October 2020 - Isofol

© ISOFOL MEDICAL AB (publ)

October 2020


Disclaimer

This company presentation of Isofol Medical AB (publ) (“Isofol”) 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 company 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 company 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 document are required to inform themselves about, and to observe, such restrictions.

The courts of Sweden shall have exclusive jurisdiction over any dispute arising out of or in connection with this document company presentation and the City Court of Gothenburg, Sweden, shall be the court of first instance.

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Isofol at a glance

Developing arfolitixorin for the treatment of colorectal cancer

Headquarters in Gothenburg

Strategic CMC partnerships with Merck & Cie and Recipharm

Listed on NASDAQ First North Premier in Stockholm (ticker: ISOFOL)

* Holding as of July 31, 2020Source: Holdings.se, June 30 2020

Board and management with broad and long experience

Strategic commercial partnership with Solasia for the Japanese market

ShareholdersNumber of

sharesCapital/Votes

(%)

Avanza Pension 4 117 908 4,94%

Bengt Gustafsson 3 515 434 4,22%

Handelsbanken Fonder 3 393 412 4,07%

Futur Pension 3 295 229 3,95%

Alfred Berg Fonder* 2 719 717 3,26%

Swedbank Robur Fonder 2 413 791 2,90%

Fjärde AP-fonden 2 400 000 2,88%

Swedbank Försäkring 1 926 660 2,31%

Urus AB 1 866 664 2,24%

Rhenman Partners Asset Management AB

1 838 061 2,20%

10 largest shareholders 27 486 876 32,97%

Other owners 55 879 090 67,03%

TOTAL 83 365 966 100%

Number of shareholders approx. 4500

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The arfolitixorin opportunity

Arfolitixorin

mCRC is a significant unmet medical need with no new treatment options for allcomers in over 16 years

[6R]-MTHF added to the cornerstone cytotoxic 5-FU more than doubles efficacy - arfolitixorin is [6R]-MTHF

Key Opinion Leaders active support in the development program

A $1B opportunity in 1st line mCRC only

Unprecedented low regulatory hurdle for approval in 1st line mCRC

Limited competition and few new drugs in development for 1st line mCRC, no branded products

4

Arfolitixorin: A Blockbuster Commercial Opportunity

5


Arfolitixorin - Significant Commercial Opportunity

6

Large Patient Population

AGENT study infirst-line mCRC

Limited competition

Straightforward adoptioninto Standard of Care

Premium pricing$mCRC Peak sales potential>$1B


Arfolitixorin - Aim to Increase Efficacy of current standard of care-the first pure form of [6R]-MTHF – the biological active substance

The Problem: 5-FU + [6R]-MTHF treatment with the pro-drug leucovorin 400 mg/m2

The Solution: 5-FU + Arfolitixorin 120 mg/m2 (120 mg/m2 [6R]-MTHF)

IV bolus push1-3 min

[6R]-MTHF essential for 5-FU anticancer effect

• With only up to 40% - 45% responding to current SOC in All-Commers

Strength of the arfolitixorin program:

• Hemisulfate guarantees stability

• Significantly higher intracellular tumor concentrations of [6R]-MTHF

• Significant higher inhibition of TS inhibition

• Use of 5-FU and arfolitixorin iv bolus push significantly inhibits TS

7

Arfolitixorin is a De-risked Opportunity

8


Arfolitixorin is a De-risked Opportunity- Phase III AGENT Study has a high probability of success with low regulatory hurdles for approval

● Significant Commercial Opportunity● Physicians understand and support the value proposition

● Established mechanism of action:● [6R]-MTHF role in potentiating 5-FU is well described in the literature1

● Arfolitixorin is the first pure form of [6R]-MTHF, require no activation and has the potential to help all patients treated with5-FU● FDA and EMA have granted approval to evaluate arfolitixorin in a first line 1st line pivotal registrational trial in mCRC setting, as an

improvement of established care based on:• Favorable safety profile with established MoA• Pre-clinical and clinical documentation

● Positive Clinical Data:● PK/PD data has demonstrated significantly increased [6R]-MTHF levels in Tumors from CRC patients vs SOC2

● Study 005 resulted in promising efficacy of 59% ORR in the ARFOX patient population after at least 16 weeks of treatment3

● Full CMC process in place:● ISOFOL and MERCK has spent over 15 years developing a manufacturing process and know-how together ● CMC and commercial scale manufacturing process has been completed and there will be no delays for clinical trials or commercial

launch

Source: 1. PV Danenberg et. al. Critical Reviews in Oncology/Haematology106 2016 118-131. 2. Y Wettergren et. al. Cancer Chemother Pharmacol. 2015 Jan;75(1):37-47. 3 Isofol data on file

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Clinical Background and Rationale

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Colorectal cancer is the third most common cancer 1

11% of cancers discovered annually are colorectal cancer

COLORECTAL CANCER FACTSHEET

The 5-year survival rate for patients with stage 4 colorectal cancer falls to around 10%2

10%

GROWING INCIDENCE

The global burden of CRC is expected to increase by over 70% from 1,8 million 2018 cases to 3,1 million in 20401

>70%

Source: (1) GLOBOCAN 2018, Cancer Incidence and Mortality Worldwide. (2) GlobalData 2017

1.8m people are diagnosed with CRC each year globally11.8m

GLOBAL CRC MARKET

Total market size $bn 2018 to 20252

Colorectal cancer (CRC)- 3rd most common and 2nd deadliest cancer with a high unmet need

0,00,20,40,60,81,01,21,41,61,82,02,2

Lung Breast Colorectal Prostate Stomach Liver

Annu

algl

obal

inci

denc

e(m

illio

ns)

12% 12%11%

8%6%

5%

2018 2025

CAGR: ~3%

118.5

11


5-FU based chemotherapy will remain a cornerstone treatment in CRC

Metastatic CRC, spread

to distant organs

1st line 2nd line 3rd line

Localtumour

Tumour spread

to nearbylymph nodes

Source: (1) GlobalData 2017 12


[6R]-MTHF plays a vital role in improving the efficacy of 5-FU

TS-Tymidylate Synthase; 5-FU – 5 Fluorouracil

5-FU displaced due to [6R]-MTHF shortage

5-FU is an anti metabolite i.e. a false building block that out competes the natural TS substrate

Arfolitixorin is [6R]-MTHF 13

i.e. [6R]/MTHF


PK/PD data from Phase I/II study ISO-CC-002 demonstrate significantly increased MTHF levels in tumors from Colorectal Cancer patients treated with arfolitixorin vs Levoleucovorin

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Significantly higher Methylene THF ([6R]-MTHF) concentrations in colorectal tumor after two equimolar dose

levels of arfolitixorin or L-LV, all dosages (analysis of variance; P < 0.01)

Methylene THF ([6R]-MTHF) levels in colorectal tumor

Con

c (p

mol

/g)

0

2000

4000

6000

8000

10000

Arfolitixorin 60mg/m2

Levoleucovorin 60mg/m2

Arfolitixorin 200mg/m2

Levoleucovorin200 mg/m2

n=32


Gene expression studies indicate that arfolitixorin has the potential to increase Progression Free Survival (PFS) in metastatic Colorectal Cancer (mCRC) patients

Background Low expression of the ABCC3 gene has been linked to

poor conversion of leucovorin into [6R]-MTHF and associated with potentially worse clinical outcome

Source: ASCO 2018, Isofol Data on file

PFS is dependent on ABCC3 expression High ABCC3 expression: 11,4 months Low ABCC3 expression: 6.7 months

Hypothesis 75% of patients with low expression of ABCC3 do not optimally

benefit from LV optimization of 5-FU efficacy and correlates with worse PFS vis-à-vis high gene expression

GENE EXPRESSION DATA based on validated method

∆ = 4.7

Fig. 1 & 2. Kaplan-Meier Curves showing PFS when patients with synchronous mCRC were categorised based on ABCC3 expression

High ABCC3 in 25% of pts

Low ABCC3 in 75% of pts

N=144; p:0.0002Quartiles

ABCC3 expression levels and PFSin patients treated with 5-FU/LV regimens

Results from the phase III AGENT study will confirm the Hypothesis that arfolitixorin substitution of leucovorin results in significant better efficacy, with those with low gene expression having the most benefit

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Presentatör

Presentationsanteckningar

We have gene expression data showing a separation of leucovorin-treated patients based on the expression of a folate related gene called ABCC3. Low expression of the ABCC3 gene has been linked to poor conversion of leucovorin into [6R]-MTHF, and therefore worse PFS. l in these patients who do not fully benefit from the 5-FU based regimens.


2. Arfolitixorin generates significantly higher [6R]-MTHF levels in patients tumors

1. [6R]-MTHF is critical for 5-FU’s mode of action

[6R]-MTHF in cancer treatment ABCC3 expression and PFS

3. Arfolitixorin could rescue up to ~ 75% of all mCRC patients treated with 5-FU unable to convert LV

(improved Progression Free Survival PFS 11.4 vs 6.7 months)

Arfolitixorin – a novel drug for improving response and survival in mCRC patients- Arfolitixorin could improve ORR and PFS by potentiating 5-FU cytotoxicity

Based upon solid preclinical data, early clinical data, a favorable safety profile and a well understood MoA –FDA and EMA have endorsed the ongoing Phase 3 trial to form the basis for a future market registration

Methylene THF ([6R]-MTHF) levels in colorectal tumor tissue

High ABCC3 in 25% of pts

Low ABCC3 in 75% of pts

N=144; p:0.0002Quartiles

Source: ASCO 2018, Isofol Data on file

antimetabolite

5-FU TS-substrateout-competed

arfolitixorin([6R]-MTHF)

Thymidine synthetaseinhibition

persistent thymidine shortage

persistent DNAsynthesis arrest

tumor cell death through apoptosis

16

Clinical Development Planand target for arfolitixorin

17


Clinical Development Program and Accelerated Developmentresulted in a shortened route to market- Due to strong support from regulatory authorities

18


Target Product Profilearfolitixorin Minimal acceptable results Ideal Results

Primary Product IndicationFor the treatment of

1st line mCRC in combination with 5-FU

For the treatment of advanced colorectal cancer in combination with 5-FU

Patient Population 1st line mCRC 1st line mCRC

ORR (%) >55% - >10% improvement compared to current SOC

>60% - >15% improvement compared to current SOC

PFS (months)*>11,8 months –

>1,8 months improvement compared to current SOC

>12,5 months –>2,5 months improvement compared to current SOC

Incidence of Grade III/IV AEs (%)

Similar frequency to current SOC Similar frequency to current SOC

To improve efficacy

● with no additional toxicity

● by a proven concept

● no change in clinical practice required for use

● Low hurdles for incorporation into current treatment practice

Arfolitixorin promises

Arfolitixorin has the potential to optimize 5-FU based treatment efficacy

* FDA requires a positive trend in PFS as the lowest hurdle

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ISO-CC-005 – Phase I/IIa dose defining studySafety and dose finding with extension cohorts

Dose finding part; MTD & RP2D

Patients (n=62)mCRC 1st to 5th line

MTD and RP2D

Primary Endpoint

Secondary Endpoints2020ARF/ARFOX/ARFIRI +/- BevacizumabmCRC

ORR @ 8wObjective response rate

Patients (n=43)mCRC 1st line

ARFOX or ARFIRI (120mg/m2)mCRC

Safety2020

ORR @ 8w

Primary Endpoint

Secondary Endpoints

Objective response rate

Final results(Expected)

Safety extension cohorts 1 & 2 Treatment/Efficacy(followed 16 weeks and beyond with CT)

1st line Cohorts 1 & 2 (31 patients)

SafetyTo date, no safety issues related to the use of arfolitixorin have been raised at the dose of 120 mg/m2

Overall Response Rate (ORR)

ARFOX 59%ARFIRI 50%

Final results(Expected)

Results 1st-5th line (62 patients)

Dose FindingMaximal Tolerated DoseRecommended Phase 2 Dose

120 mg/m2 arfolitixorinWas the selected dose

SafetyTo date, no safety issues related to the use of arfolitixorin have been

raised at any tested dose

Recommended Phase 2 Dose

Source: Isofol data on file20


55% Overall Response Rate (≥-30%) in 31 first line patients in ISO-CC-005 (Cohort I & II)- Results 16 weeks and beyond of treatment with 120 mg/m2 Arfolitixorin + 5-FU + irinotecan or oxaliplatin (ARFIRI/ARFOX)

Source: Isofol Data on file

17 out of 31 patients had partial response, PR (≥-30%)

ORR according to RECIST 1.1

PD (≥20%)

PR (≥-30%)

ARFOX 59%ARFIRI 50%

0,00% 0,00% 0,00% 0,00%

-5,63%

-11,54%-14,71% -16,00%

-29,69%-34,02%

-36,67% -37,18%

-44,00%-46,22%

-50,00%

-57,00% -57,45% -57,69%

-63,64% -64,15%-67,35% -68,00%

-73,77% -75,53%-79,59%

-84,71%-90,00%

-80,00%

-70,00%

-60,00%

-50,00%

-40,00%

-30,00%

-20,00%

-10,00%

0,00%

10,00%

20,00%

30,00%

40,00%

#1 1

20 m

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FOX

#2 1

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#20

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#5 1

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% CHANGE OF TUMOUR SIZE FROM BASELINE

*

*

*

*

SD19 mts*

PR21 mts

pCR15 mts*

• 1 Patient (#9) with SD followed for 19 months and censored at study end.

• 1 Patient (#18) with PR resected and reached pCR after surgery at 15 months.

• 1 (#16) Patient with PR + resection was followed for 21 months until PD.

* Received bevacizumab after 8 weeks** Received panitumumab after 8 weeks+ 13 Confirmed responses according to RECIST 1.1

++ + +++ ++ +++ +

**

*

*

*

*

Extension cohort I & II (ORR beyond 8 weeks – 31 patients) of ISO-CC-005 - ARFOX/ARFIRI

+

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ORR The ORR for Arfolitixorin in the ISO-CC-005 (ARFOX/ARFIRI) trial is higher compared to the commonly used chemotherapy combinations in all-comer patient populations and is in line with the target readout from the ongoing Phase 3 AGENT study.

Abbreviations: 5-FU: 5-fluorouracil; anti-EGFR: anti-epidermal growth factor receptor; ARFOX: : infusional 5-FU,Arfolitixorin, oxaliplatin; ARFIRI: : infusional 5-FU,Arfolitixorin, irinetocan; FOLFIRI: infusional 5-FU, l-leucovorin, irinetocan; FOLFOX: infusional 5-FU, l-leucovorin, oxaliplatin; BV: bevacizumab; CTX: cetuximab; ORR: overall/objective response rate; PFS: progression free survival; PMAB: panitumumab; SOC: standard of care; LV: leucovorin; mCRC: metastatic colorectal cancerSource: [1] Giuliani and Bonetti (2018) First-line therapies in metastatic colorectal cancer: integrating clinical benefit with the costs of drugs. International Journal of Colorectal Disease

Syneos Health analysis of average ORR based on pivotal Phase III trials considered in a recentmeta-analysis/review by Giuliani & Bonetti [1] compared to ISO-CC-005 patients with poor prognostic factors

20,0%

27,0%

45,0%

59,0%

40,0%

50,0%

0,0%

10,0%

20,0%

30,0%

40,0%

50,0%

60,0%

70,0%

5FU/LV capacitabine FOLFOX ARFOX FOLFIRI ARFIRI

005 Data

Historical controls

22


AGENT study – Ongoing global Phase 3 study designStudy summary:

Study sites

43US, Canada

34

IndicationFirst line treatment

Randomized controlled study

mCRC

mFOLFOX-6 + Bevacizumab**

ORRObjective response rate

Primary Endpoint

PFS, DORProgression-free survivalDuration of Response

Key Secondary Endpoints

H12022

Final results

EuropeJapan

*ARFOX (Arfolitixorin + 5-FU + Oxaliplatin) + bevacizumab**mFOLFOX-6 (Leucovorin + 5-FU + Oxaliplatin) + bevacizumab

Australia

4

2

ARFOX + Bevacizumab*

440 patientsmFOLFOX-6 + Bevacizumab**

Interim analysis around year-end 2020 – Adaptive design330 patients observed for 16 weeks - event driven

Additionallysites in Japan and Australia are planned to be initiated+

DSMBrecommendation

Possible sample size increase with 220

Coordinating Principal Investigator:

Prof Joseph Tabernero, MD, PhD

Prof Heinz-Josef Lenz, MD, PhD

H22021

Final results

* As of August 2020

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660 patients


Regulatory requirement for marketing approval of arfolitixorin:

FDA & EMA, TGA (Aus) and PMDA (Jpn)

● Primary Objective: Response Rate, at least 10% increase above SOC

● Secondary Objective: Positive trend in PFS and DOR

● Safety: No deterioration in OS, at least maintained risk/benefit ratio

● Required sample size: 440 patients

Interim Analysis

● Basis for adaptive design● When patient number 330 has been observed for at least 16 weeks (end 2020) the DSMB will review safety

and efficacy (ORR and trend in PFS) and recommend based on outcomes;

AGENT study – with Adaptive Design, a De-Risked Program

1.Stop recruitment at 440 patientsCarry on observing the 440 patients

2.Sample size increase to 660 patientsIncrease sample size to 660 patients to

reach statistical significance on PFS

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Strong support from leading CRC KOL’sProf. Heinz Josef Lenz – Keck School of Medicine,

University of Southern California, USA

Professor Lenz has supported the AGENT study for theinitiation of the project. He is also chairman for ourinternational advisory board. During our last adboard, hegave his strong support for our project and helped infacilitating the connections with the leading KOL networkinternationally.

Professor Tabernero, is the coordinating PI for the AGENTtrial and as previous chairman for ESMO he is also one ofthe leading KOL’s worldwide. Prof. Tabernero recentlypublished a very positive review on the arfolitixorinopportunity (attached) and has been a strong supporter ofour program for several years back. He is also part of ourinternational advisory board.

Prof Joseph Tabernero - Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain

Prof. Sebastian Stintzing - CharitéUniversitätsmedizin Berlin, Berlin, Germany

Professor Yoshino is the leading colorectal KOL in Japan.When presented to the AGENT trial and arfolitixorin a bitmore than a year ago, he immediately realized theimportance of the molecule and agreed to be PI in Japan, heis also part of our international adboard. Prof Yoshino waspivotal for the success in discussions with PMDA and a verystrong supporter of the study design and endpoints.

Prof. Takayuki Yoshino - National Cancer Center Hospital East, Chiba, Japan

Professor Stintzing participated in our recent oncologyseminar in Stockholm and is also both an investigator andadboard member. His message during the seminar is thatArfolitixorin is a unique opportunity in 1st line mCRCwhere there have been no improvements for a decade. Healso strongly supports our endpoints in the AGENT trial.He also clearly stated the importance of the AGENT trialas a physician. Link to presentation

25

https://tv.streamfabriken.com/isofol-medical-oncology-seminar-2019?seek=4020

Market Opportunity

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Blockbuster potential in Colorectal Cancer alone

~ $1Bin annual market potential only in the 1st line treatment setting

in the 7MM

1.8mGlobal colorectal cancer (CRC)

incidence

>370kAnnual mCRC drug treated patient

pool in 1st-3rd treatment line

Source: GLOBOCAN 2018, Cancer Incidence and Mortality Worldwide.;GlobalData 2017; GlobalData Colorectal Cancer: Competitive landscapeto 2026; Deallus Market research and forecast model 2018.

27


Primary market research in 7 major markets (7MM) + South Korea- Healthcare professionals (HCPs) view on arfolitixorin TPP

0% 20% 40% 60% 80% 100%

Asia

EU

US

Global

Minor Importance Significant Improvement Very significant Improvement

HCP opinion on arfolitixorin significance

HCPs were excited about arfolit ixorin, 74% of HCPs indicated it offered a s ignif icant or very s ignif icant

improvement vs. current treatment options

Region 1 2 3 4 5 6 7 8 9 10

Global

US

EU

Asia

Very excitingNot exciting

Source: Deallus Market research and forecast model 2018

A total of 34 physicians were interviewed (N=34 (US: 12, EU: 16, Asia: 6). Study performed by Deallus Consulting for Isofol Medical.

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Arfolitixorin could see market share of 50%, 42% and 31% in the US, Asia and EU respectively within the 1L mCRC setting

Source: Deallus Market research and forecast model 2018

A total of 34 physicians were interviewed (N=34 (US: 12, EU: 16, Asia: 6). Study performed by Deallus Consulting for Isofol Medical.

31%40%

31%24%25%

50%

33%

20%29% 31%

26%20%

47%42% 40% 40%

0%

10%

20%

30%

40%

50%

60%

Adjuvant 1L mCRC 2L mCRC 3L mCRC

Arfolitixorin MS (%) by Region & Line of Therapy

Global US EU Asia

• Arfolitixorin market share data is based on HCP willing to prescribe among all drug treated patients in each line of therapy

• Willingness to prescribe Arfolitixorin is greatest in the US (50% in 1LmCRC), followed by Asia (42% in 1L mCRC) and lowest in the EU (31% in 1L mCRC)

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© ISOFOL MEDICAL AB (publ)Source: GLOBOCAN 2018, Cancer Incidence and Mortality Worldwide.;GlobalData 2017; GlobalData Colorectal Cancer: Competitive landscapeto 2026; Deallus Market research and forecast model 2018.

Arfolitixorin target patient populations and estimated market share- A large number of drug treated mCRC patients in 1st to 3rd line is expected to be treated with arfolitixorin

mCRC treated patient pool 7MM

372 000

US: 50%

22 500 Arfolitixorin market share 1st line

26 700 15 600About 65 000

mCRC patients eligible for arfolitixorintreatment in 1st line in the 7MM

EU531%

Japan42%

~ 9 months Average treatment length

Arfolitixorin market potential 1st line

16 000 Additional market share for arfolitixorin in 2nd-3rd line

24 000 19 000

Annual mCRC drug treated patient pool independent of 1st-3rd

treatment line

Arfolitixorin peak market share in 1st

line mCRC

About 60 000additional mCRC patients eligible for arfolitixorin

treatment in 2nd to 3rd line in the 7MM

>$1Bin annual market potential only in the 1st line treatment setting in the 7MM

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© ISOFOL MEDICAL AB (publ)Source: GlobalData 2017

Colorectal cancer market 2015 – 2025 (7MM)- Arfolitixorin expected to be used in 1st – 3rd line with peak market sales >$1B

VEGF inhibitorsAvastin, Zaltrap, Cyramza

1st and 2nd line Target population: 100%

CRC market 2025 - ~$3B

EGFR inhibitors Erbitux & Vectibix

1st and 2nd lineTarget population: ~40%


PD1/PD-L1 inhibitorsKeytruda & Optivo

1st and 2nd lineTarget population: 4%


Novel 3rd line drugsLonsurf & Stirvaga

3rd and 4th lineTarget population: 100%

CRC market 2025 - ~$500M

Arfolitixorin – Novel TS inhibition1st line trial (possible extension to 2nd and 3rd)

Target population: 100%

CRC market 2026 > $1B in first line alone

Approved drugs

Clinical development

31


GlobalData CRC report 2018 – 2028 for 8MM- Arfolitixorin is presented as one of the most promising pipeline drugs in the new CRC report by GlobalData

● Global sales in 2028 estimated to be 8,1BUSD in 8MM with anCAGR of 2,4% from 2018. China has the highest growth rate,CAGR 4,8%.

● Avastin will maintain leadership despite introduction of biosimilarswith decreased sales from 2,4BUSD in 2018 to 1,5BUSD in 2028

● Arfolitixorin is perceived as one of the most promising pipelinedrugs in CRC together with encorafenib (Braftovi).

● In US, EU and Japan, Global Data rate the launch of arfolitixorinas one of few events with major impact on the market.

● In the rating of the most important events the expected launch ofarfolitixorin in 2023 is expected to have a significant impact of themarket and perceived as a future leading brand.

Avastin

Clinical attributes

Low High

Com

mer

cial

att

ribut

es

High

Low

Pipeline candidates

Marketed drugs

Zaltrap

Cyramza

ArfolitixorinOpdivo + Yervoy

Keytruda

Erbitux

VectibixGRANITE-001

TS-1

LonsurfNapabucasin

Stivarga

Tucatinib

Vitrakvi

Note: Adapted from ”Figure 3: Competitive Assessment of the Late-Stage CRC Pipeline Agents” from GlobalData April 2020 CRC report.Bubble size represents approximate peak-year sales extimates for recently approved and late-stage pipeline drugs for the treatment of CRC.

Mektovi + Braftovi

Tafinlar + Mekinist

Isofol’s drug candidateArfolitixorin

32


Arfolitixorin is the only drug in late stage to improve SoC for all-comers

3rd-line or greater1st-line 2nd-line 3rd-line

Novel Immuno CRC Agent~4% of patients

Stat inh + SoCNo threat to Arfolitixorin

B-Raf/MEK inh10% of patients

Line extension projectsSmall fraction of fragile

patients

ARFOX vs mFOLFOX6+ bevAGENT

Very few late stage development projects in 1st or 2nd Line mCRC• IO projects targets 4% of patient population• Line extension project in a very small patient population• 2nd line projects in niche patient populations or on top of SoC

Arfolitixorin only drug in late stage to improve SoC and target all-comers

Current Phase III development landscape for mCRC Competitive analysis performed by Deallus Consulting

Source: Adapted from Oncology Resources Group , ONCrg Pipelines Strategies 2019. Deallus Primary Market research 2018

33

https://clinicaltrials.gov/show/NCT02563002



https://clinicaltrials.gov/ct2/show/NCT03869892

https://clinicaltrials.gov/ct2/show/NCT03869892


Breakthrough license agreement entered with Solasia Pharma K.K. to develop and commercialize arfolitixorin in Japan

Securing the Japanese market – the 2nd largest market for arfolitixorin

Strong validation from a specialized innovative oncology partner

Significant deal value – ~ USD 100 million as upfront and milestone payments

Tiered royalties on net sales in solid double-digit figures

Additional indications will be evaluated jointly by Solasia Pharma K.K. and Isofol

Solasia’s proven capabilities to develop and commercialize oncology treatments in Japan and other Asian markets as well as their commitment to cancer patients make them the ideal partner to support our development and commercialization

efforts in Japan

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Route to the market – Commercial plan

Active business development reach out to secure commercial partnerFocus on global partnering deal for RoW

Solid commercial forecast model established● Favorable competitive environment

● Pricing and market access analysis

● Commercial uptake analysis

Partnering● Japanese partner agreement secured August 2020

● Market preparations are initiated

Global commercial plan in development● Partnership with Syneos Health to support in commercialization

● Medical affairs activities initiated in major markets and medical communication platform

● Establishment of a Global commercial plan including life cycle management plans

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© ISOFOL MEDICAL AB (publ)Source: (1) GLOBOCAN 2018, Cancer Incidence and Mortality Worldwide. (2)GlobalData 2019, (3) Deallus Consulting December 2014, (4) Datamonitor gastriccamcer treatment tree Sruvery 2016, (5) Monocl Strategy Servoces Analysis 2016

Life cycle management - additional indications- Arfolitixorin can be used anywhere 5-FU is used and as rescue therapy after High Dose Methotrexate Treatment (HDMTX)

Pancreatic Cancer

Head & Neck Cancer

Gastric Cancer

Tripple Negative Breast CancerAdjuvant treatment setting• Almost 120 000 annual

Stage II/III patient treatments with 5-FU/LV in 7MM

Colorectal Cancer

Large cancer populations in which the current 5-FU/LV or capecitabine treatments can be optimized. Only for gastric and pancreatic cancer, the annual number of 5-FU/LV treated patients are about 63 000 in the 7MM

Suggested additional label expansions in combination with 5-FU Additional label expansions in HDMTX indications

Osteosarcoma

Burkitt’s Lymphoma PCNSLPrimary central nervous system lymphoma

About 33 000 patients in the 7MM are estimated to be treated with HDMTX followed by rescue therapy with reduced folates (LV/LLV)

ALLAcute Lymphoblastic Leukemia

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CMC and IPR

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Commercial grade manufacturing process in place

ACTIVE PHARMACEUTICAL INGREDIENT

arfolitixorin

Production technology patented by Merck

Use patents by Isofol

First large scale GMP batch completed and released summer 2017

First validation batch manufactured in February 2020

IP & SUPPLY AGREEMENTS WITH MERCK & CIE VALID AT LEAST UNTIL 2038

FINAL DRUG PRODUCT

LARGE SCALE DRUG MANUFACTURING SECURED

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Patent Type Region Expiry Status Patent holder

[6R]-MTHF Substance / Formulation USA 2037 Granted

Europe, Japan, China, etc. 2034 Granted in several regions including

Europe, Japan & China

MTHF Formulation USA 2029 Granted

Europe, Japan, Canada, etc. 2024 Granted

New clinical discovery Clinical treatment, dosage regimen

US, Europe, Japan, Canada, etc. 2038 Granted in US and Japan pending in

other regions

New clinical discovery Clinical treatment,dosage regimen

US, Europe, Japan, Canada, etc. 2038 Patent pending

New clinical discovery Gene Expression US, Europe, Canada and Australia 2035 Granted in US, pending in other regions

New clinical discovery Biomarker in blood US, Europe, Japan,Canada, etc. 2038 Granted in US, pending in other regions

New clinical discovery Clinical treatment, dosage regimen

US, Europe, Japan,Canada, etc. 2039 Patent pending

Intellectual property overview of main patents

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Organization

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ManagementJarl Ulf Jungnelius, MD

CEO

Sven Erickson, PhDChief Commercial Officer

Gustaf Albèrt, MSCChief Financial Officer, Vice CEO

Roger Tell, MD, PhDChief Medical OfficerChief Scientific Officer

Pär-Ola Mannefred, MBAChairman of the Board

Experience as aBoard memberand investments

Magnus Björsne, PhD, MBABoard Member

Paula BoultbeeBoard Member

Alain Herrera, MD, PhDBoard Member

Anna Belfrage, MBABoard Member

Bob Marchesani, MBABoard Member

Board of directors

Aram Mangasarian, PhD, MBABoard Member

Experienced Leadership

Over 20 years experiencein the biotechnology industry

Over 20 years of oncologycommercialization

Over 20 years of oncologysales & marketing

Over 20 years of oncology drug development experience

Over 20 years of businessdevelopment

Over 20 years of oncology drug development experience

Board certified Oncologist

Exclusive experience asa Board member with financial background

PhD in Experimental Oncology fromThe Karolinska Institute.

Master of Science in Economics andInternational Accounting and Auditing

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https://isofolmedical.com/?team=ulf-jungnelius-chairman-of-the-board

https://isofolmedical.com/?team=sven-erickson-md-2

https://isofolmedical.com/?team=gustaf-albert-msc

https://isofolmedical.com/?team=roger-tell-md-phd

https://isofolmedical.com/?team=par-ola-mannefred

https://isofolmedical.com/?team=magnus-bjorsne

https://isofolmedical.com/?team=paula-boultbees

https://isofolmedical.com/?team=dr-alain-herrera

https://isofolmedical.com/?team=anna-belfrage

https://isofolmedical.com/?team=sten-nilsson-md-phd-2

https://isofolmedical.com/?team=ulf-jungnelius-chairman-of-the-board

Key Milestones and Summary

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The arfolitixorin opportunity

Arfolitixorin

mCRC is a significant unmet medical need with no new treatment options for allcomers in over 16 years

[6R]-MTHF added to the cornerstone cytotoxic 5-FU more than doubles efficacy - arfolitixorin is [6R]-MTHF

Key Opinion Leaders active support in the development program

A $1B opportunity in 1st line mCRC only

Unprecedented low regulatory hurdle for approval in 1st line mCRC

Limited competition and few new drugs in development for 1st line mCRC, no branded products

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Isofol Medical AB (publ)

Biotech CenterArvid Wallgrens Backe 20SE-413 46 Göteborg, Sweden

[email protected]

Isofol Medical AB (publ)

Biotech CenterArvid Wallgrens Backe 20SE-413 46 Göteborg, Sweden

[email protected]

© Isofol Medical AB (publ) Company presentation, October 2020. ISO-44, rev4

October 2020 - Isofol

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Transcript of October 2020 - Isofol