Veru Inc. · NASDAQ:VERU
Veru — Investor Presentation (January 2022)
59 slides from Veru's investor presentation, January 2022
Slide 1: Oncology Biopharmaceutical Company Focused on Breast Cancer and Prostate Cancer
Veru Inc. Nasdaq:VERU Oncology Biopharmaceutical Company Focused on Breast Cancer and Prostate Cancer Veru Corporate Presentation January 2022
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 Focus on breast cancer and prostate cancer with a sexual health division UREV Veru Sexual Health Division Drug Pipeline FDA APPROVED for BPH December 2021 Breast Cancer Enobosarm Sabizabulin 32mg FC2 Female Condom (internal condom) Prostate Cancer Sabizabulin 32mg
Slide 4: Drug candidate pipeline
Drug candidate pipeline Oncology biopharmaceutical company focused on breast cancer and prostate cancer Program Mechanism Indication Preclinical Phase 1 Phase 2 Phase 3 Breast Cancer AR+ ER+ HER2- metastatic breast Selective androgen receptor Phase 3 ARTEST: 210 Patients Enobosarm cancer with AR ≥ 4
Slide 5: Breast Cancer – Novel Medicines
Breast Cancer – Novel Medicines Program Mechanism Indication Preclinical Phase 1 Phase 2 Phase 3 Breast Cancer AR+ ER+ HER2- metastatic Selective androgen breast cancer with AR ≥ Enobosarm Phase 3 ARTEST: 210 Patients receptor targeting agonist 40% (3rd line metastatic setting) Ongoing AR+ ER+ HER2-
Slide 6: Current Endocrine Therapies
Endocrine therapies that block estrogen are effective against ER+ breast cancer Current Endocrine Therapies Selective estrogen receptor modulators (tamoxifen and toremifene) Resistance to endocrine and CDK4/6 inhibitor therapies ER antagonists and degraders (fulvestrant) eventually occurs which requ
Slide 7: Androgen receptor is the most abundantly expressed sex hormone receptor in breast cancers
Androgen receptor is the most abundantly expressed sex hormone receptor in breast cancers with up to 95% of breast cancers2-6 • 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 8: Enobosarm, first-in-class oral selective AR targeting agonist
Enobosarm, first-in-class, novel oral selective AR targeting agonist for the treatment for AR+ER+ metastatic breast cancer • Enobosarm is a non-steroidal, selective androgen receptor agonist1, 2 Enobosarm has been evaluated in 25 • Once-a-day oral daily dosing clinical trials comprising 2,091 • Sele
Slide 9: Mechanism of action of enobosarm in breast cancer
Mechanism of action of enobosarm in breast cancer1,2 Androgen receptor activation by enobosarm leads to breast cancer tumor suppression ER-driven breast cancer growth • Decreases ER transcriptional activity • Sequesters p300 and SRC-3 • Antagonizes ER target growth genes t en • Myb AR binds to n d •
Slide 10: Phase 2 clinical trial (G200802) design
Phase 2 clinical trial (G200802) design Targeting AR+ ER+ HER2- metastatic breast cancer in a heavily pretreated population1 Trial design • Open label, multicenter, multinational, randomized parallel design Phase 2 study to assess the efficacy and safety of Screening enobosarm 9 mg or 18 mg oral dai
Slide 11: Phase 2 clinical trial (G200802) baseline demographics
Phase 2 clinical trial (G200802) Patient baseline demographics 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 (
Slide 12: Phase 2 clinical trial (G200802) safety and efficacy summary
Phase 2 clinical trial (G200802) Overall safety and efficacy summary Safety • Enobosarm was well tolerated • Majority of events were Grade 1 and 2 9 mg 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 Efficacy
Slide 13: AR is required for an objective tumor response
Phase 2 clinical trial (G200802)- AR is required for an objective tumor response Best overall % target lesion reduction – Enobosarm 9 and 18 mg cohorts combined 13
Slide 14: Post-hoc AR expression subset analysis
Phase 2 clinical trial (G200802) - Post-hoc AR expression subset analysis Efficacy outcomes correlate with degree of AR staining (9 mg +18 mg cohorts combined) Post-hoc AR expression subset analysis: • Subset of ITT with known AR status and have measurable disease(n=84) • Combined both the 9 mg and
Slide 15: Radiographic progression free survival
Phase 2 clinical trial (G200802) Radiographic progression free survival– Enobosarm 9 and 18 mg combined cohorts AR ≥ 40% AR < 40% p<0.001 15
Slide 16: Duration of previous estrogen blocking agent response
Phase 2 clinical trial (G200802)- Post-hoc AR expression subset analysis Duration of previous estrogen blocking agent response was similar regardless of AR status • Analysis of ITT (FAS) group with known AR status and have measurable disease (n=84) • Had received at least 2 prior therapies in a meta
Slide 17: Phase 2 clinical trial (G200802) Conclusions
Phase 2 clinical trial (G200802)- Conclusions AR targeted therapy shows efficacy and safety in AR+ER+HER2- metastatic breast cancer • Enobosarm AR targeted treatment demonstrated clinical benefit with objective tumor responses in women with heavily pretreated estrogen blocking agent resistant AR+ ER
Slide 18: Enobosarm to treat CDK4/6 inhibitor and estrogen blocking agent resistant cancer
Enobosarm to treat CDK4/6 inhibitor and estrogen blocking agent resistant AR+ER+HER2- metastatic breast cancer Preclinical models (Patient derived xenografts)1,2 • Estrogen blocking agent resistant breast cancer • CDK4/6 inhibitor inhibits growth of estrogen blocking agent resistant breast cancer1,2
Slide 19: Enobosarm and/or CDK4/6 inhibitor against resistant breast cancer
Enobosarm and/or CDK4/6 inhibitor against CDK4/6 inhibitors and estrogen blocking agent resistant AR+ER+HER2- metastatic breast cancer- the real story ? Preclinical models (Patient derived xenografts)1 Both CDK4/6 inhibitor and enobosarm upregulate AR expression in estrogen blocking agent and CDK4/6
Slide 20: Phase 2 study: patients with palbociclib resistance
Phase 2 (G200802) study Evaluable patients (AR+) with palbociclib resistance in the metastatic setting Palbociclib resistant subjects with measurable disease 9 mg 18 mg Outcome Outcome • Objective tumor responses patient ID patient ID • 30% overall 7004-8120 6003-8133 • CBR at 24 weeks 7019-8066 Com
Slide 21: NCCN 2020 guidelines: CDK 4/6 inhibitors standard of care
NCCN 2020 guidelines: CDK 4/6 inhibitors are standard of care for treatment of ER+HER2- metastatic breast cancer If disease progression on CDK4/6 inhibitor treatment, there are limited data to support additional line of treatment with another CDK 4/6 inhibitor containing regimen First-Line Metastati
Slide 22: Phase 3 ARTEST clinical trial
Phase 3 registration, open label, randomized ARTEST clinical trial (V3002401)(NCT#04869943) 3rd line metastatic setting – AR staining ≥ 40%- enrolling Phase 3 Pivotal AR+ER+HER2- ARTEST Clinical Trial Design Designated Fast Track program by FDA Metastatic Breast Cancer 3rd line metastatic setting Ph
Slide 23: Phase 3 ENABLAR-2 study
Phase 3 (V2000701) ENABLAR-2 study- 2nd line metastatic setting- AR staining ≥ 40% Open label, dose finding, efficacy and safety of CDK4/6 inhibitor (abemaciclib) + enobosarm combination versus active control estrogen blocking agent in AR+ER+HER2- metastatic breast cancer Anticipated start date is c
Slide 24: Sabizabulin disrupts the cytoskeleton
Sabizabulin is an oral targeted cytotoxic and cytostatic anticancer agent that disrupts the cytoskeleton • Microtubules are critical components of the cytoskeleton and a validated target for anticancer drugs • Sabizabulin targets microtubules at both the “colchicine binding site” on β-tubulin and an
Slide 25: Phase 2b sabizabulin clinical trial (V2011201)
Phase 2b open label, randomized sabizabulin clinical trial (V2011201) 3rd line metastatic setting – AR staining < 40%- anticipated start Q1 2022 Phase 2b ER+HER2- (AR<40%) Clinical Trial Design Metastatic Breast Cancer 3rd line metastatic setting Phase 2b open label, multicenter, multinational, rand
Slide 26: Sabizabulin 32mg
Sabizabulin 32mg for the treatment of chemotherapy resistant metastatic triple negative breast cancer 26
Slide 27: Sabizabulin efficacy against taxane resistant triple negative breast cancer
Preclinical studies show that sabizabulin has efficacy against taxane resistant triple negative breast cancer1 Taxane sensitive Taxane resistant • HCI-10-Luc2 TNBC - taxane resistant Sabizabulin (VERU-111) has antitumor activity in MDA-MB-231 TNBC Model1 • HCI-2-Luc2 TNBC – taxane sensitive TRODELVY
Slide 28: Pembrolizumab + enobosarm in AR+ metastatic TNBC
Combination of pembrolizumab + enobosarm in AR+ metastatic 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 we
Slide 29: Phase 2b study: Sabizabulin + enobosarm in TNBC
Phase 2b clinical study (V2011801): Sabizabulin + enobosarm for metastatic triple negative breast cancer with tumor progression after receiving at least 2 chemotherapies Trial study design • Patients previously treated with a least 2 systemic chemotherapies for metastatic triple negative breast canc
Slide 30: Veru’s breast cancer programs
Veru’s breast cancer programs First-Line Second-Line Third-Line Coming soon Phase 3: ARTEST AR+ ER+ HER2- AR+ ≥ 40% Phase 3: ENABLAR-1 AR+ ER+ HER2- Exemestane ± AR+ ≥ 40% Enobosarm Versus Everolimus Monotherapy Enobosarm or + SERM CDK 4/6i CDK 4/6i + Versus + Estrogen Blocking Estrogen Blocking Pha
Slide 31: Prostate Cancer – Novel Medicines
Prostate Cancer – Novel Medicines Program Mechanism Indication Preclinical Phase 1 Phase 2 Phase 3 Prostate Cancer Metastatic castration and androgen receptor Oral targeted cytoskeleton Sabizabulin targeting agent resistant Phase 3 VERACITY: 245 Patients disruptor prostate cancer prior to IV- chemo
Slide 32: Sabizabulin prostate cancer treatment paradigm
Sabizabulin prostate cancer treatment paradigm: Focus is on the prechemotherapy space which is a growing unmet need Pre- PARP inhibitor Chemotherapy chemotherapy Olaparib DNA repair Current indication 10% alterations (BRCA1 and BRCA2) Metastatic castration ARTA resistant prostate Metastatic castrati
Slide 33: Sabizabulin clinical development
Sabizabulin clinical development Phase 1b (expansion cohort) and Phase 2 clinical study design- ONGOING STUDY Phase 2- Evaluate safety and efficacy Phase 1b- Dose escalation to evaluate of sabizabulin RP2D 63mg daily in safety of sabizabulin in men with metastatic castration resistant metastatic cas
Slide 34: Phase 1b and 2 baseline demographics
Phase 1b and 2 clinical studies Baseline demographics Phase 1b Phase 2 Characteristic N=39 N=41 Age, years Median (range) 74 (61-92) 73 (57-86) Race/Ethnicity, n (%) Caucasian 28 (72%) 31 (76%) African American 8 (21%) 4 (10%) Hispanic 3 (8%) 5 (12%) Other 0 1 (2%) ECOG performance status, n (%) 0 2
Slide 35: Sabizabulin safety, Phase 1b and Phase 2
Sabizabulin clinical development Safety- Phase 1b (expansion cohort) and Phase 2 clinical study Most prevalent adverse events regardless of grade (>10% frequency) in patients that received 63 mg dose N=54 At the recommended Phase 2 dose (RP2D) of 63 mg oral daily dose of sabizabulin • Sabizabulin wa
Slide 36: Sabizabulin Phase 1b efficacy
Sabizabulin Phase 1b efficacy PCWG3 criteria to evaluate efficacy after 12 weeks of treatment (4 cycles) 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 f
Slide 37: Sabizabulin efficacy, Phase 1b and Phase 2
Sabizabulin clinical development Efficacy- Phase 1b (expansion cohort) and Phase 2 study Sabizabulin had evidence of significant and durable objective tumor responses In ITT population, all patients with measurable ORR (5PR +1CR observed): 20.7%1 disease at baseline (n=29) All evaluable patients tha
Slide 38: Phase 1b case study patient 104-001
Sabizabulin 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 • mCRPC with lymph node only disease • P
Slide 39: Phase 2 case study patient 104-017
Sabizabulin clinical development Phase 2 case study patient 104-017 July 8, 2020: Screening CT scan September 29, 2020: 3 months follow-up Left common femoral node 1.4 cm Left common femoral node 0.7 cm (target lesion) (-50% decrease to nonpathologic node) Patient: 104-017 • mCRPC with lymph node on
Slide 40: Sabizabulin 1b/2 clinical development: Conclusions
Sabizabulin 1b/2 clinical development: Conclusions Sabizabulin was well tolerated with evidence of significant and durable objective tumor responses • At the recommended Phase 2 dose (RP2D) of 63 mg oral daily dose of sabizabulin • Well tolerated with no reports of significant neutropenia or neuroto
Slide 41: Phase 3 VERACITY clinical trial
Phase 3 VERACITY clinical trial (V3011102) (NCT#-04844749) Enrolling in approximately 45 clinical sites VERACITY - Randomized, Active-Controlled, Open label Phase 3 Study of Sabizabulin 32 mg for the Treatment of Metastatic Castration-Resistant Prostate Cancer in Patients Whose Prior Treatment Progr
Slide 42: Prostate cancer treatment paradigm: prechemotherapy space
Sabizabulin prostate cancer treatment paradigm: Focus is on the prechemotherapy space- largest segment of advanced prostate cancer Pre- PARP inhibitor Chemotherapy chemotherapy Olaparib DNA repair Current indication 10% alterations (BRCA1 and BRCA2) ARTA Metastatic castration resistant prostate Meta
Slide 43: 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® Depot (IM) and FIRMAGON® (degarelix) (SC) ELIGARD® (SC) are leuprolide products • Concerns over initial surge in T levels- “T surge” • Painful subcutane
Slide 44: 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 profile1 Phase 2 • Novel proprietary GnRH antagonist decapeptide delivery formulation Open label, dose finding VERU-100 GnRH antagonist • 3-m
Slide 45: Sabizabulin 9 mg for hospitalized COVID-19 patients
Sabazibulin 9 mg for the treatment of hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome 45
Slide 46: Coronavirus spike protein interacts with 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 • Sabizabulin
Slide 47: Sabizabulin: Phase 2 clinical trial design for COVID-19
Sabizabulin: Phase 2 clinical trial design for COVID-19 Double-Blind, Placebo-Controlled, Phase 2 Study of Sabizabulin 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 demog
Slide 48: Phase 2 clinical trial of sabizabulin 18 mg endpoints
Phase 2 clinical trial of sabizabulin 18 mg Endpoints Relative Primary Endpoint Placebo Sabizabulin 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 Sabizabulin p-value Reduction Deaths (IT
Slide 49: Safety outcomes for Sabizabulin 18 mg
Safety outcomes for Sabizabulin 18 mg from Phase 2 clinical trial Any adverse event that occurred in ≥ 2 patients on study Sabizabulin 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
Slide 50: Phase 3 Study of Sabizabulin in Hospitalized COVID-19 Patients
Double-Blind, Placebo-Controlled, Phase 3 Study of Sabizabulin for the Treatment of in Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome (V3011902)(NCT#04842747) – enrolling • Trial size is N=300 with a 2:1 randomization Patients at high risk for ARDS, hospitalized,
Slide 51: Sexual Health Division
UREV Sexual Health Division 51
Slide 52: ENTADFI capsule approved for BPH
ENTADFITM capsule (finasteride and tadalafil), a new treatment for BPH with low UREV potential for adverse sexual side effects, approved in 12/20211-3 Sexual Health Only BPH treatment that prevents BPH progression with low potential for adverse sexual side effects US and global markets expected to b
Slide 53: ENTADFI: prevents BPH progression with low potential for sexual dysfunction
TM ENTADFI , only BPH treatment that prevents progression of BPH and has low UREV potential for sexual dysfunction1,2 Sexual Health ED symptom score2 ED symptom score2 Men with baseline ED Men without baseline ED • International, randomized, double- blind study in approximately 700 men • 350 men tre
Slide 54: FC2 Female Condom business revenues are growing
UREV FC2® Female Condom (internal condom) business revenues are growing Sexual Health Sold in U.S. and 149 other countries FC2 Female Condom (internal condom) is the only FDA approved female use product Manufacturing plant with annual capacity of 100 million units to prevent pregnancy and transmissi
Slide 55: FC2 revenues
UREV FC2® revenues Sexual Health FC2 global public sector & FC2 US prescription revenues ($ mm) $17.66 $15.65 $4.15 $2.09 Global Public Sector $13.75 $13.34 FC2 Revenues US Prescription FY 2018: $ 15.9 mm FY 2019: $ 30.9 mm $10.96 $4.65 $3.03 FY 2020: $ 40.6 mm $10.42 FY 2021: $ 60.4 mm $9.52 $9.65
Slide 56: Financial highlights
Financial highlights Veru – Fiscal year Veru – Balance Sheet as of September 30, 2021 Net Revenues FY 2021 Net Revenues $ 61.3 mm Cash $ 122.4 mm FY 2020 Net Revenues $ 42.6 mm Receivables $ 8.8 mm FY 2019 Net Revenues $ 31.8 mm PREBOOST Payment Due $ 5.0 mm2 FY 2018 Net Revenues $ 15.9 mm US/UK NOL
Slide 57: Milestones
Milestones Program Mechanism Indication 2021 2022 2023 2024 Breast Cancer AR+ ER+ HER2- metastatic breast Selective androgen receptor Phase 3 FPI Phase 3 data NDA Enobosarm cancer with AR ≥ 40% targeting agonist (3rd line metastatic setting) Phase 3 ARTEST study AR+ ER+ HER2- metastatic breast Oral
Slide 58: Appendix
Appendix 58
Slide 59: Sabizabulin is an oral agent that targets and disrupts the cytoskeleton
Sabizabulin is an oral agent that targets and disrupts the cytoskeleton AR independent Only sabizabulin, not the other classes of microtubule Targets cytoskeleton to crosslink and inhibit targeting agents, disrupts and fragments microtubules microtubule assembly1 Control Sabizabulin Paclitaxel Colch