Veru Inc. · NASDAQ:VERU
Veru — Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit 2020
54 slides from Veru's conference presentation, September 2020
Slide 1: Veru Corporate Presentation
Veru Inc. Nasdaq:VERU The Prostate Cancer Company Novel Medicines Veru Corporate Presentation Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit September 21-23, 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 has revenues from sexual health division
Veru has revenues from sexual health division Oncology Division Sexual Health Division VERU-111 TADFINTM VERU-100 PREBOOST®/Roman Swipes Zuclomiphene FC2® female/internal condom 3
Slide 4: Pipeline of proprietary product candidates
Pipeline of proprietary product candidates Product Target Indication Preclinical Phase 1 Phase 2 Phase 3 Prostate Cancer Novel Medicines Metastatic castration and androgen Preclinical Planned receptor targeting Complete Phase 1b Phase 2 Phase 3 Oral, targeted agent resistant α & β tubulin inhibitor
Slide 5: Experienced in clinical practice, drug development and commercialization
Experienced in clinical practice, drug development and commercialization Mitchell Steiner, MD Harry Fisch, MD Gary Barnette, PhD Gary Bird, PhD FOUNDER, CHAIRMAN, FOUNDER, CHIEF CHIEF SCIENTIFIC OFFICER PHARMA MANUFACTURING PRESIDENT & CEO CORPORATE OFFICER & Sr. VP Scientific and Reg VP Reg Affairs
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 of stopping cancer progression1 prostate cancer treatments2 • Inadequate
Slide 8: VERU-111
VERU-111 For the treatment of metastatic castration resistant prostate cancer 8
Slide 9: Growing unmet need: metastatic castration resistant prostate cancer
Growing unmet need Metastatic castration resistant prostate cancer Androgen Receptor Targeting Agent - 15-25% of men have no response1 - 75-85% of men progress in 9-15 months1 ADT + Androgen novel AR targeting Need for new safe and Deprivation agent: enzalutamide effective treatment Therapy (ADT) or
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 Preclinical Product profile1-4, 6 assembly5 • Binds to “colchicine binding site” to crosslink α and
Slide 11: VERU-111 clinical development: Open label Phase 1b/2
VERU-111 clinical development: Open label Phase 1b/2 (expansion cohort) initiated January 2019- Johns Hopkins- Kimmel Comprehensive Cancer Center (lead center) Phase 1b Phase 2 3+3 design Open label Open label N=39 N=40 Population: Metastatic Population: Metastatic castration and novel castration an
Slide 12: VERU-111 Phase 1b Clinical Trial Design
VERU-111 Phase 1b Clinical Trial Design Dose escalation Phase 1b clinical trial of VERU-111 in men with metastatic castration resistant prostate cancer following at least one prior AR targeted therapy. • 7 US sites – Johns Hopkins lead site • 39 patients total enrolled across all sites • 1 prior AR
Slide 13: VERU-111 Phase 1b Patient Demographics
VERU-111 Phase 1b Patient Demographics Characteristic # of patients Characteristic # of patients Total number of 39 Metastatic disease patients Age, median 74 (61-92) Bone only 21 (55%) (range) LN only 6 (16%) Gleason score, 8 (5-10) median (range) Bone and LN 8 (21%) Race Caucasian 28 (72%) Viscera
Slide 14: VERU-111 Phase 1b safety results
VERU-111 clinical development: Safety results for Phase 1b clinical trial conducted in 7 US centers • Safety results • Dose escalated from 4.5mg to 81mg • MTD was determined to be 72mg; 3 of 11 men had reversible Grade 3 diarrhea • Recommended Phase 2 dose is 63mg for continuous 21-day cycle • No Gr
Slide 15: VERU-111 Phase 1b 63 mg dose safety summary
VERU-111 Phase 1b clinical trial – 63 mg dose safety summary Almost all adverse events were grade 1 and 2 25 patients in the Phase 1b study have been dosed with 63 mg per day for at least one cycle All Adverse Events Observed All Drug Related Adverse Events Incidence Incidence (%) (%) Diarrhea 14 (5
Slide 16: VERU-111 clinical development: Efficacy Data
VERU-111 clinical development: Efficacy Data Efficacy signals: Efficacy (antitumor activity) Ten men have reached ≥ 4 21-day cycles of • 10 men have reached at least four 21-day cycles of continuous dosing continuous dosing PSA responses in men receiving ≥ 4 cycles (21 days) of VERU-111 (21- day cyc
Slide 17: VERU-111 Phase 1b example case 104-001
VERU-111 Phase 1b clinical study 104-001 example case 88 yo subject (104-001-27-63mg) with Gleason 9 mCRPC, node only disease; Prior treatment included: sipuleucel-T, enzalutamide, and abiraterone On study 16 months, -63% PSA from 21 day cycle initiation baseline Screening CT scan: RP LN 1.7cm X 1.5
Slide 18: Example case: lymph node metastases coronal CT images
VERU-111 Phase 1b clinical study 104-001 example case lymph node metastases coronal CT images March 08, 2019 June 10, 2020 Screening scan 15 months follow-up A B Coronal CT C 18
Slide 19: Phase 1b Efficacy Analysis at recommended Phase 2 dose
VERU-111 clinical development: Phase 1b Efficacy Analysis: Summary of evaluable patients at recommended Phase 2 dose (63 mg) (July 2020 unaudited) Patient characteristics: Pre-taxane Treated with at least one dose of 63 mg per day or higher In all patients: N=16 Mean duration of treatment = 6.8+ mon
Slide 20: Conclusions
Conclusions • VERU-111 appears to be well tolerated in the Phase 1b portion of the study • MTD (72 mg daily) was reached with the dose limiting toxicity being Grade 3 diarrhea • Daily chronic drug administration is feasible and safe • The recommended Phase 2 dose (RP2D) is 63mg oral daily dose for 2
Slide 21: Open label Phase 2 clinical trial design
VERU-111 clinical development plan: Open label Phase 2 clinical trial will complete enrollment in August 2020 Veru-111 Androgen receptor targeting agent - 15-25% of men have no response1 • First in class, novel oral antitubulin agent that - 75-85% of men progress in 9-15 months1 disrupts the cytoske
Slide 22: Pivotal Phase 3 clinical trial design following FDA input
VERU-111 clinical development plan: Pivotal Phase 3 clinical trial design following FDA input Phase 3 trial design • Phase 3: Efficacy and safety of VERU-111 versus an alternative androgen • Open label blocking agent (abiraterone or enzalutamide) in men with metastatic castration resistant prostate
Slide 23: VERU-111 market opportunity
VERU-111 market opportunity Estimated annual market for advanced prostate cancer drugs - $6 billion market for novel androgen receptor targeting agents for prostate cancer in 2018 1 - ZYTIGA® (abiraterone) $3.5 billion - XTANDI ® (enzalutamide) $2.59 billion Prechemotherapy estimated annual market f
Slide 24: 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 Japanes
Slide 25: 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 26: VERU-100
VERU-100 For the treatment of advanced prostate cancer 26
Slide 27: 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 • Concerns over initial surge • Painful injection as degarelix in T levels- “T sur
Slide 28: New potential product to address 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 29: GnRH antagonist has lower cardiovascular events than LHRH agonist
In prospective randomize Phase 3 study, GnRH antagonist has lower cardiovascular events compared to LHRH agonist • Prospective randomize Phase 3 study in 930 men with advanced prostate cancer comparing oral GnRH antagonist to LHRH agonist (leuprolide)1 • CV events lower with GnRH antagonist (relugol
Slide 30: Preclinical VERU-100 long acting GnRH antagonist in rats
Preclinical VERU-100 long acting GnRH antagonist in rats Administration of VERU-100 formulation variants Testosterone levels decreased to undetectable resulted in undetectable testosterone levels within hours after injection without flare which lasted more than six months 1Getzenberg R et al. GU ASC
Slide 31: Preclinical VERU-100 in rats: Conclusions
Preclinical VERU-100 long acting GnRH antagonist in rats Conclusions • With a single, subcutaneous injection, formulations of VERU-100 in rats resulted in >1 ng/mL blood levels of GnRH antagonist for more than six months • VERU-100 administration resulted in undetectable total testosterone levels fo
Slide 32: VERU-100 clinical development program
VERU-100 for the treatment of advanced prostate cancer Clinical development program • Veru plans to submit an Investigational New Drug application 4Q 2020 to support initiation of Phase 2 dose finding study • Nonclinical studies to support Phase 2 and Phase 3 completed • Clinical supply GMP manufact
Slide 33: 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 34: Zuclomiphene
Zuclomiphene For the treatment of hot flashes in men on ADT for advanced prostate cancer 34
Slide 35: 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 36: Zuclomiphene Phase 2 placebo controlled dose finding study
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 on ADT randomized in 24 US clinical sites • Trial design
Slide 37: 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 38: VERU-111 18mg for the treatment of COVID-19
VERU-111 18mg For the treatment of COVID-19 38
Slide 39: 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 40: Targeting viral-host interactions: cytoskeleton and SARS-CoV-2 replication
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 41: VERU-111 two-pronged approach: antiviral and anti-inflammatory
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 42: 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 43: 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 initiated in June 2020 1 U.S. Food & Drug Administrati
Slide 44: Sexual Health Division
Sexual Health Division 44
Slide 45: TADFIN capsule (tadalafil + finasteride combo)
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 46: Pre-NDA meeting on 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 47: 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 48: Roman Swipes (PREBOOST)
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 and extended in August 2020 • Premier men’s health telemedicine company • 3 year multi-year multi-million US suppl
Slide 49: 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 50: Financial highlights: Veru Business
Financial highlights: Veru Business 9 Months Ended June 30, 2019 vs. 2020 Net Revenues Gross Profit Operating Loss June 30th, 2019 FYTD June 30th, 2020 FYTD 50
Slide 51: Financial highlights (in millions)
Financial highlights (in millions) Capitalization – approximately 69.9 million1 common shares outstanding as of June 30, 2020 Results of Operations for Jun FYTD 2020 • Net revenues $ 30.8 • Gross profit $ 21.2 • Operating loss $ 3.5 Balance sheet as of June 30, 2020 • Cash $ 15.4 • Receivables $ 4.1
Slide 52: Veru projected milestones
Veru projected milestones Product Indication 2019 2020 2021 2022 2023 Oncology Novel Medicines P1b Metastatic castration resistant & AR targeting P2 agent resistant prostate cancer P3 NDA VERU-111 Oral antitubulin SARS-CoV-2 infection P2 VERU-100 Advanced hormone GnRH antagonist sensitive prostate c
Slide 53: 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) Roman Swipes Premature Ejaculation Marketed The Female Health Company Division Dual birth control & STI FC2 prevention Marketed Repr
Slide 54: Next Steps for 2020
Next Steps for 2020 Clinical stage assets • VERU-111 – • Phase 2 – Complete enrollment for ongoing metastatic castration & androgen receptor targeting agent resistant prostate cancer and prior to IV chemo • Planned Phase 3 – Metastatic castration & androgen receptor targeting agent resistant prostat
Veru — Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit 2020 on 6ix