are diagnosed at the local stage.
+Added: The 5-year relative survival for localized ovarian cancer is 91.9%.
are developing a therapeutic solution for the treatment of patients with advanced stages of cancer targeting solid tumors, which is cancer
5 unchanged sentences
therapeutic options for the treatment of cancer offer, at most, a few months of extra life or tumor stabilization.
−Removed: believe that drugs that kill most tumor cells do not affect cancer stem cells, which can regenerate the tumor (e.g., chemotherapy).
−Removed: Studies reveal the genetic changes in cells that cause cancer and spur its growth.
−Removed: This research is providing scientific researchers
−Removed: with many potential targets for drugs.
+Added: Some experts believe
+Added: that drugs that kill most tumor cells do not affect cancer stem cells, which can regenerate the tumor (e.g., chemotherapy).
+Added: Studies reveal
+Added: the genetic changes in cells that cause cancer and spur its growth.
+Added: This research is providing scientific researchers with many potential
+Added: targets for drugs.
Tumor cells, however, can develop resistance to drugs.
1 unchanged sentence
was developed because of the limitation of current cancer therapies.
−Removed: While surgery is often safe and effective for early-stage
−Removed: cancer, many standard therapies for late-stage cancer urgently need improvement;
−Removed: current treatments generally provide modest
−Removed: benefits and frequently cause significant adverse effects.
−Removed: Our focus is to provide oncologists and their patients with therapies for
−Removed: metastatic cancer which are more effective than current therapies, and which have a substantially reduced side effect
+Added: While surgery is often safe and effective for early-stage cancer,
+Added: many standard therapies for late-stage cancer urgently need improvement;
+Added: current treatments generally provide modest benefits and frequently
+Added: cause significant adverse effects.
+Added: Our focus is to provide oncologists and their patients with therapies for metastatic cancer which
+Added: 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 fifteen
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Validation of the bioanalytical method will also be completed prior to lodging our first CTA,
−Removed: which we plan to undertake at the Peter MacCallum Cancer Centre in Melbourne, Victoria, Australia’s largest cancer hospital.
−Removed: are collaborating with CROs, manufacturing partners and consultants to complete activities prior to preparing the CTA for the Phase Ib
+Added: which we plan to undertake across investigator sites nationally across Australia.
+Added: We are collaborating with CROs, manufacturing partners
+Added: and consultants to complete activities prior to preparing the CTA for the Phase Ib study.
have received expressions of interest to evaluate proenzyme therapy as a method to prevent recurrence and metastasis of solid tumors
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therapy in patients with advanced solid tumors is completed at the Peter MacCallum Cancer Centre.
−Removed: Australia, we receive an up to 43.5% “cash-back” benefit in the form of a refund of our qualified research and, development
−Removed: costs and expenses.
−Removed: We received a refund of $0 and $196,937 AUD ($129,132) for the years ended June 30, 2025, and
−Removed: 2024, respectively.
+Added: Australia, we may receive an up to 43.5% “cash-back” benefit in the form of a refund of our qualified research and,
+Added: development costs and expenses subject to approval.
+Added: We received a refund of $0 for both periods for the years ended June 30, 2026,
+Added: and 2025, respectively.
We are continuing to evaluate all options to conduct our planned clinical trials in the most cost-efficient
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be driven by the need to increase our internal resources in order to effectively manage our research and development activities.
−Removed: second calendar quarter of 2025, we anticipate the submission of the CTA for PRP.
−Removed: We anticipate receiving approval in the second
−Removed: half of the 2025 calendar year.
−Removed: Following the CTA approval, we plan to commence our study preparation process, including CRO Selection and
−Removed: Contracts, Analytical Lab Selection Contracts and Trial Sites Selection and Contracts.
+Added: fourth quarter of 2026, we anticipate the submission of the CTA for PRP.
+Added: We anticipate receiving approval in the first quarter of
+Added: the 2027 calendar year.
+Added: Following the CTA approval, we plan to commence our study preparation process in collaboration with our appointed CRO, including selection of investigators and test sites.
In connection with the CTA, this product will
−Removed: be part of our Investigation Medicinal Product Dossier, study protocol and Investigator’s Brochure.
−Removed: In the second half of the
−Removed: 2025 calendar year, we hope to complete the study preparation process together with the Preparation of Logistics and Trial Sites
−Removed: Initiation Visits and complete our CTA review.
−Removed: Commencing in the second half of the 2025 calendar year, we intend to initiate a
−Removed: Phase Ib study in advanced cancer patients with solid tumors and we anticipate costs to be approximately $6.5 million.
−Removed: to raise additional financing to fund our planned Phase I, II and III clinical trials and for working capital.
−Removed: 2025 – April 2026
−Removed: Investigational
−Removed: Medicinal Product Dossier
+Added: be part of our study protocol and Investigator’s Brochure.
+Added: In the first quarter of the 2027 calendar year, we hope to complete
+Added: the study preparation process together with the Preparation of Logistics and Trial Sites Initiation Visits and complete our CTA
+Added: Commencing the second quarter of the 2027 calendar year, we intend to initiate a Phase Ib study in advanced cancer patients
+Added: with solid tumors, and we anticipate costs to be approximately $6.5 million.
+Added: We will need to raise additional financing to fund our
+Added: planned Phase I, II and III clinical trials and for working capital.
+Added: 2025 – September 2026
Ib Clinical Study Protocol
Investigator’s
−Removed: 2026 – June 2026
−Removed: 2026 – August 2026
+Added: 2026 – November 2026
+Added: 2027 – February 2027
Research Organization and Contracts
−Removed: 2026 – June 2026
+Added: 2027 – March 2027
Laboratory Selection and Contracts
Site Selection and Contracts
−Removed: 2026 – September 2026
+Added: 2027 – March 2027
Site Initiation Visits
3 unchanged sentences
genetic and protein expression that occur in cancer cells because of being exposed to our proenzyme formulation.
−Removed: The objective
−Removed: of this work is to understand at the molecular level the targets of our proenzyme formulation, thereby providing the opportunity for
−Removed: new, patentable drugs which can be developed further.
−Removed: We plan to commence a targeted drug discovery program utilizing the identified
−Removed: molecular target to search for novel anticancer agents.
+Added: The objective of this
+Added: work is to understand at the molecular level the targets of our proenzyme formulation, thereby providing the opportunity for new, patentable
+Added: drugs which can be developed further.
+Added: We plan to commence a targeted drug discovery program utilizing the identified molecular target
+Added: to search for novel anticancer agents.
POP1 Program has produced synthetic recombinant versions of the two proenzymes, trypsinogen and chymotrypsinogen.
14 unchanged sentences
initial focus is to organize, coordinate and finance the various parts of our drug development pipeline.
−Removed: We intend to carefully
−Removed: introduce new personnel into our Company over time as our R&D activities expand.
−Removed: We plan for such personnel to have specific
−Removed: expertise in product development, manufacture and formulation, regulatory affairs, toxicology, clinical operations and business
−Removed: development (including intellectual property management, licensing and other corporate activities).
−Removed: Additional clinical management
−Removed: and development expertise will likely be required at the outset to assist with the development of PRP.
−Removed: Therefore, we anticipate
−Removed: hiring additional employees to effectively manage our contractors as our development activities progress.
+Added: We intend to carefully introduce
+Added: new personnel into our Company over time as our R&D activities expand.
+Added: We plan for such personnel to have specific expertise in product
+Added: development, manufacture and formulation, regulatory affairs, toxicology, clinical operations and business development (including intellectual
+Added: property management, licensing and other corporate activities).
+Added: Additional clinical management and development expertise will likely
+Added: be required at the outset to assist with the development of PRP.
+Added: Therefore, we anticipate hiring additional employees to effectively
+Added: 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
−Removed: to progress a project, as the required skills change as the project progresses from discovery, through manufacturing and
−Removed: non-clinical development and into clinical trials.
−Removed: We anticipate that we will continue to use this model, thereby retaining the flexibility
−Removed: to contract in the appropriate resource as and when required.
+Added: to progress a project, as the required skills change as the project progresses from discovery, through manufacturing and non-clinical
+Added: development and into clinical trials.
+Added: We anticipate that we will continue to use this model, thereby retaining the flexibility to contract
+Added: in the appropriate resource as and when required.
intend to seek and identify potential licensing partners for our product candidates as they progress through the various development
20 unchanged sentences
such other products have currently been made and it is unknown whether we will engage in any such discussion soon.
−Removed: as we further develop PRP within the development pathway, we intend to assess future opportunities that may arise to use the expertise
−Removed: of our management and scientific personnel for future prospective R&D projects.
+Added: However, as we further
+Added: develop PRP within the development pathway, we intend to assess future opportunities that may arise to use the expertise of our management
+Added: and scientific personnel for future prospective R&D projects.
are at a pre-revenue stage.
14 unchanged sentences
20.6 million new cancer cases and almost 10 million cancer deaths occurred in 2024.
+Added: Without urgent action, annual cancer cases are projected to rise to nearly
+Added: 35 million by 2050.
As such, global demand for new cancer treatments
3 unchanged sentences
plan to target patients with solid tumors, most likely pancreatic and ovarian tumors, for whom other treatment options have been exhausted.
−Removed: Globally these cancers resulted in over 673,255 deaths combined in 2020, according to the World Health Organization.
+Added: Globally these cancers resulted in over 674,365 deaths combined in 2022, according to the World Cancer Research Fund.
With such a high
mortality rate, a substantial unmet medical need exists for new treatments.
−Removed: Once the efficacy and safety of PRP is demonstrated
−Removed: in late-stage patient populations, we plan to undertake exploration of the utility of the drug in earlier stage disease, together with
−Removed: investigation of the drug’s utility in other types of cancer.
+Added: Once the efficacy and safety of PRP is demonstrated in late-stage
+Added: patient populations, we plan to undertake exploration of the utility of the drug in earlier stage disease, together with investigation
+Added: of the drug’s utility in other types of cancer.
Market Potential
61 unchanged sentences
we agreed to pay five percent of each, and every license agreement subscribed for.
−Removed: The contract may be cancelled at any time by
−Removed: either party.
+Added: The contract may be cancelled at any time by either
To date, no amounts are owed under the agreement.
of Jaén Collaboration Agreement
−Removed: have established a collaboration with the University of Jaén to carry out a research project aimed at the synthetic
−Removed: development of PRP and its subsequent validation.
−Removed: The University of Jaén is providing scientific research activities, the
−Removed: Department of Health Sciences, which provides the necessary technical and human resources to carry out the programmed
−Removed: A Collaboration Agreement (the “Collaboration Agreement”), dated October 1, 2020, was entered into with the main
−Removed: objective for the synthetic development of PRP and its subsequent validation.
−Removed: Pursuant to the Collaboration Agreement, a
−Removed: pre-clinical protocol of safety evaluation was established relating to the antitumor efficacy on cancer stem cells and in orthotopic
−Removed: xenotransplantations derived from cancer stem cells isolated from tumor cell lines, and newly developed synthetic formulation based
−Removed: on the two pancreatic zymogens.
−Removed: ownership of potential intellectual property rights that may arise because of the knowledge obtained through such research project
−Removed: will belong to us.
−Removed: In consideration for payment of compensation, the University of Jaén assigned and agreed to do all things
−Removed: reasonably required to assign to the contracting entity all industrial property rights arising from such research project.
+Added: have established a collaboration with the University of Jaén to carry out a research project aimed at the synthetic development
+Added: of PRP and its subsequent validation.
+Added: The University of Jaén is providing scientific research activities, the Department of Health
+Added: Sciences, which provides the necessary technical and human resources to carry out the programmed works.
+Added: A Collaboration Agreement (the
+Added: “Collaboration Agreement”), dated October 1, 2020, was entered into with the main objective for the synthetic development
+Added: of PRP and its subsequent validation.
+Added: Pursuant to the Collaboration Agreement, a pre-clinical protocol of safety evaluation was established
+Added: relating to the antitumor efficacy on cancer stem cells and in orthotopic xenotransplantations derived from cancer stem cells isolated
+Added: from tumor cell lines, and newly developed synthetic formulation based on the two pancreatic zymogens.
+Added: ownership of potential intellectual property rights that may arise because of the knowledge obtained through such research project will
+Added: belong to us.
+Added: In consideration for payment of compensation, the University of Jaén assigned and agreed to do all things reasonably
+Added: required to assign to the contracting entity all industrial property rights arising from such research project.
return for ownership of the industrial property rights arising from such research project, we agreed to pay the University of Jaén
3 unchanged sentences
effect of pancreatic proenzymes against the tumor microenvironment and premetastatic niche.
−Removed: The specific tasks developed under this
−Removed: collaboration focused on the effects of PRP on cancer-associated fibroblasts within the tumor microenvironment.
−Removed: Consistent with
−Removed: existing rights, Propanc will own any intellectual property developed.
−Removed: The personnel of the investigation team of the universities
−Removed: of Jaén and Granada whose work has contributed to the creation of knowledge that gives rise to industrial property rights
−Removed: should be listed as inventors.
−Removed: Further, Professor Macarena Perán from the University of Jaén and Professor Marchal
−Removed: 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
−Removed: behalf, which fall within the scope of protection of such industrial property rights.
−Removed: The commencement date for the experiments was
−Removed: September 1, 2022, and the estimated length of time for completion was 24 months.
+Added: The specific tasks developed under this collaboration
+Added: focused on the effects of PRP on cancer-associated fibroblasts within the tumor microenvironment.
+Added: Consistent with existing rights, Propanc
+Added: will own any intellectual property developed.
+Added: The personnel of the investigation team of the universities of Jaén and Granada
+Added: whose work has contributed to the creation of knowledge that gives rise to industrial property rights should be listed as inventors.
+Added: Further, Professor Macarena Perán from the University of Jaén and Professor Marchal from the University of Granada will
+Added: 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
+Added: protection of such industrial property rights.
+Added: The commencement date for the experiments was September 1, 2022, and completed in June
+Added: third collaborative, two-year research project commenced in March of 2026, with the universities of Jaén and Granada undertaking
+Added: the evaluation of a senescence-modulating compound to mitigate gemcitabine-induced normal cell senescence in pancreatic cancer models.
+Added: The project will specifically evaluate the protective and senescence-modulating effects of PRP against gemcitabine-induced normal cell
+Added: senescence using in vitro and in vivo models of pancreatic cancer in the first year.
+Added: This will be expanded into the effects of PRP on
+Added: tissue rejuvenation and anti-aging by evaluating how PRP attenuates age-associated cellular senescence and promotes tissue rejuvenation
+Added: by fine-tuning TGF-β driven signaling networks, restoring cellular plasticity and reducing maladaptive stress responses.
+Added: The ownership
+Added: of potential industrial property rights that may arise as a result of the knowledge obtained through the project will belong to Propanc.
+Added: In consideration for payment of compensation, UJA and UGR hereby assign and agree to do all things reasonably required to assign to the
+Added: contracting entity all industrial property rights arising from the Project.
+Added: In return for ownership of the entire right and title in
+Added: all industrial property rights arising from the Project, Propanc agrees to pay the University of Jaén five percent (5%), and the
+Added: University of Granada five percent (5%), in both cases of the net sales of any products sold by Propanc which fall within the scope of
+Added: the protection of such industrial property rights.
+Added: This supersedes any previous royalty rates assigned to the University of Jaén
+Added: and the University of Granada, including any previously nominated individual employees, and also represents a maximum royalty rate to
+Added: be applied to any industrial property rights between the University of Jaén, the University of Granada and Propanc relating to
+Added: the use of PRP, whether sourced from animal derived, or synthetic recombinant materials, in the field of cancer, chronic diseases, or
+Added: any health conditions, including, but not limited to cell rejuvenation, anti-ageing, etc.
continue to learn the properties of proenzymes with the long-term aim of screening new compounds for development.
28 unchanged sentences
pharmaceutical composition and use of chymotrypsinogen or tripsinogen
−Removed: ZL201710885368.4
−Removed: pharmaceutical composition for treating cancer comprising trypsinogen and chymotrypsinogen
−Removed: 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
+Added: 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
+Added: ZL201710885368.4
+Added: pharmaceutical composition for treating cancer comprising trypsinogen and chymotrypsinogen
Patent Convention
4 unchanged sentences
composition for treating cancer comprising trypsinogen and chymotrypsinogen
−Removed: & Liechtenstein
Pharmaceutical
18 unchanged sentences
composition for treating cancer comprising trypsinogen and chymotrypsinogen
+Added: & Liechtenstein
Pharmaceutical
4 unchanged sentences
composition for treating cancer comprising trypsinogen and chymotrypsinogen
−Removed: pharmaceutical composition for treating cancer comprising trypsinogen and chymotrypsinogen
Pharmaceutical
composition for treating cancer comprising trypsinogen and chymotrypsinogen
+Added: pharmaceutical composition for treating cancer comprising trypsinogen and chymotrypsinogen
pharmaceutical composition comprising trypsinogen and chymotrypsinogen
10 unchanged sentences
selenium compound, a vanilloid compound and a cytoplasmic glycolysis reduction agent
−Removed: MX/a/2017/009455
pharmaceutical composition for treating cancer comprising trypsinogen and/or chymotrypsinogen and an active agent selected from a
16 unchanged sentences
a vanilloid compound and a cytoplasmic glycolysis reduction agent
−Removed: States of America
−Removed: Pharmaceutical
−Removed: composition for treating cancer comprising trypsinogen and/or chymotrypsinogen and an active agent selected from a selenium compound,
−Removed: a vanilloid compound and a cytoplasmic glycolysis reduction agent
−Removed: by client (D)
201680070907.2
9 unchanged sentences
States of America
−Removed: of proenzymes for cancer treatment
−Removed: by client (D)
−Removed: 201780021479.9
−Removed: of proenzymes for cancer treatment
Patent Convention
2 unchanged sentences
of proenzymes for cancer treatment
−Removed: & Liechtenstein
of proenzymes for cancer treatment
3 unchanged sentences
of proenzymes for cancer treatment
−Removed: of proenzymes for cancer treatment
−Removed: of proenzymes for cancer treatment
+Added: & Liechtenstein
of proenzymes for cancer treatment
of proenzymes for cancer treatment
−Removed: States of America
of proenzymes for cancer treatment
−Removed: by client (D)
+Added: of treating resistant cancer
+Added: of treating diseases
+Added: expression system
+Added: and methods thereof
oversight of the pharmaceutical industry is usually classified into pre-approval and post-approval categories.
−Removed: therapeutically significant innovative products marketed today are the subject of New Drug Applications (“NDA”).
−Removed: Preapproval of activities, based on these detailed applications, are used to ensure the product is safe and effective before
−Removed: In the United States, The Center for Drug Evaluation and Research (“CDER”), is the FDA organization
−Removed: responsible for over the counter and prescription drugs, including most biological therapeutics, and generic drugs.
+Added: Most of the therapeutically
+Added: significant innovative products marketed today are the subject of New Drug Applications (“NDA”).
+Added: Preapproval of activities,
+Added: based on these detailed applications, are used to ensure the product is safe and effective before marketing.
+Added: In the United States, The
+Added: Center for Drug Evaluation and Research (“CDER”), is the FDA organization responsible for over the counter and prescription
+Added: drugs, including most biological therapeutics, and generic drugs.
approval, the FDA may inspect and audit the development facilities, planned production facilities, clinical trials, institutional review
6 unchanged sentences
Food, Drug and Cosmetic Act and Public Health Service Act
−Removed: drug and biologic products are subject to extensive pre- and post-market regulations by the FDA, including regulations that govern
−Removed: the testing, manufacturing, safety, efficacy, labelling, storage, record keeping, advertising and promotion of such products under
−Removed: the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, and their implementing regulations.
−Removed: The process of obtaining
−Removed: FDA approval and achieving and maintaining compliance with applicable laws and regulations requires the expenditure of substantial
−Removed: time and financial resources.
−Removed: Failure to comply with applicable FDA or other requirements may result in refusal to approve pending
−Removed: applications, a clinical hold, warning letters, civil or criminal penalties, recall or seizure of products, partial or total
−Removed: suspension of production or withdrawal of the product from the market.
−Removed: FDA approval is required before any new drug or biologic,
−Removed: including a new use of a previously approved drug, can be marketed in the United States.
−Removed: All applications for FDA approval must
−Removed: contain, among other things, information relating to safety and efficacy, stability, manufacturing, processing, packaging, labelling
−Removed: and quality control.
+Added: drug and biologic products are subject to extensive pre- and post-market regulations by the FDA, including regulations that govern the
+Added: testing, manufacturing, safety, efficacy, labelling, storage, record keeping, advertising and promotion of such products under the Federal
+Added: Food, Drug and Cosmetic Act, the Public Health Service Act, and their implementing regulations.
+Added: The process of obtaining FDA approval
+Added: and achieving and maintaining compliance with applicable laws and regulations requires the expenditure of substantial time and financial
+Added: Failure to comply with applicable FDA or other requirements may result in refusal to approve pending applications, a clinical
+Added: hold, warning letters, civil or criminal penalties, recall or seizure of products, partial or total suspension of production or withdrawal
+Added: of the product from the market.
+Added: FDA approval is required before any new drug or biologic, including a new use of a previously approved
+Added: drug, can be marketed in the United States.
+Added: All applications for FDA approval must contain, among other things, information relating
+Added: to safety and efficacy, stability, manufacturing, processing, packaging, labelling and quality control.
Drug Applications (“NDAs”)
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to and approval by the FDA of an NDA.
−Removed: preclinical and clinical testing and approval process requires substantial time, effort and financial resources, and we cannot
−Removed: guarantee that any approvals for our product candidates will be granted on a timely basis, if at all.
−Removed: Preclinical tests include
−Removed: laboratory evaluation of toxicity and immunogenicity in animals.
−Removed: The results of preclinical tests, together with manufacturing
−Removed: information and analytical data, are submitted as part of an IND application to the FDA.
−Removed: The IND automatically becomes effective 30
−Removed: days after receipt by the FDA, unless the FDA raises concerns or questions about the conduct of the clinical trial, including
−Removed: concerns that human research subjects will be exposed to unreasonable health risks.
−Removed: In such a case, the IND sponsor and the FDA must
−Removed: resolve any outstanding concerns before clinical trials can begin.
−Removed: Our submission of an IND may not result in FDA authorization to
−Removed: commence clinical trials.
−Removed: A separate submission to an existing IND must also be made for each successive clinical trial conducted
−Removed: during product development.
−Removed: Further, an independent institutional review board (“IRB”) covering each medical center
−Removed: proposing to conduct clinical trials must review and approve the plan for any clinical trial before it commences at that center and
−Removed: it must monitor the study until completed.
−Removed: The FDA, the IRB or the Sponsor may suspend a clinical trial at any time on various
−Removed: grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk.
−Removed: Clinical testing also
−Removed: must satisfy extensive “good clinical practice” (“GCP”) regulations, which include requirements that all
−Removed: research subjects provide informed consent and that all clinical studies be conducted under the supervision of one or more qualified
−Removed: investigators.
+Added: preclinical and clinical testing and approval process requires substantial time, effort and financial resources, and we cannot guarantee
+Added: that any approvals for our product candidates will be granted on a timely basis, if at all.
+Added: Preclinical tests include laboratory evaluation
+Added: of toxicity and immunogenicity in animals.
+Added: The results of preclinical tests, together with manufacturing information and analytical data,
+Added: are submitted as part of an IND application to the FDA.
+Added: The IND automatically becomes effective 30 days after receipt by the FDA, unless
+Added: the FDA raises concerns or questions about the conduct of the clinical trial, including concerns that human research subjects will be
+Added: exposed to unreasonable health risks.
+Added: In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before clinical
+Added: trials can begin.
+Added: Our submission of an IND may not result in FDA authorization to commence clinical trials.
+Added: A separate submission to
+Added: an existing IND must also be made for each successive clinical trial conducted during product development.
+Added: Further, an independent institutional
+Added: review board (“IRB”) covering each medical center proposing to conduct clinical trials must review and approve the plan for
+Added: any clinical trial before it commences at that center and it must monitor the study until completed.
+Added: The FDA, the IRB or the Sponsor
+Added: may suspend a clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an
+Added: unacceptable health risk.
+Added: Clinical testing also must satisfy extensive “good clinical practice” (“GCP”) regulations,
+Added: which include requirements that all research subjects provide informed consent and that all clinical studies be conducted under the supervision
+Added: of one or more qualified investigators.
purposes of an NDA submission and approval, human clinical trials are typically conducted in the following sequential phases, which may
20 unchanged sentences
to as Phase IV clinical trials.
−Removed: reports detailing the results of the clinical studies must be submitted at least annually to the FDA and safety reports must be
−Removed: submitted to the FDA and the investigators for serious and unexpected adverse events.
−Removed: Concurrently with clinical studies, sponsors
−Removed: usually complete additional animal studies and must also develop additional information about the product and finalize a process for
−Removed: manufacturing the product in commercial quantities in accordance with CGMP requirements.
−Removed: The manufacturing process must be capable
−Removed: of consistently producing quality batches of the product and, among other things, the manufacturer must develop methods for testing
−Removed: the identity, strength, quality and purity of the final product.
−Removed: Moreover, appropriate packaging must be selected and tested, and
−Removed: stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its
−Removed: results of product development, preclinical studies and clinical trials, along with the aforementioned manufacturing information,
−Removed: are submitted to the FDA as part of an NDA.
+Added: reports detailing the results of the clinical studies must be submitted at least annually to the FDA and safety reports must be submitted
+Added: to the FDA and the investigators for serious and unexpected adverse events.
+Added: Concurrently with clinical studies, sponsors usually complete
+Added: additional animal studies and must also develop additional information about the product and finalize a process for manufacturing the
+Added: product in commercial quantities in accordance with CGMP requirements.
+Added: The manufacturing process must be capable of consistently producing
+Added: quality batches of the product and, among other things, the manufacturer must develop methods for testing the identity, strength, quality
+Added: and purity of the final product.
+Added: Moreover, appropriate packaging must be selected and tested, and stability studies must be conducted
+Added: to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf-life.
+Added: results of product development, preclinical studies and clinical trials, along with the aforementioned manufacturing information, are
+Added: submitted to the FDA as part of an NDA.
NDAs must also contain extensive manufacturing information.
−Removed: Under the Prescription Drug
−Removed: User Fee Act, the FDA agrees to specific goals for NDA review time through a two-tiered classification system, Standard Review and
−Removed: Priority Review.
+Added: Under the Prescription Drug User
+Added: Fee Act, the FDA agrees to specific goals for NDA review time through a two-tiered classification system, Standard Review and Priority
Standard Review is applied to products that offer at most only minor improvement over existing marketed therapies.
−Removed: Standard Review NDAs have a goal of being completed within a ten-month timeframe, although a review can take significantly longer.
−Removed: Priority Review designation is given to products that offer major advances in treatment or provide a treatment where no adequate
−Removed: therapy exists.
−Removed: A Priority Review takes the FDA six months to review an NDA.
−Removed: It is likely that our product candidates will be
−Removed: granted Standard Reviews.
−Removed: The review process is often significantly extended by FDA requests for additional information or
−Removed: clarification.
−Removed: The FDA may refer to the application to an advisory committee for review, evaluation and recommendation as to whether
−Removed: the application should be approved.
−Removed: The FDA is not bound by the recommendation of an advisory committee, but it generally follows
−Removed: such recommendations.
+Added: Standard Review
+Added: NDAs have a goal of being completed within a ten-month timeframe, although a review can take significantly longer.
+Added: A Priority Review
+Added: designation is given to products that offer major advances in treatment or provide a treatment where no adequate therapy exists.
+Added: Review takes the FDA six months to review an NDA.
+Added: It is likely that our product candidates will be granted Standard Reviews.
+Added: process is often significantly extended by FDA requests for additional information or clarification.
+Added: The FDA may refer to the application
+Added: to an advisory committee for review, evaluation and recommendation as to whether the application should be approved.
+Added: The FDA is not bound
+Added: by the recommendation of an advisory committee, but it generally follows such recommendations.
FDA may deny approval of an NDA if the applicable regulatory criteria are not satisfied, or it may require additional clinical data or
43 unchanged sentences
An NDA supplement
−Removed: for a new indication typically requires clinical data like that in the original application, and the FDA uses the same procedures
−Removed: and actions in reviewing NDA supplements as it does in reviewing an NDA.
+Added: for a new indication typically requires clinical data like that in the original application, and the FDA uses the same procedures and
+Added: actions in reviewing NDA supplements as it does in reviewing an NDA.
event reporting and submission of periodic reports is required following FDA approval of an NDA.
3 unchanged sentences
June 2017, we were notified by the FDA that PRP had been granted orphan drug designation for the treatment of pancreatic cancer.
−Removed: Orphan drug designation may be granted by the FDA when a rare disease or condition is implicated, and a potential treatment
−Removed: qualifies under the Orphan Drug Act and applicable FDA regulations.
−Removed: This qualifies us for various developmental incentives,
−Removed: including protocol assistance, the potential for research grants, the waiver of future application fees, and tax credits for
−Removed: clinical testing if we choose to host future clinical trials in the United States.
+Added: drug designation may be granted by the FDA when a rare disease or condition is implicated, and a potential treatment qualifies under
+Added: the Orphan Drug Act and applicable FDA regulations.
+Added: This qualifies us for various developmental incentives, including protocol assistance,
+Added: the potential for research grants, the waiver of future application fees, and tax credits for clinical testing if we choose to host future
+Added: clinical trials in the United States.
October 2017, we submitted a request for a second orphan drug designation for PRP, this time for ovarian cancer.
9 unchanged sentences
a suitable sub-population in ovarian cancer, which may meet the target threshold.
−Removed: addition to regulations in the United States, we will be subject to a variety of foreign regulations governing clinical trials,
−Removed: commercial sales and distribution of our products if we conduct trials for, and market and sell our products, abroad.
−Removed: Whether or not
−Removed: we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory authorities of foreign
−Removed: countries before we can commence clinical trials or market our product in those countries.
−Removed: The approval process varies from country
−Removed: to country, and the time may differ than that required for FDA approval.
−Removed: The requirements governing the conduct of clinical trials,
−Removed: product licensing, pricing and reimbursement vary greatly from country to country.
−Removed: Despite these differences, the clinical trials
−Removed: will be conducted according to international standards, such as GCP, GMP and GLP, which is recognized by each foreign country under
−Removed: the International Conference of Harmonization Guidelines.
−Removed: We plan to conduct our trials in each foreign jurisdiction according to
−Removed: these standards, undertaking a FIH Phase Ib study in patients with advanced solid tumors, evaluating the safety, pharmacokinetics,
−Removed: and anti-tumor efficacy of PRP.
−Removed: This will be followed by two Phase II studies evaluating the efficacy and safety of PRP.
−Removed: harmonization between the jurisdictions, we intend to conduct regulatory meetings in the country in which trials are conducted, as
−Removed: well as with the FDA and the EMA.
−Removed: A pre-IND meeting will be held with the FDA once initial patient data has been collected from the
−Removed: FIH study to ensure acceptability of future planned Phase II trials.
+Added: addition to regulations in the United States, we will be subject to a variety of foreign regulations governing clinical trials, commercial
+Added: sales and distribution of our products if we conduct trials for, and market and sell our products, abroad.
+Added: Whether or not we obtain FDA
+Added: approval for a product, we must obtain approval of a product by the comparable regulatory authorities of foreign countries before we
+Added: can commence clinical trials or market our product in those countries.
+Added: The approval process varies from country to country, and the time
+Added: may differ than that required for FDA approval.
+Added: The requirements governing the conduct of clinical trials, product licensing, pricing
+Added: and reimbursement vary greatly from country to country.
+Added: Despite these differences, the clinical trials will be conducted according to
+Added: international standards, such as GCP, GMP and GLP, which is recognized by each foreign country under the International Conference of
+Added: Harmonization Guidelines.
+Added: We plan to conduct our trials in each foreign jurisdiction according to these standards, undertaking a FIH
+Added: Phase Ib study in patients with advanced solid tumors, evaluating the safety, pharmacokinetics, and anti-tumor efficacy of PRP.
+Added: will be followed by two Phase II studies evaluating the efficacy and safety of PRP.
+Added: To ensure harmonization between the jurisdictions,
+Added: we intend to conduct regulatory meetings in the country in which trials are conducted, as well as with the FDA and the EMA.
+Added: meeting will be held with the FDA once initial patient data has been collected from the FIH study to ensure acceptability of future planned
+Added: Phase II trials.
European Union regulatory systems, we must submit and obtain authorization for a CTA in each member state in which we intend to conduct
52 unchanged sentences
prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted.
−Removed: authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which medications
−Removed: they will pay for and establish reimbursement levels.
+Added: authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which medications they
+Added: will pay for and establish reimbursement levels.
A primary trend in the U.S.
−Removed: healthcare industry and elsewhere is cost
−Removed: Government authorities and third-party payors have attempted to control costs by limiting coverage and the amount of
−Removed: reimbursement for specific medications.
−Removed: Increasingly, third-party payors are requiring that drug companies provide them with
−Removed: predetermined discounts from list prices and are challenging the prices charged for medical products.
+Added: healthcare industry and elsewhere is cost containment.
+Added: authorities and third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for specific
+Added: Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices
+Added: and are challenging the prices charged for medical products.
are also subject to numerous federal, state, and local laws relating to such matters as safe working conditions, manufacturing practices,
3 unchanged sentences
biotechnology and pharmaceutical industries are characterized by continuing technological advancement and significant competition.
−Removed: While we believe that our technology platforms, product candidates, know-how, experience and scientific resources provide us with
−Removed: competitive advantages, we face competition from major pharmaceutical and biotechnology companies, academic institutions,
−Removed: governmental agencies and public and private research institutions, among others.
−Removed: Any product candidates that we successfully
−Removed: develop and commercialize will compete with existing therapies and new therapies that may become available in the future.
−Removed: product features that would affect our ability to effectively compete with other therapeutics include the efficacy, safety and
−Removed: convenience of our products.
−Removed: The level of generic competition and the availability of reimbursement from government and other
−Removed: third-party payers will also significantly impact on the pricing and competitiveness of our products.
−Removed: Our competitors also may
−Removed: obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in
−Removed: our competitors establishing a strong market position before we are able to enter the market.
+Added: we believe that our technology platforms, product candidates, know-how, experience and scientific resources provide us with competitive
+Added: advantages, we face competition from major pharmaceutical and biotechnology companies, academic institutions, governmental agencies and
+Added: public and private research institutions, among others.
+Added: Any product candidates that we successfully develop and commercialize will compete
+Added: with existing therapies and new therapies that may become available in the future.
+Added: Key product features that would affect our ability
+Added: to effectively compete with other therapeutics include the efficacy, safety and convenience of our products.
+Added: The level of generic competition
+Added: and the availability of reimbursement from government and other third-party payers will also significantly impact on the pricing and
+Added: competitiveness of our products.
+Added: Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than
+Added: we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter
of our competitors have significantly greater financial resources and expertise in R&D, manufacturing, preclinical testing, conducting
5 unchanged sentences
and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.
−Removed: of June 30, 2025, we had one full-time and one part-time employee.
+Added: of June 30, 2026, we had two full-time and employees.
In addition to our employees, we engage key consultants and utilize
7 unchanged sentences
is based in Camberwell, Victoria, Australia.
−Removed: Since its inception, substantially all the operations of the Company have been focused
−Removed: on the development of new cancer treatments targeting high-risk patients, particularly cancer survivors, who need a follow-up, non-toxic,
+Added: Since its inception, substantially all the operations of the Company have been focused on
+Added: the development of new cancer treatments targeting high-risk patients, particularly cancer survivors, who need a follow-up, non-toxic,
long-term therapy designed to prevent the cancer from returning and spreading.
4 unchanged sentences
Company was originally formed in Melbourne, Victoria, Australia on October 15, 2007, as Propanc PTY LTD.
−Removed: On November 23, 2010,
−Removed: Propanc Health Group Corporation was incorporated in the State of Delaware, and in January 2011, to reorganize the Company, all the
−Removed: outstanding shares of Propanc PTY LTD were acquired on a one-for-one basis by Propanc Health Group Corporation, with Propanc PTY LTD
−Removed: becoming a wholly-owned subsidiary of the Company.
−Removed: July 22, 2016, the Company formed another wholly owned subsidiary, Propanc (UK) Limited under the laws of England and Wales for the
−Removed: purpose of submitting an orphan drug application to the European Medicines Agency (the “EMA”) as a small and
−Removed: medium-sized enterprise.
+Added: On November 23, 2010, Propanc
+Added: Health Group Corporation was incorporated in the State of Delaware, and in January 2011, to reorganize the Company, all the outstanding
+Added: shares of Propanc PTY LTD were acquired on a one-for-one basis by Propanc Health Group Corporation, with Propanc PTY LTD becoming a wholly-owned
+Added: subsidiary of the Company.
+Added: July 22, 2016, the Company formed another wholly owned subsidiary, Propanc (UK) Limited under the laws of England and Wales for the purpose
+Added: of submitting an orphan drug application to the European Medicines Agency (the “EMA”) as a small and medium-sized enterprise.
As of the date of this filing, there has been no activity within this entity.
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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.