Isofol Medical AB · OMXSTO:ISOFOL
Isofol Medical AB — Investor Presentation (November 2025)
34 slides from Isofol Medical AB's investor presentation, November 2025
Slide 1: Isofol Medical AB Corporate Presentation
Isofol Medical AB Corporate Presentation November 2025
Slide 2: Disclaimer
Disclaimer Forward-looking statements This presentation of Isofol Medical AB (publ) ("Isofol") contains certain forward-looking statements with respect to certain of the company's current expectations and projections about future events. These statements, which sometimes use words such as "intend,"
Slide 3: Isofol in short
Isofol in short Oncology-focused biotech company listed on Nasdaq Stockholm Our goal is to make today’s and tomorrow’s cancer treatment better with arfolitixorin, a next-generation folate drug candidate designed to replace leucovorin and enhance the efficacy of standard 5-FU-based treatments for sol
Slide 4: Isofol's value creation rests on three solid pillars
Isofol’s value creation rests on three solid pillars 01 02 03 High unmet medical High-potential drug Large market need candidate opportunity 4
Slide 5: Isofol's value creation rests on three solid pillars
Isofol’s value creation rests on three solid pillars 01 02 03 High unmet medical High-potential drug Large market need candidate opportunity Arfolitixorin aims to potentiate 5-FU-based chemotherapy – todays and tomorrow’s standard treatment for several types of cancer where better treatments are urg
Slide 6: Arfolitixorin aims to potentiate 5-FU-based chemotherapy
Arfolitixorin aims to potentiate 5-FU-based chemotherapy, a standard treatment for several types of cancer 5-FU The chemo basis of cytostatic combinations (for example FOLFOX) + Folate Added to enhance the effect by delivering MTHF to tumors (today: leucovorin) arfolitixorin next-gen folate Used in
Slide 7: Mode of Action: 5-FU + folate targets the TS enzyme
Mode of Action (simplified): 5-FU + folate targets the TS enzyme to kill tumor cells 5-FU Target: TS (thymidylate synthase) – enzyme essential for tumor cell growh FdUMP The standard chemotherapy 5-FU is swiftly converted intracellularly to FdUMP Folate MTHF (leucovorin) FdUMP binds to TS forming an
Slide 8: Arfolitixorin potential across several cancer types, starting with mCRC
Arfolitixorin has potential across several cancer types treated with 5-FU-based chemotherapy, starting with metastatic colorectal cancer as the lead indication Colorectal cancer is a major medical problem worldwide because of its high incidence and low survival rates among patients with advanced/met
Slide 9: 5-FU with folate is backbone first-line treatment for 95% of mCRC
5-FU combined with folate is the backbone first-line treatment for 95% of all mCRC patients, today as well as tomorrow. MSS/pMMR (95% of patients) Lasting market opportunity: 5-FU combined MSI-H/dMMR (5%) RAS/BRAF mutant RAS/BRAF wild-type with folate will remain the backbone treatment Patients elib
Slide 10: Folates are used in 9 out of 10 mCRC regimens
Folates are used in 9 out of 10 mCRC regimens – creating a large opportunity Regimen* Irinotecan Oxaliplatin Leucovorin¶ Fluorouracil/capecitabine Schedule 2 Fluorouracil 400 mg/m bolus for value creation 2 [1] 180 400 mg/m over two day 1, followed by 2400 to 3000 FOLFIRI 2 2Δ Every two weeks mg/m d
Slide 11: Isofol's value creation rests on three solid pillars
Isofol’s value creation rests on three solid pillars 01 02 03 High unmet medical High-potential drug Large market need candidate opportunity Arfolitixorin is the first and only direct-acting folate, designed to enhance 5-FU efficacy and improve outcomes of standard treatments across multiple cancer
Slide 12: Arfolitixorin's key advantage: bypassing metabolic activation steps
Arfolitixorin’s key advantage: Bypassing the metabolic activation steps required by today’s folate drugs Leucovorin (prodrug) Multi-step conversion to MTHF driven by endogenous enzymes Effect Direct-acting: the active metabolite [6R]-MTHF in itself Arfolitixorin (active drug) resulting in several-fo
Slide 13: Higher concentrations: several-fold higher MTHF levels in tumors
Higher concentrations: Arfolitixorin gives several-fold higher levels of MTHF in tumors, optimizing conditions for TS inhibition MTHF levels in colorectal tumors PK/PD data from the randomized Phase I/II 8000 study ISO-CC-002 demonstrate significantly 7000 n=32 increased MTHF levels in mCRC tumors P
Slide 14: Dose-response: efficacy increases with dose (1/3)
Dose-response: Studies indicate that arfolitixorin’s efficacy increases with dose, setting it apart from leucovorin (1/3) It is well known that the clinical efficacy of Effect of folate dosage on dUr concentration* leucovorin (LV) does not increase with higher doses. in matching tumor homogenates Th
Slide 15: Dose-response: efficacy increases with dose (2/3)
Dose-response: Studies indicate that arfolitixorin’s efficacy increases with dose, setting it apart from leucovorin (2/3) A preclinical study, conducted on Patient-Derived CRC Tumoroids tested arfolitixorin vs. leucovorin in combination with 5-FU and oxaliplatin*, reproduces the dose-response relati
Slide 16: Dose-response: efficacy increases with dose (3/3)
Dose-response: Studies indicate that arfolitixorin’s efficacy increases with dose, setting it apart from leucovorin (3/3) The Modelle-001 trial, conducted on CRC tumor samples from liver metastases from living patients, adds to the body of evidence for the dose-response relationship. Median TS inhib
Slide 17: Previous phase III trial indicated similar efficacy with suboptimal dosing
A previous phase III trial* indicated similar efficacy of arfolitixorin as leucovorin with a suboptimal dosing regimen Arfolitixorin was given 30 min after 5-FU bolus, in contrast to leucovorin which was given before as per clinical practice Wrong timing Too late to be able to chemically fully poten
Slide 18: Earlier studies form a dataset that de-risks continued development
In summary, earlier studies form a comprehensive dataset that de-risks the continued development ISO-CC-002 (Phase I/II) AGENT (Global phase iII) Patient-Derived Tumoroid studies ISO-CC-005 (Phase I/II) AGENT post-hoc analyses Tumor homogenate studies Tissue-level studies Phase I/II-studies ISO-CC-0
Slide 19: Data form a solid evidence platform for continued clinical development
Taken together, the data form a solid evidence platform for continued clinical development 1 Established efficacy: Arfolitixorin has already shown efficacy comparable to SoC in a global phase III-study with suboptimal dosing (too low dose given too late). 2 Pharmacokinetics, pharmacodynamics and ava
Slide 20: Now conducting a new clinical phase Ib/II study
Now conducting a new clinical phase Ib/II- study with an optimized dosing regimen The study enrolls treatment-naïve patients with metastatic colorectal cancer, uses standard chemotherapy regimens (such as FOLFOX) where arfolitixorin (ARF) replaces leucovorin. Ongoing phase 1b 2025-2026: Planned pha
Slide 21: Clinical development in collaboration with Charité
Clinical development in collaboration with Charité – a world leading hospital Prof. Dr. med. Sebastian Stintzing Head of the Department of Hematology, Oncology and Cancer Immunology (CCM) Coordinating Principal investigator 22
Slide 22: Isofol's Advisory Board of leading global experts
Isofol’s Advisory Board consists of leading global experts representing the US, Europe and Japan Sebastian Stintzing Heinz-Josef Lenz Takayuki Yoshino Frits Peters MD Professor MD PhD. Prof. Dr. med. MD Professor Associate Director for Clinical Professor Chair of the Japan Society of Clinical Head o
Slide 23: Clinical development and commercialization in Japan with partner
Clinical development and commercialization in Japan in collaboration with partner Isofol has licensed the rights to develop and commercialize arfolitixorin in Japan – one of the world’s biggest pharmaceutical markets – to Solasia Pharma K.K., a company listed on the Tokyo stock exchange working to b
Slide 24: CMC and large scale GMP manufacturing, partnership with Merck KGaA
Isofol has CMC and large scale GMP manufacturing in place – key partnership with Merck KGaA DRUG SUBSTANCE / API DRUG PRODUCT Merck KGaA Life Science owns and Large-scale Drug Product manufactures arfolitixorin – Isofol has manufacturing secured with global, exclusive rights for development and Reci
Slide 25: Isofol's value creation rests on three solid pillars
Isofol’s value creation rests on three solid pillars 01 02 03 High unmet medical High-potential drug Large market need candidate opportunity Arfolitixorin has blockbuster potential in the US in the lead indication alone – on a global CRC market estimated to be worth more than $17 billion by 2030. Ad
Slide 26: Large and growing market for CRC treatments and mCRC
Large and growing market for CRC treatments as well as for the lead indication mCRC The global market for CRC treatments is valued at $13.5 B today and is expected to grow to $16.9 B in 2030; whereas the mCRC market is expected to grow from $6.1 B in 2025 to $7.3 B in 2030. Global CRC pharmaceutical
Slide 27: Blockbuster revenue potential in the U.S. in mCRC
Blockbuster revenue potential in the U.S. in the lead indication mCRC alone 1 Patient flow: Key assumptions: US Population Comparable safety as SoC 165k incident CRC patients Efficacy benefit of >15% absolute increase in ORR compared to SoC 131k diagnosed Stages I-III 36k diagnosed Stage IV billion
Slide 28: Further opportunities beyond the lead indication in the US
Further opportunities beyond the lead indication in the US add to the potential as additional markets are added and the clinical use expands 1 Additional markets ex-U.S. Incl. e.g. Japan, Canada, Europe, Middle East, Asia. + Licensing partnerships already established in Japan (Solasia Pharma K.K) an
Slide 29: Suite of patents provide strong intellectual property protection
Suite of patents provide for strong intellectual property protection Both Isofol and Merck KGaA are actively working to protect and enhance arfolitixorin’s suite of patents on the major markets (including but not limited to USA, Europe, Japan) Current patent portfolio (allowed/granted + new filings)
Slide 30: Isofol's value creation rests on three solid pillars
Isofol’s value creation rests on three solid pillars 01 01 02 02 03 High Highunmet unmetmedical medical High-potentialdrug High-potential drug Large market need need candidate candidate opportunity Arfolitixorin aims to Arfolitixorin is the first and Arfolitixorin has blockbuster potentiate 5-FU-bas
Slide 31: Management and Board
Management and Board Petter Dr. Roger Tell, MD Margareta Hagman Segelman Lindqvist Chief Medical Officer Chief Financial Officer Chief Executive Officer Jan-Eric Österlund Prof. Sten Nilsson, MD Dr. Helena Taflin, MD Dr. Alain Herrera, MD Lars Lind Chairman Board Director Board Director Board Direct
Slide 32: The Isofol opportunity in short
The Isofol opportunity in short Focusing on areas in oncology of high unmet medical need Large amount of data available: de-risking development. CMC and large-scale manufacturing established. Next-gen version of an established mechanism of action with widespread clinical use: facilitates market adop
Slide 33: Our goal
Our goal We aim to have a central impact on tomorrow’s cancer treatment by giving millions of patients the opportunity to respond better to their treatment, improve their prognosis, and gain more time with life. By this, we strive to create significant value for patients and their families, healthca
Slide 34: Isofol Medical AB (publ)
Isofol Medical AB (publ) [email protected] www.isofolmedical.com
Isofol Medical — Investor Presentation (November 2025) on 6ix