Veru Inc. · NASDAQ:VERU
Veru — 2018 Cantor Fitzgerald Healthcare Conference
24 slides from Veru's conference presentation, October 2018
Slide 1: Prostate Cancer Novel Medicines and Urology Specialty Pharmaceuticals
Veru Inc. Nasdaq:VERU Prostate Cancer Novel Medicines and Urology Specialty Pharmaceuticals October 2018
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 Nonsteroidal capsules by prostate cancer estrogen agonist hormone treatment VERU-111
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: Prostate Cancer - Novel Medicines
Prostate Cancer - Novel Medicines
Slide 6: Zuclomiphene: potential to be the first FDA approved drug for hot flashes caused by prostate cancer hormone therapy
Zuclomiphene: potential to be the first FDA approved drug for hot flashes caused by prostate cancer hormone therapy Hot flashes are one of the most Zuclomiphene (aka cis-clomiphene) common and debilitating side effect is an oral estrogenic agent4,5 of androgen deprivation therapy Isolated cis-clom
Slide 7: Zuclomiphene clinical development plan: Phase 2 trial design
Zuclomiphene clinical development plan: Phase 2 trial design IND accepted 7/18 Phase 2 placebo controlled dose finding study First subject expected in 9/18 & final data Placebo expected 1H 2019 Randomize 10 mg Plan to enroll 120 men who have moderate & severe hot flashes on ADT in 10 US clinical sit
Slide 8: Zuclomiphene: greater than $600 million/year expected market
Zuclomiphene: greater than $600 million/year expected market 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 agents) i
Slide 9: VERU-111 may address key limitations of current prostate cancer treatments
VERU-111 may address key limitations of current prostate cancer treatments The only effective agents against advanced and metastatic prostate cancer are hormonal and antitubulin cytotoxic drugs Androgen blocking agents ZYTIGA (abiraterone) and XTANDI (enzalutamide) have significant cross resistance
Slide 10: VERU-111: novel, oral, next generation, tubulin inhibitor
VERU-111: novel, oral, next generation, tubulin inhibitor targeting α and β subunits of microtubules Preclinical Product profile1-3 Low nanomolar inhibition of tubulin polymerization MICROTUBULE High oral bioavailability High brain penetration Not a substrate for MDRs (P-gp, MRPs, and BCRP)
Slide 11: VERU-111 builds on a proven mechanism - inhibiting microtubule assembly
VERU-111 builds on a proven mechanism - inhibiting microtubule assembly 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 negative human breast cancer xenograft and inhibits
Slide 12: 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 13: 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 14: VERU-111 clinical development plan: Target castration and novel androgen blocking agent resistant metastatic prostate cancer
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 15: VERU-111 clinical development: we expect open label clinical data Q1 2019
VERU-111 clinical development: we expect open label clinical data Q1 2019 Successful pre-IND meeting with FDA 9/18 IND and Phase 1/2 expected calendar Q4 2018- Johns Hopkins Cancer Center (lead center) Men with metastatic castration resistant prostate cancer who have progressed on novel androgen blo
Slide 16: 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 17: VERU-111 has applications in multiple areas of oncology; strong IP
VERU-111 has applications in multiple areas of oncology; strong IP 4 abstracts at ASCO 2018 Over 29 peer-reviewed publications VERU-111 HAD EFFICACY AGAINST THE FOLLOWING HUMAN CANCER XENOGRAFT MODELS 22Rv1- human metastatic prostate cancer line resistant to enzalutamide and abiraterone 7 issued c
Slide 18: 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 19: Urology Specialty Pharmaceuticals
Urology Specialty Pharmaceuticals
Slide 20: Urology specialty pharmaceuticals: NDAs for drug products to be submitted 2019
Urology specialty pharmaceuticals: NDAs for 3 drug products to be submitted 2019 Product Indication Formulation and Market Status advantages Tamsulosin XR BPH 0.4 mg Slow release 2017 US market- Final bioequivalence capsules and granules with no food 28,341,404 scripts study will be granules Branded
Slide 21: Commercial Product
Commercial Product
Slide 22: FC2 Female Condom business profitable from FY 2006-2017
FC2 Female Condom® business profitable from FY 2006- 20171 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 million units annual capacity Public sector represents approx. 90% of revenue (cu
Slide 23: Financial highlights (in millions)
Financial highlights (in millions) Capitalization - approximately 54.7 million1 common shares outstanding as of June 30, 2018 Balance sheet as of June 30, 2018 Cash and receivables $9.2 UK NOL carryforward $62.2 US NOL carryforward $10.5 $10 million received in March 2018 under SWK Holdings sy
Slide 24: 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 capsules hormone therapy VERU-111 (bisindole) Metastatic prostate IND P1b/P2 P3 capsules cancer UROLOGY SPECIALTY PHARMACEUTICALS B