Tempest Therapeutics, Inc. · NASDAQ:TPST
Tempest Therapeutics — Millendo Therapeutics — Investor Presentation (January 2020)
24 slides from Tempest Therapeutics's investor presentation, Jan 13, 2020
Slide 1: Corporate Presentation January 2020
Exhibit 99.1 Corporate Presentation January 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 E
Slide 3: Millendo Therapeutics: A leading endocrine disease company
Millendo Therapeutics (Nasdaq: MLND) A leading endocrine disease company A LEADER IN ENDOCRINE DISEASES Clinical-stage company focused primarily on orphan endocrine significant unmet medical needs diseases with Livoletide: Pivotal stage asset for Prader-Willi syndrome (PWS) Topline results expected
Slide 4: Compelling Endocrine Disease Pipeline
Compelling Endocrine Disease Pipeline Therapeutics seeking to address significant unmet medical needs Product Formulation/ Oral Tablet BID (ATR-101) Hyperplasia (CAH) Oral Tablet (VMS) Phase 2b portion of livoletide Phase 2b/3 trial may support submission of NDA ✽ 4 CandidateIndicationDelivery Precl
Slide 5: Livoletide for Prader-Willi Syndrome
Livoletide for Prader-Willi Syndrome
Slide 6: Prader-Willi Syndrome: Hyperphagia is the top unmet need
Prader-Willi Syndrome (PWS) Hyperphagia, a chronic & insatiable hunger, is the top unmet need for PWS patients Livoletide Hyperphagia starts at 5-8 years old and usually lasts until death • • • Leads to overeating and eventual metabolic issues A root cause of morbidity and mortality Patient accident
Slide 7: Most PWS Patients Are Diagnosed
Most PWS Patients Are Diagnosed No medicines available to address hyperphagia Livoletide Birth incidence of 1:15K due to a spontaneous genetic defect •Complex disorder resulting from genetic error on chromosome 15 US PWS Market 12,000 10,000 8,000 6,000 4,000 2,000 0 Metabolic comorbidities more com
Slide 8: Potential First-In-Class Treatment of Hyperphagia in PWS
Potential First-In-Class Treatment of Hyperphagia in PWS Distinct pharmacology with objective of replacing functional deficit of UAG Livoletide PWS Patient Journey AG and UAG Levels by Age and Nutritional Phase Hyperphagic aily injectable cyclic rable in vitro and in pharmacological profiles , 2 sta
Slide 9: Significant Clinical and Preclinical Experience with Livoletide
Significant Clinical and Preclinical Experience with Livoletide Compelling molecule for an orphan indication with significant unmet medical needs Livoletide Double-blind, placebo-controlled Phase 2 clinical trial in PWS (7 European sites) • 47 patients with 2 weeks treatment • Clinically meaningful
Slide 10: 2-week Placebo-Controlled Phase 2 PWS Clinical Trial
2-week Placebo-Controlled Phase 2 PWS Clinical Trial Clinically meaningful decreases in Hyperphagia Questionnaire (HQ) Livoletide Home Residents BL > 10 Home Residents1 All Subjects BL = 12.2 14.1 BL = 12.6 14.8 BL = 17.3 17.9 0 -1 -2 -3 -4 0 -1 -2 -3 -4 -5 -6 -7 0 -1 -2 -3 -4 -5 -6 -7 Change in HQ
Slide 11: Treatment Response Seen Across Broad Set of Livoletide Patients
Treatment Response Seen Across Broad Set of Livoletide Patients 65% showed ≥ 4-point decrease in Hyperphagia Questionnaire (HQ) Livoletide 40% Home Resident Patients with BL ≥ 10 30% 20% 10% placebo (n=12) livoletide 60 μg/kg (n=14) 0% Worsening No change -1 to -3 -4 to -6 > -6 Improvement Allas et
Slide 12: Livoletide PWS Pivotal Study (ZEPHYR)
Livoletide PWS Pivotal Study (ZEPHYR) Single, pivotal Phase 2b/3 protocol Livoletide 3-month endpoint Placebo crossover / 9-month extension Phase 2b Placebo crossover / 6-month extension Phase 3 6-month endpoint • Provide flexibility to adjust endpoints and patient population ClinicalTrials.gov Iden
Slide 13: Defined Path for Livoletide Approval and Commercialization
Defined Path for Livoletide Approval and Commercialization Company engaged in key activities with topline data expected 1H20 Livoletide Useful precedent in prior PWS Phase 3 program Preparations underway for Well-defined development and regulatory path future market success Beloranib1 study establis
Slide 14: Nevanimibe for Congenital Adrenal Hyperplasia
Nevanimibe for Congenital Adrenal Hyperplasia
Slide 15: Congenital Adrenal Hyperplasia Goal: Restore Hormonal Balance
Congenital Adrenal Hyperplasia Goal: Restore Hormonal Balance Achieve physiologic exogenous cortisol doses without excessive androgens Nevanimibe U.S. 18,000 ~40,000 MONOGENIC EUROPE diagnosed at birth Based on Han, Nature Reviews 2013 15 Potentially fatal inability to produce cortisol necessitating
Slide 16: Nevanimibe for Congenital Adrenal Hyperplasia
Nevanimibe for Congenital Adrenal Hyperplasia in patients (CAH) Potential to achieve better hormonal balance Nevanimibe + Nevanimibe BALANCE Clinical Proof of Concept • Open-label Phase 2 clinical trial in CAH • Favorable safety profile in preclinical and clinical studies Normal levels of ANDROGENS
Slide 17: Nevanimibe Proof of Concept Established in CAH
Nevanimibe Proof of Concept Established in CAH Activity demonstrated through reductions in 17-OHP Nevanimibe • Mean change in 17-OHP by Study Visit Phase 2 Study Design placebo nevanimibe Intrasubject dose escalation study (n=10) • 2-week treatment and placebo periods through reduction in key steroi
Slide 18: Nevanimibe CAH Phase 2b Study
Nevanimibe CAH Phase 2b Study Intrasubject dose escalation study with 16 weeks continuous dosing Nevanimibe Cohort 1: Patients with elevated androgen and 17-OHP levels 17-OHP ≥ 4x ULN baseline period Primary Endpoint N=20-24 (10-12 per cohort) Cohort 2: Patients on high glucocorticoid (GC) doses 17-
Slide 19: MLE-301 for Vasomotor Symptoms
MLE-301 for Vasomotor Symptoms
Slide 20: MLE-301, a Selective NK3R Antagonist for Vasomotor Symptoms
MLE-301, a Selective NK3R Antagonist for Vasomotor Symptoms Over 20 million women in the U.S. suffer from VMS associated with menopause MLE-301 • MLE-301 is a potent, selective antagonist of NK3R KNDy neurons are overactive in menopausal women with VMS KNDy Neuron • NK3R plays a key role in regulati
Slide 21: Corporate
Corporate
Slide 22: Significant Potential Value Creation
Significant Potential Value Creation Meaningful corporate and clinical milestones over the next 12 months 1Q19 Initiated ZEPHYR pivotal Phase 2b/3 study of livoletide in PWS 2Q19 Established foundation for commercial organization in Lexington, MA 4Q19 ZEPHYR recruitment completed for Phase 2b portio
Slide 23: Millendo is a Leading Company in Endocrine Diseases
Millendo is a Leading Company in Endocrine Diseases Topline data readouts in 2020 set the stage for upcoming milestones Livoletide, a potential first-in-class treatment for hyperphagia in PWS patients, with topline data expected 1H20 and significant near-term value creation Nevanimibe for the treatm
Slide 24: Millendo Therapeutics
~ MILLENDO oa ERAPEUTICS
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