Veru Inc. · NASDAQ:VERU
Veru — Oppenheimer 31st Annual Healthcare Conference 2021
64 slides from Veru's conference presentation, Mar 16, 2021
Slide 1: Veru Corporate Presentation
Veru Inc. Nasdaq:VERU Oncology Biopharmaceutical Company Focused on Prostate Cancer and Breast Cancer Veru Corporate Presentation Oppenheimer 31st Annual Healthcare Conference March 16-17, 2021
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. Forward-looking statements can be identified by the use of forward-looking words or phrases such as “anticipate,” “believe,” “could,” “expect,
Slide 3: Oncology biopharmaceutical company
Oncology biopharmaceutical company Focused on prostate cancer and breast cancer VERU-111 Prostate Cancer Late-stage clinical pipeline focused on prostate cancer & VERU-100 breast cancer Late stage COVID-19 antiviral and anti-inflammatory agent Oncology COVID-19 VERU-111 5 registration clinical studi
Slide 4: Drug candidate pipeline
Drug candidate pipeline1 Oncology biopharmaceutical company focused on prostate cancer and breast cancer Product Indication Preclinical Phase 1 Phase 2 Phase 3 Prostate Cancer Metastatic castration VERU-111 resistant & AR targeting VERACITY Phase 3 Preclinical Phase 1b Phase 2 Oral cytoskeleton agen
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 CORPORATE CHIEF SCIENTIFIC OFFICER PHARMA MANUFACTURING PRESIDENT & CEO OFFICER & VICE CHAIRMAN Sr. VP Scientific and Reg
Slide 6: Prostate Cancer - Novel Medicines
Prostate Cancer - Novel Medicines 6
Slide 7: VERU-111
VERU-111 For the treatment of metastatic castration resistant prostate cancer 7
Slide 8: VERU-111 Target Product Profile
VERU-111 Target Product Profile Targets the cytoskeleton: “Railroad tracks disruptor” Targets cytoskeleton and disrupts microtubule Preclinical Product profile1-4, 6 assembly5 • Binds to “colchicine binding site” to crosslink α and β tubulin subunits to disrupt microtubule polymerization • Downregul
Slide 9: VERU-111 prostate cancer treatment paradigm
VERU-111 prostate cancer treatment paradigm: Focus is on the prechemotherapy space which is a growing unmet need Chemotherapy Current indication PARP inhibitor DNA repair Olaparib alterations (BRCA1 and BRCA2) ARTA Metastatic castration Approx 10% Metastatic castration resistant prostate and ARTA re
Slide 10: VERU-111 clinical development
VERU-111 clinical development Phase 1b (expansion cohort) Dose escalation Phase 1b clinical trial of VERU-111 in men with metastatic castration resistant prostate cancer following at least one prior AR targeting therapy and up to one taxane • 7 US sites – Johns Hopkins Kimmel Comprehensive Cancer Ce
Slide 11: VERU-111 Phase 1b safety summary
VERU-111 clinical development Phase 1b - 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 (%) Diarrhe
Slide 12: VERU-111 Phase 1b efficacy
VERU-111 clinical development Phase 1b efficacy PSA waterfall plot Ten men have reached ≥ 4 cycles of continuous dosing • 10 men reached at least four cycles of continuous dosing 50 Max PSA % decrease • Disease (4 Bone;3 LN; and 3 LN+Bone) 0 from baseline • Previous treatment- (5 Abi; 2 Enz; and 3 A
Slide 13: Phase 1b rPFS analysis
VERU-111 clinical development Phase 1b efficacy analysis rPFS at recommended Phase 2 dose of 63mg Radiographic progression free survival for all patients that received > 1 dose of VERU-111 63mg or higher (n=19) Progression free survival rate Time on study (days) Median radiographic progression free
Slide 14: Phase 1b case study patient 4-001
VERU-111 clinical development Phase 1b case study patient 104-001 March 08, 2019: Screening CT scan June 10, 2020: 15 months follow-up RP LN 1.7cm X 1.5cm RP LN 1.1cm X 1.0cm (measurable target lesion) (-33% decrease to nonpathologic node) Patient: 104-001 Gleason 9 mCRPC with lymph node only diseas
Slide 15: Phase 1b conclusions
VERU-111 clinical development Phase 1b conclusions MTD (72 mg daily) was reached with the dose limiting toxicity being Grade 3 diarrhea Daily chronic drug administration is feasible and safe VERU-111 appears to be well tolerated in the Phase 1b portion of the study The recommended Phase 2 dose (RP2D
Slide 16: VERU-111 Phase 2 study
VERU-111 clinical development Phase 2 clinical study ongoing and completed enrollment of 41men in September 2020 • Conducted in 13 US clinical centers • Population: Men who have metastatic castration resistant prostate cancer and who have also become resistant to an ADT + androgen receptor targeting
Slide 17: VERU-111 clinical development plan (VERACITY Phase 3)
VERU-111 clinical development plan VERACITY Phase 3 clinical trial design following FDA input – planned initiation 1Q 2021 • Open label Phase 3: Efficacy and safety of VERU-111 versus an alternative androgen receptor target agent (abiraterone or enzalutamide) in men with metastatic castration • VERU
Slide 18: VERU-111 may have efficacy beyond prostate cancer
VERU-111 may have efficacy beyond prostate cancer Antitumor activity of VERU-111 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 cance
Slide 19: VERU-111 intellectual property protection
VERU-111 has strong global intellectual property 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 •
Slide 20: VERU-111 market
VERU-111 market Prechemotherapy estimated annual market for oral agents for prostate cancer 2018 $6 billion global annual sales; $3.1 billion in the US 1 Androgen receptor 15-25% of men have no response3 $4.9 billion global targeting agents for $1.5 billion annual sales in metastatic Japan, the cast
Slide 21: VERU-100
VERU-100 For the treatment of advanced prostate cancer 21
Slide 22: Quest for a better androgen deprivation therapy: VERU-100
Quest for a better androgen deprivation therapy: VERU-100 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 leve
Slide 23: 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 24: VERU-100 target product profile
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 Clinical development program • Novel proprietary GnRH antagonist decapeptide as agreed upon by FDA formulation1 Open label Phase 2 •
Slide 25: Breast Cancer - Novel Medicines
Breast Cancer - Novel Medicines 25
Slide 26: Enobosarm
Enobosarm for the treatment of AR+ ER+ HER2 - advanced breast cancer 26
Slide 27: Current Endocrine Therapies
Endocrine therapies that target estrogen receptor axis are effective against ER+ breast cancer Current Endocrine Therapies Selective estrogen receptor modulators (tamoxifen and toremifene) Resistance to endocrine therapies eventually occurs ER antagonists and degraders (fulvestrant) which requires a
Slide 28: Androgen receptor in breast cancers
Androgen receptor is the most abundantly expressed sex hormone receptor in breast cancers with up to 95% of breast cancers 2-6 • What is the androgen receptor’s function in breast tissue? • Does activation of the androgen receptor stimulate or suppress breast cancer growth? • In normal and cancerous
Slide 29: Enobosarm, first-in-class selective AR targeting agent
Enobosarm, first-in-class, novel oral selective AR targeting and activating agent for the treatment for AR+ER+ advanced breast cancer • Enobosarm is a non-steroidal, selective androgen receptor agonist1, 2 • Once-a-day oral daily dosing • Selectivity to activate the androgen receptor with no cross-r
Slide 30: Enobosarm extensive clinical experience
Enobosarm has an extensive clinical experience • Enobosarm has been evaluated in 25 clinical trials comprising 2,091 subjects (348 subjects dosed at > 9mg) • 6 Phase 2 studies in breast cancer (5) or breast disease (1) • G200801 – Proof of concept 9 mg Enobosarm in AR+ ER+ metastatic breast cancer •
Slide 31: Phase 2 trial G200802 presented at SABCS
Phase 2 clinical trial (G200802): AR+/ER+ metastatic breast cancer presented at San Antonio Breast Cancer Symposium December 2020 Efficacy and safety of Enobosarm, a selective androgen receptor agonist, to target AR in women with advanced AR+/ER+ breast cancer – final results from an international P
Slide 32: Phase 2 trial G200802 design
Phase 2 clinical trial (G200802) design Targeting AR+ER+ metastatic breast cancer in a heavily pretreated population1 Enobosarm 9 mg N=72 Randomization Screening 1:1 Enobosarm 18 mg N=64 • Trial design • Open label, multicenter, multinational, randomized parallel design Phase 2 study to assess the e
Slide 33: Phase 2 G200802 patient demographics
Phase 2 clinical trial (G200802) Patient demographics 9 mg cohort 18 mg cohort Age (median), years (range) 60.5 (35-83) 62.5 (42-81) Caucasian (%) 98.0 94.2 Initial presentation of Stage IV metastatic breast cancer 12% 26.9% Median months since initial diagnosis (range) 110.0 (19-435) 86.0(15-323) M
Slide 34: Efficacy summary, evaluable population
Phase 2 clinical trial (G200802) Efficacy summary Evaluable Population 9mg cohort 18mg cohort Number of evaluable patients 50 52 Primary endpoint: 32% (95% C.I. 19.5%;46.7%) 29% (95% C.I. 17.1%;43.1%) CBR at 24 weeks Median rPFS (range) >5.6 months (0->27.5) 4.2 months (0-16.5) 34
Slide 35: Duration of clinical benefit
Phase 2 clinical trial (G200802): Duration of CBR is approximately 12-14 months 9 mg 18 mg Please note that the x-axis is different 35
Slide 36: Best objective tumor responses
Phase 2 clinical trial (G200802) Best objective tumor responses Efficacy results- RECIST 1.1 best overall tumor responses (BOR) by central read at any time during the study in patients with measurable disease at baseline • 9 mg cohort (n=34) • 2 (5.9%) complete responses • 8 (23.5%) partial response
Slide 37: % Best Reduction in Target Lesion
% Best Reduction in Target Lesion 0 -150 -100 -50 50 100 150 7004-8155 7025-8076 7021-8028 7004-8085 7006-8007 6002-8140 7025-8124 7019-8021 6003-8134 7004-8110 7025-8038 7004-8111 6002-8070 7004-8175 Phase 2 clinical trial (G200802) 7015-8023 7025-8102 7004-8170 6002-8128 4003-8016 7026-8104 7004-8
Slide 38: % Best Reduction in Target Lesion (9mg)
% Best Reduction in Target Lesion 0 20 40 60 80 -120 -100 -80 -60 -40 -20 7004-8135 7021-8028 7006-8007 6002-8140 7025-8124 7004-8112 6003-8134 7004-8110 7002-8114 6002-8070 7004-8175 7001-8147 Phase 2 clinical trial (G200802) 7028-8083 3001-8045 7004-8170 7004-8173 7004-8103 4003-8016 3005-8030 700
Slide 39: QOL assessment
Phase 2 clinical trial (G200802) QOL assessment • EuroQol-visual analogue scale (EQ-VAS) scores were obtained at baseline and during the study (week 24 and EOT) • For the entire instrument there was 8.6 (14.69) (p=0.002) for 9mg and 7.3 (16.67) (p=0.011) for 18mg decrease in score (improvement) from
Slide 40: Safety summary all patients ITT
Phase 2 clinical trial (G200802) Safety summary all patients ITT Enobosarm was well tolerated; majority of events were Grade 1 and 2 Enobosarm 9 mg Enobosarm 18 mg N=75 N=61 Patients with any SAEs 8 (10.7%) 10 (16.4%) Grade 3 Drug Related Adverse Events 5 9 Grade 4 Drug Related Adverse Events 1 1 Pa
Slide 41: Conclusions: AR targeted therapy efficacy and safety
Phase 2 clinical trial (G200802) Conclusions- AR targeted therapy shows efficacy and safety in AR+ ER+ breast cancer • Enobosarm AR targeted treatment demonstrated clinical benefit with objective tumor responses in women with heavily pretreated estrogen receptor targeted resistant AR+ ER+ metastatic
Slide 42: Enobosarm and CDK4/6 inhibitors preclinical models
Role of enobosarm and CDK4/6 inhibitors in estrogen receptor targeting agent resistant AR+/ER+ metastatic breast cancer- preclinical models (Patient derived xenografts)1,2 • CDK4/6 inhibitor suppressed growth of ER targeting agent resistant breast cancer1,2 • Enobosarm monotherapy had greater inhibi
Slide 43: CDK 4/6 inhibitor resistant patients
Phase 2 clinical study (G200802) Evaluable patients (AR+) with CDK 4/6 inhibitor resistance in the metastatic setting CDK 4/6 inhibitor resistant subjects with measurable disease • Objective tumor responses 9 mg Outcome 18 mg Outcome patient ID patient ID • 30% overall 7004-8120 6003-8133 • CBR at 2
Slide 44: Assumptions for Phase 3 Design
Assumptions for Phase 3 Design Summary of efficacy for two Phase 2 clinical trials (G200801 and G200802) G200801 and G200802 efficacy summary for 9mg Phase 2 801 Phase 2 802 (n=22) (n=50) 32% (95% C.I. Active Control Assumption 35.3% (90% CBR at 6 months 19.5%;46.7%) CI:16.6%,58%) rPFS for exemestan
Slide 45: Pivotal Phase 3 ARTEST clinical trial
Enobosarm, AR targeted endocrine therapy pivotal Phase 3 open label, randomized ARTEST clinical trial- anticipated to start Q2 2021 ARTEST Clinical Trial Design ARTEST Indication Phase 3 Pivotal AR+ER+HER2- Phase 3 open label, multicenter, multinational, Treatment of AR+ER+HER2- metatstatic breast M
Slide 46: Pembrolizumab + enobosarm in AR+ TNBC
Combination of pembrolizumab + enobosarm in AR+ triple negative breast cancer • Preclinical models of AR+ TNBC show enobosarm has antitumor activity in animal models1 • Phase 2 clinical trial2 • Open label, single arm • Enobosarm 18 mg oral daily dosing • Pembrolizumab 200mg IV every 3 weeks • 18 wo
Slide 47: Enobosarm intellectual property protection
Enobosarm has strong global intellectual property protection Licensed from the University of Tennessee Research Foundation in 2020 Composition of matter (molecule and polymorphs) issued or allowed patents • 5 US latest expiry 2029 (with patent extension for NCE expiry 2034) • 3 EU latest expiry 2028
Slide 48: VERU-111 for taxane resistant triple negative breast cancer
VERU-111 for the treatment of taxane resistant triple negative breast cancer 48
Slide 49: IMMU-132 (TRODELVY) vs VERU-111 in TNBC animal model
Comparison of IMMU-132 (TRODELVY) and VERU-111 in MDA-MB-231 triple negative breast cancer animal model TRODELVY (IMMU-132) has no activity Oral VERU-111 has antitumor activity in MDA-MB-231 TNBC Animal Model2 in MDA-MB-231 TNBC Animal Model1 1US patent US2018/0271992 A1|2 Deng et al, Mol Can Therap
Slide 50: Phase 2b study: VERU-111 for taxane resistant TNBC
Phase 2b clinical study: VERU-111 for taxane resistant triple negative breast cancer Trial study design • Confirmed metastatic TNBC who failed taxane based chemotherapy Phase 2b pivotal taxane resistant triple negative breast cancer • Randomized open label study • VERU-111 versus TRODELVY • 212 subj
Slide 51: VERU-111 for hospitalized COVID-19 patients
VERU-111 18mg For the treatment of hospitalized patients with COVID-19 at high risk for acute respiratory distress syndrome 51
Slide 52: Coronavirus spike protein and microtubules
Coronavirus’s spike (S) protein is the key structure that interacts with microtubules in the cytoskeleton during intracellular trafficking4 • Virus’s most critical task is to hijack the host’s internal transportation system, the microtubules in the cytoskeleton1,3 SARS-CoV-2 structure4 • VERU-111 di
Slide 53: VERU-111 Phase 2 trial design for COVID-19
VERU-111: Phase 2 clinical trial design for COVID-19 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 Trial design Patient demographic
Slide 54: Phase 2 trial of VERU-111 18 mg endpoints
Phase 2 clinical trial of VERU-111 18 mg Endpoints - patients that received >1 dose of drug Relative Primary Endpoint Placebo VERU-111 p-value Reduction Treatment failures, i.e. death or respiratory failure at Day 29 (MITT) 6/20 (30%) 1/18 (5.6%) 81% p=0.05 Relative Secondary Endpoints Placebo VERU-
Slide 55: Safety outcomes for VERU-111 18mg
Safety outcomes for VERU-111 18mg from Phase 2 clinical trial Any adverse event that occurred in ≥ 2 patients on study VERU-111 18 mg Placebo Preferred Term (n=19) (n=20) N (%)/ events N (%)/events Safety Any 10 (52.6)/27 11 (55.0)/41 • There were no treatment related Constipation 2 (10.5)/2 2 (10.0
Slide 56: Next steps clinical development for COVID-19
Next steps clinical development of VERU-111 for high risk COVID-19 patients • End of Phase 2 meeting with FDA February 2021 • FDA agrees that Phase 2 clinical findings suggest a clinically meaningful benefit for use of VERU-111 in hospitalized COVID-19 patients at high risk for ARDS • FDA agrees to
Slide 57: COVID-19 Phase 3 clinical trial
COVID-19 Phase 3 clinical development clinical trial will start in April 2021 Double-Blind, Placebo-Controlled, Phase 3 Study of VERU-111 for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Hospitalized Patients at High Risk for Acute Respiratory Distress Syndrome (A
Slide 58: Sexual Health Division
Sexual Health Division 58
Slide 59: TADFIN
NDA submitted 2/21 for TADFINTM capsule (tadalafil 5mg + finasteride 5mg combo) to improve compliance & safety COMBINATION Pre-NDA meeting on Proprietary TADFINTM capsule • Single dose randomized two period, TADFIN TM crossover study in 33 healthy males over the age 45 years • Process of getting 12
Slide 60: 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 61: FC2 revenues
FC2 revenues FC2 global public sector & FC2 US prescription revenues (Millions USD) $13.75 FC2 Revenues Global Public Sector US Prescription $10.96 $10.42 $4.65 FY 2018: $ 15.9 mm $9.52 $9.65 FY 2019: $ 30.9 mm $9.28 $2.23 FY 2020: $ 40.6 mm $8.47 $4.37 $2.57 $6.84 $4.25 $6.32 $4.91 $3.80 FC2 US Pre
Slide 62: Financial highlights
Financial highlights Results of Operations FY 2020 Net Revenues $ 42.6 mm FY 2020 Gross Profit $ 30.8 mm FY 2020 Operating Loss $ 14.7 mm FY 2020 Adjusted Operating Loss1 $ 0.6 mm Record quarter for revenue growth from sexual health Q1 FY 2021 Net Revenues $ 14.6 mm business $14.6 million with Q1 FY
Slide 63: Drug candidate pipeline
Drug candidate pipeline1 Oncology biopharmaceutical company focused on prostate cancer and breast cancer Product Indication Preclinical Phase 1 Phase 2 Phase 3 Prostate Cancer Metastatic castration VERU-111 resistant & AR targeting VERACITY Phase 3 Preclinical Phase 1b Phase 2 Oral cytoskeleton agen
Slide 64: Milestones
Milestones 5 registration clinical studies expected to be initiated in calendar year 20211 Prostate cancer Breast Cancer COVID-19 VERU-111 Enobosarm VERU-111 • Phase 2 trial: completely enrolled • Initiate Phase 3 clinical study • Initiate Phase 3 trial in 2Q of 2021 and ongoing metastatic castratio
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