Innovation Pharmaceuticals Inc. · OTC:IPIX
Innovation Pharmaceuticals — Technical Presentation (July 2017)
23 slides from Innovation Pharmaceuticals's technical presentation, Jul 13, 2017
Slide 1: First-in-Class Drug Candidates
FIRST-IN-CLASS DRUG CANDIDATES 100 Cummings Center, Beverly, MA Ticker: IPIX
Slide 2: Safe Harbor; Forward-Looking Statements
Safe Harbor; Forward-Looking Statements ‘This presentation contains forward-looking statements made pursuant to the safe harbor provsions of the Private Securities Litigation Reform ‘Act of 1995 that involve risks, uncertainties and assumptions that could cause Innovation Pharmaceuticals’ actual res
Slide 3: Innovation Pharmaceuticals Inc.
Tnnovation Pharmaceuticals Inc. ee 100 Cummings Center me, fatten SE lot Matsa Suite 151B Garner wai tO Beverly, MA 01915 oily Cambridge, Boston. Woreeste™ cdpam
Slide 4: Brilacidin
Brilacidin Chemical Properties and Design Formula — CygHsoF<NysO5 Molar Mass 936.9 g/mol Design Approach ‘The biological activities of host defense proteins depend on an amphiphific helix Magainin Host defense protein (HDP) pete == bs ‘Synthetic non-peptidic mimetic. compcind nes ~~~ Biomimetic Poly
Slide 5: Brilacidin—Mechanism of Action
Brilacidin—Mechanism of Action Immunomodulatory: Inhibits PDE4 Brilacidin as a novel anti-inflammatory candidate , acts through inhibition of PDE4 * Being developed as a localized treatment agent for inflammatory diseases * Anti-inflammatory properties "Functions through the cyclic AMP/cyclic GMP pa
Slide 6: Brilacidin for Oral Mucositis (OM)
Brilacidin for Oral Mucositis (OM) A Painful and Common Complication of Chemoradiation Clinical Overview * Frequent complication of chemoradiation for Head and Neck Cancer * Painful and debilitating inflammation 8 ulceration; increases susceptibility to bacterial infections * Patients unable to spea
Slide 7: Brilacidin for OM: Current Treatments
Brilacidin for OM Current Treatments; Largely Palliative in Nature (Symptom Relief) Current Treatments + Only one drug treatment available ‘= Kepivance for V infusion ‘+ Limited label (HSCT) = Some medical devices + Noor litte relevant efficacy data (e.g, Gelair) + In development = Soligenix(v-admin
Slide 8: CTIX-BRI-205: Oral Mucositis
CTIX-BRI-205: Oral Mucositis Trial Design * Phase 2, multi-center (USA), randomized, double-blind, placebo-controlled study * Efficacy and Safety of Brilacidin oral rinse administered tid for 7 weeks (49 days) * Daily treatment aimed at attenuating Oral Mucositis (OM) in subjects with Head and Neck
Slide 9: CTIX-BRI-205 (OM): Efficacy Data
CTIX-BRI-205 (OM): Efficacy Data Positive Results: Ad-Hoc Interim Analysis + Brilacidin markedly reduced the Incidence of Severe OM (WHO Grade 2 3) experienced during chemoradiation therapy by subjects with Head and Neck Cancer receiving a cumulative radiation dose of at least 55 Gy and reached or p
Slide 10: CTIX-BRI-205 (OM): Safety Data/PK
CTIX-BRI-205 (OM): Safety Data/PK Brilacidin was Generally Well-Tolerated with No Measurable Systemic Exposure Adverse Events + Majority of Treatment-Emergent AEs (TEAEs) related to chemoradiation or underlying indication = Nine (9) SAEs reported; No Deaths. SAEs typical for subject population Safet
Slide 11: Inflammatory Bowel Disease (IBD)
Inflammatory Bowel Disease (IBD) A Hard-to-Treat Chronic Condition That Affects Over a Mi Group of inflammatory Conditions of Colon & Small Intestine Principle types: Crohn's disease (CD) and Uleratve colts (UC (Ulcerative rocttis (UP) and Ulcerative Proctosigmoidits (UPS) are subcategories of UC] ‘
Slide 12: CTIX-BRI-206: Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS)
CTIX-BRI-206: Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS) Proof-of-Concept Trial Design * Phase 2, Open Label, Dose-Escalation Trial * Active Mild-to-Moderate Ulcerative Proctitis (UP) or Ulcerative Proctosigmoiditis (UPS) = Treated 17 subjects + Six(6) Subjects in each of Cohorts A a
Slide 13: CTIX-BRI-206 (UP/UPS): Proof of Concept
CTIX-BRI-206 (UP/UPS): Proof of Concept Efficacy Endpoints Primary Efficacy Endpoint: Clinical Remission at Day 42/Week 6, defined by Modified Mayo scoring Endoscopy Findings [E] subscore $1 Rectal Bleeding [RB] | ))p) | Stool Frequency [SF] subscore improvement AND | subscore = 0 or no change from
Slide 14: CTIX-BRI-206 (UP/UPS): Efficacy Data
CTIX-BRI-206 (UP/UPS): Efficacy Data Primary Efficacy Endpoint, Topline Results Clinical Remission in > 50% subjects (Day 42) cin nenision: ¥ofsubjcts Similar across cohorts + 60% Cohort A (3 of 5) + 67% Cohort B (4 of 6) + 75% Cohort C (3 of 4) nae pont cae nc wih tae, ee Heenan el Pg nbc hor cnn t
Slide 15: CTIX-BRI-206 (UP/UPS): Endoscopy
CTIX-BRI-206 (UP/UPS): Endoscopy Examples Clinical Remission; Treated with Brilacidin 100mg (Cohort B) o & Q a 9 o Subject 990216 (rectum) Subject 990215 (rectum) Note: Basine/D42/te Treatment series ot necessary identical anatomical postions
Slide 16: CTIX-BRI-206 (UP/UPS): Patient Quality-of-Life
CTIX-BRI-206 (UP/UPS): Patient Quality-of-Life Quality-of-Life Better Overall Improvement in Quality-of-Life (QoL) reported by 16 of 17 subjects after six weeks of treatment * Qol instrument used was Short Inflammatory Bowel Disease Questionnaire [SIBDQ] * Clinically Important Change in Disease Acti
Slide 17: CTIX-BRI-206 (UP/UPS): Efficacy Data
CTIX-BRI-206 (UP/UPS): Efficacy Data Rectal Bleeding Response Shows Marked Improvement Rectal Bleeding (RB) subscore %of Subjects With No Rectal Bleeding by Week som * Improved for all subjects, all cohorts + No rectal bleeding (RB=0) at Day42 | * 5 of 6 subjects Cohort A so = All6 subjects Cohort B
Slide 18: CTIX-BRI-206 (UP/UPS): Safety Data
CTIX-BRI-206 (UP/UPS): Safety Data Brilacidin was Generally Well-Tolerated + Adverse Events * No Serious Adverse Events (SAEs) * No severe adverse events; all AEs mild or moderate severity * Treatment-emergent AEs, experienced by 8 subjects * Investigator Causality: Posibly Related (1); Unlikely Rel
Slide 19: CTIX-BRI-206 (UP/UPS): Pharmacokinetics
CTIX-BRI-206 (UP/UPS): Pharmacokinetics Systemic Exposure is Limited (when administered by Rectal Enema) Brilacidin Concentrations (plasma) by Cohort * Cohort A © Allsubjects <100 ng/mL. * Cohort B * Maximum 605 ng/mL ® Average Coax 215 ng/mL * Cohort C = Maximum 1264 ng/ml. © Average C,..,743 ng/mL
Slide 20: CTIX-BRI-206 (UP/UPS): Enema Retention Times
CTIX-BRI-206 (UP/UPS): Enema Retention Times Enemas Well-Retained Overall, good retention for a water-based enema Most prevalent retention time category per subject highlighted in green Cohort A Cohort B Cohort ¢ Brilacidin 50 mg Brilacidin 100 mg Brilacidin 200 mg Incidence of Retention Times < 30m
Slide 21: Perspectives on CTIX-BRI-205 and CTIX-BRI-206 Trial Results
Perspectives on CTIX-BRI-205 and CTIX-BRI-206 Trial Results * Brilacidin efficacy favorable in chemoradiation-induced Severe Oral Mucositis (SOM) + Markedly reduced rate of Severe OM (WHO Grade 2 3) [interim analysis] + Active Arm (BRI): 2 of 9 subjects (22.2 percent); Control Arm (Placebo): 7 of 10
Slide 22: Acknowledgments
Acknowledgments Co-Authors Jane A. Harness, Innovation Pharmaceuticals Francis A. Farraye, MD, Boston Medical Center Stephen T. Sonis, DMD, DMSc, Brigham and Women's Hospital Clinical Team Edward Walters, Kristine McGuigan- Innovation Pharmaceuticals CROs Clinical Assistance Programs (OM) PRI Clinic
Slide 23: Innovation Pharmaceuticals Inc. Cummings Center
Innovation Pharmaceuticals Inc. 100 Cummings Center Beverly, MA July 2017 Ticker: IPIX
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