Algorae Pharmaceuticals — company, drug programme and AI platform record

AI-powered research: MII Research actively used AI for evidence extraction, comparison, analysis, drafting and explanatory presentation. Material claims were checked against the cited public sources before publication.

Recording rule: This report separates a company objective from a completed result. A signed agreement, regulatory submission, acceptance for evaluation, approval, product receipt, market availability, customer order, recognised revenue and cash receipt are different states. Company-reported experimental results are identified as such, and undisclosed economics or outcomes are not estimated.

In FY2021 and FY2022 the company's principal work concerned NTCELL and cell-therapy research. AI-116 was disclosed in 2023; AI-168 and AlgoraeOS followed around FY2024. The present AlgoraeRx manufacturing-partner agreements were first announced after the FY2025 balance date, beginning in September 2025.

FY2021 — peptide research ended and the development direction was reconsidered

• The annual report said that existing data did not make NTCELL readily commercialisable and that the company had broadened its work to long-acting peptide programmes.
• University of Auckland migraine and obesity peptide work did not meet its specified objectives, and the related contracts were terminated.
• Dr Ken Taylor left the chief executive and director roles in July 2021. The Chief Operating Officer role was made redundant following termination of the university contracts.
• The company referred to discussions about combinations or partnerships, but the FY2021 annual report did not identify a completed new transaction.
• Reported income and other income were A$0.268m; loss after tax A$1.461m; R&D expense A$1.609m; operating cash outflow A$1.462m; and cash plus term deposits A$1.569m.

FY2022 — preparation for a proposed third NTCELL trial

• The company said it was preparing a third NTCELL clinical trial in Parkinson's disease.
• In March 2022 it announced a University of Technology Sydney agreement for research on Australian NTCELL production.
• In May 2022 it contracted OptiCellAI to use AI in quality selection and production optimisation for encapsulated NTCELL cells.
• Financing comprised A$3.5m before costs through convertible securities and a placement, plus approximately A$0.361m through an entitlement offer.
• Income and other income were A$0.003m; loss after tax A$1.957m; R&D A$1.463m; operating cash outflow A$2.042m; and cash plus term deposits A$4.239m.

FY2023 — NTCELL preparation stopped and a new combination programme was disclosed

• After a government import permit was obtained, New Zealand choroid plexus tissue was shipped to a Sydney research partner in August 2022. The shipment was manufacturing-research preparation, not clinical-trial approval or patient dosing.
• The company announced completion of the first design stage of OptiCellAI work in September 2022, then announced cessation of that agreement in November 2022.
• The previously stated objective of dosing a first participant in 2024 did not result in patient dosing during FY2023.
• In July 2023 the company announced a provisional patent application for AI-116, a dementia candidate combining CBD with an initially undisclosed established drug ingredient.
• The planned corporate name change and reservation of ASX code 1AI were announced in July 2023 and became effective after year end in September 2023.
• Income and other income were A$0.042m; loss after tax A$2.108m; restated comparative R&D A$1.308m; operating cash outflow A$1.986m; and cash plus term deposits A$4.111m.

FY2024 — Algorae name adopted; AI-116, AI-168 and AlgoraeOS assembled

• The legal name and ASX code changed to Algorae Pharmaceuticals/1AI on 11 September 2023.
• In October 2023 the company entered a UNSW research agreement for an AI platform intended to predict drug-combination and repurposing candidates.
• AI-116 was identified as a fixed-dose combination of CBD and donepezil hydrochloride. The company reported in-vitro amyloid-beta and glutamate neurotoxicity experiments.
• In an additional glutamate experiment the company reported relative cell-viability recovery of 17% for donepezil alone, 42% for CBD alone and 53% for the selected combination dose. These are results from the stated cellular conditions, not human clinical outcomes.
• The company reported at least 21 genes uniquely regulated by the combination compared with the individual components in its RNA-sequencing work.
• AI-168 was disclosed as a cannabinoid/established-drug cardiovascular combination, with work at Monash University and the Victorian Heart Institute.
• The NZeno tissue-supply agreement for NTCELL ended during FY2024. The company said it was reviewing the NTCELL protocol and development plan.
• Interest income was A$0.125m; loss after tax A$2.096m; R&D A$0.739m; operating cash outflow A$1.523m; cash A$0.808m; and term deposits A$2.300m.

FY2025 — AlgoraeOS v1 launched and external experiments were prepared

• AlgoraeOS v1 was launched in September 2024; the company described it as Technology Readiness Level 3+.
• In November 2024 the company announced 24 oncology fixed-dose-combination targets for preclinical work after review of an initial AI-generated list.
• AlgoraeOS v2 was developed with the UNSW AI Institute and three UNSW-recruited PhD researchers. Company disclosures say CSIRO funds about two-thirds and Algorae about one-third of scholarship costs over three years.
• La Trobe University preclinical work on AI-116 and Monash/Victorian Heart Institute work on AI-168 were finalised in the first half of 2025.
• In May 2025 the company announced a Peter MacCallum Cancer Centre/VCFG programme to test 21 oncology combinations in brain, breast, pancreatic and prostate cancer models. Public material did not fully reconcile the earlier 24 targets with the 21 experimental combinations.
• Vishal Shah was appointed Chief Commercial Officer in April 2025. None of the five current AlgoraeRx manufacturer agreements had been announced by the FY2025 balance date.
• Interest income was A$0.141m; loss before tax A$1.540m; reported loss after tax A$0.803m; R&D A$0.855m; and operating cash outflow A$0.785m.
• At 30 June 2025 cash was A$0.469m, term deposits A$1.850m, total assets A$2.399m, total liabilities A$0.170m and net assets A$2.229m. Non-current assets were reported as nil.

*FY2023 R&D uses the later A$1.30835m comparative in the FY2024 annual report. A A$1,250 difference from the FY2023 report remains disclosed. FY2025 issued-capital carrying value was unchanged from FY2024.

• Across FY2021–FY2025, income/other income and interest totalled about A$0.579m, aggregate losses after tax about A$8.425m and aggregate operating cash outflow about A$7.798m.
• The FY2022 share-count increase was associated with convertible securities, a placement and an entitlement offer; placements, shortfall securities and option-related issues continued in FY2023.
• The FY2025 cash-flow statement recorded A$0.737m of R&D tax-credit receipts, A$1.688m paid to suppliers and employees, and A$0.165m interest received.

AlgoraeRx has not been disclosed as owning factories that manufacture its medicines. Its stated model is to identify external manufacturers' products, secure contractual rights, manage required TGA registration and market access, and supply Australia and New Zealand.

The July 2026 quarterly report aggregated these agreements as five manufacturing partners and a 21-product pipeline. That count describes contract-scope commercialisation targets; it does not mean that 21 distinct approved medicines, inventories or revenue streams had already been obtained.

• Three product dossiers had been submitted to the TGA by the end of July 2026 and two had been accepted for formal evaluation. Acceptance for evaluation is not approval or ARTG registration.
• The company expected a preliminary decision on the third application in August 2026; that outcome was outside this report's evidence cut-off.
• The first Dr. Reddy's capecitabine shipment was reported received in January 2026. Quantity, batch release, inventory carrying value, units sold and customer payment were not disclosed.
• The June-quarter report described “1 product in market”, while its FY2026 Appendix 4C recorded nil receipts from customers for the 12 months.
• AlgoraeRx was selected as one of multiple non-exclusive suppliers under a HealthShare NSW standing offer. The initial term is three years with two optional one-year extensions.
• The standing offer has no minimum volume or minimum spend. The company said it could not quantify the financial impact for the current calendar year.

Count discipline: 500,000, 9m, 478,000 and 6,000 refer to different datasets, filters and cell-line conditions. They are not additive and do not represent the same number of independent medicines, patents or clinical programmes.

Phenomics Australia announced a A$49,109 award toward future multi-anchor validation. Public material did not specify whether it was cash, reimbursement or in-kind support, or whether it had been received or recognised by the reporting date.

AI-116 — dementia and Alzheimer's disease

• Disclosed composition: a fixed-dose combination of cannabidiol and donepezil hydrochloride.
• Following a 2023 provisional application, PCT/AU2024/050791 and WIPO publication WO/2025/019898 were identified. These are patent applications; this review did not identify a granted worldwide patent.
• The company reported FY2024 in-vitro neural-cell experiments and RNA-sequencing results.
• La Trobe University preclinical studies ended in the first half of 2025.
• The 2026 half-year report said the next pathway, including indication, study design and regulatory strategy, was under external-expert review.
• No public TGA CTN/CTX, ethics approval, GMP clinical product or first human dose was identified by the cut-off.

AI-168 — cardiovascular programme

• Disclosed composition: a fixed-dose combination of a cardioselective beta blocker and cannabidiol.
• Work used established in-vitro cardiovascular models at the Victorian Heart Institute, Monash University.
• The company reported cardioprotective effects relative to benchmark beta-blocker controls.
• Preclinical studies ended in the first half of 2025. Further preclinical scope and the development pathway were under review.
• PCT/AU2024/051253 and WIPO publication WO/2025/107042 were identified and are recorded as pending applications rather than grants.

NTCELL — legacy Parkinson's disease programme

• NTCELL is the former Living Cell Technologies programme using alginate-coated choroid plexus cell capsules.
• ClinicalTrials.gov records the prior sponsor trials NCT01734733 and NCT02683629 as completed. Completion of those historic trials does not mean a new current trial is active.
• The company announced a third-trial plan and a 2024 dosing objective in 2022, but the OptiCellAI agreement ended in November 2022 and the NZeno tissue agreement ended in FY2024.
• FY2025 and the 2026 half-year material described a scientific review of the prior protocol, development plan, IP and commercial lifecycle.
• No new active registered trial, replacement supply agreement, final protocol, budget or first-patient date was identified at the cut-off.

• AlgoraeRx entered a A$3m receivables-based ScotPac working-capital facility in January 2026. The initial term is 24 months, disclosed pricing is BBSY plus 6.70%, and security over AlgoraeRx trade receivables and a parent guarantee were included.
• The facility was fully undrawn at 30 June 2026 and is therefore not included in cash. Company-presented available funding combined A$3.937m cash with the A$3m undrawn facility to reach A$6.937m.

• All 21 AlgoraeRx product names and contract-level pricing, margin, minimum purchase, royalty, term and termination conditions.
• Product-level identifiers, sponsors, dossier/data rights and expected review dates for the three TGA submissions.
• Capecitabine quantity received, inventory carrying value, batch release, unit sales, invoices and customer cash receipts.
• Purchase orders, supplied volumes, invoices, revenue or cash under the NSW Health standing offer.
• AlgoraeOS source code, model weights, training-data licences and complete background/foreground IP terms with collaborators.
• AI-116 and AI-168 dose, formulation, toxicology, pharmacokinetics, CMC, human protocol and development budgets.
• Current NTCELL tissue supply, manufacturing, protocol, regulatory strategy, trial budget and restart date.

• Living Cell Technologies FY2021 Annual Report
• Living Cell Technologies FY2023 Annual Report
• Algorae FY2024 Annual Report
• Algorae FY2025 Annual Report
• 1H FY2026 Half-Year Report
• June 2026 Quarterly Activities Report and Appendix 4C
• Sakar agreement
• Dr. Reddy's capecitabine agreement
• Cadila agreement
• Zydus agreement
• Torrent agreement
• NSW Health standing-offer supplementary announcement
• Peter Mac AOS2 validation announcement
• NTCELL trial NCT01734733 · NTCELL trial NCT02683629

Evidence treatment and copyright

The report separates the five annual periods from later announcements, labels company-reported findings and does not merge contract, regulatory, supply, revenue and cash states. Tables and status summaries were newly prepared from reported figures. No company photographs, proprietary charts or long passages are reproduced.