Inhibitor Therapeutics Inc. · OTC:INTI
Inhibitor Therapeutics — Investor Presentation (August 2019)
21 slides from Inhibitor Therapeutics's investor presentation, Aug 20, 2019
Slide 1: Corporate Presentation August 2019
Corporate Presentation August 2019 OTCQB:INTI Exhibit 99.2
Slide 2: Cautionary Note on Forward-Looking Statements and Disclaimers
Cautionary Note on Forward-Looking Statements and Disclaimers This presentation includes or incorporates by reference statements that constitute “forward-looking statements” within the meaning of the U.S. federal securities laws. These statements relate to future events or to our future performance,
Slide 3: Mission Statement
Mission Statement We are focused on the discovery, development and commercialization of innovative therapeutics to inhibit the progression of cancerous and non-cancerous proliferation disorders Skin Cancer Itraconazole- based Therapies Prostate Cancer Orphan Oncology Proliferation Disorders Lung Can
Slide 4: Itraconazole: FDA-Approved Oral Anti-Fungal with Anti-Cancer Activity
Itraconazole: FDA-Approved Oral Anti-Fungal with Anti-Cancer Activity Itraconazole inhibits hedgehog signaling pathway via novel mechanism Significant and safe history as an FDA-approved anti-fungal therapy Demonstrated activity against multiple tumor types In vitro, in vivo and physician-sponsored
Slide 5: Challenges with Generic Itraconazole as an Anti-Cancer Therapy
Challenges with Generic Itraconazole as an Anti-Cancer Therapy Itraconazole is poorly bioavailable (~55% when dosed orally) Inconsistent blood plasma levels from one dose to the next Inconsistent blood plasma levels between patients at the same dose Less predictable at higher doses required for anti
Slide 6: SUBA-Itraconazole: Best-in-Class Potential
SUBA-Itraconazole: Best-in-Class Potential SUBA = “Super Bioavailability”; polymer-based drug dispersion – intestinal release Fulfils unmet need for low toxicity, continuous hedgehog pathway inhibition or anti-angiogenic therapy Does not require the high doses necessary for generic itraconazole anti
Slide 7: Pipeline: Indications, Trial Design and Next Milestones
Indication Trial Design Pre-Clinical Phase 1 Phase 2 Phase 3 Next Milestone(s) Basal Cell Carcinoma (BCC) in Basal Cell Carcinoma Syndrome (BCCNS) SUBA-Itraconazole 1st line stand-alone therapy to delay or eliminate BCC lesion surgeries Mayne Pharma* to initiate FDA/EMA Global Ph 3 Registration tria
Slide 8: Clinical Experience Supports Pipeline Expansion
Clinical Experience Supports Pipeline Expansion Completed Ph 2b trial in Basal Cell Carcinoma Nevus Syndrome (BCCNS) in 38 patients across 5 U.S. sites SUBA-Itraconazole decreased 57% of 477 BCC target lesions by 30% or more in size Only 6 lesions required surgical excision across all 38 patients 13
Slide 9: Opportunity for SUBA-Itraconazole in Late-Stage Prostate Cancer
Opportunity for SUBA-Itraconazole in Late-Stage Prostate Cancer Metastatic, Castrate-Resistant Prostate Cancer (mCRPC) Aberrant hedgehog signaling suggests a direct role in prostate cancer* Promotes tumor formation and invasion Contributes toward development of castrate-resistance and ADT failure Se
Slide 10: Clinical Proof-of-Concept for Itraconazole in Late-Stage Prostate Cancer
Clinical Proof-of-Concept for Itraconazole in Late-Stage Prostate Cancer Randomized, multicenter Phase 2 study* Oral itraconazole (generic) Men with metastatic castrate-resistant prostate cancer 90% of men who achieved therapeutic levels of itraconazole had dramatic reductions in PSA which correlate
Slide 11: Clinical Strategy for SUBA-Itraconazole in Late-Stage Prostate Cancer
Clinical Strategy for SUBA-Itraconazole in Late-Stage Prostate Cancer Phase 2b PREDICT* Trial Design: Randomized, controlled, multi-center clinical trial Oral SUBA-Itraconazole in combination with standard of care docetaxel-prednisone chemotherapy Objective: Evaluate the ability to delay disease pro
Slide 12: Opportunity for SUBA-Itraconazole in Late-Stage Lung Cancer
Opportunity for SUBA-Itraconazole in Late-Stage Lung Cancer Significant unmet need for patients with late-stage disease requiring chemotherapy Lung cancer is the leading cause of cancer-related deaths in the U.S.: 160,000 / year > colon, breast & prostate combined 85% are non-small cell lung cancer
Slide 13: Clinical Proof-of-Concept for Itraconazole in Late-Stage Lung Cancer
Randomized, controlled Phase 2 study of oral itraconazole (generic) Patients with metastatic non-squamous non-small cell lung cancer (NS NSCLC) Two-arm study: Combination with standard dose of second-line Pemetrexed Overall Survival Itraconazole + Pemetrexed Pemetrexed Alone P=0.012 Improved Median
Slide 14: Clinical Strategy for SUBA-Itraconazole in Late-Stage Lung Cancer
Clinical Strategy for SUBA-Itraconazole in Late-Stage Lung Cancer Phase 2b Trial Design: Randomized, Controlled, Multi-Center Oral SUBA-Itraconazole in combination with standard of care chemotherapy Objective: Evaluate the ability to delay disease progression in patients with advanced non-squamous n
Slide 15: Preclinical Strategy for Itraconazole Analogues in Basal Cell Carcinoma
Preclinical Strategy for Itraconazole Analogues (IAs)* in Basal Cell Carcinoma (BCC) Pre-clinical Trial Design: Basal Cell Carcinoma Mouse Model Oral IA dosing (gavage fed mouse model with human BCC xenographs) Objective: Evaluate the efficacy and safety of IA against human BCC Upcoming Milestones Q
Slide 16: Estimated Market Opportunity in Advanced Cancers and BCCNS
Estimated Market Opportunity in Advanced Cancers and BCCNS Total available markets for Itraconazole* therapies upon potential approvals * Itraconazole therapies include SUBA-Itraconazole Oral Capsules licensed from Mayne Pharma and Itraconazole Analogues optioned from the University of Connecticut *
Slide 17: Poised for Growth
Poised for Growth Collaboration and funding agreement with Mayne Pharma Strategically acquire/license additional drug candidates Exploring potential up-list to NASDAQ Exclusive option agreement with University of Connecticut evaluating next-generation itraconazole analogues with lower toxicities and
Slide 18: Management Team
Management Team Nicholas Virca, President & Chief Executive Officer 30 years in Human Therapeutics and Diagnostics (20 years at C Level) Co-founder HedgePath, Adventrx Pharmaceuticals, Diametrix Detectors, and Damon Biotech Garrison Hasara, CPA, Chief Financial Officer 20 years in Accounting and Fin
Slide 19: Board of Directors
Board of Directors Mark Watson, CPA - Chairman 40 years in Public Accounting and Auditing in healthcare and life sciences Retired Deloitte Touche Tohmatsu, serves on the boards of Sykes Enterprise and Biotechnology Sciences International Member of American Institute of Public Accountants Robert D. M
Slide 20: De-Risked, Clinically Advanced Pharmaceutical Development Company
De-Risked, Clinically Advanced Pharmaceutical Development Company Positive Phase 2 data in late-stage cancer studies Clinical proof-of-concept demonstrated in physician-sponsored Phase 2 Trials: PFS/OS benefits for generic itraconazole Completed Phase 2b of SUBA-itraconazole in BCCNS; Mayne Pharma i
Slide 21: Contact Us
Contact Us For Additional Information: Sharen Tilman Tiberend Strategic Advisors, Inc. 212-375-2664 office stilman@tiberend.com INHIBITOR Therapeutics, Inc. 4830 W. Kennedy Blvd. Suite 600 Tampa, Florida 33609
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