Veru Inc. · NASDAQ:VERU
Veru — Leerink Therapeutics Forum: I&I and Metabolism 2024
33 slides from Veru's conference presentation, Jul 9, 2024
Slide 1: Focused on metabolic diseases and oncology
Veru Inc. Nasdaq:VERU Focused on metabolic diseases and oncology Veru Corporate Presentation Leerink Therapeutics Forum: I&I and Metabolism July 9-10, 2024
Slide 2: 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 3: Drug candidate pipeline
Drug candidate pipeline Biopharmaceutical company Program Mechanism Indication 2023 2024 2025 2026 Metabolic Phase 2b Selective androgen Protect Phase 2b Enobosarm and receptor modulator muscle loss extension Obese or overweight elderly Phase 2b GLP-1 receptor agonist (SARM) patients receiving a GLP
Slide 4: Muscle loss significant side effect of GLP-1 receptor agonists weight loss drugs
Muscle loss significant side effect of GLP-1 receptor agonists weight loss drugs 4
Slide 5: GLP-1 RA drugs cause significant loss of both fat and muscle
Currently approved GLP-1 receptor agonist drugs have demonstrated significant loss of both fat and muscle in overweight or obese patients • Weight loss drugs GLP-1 receptor agonists demonstrated a 6.2-17% average total weight loss1,2 • 20-50% of the total weight loss is from muscle loss1,3,4,5 1 pou
Slide 6: Currently GLP-1 RA drugs result in significant loss of both fat and muscle
Currently GLP-1 RA drugs result in significant loss of both fat and muscle The target population is the at risk obese or overweight patients with low muscle reserves Normal5 • Approximately 42% of older adults (>60 yo) have obesity or overweight and could benefit from weight-loss drugs1 • Subpopulat
Slide 7: WEGOVY FDA label now shows fracture safety data from SELECT study
WEGOVY FDA label now shows fracture safety data from SELECT Cardiovascular outcomes study 1 Wegovy PI page 4 7
Slide 8: Lumbar surgery patients on Wegovy were at greater risk for repeat operations
1 Lumbar surgery patients on Wegovy were at greater risk for repeat operations Wegovy induced sarcopenia, or muscle loss the cause? • Patients from all-payer Mariner database • Patients aged 18-74 years with type 2 diabetes who underwent elective transforaminal lumbar interbody fusions (TLIFs) betwe
Slide 9: GLP-1 receptor agonist drug seems to have stopped working?
GLP-1 receptor agonist drug seems to have stopped working? What do I do now and how do I stop? How do I keep the weight off after stopping? 9
Slide 10: Wegovy approval clinical studies: overweight and obese adult patients
Wegovy approval clinical studies1: overweight and obese adult patients Rate of weight loss reaches a plateau • Greatest amount of absolute total weight loss between weeks 0 and 20 • Patients who discontinued treatment at week 20 had significant weight gain (rebound) • The reported weight gain was al
Slide 11: Muscle produces myokines
Muscle produces myokines Myokines regulate appetite control and energy balance1,2 Depleted muscle- low energy balance Normal muscle – normal energy balance Appetite Appetite Lipid break-down Myokines Lipid break-down Myokines 1 Dulloo A Obesity 25:277-279, 2017 | 2Grannell A et al. Muscles 1:26-47,
Slide 12: Enobosarm is a novel oral selective androgen receptor modulator (SARM)
Enobosarm is a novel oral selective androgen receptor modulator (SARM) designed to reduce fat mass and increase lean mass (muscle and bone) • Enobosarm (Ostarine, MK2866, GTx-024) is a nonsteroidal, selective androgen receptor modulator1,2 • Data from clinical trials and preclinical studies support
Slide 13: Enobosarm clinical data from clinical trials approx. 1,000 patients
Enobosarm clinical data from 5 clinical trials approx. 1,000 patients conducted by GTx or Merck in subjects with and without muscle wasting Subjects Muscle strength/ Phase Population Purpose Muscle (LBM) Fat Mass Duration Source (n=) function 3mg Dalton JT 120 (24 Males over 60 years of 3mg=0.32 kg
Slide 14: Phase 2 trial G200501 in healthy elderly men and postmenopausal women
Healthy elderly men (>60 yo) and postmenopausal women receiving enobosarm in Phase 2 double-blind placebo controlled clinical trial (G200501) demonstrated improved lean body mass and physical function • 120 subjects enrolled • 12 weeks of treatment % Change in lean mass % Change in stair climb power
Slide 15: Effects of enobosarm on muscle and physical function in cancer patients
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 • Mean age >60 yo • 159 subjects enrolled • 16 weeks of treatment Change in stair climb time and power at Day 113/EOS compa
Slide 16: Phase 3 clinical trial of enobosarm 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 chemotherapy1 3mg enobosarm treatment in 321 subjects enrolled for 21 weeks Lean body mass
Slide 17: 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 chemotherapy1 Post-hoc analysis of obese subpopulation (BMI ≥ 30) Total lean body mass Total fat mass Total body weight
Slide 18: Enobosarm +/- GLP-1 RA for the treatment of obesity
Enobosarm +/- GLP-1 RA for the treatment of obesity Clinical and regulatory strategy for all patients who are overweight or obese • New drug in combination with GLP-1 RA should show incremental increase in weight loss • Enobosarm potential direct effects: • Prevents muscle loss: active protein synth
Slide 19: If muscle is preserved, can there still be significant weight loss?
If muscle is preserved, can there still be significant weight loss? The amount of fat mass compartment is greater Preventing muscle loss (FFM deficit) blocks than the muscle mass one the trigger to increase in appetite1 1 Dulloo A Obesity 25:277-279, 2017 19
Slide 20: If muscle is preserved, no muscle deficit, there could be significant weight loss
If muscle is preserved, no muscle deficit, there could be significant weight loss Enobosarm monotherapy? + Enobosarm? Greater amount of fat loss and Prevent rebound fat and weight gain resultant weight loss on GLP-1RA? and maintain weight loss when off GLP-1RA? 1 FDA Wegovy PI |2 Dulloo AG et al. Eu
Slide 21: If muscle is preserved, could there be greater weight loss without a plateau?
If muscle is preserved, could there be greater weight loss without a plateau ? SELECT Trial: Effect of long-term testosterone in hypogonadal men with obesity Effect of semaglutide vs placebo on body weight (8 years) (4.25 years) BMI 30-34.9 BMI 35-39.9 BMI >40 1Lincoff AM, Brown-Frandsen K, Colhoun
Slide 22: Sarcopenic obese or overweight elderly patients at risk of muscle weakness
Sarcopenic obese or overweight elderly patients at risk for developing muscle weakness and functional limitations when receiving GLP-1 RA for weight loss 1 Taken from Malandrino N et al. Endocrinol Metab Clin N Am 52 (2023) 317–339 22
Slide 23: Enobosarm +/- GLP-1 RA: strategy for older patients with low muscle reserve
Enobosarm +/- GLP-1 RA for the treatment of obesity Clinical and regulatory strategy for older patients with low muscle reserve • New drug in combination with GLP-1 RA should show incremental increase in weight loss and physical function benefit • Enobosarm potential direct effects: • Prevents muscl
Slide 24: Enrolling Phase 2b QUALITY Trial design
Enrolling Phase 2b QUALITY Trial- Phase 2 double-blind, placebo controlled, randomized, dose finding trial of enobosarm in preventing muscle loss and increasing fat loss in patients receiving a GLP-1 RA for weight loss Enobosarm and GLP-1 RA combination study Primary endpoint of LBM Primary endpoint
Slide 25: Enobosarm is a muscle drug
Enobosarm is a muscle drug Muscle should be the target for greater high quality weight loss (precision weight loss) • Prevent loss of muscle to preserve physical function • Older adults with sarcopenic obesity are at risk for developing physical function decline; accelerated development of frailty •
Slide 26: Enobosarm has an extensive safety database
Enobosarm has an extensive safety database Combined Safety data from double-blind, placebo controlled clinical trials with enobosarm Treatment-emergent adverse events in at least 2% of patients in placebo or enobosarm 3mg and at least 1% or higher in one of the two groups with a frequency of ≥0.5% P
Slide 27: Enobosarm has an extensive safety database
Enobosarm has an extensive safety database Safety of special interest: Elderly healthy volunteers G200501 Phase 2 study conducted by GTx1 • 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 sign
Slide 28: 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 modulator that targets the androgen receptor, a well-established mechanism of action1,2 • Data from clinical trials and preclinical studies support enobosarm’s potential: • Adminis
Slide 29: Clinical drug candidates to prevent muscle loss with GLP-1 RA for obesity
Clinical drug candidates to prevent muscle loss with GLP-1 RA for obesity Competitive Landscape Clinical stage Data Drug Class Delivery Company Comments with GLP-1 RA expected GLP-1 RA combo Selective androgen Enobosarm Oral Phase 2b Q4 2024 and receptor modulator GLP-1 RA rescue Anti-myostatin Acqu
Slide 30: Scientific advisory board
Scientific advisory board Louis Aronne, MD- Veru’s Chief Medical Advisor Sanford Weill Professor of Metabolic Research Director, The Comprehensive Weight Control Center Caroline Apovian, MD, FACP, FTOS, DABOM Division of Endocrinology, Diabetes & Metabolism Co-Director of the Center for Weight Manag
Slide 31: Preventing muscle loss with weight-loss drugs
Preventing muscle loss with weight-loss drugs Global obesity and overweight market projected to be $100 billion by 2030 (Barclays) Overall obesity1 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 yo • 44.2 of adult women agre
Slide 32: Financial highlights
Financial highlights Q2 FYTD 2024 Results of operations Q2 FYTD 2024 Net Revenues $ 6.3 mm Q2 FYTD 2024 Gross Profit $ 1.8 mm Q2 FYTD 2024 Operating Loss $ 17.8 mm Q2 FY 2024 Results of operations Q2 2024 Net Revenues $ 4.1 mm Q2 2024 Gross Profit $ 0.7 mm Q2 2024 Operating Loss $ 9.9 mm Balance She
Slide 33: Metabolic diseases program clinical milestones
Metabolic diseases program Clinical milestones Obesity Program Phase 2b study IND cleared LBM topline data Drug candidates Enobosarm and GLP-1 receptor agonist combination Mechanism Selective androgen receptor modulator (SARM) + GLP-1 Receptor 2023 2024 2025 agonist Indication Phase 2b Phase 2b Firs
Veru — Leerink Therapeutics Forum: I&I and Metabolism 2024 on 6ix