Adhera Therapeutics Inc. · OTC:ATRX
Adhera Therapeutics — Marina Biotech — LD Micro Main Event 2016
20 slides from Adhera Therapeutics's conference presentation, Dec 8, 2016
Slide 1: LD Micro Main Event
“SMaRINA LD Micro Main Event Joseph Ramelli, Interim CEO December 7, 2016
Slide 2: Forward Looking Statement
Forward Looking Statement Statements made in this presentation may include forward-looking statements within the meaning of Federal Securities laws that are subject to certain risks and uncertainties and involve factors that may cause actual results to differ materially from those projected or sugge
Slide 3: Investment Highlights
Investment Highlights * Biopharmaceutical company focused on therapeutics for cancer and rare diseases (OTC: MRNA) * Merger with IthenaPharma brings two clinical products with straight forward 505(b)(2) paths to approval and greatly improved operational capabilities * IT-102 lisinopril/celecoxib and
Slide 4: Combination Products
Combination Products RNAi Platform CEQ-508 FAP/CRC & IT-102 FAP & IT-103 CRC
Slide 5: IthenaPharma Merger Re-focuses Marina
IthenaPharma Merger Re-focuses Marina Commercialization, indication y Development focus €xpansion to L ; with expanded colorectal cancer y _@ pipeline and and FAP y > Research and potential for near- discovery of term clinical data RNAi-based therapeutics
Slide 6: Benefits of Autotelic Consortium
Benefits of Autotelic Conso I Operational Support Scientific and Commercial Support Collaborat Stocosil Partners Autotelic Inc ‘Autotelic Taiwan Autotelic Korea Autotelic India Lipomedics Oncotelic Glucotelic Synergy on combined Programs Oral Formulation Nanoparticle technology Immune Oncology antis
Slide 7: IT-102/103
IT-102/103 ————
Slide 8: Large Market for Arthritis and HTN
Large Market for Arthritis and HTN IT-102/IT-103 is being investigated for patients with osteoarthritis pain and hypertension There are approximately 27M adults in the U.S. with osteoarthritis Approximately 15% of all U.S. adults have hypertension and are well controlled by medication Total addressa
Slide 9: Celecoxib — Introduction
Celecoxib — Introduction * Celecoxib is the only cyclooxygenase-2 (COX-2) selective inhibitor currently on the market in U.S. * Indicated for the treatment of: — Osteoarthritis (OA) — Rheumatoid arthritis (RA) — Ankylosing spondylitis (AS) Acute pain associated with post-oral and post-orthopedicsurg
Slide 10: Celecoxib — Adverse Events (AE)
Celecoxib — Adverse Events (AE) Cardiovascular Thrombotic Events — greater risk for patients with CV disease — Chronic use of Celecoxib may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke 400 mg bid — 3.4-fold increase in the composite risk 200
Slide 11: Celecoxib FDC Advantages
Celecoxib FDC Advantages “/ 4 IT-102: Lisinopril + Celecoxib E>) (i OX, ® => x) IT-103: Olmesartan + Celecoxib HY PS Cz 2 * Simultaneous treatment of two severe medical conditions * Reduces side effects (hypertension and edema) associated with Celecoxib treatment * Improve patients’ compliance to an
Slide 12: Inhibition of Edema by IT-102/IT-103
Inhibition of Edema by IT-102/IT-103 Olmesartan and lisinopril can reduce celecoxib-associated edema @ +Any @ +*Any ~® Celebrex ~@ Celebrex 40 ~@ Lisinopril + Celebrex -@ = Olmesartan + Celebrex % Edema 8 0 80 160 240 320 0 80 160 240 320 Days on Celebrex Days on Celebrex Data from our analysis of P
Slide 13: Potentially Better PK & Safety vs. Competitor (KIT-302)
Potentially Better PK & Safety vs. Competitor (KIT-302) Parameters Celecoxib Lisinopril/IT-102 Olmesartan/IT-103 Amlodipine-KIT 302 me = INo metabolism, excreted] No further metabolism i unchanged after activation Enzyme =f *imery eee CYP3A4) Not Applicable Not Applicable CYP3A4 Half life (T32) A ho
Slide 14: Clinical Development Plan
Clinical Development Pl * 505(b)(2) regulatory pathway * Clinical studies for each FDC — IT-102 or 103 * One Phase | bioequivalence and one small Phase III (efficacy and safety) study: — Bioequivalence study at highest and lowest dose strength in healthy subjects — One Phase Ill efficacy and safety
Slide 15: Clinical Trial Design
Clinical Trial Design * Phase | bioequivalence study A randomized, open label, single-dose, 2-way cross-over clinical study to compare PK of co-administration of two single agent and FDC in healthy volunteers. — Celecoxib dosage: 100 mg/ 200 mg — Lisinopril dosage: 20 mg/40 mg — Olmesartan dosage: 2
Slide 16: Clinical Trial Design
Clinical Trial Design * Phase Ill Efficacy and Safety Study (if required by FDA) — Multi-center, randomized, double-blind, placebo-control, 4-arms, 2 weeks administration, phase III clinical study for patients with osteoarthritis and hypertension. — 4-arms of 150-250 patients each: placebo, celecoxi
Slide 17: M-101 (IT-103 + CEQ-508)
“SMaRINA M-101 (IT-103 + CEQ-508) ————
Slide 18: APC/Wnt/Catenin in CRC
APC/Wnt/Catenin in CRC
Slide 19: Dual Inhibition of Catenin for treatment of CRC
Dual Inhibition of Catenin for treatment of Clinical Efficacy * Celecoxib + Shut down COX-2 escape pathway + Indirect catenin knockdown + Improved OS in CRC Clinical Safety + Qlmesartan + Shut down vascular HTN escape pathway + Improved Os in CRC Targeted Efficacy * CEQ-508 + Direct catenin knockdow
Slide 20: Investment Highlights
Investment Highlights * Biopharmaceutical company focused on therapeutics for cancer and rare diseases (OTC: MRNA) * Merger with IthenaPharma brings two clinical products with straight forward 505(b)(2) paths to approval and greatly improved operational capabilities * IT-102 lisinopril/celecoxib and