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Isofol Medical AB Corporate Presentation February 2026
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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," "proposed," "plan," "expect," and words of similar meaning, reflect management's beliefs and expectations and involve a number of risks, uncertainties and assumptions that could cause actual results and performance to differ materially from any expected future results or performance expressed or implied by the forward-looking statement. Statements contained in this presentation regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. The information contained in this presentation is subject to change without notice and, except as required by applicable law, Isofol does not assume any responsibility or obligation to update publicly or review any of the forward-looking statements contained in it. You should not place undue reliance on forward-looking statements, which speak only as at the date of this presentation. Not a prospectus This presentation has been prepared for advertisement purposes. It is not a prospectus and has not been prepared in accordance with the prospectus requirements in the Swedish Financial Instruments Trading Act (lagen 1991980) om handel med finansiella instrument) or the European prospectus regulation 809/2004/EC (the "Prospectus Regulations"). This presentation is not subject to any registration or approval requirements under the Prospectus Regulations and has not been, and will not be, examined, approved or registered by the Swedish Financial Supervisory Authority or any financial supervisory authority or other supervisory body within the EU. The presentation may not be forwarded, reproduced or made available in or into any jurisdiction in which such publication or distribution would require any additional documentation to be prepared or registration effected or that any measures are taken in addition to those required under Swedish law or where it would be in conflict with any law or regulation in such jurisdiction. Persons who come into possession of this presentation are required to inform themselves about, and to observe, such restrictions. Jurisdiction The courts of Sweden shall have exclusive jurisdiction over any dispute arising out of or in connection with this presentation and the City Court of Gothenburg, Sweden, shall be the court of first instance. 2 Disclaimer
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Oncology-focused biotech company listed on Nasdaq Stockholm Our goal is to make todayʼs and tomorrowʼs cancer treatment better with arfolitixorin , a next-generation folate drug candidate designed to replace leucovorin and enhance the efficacy of standard 5FU-based treatments for solid tumors Currently conducting a phase Ib/II trial in metastatic colorectal cancer, the 3rd most common form of cancer Isofol in short 3
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Isofolʼs value creation rests on three solid pillars 4 03 Large market opportunity 02 High-potential drug candidate 01 High unmet medical need
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Isofolʼs value creation rests on three solid pillars 5 03 Large market opportunity 02 High-potential drug candidate 01 High unmet medical need Arfolitixorin aims to potentiate 5FU-based chemotherapy – todays and tomorrowʼs standard treatment for several types of cancer where better treatments are urgently needed
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6 Arfolitixorin aims to potentiate 5 FU-based chemotherapy, a standard treatment for several types of cancer with high unmet medical need 5FU 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 various regimens for treating for example colorectal, gastric, pancreatic, esophageal and gastroesophageal, head and neck cancers . Response rates ORR) of the currently used FFU-based treatment combinations are typically below 50%.
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Mode of Action (simplified): 5FU + folate inhibits the TS enzyme to kill tumor cells TS MTHF Folate (leucovorin) arfolitixorin FdUMP 5-FU Target: Intratumoral inhibition of TS (thymidylate synthase) – an enzyme essential for tumor cell growth The stable ternary complex inhibits TS effectively, resulting in interrupted tumor cell DNA synthesis and repair The standard chemotherapy 5FU is swiftly after administration converted to FdUMP High concentrations of MTHF (active metabolite of folate) stabilize TSFdUMPMTHF in a ternary complex Anti -tumor effect FdUMP binds to TS forming an unstable binary complex
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8 Arfolitixorin has potential across several cancer types treated with 5FU-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 advanced/metastatic disease: 1 900 000 people are affected annually 3rd most common cancer 900 000 patient deaths per year 2nd most common cause of cancer death 86 % of patients with metastatic disease (mCRC) die within five years Ref: Intl Agency for Research on Cancer, World Health Organization, Accessed 30 April 2025. https://gco.iarc.who.int American Society of Clinical Oncology ASCO Cancer.Net. Accessed 12 March 2024. https://www.cancer.net/cancer-types/colorectal-cancer/statistics. 50% of patients respond to todayʼs standard treatment, and overall survival is low. Improving outcomes of first line therapies would have a high impact on a large patient group.
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9 5FU combined with folate is the backbone treatment for 95% of all mCRC patients, today as well as tomorrow. Low competition: Many drugs are in development for mCRC, all intended to be used either as an add-on to 5FU+folate or in later lines of therapy. Arfolitixorin is currently the only new drug in development for first-line use designed to replace leucovorin. Lasting market opportunity: 5FU combined with folate will remain the backbone treatment for mCRC for the foreseeable future. Consensus among clinical experts that 5FU+folate will remain the mainstay of treatment: MSS/pMMR 95% of patients) MSIH/dMMR 5% RAS/BRAF mutant RAS/BRAF wild -type Patients elibible for intensive tx 95% FOLFOX/FOLFIRI/ CAPEOX +/- bevacizumab or FOLFOXIRI +/- bevacizumab Right-sided: FOLFOX/FOLFIRI/CAPEOX/FOLFOXIRI +/- bevacizumab Keytruda Opdivo ± Yervoy Patients inelibible for intensive tx 5% Capecitabine + bevacizumab or 5FU + folate + bevacizumab Left-sided: FOLFOX/FOLFIRI +/- cetuximab +/- panitumumab Addressable patient groups for arfolitixorin (and the patient groups included in the ongoing trial) “It is inconceivable to think that 5FU backbone will not be the mainstay care, it is a very effective drug within our treatment landscapeˮ “I think we are going to get smarter and find more actionable mutations, but I do not think this will impact the 1L SoCˮ “5FU is the most effective drug in this disease, I donʼt think it will ever go away everˮ “There isnʼt anything that comes close to chemo or has a response rate high enough to replace the chemo backbone. €⁅F U ‱ gǐ ǐ ‱ ớ ḅ a gȴ ‱ ɿ ễ ḅ ‱ ṑ ớ g g gȴ ḅ ‱ ɇ ‱ ễ g ḅ‱in multi-agent chemo regimens in 1Lˮ Ref: Market research conducted by Back Bay Life Science Advisors in November 2024.
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Folates are used in most 5FU based treatment regimens for mCRC, such as FOLFOX, FOLFIRI and FOLFOXIRI Folates (folinic acid) are sold under different names, the most common one being leucovorin Arfolitixorin could potentially replace the currently used folic acid across all these regimens 10 Folates are used in 9 out of 10 mCRC regimens – creating a large opportunity for value creation Ref: Clark, J; Sanoff, H. Initial systemic therapy for metastatic colorectal cancer. In: UpToDate, Atkins M Ed, Wolters Kluwer. Accessed on Oct 18, 2025.) Regimen* Irinotecan Oxaliplatin Leucovorin ¶ Fluorouracil/capecitabine Schedule FOLFIRI 1 180 mg/m 2 day 1 400 mg/m 2 over two hours day 1 Fluorouracil 400 mg/m 2 bolus day 1, followed by 2400 to 3000 mg/m 2∆ over 46 hours, continuous infusion Every two weeks Douillard regimen 2 180 mg/m 2 day 1 200 mg/m 2 leucovorin over two hours days 1 and 2 before fluorouracil Fluorouracil 400 mg/m 2 bolus then 600 mg/m 2 over 22 hours days 1 and 2 Every two weeks FOLFOX 4 3 85 mg/m 2 day 1 400 mg/m 2 over two hours days 1 and 2 before fluorouracil ◊ Fluorouracil 400 mg/m 2 bolus, then 600 mg/m 2 over 22 hours days 1 and 2 Every two weeks FOLFOX 6 1 100 mg/m 2 day 1 400 mg/m 2 over two hours day 1 Fluorouracil 400 mg/m 2 bolus day 1, followed by 2400 to 3000 mg/m 2∆ over 46 hours, continuous infusion Every two weeks Modified FOLFOX 6 4,5 85 mg/m 2 day 1 350 mg total dose over two hours day 1 Fluorouracil 400 mg/m 2 bolus day 1, followed by 2400 mg/m 2 over 46 hours Every two weeks FOLFOX 7 6 130 mg/m 2 day 1 400 mg/m 2 over two hours day 1 Fluorouracil 400 mg/m 2 bolus, then 2400 mg/m 2 over 46 hours Every two weeks Modified FOLFOX 7 7 Optimox) 100 mg/m 2 day 1 400 mg/m 2 over two hours day 1 Fluorouracil 3000 mg/m 2 over 46 hours Every two weeks Modified FOLFOX 7 8 CONcePT § 85 mg/m 2 day 1 200 mg/m 2 over two hours day 1 Fluorouracil 2400 mg/m 2 over 46 hours Every two weeks XELOX 5 130 mg/m 2 day 1 Capecitabine 1000 mg/m 2 orally twice per day on days 1 to 14 Every three weeks FOLFOXIRI 9 165 mg/m 2 day 1 85 mg/m 2 day 1 400 mg/m 2 leucovorin over two hours day 1 Fluorouracil 3200 mg/m 2 over 48 hours Every two weeks * All doses shown are for intravenous IV) administration, except capecitabine. ¶ Leucovorin doses given for the d,l racemic mixture. ∆ 2400 mg/m2 dose is commonly used. ◊ The original trial report indicated a leucovorin dose of 200 mg/m2 daily, but this was an error, and the correct dose used in the protocol was 400 mg/m2 R Goldberg, personal communication). § FOLFOX 7 was administered with bevacizumab 5 mg/kg every two weeks) in the CONCePT trial.
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Isofolʼs value creation rests on three solid pillars 11 03 Large market opportunity 02 High-potential drug candidate Arfolitixorin is the first and only direct-acting folate, designed to enhance 5FU efficacy and improve outcomes of standard treatments across multiple cancer types. It has shown promising results in earlier studies. 01 High unmet medical need
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12 Arfolitixorinʼs key advantage: Bypassing the metabolic activation steps required by todayʼs folate drugs Standard-of-care Leucovorin (prodrug) Multi -step conversion to MTHF driven by endogenous enzymes Effect Arfolitixorin (active drug) Effect resulting in several -fold higher levels of MTHF in tumor tissue 1, and an efficacy that could increase with the dose 2 Aim: Improved clinical outcomes Direct-acting: the active metabolite 6R MTHF in itself 1 Wettergren Y et.al. A pharmacokinetic and pharmacodynamic investigation of Modufolin® (arfolitixorin) vs Isovorin® after single-dose IV administration to patients with colon cancer: a randomized study. Cancer Chemother Pharmacol. 2015;7513747. doi:10.1007/s0028001426119n. 2 According to preclinical studies, cf. next slides
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13 Higher concentrations: Arfolitixorin gives several-fold higher levels of MTHF in tumors, optimizing conditions for TS inhibition PK/PD data from the randomized Phase I/II study ISOCC002 demonstrate significantly increased MTHF levels in mCRC tumors from patients treated with arfolitixorin as compared to equimolar doses of levoleucovorin * Significantly higher levels of MTHF were also observed in the arfolitixorin 200 mg/m 2 dose cohort in comparison to the arfolitixorin 60 mg/m 2 dose cohort. This suggests that elevated doses of arfolitixorin could create conditions for an increased tumor-killing effect by further elevating the intracellular MTHF concentration. Ref: Wettergren Y, et. al. A pharmacokinetic and pharmacodynamic investigation of Modufolin® (arfolitixorin) vs Isovorin® after single-dose IV administration to patients with colon cancer: a randomized study. Cancer Chemother Pharmacol. 2015;7513747. doi:10.1007/s0028001426119 *) Levo-leucovorin contains only the L -isomer, so it delivers the same pharmacologic activity at half the dose as leucovorin tha t also has the D-isomer MTHF levels in colorectal tumors Conc (pmol/g) 0 1000 2000 3000 4000 5000 6000 7000 8000 Arfolitixorin 60 mg/m2 Levoleucovorin 60 mg/m2 Arfolitixorin 200 mg/m2 Levoleucovorin 200 mg/m2 n=32 P < 0.01 equivalent to leucovorin 400 mg/m2 and arfolitixorin 200 mg/m2 equivalent to leucovorin 120 mg/m2 and arfolitixorin 60 mg/m2
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14 Dose-response: Studies indicate that arfolitixorinʼs efficacy increases with dose, setting it apart from leucovorin 1/3 It is well known that the clinical efficacy of leucovorin LV) does not increase with higher doses . This was reconfirmed in a recent preclinical study where deoxyuridine (dUr) concentrations (a biomarker for TS inhibition as a surrogate for clinical efficacy) were measured in colorectal tumor homogenates. For arfolitixorin Arfo however, the study showed a strong dose-response relationship, i.e. that the efficacy of arfolitixorin increased with higher doses , This property is unique to arfolitixorin and distinguishes it markedly from leucovorin, whose efficacy plateaus at higher concentrations *) dUr concentration is a surrogate marker for TS inhibition. 0 200 400 600 800 1000 1200 0 5000 10000 15000 20000 25000 30000 Effect of folate dosage on dUr concentration in matching tumor homogenates Folate concentration (µM) dUr concentration (pmol/g) Arfo LV * Research by Surgical-Oncology Laboratory, Department of Surgery, Institute of Clinical Sciences, Sahlgrenska University Hospital, Sweden. E Odin , G Carlsson , B Gustavsson , Y Wettergren , Deoxyuridine as a surrogate marker of thymidylate synthase inhibition contributes to a multivariable model predicting 5 FU/LV response in metastatic colorectal cancer, Cancer Treatment and Research Communications 2025, doi: https://doi.org/10.1016/j.ctarc.2025.101076
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15 Dose-response: Studies indicate that arfolitixorinʼs 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 5FU and oxaliplatin*, reproduces the dose-response relationship. Arfolitixorin showed potent concentration- dependent cytotoxic effects that enhanced the 5FU + oxaliplatin activity more effectively than leucovorin. Oxaliplatin is a standard component of 5FU-based chemotherapy regimens Ref: P. Eide et al. 128P Cytotoxicity of arfolitixorin versus leucovorin LEU) with 5 -fluorouracil 5FU) and oxaliplatin in colorecta l cancer CRC) patient-derived tumoroids PDTs. Annals of Oncology, Volume 36, Supplement 1, 2025, Pages S56 S57, ISSN 09237534, https://doi.org/10.1016/j.annonc.2025.05.140. leucovorin 40 μM arfolitixorin 20 μM arfolitixorin 40 μM leucovorin 20 μM d = increase in AOC
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16 Dose-response: Studies indicate that arfolitixorinʼs 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 inhibition, a surrogate marker for clinical efficacy, was highest in the group receiving the highest dose of arfolitixorin. Ref: Taflin, H. et. al. 2024. Increased potentiation of 5-fluorouracil induced thymidylate synthase inhibition by 5,10-methylenetetrahydrofolate (arfolitixorin) compared to leucovorin in patients with colorectal liver metastases; The Modelle-001 Trial. BJC Reports 2024 Volume 2, Article Number 89.DOI 10.1038/s44276024001114
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17 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 5FU bolus followed by another 60 mg/m2 given 3060 minutes later was compared to 400 mg/m2 of leucovorin (equimolar to 200 mg arfolitixorin) given before 5FU. Two factors seemingly led to that the primary endpoint of superiority was not met: Wrong timing Low dose Arfolitixorin was given in a significantly lower dose than leucovorin Comparing a low dose arfolitixorin with a high dose leucovorin meant 1) an inaccurate comparison between arms, and that 2) arfolitixorinʼs dose-response relationship was not leveraged Arfolitixorin was given 30 min a ɇɿ ḅ ớthe 5FU bolus, in contrast to leucovorin (control) which was given ḅ ɇ ớḅas per clinical practice Too late to fully potentiate TS-inhibition as high MTHF levels are required from the start of the formation of the inhibitory complex *) The AGENT study was a randomized, controlled, multi-center Phase III study assessing the efficacy and safety of arfolitixorin compared to leucovorin, both used in combination with 5FU, oxaliplatin, and bevacizumab in first-line metastatic colorectal cancer (mCRC) patients. The endpoint of superiority was not met, and the trial was terminated in 2022. ) Equimolar to 200 mg arfolitixorin.
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When excluding subjects with study protocol deviations 54% of all patients), arfolitixorin shows significantly higher efficacy compared to leucovorin, in all regions excluding Japan. Significantly higher proportion of reduced 5FU doses in Japan compared to other geographical regions, which may explain the lower response rates. Result cleared from subjects with reduced 5FU doses show numerically higher efficacy also in Japan. 18 AGENT ph III Post-hoc, per-protocol analysis indicates possible superior efficacy in a ǐ ǐ ‱ớ ḅ ȩ g ȴ œ ‱ḅ ǐ ṧ g ȴ ȩ ‱ Jaṑaȴ even with the suboptimal dosing regimen used •Aldina Pivodic et al.The importance of treatment handling and compliance on overall response rate in a phase III study of metastatic colorectal cancer: Post-hoc per protocol analyses of the AGENT trial.. J Clin Oncol 43, 2052052025.DOI10.1200/JCO.2025.43.4_suppl.205 Per-protocol population
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Phase I/II-studies ISO CC002 and ISOCC005 indicate that the drug candidate is safe, well tolerated and show efficacy . It also shows significantly higher levels of MTHF in tumors following equimolar doses of arfolitixorin compared to SoC. In summary, earlier studies form a comprehensive dataset that de-risks the continued development Recent preclinical studies strengthen the evidence and underpins the restart of the clinical program, e.g. by indicating strong drug activity and pointing at a strong and unique dose -response relationship (higher doses of arfolitixorin gives higher efficacy, in contrast to leucovorin). This dose -response relationship was not leveraged in AGENT as a low dose was used Global, randomized phase III -study did not meet its endpoint of superiority but showed that the drug is efficacious with similar efficacy as leucovorin in the ITT population with the chosen dosing regimen Post-hoc analyses show that 1) the dosing was likely too low and not comparable to the control arm, and 2) that the dose was given too late Post-hoc, per-protocol analysis indicates possible superior efficacy in important regions even with the suboptimal dosing ISOCC005 Phase I/II ISOCC002 Phase I/II AGENT post-hoc analyses AGENT Global phase iII Tumor homogenate studies Patient -Derived Tumoroid studies Tissue -level studies CLINICAL SAFETY, EFFICACY CLINICAL RANDOMIZED SAFETY,EFFICACY PRECLIN/CLIN INDICATING DOSERESPONSE 19
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20 Taken together, the data form a solid evidence platform for continued clinical development 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). 1 Pharmacokinetics, pharmacodynamics and available data indicate that higher doses given before instead of after 5 FU will lead to better efficacy .2 Safety with higher doses has been established (up to 500 mg/m2, which is the highest dose to be tested in the ongoing study) in healthy volunteers.*3 *) Studies have been conducted with doses up to 500 mg/m² (in healthy volunteers) and 240 mg/m² (in patients with metastatic colorectal cancer in combination with 5FU and other drugs, ARF given in the phase III dosing sequence) with a maintained safetyprofile.
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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 Dose escalation. RAS -mutant patients 1020 patients (≤6 patients per dose level) * Dose level 1 ARF 120 mg/m 2 Dose level 2 ARF 200 mg/m 2 Dose level 4 ARF 400 mg/m 2 Dose level 3 ARF 300 mg/m 2 Dose level 5 ARF 500 mg/m 2 60 patients in Europe Dose level A ARF MTD Dose level B ARF (a dose level below) 111 R SoC (leucovorin 400 mg/m 2) Treatment administered until disease progression, undue toxicity, or any other protocol -defined stopping criterion following a BOIN, Bayesian optimal interval design. ARF= arfolitixorin; LV= leucovorin; ORR Objective Response Rate; PFS Progression Free Survival; DoR Duration of Response; OS Overall Survival; TTR Time to Response; DCR Disease Control Rate; DpR Depth of Response 20 patients in Japan Two doses selected from phase 1b for optimization Preliminary design, to be confirmed Two doses selected from phase 1b for optimization ARF is given as one short infusion prior to 5FU. In the ph III trial, ARF was given as two bolus injections of 260 mg 3090 mins after 5FU bolus) Key objectives and endpoints Primary: Safety, tolerability Secondary: ORR, PFS, DoR, OS Key objectives and endpoints Primary: Safety, tolerability; ORR, DoR Secondary: PFS, TTR, OS, DCR, DpR Planned phase 2 (randomized) 2026 2027 Dose optimization. RAS mut and RAS/BRAF WT.
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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
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Isofolʼs Advisory Board consists of leading global experts representing the US, Europe and Japan Professor Professor emeritus at the Laboratory of Medical Oncology, Amsterdam University Medical Center; Professor at the Medical University of Gdansk, Poland, and honorary Professor of Amity University i Noida, Indien. Frits Peters Prof. Dr. med. MD Professor Head of the Clinic for Hematology, Oncology and Cancer Immunology at Charité Universitätsmedizin in Berlin, Germany Sebastian Stintzing MD Professor Associate Director for Clinical Research and Co-Leader of the Gastrointestinal Cancers Program at the USC Norris Comprehensive Cancer Center, Professor of Medicine and Preventive Medicine, Section Head of GI Oncology in the Division of Medical Oncology and Co-Director of the Colorectal Center at the Keck School of Medicine of the University of Southern California, USA. Heinz-Josef Lenz MD PhD. Chair of the Japan Society of Clinical Oncology, Deputy Hospital Director, Head of the Division for the Promotion of Drug and Diagnostic Development, Chief of the Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Japan Takayuki Yoshino
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License agreement for development and commercialization Under a license agreement, Isofol is entitled to a double- digit royalty compensation based on net sales in Japan, as well as an upfront payment and milestone payments linked to development, regulatory, and sales-based targets. 24 Clinical development and commercialization in Japan in collaboration with partner Partnership solidified by shareholding In addition to investments in clinical development, Solasia established in 2025 a shareholder position in Isofol, representing an approximate 2% ownership stake as of September 30, 2025. Isofol has licensed the rights to develop and commercialize arfolitixorin in Japan – one of the worldʼs biggest pharmaceutical markets – to Solasia Pharma K.K., a company listed on the Tokyo stock exchange working to bring innovative treatments to Japan and other countries in Asia. Investments in clinical development and regulatory activities In the spring of 2025, Solasia announced its intention to invest approximately SEK 140 million in the upcoming clinical phase II and III studies of arfolitixorin in Japan, as well as in regulatory approval applications, financing a large part of the development costs in Japan. The work is being conducted in close collaboration with Isofol, which supports the Japanese development program and ensures that it aligns with development activities elsewhere and benefits regulatory processes in other geographic regions.
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DRUG SUBSTANCE / API Merck KGaA Life Science owns and manufactures arfolitixorin – Isofol has global, exclusive rights for development and commercialization in oncology Strategic partnership between Isofol and Merck KGaA Life Sience Composition of Matter / Drug Substance, production process and Drug Product patented by Merck Drug Substance / API production by Merck All use patents (clinical use / dosing regimens patented by Isofol DRUG PRODUCT Large-scale Drug Product manufacturing secured with Recipharm Several large-scale GMP batches completed and released for clinical studies Isofol has CMC and large scale GMP manufacturing in place – key partnership with Merck KGaA 25
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Isofolʼs value creation rests on three solid pillars 26 03 Large market 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. Additional indications and markets could add to the opportunity. 02 High-potential drug candidate 01 High unmet medical need
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6,1 6,1 6,2 6,5 6,7 7,3 5,5 6 6,5 7 7,5 2025 2026 2027 2028 2029 2030 Sales in billion USD Global mCRC pharmaceutical market value 27 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. Sources: mCRC Back Bay analysis, Evaluate. CRC Average of various published market analyses. 13,5 14,1 14,8 15,5 16,2 16,9 10 11 12 13 14 15 16 17 18 2025 2026 2027 2028 2029 2030 Global CRC pharmaceutical market value Sales in billion USD
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Patient flow (projected 2040 28 Blockbuster revenue potential in the U.S. in the lead indication mCRC alone Key assumptions: 1 billion USD Gross yearly sales potential for arfolitixorin in the USA in the mCRC indication alone - blockbuster potential - US Population 168k incident CRC patients 79k patients with mCRC 37k diagnosed Stage IV 131k diagnosed Stages IIII 42k progress to Stage IV 51k patients eligible for arfolitixorin Efficacy benefit of 15% absolute increase in ORR compared to SoC Pricing: Premium to SoC Length of treatment: 8 months Treatment compliance: 90% Comparable safety as SoC Market penetration 50% Source: Back Bay analysis, expert interviews; Nov 2024 (updated Dec 2025
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Further opportunities beyond the lead indication in the US add to the potential as additional markets are added and the clinical use expands 1 billion USD Gross sales potential for arfolitixorin in the USA in the mCRC indication alone - blockbuster potential - Additional indications Adjuvant /neoadjuvant CRC, other solid tumors where 5FU + folates are used (e.g. pancreatic, gastric, breast, head/neck) Additional markets ex -U.S. Incl. e.g. Japan, Canada, Europe, Middle East, Asia. Licensing partnerships already established in Japan Solasia Pharma K.K) and Canada Knight Therapeutics) + Source: Back Bay analysis, expert interviews; Nov 202429
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Suite of patents provide for strong intellectual property protection Both Isofol and Merck KGaA are actively working to protect and enhance arfolitixorinʼs suite of patents on the major markets (including but not limited to USA, Europe, Japan) Current patent portfolio (allowed/granted + new filings): C ǐ gȴ g a ǐ ‱ ṧ œḅ ‱ Owned and managed by Isofol Drug Product (granted) Applicable dose /method of use patent (granted) New dose regimen patent (filed) 2020 20502030 20402025 2035 Composition of Matter 2045 Dớ ṧȩ‱ œ ṧœ ɿaȴ ḅ‱ ‱ ɇ ớ ṧǐaɿg ȴ ‱ ‱ Owned and managed by Merck Composition of Matter (granted) International United States. 30
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Isofolʼs value creation rests on three solid pillars 31 03 Large market 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. Additional indications and markets could add to the opportunity. 02 High-potential drug candidate 02 High-potential drug candidate Arfolitixorin is the first and only direct-acting folate, designed to enhance 5FU efficacy and improve outcomes of standard treatments across multiple cancer types. It has shown promising results in earlier studies. 01 High unmet medical need 01 High unmet medical need Arfolitixorin aims to potentiate 5FU-based chemotherapy – todays and tomorrowʼs standard treatment for several types of cancer where better treatments are urgently needed
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Petter Segelman Lindqvist Chief Executive Officer Petter Lindqvist holds an MSc in Business Administration from the Stockholm School of Economics and EM Lyon. He has held leadership roles at GSK, Abbott, AbbVie and Sobi, and has experience from biotech board positions. His background spans strategic business development, global commercialization, and guiding drug candidates through clinical development and regulatory approval. He joined Isofol in 2024. Dr Roger Tell, MD, PhD Chief Medical Officer Dr Roger Tell, MD, PhD is a board- certified oncologist affiliated with Karolinska University Hospital and Karolinska Institutet. He joined Isofol in 2019 and currently leads the companyʼs medical and scientific strategy. Dr. Tell previously held senior leadership roles at Aprea Therapeutics and Servier, and he has extensive experience as a practicing oncologist and strategic advisor to several leading global biopharmaceutical companies, including Eli Lilly, AstraZeneca, and Merck Serono. He also serves as a member of the Board of Directors of Vivesto AB, a company listed on Nasdaq Stockholm. Margareta Hagman Chief Financial Officer Margareta Hagman is an experienced CFO with senior financial leadership roles, mainly at BioGaia AB, but also at Xbrane Biopharma AB and Ortivus AB and is member of the Board of Directors of Infant Bacterial Therapeutics AB – all companies listed on Nasdaq Stockholm. Margareta joined Isofol in 2024, bringing extensive expertise from listed life science companies. Management Team
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Board of Directors Jan-Eric Österlund Chairman of the Board Jan-Eric Österlund has decades of experience in private equity and management buy-outs with a strong focus on life sciences. He has served as CEO, director or chairman in public companies across the US, Canada, Switzerland and Sweden. He is based in England and brings deep strategic and international board expertise to Isofol. Dr Alain Herrera Board Member Dr Alain Herrera is an oncologist/hematologist who played a key role in the global registration of oxaliplatin, a cornerstone of modern colorectal cancer therapy FOLFOX. He has held senior global oncology leadership roles at Sanofi and other pharmaceutical companies and currently serves as a senior consultant and member of several supervisory boards in oncology. Dr Helena Taflin Board Member Dr Helena Taflin is an Associate Professor of Surgery specializing in liver surgery and transplant at Sahlgrenska University Hospital, where she also heads the Clinical Trial Unit. Her research focuses on folate metabolism in colorectal cancer, and she maintains an active role in clinical studies and national medical associations. Lars Lind Board Member Lars Lind serves on Isofolʼs Compensation, Audit, and Nominating Committees. His background includes longstanding experience from executive positions in large, international public companies as well as senior board experience, contributing with business strategy, governance and oversight capability to the company. Mr Lind was instrumental in the founding of Isofol and has served on the board for several years. Prof Sten Nilsson, MD Board Member Prof Sten Nilsson is an experienced oncologist and professor at the Karolinska Institute and independent board member bringing deep clinical and academic expertise to Isofol. With a distinguished career spanning clinical oncology and cancer drug development, he has contributed to the development of major therapies.
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The Isofol opportunity in short 34 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 adoption Blockbuster potential, favorable competitive landscape and strong IP protection Solid partner network and strong team in place to drive flawless and swift execution
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Our goal We aim to have a central impact on tomorrowʼs 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, healthcare providers, shareholders and partners – and ultimately for society at large. 35
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36 Isofol Medical AB (publ) info@isofolmedical.com | www.isofolmedical.com February 2026, ISO44, r20