Palvella Therapeutics, Inc. · NASDAQ:PVLA
Palvella Therapeutics — Pieris Pharmaceuticals — Merger or Acquisition (July 2024)
16 slides from Palvella Therapeutics's merger presentation, Jul 24, 2024
Slide 1: Merger Announcement
palvella THERAPEUTICS Merger Announcement July 24, 2024
Slide 2: Disclaimer
Disclaimer ‘out tis Presentation Forpurposes of thisnotice.the"Pesentation"thatfolwsshallmean sninlidethe sides hatfoiow,theorl presentation of thesis by members of management of Paves Therpeutes ne. (‘ates or Peis Phammaceutels,Ie-(Peris™ of any person on tal behal sy question or answer session tha
Slide 3: Disclaimer
Disclaimer Industry and Maret Data Patel o is may romtime oie provide extimates, projections and ote information concemig ts industry the gener business envionment and themarkts or eetain condition, incating estimate egsring ‘epatentatsize ofthore markets nd theetimated ieidence and prelancs of arin
Slide 4: Merger of Palvella Therapeutics and Pieris Pharmaceuticals
Merger of Palvella Therapeutics and Pieris Pharmaceuticals Creates clinical stage biopharmaceutical company focused on rare, genetic skin diseases * Palvella Therapeutics, Inc. intends to merge with Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS) + Combined company will focus on developing and commercia
Slide 5: Building the leading therapeutics company focused on rare genetic skin diseases
Building the leading therapeutics company focused on rare genetic skin diseases
Slide 6: What Sets Palvella Apart
What Sets Palvella Apart ae First-in-Disease Therapies Exclusively focused ‘on developing transformational therapies for rare diseases with no FDA approved treatments 9NQ ARare Team Team with proven history in building successful rare disease companies, including Insmed ® 4 Capital Efficiency Lean s
Slide 7: QTORIN Rapamycin: Ongoing Phase 3 Study to Support Potential FDA Regulatory Approval
QTORIN™ Rapamycin: Ongoing Phase 3 Study to Support Potential FDA Regulatory Approval Highly statistically significant Phase 2 results in Microcystic LMs 100% of patients (n=12) “much” or “very much” improved with QTORIN™ rapamycin on Clinician Global Impression of Change (p<0.0001) Ongoing Phase 3
Slide 8: QTORIN 3.9% Rapamycin Anhydrous Gel
OTORIN™ 3.9% Rapamycin Anhydrous Gel RAPAMYCIN Direct mechanistic engagement of causal mTOR pathway rorin™ 1000x higher rapamycin levels at site of disease vs. systemic rapamycin’ TOPICAL Lil ited-to-undetectable systemic absorption? atone" 49% rapanyen ‘nhyarous gel Granted U.S. patents through at
Slide 9: Microcystic Lymphatic Malformations: Serious, Debilitating, and Lifelong
Microcystic Lymphatic Malformations: Serious, Debilitating, and Lifelong Early onset: Presentat birth and significant impact to adolescents Lymphorrhea: Persistent discharge of lymphatic fluid through skin layers Genetics & Pathophysiology: ‘Somatic PIKSCA mutations cause hyperactivated PI3K/mTOR De
Slide 10: QTORIN Rapamycin: Phase 2 Study in Microcystic LM
QTORIN™ Rapamycin: Phase 2 Study in Microcystic LM n=12; QD dose @3:35@ James Treat,M.D. —_Joyce Teng, M.D., Ph.D. ‘Steve Kempers, M.D. Milton Waner, M.D. Alison Small, M.D. Children's Hospital mm Shir ‘School of or pniagelphis Stanford kin Care %Y MEDICINE Study Objectives: Safety and efficacy Resu
Slide 11: Phase 2: Clinically Meaningful, Statistically Significant Improvements
Phase 2: Clinically Meaningful, Statistically Significant Improvements & Measured Improvement (Absolute) = & & cGI-C + 2.42 (p<0.0001) at * | H H * * i * t H H H * i [| Week 4 Week 8 Week 12! Week 4 Week 8 Week 12 Clinician Global Patient Global Impression of Change Impression of Change + =p-value <
Slide 12: SELVA Phase 3 Study: Single-Arm, Baseline-Controlled
SELVA Phase 3 Study: Single-Arm, Baseline-Controlled n=40; QD dose Efficacy Evaluation Period Treatment Extension 24 weeks 24+ weeks ve Day 1 Baseline Primary Efficacy Photot Photo? Photo 3 Baseline (= 8 weeks) Primary Efficacy + mLM-IGA, a 7-point clinician change scale Datalanticipated Key Seconda
Slide 13: FDA Status: NDA Submission Planned for 2026
FDA Status: NDA Submission Planned for 2026' Completed Breakthrough Therapy Designation and End of Phase 2 meetings with FDA Seeking full FDA approval based on clinical endpoints od utilized in prospective Phase 2 and Phase 3 studies Breakthrough 505(b)(2) pathway leveraging prior FDA approvals of r
Slide 14: Market research (May 2024): Strong uptake in U.S. anticipated
Market research (May 2024): Strong uptake in U.S. anticipated Product X: topical 3. Percent of my 5 : Would you incorporate microcystic LM. baclanes fwoctd Product X into your clinical ictice? prescribe Product X: [priate Would you consider this as a firstline therapy 7 5 % for these patients? Do yo
Slide 15: Pipeline in a Product for mTOR-driven skin diseases
Pipeline in a Product for mTOR-driven skin diseases Potential 2029 U.S. launch anticipated, i Refractory Potential 2027 U.S. Ifapproved Capillary launch anticipated, Malformations if approved 15k + patients? Microcystic Cutaneous Refractory Lymphatic Venous Vascular Malformations Tumors Malformation
Slide 16: QTORIN Rapamycin: Ongoing Phase 3 Study to Support Potential FDA Regulatory Approval
QTORIN™ Rapamycin: Ongoing Phase 3 Study to Support Potential FDA Regulatory Approval Highly statistically significant Phase 2 results in Microcystic LMs 100% of patients (n=12) “much” or “very much” improved with QTORIN™ rapamycin on Clinician Global Impression of Change (p<0.0001) Ongoing Phase 3
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