Veru Inc. · NASDAQ:VERU
Veru — H.C. Wainwright Global Investment Conference May 2022
36 slides from Veru's conference presentation, May 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 H.C. Wainwright Global Investment Conference May 23-26, 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: 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: 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 10: Sabizabulin Phase 3 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 11: 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 12: 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 12
Slide 13: Market: Hospitalized COVID-19 patients at high risk for ARDS/death
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 14: 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 15: 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 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: 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 18: 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 19: Phase 3 ARTEST clinical trial, 3rd line metastatic
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, 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 21: 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 22: 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 23: 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 24: 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 25: 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 26: 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 27: 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 28: 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 29: 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 30: 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 31: Sexual Health Division
UREV Sexual Health Division 31
Slide 32: 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 33: 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 34: 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 35: 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 36: 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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