Veru Inc. · NASDAQ:VERU
Veru — HC Wainwright Healthcare Conference (September 2018)
30 slides from Veru's conference presentation, Sep 6, 2018
Slide 1: Prostate Cancer Novel Medicines and Urology Specialty Pharmaceuticals
Veru Inc. Nasdaq:VERU September 6, 2018 HC Wainwright Healthcare Conference Prostate Cancer Novel Medicines and Urology Specialty Pharmaceuticals
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
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 FPI 9/18 & final data expected 1H 2019 Placebo Plan to enroll 120 men who have moderate & Randomize 10 mg severe hot flashes on ADT in 10 US clinical sites Primary efficacy
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 profile Low nanomolar inhibition of tubulin polymerization MICROTUBULE High oral bioavailability High brain penetration Not a substrate for MDRs (P-gp, MRPs, and BCRP) N
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 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: open label clinical data Q1 2019
VERU-111 clinical development: we expect open label clinical data Q1 2019 IND and Phase 1/2 FPI expected calendar Q4 2018- Johns Hopkins Cancer Center- lead center Men with metastatic castration resistant prostate cancer who have progressed on novel AB agent (either enzalutamide or abiraterone) and
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: FLOMAX dosing has a food effect which affects compliance, impacting safety
FLOMAX dosing has a food effect which affects compliance, impacting safety FLOMAX (tamsulosin HCl) is a super selective α1- receptor blocker for the treatment of BPH1 Food effect is a serious problem with current branded and generic formulations of tamsulosin: FLOMAX has a food effect and must be
Slide 21: Tamsulosin DRS granules & XR capsules: NDA filing expected by end of 2018
Tamsulosin DRS granules & XR capsules: NDA filing expected by end of 2018 Results from two bioequivalence Expected next steps: (BE) studies show no food effect Stage 1 (completed) – 12 patients, single dose FLOMAX fed versus Tamsulosin DRS Final BE study by end of 2018 and fed and fasted results r
Slide 22: Tamsulosin DRS granules & XR capsules market strategy and commercialization
Tamsulosin DRS granules & XR capsules market strategy and commercialization Tamsulosin is the number one prescribed 2017 Long term care alpha blocker1 U.S. tamsulosin tamsulosin annual Urologists: initial target market prescriptions prescriptions 28,341,4042 3,136,000 Oral capsule branded product
Slide 23: "Male pill": combination tadalafil/finasteride to improve compliance & safety
“Male pill”: combination tadalafil/finasteride to improve compliance & safety Co-administration of CIALIS (tadalafil 5 mg) and The “male pill”: each component is approved for PROSCAR (finasteride 5 mg) is currently CIALIS (tadalafil 5 mg) daily- symptoms of approved for the initial treatment of sy
Slide 24: Solifenacin DRG granules for patients who have difficulty with swallowing pills
Solifenacin DRG granules for patients who have difficulty with swallowing pills All current selective M3 muscarinic antagonists are only available as capsules/tablets According to FDA label, these capsules/tablets should be swallowed whole and not crushed, or chewed. Expected next steps: Bioequiva
Slide 25: Commercial Product
Commercial Product
Slide 26: $14 million revenue in 2017 from the FC2 Female Condom
$14 million revenue in 2017 from the FC2 Female Condom® FC2 Female Condom only FDA approved female use product that protects against pregnancy and STD Sold in U.S. and 149 countries Public sector represents approx. 90% of revenue (customers include UNFPA, USAID, Brazil, and South Africa) FC2 b
Slide 27: Veru awarded 75% of South African female condom tender 8/18
Veru awarded 75% of South African female condom tender 8/18 The overall tender is for up to 120 million female condoms over 3 years Veru was awarded up to 29.8 million units of the 40 million total for the first year The anticipated total revenue of the South Africa tender awarded to Veru is $31 m
Slide 28: Revenue and positive operating margin from FC2 global business will help fund Veru's drug pipeline
Revenue and positive operating margin from FC2 global business will help fund Veru’s drug pipeline With the South African tender award, we expect global public sector unit volumes to return to three-year historical averages— significantly higher than the last fiscal year’s volume. In addition, we co
Slide 29: 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 $12.1 $10 million received in March 2018 under SWK Holdings sy
Slide 30: 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
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