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Other Disclosures4597Solasia Pharma K.K.Pharmaceuticals

Latest update on the Phase Ib/II clinical trial of the company's proprietary product SP-05 (disclosure by rights licensor Isofol)

Preliminary evaluation results for 10 treated patients and the future trial plan were presented for the Phase Ib trial of SP-05 (arfolitixorin). Evaluation will continue at the maximum dose of 500 mg/m², the Phase II trial will be expanded to 15–20 sites in Germany and other countries, and a Phase II trial is also planned to be conducted in parallel in Japan.

Worth reading
59In focus
0–100. This measures how worthwhile something is to read, not how good or bad the company is.
Direction
Mixed performance
Direction inferred from the company’s description.
Scale
50
Maximum reduction in sum of tumor diameters (approx. %)
Wording
Conditional
How definitive the wording is.

Announced details

SP-05 (generic name: arfolitixorin sulfate)
Applicable field (uses covered by this announcement)

Metastatic colorectal cancer with RAS mutations

What the company reported numerically
Quantitative Effects

Sum of tumor diameters decreased by approximately 50% at most; 5 of the 10 treated patients were potential candidates for tumor resection with curative intent; 0 cases of dose-limiting toxicity

Usage history

10 patients treated in the Phase Ib trial; 3 patients enrolled at the maximum dose of 500 mg/m² (3 additional patients planned)

Relationship between the counterparty and the company
Solasia Pharma K.K.4597
Relationship with the Company

Rights licensor/development partner for SP-05

CounterpartyIsofol Medical AB

The text indicates that it is a Swedish pharmaceutical development company, but its location, representative, capital, year of establishment and other details are Not disclosed

Location (as indicated in this announcement)

Trial sites in Germany, Spain, Austria and Greece (specific locations are Not disclosed)

15–20 sites (planned Phase II portion)
Impact on Business Performance

A medium- to long-term impact is expected, but there will be no impact on FY2026 earnings

The company does not address Contract Value / Offering price.

Source (materials cited by the company)

Disclosure by Isofol Medical AB dated 10 November 2026 (local time); World Health Organization (WHO)

Announced details
ItemDetails
Names of Products / Services CoveredSP-05 (generic name: arfolitixorin sulfate)
CounterpartyIsofol Medical AB
Counterparty overviewThe text indicates that it is a Swedish pharmaceutical development company, but its location, representative, capital, year of establishment and other details are Not disclosed
Relationship with the CompanyRights licensor/development partner for SP-05
Applicable areaMetastatic colorectal cancer with RAS mutations
LocationTrial sites in Germany, Spain, Austria and Greece (specific locations are Not disclosed)
Location scale15–20 sites (planned Phase II portion)
Quantitative EffectsSum of tumor diameters decreased by approximately 50% at most; 5 of the 10 treated patients were potential candidates for tumor resection with curative intent; 0 cases of dose-limiting toxicity
Usage history10 patients treated in the Phase Ib trial; 3 patients enrolled at the maximum dose of 500 mg/m² (3 additional patients planned)
Impact on Business PerformanceA medium- to long-term impact is expected, but there will be no impact on FY2026 earnings
SourceDisclosure by Isofol Medical AB dated 10 November 2026 (local time); World Health Organization (WHO)
Items this document does not state (7)
Contract ValueOffering priceContract DateLaunch dateAward/certification nameAwarding / certifying bodyRegistration number and expiry date

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

The Phase Ib trial is evaluating the safety and tolerability of a new arfolitixorin regimen in combination with standard treatment. For Phase II, the company said it will expand the trial sites and participating countries to strengthen its geographic base and patient recruitment capabilities, leading to faster and more efficient trial execution.

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Latest update on the Phase Ib/II clinical trial of the company's proprietary product SP-05 (disclosure by rights licensor Isofol) | Solasia Pharma K.K. (4597) timely disclosure | Komori