Appili Therapeutics Inc Class A · TSXV:APLI.H
Appili Therapeutics Inc Class A — Investor Presentation (March 2023)
22 slides from Appili Therapeutics Inc Class A's investor presentation, March 2023
Slide 1: Appili Therapeutics Inc.
Appili Therapeutics Inc. TSX: APLI / OTCQB: APLIF MARCH 2023
Slide 2: Disclaimer and Forward Looking Statements
Appili Therapeutics Inc – Proprietary and Confidential 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 se
Slide 3: Novel Anti-Infectives Company Driving Long-Term Value
NOVEL ANTI-INFECTIVES COMPANY DRIVING LONG-TERM VALUE Late-Stage anti-infectives / biodefense pipeline anticipating milestones / royalties in 2024 ~ $90M Invested (~$35M Non-Dilutive) Two programs potentially eligible for Priority Review Vouchers Proven leadership team 3
Slide 4: 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 5: Priority Review Voucher (PRV)
Appili Therapeutics Inc – Proprietary and Confidential PRIORITY REVIEW VOUCHER (PRV) Appili programs ATI-1701 and ATI-1801 may be eligible for priority review vouchers 33+ PRV Sales Since Program Inception 33+ PRV Sales Since Program Inception • PRVs allow holder to accelerate FDA review of any NDA
Slide 6: ATI-1701 Tularemia Vaccine
ATI-1701 Tularemia Vaccine
Slide 7: ATI-1701: Biodefense Vaccine Program
Appili Therapeutics Inc – Proprietary and Confidential ATI-1701: BIODEFENSE VACCINE PROGRAM Department of Defense is investing ~ $14M to advance ATI-1701 to IND stage Opportunity • Francisella tularensis is top priority biothreat, 1,000X more infectious than anthrax, highly lethal, and easily lyophi
Slide 8: Demonstrated Efficacy in Non-Clinical Studies
Appili Therapeutics Inc – Proprietary and Confidential DEMONSTRATED EFFICACY IN NON-CLINICAL STUDIES DTRA was the source of funding for prior studies and the source of current funding ATI-1701 protective against lethal aerosolized F. tularensis challenge and superior to LVS in cynomolgus macaques 28
Slide 9: Recent Expansion in DoD Funding
Appili Therapeutics Inc – Proprietary and Confidential RECENT EXPANSION IN DOD FUNDING DTRA funding of over $14M reaffirms DoD commitment to ATI-1701 to drive program forward • IND / Phase 1 start in late 2024 / early 2025 • With continued funding Appili plans to file a BLA in 2028 Public / Private
Slide 10: Market Opportunity for Biodefense Vaccines
Appili Therapeutics Inc – Proprietary and Confidential MARKET OPPORTUNITY FOR BIODEFENSE VACCINES Substantial stockpiling opportunities expected before approval Civilian Stockpiling (US) Stockpiling Benchmarks • Strategic National Stockpile (SNS) to secure medical counter measures for US civilians •
Slide 11: ATI-1801 Topical Treatment for Cutaneous Leishmaniasis
ATI-1801 Topical Treatment for Cutaneous Leishmaniasis
Slide 12: Cutaneous Leishmaniasis (CL) Has Significant Unmet Need
Appili Therapeutics Inc – Proprietary and Confidential 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 • WHO estimates 700K to 1.2M cases / yr
Slide 13: ATI-1801: Novel Topical Treatment for CL
Appili Therapeutics Inc – Proprietary and Confidential ATI-1801: NOVEL TOPICAL TREATMENT FOR CL Solution • Easy-to-use topical cream formulation of • Low clinical risk – positive results in several paromomycin Phase 2 and 3 studies • Repurposed drug (approved for intestinal • USAMMDA developed ATI-1
Slide 14: Parallel Pathways to Monetize ATI-1801
Appili Therapeutics Inc – Proprietary and Confidential PARALLEL PATHWAYS TO MONETIZE ATI-1801 Premarket access is quickest path while FDA approval path leads to PRV Selecting a CDMO and transferring manufacturing process initiates the next steps • Prequalification of Medicines Program • Regulatory A
Slide 15: ATI-1501 Taste-Masked Liquid Metronidazole
ATI-1501 Taste-Masked Liquid Metronidazole
Slide 16: Taste-Masked Liquid Metronidazole
Appili Therapeutics Inc – Proprietary and Confidential TASTE-MASKED LIQUID METRONIDAZOLE Opportunity • Metronidazole is a front-line anti-infective that is used to treat anaerobic and microaerophilic bacterial infections and protozoal infections • It is heavily prescribed in US with 10M+ oral Rx but
Slide 17: Taste-Masked Liquid Metronidazole
Appili Therapeutics Inc – Proprietary and Confidential TASTE-MASKED LIQUID METRONIDAZOLE Solution • ATI-1501 is a proprietary, taste-masked metronidazole suspension • Bioequivalent to metronidazole tablets (fasted and fed) • Clear taste preference over crushed tablets suspension Out-licensing deal b
Slide 18: Skilled Management Team
Appili Therapeutics Inc – Proprietary and Confidential SKILLED MANAGEMENT TEAM DON CILLA, PHARMD, MBA KENNETH HOWLING PRESIDENT AND CHIEF EXECUTIVE OFFICER ACTING CHIEF FINANCIAL OFFICER C 30+ years drug development experience, including clinical, clinical pharmacology and 25+ years of financial man
Slide 19: Board of Directors
Appili Therapeutics Inc – Proprietary and Confidential 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
Slide 20: Financial Overview and Capital Structure
Appili Therapeutics Inc – Proprietary and Confidential FINANCIAL OVERVIEW AND CAPITAL STRUCTURE FINANCING (As of September 30, 2022) CAPITAL STRUCTURE (As of September 30, 2022) Capital Raised: 121.3M Common shares outstanding • $91M raised in total 49.8M Warrants ‐ $57.0M in equity 8.3M Options ‐ $
Slide 21: Novel Anti-Infectives Company Driving Long-Term Value
NOVEL ANTI-INFECTIVES COMPANY DRIVING LONG-TERM VALUE Late-Stage anti-infectives / biodefense pipeline anticipating milestones / royalties in 2024 ~ $90M Invested (~$35M Non-Dilutive) Two programs potentially eligible for Priority Review Vouchers Proven leadership team 21
Slide 22: Contact
Appili Therapeutics Inc – Proprietary and Confidential CONTACT For more information contact: Don Cilla, PharmD, MBA, President and CEO +1 902.442.4655 ext #1 [email protected] www.appilitherapeutics.com 22
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