Tempest Therapeutics, Inc. · NASDAQ:TPST
Tempest Therapeutics — Millendo Therapeutics — Investor Presentation (June 2020)
15 slides from Tempest Therapeutics's investor presentation, Jun 23, 2020
Slide 1: Corporate Presentation June 2020
Corporate Presentation June 2020
Slide 2: Cautionary Statement Regarding Forward-Looking Statements
Cautionary Statement Regarding Forward-Looking Statements Certain statements contained in this presentation regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Ex
Slide 3: Strategic evaluation underway to reposition company for success
Millendo Therapeutics (Nasdaq: MLND) Strategic evaluation underway to reposition company for success Evaluating strategic options from position of financial strength with cash balance of $58.9M as of March 31, 2020* MLE-301, a novel NK3R antagonist for the treatment of menopausal vasomotor symptoms,
Slide 4: MLE-301 for Menopausal Vasomotor Symptoms
MLE-301 for Menopausal Vasomotor Symptoms
Slide 5: Vasomotor Symptom (VMS) Market is Significant
Vasomotor Symptom (VMS) Market is Significant Over 20 million women in the U.S. suffer from VMS associated with menopause MLE-301 • VMS are defined as hot flashes and night sweats and cause sensations of heat and/or perspiration Over 20M women are currently experiencing hot flashes in US – Median ag
Slide 6: The Market Is Looking to Break the Efficacy/Safety Trade-off
The Market Is Looking to Break the Efficacy/Safety Trade-off Potential efficacy of estrogens without cancer and cardiovascular concerns MLE-301 • Estrogens demonstrate reduction in VMS frequency by ~80-90%, while SSRI efficacy is limited (~40-60%) – Estrogen replacement therapy was significant marke
Slide 7: NK3R is a Key Receptor on KNDy Neurons
NK3R is a Key Receptor on KNDy Neurons Overactive KNDy signaling in menopausal women is believed to lead to VMS MLE-301 • Estrogen is a negative regulator of KNDy neurons – Absence of estrogen-driven negative feedback following menopause causes KNDy neurons to become hypertrophic – Hyperactivity in
Slide 8: NK3R is Implicated in Vasomotor Symptoms
NK3R is Implicated in Vasomotor Symptoms Administration of NKB induced VMS in 8/10 women MLE-301 • Robust genetic, pharmacodynamic, and clinical data support the role of NK3R in VMS NK3R Signaling Induces VMS in Women Human mutations in NK3R and its ligand NKB show defects in Hypothalamic-Pituitary-
Slide 9: NK3R Antagonist Effects Are Comparable to Estrogen
NK3R Antagonist Effects Are Comparable Clinical data has established class efficacy to Estrogen MLE-301 • Three different NK3R antagonists have been associated with reductions of hot flashes in clinical studies – MLE4901 (Millendo), NT-814 (KaNDy Therapeutics) and fezolinetant (Astellas) – Effects a
Slide 10: MLE-301: NK3R Antagonism in Preclinical Studies
MLE-301: NK3R Antagonism in Preclinical Studies MLE-301 • MLE-301 is a novel, potent, selective NK3R antagonist – Potential to demonstrate comparable vasomotor effects as other NK3R antagonist candidates – Over 25-45x as selective for NK3R vs NK1R/2R – As a chemically distinct molecule, MLE-301 is i
Slide 11: MLE-301 Pursuing Efficient Clinical De-risking Strategy
MLE-301 Pursuing Efficient Clinical De-risking Strategy Phase 1 intended to de-risk efficacy and Phase 2 to address LFT concerns MLE-301 (12-week study) 12-week HF severity substantially de-risk T = testosterone LH = luteinizing hormone HF = hot flashes 11 Accomplished Planned Preclinical SAD MAD (7
Slide 12: Nevanimibe for Congenital Adrenal Hyperplasia (CAH)
Nevanimibe for Congenital Adrenal Hyperplasia (CAH)
Slide 13: Nevanimibe CAH Phase 2b Study
Nevanimibe CAH Phase 2b Study Intrasubject, open-label dose escalation study with 16 weeks continuous dosing Nevanimibe • Study objectives: – Confirm Phase 2a proof of concept study demonstrating decrease in 17-hydroxyprogesterone nevanimibe treatment for 14 days – Determine adequate dose(s) to init
Slide 14: Nevanimibe CAH Phase 2b: Interim Data Analysis
Nevanimibe CAH Phase 2b: Interim Data Analysis Analyzed 10 subjects (9 cohort 1, 1 cohort 2) with at least 12 weeks of treatment Nevanimibe • Efficacy: – 50% of patients achieved a ≥ 50% decrease in 17-OHP, confirming nevanimibe activity in decreasing 17-OHP levels in patients with CAH – 1/10 (10%)
Slide 15: Millendo Therapeutics
™% YY MILLENDO THERAPEUT,
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