Veru Inc. · NASDAQ:VERU
Veru — H.C. Wainwright 24th Annual Global Investment Conference 2022
45 slides from Veru's conference presentation, Sep 12, 2022
Slide 1: Biopharmaceutical Company Focused on Infectious Diseases-COVID-19 and Oncology
Veru Inc. Nasdaq:VERU Biopharmaceutical Company Focused on Infectious diseases-COVID-19 and Oncology Veru Corporate Presentation H.C. Wainwright 24th Annual Global Investment Conference September 12-14, 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 COVID-19 Sabizabulin 9mg FDA APPROVED for BPH December 2021 FC2 Female Condom (internal condom) Breast Cancer Enobosarm Sabizabulin 32mg F
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: 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 6: Sabizabulin targets and disrupts microtubules halting transport of viruses
Sabizabulin is an oral agent that targets and disrupts microtubules halting transport of viruses in the cell and cytokine release Viral Infection Immune Response Targets cytoskeleton to crosslink and inhibit microtubule assembly • SARS-CoV-2 utilizes host cell receptors, proteases, and vesicular tra
Slide 7: Phase 3 Study of sabizabulin in Hospitalized Moderate-Severe COVID-19 Patients
Double-Blind, Placebo-Controlled, Phase 3 Study of sabizabulin for the Treatment of in Hospitalized Moderate-Severe COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome – COMPLETED • Patients are hospitalized with moderate to severe COVID-19 Hospitalized COVID-19 patients at high r
Slide 8: Phase 3 COVID-19 study interim analysis published in NEJM Evidence
Phase 3 COVID-19 study interim analysis published in NEJM Evidence 7-6-2022 • 8
Slide 9: Phase 3 clinical trial – Demographics
Sabizabulin: Phase 3 clinical trial – Demographics (interim analysis population) Sabizabulin Placebo Number of patients N=98 N=52 Mean age (±SD) 59.4 (14.6) 60.3 (15.0) Males (%) 70.4 63.5 Gender Females (%) 29.6 36.5 Mean WHO Score at baseline (±SD) 4.7 (0.55) 4.8 (0.65) Not vaccinated (%) 54.1 57.
Slide 10: Phase 3 COVID-19 clinical trial: primary endpoint met
Phase 3 COVID-19 clinical trial Primary endpoint, mortality rate by Day 60, was met Placebo After planned interim analysis of first 150 patients, Independent Data Monitoring Committee unanimously recommended Sabizabulin early stopping of Phase 3 study for evidence of clear benefit Sabizabulin 9mg Pl
Slide 11: Subgroup analyses of primary efficacy endpoint
Subgroup analyses of primary efficacy endpoint Relative risk of death point estimate (95%CI) Relative Risk (95% CI) Overall Study 0.45 (0.27 to 0.74) Standard of Care Treatment Received on Study Remdesivir Tx 0.42 (0.22 to 0.82) No Remdesivir Tx 0.45 (0.22 to 0.90) Dexamethasone Tx 0.55 (0.33 to 0.9
Slide 12: Key secondary endpoints
Phase 3 COVID-19 clinical trial Key secondary endpoints Treatment Mean SD Median Min,Max (days) (days) Sabizabulin 9 mg (n=98) 17.4 23.93 4.0 0,60 Placebo (n=52) 30.8 27.83 17.0 0,60 Days in the ICU Treatment Comparison LS mean SE 95% CI p-value Sabizabulin 9mg vs. Placebo -13.4 4.09 (-21.5, - 5.3)
Slide 13: Safety outcomes: Adverse Events
Safety outcomes Phase 3 clinical trial for ITT population Adverse Events Any adverse event that occurred in ≥ 5% of patients in either treatment group Sabizabulin Placebo (N=130) (N=69) N (%) / Events N (%) / Events Safety - AEs Any 80 (61.5) / 341 54 (78.3) / 285 • There is no imbalance Atrial fibr
Slide 14: Safety outcomes: Serious Adverse Events
Safety outcomes Phase 3 clinical trial for ITT population Serious Adverse Events Any serious adverse event that occurred in ≥ 2% of patients in either treatment group Safety - SAEs Sabizabulin Placebo • There is no imbalance (N=130) (N=69) N (%) / Events N (%) / Events against sabizabulin in Any 38
Slide 15: Placebo Mortality Rates by Proportion of Severe Patients Enrolled
Placebo Mortality Rates by Proportion of Severe Patients Enrolled (Severe = NIV, High Flow, and Mechanical Ventilation) up to Day 30 References on next slide 15
Slide 16: Reduction of deaths by proportion of severe patients enrolled
Reduction of deaths by proportion of severe patients enrolled (Severe = NIV, High Flow, and Mechanical Ventilation) up to Day 30 References on next slide 16
Slide 17: References on patient composition and placebo mortality rates
References that detail patient composition to determine placebo mortality rates by proportion of severe patients enrolled NIH Guidelines included trials Citation Veru - Overall Study Data on File at Veru Sabizabulin Veru - Full Interim Analysis Barnette, et al., Oral Sabizabulin for High-Risk, Hospi
Slide 18: Summary
Summary • Sabizabulin has both antiviral and anti-inflammatory activities • Sabizabulin is the first and only anti-viral agent to significantly reduce deaths in hospitalized COVID-19 patients who are at greatest risk of ARDS and dying • Sabizabulin treatment is well tolerated and sabizabulin’s safet
Slide 19: COVID-19 Treatment Guidelines: only antiviral with a mortality benefit
COVID-19 Treatment Guidelines- Although sabizabulin has dual antiviral and anti- inflammatory activities, it is the only antiviral with a mortality benefit SARS-CoV-2 viral replication Virus triggers immune response Hyperimmune response and tissue damage/ARDS/Death 19
Slide 20: NIH COVID-19 Hospitalized Adults Treatment Guide
NIH COVID-19 Hospitalized Adults Treatment Guide Potential target patients for sabizabulin treatment Sabizabulin + Dex Sabizabulin + Dex Sabizabulin + Dex Sabizabulin + Dex Sabizabulin + Dex 20
Slide 21: Sabizabulin treats patients with highest risk of dying from COVID-19
Coronavirus pandemic is in its 3rd year: society fears death from COVID-19 Sabizabulin treats patients who have the highest risk of dying from COVID-19 IN hospital: Reduce the death rate for COVID-19 OUT of hospital: general population patients at the last opportunity to do so! Treat mild-moderate T
Slide 22: 100,000,000 new cases fall and winter = 1,200,000 deaths
100,000,000 new cases fall and winter = 1,200,000 deaths1 Sabizabulin treatment would prevent 660,000 deaths 1COVID-19 Tracker (covid.cdc.gov) historical death rate/cases =1.2% 22
Slide 23: At risk population - hospitalized COVID-19 patients
AT RISK POPULATION - Hospitalized COVID-19 patients on oxygen at high risk for ARDS/death Assumptions: • Hospitalized patients with COVID-19 on at least supplemental oxygen • United States only • No new surges • May treat up to 21 days • Hospitalization rate is 5948 new admissions/day1 • WHO 4 (on o
Slide 24: Regulatory status
Regulatory status Indication: Hospitalized moderate to severe COVID-19 patients at risk for ARDS • 5/10/22 - Had pre-EUA meeting with US FDA based on current Phase 2 and Phase 3 clinical trials. Positive meeting and FDA agreed on the following: • Efficacy • No additional efficacy studies are require
Slide 25: Commercial activities for sabizabulin
Commercial activities for sabizabulin • Veru- United States • Infectious Disease Franchise formed under Joel Batten’s leadership • Having discussions with various agencies including CMS and BARDA to secure reimbursement if FDA grants EUA • Veru International • Infectious Disease Franchise for UK, EM
Slide 26: Possible additional indications for sabizabulin
Possible additional indications for sabizabulin (broad spectrum anti-viral and anti-inflammatory agent) for ARDS Each year in the United States, Influenza leads to: Each year in the United States, RSV leads, on average: • 2.1 million outpatient visits among children younger than 5 years old • 58,000
Slide 27: 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 28: 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 29: 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 30: 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 31: 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 32: Sabizabulin clinical development: Phase 1b and Phase 2 design
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 33: 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 34: 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 35: 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 36: 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 36
Slide 37: 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 38: 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 39: 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 40: 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 41: Sexual Health Division
UREV Sexual Health Division 41
Slide 42: ENTADFI capsule 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 43: FC2 Female Condom business
UREV FC2® Female Condom (internal condom) business 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 transmission of sexually transm
Slide 44: Financial highlights
Financial highlights Veru Veru – Balance Sheet as of June 30, 2022 Net Revenues FY 2021 Net Revenues $ 61.3 mm Cash $ 100.6 mm FY 2020 Net Revenues $ 42.6 mm Receivables $ 8.3 mm US/UK NOL carryforward $ 38.8/$63.5 mm FY 2019 Net Revenues $ 31.8 mm Common Shares Outstanding1 ~ 80.1 mm FY 2018 Net Re
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 – Fast Track AR+ ER+ HER2- metastatic
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