Appili Therapeutics Inc Class A · TSXV:APLI.H
Appili Therapeutics Inc Class A — Investor Presentation (October 2024)
25 slides from Appili Therapeutics Inc Class A's investor presentation, Oct 1, 2024
Slide 1: Appili Therapeutics Inc. Corporate Deck
Appili Therapeutics Inc. TSX: APLI / OTCPink: APLIF CORPORATE DECK
Slide 2: Disclaimer and Forward-Looking Statements
DISCLAIMER AND FORWARD-LOOKING STATEMENTS Disclaimer This presentation is for information only and shall not constitute an offer to buy, sell, issue or subscribe for, or the solicitation of an offer to buy, sell or issue, or subscribe for any securities in any jurisdiction. This document contains ce
Slide 3: Novel Anti-Infectives Company Driving Long-Term Value
NOVEL ANTI-INFECTIVES COMPANY DRIVING LONG-TERM VALUE Commercial-stage anti-infectives / biodefense pipeline, anticipating milestones & royalties in 2024 ~ $100M invested (~$38M Non-Dilutive) Two programs potentially eligible for Priority Review Vouchers from FDA Proven leadership team 3
Slide 4: Pipeline Snapshot
PIPELINE SNAPSHOT LIKMEZTM, novel oral taste-masked ATI-1701, potential first-in-class live- ATI-1801, novel topical antiparasitic suspension of metronidazole to treat attenuated vaccine for tularemia, a serious product to treat disfiguring skin infections serious anaerobic and protozoal infections
Slide 5: Priority Review Voucher (PRV) $123M
PRIORITY REVIEW VOUCHER (PRV) 2022+ Disclosed Transactions Seller Buyer Price 36+ PRV Sales Since Program Inception Undisclosed $110M $123M Average PRV Sale Price (range from $67.5 to $350M) Undisclosed $110M $110M • ATI-1701* and ATI-1801 may be eligible for PRVs $100M • PRVs allow holder to accele
Slide 6: ATI-1701 Tularemia Vaccine
ATI-1701 Tularemia Vaccine 6
Slide 7: ATI-1701: Biodefense Vaccine with ~14M in DoD Funding
ATI-1701: BIODEFENSE VACCINE WITH ~14M IN DOD FUNDING Opportunity • Francisella tularensis is a top priority biothreat • 1,000X more infectious than anthrax - highly lethal • No FDA approved vaccine available Solution • ATI-1701 is a novel, live-attenuated tularemia vaccine candidate Unique Developm
Slide 8: Demonstrated Efficacy in Non-Clinical Studies
DEMONSTRATED EFFICACY IN NON-CLINICAL STUDIES ATI-1701 protective against lethal aerosolized F. tularensis challenge and superior to LVS in cynomolgus macaques 28 Days Post Vaccination 90 Days Post Vaccination 100 100 ATI-1701 (n=11) ATI-1701 (n=6) Percent Survival Percent Survival 75 75 LVS (n=7) P
Slide 9: Development Path and Funding
DEVELOPMENT PATH AND FUNDING USAFA (DTRA) funding of ~ $14M reaffirms DoD commitment to ATI-1701 through IND • US Air Force Academy (Prime Contractor) and Appili (Top Tier Contractor) are driving ATI-1701 development through IND • IND late 2024 / Phase 1 start in late 2025 / early 2026 Initiate clin
Slide 10: Market Opportunity for Biodefense Vaccine
MARKET OPPORTUNITY FOR BIODEFENSE VACCINE Substantial stockpiling opportunities expected before approval Potential Military Use (NATO +) Stockpiling Benchmarks • Tularemia weaponized since mid 1900s; Iran, North Korea and Russia may stockpile • SIGA (2018): Up to $629M for 1.7M courses of smallpox a
Slide 11: ATI-1801 Topical Treatment for Cutaneous Leishmaniasis
ATI-1801 Topical Treatment for Cutaneous Leishmaniasis 11
Slide 12: Cutaneous Leishmaniasis (CL) Has Significant Unmet Need
CUTANEOUS LEISHMANIASIS (CL) HAS SIGNIFICANT UNMET NEED Opportunity: CL is a common and disfiguring disease without appropriate treatment options • Leishmaniasis is an obligate intracellular parasite that • Most common in Latin America, Middle East, North is transmitted to humans by sandfly bites Af
Slide 13: ATI-1801: Novel Topical Treatment for CL
ATI-1801: NOVEL TOPICAL TREATMENT FOR CL Day 1 Day 20 Day 168 Solution ATI-1801 Administration • Easy-to-use topical cream formulation of paromomycin • Repurposed drug (approved for intestinal amebiasis in 1960s) • Potent activity against New World and Old-World species of leishmaniasis • Low clinic
Slide 14: Pathways to Monetize ATI-1801
PATHWAYS TO MONETIZE ATI-1801 FDA approval path could lead to PRV and then open up Prequalification Path CDMO Tech Transfer initiates the next steps • Regulatory Approval • Prequalification of Medicines Program – Bridging study likely required to – Established to provide high quality link to prior e
Slide 15: LIKMEZ Taste-Masked Liquid Metronidazole
LIKMEZ TM Taste-Masked Liquid Metronidazole 15
Slide 16: LIKMEZ Metronidazole Oral Suspension
LIKMEZ TM METRONIDAZOLE ORAL SUSPENSION LIKMEZTM , Metronidazole Oral Suspension 500mg/5mL approved by FDA in September 2023. • LIKMEZ is a novel oral taste-masked suspension of metronidazole to treat serious anaerobic and protozoal infections. • LIKMEZ is the first FDA approved oral liquid form ava
Slide 17: LIKMEZ Solution and Out-Licensing Deal
LIKMEZ TM METRONIDAZOLE ORAL SUSPENSION Solution • LIKMEZTM , only liquid oral suspension of metronidazole approved in the U.S • Solves significant issue for patients who cannot tolerate the current tablet formulation Out-licensing deal brings income streams to Appili • License agreement with Saptal
Slide 18: Upcoming Milestones
Appili Therapeutics Inc – Proprietary and Confidential • USAFA Award expected to UPCOMING MILESTONES enable us to advance ATI-1701 to IND • Requesting FDA meeting to discuss ATI-1801 previously generated Phase 3 data and agree on the necessary registration package to support NDA • Expect to receive
Slide 19: Diversified Pipeline Driving Near- and Long-Term Value
DIVERSIFIED PIPELINE DRIVING NEAR- AND LONG-TERM VALUE Regulatory Program Partners Discovery Preclinical Phase I Phase II Phase III Submission / Approval Animal Rule 2028 / Complete Ongoing 2024 2024 2026 Pivotal animal studies ATI-1701 replace pivotal human studies 2029 Tularemia Vaccine (Biodefens
Slide 20: Skilled Management Team to Deliver Portfolio Value
SKILLED MANAGEMENT TEAM TO DELIVER PORTFOLIO VALUE DON CILLA, PHARMD, MBA PRESIDENT AND CHIEF EXECUTIVE OFFICER KENNETH HOWLING 30+ years drug development ACTING CHIEF FINANCIAL OFFICER experience, including clinical, clinical 25+ years of financial management pharmacology and program leadership and
Slide 21: Appili Management Team Has Substantial Experience
APPILI MANAGEMENT TEAM HAS SUBSTANTIAL EXPERIENCE Access to DON CILLA, PHARMD, MBA Key Consultants PRESIDENT AND CHIEF EXECUTIVE OFFICER • Over 140 years of cumulative pharma experience - Regulatory • Worked in 22 other biotech / (Leona Saunders) KENNETH HOWLING ACTING CHIEF FINANCIAL OFFICER pharma
Slide 22: Board of Directors
BOARD OF DIRECTORS LT COL ARMAND BALBONI, MD, PHD, JD CHAIR BRIAN BLOOM MEMBER Extensive drug development experience Chairman and CEO of Bloom Burton & Co, in civilian, academic, and military 20+ years of capital market experience organizations PRAKASH GOWD, MBA, PHARM, CDIR THERESA MATKOVITS, PHD M
Slide 23: Financial Overview and Capital Structure
FINANCIAL OVERVIEW AND CAPITAL STRUCTURE FINANCING (As of June 30, 2023) CAPITAL STRUCTURE (As of June 30, 2023) Capital Raised: • $102.9M raised in total 121.3M Common shares outstanding ‐ $58.0M in equity 58.2M Warrants ‐ $ 7.0M in debt (Long Zone Holdings) 7.8M Options ‐ $37.9M in government assi
Slide 24: Novel Anti-Infectives Company Driving Long-Term Value
NOVEL ANTI-INFECTIVES COMPANY DRIVING LONG-TERM VALUE Commercial-stage anti-infectives / biodefense pipeline, anticipating milestones & royalties in 2024 ~ $100M invested (~$38M Non-Dilutive) Two programs potentially eligible for Priority Review Vouchers from FDA Proven leadership team 24
Slide 25: Contact
CONTACT For more information contact: Don Cilla, PharmD, MBA, President and CEO +1 902.442.4655 ext #1 dcilla@appilitherapeutics.com www.appilitherapeutics.com 25 25
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