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Isofol Medical AB Corporate Presentation November 2025
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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 (1991:980) 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 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 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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Isofol’s 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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Isofol’s 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 5-FU-based chemotherapy – todays and tomorrow’s 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 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 various regimens for treating for example colorectal, gastric, pancreatic, esophageal and gastroesophageal, head and neck cancers.
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Mode of Action (simplified): 5-FU + folate targets the TS enzyme to kill tumor cells TS MTHF Folate (leucovorin) arfolitixorin FdUMP 5-FU Target: TS (thymidylate synthase) – enzyme essential for tumor cell growh The stable ternary complex inhibits TS effectively, resulting in interrupted tumor cell DNA synthesis and repair The standard chemotherapy 5-FU is swiftly converted intracellularly to FdUMP High concentrations of MTHF (active metabolite of folate) stabilize TS+FdUMP+MTHF 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 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/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. Today’s treatments are insufficient. Improving outcomes of first line therapies has the potential to have a large medical impact.
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9 5-FU combined with folate is the backbone first-line treatment for 95% of all mCRC patients, today as well as tomorrow. Lasting market opportunity: 5-FU combined with folate will remain the backbone treatment for mCRC for the foreseeable future. A large number of drugs are in development for mCRC, most intended to be used either as an add-on to 5-FU+folate or in later lines of therapy – none will replace it Consensus among clinical experts that 5- FU+folate will remain the mainstay of treatment for the foreseeable future. MSS/pMMR (95% of patients) MSI-H/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 5-FU + folate + bevacizumab Left-sided: FOLFOX/FOLFIRI +/- cetuximab +/- panitumumab Addressable patient groups for arfolitixorin, ~90% of all “It is inconceivable to think that 5-FU backbone will not be the mainstay care, it is a very effective drug within our treatment landscape” “I think we are going to get smarter and find more actionable mutations, but I do not think this will impact the 1L SoC” “5-FU is the most effective drug in this disease, I don’t think it will ever go away ever” “There isn’t anything that comes close to chemo or has a response rate high enough to replace the chemo backbone. 5-FU will remain the pyrimidine of choice in multi-agent chemo regimens in 1L” Ref: Market research conducted by Back Bay Life Science Advisors in November 2024.
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Folates are combined with all 5- FU-based treatment regimens for mCRC, such as FOLFOX, mFOLFOX6, FOLFIRI, FOLFOXIRI Folates (folinic acid) are sold under different names, the most common one being leucovorin Arfolitixorin could potentially replace 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 2Δ 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 2Δ 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. Δ 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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Isofol’s 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 5-FU 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 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 Arfolitixorin (active drug) Effect resulting in several-fold higher levels of MTHF in tumor tissue1, and an efficacy that could increase with the dose2 Aim: Improved outcomes (Objective Response Rate, Progression-Free Survival, Overall Survival) 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;75(1):37–47. doi:10.1007/s00280-014-2611-9n. 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 ISO-CC-002 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. 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;75(1):37–47. doi:10.1007/s00280-014-2611-9 *) Levo-leucovorin contains only the L-isomer, so it delivers the same pharmacologic activity at half the dose as leucovorin that also has the D -isomer (50%) 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 arfolitixorin’s 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 using colorectal tumor homogenates, measuring deoxyuridine (dUr) concentrations (a biomarker for TS inhibition as a surrogate for clinical efficacy). 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. Wettergren et al. Deoxyuridine levels in tumor homogenates may predict response to 5 -FU/LV-based chemotherapy in patients with metastatic colorectal cancer. J une 2025. Submitted for publication.
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15 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 relationship. Arfolitixorin showed potent concentration- dependent cytotoxic effects that enhanced the 5-FU + oxaliplatin activity more effectively than leucovorin. Oxaliplatin is a standard component of 5-FU-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 0923-7534, 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 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 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/s44276-024-00111-4
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17 A previous phase III trial* indicated similar efficacy of arfolitixorin as leucovorin with a suboptimal dosing regimen Wrong timing Low dose Arfolitixorin was given in a significantly lower dose than leucovorin Comparing a low dose (60mg x2)with a high dose (eqv. to 200mg) meant 1) an inaccurate comparison between arms, and 2) that arfolitixorin’s dose-response relationship was not leveraged Arfolitixorin was given 30 min after 5-FU bolus, in contrast to leucovorin which was given before as per clinical practice Too late to be able to chemically fully potentiate TS-inhibition as high MTHF levels are required from the start *) The AGENT study was a randomized, controlled, multi-center Phase III study assessing the efficacy and safety of arfolitixorin compared to leucovorin (the current folate-based treatment), both used in combination with 5-FU, 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. ) 60 mg/m2 of arfolitixorin was given in conjunction to the 5-FU bolus, and 400 mg/m2 leucovorin (equimolar to 200 mg arfolitixorin). Too little, too late: less TS inhibition and lower anti-tumor effect
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Phase I/II-studies ISO-CC-002 and ISO-CC-005 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. 18 In summary, earlier studies form a comprehensive dataset that de-risks the continued development Recent preclinical studies strengthen the evidence further 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). Global, randomized phase III-study did not meet its endpoint of superiority but showed that the drug is efficacious (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, cf. next slide ISO-CC-005 (Phase I/II) ISO-CC-002 (Phase I/II) AGENT post-hoc analyses AGENT (Global phase iII) Tumor homogenate studies Patient-Derived Tumoroid studies Tissue-level studies
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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 should 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 5-FU and other drugs, ARF given in the phase III dosing sequence) with a maintained safetyprofile.
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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: Dose escalation Planned phase 2 (randomized) 2026-2027: Dose optimization 3-20 patients (max 6 patients per dose level) * Dose level 1: ARF 120 mg/m2 Dose level 2: ARF 200 mg/m2 Dose level 4: ARF 400 mg/m2 Dose level 3: ARF 300 mg/m2 Dose level 5: ARF 500 mg/m2 ~60 patients in Europe Dose level A: ARF (MTD) Dose level B: ARF (a dose level below) 1:1:1 R SoC (leucovorin 400 mg/m2) *Treatment administered until disease progression, undue toxicity, or any other protocol-defined stopping criterion following a BOIN, Bayesian optimal interval design. Pending protocol amendment approval by BfArM (current prodocol does not include a SoC arm) and protocol approval by PMDA Ref: Adapted from a Trial-in-Progress poster presented at ESMO 2025: https://cslide.ctimeetingtech.com/esmo2025/attendee/confcal_2/presentation/list?q=908eTIP ~20 patients in Japan Two doses selected from phase 1b for optimization Preliminary design, not yet confirmed Two doses selected from phase 1b for optimization ARF is given as one short infusion prior to 5-FU. (In the ph III trial, ARF was given as two bolus injections of 2x60 mg 30-90 mins after 5-FU)
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Clinical development incollaboration 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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Isofol’s 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 world’s 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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Isofol’s 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: 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 165k incident CRC patients 105k patients with mCRC 36k diagnosed Stage IV 131k diagnosed Stages I-III 68k progress to Stage IV 68k patients eligible for arfolitixorin Efficacy benefit of >15% absolute increase in ORR compared to SoC Pricing: Premium to SoC Length of treatment: 6 months Treatment compliance: 90% Comparable safety as SoC Market penetration >50% Source: Back Bay analysis, expert interviews; Nov 2024
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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 29 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 5-FU + 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 2024
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30 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): Clinical use 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 Drug substance / formulation Owned and managed by Merck Composition of Matter (granted) International United States. *) Intention-to-grant-notice by the EPO in November 2025
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Isofol’s 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 5-FU 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 5-FU-based chemotherapy – todays and tomorrow’s standard treatment for several types of cancer where better treatments are urgently needed
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Petter Segelman Lindqvist Chief Executive Officer Jan-Eric Österlund Chairman Prof. Sten Nilsson, MD Board Director Dr. Helena Taflin, MD Board Director Dr. Alain Herrera, MD Board Director Lars Lind Board Director Dr. Roger Tell, MD Chief Medical Officer Margareta Hagman Chief Financial Officer Management and Board
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The Isofol opportunity in short 33 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 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, healthcare providers, shareholders and partners and ultimately for society at large. 34
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Isofol Medical AB (publ) info@isofolmedical.com www.isofolmedical.com