Propanc Biopharma’s CEO Tours European CDMO & Plans for GMP Production of PRP for Phase 1b, FIH Study

Propanc Biopharma (Nasdaq:PPCB) outlined its 2026 manufacturing plan for PRP, supporting a planned Phase 1b, first-in-human study in 30–40 advanced solid tumor patients.

Rhea-AI Summary

Propanc Biopharma (Nasdaq:PPCB) outlined its 2026 manufacturing plan for PRP, supporting a planned Phase 1b, first-in-human study in 30–40 advanced solid tumor patients.

The CEO toured a European GMP CDMO as the team targets preproduction in August 2026, an engineering run in October 2026, and GMP manufacture from December 2026 to back a 2026 Australian trial application.

Positive

• Defined 2026 timeline for PRP preproduction, engineering run and GMP manufacture
• European GMP CDMO selected to support PRP clinical supply
• Manufacturing plan supports Phase 1b FIH study in 30–40 cancer patients
• Four-week stability package expected to support 2026 Australian trial application

Negative

• Phase 1b first-in-human trial for PRP remains pending, with key steps scheduled into late 2026

Argus Jun 16 session

-10.23% close to close Open Argus

Details

News Market Reaction – PPCB

On Jun 16, the day this news came out, PPCB closed 10.23% below the previous close.

Data tracked by StockTitan Argus for the Jun 16 session.

Market Context

On Jun 16, the day this news came out, the stock closed 10.2% below the previous close. A negative r...

Analysis

On Jun 16, the day this news came out, the stock closed 10.2% below the previous close. A negative reaction despite operational progress fits prior patterns, where PRP development updates on May 19 and May 20 coincided with ‑7.32% and ‑5.24% moves. The stock traded well below its 200‑day average and ‑99.2% under its 52‑week high before this article, so sentiment was already fragile. Investors have also seen repeated equity financings and going‑concern language in recent filings, which can magnify downside after otherwise constructive pipeline news.

Key Figures

Phase 1b patients: 30–40 advanced cancer patients Preproduction start: August 2026 Engineering run: October 2026 +5 more

Phase 1b patients

30–40 advanced cancer patients

Planned First-In-Human PRP study

Preproduction start

August 2026

Target date for PRP preproduction

Engineering run

October 2026

Target date for engineering run

GMP manufacture

December 2026

Target start for GMP PRP manufacture

Stability data period

4 weeks

Post‑engineering run stability data to support trial application

Facility size

4,500 sqm

Total CDMO facility area across two building sites

cGMP manufacturing area

1,400 sqm

Allocated to cGMP manufacturing at CDMO

Analytical testing area

400 sqm

Allocated to analytical testing at CDMO

Historical Context

5 past events · Latest: Jun 11

5 events

1. Jun 11

   Share repurchase plan

   24h Move

   +80.0%

   Authorized a $5.0M share repurchase while advancing PRP to Phase 1b.

2. Jun 02

   Conference participation

   24h Move

   -2.2%

   CEO attended ageing‑society keynote, reiterating PRP Phase 1b plans.

3. May 20

   Pipeline development plans

   24h Move

   -5.2%

   Outlined PRP Phase 1b CTA in Australia and future Phase 2 trials.

4. May 19

   CDMO engagement

   24h Move

   -7.3%

   Engaged European CDMO for GMP PRP production for 30–40 patients.

5. May 15

   Earnings & corporate update

   24h Move

   -7.0%

   Reported Q3 2025/26 results, private placement up to $100M, and cash levels.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

gmp, cdmo, first-in-human (fih), i.v. injection, +3 more

7 terms

gmp regulatory

"toured the GMP (Good Manufacturing Practice) facility of the European CDMO"

Good Manufacturing Practice (GMP) is a set of regulatory standards and procedures that ensure products—especially medicines, medical devices, and related goods—are consistently made to meet safety, quality, and purity requirements. For investors, GMP compliance is like a factory’s hygiene and checklist system: it reduces the risk of product recalls, regulatory fines, and production stoppages, supports market access, and signals more reliable, lower-risk operations that can protect revenue and reputation.

cdmo technical

"facility of the European CDMO (Contract Development and Manufacturing Organization)"

A contract development and manufacturing organization (CDMO) is a company that provides specialized services to help develop and produce pharmaceutical products for other businesses. Think of it as a contract factory that takes a company's recipe and makes the product on their behalf. For investors, CDMOs are important because they support the growth of pharmaceutical companies and can be key partners in bringing new medicines to market.

first-in-human (fih) medical

"for the upcoming Phase 1b, First-In-Human (FIH) study in 30 – 40 advanced"

The first-in-human (FIH) designation marks the first time a new drug, vaccine, medical device, or treatment is given to people rather than tested only in labs or animals. For investors, FIH is a major milestone because it moves a candidate from preclinical testing into human safety and early effectiveness evaluation—think of it as the prototype being driven on public roads, where results strongly influence future development costs, timelines, and commercial potential.

i.v. injection medical

"trypsinogen and chymotrypsinogen administered by I.V. injection once weekly."

An i.v. injection delivers a liquid drug or medical substance directly into a vein using a needle or catheter, allowing the active ingredient to enter the bloodstream immediately. For investors, i.v. delivery matters because it affects how quickly a therapy works, the size and complexity of clinical trials, manufacturing and administration costs, and reimbursement prospects — all of which influence a medical product’s market potential and revenue timeline.

cGMP regulatory

"visualize future cGMP production of PRP, building the foundation for a strong"

cGMP (current Good Manufacturing Practice) are government-enforced quality standards that manufacturers must follow to ensure drugs, medical devices, and related products are made consistently, safely, and meet specified quality tests. For investors, cGMP compliance is like a restaurant passing health inspections: it reduces the risk of product recalls, regulatory fines, or production stoppages that can hurt revenue and company value, and it supports market access and long-term trust.

recombinant proteins medical

"decoding biologics production (plasmid DNA and recombinant proteins) providing"

Recombinant proteins are proteins produced by inserting the gene that codes for them into a host cell (like bacteria, yeast or cultured animal cells) so the cell becomes a mini factory making that exact protein. Investors care because many medicines, vaccines and diagnostic tests rely on these lab-made proteins; their commercial value depends on how easily they can be produced at scale, protected by patents, and cleared by regulators—similar to how a reliable factory and exclusive recipe affect a consumer product’s profitability.

monoclonal antibodies medical

"medicines derived from living cells, such as proteins, vaccines, and monoclonal antibodies)."

Monoclonal antibodies are lab-made proteins designed to bind a single, specific target on cells or viruses, like identical keys cut to fit one lock. They are used as medicines, tests, or targeted delivery tools and can precisely block or mark disease processes. Investors care because they can become high-value drugs with large sales, long patent protection, and binary risks tied to clinical trial results, regulatory approval, manufacturing scale and pricing.

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Pre-production, Engineering Run and GMP Manufacture of PRP in 2026

MELBOURNE, Australia, June 16, 2026 (GLOBE NEWSWIRE) -- Propanc Biopharma, Inc. (Nasdaq: PPCB) (“Propanc” or the “Company”), a biopharmaceutical company focused on developing novel treatments for chronic diseases, including recurrent and metastatic cancer, today announced that Mr. James Nathanielsz, Propanc’s Chief Executive Officer, toured the GMP (Good Manufacturing Practice) facility of the European CDMO (Contract Development and Manufacturing Organization) in preparation for the upcoming production of the Company’s lead asset, PRP, for the upcoming Phase 1b, First-In-Human (FIH) study in 30 – 40 advanced cancer patients suffering from solid tumors. In addition to touring the facility, the joint development team, consisting of Propanc’s R&D team and the key personnel from the CDMO engaged in discussions regarding the proposed project timelines, including the pre-production, engineering run and future GMP production and release of PRP, a world-first, fixed combination of two proenzymes, trypsinogen and chymotrypsinogen administered by I.V. injection once weekly. The plan is to undertake the following steps towards preparation of the finished drug product for the Phase 1b, FIH study, according to the following target dates:

• Preproduction in August 2026
• Engineering run in October 2026
• GMP manufacture to commence December 2026
  

It is anticipated that four weeks stability data post the engineering run will be sufficient to support a Phase 1B clinical trial application in Australia planned for submission in 2026.

Established in 2017, they provide services to a wide range of clients, including startups, large pharmaceutical companies, and other CDMOs, helping their biologic products reach the market efficiently. Operating across two building sites totaling 4,500sqm, with additional space reserved for future expansion, key facility allocations include 500sqm for development activities, 1,400sqm for cGMP manufacturing, 400sqm for analytical testing and a 400sqm cGMP warehouse. The company holds multiple certifications, including ISO 9001:2015, ISO 13485:2016, ISO 14001:2015, and GMP compliance, ensuring high-quality standards across all stages of biologics production.

“Visiting our CDMO partner provides tremendous benefits being able to visualize future cGMP production of PRP, building the foundation for a strong partnership and creating an understanding between the parties about the vision for the future, in particular, our plans for PRP as a world first cancer therapy for the treatment and prevention of metastatic cancer from solid tumors, which are often incurable,” said Mr. Nathanielsz. “In addition, visiting the facility in person has helped me to appreciate the significant capital investment into their modern equipment and building facilities which are perfectly suited for early-stage developers whom they desire to grow with. I am looking forward to working with our partner of choice after an extensive process to identify the right characteristics in the people, their facilities, and processes. We believe we have the tools in place to advance PRP through clinical development as efficiently as possible.”

Based in Europe, the CDMO provides end-to-end services for preclinical and clinical projects, with extensive experience in decoding biologics production (plasmid DNA and recombinant proteins) providing services of cell line generation, banking and characterization, analytical development, process development and batches production of both drug substances and drug products (decoding biologics production refers to the specialized process of understanding, optimizing, and controlling the manufacturing of complex medicines derived from living cells, such as proteins, vaccines, and monoclonal antibodies).

CDMO for biologics production

Mr Nathanielsz (far right) with Propanc & European CDMO team members

About Propanc Biopharma, Inc.

Propanc Biopharma, Inc. (Nasdaq: PPCB) is developing a novel approach to preventing cancer recurrence and metastasis by targeting and eradicating cancer stem cells through proenzyme activation. The Company’s lead product candidate, PRP, is designed to address the underlying drivers of cancer proliferation and spread.

More information: www.propanc.com

Forward-Looking Statements

All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to the Company’s expectations regarding its market position and market opportunity, expectations and plans as to its product development, manufacturing and sales, and relations with its partners and investors, made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections regarding its business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expect,” “intend,” “plan,” “project,” “believe,” “estimate,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond the Company’s control. Forward-looking statements are not guarantees of future actions or performance. Actual results may differ materially from those in the forward-looking statements because of several factors, including, without limitation, risks and uncertainties related to market conditions, as well as those risks described under “Risk Factors” in the prospectus related to the proposed offering and those described in the Company’s filings with the SEC. The Company undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.

Company:
Propanc Biopharma, Inc.
James Nathanielsz

+61-3-9882-0780

info@propanc.com

Investor Contact:

irteam@propanc.com

Photos accompanying this announcement are available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/2b950812-6479-4fc9-9b91-ef0e39b448af
https://www.globenewswire.com/NewsRoom/AttachmentNg/5e8feaf0-8d4d-43e3-a6ba-9ae0462552fd

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Propanc Biopharma (PPCB) announce about PRP manufacturing on June 16, 2026?

Propanc Biopharma announced a 2026 manufacturing plan for its lead asset PRP with a European GMP CDMO. According to Propanc, the schedule includes preproduction, an engineering run and GMP manufacture to support a planned Phase 1b, first-in-human study in advanced solid tumor patients.

When will Propanc’s European CDMO begin GMP production of PRP for the Phase 1b trial?

Propanc expects GMP manufacture of PRP to commence in December 2026 at its European CDMO partner. According to Propanc, this follows preproduction targeted for August 2026 and an engineering run in October 2026, providing clinical supply for the planned Phase 1b first-in-human study.

What is PRP in Propanc Biopharma’s (PPCB) planned Phase 1b first-in-human study?

PRP is a fixed combination of two proenzymes, trypsinogen and chymotrypsinogen, administered by weekly IV injection. According to Propanc, PRP is being developed as a potential world-first cancer therapy targeting treatment and prevention of metastatic disease from solid tumors in advanced patients.

How many patients are planned for Propanc Biopharma’s Phase 1b PRP trial?

The planned Phase 1b first-in-human PRP study will enroll approximately 30–40 advanced cancer patients with solid tumors. According to Propanc, PRP will be given once weekly by intravenous injection, with drug product supplied from the European GMP CDMO’s 2026 manufacturing campaign.

How does the 2026 PRP manufacturing plan support Propanc’s Australian trial application?

Propanc expects four weeks of stability data after the engineering run to support a Phase 1b application in Australia. According to Propanc, the engineering run is targeted for October 2026, enabling a 2026 submission for the first-in-human PRP clinical trial in solid tumor patients.

What capabilities does Propanc Biopharma’s European CDMO partner offer for PRP production?

The European CDMO provides end-to-end biologics services, including cell line generation, analytical and process development, and GMP manufacturing. According to Propanc, the partner operates two sites totaling 4,500 sqm with dedicated cGMP manufacturing, testing and warehousing space and multiple ISO and GMP certifications.