Plans To Commence World-First Phase 1b First-In-Human (FIH) Study of PRP Q1, 2027
MELBOURNE, Australia, Sept. 29, 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 an update on corporate progress and reported year-end financial results as of June 30, 2026 (Year end June 30).
CORPORATE HIGHLIGHTS
To commence a world-first Phase 1b FIH study of PRP in Q1, 2027
The multicenter, open-label study will enroll up to 50 patients with advanced solid tumors, including pancreatic, ovarian, and refractory prostate cancers, at trial centers across Australia. The two-part design, dose escalation (Part A) followed by dose expansion (Part B), is intended to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of PRP.
Several workstreams are advancing in parallel to support study start:
- Manufacturing: GMP manufacture of finished drug product is underway. A small-scale technology transfer run has been completed. Two scale-up runs are scheduled this month, with an engineering run planned for late October. Raw drug substance supply for the PRP formulation is secured after recent audit and vendor qualification processes were successfully completed.
- Bio-analytics: PK method validation has commenced. Development of an anti-drug antibody assay is underway, and in-use stability testing of the finished PRP formulation is scheduled.
- Regulatory and ethics: Supporting documentation for Human Research Ethics Committee (HREC) submission is in preparation, including the Investigator’s Brochure (IB), a briefing document drawn from the IB, and the clinical trial protocol. Documents will be provided to investigators at Australian trial sites for feasibility assessment ahead of the planned HREC submission in November 2026.
PRP will be administered as a weekly intravenous infusion on Days 1, 8, 15, and 22 of each 28-day cycle. Treatment may continue until a withdrawal criterion is met.
Compelling new preclinical and early translational data for its lead candidate PRP in pancreatic ductal adenocarcinoma (PDAC)
In orthotopic and patient-derived xenograft (PDX) models of advanced PDAC, three-times-weekly intravenous PRP achieved:
- Greater than 90%, mean, tumor growth inhibition versus vehicle controls (p < 0.001).
- Marked reduction in metastatic burden in the liver and peritoneum.
- Significant remodeling of the tumor microenvironment, including decreased cancer-associated fibroblast activity, reduced fibrosis, and suppression of epithelial-mesenchymal transition (EMT) markers.
- Enhanced sensitivity of chemo-resistant PDAC cells to standard-of-care gemcitabine/nab-paclitaxel, supporting lower chemotherapy doses with improved efficacy.
- Median overall survival extension of more than 2.5-fold in treated animals compared with controls.
Results were built on previously reported >85% tumor growth inhibition data and peer-reviewed findings on PRP’s effects on PDAC fibroblasts. Limited prior compassionate-use experience with related proenzyme formulations has shown signals of prolonged survival in advanced solid-tumor patients with a favorable safety profile and no severe treatment-related adverse events.
Memorandum of Understanding (MOU) with Avance Clinical Pty Ltd
The MOU sets out the shared intent of Propanc and Avance to work together to support the clinical delivery of Propanc’s Phase 1b, FIH clinical study for PRP. Importantly, both parties intend to approach the collaboration in a spirit of openness, scientific rigor, and shared problem-solving with the goal of advancing PRP efficiently from FIH into Proof-of-Concept and, as data supports, later-phase development. Avance Clinical is a full-service Contract Research Organization (CRO) headquartered in Australia, with extensive operations across North America, Asia Pacific, New Zealand and Europe. With more than 30 years of experience leading early phase clinical trials, they leverage the unique advantages of the Australian market, including rapid ethics approval, and up to 43.5% off with the Australian R&D tax rebate, to provide biotech companies with an accelerated pathway to clinical success.
Contract and Development Manufacturing Organization (CDMO) for GMP manufacture of PRP
The Spanish based CDMO provides end-to-end services for preclinical and clinical projects, with extensive experience in 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. Management are pleased to undertake this pivotal step for GMP production of PRP for the upcoming Phase 1 FIH clinical study.
Service Agreement with FyoniBio GmbH to Establish & Validate Pharmacokinetics Assay for Phase 1b FIH Study
Management has executed a service agreement with FyoniBio GmbH (formerly Glycotope, est. 2010), a German Contract Development Organization (CDO) based in Berlin for establishing and validating a liquid chromatography-mass spectrometry (LC-MS) based pharmacokinetics (PK) assay. The objective is to quantify the Company’s lead asset, PRP, consisting of two proenzymes trypsinogen and chymotrypsinogen, as well as their activated enzyme forms trypsin and chymotrypsin from human serum during the Phase 1b FIH study.
Multi-Yr, Anti-Aging & Cancer Research Collaboration with the Universities of Jaén & Granada, Spain
A multi-year Joint Research Collaboration Agreement has been established with the Universities of Jaén (UJA) and Granada (UGR), Spain. The collaboration involves the evaluation of a senescence-modulating (i.e., anti-aging) compound to mitigate senescence and to complete experiments to further support the claims of recently filed fibrosis and cancer related patent applications, requested by Propanc to UJA’s research group “Biological Technologies of The University of Jaén” and UGR’s Research Group, “Advanced Therapies: Differentiation, Regeneration and Cancer.”
FINANCIAL HIGHLIGHTS
Proceeds raised
In the 2025-26 financial year totaled $7.5 million, gross proceeds.
Closed an underwritten public offering
1,000,000 shares at $4.00 per share, raising gross proceeds of $4.0 million. Propanc’s common stock began trading on the Nasdaq Capital Market on August 15.
Entered into a private placement agreement for up to $100 million to accelerate clinical development
Received an initial $1,000,000 investment upon issuance of 100 shares of Series C, Convertible Preferred Stock. As of June 30, a further $3,000,000 investment was received upon exercise of 100 shares of Series C, Convertible Preferred Stock.
Commenced a share repurchase program authorizing the Company to repurchase up to $5.0 million of its common stock
The Company completed the first tranche of $500,000 within the first 30 days since of commencing its share repurchase program.
Year-end Financial Summary (Quarter Ended June 30, 2026)
- Total assets: $12.78 million
- Total liabilities reduced by $2.20 million
- Convertible notes reduced to $0 (from $538,000)
- Net cash from financing activities: $6.46 million
- Quarter-end cash: $832,006
- A further $2.0 million from the Series C facility received (post June 30)
The Company expects the financing facility to continually support planned R&D activities, including advancement of PRP and Rec-PRP.
Management Commentary
“The Propanc Executive team are delighted with advancements made in the past financial year,” said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. “The Company is poised to capitalize on the foundation set in the next financial year with the advancement of PRP to a Phase 1b FIH study in up to 50 advanced cancer patients with solid tumors such as pancreatic, ovarian and refractory prostate cancers. Recent clinical advancements observed by companies such as Revolution Medicines and Erasca through KRAS inhibitors for pancreatic cancer are groundbreaking and tremendously exciting, but there is more work to be done to eliminate recurrence and metastasis in patients suffering from this killer disease. PRP is a potential breakthrough therapy that modulates the tumor micro-environment by targeting the EMT (epithelial-mesenchymal transition) process, which drives metastasis, invasion and recurrence from CSCs (cancer stem cells) which often lie dormant, post treatment, causing the cancer to return and spread. By eliminating this threat, not only can PRP improve survival, but is also non-toxic to healthy cells, meaning that patients could have a better quality of life, as well as enhance more durable response rates in combination with other treatments such as chemotherapy, checkpoint inhibitors, or KRAS inhibitors. We look forward to executing our scientific and clinical research activities in the 2026-2027 financial year.”
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:
| Clinical Research Activity for PRP | Timeline | |
| CTA | April 2025 – September 2026 | |
| Phase Ib Clinical Study Protocol | ||
| Investigator’s Brochure | ||
| CTA Compilation | October 2026 – November 2026 | |
| CTA Submission | November 2026 | |
| CTA Approval | February 2027 | |
| CTA Review | January 2027 – February 2027 | |
| Contract Research Organization and Contracts | February 2027 – March 2027 | |
| Analytical Laboratory Selection and Contracts | ||
| Trial Site Selection and Contracts | ||
| Preparation of Logistics | February 2027 – March 2027 | |
| Trial Site Initiation Visits | ||
| First Patient/First Visit | April 2027 | |
| PROPANC BIOPHARMA, INC. AND SUBSIDIARY | ||||||||
| CONSOLIDATED BALANCE SHEETS | ||||||||
| June 30, 2026 | June 30, 2025 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash | $ | 832,006 | $ | 12,088 | ||||
| GST tax receivable | 13,694 | 5,302 | ||||||
| Prepaid expenses - current portion | 7,661,967 | 8,334,046 | ||||||
| Other current assets | 34,923 | 1,380 | ||||||
| TOTAL CURRENT ASSETS | 8,542,590 | 8,352,816 | ||||||
| Deferred offering costs | - | 291,773 | ||||||
| Prepaid expenses - long-term portion | 4,190,543 | 10,925,835 | ||||||
| Security deposit - related party | 2,074 | 1,971 | ||||||
| Operating lease right-of-use assets, net - related party | 40,790 | 59,413 | ||||||
| Property and equipment, net | 3,915 | - | ||||||
| TOTAL ASSETS | $ | 12,779,912 | $ | 19,631,808 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable | $ | 1,131,429 | $ | 1,249,596 | ||||
| Accrued expenses and other payables | 855,350 | 1,486,550 | ||||||
| Accrued interest | 128,318 | 190,795 | ||||||
| Loans payable | - | 65,280 | ||||||
| Loans payable - related parties, net of discount | 460,809 | 415,329 | ||||||
| Notes payable, net of discount | - | 543,312 | ||||||
| Convertible notes, net of discounts and including put premiums | - | 537,921 | ||||||
| Operating lease liability - related party, current portion | 24,489 | 17,664 | ||||||
| Embedded conversion option liabilities | - | 403,892 | ||||||
| Employee benefit liability | 754,038 | 667,901 | ||||||
| TOTAL CURRENT LIABILITIES | 3,354,433 | 5,578,240 | ||||||
| NON-CURRENT LIABILITIES: | ||||||||
| Loan payable - long-term - related party, net of discount | - | 105,627 | ||||||
| Operating lease liability - long-term portion - related party | 23,818 | 41,749 | ||||||
| TOTAL NON-CURRENT LIABILITIES | 23,818 | 147,376 | ||||||
| TOTAL LIABILITIES | $ | 3,378,251 | $ | 5,725,616 | ||||
| Commitments and Contingencies (See Note 9) | ||||||||
| STOCKHOLDERS’ EQUITY: | ||||||||
| Preferred stock, 1,500,005 shares authorized, $0.01 par value: | ||||||||
| Series A preferred stock, $0.01 par value; 500,000 shares previously authorized; 0 shares issued and outstanding as of June 30, 2026 and 2025 | $ | - | $ | - | ||||
| Series B preferred stock, $0.01 par value; 5 shares authorized; 1 share issued and outstanding as of June 30, 2026 and 2025 | - | - | ||||||
| Series C preferred stock, $0.01 par value, $10,000 stated value; 5 shares authorized; 9,900 shares designated and authorized, 200 (liquidation value of $2,000,000) shares and none issued and outstanding at June 30, 2026 and 2025, respectively | 2 | - | ||||||
| Common stock, $0.001 par value; 10,000,000,000 shares authorized; 3,310,827 and 464,471 shares issued and outstanding as of June 30, 2026 and 2025, respectively | 3,310 | 464 | ||||||
| Common stock issuable (487,939 and 310 shares as of June 30, 2026 and 2025, respectively) | 487 | - | ||||||
| Additional paid-in capital | 152,752,314 | 138,254,808 | ||||||
| Accumulated other comprehensive income | 1,176,255 | 1,318,917 | ||||||
| Accumulated deficit | (144,484,230 | ) | (125,621,520 | ) | ||||
| Treasury stock ($0.001 share) | (46,477 | ) | (46,477 | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | 9,401,661 | 13,906,192 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 12,779,912 | $ | 19,631,808 | ||||
| PROPANC BIOPHARMA, INC. AND SUBSIDIARY | ||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) | ||||||||
| For the years ended June 30, | ||||||||
| 2026 | 2025 | |||||||
| REVENUE | ||||||||
| Revenue | $ | - | $ | - | ||||
| OPERATING EXPENSES | ||||||||
| Administration expenses | 670,607 | 108,950 | ||||||
| Compensation and related taxes | 2,275,937 | 23,296,390 | ||||||
| Professional and consulting expenses | 14,572,616 | 33,622,510 | ||||||
| Occupancy expenses - related party | 40,932 | 26,560 | ||||||
| Research and development | 625,477 | 223,721 | ||||||
| TOTAL OPERATING EXPENSES | 18,185,569 | 57,278,131 | ||||||
| LOSS FROM OPERATIONS | (18,185,569 | ) | (57,278,131 | ) | ||||
| OTHER INCOME (EXPENSE) | ||||||||
| Interest expense | (430,539 | ) | (563,757 | ) | ||||
| Interest income | 161 | 9 | ||||||
| Derivative expense | - | (333,596 | ) | |||||
| Change in fair value of derivative liabilities | 13,709 | 212,450 | ||||||
| Change in fair value of warrant liability | (99,695 | ) | - | |||||
| Other expense | (6,000 | ) | - | |||||
| Settlement expense | (320,000 | ) | - | |||||
| Gain (loss) on extinguishment of debt, net | 133,071 | (871,032 | ) | |||||
| Foreign currency transaction gain (loss) | 32,152 | (89,243 | ) | |||||
| TOTAL OTHER INCOME (EXPENSE), NET | (677,141 | ) | (1,645,169 | ) | ||||
| LOSS BEFORE TAXES | (18,862,710 | ) | (58,923,300 | ) | ||||
| Tax benefit | - | - | ||||||
| NET LOSS | $ | (18,862,710 | ) | $ | (58,923,300 | ) | ||
| Deemed Dividend | (932,246 | ) | - | |||||
| NET LOSS AVAILABLE TO COMMON STOCKHOLDERS | $ | (19,794,956 | ) | $ | (58,923,300 | ) | ||
| BASIC AND DILUTED NET LOSS PER SHARE | $ | (17.62 | ) | $ | (371.22 | ) | ||
| BASIC AND DILUTED WEIGHTED AVERAGE SHARES OUTSTANDING | 1,123,709 | 158,727 | ||||||
| NET LOSS AVAILABLE TO COMMON STOCKHOLDERS | $ | (19,794,956 | ) | $ | (58,923,300 | ) | ||
| OTHER COMPREHENSIVE INCOME (LOSS) | ||||||||
| Unrealized foreign currency translation gain (loss) | (142,662 | ) | 49,336 | |||||
| TOTAL OTHER COMPREHENSIVE INCOME (LOSS) | (142,662 | ) | 49,336 | |||||
| TOTAL COMPREHENSIVE LOSS | $ | (19,937,618 | ) | $ | (58,873,964 | ) | ||
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