Veru Inc. · NASDAQ:VERU
Veru — Oppenheimer Healthcare Conference 2019
37 slides from Veru's conference presentation, March 2019
Slide 1: The Prostate Cancer Company Novel Medicines
Veru Inc. Nasdaq:VERU The Prostate Cancer Company Novel Medicines March 2019 Oppenheimer Healthcare Conference
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. These statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or
Slide 3: Pipeline of proprietary product candidates and specialty pharmaceuticals
Pipeline of proprietary product candidates and specialty pharmaceuticals PRODUCT INDICATION TARGET PRECLINICAL PHASE 1 PHASE 2 PHASE 3 PHASE 4 MARKETED PROSTATE CANCER NOVEL MEDICINES Zuclomiphene Hot flashes caused Oral nonsteroidal citrate capsules by prostate cancer estrogen receptor hormone trea
Slide 4: Experienced in clinical practice, drug development and commercialization
Experienced in clinical practice, drug development and commercialization Mitchell Steiner, MD Michele Greco, CPA Gary Barnette, PhD Harry Fisch, MD CHAIRMAN, PRESIDENT & CHIEF FINANCIAL & CHIEF SCIENTIFIC OFFICER CHIEF CORPORATE OFFICER CEO ADMINISTRATIVE OFFICER Sr. VP Scientific and Reg Affairs Ch
Slide 5: Veru The Prostate Cancer Company
Veru is a Prostate Cancer Company, but has revenues from Urology Specialty Pharmaceuticals and legacy product divisions Veru The Prostate Cancer Company Urology Specialty The Female Pharmaceuticals Health Company Division Division TADFINTM - NDA 2019 FC2 Female/internal condom PREBOOST®/Roman Swipes
Slide 6: Prostate Cancer - Novel Medicines
Prostate Cancer - Novel Medicines
Slide 7: Advanced prostate cancer has become a chronic disease requiring active management
Advanced prostate cancer has become a chronic disease requiring active management of the disease and side effects of from existing treatments Strategy Prostate cancer supportive care- focuses Prostate cancer treatment directed to on the issues with treatments2 issues with the disease1 ◆ Estrogen def
Slide 8: Hot flashes one of the most common side effects of androgen deprivation therapy
Hot flashes one of the most common and debilitating side effect of androgen deprivation therapy and novel androgen blocking agents1,2 Occurs in up to 80% of men treated with ADT (leuprolide or degarelix) with 30- 40% having moderate to severe hot flashes1-3 Symptoms do not subside over time ◆ 48% of
Slide 9: Zuclomiphene: potential first FDA approved drug for hot flashes from prostate cancer therapy
Zuclomiphene: potential to be the first FDA approved drug for hot flashes caused by prostate cancer hormone therapy How does ADT cause of hot flashes?1 Hot flash (vasomotor) severity definition5 ◆ In men, estrogen is derived from testosterone. ADT lowers testosterone to castrate levels resulting in
Slide 10: Zuclomiphene is an oral estrogen receptor agonist
Zuclomiphene is an oral estrogen receptor agonist Clomiphene Zuclomiphene (aka cis-clomiphene) (CLOMID) ≈70% ≈30% ◆ Isolated cis-clomiphene from CLOMID (30% cis- and 70% trans-clomiphene; approved in 1967 for female infertility) ◆ Zuclomiphene is an oral weak estrogenic agent1 never approved as a pu
Slide 11: Zuclomiphene as a part of CLOMID has a long safety database
Zuclomiphene as a part of CLOMID has a long safety database Zuclomiphene (aka cis-clomiphene) ◆ FDA database and scientific literature show zuclomiphene component of CLOMID is well tolerated with over 88,000 men/year using CLOMID off label for infertility or hypogonadism1 Number of Prescriptions MAT
Slide 12: Zuclomiphene clinical development plan: Phase 2 trial design
Zuclomiphene clinical development plan: Phase 2 trial design Phase 2 placebo controlled dose finding study First subject in 9/18 & Top line data expected 1H 2019 Placebo Plan to enroll 120 men who have moderate & Randomize severe hot flashes on ADT in ≈ 15 US clinical sites 10 mg ◆ Primary efficacy
Slide 13: Zuclomiphene: greater than $600 million/year expected market for Veru
Zuclomiphene: greater than $600 million/year expected market for Veru Market potential ◆ Indication: treatment of castration-induced hot flashes in men with advanced prostate cancer on ADT ◆ Estimated 600,000 men on hormonal therapies (androgen deprivation therapy as well as novel androgen blocking
Slide 14: VERU-111, an oral selective antitubulin, may address unmet need in refractory metastatic prostate cancer
VERU-111,an oral selective antitubulin, may address largest growing unmet medical need in refractory metastatic prostate cancer The main effective agents against advanced and metastatic prostate cancer are hormonal and antitubulin cytotoxic drugs Androgen blocking agents ZYTIGA (abiraterone) and XTA
Slide 15: VERU-111 inhibits microtubule assembly by selective binding to tubulin subunits
VERU-111 inhibits microtubule assembly by selective binding to α and β tubulin subunits of microtubules Destabilizes Microtubule assembly Microtubules (red) disrupted from spindle to globular shape control VERU-111 VERU-111 “spindle shape” “globular shape” (Crosslinks α and β subunits Triple negativ
Slide 16: VERU-111: novel, oral, next generation, selective tubulin inhibitor
VERU-111: novel, oral, next generation, selective tubulin inhibitor targeting α and β subunits of microtubules Preclinical Product profile1-3 ◆ Low nanomolar inhibition of tubulin polymerization ◆ High oral bioavailability ◆ Not a substrate for MDRs (P-gp, MRPs, and BCRP) ◆ Not a substrate for CYP3A
Slide 17: VERU-111 inhibits growth of taxane-resistant prostate cancer
VERU-111 inhibits growth of taxane-resistant prostate cancer1 ◆ PC-3 and taxane-resistant PC-3 (PC- 3/TxR) human prostate cancer xenografts were grown in mice ◆ Figure a- demonstrates that PC-3 cells are inhibited by a taxane (docetaxel) ◆ Figure b- indicates PC-3/TxR are indeed resistant to a taxan
Slide 18: VERU-111 inhibits prostate cancer tumors resistant to novel androgen blocking agents
VERU-111 inhibits prostate cancer tumors resistant to novel androgen blocking (AB) agents with no effect on body weight (surrogate for toxicity) 22Rv1- human prostate cancer model1 ◆ Contains androgen receptor ◆ Resistant to novel AB agents: variants including AR-V7 enzalutamide and abiraterone Effi
Slide 19: VERU-111 clinical development plan
VERU-111 clinical development plan: Target castration and novel androgen blocking agent resistant metastatic prostate cancer First in class, next generation, novel oral agent that targets α and β subunits of tubulin ADT = androgen deprivation therapy Novel androgen blocking agents= enzalutamide, abi
Slide 20: VERU-111 clinical development: open label clinical data first half of 2019
VERU-111 clinical development: we expect open label clinical data first half of 2019 Open label Phase 1b/2 initiated January 2019- Johns Hopkins Cancer Center and 4 other clinical centers Open label Phase 2 Phase 1b Open label 3+3 design Primary endpoint- PSA reduction N=18 N=26 Metastatic castratio
Slide 21: VERU-111 has potential to treat multiple indications in prostate cancer
VERU-111 has potential to treat multiple indications in prostate cancer Indication 2- novel AB agent and taxane chemotherapy resistant mCRPC ADT = androgen deprivation therapy ADT + Novel AB agents= enzalutamide or enzalutamide, abiraterone, abiraterone IV docetaxel IV cabazitaxel VERU-111 and apalu
Slide 22: VERU-111 has applications in multiple areas of oncology; strong IP
VERU-111 has applications in multiple areas of oncology; strong IP 3 abstracts presented on VERU-111 at Over 29 peer-reviewed publications GU ASCO 2019 ◆ 22Rv1- human metastatic prostate cancer line resistant to enzalutamide and abiraterone ◆ Animal toxicity studies 7 issued composition of matter pa
Slide 23: VERU-111 market opportunity
VERU-111 market opportunity VERU-111, like current antitubulins, Current market for advanced may have efficacy against broad prostate cancer drugs cancer types ◆ $5 billion market for secondary novel androgen ◆ VINCA ALKALOIDS: VELBAN (VINBLASTINE); blocking agents for prostate cancer1 ONCOVIN (VINC
Slide 24: Commercial and Near Commercial Products
Commercial and Near Commercial Products
Slide 25: Urology Specialty Pharmaceuticals
Urology Specialty Pharmaceuticals
Slide 26: TADFIN tablet to improve compliance & safety
TADFINTM tablet (tadalafil 5mg + finasteride 5mg combo) to improve compliance & safety Co-administration of CIALIS (tadalafil 5 mg) and Each component is approved for: PROSCAR (finasteride 5 mg) is currently ◆ CIALIS (tadalafil 5 mg) daily- symptoms of approved for the initial treatment of symptoms
Slide 27: Coadministration of Tadalafil and Finasteride more effective than finasteride alone
Coadministration of Tadalafil and Finasteride for 6 months more effective than finasteride alone to treat men with lower urinary tract symptoms and BPH1 BPH symptom score ED symptom score Safety ◆ International, randomized, double-blind study in approximately 700 men ◆ 350 men treated with placebo +
Slide 28: Coadministration of Tadalafil and Finasteride improves erectile function
Coadministration of Tadalafil and Finasteride versus Finasteride for 6 months improves erectile function in men with or without erectile dysfunction1 Erectile dysfunction at baseline No erectile dysfunction at baseline 1 Glina S et al. J Sex Med 2015; 12:129-138 – Question 3 is vaginal penetrative a
Slide 29: Successful Proprietary TADFIN tablet BA/BE study
Successful Proprietary TADFINTM tablet BA/BE study • Single dose randomized two period, crossover study in 33 healthy males over the age 45 years • Successful BA/BE study • Tadalafil Cmax in TADFIN is 25% less than Tadalafil alone • Process of getting 6 month stability data on commercial batches • N
Slide 30: TADFIN for benign prostatic hyperplasia - market
TADFINTM for benign prostatic hyperplasia - market Market potential • BPH market is up to 25% of male population and estimated 1.1 billion males world wide in 20181 • Target men who have enlarged prostate >30cc as a cause for symptoms and signs of BPH • Other men who may benefit according to Eikelan
Slide 31: PREBOOST (4% benzocaine wipes for premature ejaculation)
PREBOOST® (4% benzocaine wipes for premature ejaculation) Veru signed supply and distribution agreement with Get Roman (Roman Health Ventures Inc.) Q2 FY 2019 ◆ Telemedicine company ◆ Multi-year US supply and distribution agreement ◆ Minimum sales requirement obligates purchase of millions/year ◆ US
Slide 32: FC2 Female Condom business profitable from FY 2006-2018
FC2 Female Condom® business profitable from FY 2006- 20181 FC2 Female Condom only FDA approved female use product that protects against pregnancy & STDs ◆ Sold in U.S. and 149 countries ◆ Manufacturing plant with 100 m units annual capacity ◆ Public sector represents approx. 61% of revenue (customer
Slide 33: Financial highlights – FC2 US prescription business net revenues
Financial highlights – FC2 US prescription business net revenues 33
Slide 34: Financial highlights: Veru Business Q1 FY 2018 versus Q1 FY 2019
Financial highlights: Veru Business Q1 FY 2018 versus Q1 FY 2019 34
Slide 35: Financial highlights (in millions)
Financial highlights (in millions) Capitalization – approximately 62.8 million1 common shares outstanding as of February 11, 2019 Results of operations for the FY ended September 30, 2018 ◆ Net revenues $ 15.9 ◆ Gross profit $ 8.8 ◆ Operating loss $ 20.9 Results of operations for the Q1 FY 2019 ◆ Ne
Slide 36: Veru projected development milestones
Veru projected development milestones PRODUCT INDICATION 2018 2019 2020 PROSTATE CANCER NOVEL MEDICINES Hot flashes caused by NDA Zuclomiphene prostate cancer IND P2 P3 citrate capsules hormone therapy Refractory VERU-111 (bisindole) Metastatic prostate IND P1b/P2 P3 capsules cancer UROLOGY SPECIALT
Slide 37: Key takeaways
Key takeaways • Clinical stage assets in prostate cancer supportive care and treatment will have patient results in 2019 • Zuclomiphene Phase 2 for hot flashes in men on ADT • VERU-111Phase 1b/2 for metastatic castration and androgen blocking agent resistant prostate cancer • Sales of urology specia