Veru Inc. · NASDAQ:VERU
Veru — H.C. Wainwright BioConnect Conference 2022
45 slides from Veru's conference presentation, Jan 10, 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 H.C. Wainwright BioConnect Conference January 10-13, 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 Enobosarm Selective androgen receptor agonist cancer with AR ≥ 40% Phase 3 ARTEST: 21
Slide 5: 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 6: 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 7: 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 8: 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 9: Phase 2 clinical trial (G200802) - 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 (9mg +18mg cohorts combined) Post-hoc AR expression subset analysis: • Subset of ITT with known AR status and have measurable disease (n=84) • Combined both the 9mg and 18
Slide 10: Phase 2 clinical trial (G200802)
Phase 2 clinical trial (G200802) Radiographic progression free survival– Enobosarm 9 and 18 mg combined cohorts AR ≥ 40% AR < 40% p<0.001 10
Slide 11: Phase 2 clinical trial (G200802)
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: 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 13: Enobosarm and/or CDK4/6 inhibitor against resistant AR+ER+HER2- metastatic 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 14: Phase 2 (G200802) study
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 15: Phase 3 ARTEST clinical trial (V3002401)
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 Metastatic Breast Cancer 3rd line metastatic setting Phase 3 open label, multicenter, multin
Slide 16: Phase 3 ENABLAR-2 study- 2nd line metastatic setting
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 17: Sabizabulin is an oral targeted cytotoxic and cytostatic anticancer agent
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 18: Phase 2b open label, randomized sabizabulin clinical trial (V2011201)
Phase 2b open label, randomized sabizabulin clinical trial (V2011201) 3rd line metastatic setting – AR staining < 40%- anticipated start Q4 2021 Phase 2b ER+HER2- (AR<40%) Clinical Trial Design Metastatic Breast Cancer 3rd line metastatic setting Phase 2b open label, multicenter, multinational, rand
Slide 19: NCCN 2020 guidelines: CDK 4/6 inhibitors are 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 20: Sabizabulin 32mg
Sabizabulin 32mg for the treatment of chemotherapy resistant metastatic triple negative breast cancer 20
Slide 21: Preclinical studies show sabizabulin efficacy against taxane resistant TNBC
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 22: Combination of pembrolizumab + enobosarm in AR+ metastatic triple negative breast cancer
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 23: Phase 2b clinical study (V2011801): Sabizabulin + enobosarm
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 24: 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 25: 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 26: 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 27: Sabizabulin clinical development
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 28: Sabizabulin clinical development
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 29: Sabizabulin clinical development
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 30: 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 63mg oral daily dose of sabizabulin • Well tolerated with no reports of significant neutropenia or neurotox
Slide 31: Phase 3 VERACITY clinical trial (V3011102)
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 32mg for the Treatment of Metastatic Castration-Resistant Prostate Cancer in Patients Whose Prior Treatment Progre
Slide 32: 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 33: 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 34: Sabizabulin 9 mg
Sabazibulin 9 mg for the treatment of hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome 34
Slide 35: Coronavirus spike protein interacts with microtubules in the cytoskeleton
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 36: 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 37: 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 38: Safety outcomes for Sabizabulin 18mg from Phase 2 clinical trial
Safety outcomes for Sabizabulin 18mg 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 2
Slide 39: 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 40: Sexual Health Division
UREV Sexual Health Division 40
Slide 41: 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 42: 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 43: 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 44: 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 45: 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