Inhibitor Therapeutics Inc. · OTC:INTI
Inhibitor Therapeutics — Investor Presentation (March 2024)
29 slides from Inhibitor Therapeutics's investor presentation, March 2024
Slide 1: Corporate Deck
Corporate Deck O T C Q B : IN T I | MA RCH 2024 CON FIDE NTIA L
Slide 2: Disclaimer
Disclaimer This presentation may contain statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature identify forward-looking statements for purposes of the federal
Slide 3: Who We Are
We Are a De-Risked, Clinically Advanced Who We Are Pharmaceutical Development Company Itraconazole is FDA- Advancing proprietary Positive Phase 2 Poised for approved (anti-fungal) oral drug formulations data in late-stage Significant Growth with known anti-cancer of itraconazole cancer studies prope
Slide 4: Management
Management Chief Financial Officer JAMES A. MC NULTY, CPA Executive Chairman & CEO, Founder FRANCIS E. O ’D ONNELL , JR, MD • 26 year career in public accounting as founder of three CPA firms • Johns Hopkins University School of Medicine: MD • CFO of Mira Pharmaceuticals, Inc. and Telomir Pharmaceut
Slide 5: Board of Directors
Board of Directors FRANCIS E. O’DONNELL, JR MD EXECUT IVE CHAI RMAN MICHELLE YANEZ, MBA SAMUE L SEARS, ESQ. RON OSMAN , JD • 25 years in biotech, pharmaceuticals and • 30+ years experience in corporate and • Chairman and CEO Biovest International, Inc healthcare with companies including securities l
Slide 6: Board of Directors
Board of Directors MIKE JERMAN, CPA NIRAJ VA SIS HT, PHD • Previously a CFO of multiple private equity-backed companies in the energy, SaaS, and manufacturing industries; • CEO Avior Bio, Inc. was a Director with PwC in the US and UK; was a Captain with the United States Air Force. • 25 years experi
Slide 7: Corporate History
Corporate History 4-YEAR DELAY IN DEVELOPME NT OF ITRACONAZO LE STOCK PRICE COLLAPSE CAUSE D BY CONFLICT WITH SUPPLY PA RTNER At th e e n d o f 2 0 1 8, th e s t o ck p ri c e c o l l a p se s i n a n ti c i p a ti o n o f s u p pl y • Su p p l y p a rt n er f o r i tr aco n a zol e eve n t ua l l y
Slide 8: Settlement Key Features
Settlement Key Features KEY FEATU RES OF SE TTLEM ENT W ITH AN PARALLEL ITRACON AZOLE D EVELOPMENT EFFECTIVE DATE O F 12/13/2022 POTENTIAL (FROM SETTLEME NT) • Su p p l y p a rt n er ca n ce ls a l l i t s e q u i ty i n I NTI , i n cl u di n g ~2 2 M Af t er t h e e f fe c ti v e da t e , s up p l
Slide 9: Pipeline & Growth Strategy
Pipeline & Growth Strategy CORPO RATE CHAN GES ITRACONAZOLE DEVE LO PMENT GROW TH IN AD DITIONAL INDICATIONS • Ne w Bo a rd an d Off i c er s e x p e ri e nc e d in • De ve l op me n t of i tr aco n a zol e ad d i ti o n a l • En g a g eme n t o f CDMO to de ve l op a d ru g d e ve l op me nt an d c
Slide 10: 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 INHIBITOR management and clinical/regulatory teams demonstrated solid execution of first BCCNS trial • Itraconazole (SUBATM brand) decreased 57% o
Slide 11: Scientific Advisory Board
Scientific Advisory Board Dr Elizabeth M. Billingsley, MD. Dr Marc D . Brown, MD. Dr Ian Maher, MD. Head of the SAB, Dr. Billingsley is a Professor of Dr. Brown developed an interest in dermatology after Dr. Maher is a Professor of Dermatology and Director Dermatology with Penn State Health Hershey
Slide 12: Scientific Advisory Board
Scientific Advisory Board Dr Allison Vidim os, RPh, MD. Dr Sean R . Christensen, MD, P hD. Dr. Vidimos was appointed Chairman of the Department of Dermatology at Cleveland Clinic Dr. Christensen is an Associate Professor of Dermatology; Director of Resident Education in 2005 and Vice Chairman of the
Slide 13: SAB - Clinical Study Report Review
SAB - Clinical Study Report Review Ou r Sci e n ti f i c A dvi so ry Bo a rd (S AB) w as t aske d w i th re vi ew i ng th e e xi st i ng cl in i ca l st u dy re p o rt SC ORI NG T ri a l : P ha se 2 ( b) Op e n -l a be l Tr i a l o f SU BA TM -I tr aco n a zol e i n Su b j e cts wi th Ba sa l C el l
Slide 14: SAB - Clinical Study Report Review
SAB - Clinical Study Report Review 2. A s s uch, sh oul d a n e ff icac y a sse ssm en t b e b ased on t he e ff ect s o n e ach tum o r r ath er tha n be l im it ed to ag greg ate ef fec ts on eac h p ati ent ( so c all ed RECI ST c rit eri a)? Dr. Ian Maher: The development of some NEW tumors in B
Slide 15: SAB - Clinical Study Report Review
SAB - Clinical Study Report Review 3. D o you be li eve th at thi s c li nic al stu dy supp ort s t he pro posi ti on tha t i tr acon azol e is a c li nic all y u sef ul opt ion as pa rt of th erap eut ic m anag em ent o f B CC i n G o rli n S yndr om e (BCCNS) ? Dr. Ian Maher: Yes. While the effica
Slide 16: Proven Value Creation Using the 505(b)(2) Pathway
Proven Value Creation Using the 505(b)(2) Pathway • Our team has deep experience developing and commercializing differentiated, clinically valuable, patent -protected specialty pharmaceuticals using the 505(b)(2) pathway. • Example: BioDelivery Sciences Int., Inc (NASDAQ:BDSI) founded by Dr. Frank O
Slide 17: Itraconazole – Treatment of BCCNS
Itraconazole – Treatment of BCCNS CON FIDE NTIA L 17
Slide 18: BCCNS' Unmet Need
BCCNS’ Unmet Need AN UNMET CLINICAL NEE D IN PATIENTS SUFFERING WITH BASAL CELL CARCINOMA NEVUS SYNDRO ME • He re d i t ar y B CC: B CCN S occu r s i n Go rl i n Syn d ro me A ut o so ma l Do mi n a n t In h e ri t ed Di so rd e r • Di a g n osi s by vi su al i n sp e ct io n (mu l ti p l e B CC’ s
Slide 19: Development of Itraconazole
Development of Itraconazole BEST REDUCTION IN POSITIVE PHASE II DATA POSITIONING ALL TARGET ITRACONAZOLE FOR SIGNIFICANT GROWTH LESSIONS (N=447) • We cu rre n t ly o wn t h e r ig h t s t o mu l ti p l e p a te n ts a s n o te d in th e “Ow ne d In t el l e ctu a l Pro p e rt y” sl id e s be l o w.
Slide 20: Scoring Phase II(b) Trial: Subject
Scoring (BASELINE, 8 AND 12 WEEK Phase II(b) VISITS Trial: Subject 103001-10 Mid back posterior Non-ulcerated 5 mm Target Lesion Non-ulcerated 3 mm Target Lesion Non-ulcerated 0 mm Target Lesion (-100% from baseline) CR Target Lesion Responses Mid post neck Non-ulcerated 0 mm Target Non-ulcerated 5
Slide 21: Owned Intellectual Property
Owned Intellectual Property Date US Patent # Title Date Issued Exemplary Claim Applied Treatment and Prognosis A method of treating a proliferation disorder (basal cell Monitoring of Proliferation carcinoma, prostate and lung cancer), composition is 9,192,609 Disorders Using Hedgehog 02/05/14 11/25/
Slide 22: Owned Intellectual Property
Owned Intellectual Property US Patent # Title Date Applied Date Issued Exemplary Claim Treatment and Prognosis A method for treating a non-cancerous proliferation disorder. Monitoring of Non-Cancerous Composition is orally administered to achieve a plasma trough 9,968,600 Proliferation Disorders Usi
Slide 23: Exclusively Licensed to JHU Patent
Exclusively Licensed to JHU Patent Date Extension US Patent # Title Date Applied Exemplary Claims Issued Information A method of inhibiting angiogenesis in The term of this patent is Angiogenesis undesired tissue in a subject consisting of extended or adjusted under 8,980,930 06/27/05 03/17/15 Inhib
Slide 24: Clinical Programs for Itraconazole
Clinical Programs for Itraconazole Indication Trial Design Pre-Clinical Phase 1 Phase 2 Phase 3 Next Milestone(s) Basal Cell Carcinoma Itraconazole 1st line stand- (BCC) in Basal Cell alone therapy to delay or 505(b)(2) Regulatory Pathway Meet with Dermatology Division of FDA Carcinoma Syndrome elim
Slide 25: Estimated Market Opportunity in Advanced Cancers and BCCNS
Estimated Market Opportunity in Advanced Cancers and BCCNS Total available markets for Itraconazole upon potential approvals Peak Sales Indication Patients (U.S.) Positioning Monthly Cost Estimate** BCCNS 1st line therapy to ~10,000 $4,000 - $5,000 $300 million Itraconazole delay surgeries Late-Stag
Slide 26: Additional Opportunities
Additional Opportunities LATE-STAGE PROSTATE CANCER TREATMENT LATE-STAGE LUNG CANCER TREATMENT WITH WITH ITRACONAZOLE ITRACONAZOLE • Pr o sta t e ca nce r i s th e se co nd most co mmo n ca use of can ce r - • L u ng can ce r i s t h e l e a di n g ca u se o f ca n cer r e la t e d d ea t h s i n re
Slide 27: 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 (n=29) Dropout Rates Due to Toxicity itraconazole had
Slide 28: Clinical Proof-of-Concept for Itraconazole in Late-Stage Lung Cancer
Clinical Proof-of-Concept for Itraconazole in Late- Overall Survival Stage Lung Cancer Itraconazole + Pemetrexed (n=15) • Randomized, controlled Phase 2 study of oral itraconazole (generic) Pemetrexed Alone (n=8) • Patients with metastatic non-squamous non-small cell lung cancer (NS NSCLC) • Two-arm
Slide 29: For More Information
For More Information • INHIBITOR Therapeutics, Inc. • 900 West Platt St; Suite 200 • Tampa, Florida 33606 W W W. I N H I B I TO R T X . C O M
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