H1-2021 Presentation 26th August 2021 - | Investor Presentation - Faron Pharmaceuticals
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H1-2021 Presentation 26 th August 2021 | Investor Presentation Faron Pharmaceuticals | Non-Confidential Information
Corporate Disclaimer The contents of this presentation have not been approved by an authorised person within the The contents of this presentation have not been independently verified. The contents of this meaning of Section 21 of the Financial Services and Markets Act 2000 (as amended) ("FSMA"). presentation are being supplied to you solely for your information and may not be reproduced, re- Reliance on the contents of this presentation for the purpose of engaging in any investment activity distributed or passed to any other person or published in whole or in part for any purpose. If this may expose an individual to a significant risk of losing all of the property or other assets invested. document has been received in error, it must be returned immediately to the Company. This presentation and the information contained herein regarding the Company are strictly confidential This presentation has been produced by Faron Pharmaceuticals Oy (the “Company” or “Faron”) and and are being shown to you solely for your information. The information may not be reproduced, has not been, and will not be, reviewed or approved by the Financial Conduct Authority of the distributed to any other person or published, in whole or in part, for any purpose. By receiving this United Kingdom (“FCA”), London Stock Exchange plc ("LSE"), the Finnish Financial Supervisory presentation, you become bound by the above-referred confidentiality obligation. Failure to comply Authority or any other authority or regulatory body. with such confidentiality obligation may result in civil, administrative or criminal liabilities. 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Risks include, but are not limited to, that early data from initial patients in the MATINS trial may not be replicated in larger patient numbers and the outcome of No undertaking, representation, warranty or other assurance, express or implied, is made or given clinical trials may not be favourable or clinical trials over and above those currently planned may be by or on behalf of Faron or any its respective directors, officers, partners, employees, agents or required before the Company is able to apply for marketing approval for a product. Faron expressly advisers or any other person as to the accuracy or completeness of the information or opinions disclaims any intention or obligation to update or revise any Forward-looking Statements whether as contained in this presentation and no responsibility or liability is accepted by any of them for any a result of new information, events or otherwise. 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The information by any person on behalf of the Company and any question-and-answer session that follows any such and opinions contained in this presentation are provided as at the date of this presentation and are oral presentation (collectively, the "Information"). By accepting this presentation, you agree to be subject to change without notice. bound by the foregoing instructions and limitations in respect of the Information. 2 Faron Pharmaceuticals | Non-Confidential Information
Faron is Focused on Building the Future of Immunotherapy A unique macrophage focused therapy targeting CLEVER-1 with demonstrated 1 single agent activity in multiple advanced solid tumors 30%+ clinical benefit positions macrophage-targeting Bexmarilimab to 2 change the treatment paradigm in difficult to treat cancers Favorable safety profile of Bexmarilimab allows for further expansion 3 and dose confirmation trials Worldwide rights to all indications for Bexmarilimab with strong 4 IP coverage through at least 2037 5 Multiple near-term value inflection points in the next 18 months for Bexmarilimab Other macrophage targets (e.g., CD47) attract significant attention from 6 investors and pharma companies Additional pipeline assets focused on organ protection and regenerative medicine 7 show early signs of preclinical and clinical efficacy 3 Faron Pharmaceuticals | Non-Confidential Information
Harness the Power of the Immune System Modulating the immune system is key to tackling cancer and inflammation Programs Phase of Development Anticipated Indication(s) (Target) Preclinical Phase 1 Phase 2 Phase 3 Key Milestones Immuno-Oncology Additional data to be presented at ESMO Solid Tumors (MATINS) Congress 2021 in September Pivotal cohorts to begin recruitment H1 ’22 NSCLC First-patient-in expected in Q4 ‘21 Bexmarilimab (MATINS-05 LUNG) (anti-CLEVER-1 mAb) Neoadjuvant in Solid Tumors First-patient-in expected in Q4 ‘21 (RENACOL) Hematological Malignancies First-patient-in expected in Q4 ‘21 (MATINAML) Phase 1 data in Q3 ’22 Organ Protection ARDS & COVID-19 First patient dosed August ‘21 (HIBISCUS) Traumakine (Intravenous IFN ARDS & COVID-19 beta-1a) Additional data expected in '21 (REMAP-CAP) Regenerative Medicine Hematological Malignancies Haematokine Anticipated IND submission in 2022 (A0C3 Inhibitor) Bone Marrow Failure 4 Faron Pharmaceuticals | Non-Confidential Information
Pipeline Highligths H1-2021 and post period • Bexmarilimab demonstrates compelling antitumor activity in multiple advanced solid tumor types in the completed Part I and ongoing Part II of the MATINS study • Strongest results were observed in cutaneous melanoma, gastric cancer, cholangiocarcinoma, and hepatocellular carcinoma, with a 30% - 40% disease control rate across these tumor types • Additional clinical trials are planned to start in Q4 2021 • Secured patents in the US and Japan protecting the composition of matter of bexmarilimab • Companion diagnostics (CDx) for Clever-1 detection in histological samples developed and validated with Laboratory Corporation of America (“Labcorp”) • Additional MATINS data accepted as LBA for presentation at ESMO Congress 2021 in mid-September • Traumakine® development accelerated for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. • Dosing commenced in the Phase II/III HIBISCUS trial – co-funded by US Department of Defense • Signed a sub-license agreement covering a relevant manufacturing patent in the US • Partnership established with the 59th Medical Wing of the U.S. Air Force and U.S. Army and U.S. Army Institute of Surgical Research to explore the use of Traumakine for organ protection in combat wounds • New manufacturing process is progressing as planned in collaboration with AGC Biologics. 5 | 08.26.21 Faron Pharmaceuticals | Non-Confidential Information
Financial Highlights 1 January – 30 June 2021 (unaudited) • Cash balances of €7.0 million at 30 June 2021 (2020: €11.6 million). • Operating loss of €10.4 million for the six months ended 30 June 2021 (2020: €7.1 million). The increase mainly driven by an additional €3.5m million in R&D expenses due to acceleration of the pipeline assets • Net assets of €2.8 million at 30 June 2021 (2020: €7.3 million). • Strengthened the balance sheet in February 2021 by raising €15 million gross (€14.4 million net) from new and existing shareholders through an issuance of 3,521,127 new ordinary shares. • Received $6.1 million commitment from the US Department of Defense (DoD) to support the HIBISCUS trial as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act 6 | 26 August 2021 Faron Pharmaceuticals | Non-Confidential Information
Bexmarilimab (anti-CLEVER-1 mAb) | Investor Presentation Faron Pharmaceuticals | Non-Confidential Information
A CLEVER Antibody: Outsmarting Cancer with Early Signs of Efficacy A unique macrophage focused therapy targeting CLEVER-1 1 with demonstrated single agent activity in multiple advanced solid tumors Favorable safety profile enables extensive combinations with 2 checkpoint inhibitors Opportunity to transform the treatment of cancers that are 3 not responsive to current treatment options Extensive IP Coverage through 2037 with further protection 4 being sought via regulatory designations 8 Faron Pharmaceuticals | Non-Confidential Information
Bexmarilimab Opportunity Benefiting those who do not respond to checkpoint inhibition CPIs were among the first drugs to significantly impact survival in metastatic melanoma and lung cancer, which were in-curable before The adoption of CPIs has occurred very quickly due to their success this in improving overall survival, despite poor response rates1 All Comers Responders 13% 87% Non-Responders Kaplan-Meier Curver from: KEYNOTE-407 Pembrolizumab and Chemotherapy for NSCLC 1) O’Connor et al. (2018) JAMA Oncol.;4(8):e180798. Paz-Ares. et al. (2018) NEJM. 379: 2040-2051 Pie Chart adapted from: Haslam and Prasad (2019) JAMA Netw Open. 2019 May; 9 2(5): e192535. Faron Pharmaceuticals | Non-Confidential Information
Macrophages: The Next Breakthrough in Oncology A poorly understood, but promising area of IO 1 Why Macrophages? Macrophages make up nearly 50% of cancer mass 7 • Macrophages promote tumor growth and metastases M2, but not M1 macrophages play a central role in promoting proliferation, colony formation, migration and treatment resistance 5 • Macrophages create a highly immunosuppressive environment • Targeting tumor associated macrophages (TAMs) has shown promising preclinical results 1,2 CRC • Continued evidence shows that macrophages are key in treatment resistance 3 • Repolarisation of pro-tumoral M2 macrophages to anti-tumor M1 macrophages causes a tumor suppressive effect 3,4 • Activating macrophages has shown to remove resistance against Melanoma the current regime of targeted therapies across indications 4,5,6 1) Jahchan et al (2019) Front Immunology. 10:1611 2) Cassetta and Pollard (2018) Nature Reviews: Drug Discovery 17(12) 887-904 3) Guerriero (2018) Trends in Molecular Medicine. 24 (5) 472-489 4) Duan & Luo (2021) Signal Trans and Targ. Ther. 6 (127) Tumors high in macrophages impede the entrance of effector T- 5) 6) Dong et al (2019) BJC. 121 22-33 Peranzoni et al (2018) PNAS. 115 (17) E4041-4050 cells limiting the effect of current checkpoints therapies 6 7) Vinogradov et al (2014) Nanomedicine. 9(5) 695-707 8) Virtakoivu et al. (2021) Clin Cancer Res June 2, 2021, DOI: 10.1158/1078- Tumor samples from MATINS Patients 8 0432.CCR-20-4862 10 Faron Pharmaceuticals | Non-Confidential Information
CDx (Companion Diagnostics) for Clever-1 Detection in Tissue Samples Significant milestone achieved • Clone identification and initial characterization • Protocol • Accuracy, Precision, Sensitivity, Specificity -> Laboratory Developed Test (LDT) is working, and clinical trial testing & feasibility assessment can be initiated • Next steps – Manufacturing capability for reagents/kits – Partnerships with IVD manufacturers – FDA submissions – Commercialization – Market access strategy, product launch and reimbursement strategy 11 | 08.26.21 Faron Pharmaceuticals | Non-Confidential Information
The Most Promising Macrophage Strategy: Reprogramming 1 Novel and diverse antibody with broad applicability Bexmarilimab CLEVER-1 Bexmarilimab is a humanised anti-CLEVER-1 IgG4 antibody currently in clinical trials • A large glycoprotein receptor that is expressed on the for solid tumors and expanding into hematological malignancies. 2 surface of immunosuppressive macrophages 2 Faron holds the worldwide rights to the Bexmarilimab program in all indications. • As a scavenger receptor it is known to bind to a wide range of Proposed mechanism of action ligands and therefore central to tissue homoeostasis and tolerance 2 • CLEVER-1 positive macrophages are highly immunosuppressive; high expression levels are only seen in cancer and pregnancy 3 • CLEVER-1 has been shown to be central to treatment resistance in both solid and liquid tumors alike 4,5,6,7 • CLEVER-1 is a multifaceted molecule with a major impact on tumor immune response 2 1) Li et al (2021) JITC. 9: e001341 2) Hollmen et al., (2020) BJC. 123. 501-509 3) Palani et al., (2011) Eur. J. Immunol. 41 2052-2063 4) Kwon et al., (2019) Head Neck. 41 2058-2064 Bexmarilimab 5) Yin et al., (2020) Oncol. Lett. 19(3)2404-2412 6) Dong et al (2019) BJC. 121 22-33 7) Lin et al (2019) Mol. Ther. Nuc. Acids. 18 476-484 12 Faron Pharmaceuticals | Non-Confidential Information
CLEVER-1: a Master T Cell Suppressor Tackling both immunosuppressive macrophages and soluble protein that inactivates T-cells Advanced cancer patients have elevated levels of Bexmarilimab CLEVER-1 macrophages and the soluble form Bexmarilimab inhibits soluble CLEVER-1 from interfering with the immunological synapse and T-cell activation, a tool for cancer to create systemic immune suppression 13 Faron Pharmaceuticals | Non-Confidential Information
Inhibition of CLEVER-1 Leads to Responses in Refractory Mice Models Macrophages are central to tumor growth and survival Silencing the STAB1 gene for CLEVER-1 shows a dramatic improvement in AML cell lines * * * 500 LLC 1 400 2 300 * * mm3 200 100 Tumors cannot grow in mice that do not have 00 5 10 15 CLEVER-1 positive macrophages 1 Days Anti-CLEVER-1 has single agent activity in anti-PD-1 refractory models such as LLC and B16 1,2 1) Viitala et al. (2019) Clin Cancer Res. 25(11) 2) Karikoski et al. (2014) Clin. Cancer Res. 20(24) 14 Faron Pharmaceuticals | Non-Confidential Information
Bexmarilimab’s Ability to Turn Cold Tumors Hot 23% of immune suppressed cancer patients show an IFNy response during dose finding Robust T-Cell Restoration of Pro-Inflammatory Mice 1 MATINS patient 2 Activation 2 IFNy Response 2 Pre- Wild Type Treatment IFNy Post- CLEVER KO Treatment Cytotoxic granzyme B positive CD8 T cells can be seen in green and red 1) Viitala et al. (2019) Clin Cancer Res. 25(11) 2) Virtakoivu et al. (2021) Clin Cancer Res June 2 2021 DOI: 10.1158/1078-0432.CCR-20-4862 15 Faron Pharmaceuticals | Non-Confidential Information
MATINS Trial Design and Rationale A first-in-human study in advanced solid tumors with high levels of macrophages Design Biology Milestones Macrophages are central for changing the Open-label Phase 1/2 adaptive clinical treatment paradigm in IO 1 trial in selected metastatic or inoperable solid tumors 5 Additional data from Phase 1/2 trial to be CLEVER-1 is a prognostic marker for multiple presented at ESMO Congress 2021 in solid tumors 2,3,4,5 Currently evaluating multiple doses September and frequencies including 1W, 2W and CLEVER-1 has multiple functions that are key to 3W dosing for optimal target coverage fighting tumors 1,6 First Pivotal Cohorts to begin recruitment H1 2022 Tumor-associated M2 macrophages can make Focus on advanced hard-to-treat solid up to 50% of the tumor mass 7 cancers with exhausted treatment options 5 Companion Diagnostics will be incorporated into the pivotal expansion of the cohorts into larger trials and larger indications where patient populations are very heterogenic. The current plan is to evaluate IHC, sCLEVER-1 and other T-cell activation markers. 1) Duan & Luo (2021) Signal Trans and Targ. Ther. 6 (127) 2) Kwon et al., (2019) Head Neck. 41 2058-2064 3) Yin et al., (2020) Oncol. Lett. 19(3)2404-2412 4) Zhao et al (2019) J. Canc. Res. & Clin. Onco. 145:3005-3019 5) Dong et al (2019) BJC. 121 22-33 6) Hollmen et al., (2020) BJC. 123. 501-509 7) Vinogradov et al., (2014) Nanomedicine. 9(5) 695-707 16 Faron Pharmaceuticals | Non-Confidential Information
A Dramatic Turnaround for Last Line Patients Overall survival in all MATINS patients Patients who are at the end of life have a significant survival benefit • In all comers, last line, unoptimized setting patients with cutaneous melanoma, gastric cancer, cholangiocarcinoma and hepatocellular carcinoma disease control was seen in up to 30 - 40% of patients 1,2 • Patients who benefit (PR or SD) from Bexmarilimab have 100% 6-month survival estimate 3 • Compared to 30% survival in non-responding patients • This almost doubled the survival of advance cholangiocarcinoma patients, when comparing to historical survival 4 • Progression free survival was the same in non-responding and Response to Bexmarilimab –treatment responding patients prior to treatment with Bexmarilimab Non-responders Responders Data available from company press release 1,2,3 1)Faron Pharmaceuticals Ltd (2021 May 17th) Bexmarilimab monotherapy shows promising anti-tumour activity in multiple advanced solid tumours. [Press release] https://www.faron.com/news- events/news-and-press-releases?rnsid=1476431&cid=2223 2) Faron Pharmaceuticals Ltd (2021 June 22nd) Updated corporate presentation 3) Faron Pharmaceuticals Ltd (2021 March 22nd) Bexmarilimab (Clevegen) development update. [Press release] https://www.faron.com/news-events/news-and-press-releases?rnsid=1462608&cid=2223 4) Smyth and Moehler (2019) Ther Adv Med Oncol. 17 | 26 August, 2021 Faron Pharmaceuticals | Non-Confidential Information
MATINS Phase I/II Top Line Data Safety and efficacy data from over 140 patients Top Line Efficacy Data Subsequent expansion and dose confirmation cohorts Response in based on the responses seen in first 10 target lesion (%) patients/indications include: Gastric cancer, cutaneous melanoma, cholangiocarcinoma and hepatocellular carcinoma *Part I patient with tumor shrinkage but hemorrhagic brain metastases leading to PD 18 of treatment EOT = end Faron Pharmaceuticals | Non-Confidential Information
Soluble CLEVER-1: a Master Regulator of T Cell Activation Bexmarilimab treatment downregulates major checkpoints PD-1 Levels in Patients What makes Bexmarilimab different? CD4 Cells Dosing Unique macrophage focused therapy to show signs of survival benefit in multiple advanced cancer types as a monotherapy Ability to specifically target and reprogram immunosuppressive M2 macrophages CD8 Cells Transformative effect on T cells by targeting macrophages; increasing T cell activity and improving their Level of active sCLEVER-1 during Bexmarilimab cytotoxic effectiveness treatment The downward trend in expression of major checkpoints aligns with the inhibition of soluble CLEVER-1 19 Faron Pharmaceuticals | Non-Confidential Information
Indications Chosen for MATINS Expansion Response Rates, Patient Populations and Annual Incidence Standard of Care and Bexmarilimab benefit in Refractory Annual Incidence 1 Refractory Population Population 10,11,12 USA: 98,000 5EU: 77,500 CPIs as standard of care at 1stL 30% Cutaneous Melanoma Japan: 13,000 60-70% refractory to 1stL 2,3 (3/10) China: 9,500 USA: 29,500 5EU: 54,000 3rdL approval 4 30% Gastric Cancer Japan: 140,500 80% refractory to 3rdL CPIs 5,6 (3/10) China: 478,500 USA: 10,500 1stL generic chemotherapy 5EU: 4,000 30% Cholangiocarcinoma No established 2ndL 7 Japan: 7,500 (3/10) 85% refractory to CPI treatment 8 China: 48,000 USA: 34 500 Recent approval 1stL SOC to Hepatocellular 5EU: 43 500 40% Atezolizumab–Bevacizumab (PD1-VEGF) Carcinoma Japan: 30 500 (4/10) 75% refractory to combo treatment 9 China: 167 500 1) GlobalData Epidemiology and Market Size Database 2) Asher et al (2020) Cancers. 12 (8) 2329; 3) Hamid et al (2019) Ann. Onco. 30(4) 582-588; 4) Le et al (2020) CCC. 19(1) 32-38; 5) Magalhaes et al (2018) Can J Gastro Hepatol 2018; 6) Brar and Shah (2019) Ther Adv Gastro 12; 7) Saeed et al (2019) CCR 18(2); 8) Guo and Shen (2020) Onco. Letters 20(6) 9) Finn et al (2020) NEJM. 382: 1894-1905 10)Faron Pharmaceuticals Ltd (2021 May 17th) Bexmarilimab monotherapy shows promising anti-tumour activity in multiple advanced solid tumours. [Press release] https://www.faron.com/news-events/news-and- press-releases?rnsid=1476431&cid=2223 11) Faron Pharmaceuticals Ltd (2021 March 22nd) Bexmarilimab (Clevegen) development update. [Press release] https://www.faron.com/news-events/news-and-press- releases?rnsid=1462608&cid=2223 12) Faron Pharmaceuticals Ltd (2021 June 22nd) Updated corporate presentation 13) xxxxxxx 20 | 08.26.21 Faron Pharmaceuticals | Non-Confidential Information
Bexmarilimab Clinical Development Plan in Solid Tumors Following the well-established path of other immuno-oncology drugs Today FDA Exploring meeting Pivotal Expansion BLA Dose Confirmation indications & doses Once Bexmarilimab has shown a potential therapeutic One or two doses will go into benefit in a given indication a final pivotal expansion as pre- Conditional approval multiple dose and frequency defined in an FDA meeting for indication expansion will be conducted An All Comers Platform Trial 29 patients/group 50 - 100 patients/group Investigating dose and frequency prior to moving it into pivotal expansion cohorts Promising cancers Up to 4 different doses 1 to 2 doses will be One dose for expanded from the & frequencies are evaluated in pivotal approval MATINS platform typically evaluated expansion Q3-2021 Q1-2022 2023 A similar strategy has been successfully utilised by major checkpoints, such as Keytruda, Opdivo and Yervoy Faron Pharmaceuticals | Non-Confidential Information
Bexmarilimab Clinical Development Plan Evidence based clinical trials to allow for registration 2021 2022 2023 2024 Sites Involved The MATINS Platform Trial 1,2 Comprehensive Cancer Centre Gastric Melanoma Solid tumors Cholangiocarcinoma Hepatocellular carcinoma Neo-adjuvant study in multiple indications 2 NSCLC in 1st line with a PD-1 inhibitor 2,3,4 Hematological malignancies Ph I/II AML & MDS 1,2 Pivotal Study in AML & MDS 2,4 1) Open label adaptive trials aiming to become pivotal studies 2) These trials are Faron’s future plans and therefore subject to changes depending on multiple factors 3) Investigator sponsored study design 4) RCT in combination with first line standard of care (SOC) Faron Pharmaceuticals | Non-Confidential Information
HOT or COLD Tumor - Can RENACOL Answer That? Testing neoadjuvant bexmarilimab treatment in localized renal cell and colon carcinoma Target: Localized renal cell and colon carcinoma prior surgical tumor removal Dosing: Single dosing 1-10 mg/kg (with option to go up 30 or 100 mg/kg) two weeks prior surgical operation Tumor analysis: Can we reinvigorate healthy immune system against cancer? • Pathological response (tumour necrosis) • Immune cell (T-cell) migration into the tissue • DC migration (collection of lymph nodes) • Gene expression in tissues • Efficacy (DFS; 1, 3 & 5 yrs) Safety: Focus on complications after surgery e.g., Bexmarilimab 25 mg/ml Checkpoint wound healing concenrate for solution inhibitors for infusion 23 | 08.26.21 Faron Pharmaceuticals | Non-Confidential Information
Faron is Focused on Building the Future of Immunotherapy A unique macrophage focused therapy targeting CLEVER-1 with demonstrated 1 single agent activity in multiple advanced solid tumors 30%+ clinical benefit positions macrophage-targeting Bexmarilimab to 2 change the treatment paradigm in difficult to treat cancers Favorable safety profile of Bexmarilimab allows for further expansion 3 and dose confirmation trials Worldwide rights to all indications for Bexmarilimab with strong 4 IP coverage through at least 2037 5 Multiple near-term value inflection points in the next 18 months for Bexmarilimab Other macrophage targets (e.g., CD47) attract significant attention from 6 investors and pharma companies Additional pipeline assets focused on organ protection and regenerative medicine 7 show early signs of preclinical and clinical efficacy 24 Faron Pharmaceuticals | Non-Confidential Information
Traumakine (Intravenous IFN beta-1a) | Investor Presentation Faron Pharmaceuticals | Non-Confidential Information
Interferon Beta Induces CD73 for Organ Protection An effective pharmacotherapy for producing anti-inflammatory adenosine Pro-inflammatory Anti-inflammatory Capillary Alveolus ATP AMP Adenosine Capillary CO2 O2 Alveolus Protein-rich fluid Normal CO2 O2 Red O2 CO 2 blood cells Red blood cells AMP Capillary leakage Leukocyte CD39 CD73 Adenosine Interferon CD73 Leukocyte β expression Maximising the upside potential of a blockbuster • In Comparison with Dexamethasone • First patient in Q3 2021 26 Faron Pharmaceuticals | Non-Confidential Information
HIBISCUS: A Phase 2/3 Co-funded by the Department of Defence Supporting Hospitalised COVID-19 Patients to prevent ARDS and admission to the ICU Phase 2 Phase 3 Interim Analysis Traumakine better than Adjust dexamethasone powering according to interim results Require No and continue Mechanical Randomization Interim Analysis enrolment Ventilation at 70 Patients ? 1:1 COVID-19 patients Traumakine: Yes needing hospitalization Dexamethasone and supplemental Patient requires oxygen Stop the trial steroids and is for futility excluded from the trial The HIBISCUS Trial in the US: Primary end-point: Clinical Status at D14 Fueillet et al. 2021 An RCT, which aims to prove the superiority Secondary end-points: Mortality at D28, ICUfree days at D28, Ventilation free Days of Traumakine against current standard of care (dexamethasone) when given early in Size of Phase II: 140 patients hospitalized COVID-19 patients who do not The use of steroids concomitantly is not allowed, but steroids can be used after IFN beta yet require mechanical ventilation The first COVID trial to assess the sequenced use of two immunomodulatory agents (IFN beta & steroids) 27 | 26 August 2021 Faron Pharmaceuticals | Non-Confidential Information
Corporate Highlights | Investor Presentation Faron Pharmaceuticals | Non-Confidential Information
A push towards approval 1 Single agent activity in multiple solid tumors which are refractory to standard of care 2 We see a significant clinical benefit in an all comers setting 3 HCC 1st line recent SOC with 75% refractory to combo treatment 4 2nd Line Melanoma is forecast to be 1 Bn by 2026 from 20,000 patients 3rd Line Gastric is likely to have a CAGR of 600% in Western Markets 5 over the next 5 years with 22% ORR Cholangiocarcinoma currently has a limited market size 6 due to no innovative drug approval CPIs have been approved with similar sized trials (Approx. n. 100-200 patients) 7 with low ORR (10-20%) 29 Faron Pharmaceuticals | Non-Confidential Information
Multiple Near-Term Catalysts For Bexmarilimab Discovery of Soluble CLEVER CMC Commercial Scale Preparation Topline data from MATINS Phase 1 Dramatic Survival Benefit was seen in responding patients Selection of Expansion Cohorts (Gastric, Melanoma and Cholangiocarcinoma) Key Intellectual Property (Confirmation of Matter) Awarded Major Publication of Phase 1 Data in Clinical Cancer Research Additional data release on MATINS solid tumors in Q3 ’21 Confirmation of final dosage and frequency for pivotal expansion FDA Meeting for pivotal expansion Pivotal cohorts to begin recruitment in H1 ’22 First-patient-in for neo-adjuvant (RENACOL) study in Q4’21 First-patient-in for hematological malignancies in Q4’21 Phase 1 data in Q3 ’22 Investigator Initiated trials to begin Anti-PD-1 combination 30 | 26 August 2021 Faron Pharmaceuticals | Non-Confidential Information
And Across Entire Pipeline CMC Commercial Scale Preparation HIBISCUS first patient dosed Traumakine Interim analysis Poster Presentation at Military Health System Research Symposium REMAP-CAP Interim Readout Organ protection data release with the DoD Ongoing pre-clinical studies with humanized AOC3 mice and with ex vivo human cells Haematokine Clinical Development plan to be announced Anticipated IND submission in 2022 31 | 26 August 2021 Faron Pharmaceuticals | Non-Confidential Information
Thank you | Investor Presentation Faron Pharmaceuticals | Non-Confidential Information
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