Isofol Medical Ab · OMXSTO:ISOFOL
Isofol Medical Ab — Shareholder Meeting (March 2024)
45 slides from Isofol Medical Ab's shareholder meeting presentation, Mar 19, 2024
Slide 1: Shareholder meeting March 19, 2024
Shareholder meeting March 19, 2024 Dr Roger Tell, Chief Medical Officer
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: Introduction
Introduction Jan-Eric Österlund, Chairman of the Board Dr Roger Tell, Chief Medical Officer
Slide 4: Agenda
Agenda Introduction Jan-Eric Österlund Chairman of the Board The road ahead Petter Segelman Lindqvist CEO Clinical study Roger Tell CMO Why arfolitixorin? Dr. Alain Herrera Board Member © ISOFOL MEDICAL AB (publ) 4
Slide 5: How Isofol was created
How Isofol was created The inventor A network of business angels 5
Slide 6: Our shareholders are a great asset
Our shareholders are a great asset A unique and The stock market dedicated core rules set the We value your group that has framework commitment and grown to more for our input. than 10,000 communication. shareholders. 6
Slide 7: A board with a wide range of expertise
A board with a wide range of expertise Jan-Eric Österlund Sten Nilsson Helena Taflin Alain Herrera Lars Lind Chairman 7
Slide 8: Our guiding principles
Our guiding principles Our information We are convinced We are responsive should be open, of the potential of to input from honest and arfolitixorin. experts. transparent. 8
Slide 9: Arfolitixorin and the AGENT study
Arfolitixorin and the AGENT study The AGENT study: • Comprised of two arms, one with arfolitixorin and a control arm with leucovorin. • Both showed similar results. • However, the study was designed to show the superiority of arfolitixorin. Why was arfolitixorin not shown to be superior? • The effec
Slide 10: Size matters!
Size matters! • A new study will use a higher dose of arfolitixorin A new study is • Several studies have shown that a higher needed to dose leads to better TS inhibition, which in turn leads to the death of more cancer cells. establish a safe • So why was not a higher dose used in the and optimal d
Slide 11: Focus on a new clinical study
Focus on a new clinical study • Laboratory tests or organoid studies cannot replace patient data. • Only a new clinical trial can provide the evidence of good efficacy and safety that investors and pharmaceutical companies are looking for. 11
Slide 12: Petter Segelman Lindqvist
Petter Segelman Lindqvist CEO since January 9, 2024 12
Slide 13: Agenda
Agenda Introduction Jan-Eric Österlund Chairman Our way forward Petter Segelman Lindqvist CEO Clinical trial Dr. Roger Tell CMO Why arfolitixorin? Dr. Alain Herrera Board member 13
Slide 14: The road ahead for Isofol
The road ahead for Isofol Petter Segelman Lindqvist, CEO Dr Roger Tell, Chief Medical Officer
Slide 15: New CFO and CMO since January
New CFO and CMO since January Magnus Hurst Roger Tell Chief Financial Officer Chief Medical Officer 15
Slide 16: Colorectal cancer remains a major medical problem
Colorectal cancer remains a major medical problem 154,000 53,000 86 % people annually are patient deaths per of patients with affected in the USA year in the metastatic disease die alone USA alone within five years Ref: American Society of Clinical Oncology (ASCO) Cancer.Net. Accessed 12 March 2024.
Slide 17: 5-FU-based chemotherapy and arfolitixorin
The same 5-FU-based standard treatment for 50 chemotherapy in combination with leucovorin is expected to years remain the mainstay of treatment. 17 One of few Arfolitixorin Potential to replace leucovorin and significantly innovations enhance the efficacy of 5-FU therapy without compromising safety.
Slide 18: The colorectal cancer market is large and growing
The colorectal cancer market is large and growing 85 billion SEK 105 billion SEK Current market size for Expected market size pharmaceutical in the year of treatments1 20321 1. Base year 2022. US, France, Germany, Italy, Spain, UK, Japan. Garcìa, L, Webster, R. The colorectal cander drug market. Nat
Slide 19: The basis for our value creation
The basis for our value creation Arfolitixorin has the potential to Huge unmet Large and significantly medical need growing market improve patient outcomes.
Slide 20: Comprehensive dataset as a basis for the next step
Comprehensive dataset as a basis for the next step Preclinical studies at Sahlgrenska ISO-CC-002 (Phase I/II) University Hospital ISO-CC-005 (Phase I/II) Cell line experiments ISO-MC-091 (Phase I/II) Studies on organoids The investigator-initiated The AGENT study (Phase III) Modelle study Laboratory
Slide 21: The AGENT study
The AGENT study • Too low dose: (120 mg/m2) instead of the leucovorin equimolar one (200 mg/m2) Why were no differences in effectiveness → unfair comparison. seen between arfolitixorin and leucovorin? • Suboptimal administration: (bolus 2 x 60 mg/m2) → the concentration of the drug candidate was too
Slide 22: Dosing and administration could be optimized
The dosing and administration regiment could be optimized aiming at further improving arfolitixorin’s efficacy. We have a responsibility to patients, shareholders, and society at large to move arfolitixorin forward. 22
Slide 23: Focus on a new phase I/II clinical trial
Focus on a new phase I/II clinical trial In parallel, we are conducting further analyses and laboratory studies to optimize the study design and facilitate the dialogue with regulatory authorities. 23
Slide 24: Key components of our strategic plan for value creation
Key components of our strategic plan for value creation Continued Leverage on Proper cost clinical our control development partnerships 24
Slide 25: Continued clinical development
Initiate a phase I/II study in colorectal cancer to identify an optimal dose regime, safety profile and efficacy. Continued Perform a time- and cost-effective study within our financial framework clinical with the aim of starting the study (FPI) before the end of 2024/25. development The aim is to c
Slide 26: Leverage on our partnerships
Strategic development partner and manufacturer. Leverage Partner for development and on our commercialization in Japan. partnerships KEY OPINION Close collaboration with LEADERS leading clinical expertise. 26
Slide 27: Proper cost control
Cost control allows the current cash position to take us to interim and top-line read-outs of study data. Proper Full focus on value-adding cost activities → clinical study. control Collaborating with consultants and subcontractors provides flexibility. 27
Slide 28: Arfolitixorin has the potential to revolutionize treatment
We are convinced that arfolitixorin has the potential to revolutionize the treatment of colorectal cancer. Now the journey continues.
Slide 29: Agenda
Agenda Introduction Jan-Eric Österlund Chairman Our way forward Petter Segelman Lindqvist CEO Clinical trial Dr. Roger Tell CMO Why arfolitixorin? Dr. Alain Herrera Board member 29
Slide 30: Next step in the clinical development of arfolitixorin
Next step in the clinical development of arfolitixorin DrDrRoger Tell, Chief Medical Officer Roger Tell, Chief Medical Officer
Slide 31: A phase I/II clinical study
A phase I/II clinical study A study in Arfolitixorin is Optimized dose treatment-naïve used in addition to and administration patients with 5-FU-based based on metastatic chemotherapy previously colorectal cancer. treatments. generated data. 31
Slide 32: Dose level and administration
Dose level and administration The AGENT The new study study 2 x 60 mg/m2 Up to 1 x 400 mg/m2 Intravenous Intravenous bolus bolus injection injection / short infusion 32
Slide 33: Preliminary study plan
Preliminary study plan Phase I – dose escalation Phase II – dose optimization Three dose levels Maximum tolerated dose up to 400 mg/m2 (20 patients) Intravenous bolus injection / short infusion Second highest tolerated dose (6–30 patients) (20 patients) Interim data (10+10 patients) 33
Slide 34: Preliminary endpoints
Preliminary endpoints Phase I – dose escalation Phase II – dose optimization • Objective response • Safety and • Progression-free survival tolerability • Overall survival • Efficacy read-out • Pharmacokinetics • ctDNA • Biopsy analyses 34
Slide 35: Value creating milestones
Value creating milestones Authority Interim clearance results Phase I Phase II Phase I Initiation of Top line results and recruitment results dose selection 35
Slide 36: Agenda
Agenda Introduction Jan-Eric Österlund Chairman Our way forward Petter Segelman Lindqvist CEO Clinical trial Dr. Roger Tell CMO Why arfolitixorin? Dr. Alain Herrera Board member 36
Slide 37: Is there still a need to improve the effectiveness of 5-FU chemotherapy?
Is there still a need to improve the effectiveness of 5-FU chemotherapy? Patients with mCRC (stage IV) are seldom curable, with a 5-year survival rate of less than 10 percent. 37
Slide 38: Is there still a possibility to improve 5-FU effectiveness?
Is there still a possibility to improve the effectiveness of 5-FU chemotherapy? …even with the addition of leucovorin, only about 20% of mCRC patients respond do treatment, compared to approximately 10% response to 5-FU alone. …there have been no significant advances to therapies for mCRC for decade
Slide 39: Is arfolitixorin a good potential candidate?
Is arfolitixorin a good potential candidate to improve the effectiveness of 5-FU chemotherapy? …the development of agents such as arfolitixorin which bypass the need for metabolic conversion remains promising for future therapeutic candidates. 39
Slide 40: If so, why did the AGENT study fail?
If so, why did the AGENT study fail? 40
Slide 41: If so, why did the AGENT study fail?
If so, why did the AGENT study fail? Arfolitixorin (120 mg/m2) did not improve the ORR, potentially indicating a suboptimal dose. 41
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Slide 43: We may have lost a battle, we will win the war
So, We may have lost a battle We will win the war 43
Slide 44: ISOFOLU
ISOFOLU
Slide 45: Arfolitixorin has the potential to revolutionize treatment
We are convinced that arfolitixorin has the potential to revolutionize the treatment of colorectal cancer. Now the journey continues.