Hepion Pharmaceuticals, Inc. · OTC:HEPA
Hepion Pharmaceuticals — Merger or Acquisition (July 2024)
28 slides from Hepion Pharmaceuticals's merger presentation, Jul 22, 2024
Slide 1: Pharma Two B and Hepion Pharmaceuticals Merger Announcement
Pharma Two B To be better 2 §* HEPION PHARMACEUTICALS Merger Announcement July 22, 2024
Slide 2: Disclaimer
ee a a Disclaimer ‘Ths presentation [ths "Presentation" is for Informational purposes only to assist interested partesin makinastheir ow evaluation with fespoct to the proposed business combination {the “Business Combination’ between HHopion Pharmaceuticals, ne. (Hepion") ard Pharma Two B Lic [Pha/m
Slide 3: Disclaimer (Cont.)
ee a aN Disclaimer (Cont.) No offeror Solicitation ‘This communication doos not constitute an offer to sel ora solicitation of an offer to buy oF the solication of ary vate or approual in ary jurisdiction in connection with the proposed Business Combination or any related, ‘yansactions, nor shallthe
Slide 4: Merger of Pharma Two B and Hepion Pharmaceuticals
a Merger of Pharma Two B and Hepion Pharmaceuticals Transaction Summary + Pharma Two B intends to merge with Hepion Pharmaceuticals (Nesdag: HEPA) + Hepion has entered into e purchase agreement with institutional investors for the purchase of an interest-free $29M senior unsecured note (with $400k o
Slide 5: Management Team
Management Team Extensive experience in Parkinson’s Disease £ BbB9O6 Dan Teleman Irit Zalayet Hadas Friedman Pninit Litman a Zaksh Cheryl Fitzer-Attas MSCMBA PA MA in Lh vP Clinical " Director of PhD, MBA ' CEO Law VP QA, RA Operations CMe Head of Medical Affairs 2. teva «vcr @& oe nae, i Boehringer
Slide 6: Corporate Overview
Corporate Overview Pharma Two Bis a private, late-stage company that is developing 28001, an innovative combination product candidate in development for the treatment of Parkinson's Disease (PD) that has the potential to become a first line treatment in early to moderate PD. Ina Phase 3 clinical tri
Slide 7: Treatment Algorithm for PD
Treatment Algorithm for PD MAO-B inhibitors and/or dopamine agonists are first line therapies for PD patients L-Dopa Y High Efficacy X Motor Complications early moderate X Convenience Dopamine Agonists (DA) Y Adequate Efficacy and/or and/or and/or X Dopaminergic Side Effects* ‘Apome or X Convenience
Slide 8: P2B001 - A Novel, Proprietary Product
P2B001 - A Novel, Proprietary Product Designed to Potentially Improve Efficacy, Safety and Convenience, as Compared to Current Standard of Care Two Important Modifications Ural once-toy 1, Low Doses of Pramipexole 0.6mg combination of ow doses 3 inhibitor and Rasagiline 0.75mg - not and extende/-lea
Slide 9: Phase III Trial Design
Phase III Trial Design* Trial enrolled 544 patients at 70 clinical centers A 12-week, multi-center, multinational, randomized, double-blind, double-dummy, active-controlled, parallel group clinical trial Titration* Maintenance 2week safety/ phase phase down titration Week 1 67 2 phase Key inclusion
Slide 10: P2B001 Successfully Met its Primary and Secondary Endpoints
P2B001 Successfully Met its Primary and Secondary Endpoints* v Primary endpoint Change from baseline to Week 12 in UPDRS Total score (sum of Parts I] and Ill) between P2BO01 and each of its components: * PPX 0.6 mg + RAS 0.75 mg -Olano et al 2023 Secondary endpoints (hierarchical gate-keeping method
Slide 11: P2B001 vs Components
P2B001 vs Components* Primary Endpoint: Total UPDRS (Parts II + III) Change in UPDRS Total (Parts II+III) score P2B001 difference in LSM of change from baseline to Week 12 95% Cl: ~4.33, -1.00; p=0.0018 P2B001 Vs RAS 0.75: -3.30; 95% Cl: ~4.96, -1.63; p=0.0001 in UPDRS Total score LS mean (SE) chang
Slide 12: P2B001 Comparable Clinical Activity to PramiER with Less Daytime Sleepiness
In Phase 3 - P2B0O01 Treatment Resulted in Comparable Clinical Activity to PramiER on Improving Symptoms of PD, with Significantly Less Daytime Sleepiness** Change in UPDRS Total (Parts IlsilI) score a 5 8 2 Week e-P28001 (n=147) —e PramiER (n=72) Change in ESS* Total score 1 5 8 12 Week —e P2B001 1
Slide 13: Percentage Responders on UPDRS Total Score
Percentage Responders on UPDRS Total Score P2B001 was comparable to PramiER on UPDRS responders (24 points) UPDRS Total responder at Week 12 4 80 P P2B001 difference in e odds ratios at Week 12 5 , z H 75.8 143 H , § 70 H Versus PramiER: 87; 3 H 95% Cl: 0.44, 1.75; p=0.7040 E 8 0 H Versus PPX 0.6: O
Slide 14: P2B001 Demonstrated Significantly Less Excessive Daytime Sleepiness Compared to PramiER
P2B001 Demonstrated Significantly Less Excessive Daytime Sleepiness Compared to PramiER* ESS >10 considered as excessive day time sleepiness™ Shift Analysis . . % Subjects with ESS Score <=10 at Baseline to >10 Post Baseline % subjects with ESS score <10 at baseline was similar between groups (81.4%
Slide 15: Dopaminergic Adverse Events Reduce Patients Quality of Life and Cause High Economic Burden
Dopaminergic Adverse Events Reduce Patients Quality of Life and Cause High Economic Burden + Excessive Daytime Sleepiness (EDS) affects 16%-55% of PD patients - Reduced daily functioning and cognition, increased work absenteeism and risk of heavy machinery and road traffic accidents - DAs significan
Slide 16: P2B001 Showed Less Dopaminergic-Related TEAEs Compared to PramiER
P2B001 Showed Less Dopaminergic-Related TEAEs Compared to PramiER Throughout the Entire Trial Temporality of dopaminergic-related TEAEs —P2B001 (n-150) —PPX 0.6 (n=148) 2. —RAS 0.75 (n=147} 20 16 —PramiER (n=74) a 4 oo 2 4 4 50 6 7 80 ff 20 10 reatment day, ‘elated TEAE Percentage of patients with e
Slide 17: P2B001 Showed Lower Incidence of Dopaminergic-Related TEAEs vs PramiER
P2B001 Showed Lower Incidence of Dopaminergic-Related TEAEs vs PramiER* (Incidence of TEAEs occurring in =2% of patients) P2B001 PPX 0.6 RAS 0.75 PramiER (n=150) (n=148) (n=147) (n=74) At least one TEAE 67 (44.7%) 72 (48.6%) 50 (34.0%} 49 (66.2%) =) Nausea 28 (18.7%) 24 116.2%) 10 (6.8%) 17 (23.0%)
Slide 18: P2B001 Value Proposition and Market Opportunity
P2BO01 Value Proposition and 2 Market Opportunity
Slide 19: P2B001 is Targeting Early to Moderate PD Patients, ~80% of the Market
P2B001 is targeting Early to Moderate PD patients, reflecting an ~80% of the market Parkinson’s Disease patient therapy by age group and disease stage" Percent of survey respondents (n=97) 00 )\Any other menctherapy ‘Any other combination therapy MAO-B inhibitor menetherapy 80 Dopamine agonist + MAO
Slide 20: Dopamine Agonists and MAO-B Inhibitors in US
Dopamine Agonists (DA) and MAO-B Inhibitors in US Estimated Market Value ~$2.4B by 2029 DAs ~33 % of US Sales DAY $2.1B 33% US sales us. 2029 Current DAs $1.47B /57 % of [*| MAO-B US Sales us. $038 MAO-B $0.38 2020 2029F $ ‘Source: Bloomberg Symphony; Analyst reperts (GlobalData, GM Insights, Verifi
Slide 21: U.S. Base Case Net Revenue Expected to Reach ~$558m by 2031
U.S. only: in the base case, P2B001 is expected to reach a non-risk adjusted net revenue of ~ $558m by 2031 500 558 523 Bard 400 439 Patent 300 expity 326 W 200 210 100 ° 29F «30F «= 31F —32F 24F 25F 26F 27F = 28F 33F ‘Thousands of patients prescribed P2801 after competitive and market access adjust
Slide 22: P2B001 Ahead of Competition in Early PD
P2B001 Ahead of Competition in Early PD Molecule Company Class/Form Phase Status Combination of P2B001 PharmaTwoB DA&MAO-B Pre-Reg Successfully completed Phase 3 Oral D1,D5 selective Tavapadon —_Cerevel DAcoeal Phase 3 Phase 3 ongoing Tavapadon’s emerging clinical profile includes potential adverse
Slide 23: Potential Label Expansion
Potential Label Expansion P2B001 has the potential to reduce the risk of motor complications with Levodopa - May delay the need for start of levodopa by expanding the treatment duration: A Phase 3, Randomized, Double-blind, Double Dummy, Parallel groups, Long Term Clinical Trial to Compare the Abili
Slide 24: Projected Drug Developmental Timeline
Projected Drug Developmental Timeline Closing - NDA Combined Submission ‘company 12026 Q2 2024 _Q32024 _Q42024 _Q12025 _Q22025 _Q32025 _Q4 2025 12026 Process development GMP batches production (cmc) Estimated s
Slide 25: Summary of Balance Sheet
ee a a Summary of Balance Sheet September 30, 2023 December 31, 2022 $ in thousands Current assets 2,825 6,086 Non-current assets 3 66 Total assets 2,828 6,152 Current liabilities 760 2,116 Non-current liabilities 5,757 5,757 Shareholders’ equity (deficit) (3,683) (1,718) Total liabilities and share
Slide 26: Summary of Statement of Operations
ee Se a Summary of Statement of Operations For the nine For the year ended months ended December 31, September 30, 2022 2023 $ in thousands Research and development expenses - net (1,052) 6.551) General and administrative expenses 3 (2,743) Operating loss (1,021) 8,294) Financial income, net 143 122
Slide 27: Robust Intellectual Property
Robust Intellectual Property “Pharmaceutical Compositions for Treatment of Parkinson's Disease” Scope: Combination of pramipexole and rasagiline in sub-therapeutic doses Granted US, EU, Japan and more In force until 2029 “Fixed Dose Combination Therapy of Parkinson's Disease” Scope: Combination of p
Slide 28: Value Proposition
Pharma Two B Value Proposition FO} Addresses a Major Unmet Need € Pil Targets Large and Growing PD Population & Goal to Become 1* Line of Treatment for Early to moderate PD Well protected by patents to 2033 Total capital raised - $70M NDA expected in 1H 2026 Licensing partnerships in place in China
Hepion Pharmaceuticals — Merger or Acquisition (July 2024) on 6ix