Veru Inc. · NASDAQ:VERU
Veru — Oppenheimer 32nd Annual Healthcare Conference 2022
48 slides from Veru's conference presentation, Mar 15, 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 Oppenheimer 32nd Annual Healthcare Conference March 15-17, 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 UREV Drug Pipeline Sexual Health Division Breast Cancer Enobosarm Sabizabulin 32mg FDA APPROVED for BPH December 2021 FC2 Female Condom (internal condom) Sabizabulin 32mg VERU-100
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 Selective androgen receptor AR+ ER+ HER2- metastatic breast Enobosarm targeting agonist cancer with AR ≥ 40% Phase 3
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 to treat ER+ breast cancer eventually develop drug resistance and tumor progression Current Endocrine Therapies Selective estrogen receptor modulators (tamoxifen and toremifene) Resistance to endocrine and CDK4/6 inhibitor therapies ER antagonists and degrader
Slide 7: Up to 95% of breast cancers express the androgen receptor
Up to 95% of breast cancers express the androgen receptor 1-6 • 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 breast tissue, androgens inhibit cellular proliferation 1-3 Duct
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 nonsteroidal, selective androgen receptor agonist1, 2 • Once-a-day oral daily dosing Enobosarm has been evaluated in 25 • Selectivity to activate the androgen r
Slide 9: 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 10: 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 11: 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 12: 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 12
Slide 13: 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 14: 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 14
Slide 15: 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 selective AR targeting treatment demonstrated clinical benefit with objective tumor responses in women with heavily pretreated estrogen blocking agent resis
Slide 16: 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 17: 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 18: 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 19: 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 20: 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 21: 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 22: Phase 2b sabizabulin clinical trial
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 23: 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 Sabizabulin Oral cytoskeleton disruptor targeting agent resistant Phase 3 VERACITY: 245 Patients prostate cancer prior to IV- chemo Ongoing L
Slide 24: 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 25: Sabizabulin 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
Slide 26: Sabizabulin clinical development
Sabizabulin clinical development Phase 1b (expansion cohort) and Phase 2 clinical study design- 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 castration resist
Slide 27: 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 28: Sabizabulin clinical development: efficacy
Sabizabulin clinical development Efficacy- Phase 1b (expansion cohort) and Phase 2 study Sabizabulin had evidence of significant and durable objective tumor responses- cytotoxic activity? In ITT population, all patients with measurable ORR (5PR +1CR observed): 20.7%1 disease at baseline (n=29) All e
Slide 29: Sabizabulin clinical development: safety
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 30: 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 31: 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 32: 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 33: 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 34: 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 35: 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 36: Sabizabulin 9 mg
Sabazibulin 9 mg for the treatment of hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome 36
Slide 37: Coronavirus spike protein interacts with cytoskeleton 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 38: 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 39: Phase 2 clinical trial of sabizabulin 18 mg
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 40: Safety outcomes for Sabizabulin 18 mg from Phase 2 trial
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 41: 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 Hospitalized COVID-19 patients at high risk f
Slide 42: UREV Sexual Health Division
UREV Sexual Health Division 42
Slide 43: ENTADFI capsule, a new treatment 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 44: 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 45: 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 46: FC2 revenues
UREV FC2® revenues Sexual Health FC2 global public sector & FC2 US prescription revenues ($ mm) $17.66 $15.65 $4.15 $13.75 $2.09 $14.14 FC2 Revenues $13.34 FY 2018: $ 15.9 mm Global Public Sector $2.56 FY 2019: $ 30.9 mm US Prescription $3.03 FY 2020: $ 40.6 mm $10.96 $10.42 $4.65 FY 2021: $ 60.4 mm
Slide 47: Financial highlights
Financial highlights Veru Veru – Balance Sheet as of December 31, 2021 Net Revenues FY 2021 Net Revenues $ 61.3 mm Cash $ 116.1 mm FY 2020 Net Revenues $ 42.6 mm Receivables $ 8.1 mm PREBOOST Payment Due $ 2.5 mm2 FY 2019 Net Revenues $ 31.8 mm US/UK NOL carryforward $ 38.6/$63.5 mm FY 2018 Net Reve
Slide 48: 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 – Fast Track AR+ ER+ HER2- metastatic
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