Veru Inc. · NASDAQ:VERU
Veru — Investor Presentation (January 2021)
66 slides from Veru's investor presentation, January 2021
Slide 1: Veru Corporate Presentation – January 2021
Veru Inc. Nasdaq:VERU Oncology Biopharmaceutical Company Focused on Prostate Cancer and Breast Cancer Veru Corporate Presentation – January 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: Veru
Veru Oncology biopharmaceutical company focused on prostate cancer and breast cancer Sold 12/08/20 Funding Commercial PREBOOST® Oncology Products FC2® Prostate Breast Female/ Cancer Cancer TADFYNTM Internal Condom VERU-111 VERU-100 Enobosarm VERU-111 Significant and growing revenues from FC2® Female
Slide 4: Pipeline & Milestones
Pipeline & Milestones Oncology biopharmaceutical company focused on prostate cancer and breast cancer PRODUCT INDICATION 2020 2021 2022 2023 2024 Prostate cancer P1b Metastatic castration VERU-111 resistant & AR targeting Oral cytoskeleton agent resistant prostate P2 disruptor cancer prior to IV che
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
Slide 7: VERU-111 prostate cancer treatment paradigm: prechemotherapy space
VERU-111 prostate cancer treatment paradigm: Focus is on the prechemotherapy space which is a growing unmet need Current indication is prechemotherapy space MSI- Pembrolizumab H/dMMR PARP inhibitor Chemotherapy Mutations Olaparib DNA repair 3% alterations (BRCA1 and BRCA2) ARTA Metastatic castration
Slide 8: VERU-111
VERU-111 For the treatment of metastatic castration resistant prostate cancer 8
Slide 9: 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 cytoskeleton Targets cytoskeleton and disrupts microtubule Preclinical Product profile1-4, 6 assembly5 • Binds to “colchicine binding site” to crosslink α and β tubulin subunits
Slide 10: VERU-111 clinical development: Phase 1b ongoing
VERU-111 clinical development: Phase 1b (expansion cohort) ongoing Phase 1b Population: Metastatic castration and androgen 3+3 design receptor targeting agent resistant prostate cancer Open label ± 1 taxane N = 39 Dose escalation Phase 1b clinical trial of VERU-111 in men with metastatic castration
Slide 11: VERU-111 Phase 1b Patient Demographics
VERU-111 Phase 1b Patient Demographics Characteristics Subjects 39 Metastatic Disease Age 74 yo median Bone only 21 (55%) (61-92) Gleason sum 8 (5-10) LN only 6 (16%) Race Bone and LN 8 (21%) Caucasian 28 (72%) Visceral 1 (3%) African 8 (21%) Visceral and 1 (3%) American bone Hispanic 3 (8%) Prior t
Slide 12: VERU-111 Phase 1b Patient Safety
VERU-111 Phase 1b Patient Safety Safety results for Phase 1b clinical trial conducted in 7 US centers • 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 Grade 3 diarrhea
Slide 13: VERU-111 Phase 1b efficacy (antitumor activity)
VERU-111 clinical development: Phase 1b efficacy (antitumor activity) • 10 men reached at least four 21-day cycles of continuous Efficacy signals: dosing Ten men have reached ≥ 4 21-day cycles of continuous dosing • Disease (4 Bone;3 LN; and 3 LN+Bone) 50 Previous Tx- (5 Abi; 2 Enz; and 3 Abi+Enz) d
Slide 14: VERU-111 Phase 1b clinical study: Case study patient 104-001
VERU-111 Phase 1b clinical study: 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 node only disease Prior treatmen
Slide 15: VERU-111 1b clinical development: Conclusions
VERU-111 1b clinical development: 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 (RP2
Slide 16: VERU-111 Phase 2 clinical study ongoing
VERU-111 Phase 2 clinical study ongoing and completed enrollment of ≈ 40 men in September 2020 • Conducted in 14 US clinical centers • Population: Men who have metastatic castration resistant prostate cancer and who have also become resistant to an androgen receptor targeting agent (ARTA), but prior
Slide 17: VERU-111 Pivotal Phase 3 clinical trial design
VERU-111 clinical development plan: Pivotal Phase 3 clinical trial design following FDA input – initiating 1Q 2021 Phase 3: Efficacy and safety of VERU-111 versus an alternative androgen receptor VERACITY Phase 3 trial design target agent (abiraterone or enzalutamide) in men with metastatic castrati
Slide 18: VERU-111 Phase 1b Efficacy Analysis at recommended Phase 2 dose
VERU-111 Phase 1b clinical development: Efficacy Analysis at recommended Phase 2 dose of 63mg • Patient characteristics: • Pre-taxane • Treated with at least one dose of 63 mg per day or higher • In all patients (n=16): • Median duration of treatment without progression = 5.8+ months (range 0-21+ mo
Slide 19: 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 20: 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 canc
Slide 21: VERU-111 prostate cancer treatment paradigm: largest segment
VERU-111 prostate cancer treatment paradigm: Focus is on the prechemotherapy space- largest segment of advanced prostate cancer Current indication MSI- Pembrolizumab H/dMMR PARP inhibitor Chemotherapy Mutations Olaparib DNA repair 3% alterations ARTA (BRCA1 and BRCA2) Metastatic castration 10% resis
Slide 22: VERU-111 has strong global 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 23: VERU-100
VERU-100 For the treatment of advanced prostate cancer 23
Slide 24: 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 25: 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 26: 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 27: VERU-100 clinical development program agreed upon by FDA
VERU-100 for the treatment of advanced prostate cancer Clinical development program as agreed upon by FDA • Nonclinical studies to support Phase 2 and Phase 3 completed • Clinical supply GMP manufacturing completing Single Phase 2 Single registration Phase 3 Scheduled for 1H 2021 Scheduled for 2H 20
Slide 28: 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 29: Breast Cancer - Novel Medicines
Breast Cancer - Novel Medicines 29
Slide 30: Enobosarm
Enobosarm for the treatment of AR+ ER+ HER2 - advanced breast cancer 28
Slide 31: Current Endocrine Therapies
Endocrine therapies that target estrogen receptor axis 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 alter
Slide 32: A selective AR agonist may be the next important class of endocrine therapy
A selective AR agonist targeting the androgen receptor may be the next important class of endocrine therapy in breast cancer • Historically, androgens have been used in breast cancer treatment but their virilizing effects, increase in hematocrit, and liver toxicity have limited their clinical applic
Slide 33: Enobosarm, first-in-class oral selective AR targeted treatment
Enobosarm, first-in-class, novel oral selective AR targeted treatment for AR+ER+ advanced breast cancer • Enobosarm is a non-steroidal, selective androgen receptor agonist1, 2 • Once-a-day oral daily dosing • Selectivity for androgen receptor with no cross-reactivity or binding to other steroidal ho
Slide 34: Enobosarm has extensive clinical experience
Enobosarm, first-in-class, novel oral selective AR targeted treatment for AR+ER+ advanced breast cancer has extensive clinical experience • Enobosarm has extensive nonclinical and clinical experience as it as been evaluated in 25 clinical trials comprising 2,091 subjects (348 subjects dosed at > 9mg
Slide 35: Phase 2 clinical trial (G200801): AR+ER+ advanced breast cancer
Phase 2 clinical trial (G200801): AR+ER+ advanced breast cancer • Phase 2 Trial design (G200801) • Single arm Phase 2 proof of concept study with 9mg daily dose • Efficacy primary endpoint- To assess the clinical benefit rate (CBR) (CR+ PR + SD) in subjects with AR+ ER+ advanced breast cancer treate
Slide 36: Efficacy results
Phase 2 clinical trial (G200801): AR+ER+ metastatic breast cancer Efficacy results • Median time on drug 86 days (2-363 days) • Clinical benefit rate at 6 months =35.3% (90% CI:16.6%,58%) • One patient had decrease in lung lesion from 25mm to 17mm on day 84, but also had evidence of liver progressio
Slide 37: Phase 2 clinical trial (G200801): Safety
Phase 2 clinical trial (G200801): AR+/ER+ metastatic breast cancer Safety • Enobosarm was well tolerated • 21 subjects experienced 87 mostly mild to moderate intensity treatment-related AEs • 2 AEs (fatigue and generalized weakness and bone pain) • 2 AR+ subjects had SAEs of severe bone pain • 2 sub
Slide 38: Phase 2 clinical trial (G200802) presented at San Antonio Breast Cancer Symposium
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 39: Phase 2 clinical trial (G200802): trial design
Phase 2 clinical trial (G200802): AR+ER+ metastatic breast cancer who previously responded to endocrine treatment, heavily pretreated population Enobosarm 9mg 72 Patients Screening RANDOMIZATION 1:1 Enobosarm 18mg 64 Patients • Trial design • Open label, multicenter, multinational, randomized parall
Slide 40: Phase 2 clinical trial (G200802): baseline demographics
Phase 2 clinical trial (G200802): baseline demographics heavily pre-treated population 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 (ran
Slide 41: Phase 2 clinical trial (G200802): Efficacy summary
Phase 2 clinical trial (G200802): Efficacy summary Evaluable Population 9mg cohort 18mg cohort Number of evaluable patients 50 52 CBR at 24 weeks 32% (95% C.I. 19.5%;46.7%) 29% (95% C.I. 17.1%;43.1%) Median rPFS (range) >5.6 months (0->27.5) 4.2 months (0-16.5) 41
Slide 42: Phase 2 (G200802): duration of clinical benefit
Phase 2 clinical trial (G200802): duration of clinical benefit in patients with clinical benefit at week 24 9 mg 18 mg Please note that the x-axis is different 42
Slide 43: Phase 2 (G200802): best overall tumor responses
Phase 2 clinical trial (G200802): best overall tumor responses • Efficacy results- RECIST 1.1 best overall tumor responses by central read at any time during the study in patients with measurable disease at baseline • 9 mg cohort (n=34) • 1 (2.9%) complete response • 11 (32.4%) partial response • 35
Slide 44: Phase 2 clinical trial (G200802): 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) and 7.3 (16.67) (p=0.011) decrease in score (improvement) from baseline to the
Slide 45: Phase 2 clinical trial (G200802): safety
Phase 2 clinical trial (G200802): safety Enobosarm was well tolerated; majority of events were Grade 1 and 2 Summary of safety (all patients - ITT) 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 Advers
Slide 46: Phase 2 (G200802): Conclusions
Phase 2 clinical trial (G200802): AR+ER+ metastatic breast cancer Conclusions- AR targeted therapy shows efficacy in ER resistant breast cancer • Enobosarm AR targeted treatment demonstrated clinical benefit with objective tumor responses in women with heavily pretreated estrogen receptor targeted r
Slide 47: G200801 and G200802 efficacy summary for 9mg
Assumptions for Phase 3 Design Summary of efficacy for Phase 2 clinical trials (G200801 and G200802) G200801 and G200802 efficacy summary for 9mg Phase 2 801 Phase 2 802 (n=22) (n=50) CBR at 6 months 35.3% (90% 32% (95% C.I. Active Control Assumption CI:16.6%,58%) 19.5%;46.7%) rPFS for exemestane wa
Slide 48: Agreement with FDA to advance Enobosarm to pivotal Phase 3
Reached agreement with FDA to advance Enobosarm, AR targeting endocrine therapy, to pivotal Phase 3 open label, randomized clinical trial Indication- treatment of ER+/HER2- advanced breast cancer in subjects who have failed a nonsteroidal aromatase inhibitor(NSAI), fulvestrant, and CDK4/6 inhibitor
Slide 49: Enobosarm and CDK4/6 inhibitors in resistant breast cancer preclinical models
Role of enobosarm and CDK4/6 inhibitors in estrogen receptor targeting agent resistant metastatic breast cancer- preclinical models (Patient derived xenografts)1,2 • CDK4/6 inhibitor inhibits growth of ER targeting agent resistant breast cancer1,2 • Enobosarm monotherapy has greater inhibition of ER
Slide 50: Enobosarm has strong global 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 51: Market opportunity: endocrine treatments for advanced breast cancer
Market opportunity: Current annual market for an endocrine treatments for advanced breast cancer drugs • Injectable –FASLODEX® (fulvestrant) revenues • Global $1 billion market in 20181 • US $537 million market in 20181 • Oral agent - CDK4/6 inhibitors in combination with endocrine therapies (AI or
Slide 52: VERU-111 for taxane resistant triple negative breast cancer
VERU-111 for the treatment of taxane resistant triple negative breast cancer 52
Slide 53: Preclinical studies in TNBC xenografts: VERU-111
Preclinical studies in TNBC MDA-MB-231 and taxane resistant HCl-10-Luc2 TNBC xenografts: VERU-111 for taxane resistant triple negative breast cancer1 Taxane sensitive Taxane resistant 1 Deng S et al. Mol Cancer Ther 19:348-63, 2020 53
Slide 54: Comparison of IMMU-132 (TRODELVY) and VERU-111 in TNBC 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 in Oral VERU-111 has antitumor activity in MDA-MB-231 TNBC Animal Model1 MDA-MB-231 TNBC Animal Model2 1US patent US2018/0271992 A1|2 Deng et al, Mol Can Therap
Slide 55: Phase 2b clinical 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 • 200 subj
Slide 56: VERU-111 18mg For the treatment of COVID-19
VERU-111 18mg For the treatment of COVID-19 56
Slide 57: VERU-111 for 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 58: Sexual Health Division
Sexual Health Division 58
Slide 59: TADFYN capsule (tadalafil + finasteride combo)
TADFYNTM capsule (tadalafil 5mg + finasteride 5mg combo) to improve compliance & safety Co-administration Pre-NDA meeting on Proprietary TADFYNTM capsule • Single dose randomized two period, TADFYN TM crossover study in 33 healthy males over the age 45 years • Process of getting 12 month stability C
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: Financial highlights: Prescription sales & FC2 trends
Financial highlights: Prescription sales (12 pack units) & FC2 trends FC2 Prescription Quarterly Sales FC2 Prescription Yearly Sales 12-Pack Units 12-Pack Units 108,459 90,456 81,435 342,119 9% 61,769 25 54,955 51,812 R: G CA 158,976 28,107 24,102 15,172 4,164 24,083 2,011 2,736 7,396 Q1 FY18 Q2 FY1
Slide 62: Commercial Products
Commercial Products FC2 Global Public Sector & FC2 US Prescription Revenues (Millions USD) $10.96 $10.42 FC2 Revenues Global Public Sector $9.52 $9.65 $9.28 $2.23 US Rx $8.47 FY 2018: $ 15.9 mm $4.37 $2.57 FY 2019: $ 30.9 mm $4.25 FY 2020: $ 40.6 mm $6.84 $6.32 $4.91 $3.80 $5.50 $5.20 FC2 US Prescri
Slide 63: Financial highlights
Financial highlights Results of Operations FY 2020 Net Revenues $ 42.6 mm Record year for revenue growth from sexual health business FY 2020 Gross Profit $ 30.8 mm $42.6 million with profitable FY 2020 Operating Loss $ 14.7 mm operating income in Q4 FY FY 2020 Adjusted Operating Loss3 $ 0.6 mm 20203
Slide 64: Pipeline & Milestones
Pipeline & Milestones Oncology biopharmaceutical company focused on prostate cancer and breast cancer PRODUCT INDICATION 2020 2021 2022 2023 2024 Prostate cancer P1b Metastatic castration VERU-111 resistant & AR targeting Oral cytoskeleton agent resistant prostate P2 disruptor cancer prior to IV che
Slide 65: Veru projected milestones
Veru projected milestones PRODUCT INDICATION 2019 2020 2021 2022 2023 SEXUAL HEALTH DIVISION* TADFYNTM BPH BE NDA US launch (tadalafil/finasteride) ` THE FEMALE HEALTH COMPANY DIVISION Dual birth control FC2 Marketed & STI prevention Represent Management’s current expectations and are not a guarante
Slide 66: Veru – FY 2021 registration clinical studies expected
Veru – FY 2021 4 registration clinical studies expected to be initiated in VERU-111 calendar year 2021 Prostate Cancer Prostate Cancer - VERU-111: Phase 2 trial: completely enrolled and ongoing metastatic castration & androgen receptor targeting agent resistant prostate cancer prior to IV chemo VERU