Veru Inc. · NASDAQ:VERU
Veru — Oppenheimer 34th Annual Healthcare Life Sciences Conference 2024
26 slides from Veru's conference presentation, Feb 13, 2024
Slide 1: Focused on metabolic diseases and oncology
Veru Inc. Nasdaq:VERU Focused on metabolic diseases and oncology Veru Corporate Presentation Oppenheimer 34th Annual Healthcare Life Sciences Conference February 13-14, 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 Protect Rescue Enobosarm and receptor modulator Phase 2b GLP-1 receptor agonist (SARM) Obese or overweight elderly IND FPI muscle loss open-label Active p
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: Approved GLP-1 receptor agonist 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 1Wild
Slide 6: 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 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 8: 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? 8
Slide 9: 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 is a nonsteroidal, selective androgen receptor agonist1, 2 Data from clinical trials and preclinical studies support enobosarm’s potential: • Once-a-d
Slide 10: 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 11: Phase 2 trial G200501 improved lean body mass and physical 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 12: Phase 3 trial in non-small cell lung cancer muscle wasting
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 13: 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 14: Enobosarm +/- GLP-1 RA for obesity: Strategy 1
Enobosarm +/- GLP-1 RA for the treatment of obesity Clinical and regulatory strategy Enobosarm potential direct effects: • Prevents muscle loss: active protein synthesis in muscle • Increases fat loss: increase in lipolysis and decrease in lipogenesis Strategy 1 - Entire obesity population High qual
Slide 15: 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 15
Slide 16: Sarcopenic obese or overweight elderly patients at risk when receiving 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 16
Slide 17: Enobosarm +/- GLP-1 RA for obesity: Strategy 2
Enobosarm +/- GLP-1 RA for the treatment of obesity Clinical and regulatory strategy Enobosarm potential direct effects: • Prevents muscle loss: active protein synthesis in muscle • Increases fat loss: increase in lipolysis and decrease in lipogenesis Strategy 2 - Obesity Regulatory High quality wei
Slide 18: Phase 2b enobosarm and GLP-1 RA combination study design
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: at 16 weeks • LBM (muscle mass)
Slide 19: Enobosarm has an extensive safety database
Enobosarm has an extensive safety database Combined Safety data from 5 Phase 2 and 3 clinical trials in cancer and healthy subjects and Phase 1 studies Percentage of healthy and cancer subjects in all 5 clinical and Percentage of healthy and cancer subjects in all 5 clinical and Phase 1 clinical tri
Slide 20: Enobosarm has an extensive safety database
Enobosarm has an extensive safety database Safety of special interest: Elderly healthy volunteers G200502 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 21: 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 2H 2024 and receptor modulator GLP-1 RA rescue Anti-myostatin Acqu
Slide 22: 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: • Administ
Slide 23: 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 24: Financial highlights
Financial highlights Fiscal Year 2023 Results of operations FYTD 2023 Net Revenues $ 16.3 mm FYTD 2023 Gross Profit $ 7.6 mm FYTD 2023 Operating Loss $ 93.7 mm Q1 Fiscal Year 2024 Results of operations Q1 FY 2024 Net Revenues $ 2.1 mm Q1 FY 2024 Gross Profit $ 1.2 mm Balance Sheet as of December 31,
Slide 25: Metabolic diseases program clinical milestones
Metabolic diseases program Clinical milestones Obesity Program Phase 2b Protect muscle IND cleared loss from GLP-1 Drug candidates LBM data Enobosarm and GLP-1 receptor agonist combination Mechanism Selective androgen receptor modulator (SARM) + GLP-1 Receptor 2023 2024 2025 agonist Indication Phase
Slide 26: Enobosarm 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 new chemical entity • Enobosarm issued specific molecule composition of matter patents and issued specific molecule composition of matter polymorphs patents – Last expiry patent ter
Veru — Oppenheimer 34th Annual Healthcare Life Sciences Conference 2024 on 6ix