Avenue Therapeutics, Inc. - PowerPoint Presentation

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Avenue Therapeutics, Inc.

April 2017Slide2

Forward Looking StatementsStatements 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 statements by terminology including “anticipates,

” “

believes,

”

“can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “should,” or “will” or the negative of these terms or other comparable terminology. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are risks relating to: our growth strategy; results of research and development activities; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to update or revise any statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances after the date of this presentation.

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Avenue and its Value Proposition

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What We

Do and Why

We focus on pharmaceuticals for the acute/intensive care hospital setting

U.S. hospital market is concentrated and requires a small sales forceOur lead asset intravenous (IV) tramadol is ready to enter Phase III developmentTrend on “multimodal” treatment for pain favors new products that help patients avoid strong narcoticsTramadol is an opioid without the typical side effects of narcoticsWe are a subsidiary of Fortress Biotech that is run by an experienced management team and advisorsBacking by Fortress’ BD effort = New pipeline product candidatesSlide4

U.S. Post-Op Pain Market IV analgesics sells

~$1 billon (~300 million units)/yrIV acetaminophen sells ~$250MM - ~25% of total dollar market with approximately 3 to 4% of the volumeRoom for Improvement

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Available Classes

Pain

LevelsCommon Limitations & ContraindicationsIV narcoticsModerate to severeStrong sedationRespiratory depressionConstipationRisk of dependenceIV NSAIDSMild to moderately severePost-op bleeding riskGI side effectsRenal impairmentIV acetaminophenMild to moderateHepatic impairmentSlide5

What is Tramadol

Not a typical opioidTwo distinct mechanisms of action: (1)weak opioid agonist, and (2)inhibitor of monoamine neurotransmitter reuptake

Labeled for “moderate to moderately severe pain”

Analgesic

effect similar to

other opioid therapies Differentiated safety profile compared to other opioidsOral tramadol widely prescribed in the U.S.Schedule IV and one of the most prescribed pain medicationsPrescriptions increased from 23.3 million in 2008 to 43.8 million in 2013~$1.2 billion annual sales despite being genericIV tramadol widely used outside the U.S.Accounts for ~10% of IV analgesic use in the post-op setting in E.U.5Slide6

IV Tramadol

Summary

Indication

Moderate to moderately severe pain

Regulatory pathway

505b(2)Stage of developmentPhase III to begin in 2017Clinical efficacy*Parenteral tramadol has been tested in several randomized, double-blind, parallel-group, comparative studies. It effectively relieved moderate to severe post-op pain associated with several types of surgeries (abdominal, orthopedic, and cardiac surgery) in these studies.Tolerability*In general, tramadol was well tolerated in clinical studies. The most common adverse events were nausea, dizziness, drowsiness, tiredness, sweating, vomiting, and dry mouth.

Unlike other opioids, it did not cause clinically relevant respiratory depression.

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*Tramadol: A Review of its Use in Perioperative Pain. Scott LJ, Perry CM.

Drugs

. 2000

Jul;60(1):139-76.Slide7

New Restrictions on OpioidsNew guidelines from CDC to physicians attempts to limit opioid prescribing Many states have passed laws restricting opioid prescriptions The U.S. DEA has reduced the amount of almost every Schedule II opioid medication that may be

produced in the U.S. in 2017 by 25 percent or more7Slide8

IV Tramadol Opportunity IV tramadol may be used in all types of inpatient and outpatient surgeries and as

part of a multimodal analgesic plan for major surgery It may be an improved option for patientsWith poor cardiopulmonary function

Elderly patients at risk for respiratory depression

Obese patients with sleep apnea

Contraindicated

for NSAIDS Patients who cannot tolerate strong narcotics such as morphine due to side effects such as sedation, constipation, and history of drug dependence, etc.8Slide9

Results from a Survey of 30 U.S. Anesthesiologists*9

*Survey conducted through LEERINK and available upon request

Patients taking

Switch

to IV tramadol

Add IV tramadolIV morphine40%41%IV NSAIDS26%37%IV acetaminophen24%35%Slide10

Advantages of IV Tramadol Documented efficacy and safetyPhysician familiarity with tramadol

Less addictive than widely prescribed narcotics in the hospitalAvailable “step-down” therapyOur IV tramadol dosing regimen provides similar

Cmax and AUC to that of oral Ultram 100 mg Q6h at steady state.

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Phase 3 Program*11

StudyGoalsDesign

Orthopedic model(Bunionectomy

)

To demonstrate

safety and efficacy of IV tramadol (50 mg dose) versus placeboTo understand dose response405 patients, 3-arm (IV tramadol 50 mg, 25 mg, or placebo), 1:1:1 randomized, and double-blind studySoft tissue model(Abdominoplasty)To demonstrate safety and efficacy of IV tramadol (50 mg dose) versus placeboTo understand safety and tolerability versus standard of care360 patients, 3-arm (IV tramadol 50 mg, placebo, or morphine), 3:3:2 randomized, and double-blind studySafety studyTo achieve total exposure of 500 patients on IV tramadol (50 mg dose)To understand safety in “real-world” situations250 patients, open-label, single arm, all surgical types*Key elements clarified and confirmed at EOP2 MeetingSlide12

Intellectual PropertyU.S. Patent No. 8,895,622 “Intravenous Administration of Tramadol” Issued on November 25,

2014U.S. Patent Applications Serial No. 14/713,775 and No. 14/550,279

Both are continuation applications of the ‘622 patent and will issue as patents in Q1 2017

U.S. Patent Application Serial No. 15/163,111

This

is a new patent filing Further Patent Applications are contemplated for filing in 2017 *A Notice of Allowance is issued after the USPTO makes a determination that a claimed invention is novel and nonobvious in light of all known technology in existence, and that a patent should be granted from such an application12Slide13

Executive Team and Key AdvisorLindsay Rosenwald,

MD, Executive ChairmanChairman and CEO of Fortress Biotech, Inc.Prolific

and successful investor in the life sciences industry for over 20 years

Co-founder and Co-Portfolio

Manager

of Opus Point PartnersLucy Lu, MD, Interim President & Chief Executive OfficerEVP and CFO of Fortress Biotech, Inc.Former Senior Analyst at Citi Investment Research15 years of experience in life sciencesDavid Horin, Interim Chief Financial OfficerManaging Partner, Chord Advisors, LLC.Former Chief Financial Officer of Rodman & Renshaw Capital Group, Inc.Former Managing Director of Accounting Policy and Financial Reporting at Jefferies Group, Inc.Scott Reines, MD-PhD, Interim Chief Medical OfficerFormer Vice President/Senior Vice President at Merck Research Laboratories and Johnson & Johnson Pharmaceutical R&DOversaw development and approval of drugs including INVEGA, NUCYNTA, RISPERDAL CONSTA, TOPAMAX, EMEND, MAXALT, SINEMET, etc.

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Scientific Advisory BoardRobert Dworkin, PhD

Director of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION)

Harold Minkowitz

, MD

Assistant Professor of Anesthesiology at the University of Texas Health Science Center at

HoustonNeil Singla, MDFounder and Chief Scientific Officer, Lotus Clinical ResearchMark Wallace, MDDirector, Center for Pain Medicine, UC San Diego14Slide15

Upcoming Milestones

Commence Phase 3 program in 2017Phase 3 Data 2018

NDA filing 2019

~$30 million to complete Phase 3 Program

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Avenue Therapeutics, Inc.Contact:

Lucy Lu, M.D.2 Gansevoort St., 9th FloorNew York, NY 10014

Tel: 781-652-4511Email: llu@avenuetx.com

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