Veru Inc. · NASDAQ:VERU
Veru — 2024 Cantor Global Healthcare Conference
45 slides from Veru's conference presentation, September 2024
Slide 1: Focused on metabolic diseases and oncology
Veru Inc. Nasdaq:VERU Focused on metabolic diseases and oncology Veru Corporate Presentation 2024 Cantor Global Healthcare Conference September 17-19, 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 Phase 2b Selective androgen QUALITY- Extension Enobosarm and receptor modulator Phase 2b Preserve Topline data Obese or overweight elderly GLP-1 receptor agonist (SARM) patients rece
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
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: rate of weight loss reaches a plateau
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 Appetite Energy expenditure Lipid break-down Myokines 1 Dulloo A Obesity 25:277-279, 2017 | 2Grannell A et al. Muscles 1:26-47, 2022 11
Slide 12: 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 (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: lean body mass and function
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: Enobosarm effects on muscle and function in cancer patients, Phase 2b
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 3 504 trial 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, 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 elderly patients at risk for muscle weakness on GLP-1 RA
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: Phase 2b QUALITY Trial design
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- Enrollment completed Primary endpoint of LBM at 16 weeks Induction Maintenance Primary end
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 • 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
Slide 28: Enobosarm: Lipid profile
Enobosarm: Lipid profile Safety of special interest: Elderly healthy volunteers G200501 Phase 2 study conducted by GTx1 Lipid profile change from baseline Day 84 PBO 3mg Lipids n=24 n=24 3mg vs. PBO HDL (total)(mg/dL) 1.5 3.10% -16.2 -29.60% -17.6 -32.70% VLDL + chylomicron triglycerides (total) (mg
Slide 29: Time course of testosterone replacement effects on lipids
Time course of testosterone replacement effects on lipids 1 Saad F et al. Eur J Endo 165:675-685, 2011- Liiterature review 29
Slide 30: Cardiovascular safety of long-term testosterone replacement therapy
Cardiovascular safety of long-term testosterone replacement therapy 2-year cardiovascular study in 5246 men 45 to 80 years of age who had pre- existing or high risk of cardiovascular disease with follow-up of 33 months • Conclusions: • Testosterone therapy was noninferior to placebo with respect to
Slide 31: 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 32: 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 January 2025 and receptor modulator GLP-1 RA rescue Anti-myostatin
Slide 33: 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 34: 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 35: Financial highlights
Financial highlights Q3 FYTD 2024 Results of operations Q3 FYTD 2024 Net Revenues $ 10.2 mm Q3 FYTD 2024 Gross Profit $ 3.2 mm Q3 FYTD 2024 Operating Loss $ 28.7 mm Q3 FY 2024 Results of operations Q3 2024 Net Revenues $ 4.0 mm Q3 2024 Gross Profit $ 1.3 mm Q3 2024 Operating Loss $ 10.9 mm Balance S
Slide 36: Metabolic diseases program: clinical milestones
Metabolic diseases program Clinical milestones Obesity Program Phase 2b QUALITY study IND cleared LBM topline Drug candidates data Enobosarm and GLP-1 receptor agonist combination Mechanism Selective androgen receptor modulator (SARM) + GLP-1 Receptor 2023 2024 2025 agonist Indication Phase 2b Phase
Slide 37: Appendix
Appendix 37
Slide 38: Intellectual property
Intellectual property 38
Slide 39: Enobosarm for weight loss: IP portfolio and regulatory protection
Enobosarm for weight loss– IP portfolio and regulatory protection create significant barriers to entry • Enobosarm qualifies as new chemical entity • FDA grants 5 years market exclusivity for first indication • US Patent and Trademark Office-may qualify for 5 additional years patent term extension •
Slide 40: Physical function endpoint
Physical function endpoint 40
Slide 41: Physical function: testosterone as an anabolic agent
Physical function: testosterone as an anabolic agent1-3 Muscle Physical Lean mass Muscle Mass Strength QOL Function • Testosterone replacement in men • Increase in lean mass and muscle mass • Increase in quadriceps muscles –weight bearing muscles • Increase chest and leg press strength • Leg press c
Slide 42: Physical function: enobosarm is a potent anabolic agent
Physical function: enobosarm is a potent anabolic agent Muscle Physical Lean mass Muscle Mass QOL Strength Function + LBM: DEXA and/or MRI + Leg press + Stair climb: speed & power + FAACT and FACIT-F • Phase 1b in PM women • Phase 2 501 in men & PM women • Phase 2b 502 cancer men & women • Phase 1b
Slide 43: LBM and stair climb test results from 501, 502, and 504 studies
LBM and stair climb test results from 501, 502, and 504 enobosarm clinical studies Phase 2 501 Phase 2b 502 Phase 3 504 Elderly men & women Multiple cancers wasting Late-stage lung cancer patients • Mean age >60 yo • Mean age >60 yo • Mean age >60 yo • 120 subjects • 159 subjects • 321 subjects • 12
Slide 44: What we know about the obesity population receiving GLP-1 RA?
What we know about the obesity population receiving GLP-1 RA? Expected physical function outcomes with enobosarm • Patients with obesity receiving semaglutide GLP-1 RA treatment • Actively losing muscle and fat mass while decreasing appetite and inducing a low energy state • 40% of weight loss consi
Slide 45: Loaded stair climb test
Loaded stair climb test1 Stair climb power (Watts)= (Body weight + load carried (kg)) X 9.81 m/s2 X total stair rise (m) time (s) • 8 step staircase with a computer timer switch pad placed at base and top step Top step switch • Subject is loaded by placing iron plates in a backpack equal to 10% of b