Slide 1: Veru Corporate Presentation June 2020
Veru Inc. Nasdaq:VERU The Prostate Cancer Company Novel Medicines Veru Corporate Presentation June 2020
Slide 2: Forward looking statements
Forward looking statements This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or
Slide 3: Veru, the prostate cancer company, has revenues from urology and legacy divisions
Veru, the prostate cancer company, has revenues from Urology Specialty Pharmaceuticals and legacy product divisions Veru The Prostate Cancer Company Urology Specialty The Female Pharmaceuticals Health Company Division Division TADFINTM – Targeting NDA FC2 ® Female/internal submission late 2020 / ear
Slide 4: Pipeline of proprietary product candidates
Pipeline of proprietary product candidates PRODUCT TARGET INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 PHASE 4 MARKETED PROSTATE CANCER NOVEL MEDICINES Phase 1b portion Metastatic castration and androgen Phase 1b completed and Phase 2 enrolling blocking agent Phase 2 resistant prostate Oral, targe
Slide 5: Experienced in clinical practice, drug development and commercialization
Experienced in clinical practice, drug development and commercialization Mitchell Steiner, MD Michele Greco, CPA Gary Barnette, PhD Harry Fisch, MD CHAIRMAN, PRESIDENT & CHIEF FINANCIAL & CHIEF SCIENTIFIC OFFICER CHIEF CORPORATE OFFICER & CHIEF EXECUTIVE OFFICER ADMINISTRATIVE OFFICER Sr. VP Scienti
Slide 6: Prostate Cancer - Novel Medicines
Prostate Cancer - Novel Medicines 6 6
Slide 7: Our Strategy
Advanced prostate cancer is a chronic disease requiring active management of the disease and side effects from existing treatments Our Strategy New prostate cancer treatments directed to New therapies to ameliorate side effects stopping cancer progression1 of prostate cancer treatments2 • Inadequate
Slide 8: Growing unmet need: metastatic castration and androgen blocking agent resistant prostate cancer
Growing unmet need Metastatic castration and androgen blocking agent resistant prostate cancer Androgen blocking agent • 15-25% of men have no response1 • 75-85% of men progress in 9-15 months1 ADT + novel AB agent: enzalutamide or • Androgen Receptor (AR) ADT abiraterone targeted drug approaches ha
Slide 9: Current therapeutic limitations to address growing unmet medical need
Current therapeutic limitations to address this growing unmet medical need in metastatic castration resistant prostate cancer • AR targeted drugs have been exhausted in the treatment of advanced prostate cancer1 • Men who progress on androgen blocking agents are being treated with IV chemotherapies
Slide 10: VERU-111 targets the cytoskeleton: Railroad tracks disruptor
VERU-111 targets the cytoskeleton: “Railroad tracks disruptor” Binds to α & β tubulin subunits of microtubules to disrupt intracellular receptor transport Targets cytoskeleton and disrupts microtubule assembly5 Preclinical Product profile1-4, 6 • Binds to “colchicine binding site” to crosslink α and
Slide 11: VERU-111 clinical development: Phase 1b results
VERU-111 clinical development: Positive results reported in May 2020 for Phase 1b clinical trial conducted in 7 US centers • Trial design is an open label standard 3X3 to • Safety results determine Maximum Tolerated Dose (MTD) in • Dose escalated from 4.5mg to 81mg men who have metastatic castration
Slide 12: VERU-111 Phase 1b efficacy
VERU-111 clinical development: Positive results reported in May 2020 for Phase 1b clinical trial conducted in 7 US centers Efficacy (antitumor activity)1 Efficacy signals: Eight men have reached ≥ 4 21-day cycles of continuous dosing • 8 men have reached at least four 21-day cycles of continuous dos
Slide 13: VERU-111 Phase 1b clinical study case study
VERU-111 Phase 1b clinical study case study Subject with metastatic castration resistant node only disease dosed 3/19 after prostate cancer progression following treatment with leuprolide, bicalutamide, sipuleucel-T, enzalutamide, and abiraterone. VERU-111 for 11 months and -63% PSA from peak. 3/19
Slide 14: VERU-111 open label Phase 2 clinical trial
VERU-111 clinical development plan: Open label Phase 2 clinical trial initiated 2/26/20 is enrolling First in class, novel oral antitubulin agent that disrupts the cytoskeleton Indication: metastatic castration resistant prostate cancer that has also become resistant to androgen blocking agent and p
Slide 15: VERU-111 plan for pivotal Phase 3 trial with FDA
VERU-111 clinical development plan: VERU plans to meet with FDA to reach agreement on pivotal Phase 3 clinical trial • First indication: chemotherapy naïve men who have metastatic castration resistant prostate cancer and have failed one androgen blocking agent (abiraterone or • Open label enzalutami
Slide 16: VERU-111 market opportunity
VERU-111 market opportunity • Estimated annual market for advanced prostate cancer drugs • $6 billion market for novel androgen blocking agents for prostate cancer in 20181 • ZYTIGA® (abiraterone) $3.5 billion • XTANDI ® (enzalutamide) $2.59 billion Prechemotherapy estimated annual market for oral a
Slide 17: VERU-111 has global intellectual patent protection
VERU-111 has global intellectual patent protection • Licensed from the Ohio State Innovation Foundation in 2015 • Composition of matter (molecule and polymorphs) issued or allowed patents • 2 US latest expiry 2031 (with possible patent extension for NCE expiry 2036) • 1 EU latest expiry 2029 • 2 Jap
Slide 18: VERU-111 clinical development plan summary
Veru’s strategy is to focus on prostate cancer VERU-111 clinical development plan summary First in class, novel oral antitubulin agent that disrupts the cytoskeleton Phase 1b Phase 2 Planned Phase 3s Indication 1: Chemotherapy naïve metastatic castration and novel androgen blocking agent resistant p
Slide 19: VERU-111 antitumor activity in preclinical models of other tumor types
VERU-111 has shown antitumor activity in preclinical models of other tumor types: • Triple negative breast cancer (taxane resistant)1 • Cervical cancer (taxane resistant)2 • Lung cancer (taxane resistant)3 • Ovarian cancer (taxane resistant)4 • Uterine cancer5 • Pancreatic cancer6 • Melanoma7 • Huma
Slide 20: Quest for a better androgen deprivation therapy
Quest for a better androgen deprivation therapy Current commercial limitations LHRH agonist GnRH antagonist Long-acting products: LUPRON® FIRMAGON® (degarelix) (SC) Depot (IM) and ELIGARD® (SC) are leuprolide products • Painful injection as • Concerns over initial surge degarelix requires large in T
Slide 21: New potential product addressing limitations of current ADT
New potential product to addresses limitations of current ADT Long-acting 3 month depot GnRH antagonist may provide better alternative VERU-100 target product profile2 • Novel proprietary GnRH antagonist decapeptide formulation1 • 3 month slow release subQ depot (1cc SQ injection) with no loading do
Slide 22: VERU-100 clinical development program discussed with FDA
VERU-100 for the treatment of advanced prostate cancer Clinical development program has been discussed with FDA • Pre-IND meeting with FDA on April 19, 2019 reached agreement on an expedited regulatory pathway: • Clinical supply GMP manufacturing in progress • Single Phase 2 – Open label, multicente
Slide 23: ADT market for advanced prostate cancer is well established
ADT market for advanced prostate cancer is well established Total global sales of ADT drugs in 2018 was $2.6 billion (IQVIA 2018) VERU-100 could have peak sales of $750 million with 28% global market share Year Total US Ex-US 2018 $1,150M1 $1,484 M1 Intellectual property Formulation patents expire i
Slide 24: Hot flashes are a common and debilitating side effect of ADT
Hot flashes are one of the most common and debilitating side effects of androgen deprivation therapy1,2 Occur in up to 80% of men treated with ADT (leuprolide or degarelix) with 30- 40% having moderate to severe hot flashes1-3 Symptoms do not subside over time • 48% of men at 5 years and 40% of men
Slide 25: Zuclomiphene Phase 2 interim topline results
Zuclomiphene, an oral estrogen receptor agonist, is planning to advance into pivotal Phase 3 following report of positive interim topline results from Phase 2 placebo controlled dose finding study 93 men who have moderate & severe hot flashes Placebo on ADT randomized in 24 US clinical sites Randomi
Slide 26: Zuclomiphene: potential first FDA approved drug for ADT-induced hot flashes
Zuclomiphene: Potential to be the first FDA approved drug for ADT-induced hot flashes Market potential • Indication: treatment of ADT-induced moderate to severe hot flashes in men with advanced prostate cancer • Estimated 600,000 men on ADT in the U.S.1 • Number of men with hot flashes in 2020 expec
Slide 27: SARS-CoV-2
SARS-CoV-2 27
Slide 28: Global medical need for treatment of COVID-19
Global medical need for the treatment of coronavirus, also known as COVID-19 or SARS-CoV-2 SARS-CoV-2 Pandemic • SARS-CoV-2 is an enveloped, nonsegmented, positive RNA virus that has club-like spikes on surface • Global pandemic with over 4,308,357 cases and 290,165 deaths worldwide and rising1 • Cl
Slide 29: Targeting coronavirus viral-host interactions: cytoskeleton and replication cycle
Design drugs to target well-conserved coronavirus viral-host interactions: cytoskeleton (microtubules) and the SARS-CoV-2 replication cycle Virus’s most critical task is to hijack the host’s internal transportation system, the microtubules in the cytoskeleton1 • Given the spatial distances between t
Slide 30: Spike protein interacts with microtubules during intracellular trafficking
Coronavirus’s spike (S) protein is the key structure that interacts with microtubules in the cytoskeleton during intracellular trafficking4 • The first stage of interaction with the microtubule cytoskeleton occurs when the spike (S) protein on the surface of coronavirus mediates attachment to the ce
Slide 31: Colchicine has antiviral and anti-inflammatory activity but safety concerns
Microtubule depolymerization agent, colchicine, has antiviral activity and has potent anti-inflammatory effects, but also has serious safety concerns Colchicine1 is indicated for treatment of Colchicine- broad spectrum activity inflammation associated with: against multiple types of viruses in vitro
Slide 32: VERU-111 more potent inhibitor of microtubule polymerization than colchicine
VERU-111 is a more potent inhibitor of microtubule polymerization than colchicine in vitro1 Microtubule polymerization Control Colchicine (5 microM) VERU-111 (5 microM) VERU-111 (10 microM) Tubulin (0.4 mg/assay) was exposed to 5, 10 μM of VERU-111 (6a) versus vehicle control, 5% DMSO 1 Chen J et al
Slide 33: VERU-111 two-pronged approach to SARS-CoV-2
VERU-111, as a microtubule depolymerization agent, may have a two-pronged approach to the treatment of SARS-CoV-2: antiviral and anti-inflammatory agent • Based on VERU-111’s mechanistic similarities to other microtubule depolymerizing agents as well as its preclinical and clinical efficacy and safe
Slide 34: VERU-111 SARS-CoV-2 clinical development plan
VERU-111 as a potential treatment for SARS-CoV-2: Clinical development plan Double-Blind, Placebo-Controlled, Phase 2 Study of VERU-111 for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS)1 • Approxi
Slide 35: VERU-111 SARS-CoV-2 regulatory pathway
VERU-111, a novel microtubule polymerization agent, as a potential treatment for SARS-CoV-2: Regulatory pathway Regulatory update • FDA program: Coronavirus Treatment Acceleration Program (CTAP) • FDA granted IND permission on 5/12/201 • Phase 2 expected to commence in June 2020 1 U.S. Food & Drug A
Slide 36: Urology Specialty Pharmaceuticals
Urology Specialty Pharmaceuticals 36
Slide 37: TADFIN capsule to improve compliance and safety
TADFINTM capsule (tadalafil 5mg + finasteride 5mg combo) to improve compliance & safety Co-administration of CIALIS (tadalafil 5 mg) and Each component is approved or, for PROSCAR, PROSCAR (finasteride 5 mg) is currently used off label for: approved for the initial treatment of symptoms of • CIALIS
Slide 38: Pre-NDA meeting on proprietary TADFIN capsule
Pre-NDA meeting on Proprietary TADFINTM capsule • Single dose randomized two period, crossover study in 33 healthy males over the age 45 years • Tadalafil Cmax in TADFIN is 25% less than Tadalafil alone • Process of getting 12 month stability data on commercial batches • Pre-NDA meeting held May 23,
Slide 39: TADFIN for benign prostatic hyperplasia – market opportunity
TADFINTM for benign prostatic hyperplasia – market opportunity Market potential • BPH market is up to 25% of male population and estimated 1.1 billion males worldwide in 20181 • Company estimates US and global markets to be >$200 million through telemedicine and salesforce channels2 • Target men who
Slide 40: Roman Swipes (PREBOOST; benzocaine wipes for premature ejaculation)
Roman Swipes (PREBOOST® ; 4% benzocaine wipes for premature ejaculation) Veru entered into supply and distribution agreement with Get Roman (Roman Health Ventures Inc.) in February 2019 • Telemedicine company • Multi-year US supply and distribution agreement • Minimum sales requirement obligates pur
Slide 41: FC2 Female/internal Condom business revenues are growing
FC2® Female/internal Condom business revenues are growing FC2 Female/Internal Condom is the only FDA approved female use product to prevent pregnancy and transmission of sexually transmitted infections • Sold in U.S. and 149 other countries • Manufacturing plant with annual capacity of 100 million u
Slide 42: Financial highlights: Veru Business Six Months Ended March 31
Financial highlights: Veru Business Six Months Ended March 31, 2019 vs. 2020 Six Months Ended Six Months Ended March 31, 2019 March 31, 2020 42
Slide 43: Veru projected milestones
Veru projected milestones PRODUCT INDICATION 2019 2020 2021 2022 2023 PROSTATE AND ONCOLOGY NOVEL MEDICINES P1b Metastatic castration P2 resistant & AB agent resistant prostate cancer P3 NDA VERU-111 Nonmetastatic castration Oral antitubulin resistant & AB agent P3 resistant prostate cancer Intend t
Slide 44: Veru projected milestones
Veru projected milestones PRODUCT INDICATION 2019 2020 2021 2022 2023 UROLOGY SPECIALTY PHARMACEUTICALS DIVISION* TADFINTM BPH BE NDA US launch (tadalafil/finasteride) Premature ` Roman Swipes Marketed ejaculation THE FEMALE HEALTH COMPANY DIVISION Dual birth control FC2 Marketed & STI prevention Re
Slide 45: Next Steps for 2020
Next Steps for 2020 Clinical stage assets • VERU-111 – • Phase 2 – Complete enrollment June 2020 for ongoing metastatic castration & androgen blocking agent resistant prostate cancer prior to IV chemo • Planned Phase 3 – Metastatic castration & androgen blocking agent resistant prostate cancer prior