Isofol Medical Ab · OMXSTO:ISOFOL
Isofol Medical Ab — Investor Presentation (March 2026)
37 slides from Isofol Medical Ab's investor presentation, March 2026
Slide 1: Isofol Medical AB Corporate Presentation
Isofol Medical AB Corporate Presentation March 2026
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 with high unmet medical need 5-FU The chemo basis of cytostatic combinations (for example FOLFOX) + Folate Added to enhance the effect by delivering MTHF to tumors (today: leucovorin) arfolitix
Slide 7: Mode of Action (simplified): 5-FU + folate inhibits the TS enzyme
Mode of Action (simplified): 5-FU + folate inhibits the TS enzyme to kill tumor cells 5-FU Target: Intratumoral inhibition of TS (thymidylate synthase) – an enzyme essential for tumor cell growth FdUMP The standard chemotherapy 5-FU is swiftly after administration converted to FdUMP Folate MTHF (leu
Slide 8: Arfolitixorin potential across cancer types, starting with mCRC
Arfolitixorin has potential across several cancer types treated with 5-FU-based chemotherapy, starting with metastatic colorectal cancer (mCRC) as the lead indication Colorectal cancer is a major medical problem worldwide because of its high incidence and low survival rates among patients with advan
Slide 9: 5-FU combined with folate is the backbone treatment for 95% of mCRC patients
5-FU combined with folate is the backbone treatment for 95% of all mCRC patients, today as well as tomorrow. MSS/pMMR (95% of patients) Low competition: Many drugs are in MSI-H/dMMR (5%) RAS/BRAF mutant RAS/BRAF wild-type development for mCRC, all intended to be used Patients elibible for intensive
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 folinic acid drugs Direct-acting: the active metabolite [6R]-MTHF in itself Arfolitixorin (active drug) resulting in several-fold higher levels of MTHF in tumor tissue1, and an efficacy that could increase wi
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: Comparable efficacy to leucovorin in previous phase III trial
Arfolitixorin demonstrated comparable efficacy to leucovorin in a previous phase III trial* – despite the use of a suboptimal dosing regimen Incongruent dosing regimens: 60 mg/m2 of arfolitixorin given 30 minutes after the 5-FU bolus followed by another 60 mg/m2 given 30-60 minutes later was compare
Slide 18: AGENT ph III: Post-hoc per-protocol analysis
AGENT ph III: Post-hoc, per-protocol analysis indicates possible superior efficacy in all regions excluding Japan even with the suboptimal dosing regimen used Per-protocol population When excluding subjects with Significantly higher Result cleared from study protocol deviations proportion of reduced
Slide 19: Earlier studies form a comprehensive dataset that de-risks development
In summary, earlier studies form a comprehensive dataset that de-risks the continued development CLINICAL CLINICAL RANDOMIZED PRECLIN/CLIN SAFETY, EFFICACY SAFETY,EFFICACY INDICATING DOSE-RESPONSE ISO-CC-002 (Phase I/II) AGENT (Global phase iII) Patient-Derived Tumoroid studies ISO-CC-005 (Phase I/I
Slide 20: Data form a solid evidence platform for continued 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 Available data indicate a strong dose-resp
Slide 21: Arfolitixorin phase Ib/II-study
Arfolitixorin phase Ib/II-study Enrolling 1st line mCRC patients to be treated with standard chemotherapy regimens (ph 1b: FOLFOX+bev, ph 2: FOLFOX/FOLFIRI+bev/cet/pan) where ARF replaces LV in the experimental arms Ongoing phase 1b 2025-2026: Planned phase 2 (randomized) 2026-2027: Dose escalation.
Slide 22: Phase Ib/II-study – promising early interim readout
Arfolitixorin phase Ib/II-study – promising early interim readout To date, no dose-limiting side effects have been observed in the treated patients. Preliminary results show that all patients included in the study to date have responded to treatment and exhibited tumor shrinkage, with total tumor bu
Slide 23: 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 23
Slide 24: 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 25: 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 26: 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 27: 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 28: 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 29: Blockbuster revenue potential in the U.S. in mCRC alone
Blockbuster revenue potential in the U.S. in the lead indication mCRC alone 1 Patient flow Key assumptions: (projected 2040): US Population Comparable safety as SoC ~168k incident CRC patients Efficacy benefit of >15% absolute increase in ORR compared to SoC ~131k diagnosed Stages I-III ~37k diagnos
Slide 30: 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 31: 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 32: 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 33: Management Team
Petter Segelman Lindqvist Dr Roger Tell, MD, PhD Margareta Hagman Chief Executive Officer Chief Medical Officer Chief Financial Officer Petter Lindqvist holds an MSc in Dr Roger Tell, MD, PhD is a board- Margareta Hagman is an Business Administration from the certified oncologist affiliated with exp
Slide 34: Board of Directors
Jan-Eric Österlund Dr Alain Herrera Dr Helena Taflin Lars Lind Prof Sten Nilsson, MD Chairman of the Board Board Member Board Member Board Member Board Member Jan-Eric Österlund has Dr Alain Herrera is an Dr Helena Taflin is an Lars Lind serves on Isofol’s Prof Sten Nilsson is an decades of experien
Slide 35: 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 36: 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 37: Isofol Medical AB (publ)
Isofol Medical AB (publ) info@isofolmedical.com | www.isofolmedical.com February 2026, ISO-44, r20 37