Adhera Therapeutics Inc. · OTC:ATRX
Adhera Therapeutics — Marina Biotech — Annual LD Micro Invitational 2017
22 slides from Adhera Therapeutics's conference presentation, Jun 7, 2017
Slide 1: Annual LD Micro Invitational
“RMaARINA 7 Annual LD Micro Invitational Joseph Ramelli, CEO June 2017
Slide 2: Forward Looking Statement
Forward Looking Statement Statements made in this presentation may include forward-looking statements within the meaning of Federal Securities to differ materially from those projected or suggested. aws that are subject to certain risks and uncertainties and involve factors that may cause actual res
Slide 3: About Marina Biotech
About Marina Biotech (OTCQB: MRNA) Specialty Pharma addressing the disease intersections of hypertension, pain, arthritis and cancer Commercial Therapy: Prestalia® - FDA approved treatment for hypertensive patients not adequately treated by monotherapy + Acquired in June 2017; Sales to ramp starting
Slide 4: Financial Snapshot
Financial Snapshot OTCQB: MRNA Mkt. Cap: $36.9M (as of 4/13/17) Shares Outstanding: 97.2 Million Daily volume: 84,378 Insider ownership: 60% “RMARINA
Slide 5: Experienced Management Team
Experienced Management Team Vuong Trieu, Ph.D. Chairman of the Board — An expert in pharmaceutical development and commercialization. Founder of the Autotelic consortium of companies include the highly successful exit at Igdrasol where it was acquired for up to $1.2 billion by NantPharma. Joseph W.
Slide 6: Robust Pipeline
Robust Pipeline es a Hypertension Pain & Hypertension: COX-2 505(b)(2)/Launch 2019 SUESKK Mae §505(b)(2)/Launch 2020 High Intensity Pain/Opioid Substitution: COX-2 EET 50500 EEE «60 Oncology: beta- Catenin/COX-2
Slide 7: Long Term Investment — Developing Next Generation Celecoxib
Long Term Investment — Developing Next Generation Celecoxib
Slide 8: The Opioid Epidemic
The Opioid Epidemic lane I New highs United States, drug overdose deaths*, monthly 1,200 1,000 Prescription opioids 800 600 400 S . 200 AMERICANS Facade i { die every day from 2000 02 04 06 08 10 12 : an opioid overdose *D (that includes prescription opioids and heroin) * New FDA Commissioner, Dr. S
Slide 9: Opioid Alternative
Opioid Alternative * Celecoxib reduces need for opioids * Less opioids, less chance for abuse * Potential labeling for numerous pain management needs * Post-operative/ Cancer Morphine consumption 40 -e control —@ celecoxib T T r 6h 12h 24h 48h “BMARINA
Slide 10: Need for Alternative to Opioids
Need for Alternative to Opioids * Celecoxib best alternative as it provides comparable pain relief to opioid drugs BUT at high dose it increases cardiovascular risk * Need high doses to be effective substitute for opioids * How to create a next generation of celecoxib that is safe at high dose? Rede
Slide 11: Next Generation Celecoxib
Next Generation Celecoxib Marina took a different approach to developing a next generation celecoxib * Look for an already approved drug, that when taken with celecoxib, makes the celecoxib safer — Advantage: combing two approved drugs can go 505(b)(2) pathway, taking years off of clinical trials an
Slide 12: Enhancing Celecoxib Safety with FDCs
Enhancing Celecoxib Safety with FDCs! Lisinopril and Olmesartan can reduce celecoxib-associated edema (T-102 IT-103 ~@ +Any @ +Any -® Celebrex ~® Celebrex 40 @ Lisinopril + Celebrex -@ Olmesartan + Celebrex 10 o—*,_ 4 T T 0 80 160 240 320 9 80 160 240 320 Days on Celebrex Days on Celebrex Data from
Slide 13: Short Term Investment — Developing Celecoxib FDCs
Short Term Investment — Developing Celecoxib FDCs
Slide 14: Celecoxib FDCs for the Treatment of Combined HTN/Pain
Celecoxib FDCs for the Treatment of Combined HTN/Pain Rapid access to market: Rapid regulatory 505(b)2 pathway for treatment of combined arthritis/hypertension Convenience for the patients - One Pill/One Rx Improved compliance- One Pill/Two Drugs Growing population of elderly with multiple diseases
Slide 15: Potentially Better PK & Safety vs. Competitor (KIT-302)
Potentially Better PK & Safety vs. Competitor (KIT-302) Parameters Celecoxib Lisinopril in IT-102 Olmesartanin IT-103 Amlodipine in KIT-302 : . 'No metabolism, excreted| No further metabolism ; Metabolism Liver ees Liver unchanged after activation Enzyme Primary. CYP2C9; CYP3A4) ot applicable Not Ap
Slide 16: Clearly Defined Regulatory Path
Clearly Defined Regulatory Path 505(b)(2) regulatory pathway Clinical studies for each Fixed Dose Combination IT-102 or 103 One Phase I bioequivalence and one small Phase III (efficacy and safety) study: — Bioequivalence study at highest and lowest dose strength in healthy subjects — One Phase III e
Slide 17: Large and Growing Market for Arthritis and HTN
Large and Growing Market for Arthritis and HTN * Total market size approx. $420M for Arthritis and HTN — 10% market penetration that is $42M annually * Total addressable market of ~3.5M _ patients — Large salesforce targeting GP doctors — Partnering opportunity with large pharma * Carve out for a sm
Slide 18: Building A Commercial Franchise Now
Building A Commercial Franchise Now
Slide 19: Prestalia®
Prestalia® * Acquired June 5 2017 from Symplmed Pharmaceuticals * Prestalia® indicated treatment of hypertension to lower blood pressure — Combination therapy that contains perindopril arginine, an ACE inhibitor, and amlodipine, a dihydropyridine calcium channel blocker — Used in patients whose bloo
Slide 20: Prestalia® Messaging
Prestalia® Messaging * One pill, once per day * Only fixed dose combination indicated for first line therapy * 46% reduction in CV death when administered as a FDC vs. amlodipine alone * Rapid and sustained blood pressure control * Peak efficacy achieved at week 3 and sustained out to week 6 (durati
Slide 21: Marketing History
Marketing History ° Approved January 21, 2015 ° Sub part H * Orange book patents ° Patent # 6696481 — 2023 ° Patent #7846961 — 2029 * Commercial launch August 2015 * Wholesale Acquisition Cost : $469.80 (90 count) * 98% of all Rx volume through direct fulfillment channel * ~70% of commercial plans c
Slide 22: About Marina Biotech
About Marina Biotech (OTCQB: MRNA) Specialty Pharma addressing the disease intersections of hypertension, pain, arthritis and cancer Commercial Therapy: Prestalia® - FDA approved treatment for hypertensive patients not adequately treated by monotherapy + Acquired in June 2017; Sales to ramp starting