Veru Inc. · NASDAQ:VERU
Veru — Jefferies Healthcare Conference 2022
40 slides from Veru's conference presentation, Jun 8, 2022
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 Jefferies Healthcare Conference June 8 – June 10, 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: 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: 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 7: Sabizabulin is an oral agent that 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 8: Coronavirus spike protein interacts with microtubules for transport
Coronavirus’s spike(S) protein interacts with microtubules for transport 1-4 Sabizabulin, novel oral drug, disrupts microtubules Sabizabulin has dual activities: antiviral and anti-inflammatory • Virus’s most critical task is to hijack the host’s internal transportation system, the microtubules in t
Slide 9: Sabizabulin: Phase 2 COVID-19 clinical trial design
Sabizabulin: Phase 2 COVID-19 clinical trial design 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 demograph
Slide 10: Phase 2 clinical trial of Sabizabulin – hospitalized COVID-19 patients
Phase 2 clinical trial of Sabizabulin – hospitalized COVID-19 patients Key efficacy endpoints Safety Sabizabulin Placebo Preferred Term (n=19) (n=20) N (%)/ events N (%)/events Efficacy Relative Placebo Sabizabulin p-value Endpoints Reduction Any 10 (52.6)/27 11 (55.0)/41 Deaths (ITT) 6/20 (30%) 1/1
Slide 11: Phase 3 Study of Sabizabulin in Hospitalized COVID-19 Patients
Double-Blind, Placebo-Controlled, Phase 3 Study of Sabizabulin for the Treatment of Hospitalized Moderate-Severe COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome (V3011902)(NCT#04842747) – COMPLETED • Patients are hospitalized with severe COVID-19 • Key inclusion criteria: high
Slide 12: Sabizabulin: Phase 3 COVID-19 clinical trial - Demographics
Sabizabulin: Phase 3 COVID-19 clinical trial - Demographics Patient demographics (interim efficacy 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 13: 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 14: FDA status
FDA status Indication: Hospitalized moderate to severe COVID-19 patients at risk for ARDS • 1/22 - COVID-19 Sabizabulin program received Fast Tack designation • 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 foll
Slide 15: Commercial activities for sabizabulin
Commercial activities for sabizabulin • 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 • Ex- US • Veru has initiated regulatory discussions in Europe, Grea
Slide 16: 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 3335 new admissions/day1 • WHO 4 (on o
Slide 17: 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 18: New cases fall and winter and deaths prevented
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% 18
Slide 19: 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 20: Possible additional indications for sabizabulin
Possible additional indications for sabizabulin (broad spectrum anti-viral and anti-inflammatory agent) • 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 syncy
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: Phase 3 registration 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 - 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 Enrolling Combination group
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 Sabizabulin Oral cytoskeleton disruptor targeting agent resistant Phase 3 VERACITY: 245 Patients prostate cancer prior to IV- chemotherapy On
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 ARTA BRCA2) Metastatic castration resistant prostate Metastatic castrati
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 clinical studies
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: 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 30: 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 31: 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 31
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 long
Slide 36: UREV Sexual Health Division
UREV Sexual Health Division 36
Slide 37: 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 38: 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 39: Financial highlights
Financial highlights Veru Veru – Balance Sheet as of March 31, 2022 Net Revenues FY 2021 Net Revenues $ 61.3 mm Cash $ 112.0 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 Revenue
Slide 40: 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