Veru Inc. · NASDAQ:VERU
Veru — Investor Presentation (December 2023)
19 slides from Veru's investor presentation, Dec 13, 2023
Slide 1: Forward looking statements and safe harbor
Forward looking statements and safe harbor The statements in this document 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 document include statements regarding: the pla
Slide 2: GLP-1 drugs cause significant loss of both fat and muscle
Currently approved GLP-1 receptor agonist drugs for the treatment of obesity have demonstrated significant loss of both fat and muscle in obese patients Weight loss drugs GLP-1 receptor agonists demonstrated a 6.2-12.4% average total weight loss in third-party clinical trials1,2 20-50% of the total
Slide 3: Target population: at-risk obese or overweight patients with low muscle reserves
Currently approved GLP-1 RA drugs for the treatment of obesity have demonstrated significant loss of both fat and muscle in clinical trials The target population is the at risk obese or overweight patients with low muscle reserves Approximately 42% of older adults (>60 yo) have obesity or overweight
Slide 4: Enobosarm is a novel oral selective androgen receptor modulator
Enobosarm is a novel oral selective androgen receptor modulator (SARM) designed to reduce fat mass and increase lean mass (muscle and bone) Enobosarm is a non-steroidal, selective androgen receptor agonist1, 2 Data from clinical trials and preclinical studies support enobosarm’s potential: Once-a-da
Slide 5: Enobosarm clinical data from GTx or Merck trials
Enobosarm clinical data from 5 clinical trials conducted by GTx or Merck in subjects with and without muscle wasting Sarcopenic= presence of low muscle mass; LBM= lean body mass; SCP= stair climb power (Watts), power exerted in a 12-step stair climb; CSR=clinical study report ; N.S.=not significant
Slide 6: Phase 2 trial G200501 in healthy elderly men and postmenopausal women
Healthy elderly men (60 yo) and postmenopausal women receiving enobosarm in GTx conducted Phase 2 double-blind placebo controlled clinical trial (G200501) demonstrated improved lean body mass and physical function 1 Dalton JT et al. J Cachexia Sarcopenia Muscle 2:153-161, 2011|2 G200501 Clinical Stu
Slide 7: Phase 2b G200502 trial in patients with cancer
Reported effects of enobosarm on muscle and physical function in patients with cancer: a double-blind, randomized controlled Phase 2b (G200502) clinical trial conducted by GTx1,2 1 Dobs AS et al. Lancet Oncol 14:335-345, 2013 |2 G200502 Clinical Study Report Mean age >60 yo 159 subjects enrolled 16
Slide 8: Phase 3 trial G300504 in non-small cell lung cancer
Phase 3 randomized, double-blind, placebo-controlled 504 clinical trial of evaluating the effects of enobosarm on muscle wasting in patients with non-small cell lung cancer on first line platinum plus a taxane chemotherapy conducted by GTx1 1 Study G300504 CSR data on file Veru 3mg enobosarm treatme
Slide 9: G300504 post-hoc analysis of obese subpopulation
Phase 3 randomized, placebo-controlled 504 clinical trial of evaluating enobosarm on muscle wasting in patients with non-small cell lung cancer on first line platinum plus a taxane chemotherapy conducted by GTx1 1 Study G300504 CSR data on file Veru Up to Day 84 visit Total lean body mass Up to Day
Slide 10: Data from third-party trials of approved GLP-1 RAs
Data from third-party clinical trials of currently approved GLP-1 RAs 1FDA Wegovy PI Stopped drug Patients demonstrated greatest amount of absolute total weight loss (fat + muscle) between weeks 4 and 20 Patients that discontinued treatment at week 20 had significant weight gain (rebound) The report
Slide 11: Enobosarm +/- GLP-1 RA clinical and regulatory strategy
Enobosarm +/- GLP-1 RA for the treatment of obesity Clinical and regulatory strategy Enobosarm potential direct effects: active protein synthesis in muscle (increasing muscle mass) and increase in lipolysis leads to greater fat loss GLP-1 RA Treatment of Obesity Sarcopenic obesity or over weight >60
Slide 12: Phase 2b enobosarm and GLP-1 RA combination study design
Phase 2b double-blind, placebo controlled, randomized, dose finding trial to evaluate the efficacy and the safety of enobosarm in preventing muscle loss and increasing fat loss in patients receiving a GLP-1 RA to treat obesity Randomization 1:1:1 Enobosarm 3 mg PO + GLP-1 RA Placebo + GLP-1 RA Treat
Slide 13: Scientific advisory board
Scientific advisory board Shalender Bhasin, MB, BS Professor of Medicine, Harvard Medical School Director, Research Program in Men's Health: Aging and Metabolism Director, Boston Claude D. Pepper Older Americans Independence Center Brigham and Women's Hospital Dennis T. Villareal, MD Professor of Me
Slide 14: Enobosarm has an extensive safety database
Percentage of healthy and cancer subjects in all 5 clinical and Phase 1 clinical trials reporting a treatment-emergent serious adverse event with a frequency of ≥ 1% Enobosarm has an extensive safety database Combined Safety data from 5 Phase 2 and 3 clinical trials in cancer and healthy subjects an
Slide 15: Enobosarm safety database across >1580 subjects
Enobosarm has an extensive safety database Evaluated in 27 clinical trials comprising >1580 subjects dosed (235 subjects dosed at > 9mg) Data reported from 12 Phase 1 studies: No QT effects No significant drug-drug interactions2 No significant food effect No significant renal or hepatic effects Majo
Slide 16: IP portfolio and regulatory protection create barriers to entry
Enobosarm for weight loss–IP portfolio and regulatory protection create significant barriers to entry Enobosarm is a novel SARM Enobosarm issued specific molecule composition of matter patents and issued specific molecule composition of matter polymorphs patents – Last expiry patent term (6 patents)
Slide 17: Competitive landscape: clinical candidates to prevent muscle loss with GLP-1 RA
4_81 Clinical drug candidates to prevent muscle loss with GLP-1 RA for obesity Competitive Landscape Drug Class Delivery Clinical stage with GLP-1 RA Data expected Company Comments Enobosarm Selective androgen receptor modulator Oral Phase 2b 2H 2024 GLP-1 RA combo and GLP-1 RA rescue Bimagrumab Ant
Slide 18: Enobosarm and GLP-1 receptor agonists target product profile
Enobosarm and GLP-1 receptor agonists Target product profile Enobosarm is a nonsteroidal, selective androgen receptor agonist that targets the androgen receptor, a well-established mechanism of action1,2 Data from clinical trials and preclinical studies support enobosarm’s potential: Administration:
Slide 19: Preventing muscle loss in patients receiving treatment for obesity
Preventing muscle loss in patients receiving treatment for obesity 1CDC 2017-2020 | 2 Malenfant J J Glob Health Rep 3:e2019045, 2019|3Lutski M et al. Prev Chronic Dis 17:200167, 2020 US obesity market1-3 45.9% of adult men aged 40-59 yo 38.4% of adult men aged 60+ yo 42.8% of adult women aged 40-59