Veru Inc. · NASDAQ:VERU
Veru — Investor Presentation (June 2021)
59 slides from Veru's investor presentation, June 2021
Slide 1: Oncology Biopharmaceutical Company Focused on Prostate Cancer and Breast Cancer
Veru Inc. Nasdaq:VERU Oncology Biopharmaceutical Company Focused on Prostate Cancer and Breast Cancer Veru Corporate Presentation June 2021
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 Focused on prostate cancer and breast cancer Sabizabulin Prostate Cancer Late-stage clinical pipeline focused on prostate cancer & VERU-100 breast cancer Late stage COVID-19 antiviral and anti-inflammatory agent Oncology COVID-19 Sabizabulin 5 registration clinical
Slide 4: Drug candidate pipeline
Drug candidate pipeline1 Oncology biopharmaceutical company focused on prostate cancer and breast cancer Program Mechanism Indication Preclinical Phase 1 Phase 2 Phase 3 Metastatic castration and AR Sabizabulin (VERU-111) targeting agent resistant Phase 3 VERACITY: Planned Q2 2021 - 245 Patients pro
Slide 5: Prostate Cancer – Novel Medicines
Prostate Cancer – Novel Medicines Program Mechanism Indication Preclinical Phase 1 Phase 2 Phase 3 Metastatic castration and AR targeting Phase 3 VERACITY: 245 Patients Sabizabulin agent resistant (VERU-111) prostate cancer Oral cytoskeleton disruptor and androgen receptor transport disruptor Metast
Slide 6: Sabizabulin prostate cancer treatment paradigm
Sabizabulin prostate cancer treatment paradigm: Focus is on the prechemotherapy space which is a growing unmet need Chemotherapy Current indication PARP inhibitor DNA repair Olaparib alterations (BRCA1 and AR targeting Metastatic castration BRCA2) agent Approx 10% Metastatic castration and AR target
Slide 7: Sabizabulin disrupts transport of androgen receptor into the nucleus
Sabizabulin disrupts transport of androgen receptor into the nucleus Cytoplasm AR binding to DHT and dimerization DHT DHT DHT AR Nucleus DHT AR AR DHT AR AR Growth and DHT metastasis DHT genes DHT turned on AR AR DHT Translocation of dimerized AR into nucleus by dynein motor X AR DHT AR DHT proteins
Slide 8: Sabizabulin clinical development
Sabizabulin clinical development Phase 1b (expansion cohort) and Phase 2 study design Phase 1- Dose escalation to evaluate safety of sabizabulin in men with metastatic castration Phase 2- Evaluate safety and efficacy of resistant prostate cancer following at least one sabizabulin RP2D 63mg PO q d in
Slide 9: Phase 1b and Phase 2 baseline demographics
Phase 1b and 2 clinical studies Baseline demographics Phase 1b Phase 2 9
Slide 10: Sabizabulin safety
Sabizabulin safety Phase 1b and 2 combined ITT population for 63 mg dose Adverse events were mostly grade 1 and 2 Most prevalent adverse events regardless of grade (>10% frequency) in patients that received 63 mg dose (n=54) * * Diarrhea was mostly (88%) grade 1 and 2 and medically manageable as onl
Slide 11: Sabizabulin Phase 1b efficacy
Sabizabulin Phase 1b efficacy PSA waterfall plot Ten men have reached ≥ 4 cycles of continuous dosing • 10 men reached at least four cycles of continuous dosing 50 Max PSA % decrease • Disease (4 Bone;3 LN; and 3 LN+Bone) 0 from baseline • Previous treatment- (5 Abi; 2 Enz; and 3 Abi+Enz) -50 • PSA
Slide 12: 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 Gleason 9 mCRPC with lymph node only dis
Slide 13: Combined Phase 1b/2 efficacy data summary
Combined Phase 1b/2 efficacy data in men who received sabizabulin 63mg dose Summary • In ITT population, all patients with measurable disease at baseline (n=29), the ORR (5PR +1CR observed) was 20.7% • All evaluable patients that would qualify for the Phase 3 study with measurable at baseline (n=26)
Slide 14: 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 neurotox
Slide 15: Phase 3 VERACITY clinical trial
Phase 3 VERACITY clinical trial (V3011102) (NCT#-04844749) - planned initiation May 2021 VERACITY - Randomized, Active-Controlled, Phase 3 Study of • Open label, multicenter, multinational, Sabizabulin for the Treatment of Metastatic Castration-Resistant randomized, sabizabulin 32 mg daily oral dosi
Slide 16: 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® FIRMAGON® (degarelix) (SC) Depot (IM) and ELIGARD® (SC) are leuprolide products • Concerns over initial surge • Painful injection as degarelix in T leve
Slide 17: 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 profile1,2 • Novel proprietary GnRH antagonist decapeptide delivery formulation • 3 month slow release subQ depot (1.5 cc SQ injection) with
Slide 18: VERU-100 trial design
VERU-100 (NCT#04843319) Open label, dose finding Phase 2 clinical trial anticipated to begin enrollment June 2021 • 7 clinical sites in US • Hormone sensitive advanced prostate cancer Stage 1 Stage 2 Add 15 patients at 150 mg ≥90% castrate Day 28 and Day 91 and 10 patients at 100 mg sc injection Ass
Slide 19: Breast Cancer – Novel Medicines
Breast Cancer – Novel Medicines Program Mechanism Indication Preclinical Phase 1 Phase 2 Phase 3 AR+ER+HER2- Phase 3 ARTEST: Planned Q2 2021 – 210 Patients metastatic breast Enobosarm cancer (3rd line metastatic) Selective androgen receptor targeted agonist AR+ER+HER2- Phase 2: Planned Q3 2021 – 106
Slide 20: Current Endocrine Therapies
Endocrine therapies that target estrogen receptor axis are effective against ER+ breast cancer Current Endocrine Therapies Selective estrogen receptor modulators (tamoxifen and toremifene) Resistance to endocrine and CDK4/6 inhibitor therapies eventually ER antagonists and degraders (fulvestrant) oc
Slide 21: NCCN 2020 guidelines: CDK 4/6 inhibitors standard of care
NCCN 2020 guidelines: CDK 4/6 inhibitors are standard of care for treatment of Estrogen blocking agent naïve and resistant ER+HER2- metastatic breast cancer • First line metastatic • Nonsteroidal aromatase inhibitor + CDK4/6 inhibitor • Fulvestrant + CDK 4/6 inhibitor • Second line metastatic • Fulv
Slide 22: 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 23: Enobosarm, first-in-class oral selective AR targeting agent
Enobosarm, first-in-class, novel oral selective AR targeting and activating agent for the treatment for AR+ER+ metastatic breast cancer • Enobosarm is a non-steroidal, selective androgen receptor agonist1, 2 • Once-a-day oral daily dosing • Selectivity to activate the androgen receptor with no cross
Slide 24: Enobosarm has an extensive clinical experience
Enobosarm has an extensive clinical experience – safety de-risked • Enobosarm has been evaluated in 25 clinical trials comprising 2,091 subjects (348 subjects dosed at > 9mg) • 6 Phase 2 studies in breast cancer (5) or breast disease (1) • G200801 – Proof of concept 9 mg enobosarm in AR+ ER+ metasta
Slide 25: Phase 2 clinical trial (G200802) presented at SABCS
Phase 2 clinical trial (G200802): AR+ER+ metastatic breast cancer presented at San Antonio Breast Cancer Symposium December 2020 Efficacy and safety of Enobosarm, a selective androgen receptor agonist, to target AR in women with advanced AR+ER+ breast cancer – final results from an international Pha
Slide 26: Phase 2 clinical trial (G200802) design
Phase 2 clinical trial (G200802) design Targeting AR+ER+ metastatic breast cancer in a heavily pretreated population1 Enobosarm 9 mg N=72 Randomization Screening 1:1 Enobosarm 18 mg N=64 • Trial design • Open label, multicenter, multinational, randomized parallel design Phase 2 study to assess the e
Slide 27: Phase 2 clinical trial (G200802) patient demographics
Phase 2 clinical trial (G200802) Patient 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 (19-435) 86.0(15-323) M
Slide 28: Phase 2 efficacy summary
Phase 2 clinical trial (G200802) Efficacy summary Evaluable Population (AR+) 9mg cohort 18mg cohort Number of evaluable patients 50 52 Primary endpoint: 32% (95% CI: 19.5%;46.7%) 29% (95% CI: 17.1%;43.1%) CBR at 24 weeks 28
Slide 29: Best objective tumor responses
Phase 2 clinical trial (G200802) Best objective tumor responses Efficacy results- RECIST 1.1 best overall tumor responses (BOR) by central read at any time during the study in patients with measurable disease at baseline • 9 mg cohort (n=34) • 2 (5.9%) complete responses • 8 (23.5%) partial response
Slide 30: Best overall % target lesion reduction
Phase 2 clinical trial (G200802) Best overall % target lesion reduction – Enobosarm 9 and 18 mg 30
Slide 31: Determination of AR status - companion diagnostic test
Determination of AR status - companion diagnostic test (CDx) • AR staining was performed using a validated immunohistochemistry (IHC) protocol conducted by HistoGeneX as the central laboratory • Slides were stained using an autostainer and then scanned and analyzed digitally with a pathology image a
Slide 32: 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 33: rPFS – Enobosarm 9 mg and 18 mg
Phase 2 clinical trial (G200802) rPFS– Enobosarm 9 and 18 mg 33
Slide 34: Duration of previous estrogen blocking agent response
Phase 2 clinical trial (G200802)- Post-hoc AR expression subset analysis Duration of previous estrogen blocking agent response as a surrogate for Phase 3 active control predicted response • Analysis of ITT (FAS) group with known AR status and have measurable disease (n=84) • Had received at least 2
Slide 35: Safety summary all patients ITT
Phase 2 clinical trial (G200802) Safety summary all patients ITT Enobosarm was well tolerated; majority of events were Grade 1 and 2 Enobosarm 9 mg Enobosarm 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 Pa
Slide 36: Conclusions - AR targeted therapy shows efficacy and safety
Phase 2 clinical trial (G200802) Conclusions - AR targeted therapy shows efficacy and safety in AR+ER+ breast cancer • Enobosarm AR targeted treatment demonstrated clinical benefit with objective tumor responses in women with heavily pretreated estrogen blocking agent resistant AR+ ER+ HER2- metasta
Slide 37: Role of enobosarm and CDK4/6 inhibitors in resistant breast cancer
Role of enobosarm and CDK4/6 inhibitors in 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 cancer
Slide 38: Patients previously treated with a CDK 4/6i
Patients Phase previously treated with a CDK 4/6i (Table 2) 2 802 study Evaluable patients (AR+) with palbociclib resistance in the metastatic setting Patient # AR% Staining BOR rPFS (months) Planned Actual Lines of treatment Comment dose dose (metastatic) 7019-8106 16.07 SD 5.17 18 9 3 Censored wit
Slide 39: Evaluable patients with palbociclib resistance
Phase 2 802 study Evaluable patients (AR+) with palbociclib resistance in the metastatic setting Palbociclib resistant subjects with measurable disease • Objective tumor responses 9 mg Outcome 18 mg Outcome • 30% overall patient ID patient ID 7004-8120 6003-8133 • CBR at 24 weeks • 50% overall 7019-
Slide 40: Next potential treatment regimens for resistant metastatic breast cancer
What are the next potential treatment regimens for estrogen blocking agent and CDK 4/6 inhibitor resistant AR+ER+HER2- metastatic breast cancer ? • 3rd line treatment - Failed nonsteroidal aromatase inhibitor, fulvestrant, and CDK 4/6 inhibitor? • Evaluate agent with new mechanism of action targetin
Slide 41: Enobosarm Phase 3 ARTEST clinical trial
3rd line metastatic setting resistant to estrogen blocking agent and CDK4/6 inhibitor: Enobosarm, AR targeted therapy, Phase 3 registration, open label, randomized ARTEST clinical trial (V3002401)(NCT#04869943)- anticipated start Q2 2021 Phase 3 Pivotal AR+ER+HER2- ARTEST Clinical Trial Design ARTES
Slide 42: 2nd line metastatic setting: Phase 2 study
2nd line metastatic setting: Phase 2 (V2000701) study start expected Q3 2021 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 Palbociclib resistance Combinatio
Slide 43: Sabizabulin 32mg
Sabizabulin 32mg for the treatment of chemotherapy including taxane resistant metastatic triple negative breast cancer 43
Slide 44: Phase 2b clinical study (V2011801)
Phase 2b clinical study (V2011801): anticipated start calendar Q3 2021 Sabizabulin for metastatic triple negative breast cancer that has failed 2 chemotherapies Trial study design • Patients previously treated with a least 2 systemic chemotherapies for metastatic triple negative breast cancer N=50 •
Slide 45: Sabizabulin 9 mg for hospitalized COVID-19 patients
Sabazibulin 9 mg For the treatment of hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome 45
Slide 46: Coronavirus spike protein interacts with microtubules
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 47: 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 48: 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 49: Safety outcomes for Sabizabulin 18mg from Phase 2
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 50: 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) – enrollment commenced May 2021 • Trial size is N=300 with a 2:1 randomization • Dosing: daily dosing up
Slide 51: Sexual Health Division
Sexual Health Division 51
Slide 52: TADFIN capsule combination
TADFINTM capsule (tadalafil 5mg + finasteride 5mg combo) to improve compliance & safety COMBINATION TADFIN TM Co-administration of CIALIS Each component is approved for: (tadalafil 5 mg) and • CIALIS (tadalafil 5 mg) daily- symptoms PROSCAR (finasteride 5 mg) of BPH and erectile dysfunction is curre
Slide 53: Tadalafil and Finasteride, only BPH treatment that prevents progression
Tadalafil and Finasteride, only BPH treatment that prevents progression of BPH and improves sexual function1,2 ED symptom score2 ED symptom score2 Men with baseline ED Men without baseline ED Safety ◆ International, randomized, double-blind study in approximately 700 men ◆ 350 men treated with place
Slide 54: TADFIN, only BPH treatment that prevents progression of BPH
TADFIN, only BPH treatment that prevents progression of BPH and improves sexual function1,4 Pre-NDA meeting on Proprietary Market potential TADFINTM capsule • BPH market is up to 25% of male population and estimated 1.1 billion males world wide in 20181 • Single dose randomized two period, crossover
Slide 55: FC2 Female Condom business revenues are growing
FC2® Female Condom (internal condom) business revenues are growing FC2 Female Condom (internal condom) is the only FDA approved female use product to prevent pregnancy and transmission of sexually transmitted infections • Sold in U.S. and 149 other countries • Manufacturing plant with annual capacit
Slide 56: FC2 revenues
FC2 revenues FC2 global public sector & FC2 US prescription revenues ($ mm) $13.75 $13.34 US Prescription $3.03 FC2 Revenues $10.96 $4.65 FY 2018: $ 15.9 mm Global Public Sector $10.42 FY 2019: $ 30.9 mm $9.65 $9.28 $9.52 $2.23 FY 2020: $ 40.6 mm $8.47 FYTD 2021: $ 27.1 mm $4.37 $2.57 $4.25 $6.84 $6
Slide 57: Financial highlights
Financial highlights Results of Operations FYTD 2021 Net Revenues $ 28.0 mm FYTD 2021 Gross Profit $ 21.7 mm FYTD 2021 Operating Income $ 17.7 mm FYTD 2021 Adjusted Operating Loss1 $ 0.7 mm Record revenue FYTD from sexual health business $28.0 million Q2 FY 2021 Net Revenues $ 13.3 mm Q2 FY 2021 Gro
Slide 58: Drug candidate pipeline
Drug candidate pipeline1 Oncology biopharmaceutical company focused on prostate cancer and breast cancer Program Mechanism Indication Preclinical Phase 1 Phase 2 Phase 3 Metastatic castration and AR Sabizabulin (VERU-111) targeting agent resistant Phase 3 VERACITY: Planned Q2 2021 - 240 Patients pro
Slide 59: Milestones: 5 registration clinical studies expected in 2021
Milestones 5 registration clinical studies expected to be initiated in calendar year 20211 Prostate cancer Breast Cancer COVID-19 Sabizabulin Enobosarm Sabizabulin • Phase 2 trial: completely enrolled • Initiate Phase 3 clinical study • Phase 3 trial - enrolling and ongoing metastatic castration eno