Avenue Therapeutics, Inc. · OTC:ATXI
Avenue Therapeutics — Investor Presentation (May 2018)
24 slides from Avenue Therapeutics's investor presentation, May 25, 2018
Slide 1: Avenue Therapeutics, Inc. NASDAQ: ATXI May 2018
AVENUE THERAPEUTICS, INC. ⎸ NASDAQ: ATXI ⎸ MAY 2018
Slide 2: Forward Looking Statements
Forward Looking Statements Statements in this presentation that are not descriptions of historical facts are forward - looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. We have attempted to identify forward - looking statem
Slide 3: Developing IV Tramadol to Address Significant Unmet Need in Postoperative Pain
Developing IV Tramadol to Address Significant Unmet Need in Postoperative Pain Uniquely Positioned to Address a Clear Need for New Therapies Amidst Opioid Crisis • Double MOA delivers opioid efficacy with less abuse potential and risk of dependence • Fills in the gap in acute care space between IV a
Slide 4: Future Paradigm: Simplified IV Analgesic Ladder
Future Paradigm: Simplified IV “Analgesic Ladder” Post - 2020 Systemic Pharmacotherapy to Remain the Mainstay of Post - surgical Pain Management STEP 1 STEP 2 Non - opioid analgesics IV acetaminophen (+ IV NSAIDs) Atypical opioid IV tramadol + + Strong conventional opioids IV morphine/ hydromorphone
Slide 5: Unique Dual Mechanism of Action Among IV Analgesics
Unique Dual Mechanism of Action Among IV Analgesics IV TRAMADOL Blocking pain signal transmission at both the spinal and brain levels OPIOID AGONIST Blocking pain signal transmission at the spinal level INHIBITOR OF NOREPINEPHRINE & SEROTONIN RE - UPTAKE Opioid Efficacy with Less Abuse Potential Sch
Slide 6: Phase 3 Program Overview
Phase 3 Program Overview Orthopedic Model (Bunionectomy) 405 Patients Placebo (n=135) IV tramadol 25 mg (n=135) IV tramadol 50 mg (n=135) Soft Tissue Model (Abdominoplasty) 360 Patients Placebo (n=135) IV tramadol 50 mg (n=135) Morphine (n=90) PRIMARY ENDPOINT Sum of Pain Intensity Differences (SPID
Slide 7: Bunionectomy Study Results
• P=0.005 for the primary endpoint of SPID48 (Sum of Pain Intensity Difference over 48 hours) • Key secondary endpoints included: • SPID24 • Total consumption of rescue medicine • Patient Global Assessment, captures patients’ perception of treatment • Rapid onset of efficacy • Statistically signific
Slide 8: Favorable Patient Reported Outcome
Favorable Patient Reported Outcome The Patient Global Assessment (PGA), which captures patients’ perception of the treatment, demonstrated statistically significant improvement over placebo. PGA Outcome at 24 Hours Poor Fair Good Very Good Excellent Percent of Patients RespondingPatient Global Asses
Slide 9: Statistically Significant Dose Response
Statistically Significant Dose Response A clear dose response confirms that the 50 mg dose will move forward. IV Tramadol Dose (mg) 0 25 50 LSMean (SE) SPID48 -140 -130 -120 -110 -100 -90 -80 LSMean (SE) SPID48 Dose Response Line Placebo Dose Response of SPID48 Outcome
Slide 10: No Surprise in Safety Outcomes
• There were no drug - related serious adverse events (SAEs) • The most common (≥5%) adverse events in the trial where IV tramadol 50 mg differed from placebo were nausea, vomiting, dizziness and somnolence. • Most of these adverse events were mild or moderate (Grade 1 or 2) with only 4 (3%) patient
Slide 11: Novel Dosing Regimen Maximizes Efficacy and Tolerability
• IV tramadol 50 mg is infused intravenously over 15 minutes at Hours 0, 2, 4, and once every 4 hours thereafter • Similar C max and AUC to that of 100 mg oral tramadol given every 6 hours at steady state Novel Dosing Regimen Maximizes Efficacy and Tolerability
Slide 12: Post-Surgical Pain Management is a Gateway to Opioid Dependence
Post - Surgical Pain Management is a Gateway to Opioid Dependence Approximately 6% of patients become new persistent opioid users in the post - surgical setting “In this population - based study of 36,177 surgical patients, the incidence of new persistent opioid use after surgical procedures was 5.9
Slide 13: Opioid Crisis Puts Pressure on the Use of Conventional Narcotics
• Release of the CDC guidelines: “ When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate - release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less wi
Slide 14: What is the Unmet Need in Post-op Pain Care?
What is the Unmet Need in Post - op Pain Care? Current Post - Op Pain Management Paradigm IV Acetaminophen IV NSAIDS IV Opioids Schedule II MILD MODERATE MODERATELY SEVERE SEVERE Common Limitations & Contraindications Hepatic Impairment Bleeding Risk Slowed Healing Process GI Side Effects Renal Impa
Slide 15: IV Tramadol Ideally Suited for Wide Range of Patients
IV Tramadol Ideally Suited for Wide Range of Patients Future Post - Op Pain Management Paradigm IV Acetaminophen IV NSAIDS IV Opioids Schedule II IV Tramadol Schedule IV MILD MODERATE MODERATELY SEVERE SEVERE Common Limitations & Contraindications Hepatic Impairment Bleeding Risk Slowed Healing Proc
Slide 16: Many Patients Could Benefit from IV Tramadol
IV TRAMADOL is a better option when strong opioids are not desirable Many Patients Could Benefit from IV Tramadol Cannot Tolerate Strong Narcotics Contra - indicated for NSAIDS Obese Patients with Sleep Apnea Elderly at Risk for Respiratory Depression For the other patients: Why use a conventional (
Slide 17: Physician Excitement for IV Tramadol Product Profile
Physician Excitement for IV Tramadol Product Profile Surgeons valued the potential benefits of IV Tramadol as an important addition to the IV analgesic armamentarium, assigning IV Tramadol a mean rating of 4.9 • 80% of orthopedic surgeons and 76% of general surgeons rated IV Tramadol “ 5 or higher ”
Slide 18: Characteristics Supportive of IV Tramadol Usage
Characteristics Supportive of IV Tramadol Usage 0% 20% 40% 60% 80% 100% Relative abuse liability (Schedule IV) Demonstrated effective pain relief in a bunionectomy study Hepatic safety/tolerability profile Renal safety/tolerability profile Demonstrated effective pain relief in an abdominoplasty stud
Slide 19: Strong Patent Portfolio
• U.S. Patents No. 8,895,622, No. 9,561,195, No. 9,566,253, No. 9,962,343 • Expire in 2032 • U.S. Patents No. 9,693,949, No. 9,968,551, No. 9,980,900 • Expire in 2036 • Potential for Additional Patents Strong Patent Portfolio
Slide 20: A Prior Success Story – IV Acetaminophen, Cadence Pharmaceuticals - Ofirmev
• Licensed drug from Bristol - Myers Squibb in 2006 – upfront fee of $25 million and $15 million milestone upon FDA approval • FDA approval in November 2010 and launched in January 2011 • List price of $14.75 per vial as of 2013 • Royalties in mid - teens to mid - twenties • Acquired on February 11,
Slide 21: Key Analogue for IV Tramadol
Ofirmev ® accounts for ~30% of the total dollar market on approximately 3 to 4% of the unit volume Key Analogue for IV Tramadol Revenues for Ofirmev ® (IV acetaminophen) are ~$300 MM per year 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Units Sales IV acetaminophen All others
Slide 22: Financial Highlights
Financial Highlights Market capitalization ~$40 million Outstanding shares (As of 3/31/18) 10.6 million Cash position (As of 3/31/18) $15.0 million
Slide 23: Upcoming Milestones
Upcoming Milestones Initiated Phase III bunionectomy study 3Q 2017 x Initiated Safety study 4Q 2017 x Positive topline data from Phase III bunionectomy study 2Q 2018 x Initiate Phase III abdominoplasty study 3Q 2018 Topline data from Phase III abdominoplasty study 2Q 2019 Complete Safety study 2Q 20
Slide 24: Avenue Therapeutics, Inc. NASDAQ: ATXI May 2018
AVENUE THERAPEUTICS, INC. ⎸ NASDAQ: ATXI ⎸ MAY 2018
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