Slide 1: Biopharmaceutical Company Focused on COVID-19 and Oncology
Veru Inc. Nasdaq:VERU Biopharmaceutical Company Focused on COVID-19 and Oncology Veru Corporate Presentation May 2022
Slide 2: Forward looking statements
Forward looking statements The statements in this release that are not historical facts are “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this release include statements regarding: whether and when the Comp
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 AR+ ER+ HER2- metastatic breast Selective androgen receptor Enobosarm cancer with AR ≥ 40% Phase 3 ARTEST: 210 Patien
Slide 5: Sabizabulin 9 mg
Sabizabulin 9 mg for the treatment of hospitalized moderate-severe COVID-19 patients at high risk for acute respiratory distress syndrome 5
Slide 6: Sabizabulin is an oral agent that targets and disrupts microtubules
Sabizabulin is an oral agent that targets and disrupts microtubules halting transport of viruses in the cell and cytokine release Only sabizabulin, not the other classes of microtubule Targets cytoskeleton to crosslink and inhibit targeting agents, disrupts and fragments microtubules microtubule ass
Slide 7: Coronavirus spike protein interacts with microtubules for intracellular transport
Coronavirus’s spike(S) protein is the key structure that interacts with microtubules for intracellular transport 4 • Virus’s most critical task is to hijack the host’s internal transportation system, the microtubules in the cytoskeleton, to replicate and to release new viruses for infection1-3 • Sab
Slide 8: Coronavirus pandemic is in its 3rd year
Coronavirus pandemic is in its 3rd year Society fears death from COVID-19 infection Collective risk of death from COVID-19 is still too high: Need new drugs like sabizabulin IN hospital ! IN hospital: death rate for COVID-19 OUT of hospital: general population is up to 21-67% Treat mild-moderate Tre
Slide 9: 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 10: Phase 2 clinical trial of sabizabulin 18 mg
Phase 2 clinical trial of sabizabulin 18 mg Endpoints Relative Efficacy Endpoints Placebo Sabizabulin p-value Reduction Deaths (ITT) 6/20 (30%) 1/19 (5.3%) 82% p=0.0442 9.6±12.40 2.6±5.78 Mean days in ICU +/- SD 73% p=0.0261 (n=20) (n=18) Mean days on Mechanical Ventilation +/- SD 5.1±11.24 1.2±6.06
Slide 11: Safety outcomes for Sabizabulin 18 mg from Phase 2 clinical 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 12: Phase 3 Study of Sabizabulin in Hospitalized Severe COVID-19 Patients
Double-Blind, Placebo-Controlled, Phase 3 Study of Sabizabulin for the Treatment of in Hospitalized Severe COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome (V3011902)(NCT#04842747) – COMPLETED • Patients are hospitalized with severe COVID-19 Designated Fast Track program by FDA
Slide 13: Sabizabulin: Phase 3 clinical trial design for COVID-19 Demographics
Sabizabulin: Phase 3 clinical trial design for COVID-19 Demographics Patient demographics (interim analysis set) Sabizabulin Placebo Number of N=98 N=52 patients Mean age 59.4 (14.6) 60.3 (15.0) (±SD) Males (%) 68.2 63.8 Gender Females (%) 31.8 36.2 Mean WHO Score at 4.8 (0.61) 4.8 (0.65) baseline (
Slide 14: Phase 3 COVID-19 clinical trial
Phase 3 COVID-19 clinical trial Primary endpoint, mortality rate by Day 60, was met After planned interim analysis of first 150 patients, Independent Data Monitoring Committee unanimously recommended early stopping of Phase 3 study for evidence of benefit and no safety issues were identified Sabizab
Slide 15: Safety database for sabizabulin ≥ 9mg
Safety database for sabizablin ≥ 9mg Study Doses Number of subjects Phase 2 COVID study 9mg 19 Phase 3 COVID Study 9mg 130 Phase1b/2 Prostate 9mg-40.5mg 74 Phase 3 Prostate 32mg 42 Total 265 15
Slide 16: Additional indications to develop sabizabulin
Additional indications to develop sabizabulin • In COVID-19: Each year in the United States, Influenza leads to: • Sabizabulin monotherapy for prehospital patients at risk • Other serious virus infections • Influenza virus • Respiratory syncytial virus • Acute respiratory distress syndrome Each year
Slide 17: Market
Market Hospitalized COVID-19 patients (WHO 4 or greater) at high risk for ARDS/death Assumptions: • United States only • Hospitalization rate is 2603 new admissions/day1 • WHO 4 or greater is 52% of hospitalizations2 • Target population 2603 X 0.52 X 7days= 9,475 patients/week • COVID-19 deaths 350/
Slide 18: Market- Upside
Market- Upside Hospitalized COVID-19 patients (WHO 4 or greater) at high risk for ARDS/death Upside could include: • US Advanced Purchase Agreement • US Stock piling • Rest of the world • Distribution • Advanced Purchase Agreements • Stock piling • Development of sabizabulin for other viral diseases
Slide 19: Sabizabulin manufacturing capacity
Sabizabulin manufacturing capacity • Manufacturing of sabizabulin and finished product to supply the US and then rest of world when Regulatory authorization and approvals are gained • Drug available to treat patients • July 2022 ≈ 57,000 patients • August 2022 ≈ 100,000 patients • September and then
Slide 20: Sabizabulin Next Steps
Sabizabulin Next Steps • Veru had pre-EUA meeting with US FDA on May 10th 2022 • Phase 2 and Phase 3 efficacy and safety is sufficient for request for EUA submission • Request for EUA will be submitted Q2 2022 • Veru has initiated discussion with government agencies on obtaining Advance Purchase Agr
Slide 21: 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) Fast Track Designatio
Slide 22: 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 23: 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 24: 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 25: 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 26: 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 27: 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 28: 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 28
Slide 29: 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 30: 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 30
Slide 31: 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 32: Enobosarm to treat CDK4/6 inhibitor resistant metastatic breast 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 33: 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 34: Phase 2 study: evaluable 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 35: 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 36: 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 37: 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 Enrolling Combination group
Slide 38: 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- chemotherapy On
Slide 39: 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 ARTA BRCA2) Metastatic castration resistant prostate Metastatic castrati
Slide 40: Sabizabulin targets and disrupts the cytoskeleton
Sabizabulin is an oral agent that targets and disrupts the cytoskeleton 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 Colchicine Human Lun
Slide 41: 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 42: Phase 1b and 2 clinical studies 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 43: 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 44: Radiographic Progression Free Survival
Radiographic progression free survival of combined Phase 1b/2 study at 63mg dose- cytostatic activity? Radiographic Progression Free Survival 100 Median = 11.4 months (95% C.I. 29.63-65.79) n=55 50 0 0 10 20 30 40 Months on study drug All patients that received 63mg dose Kaplan-Meier analysis of com
Slide 45: 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 46: Phase 1b 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 47: 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 48: Clin Cancer Res. 2022 publication
Clin Cancer Res. 2022 Apr 13:clincanres.0162.2022. doi: 10.1158/1078-0432.CCR-22- 0162. Online ahead of print.PMID: 35416959 48
Slide 49: Adverse events in mCRPC: VERU-111 vs abiraterone, enzalutamide, docetaxel
Adverse events and significant laboratory events in mCRPC: Comparison of VERU-111 with abiraterone, enzalutamide and docetaxel Safety/toxicity of VERU-111 is comparable to abiraterone and enzalutamide, but not to docetaxel Product (% Any Adverse event / % Grade ≥3 adverse event) AE or Sig. Lab Event
Slide 50: 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 51: 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 52: Prostate Cancer External Advisory Committee
Prostate Cancer External Advisory Committee • Philip Kantoff MD- Medical Oncologist Past Chair, Department of Medicine – Memorial Sloan Kettering Cancer Center • Eric Klein MD- Urologist Chair, Glickman Urological & Kidney Institute - Cleveland Clinic • Robert Dreicer MD- Medical Oncologist Professo
Slide 53: Sabizabulin prostate cancer treatment paradigm
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 54: 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 55: 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 long
Slide 56: UREV Sexual Health Division
UREV Sexual Health Division 56
Slide 57: 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 58: 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 59: 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 60: 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 61: 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 62: 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