Tempest Therapeutics, Inc. · NASDAQ:TPST
Tempest Therapeutics — Millendo Therapeutics — Investor Presentation (March 2019)
25 slides from Tempest Therapeutics's investor presentation, Mar 22, 2019
Slide 1: Corporate Presentation March 2019
Presentation to Lorem Ipsum Dolor May 2018 Corporate Presentation March 2019
Slide 2: Cautionary Statement Regarding Forward-Looking Statements
2 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 21E of the Securities Exchange Act of 1934, as amended, and the Private Securiti
Slide 3: Millendo Therapeutics: Leading orphan endocrine disease company
Millendo Therapeutics Leading orphan endocrine disease company Clinical-stage company focused on orphan endocrine diseases • Clinically-validated molecules with differentiated mechanisms • High unmet medical needs in orphan indications Total proceeds of $85M from successful merger and associated fin
Slide 4: Millendo Executive Leadership
JULIA OWENS, PhD Chief Executive Officer LOUIS ARCUDI III Chief Financial Officer JEFF BRINZA Chief Administrative Officer & General Counsel PHARIS MOHIDEEN, MD Chief Medical Officer THOMAS HOOVER SVP Commercial Strategy RYAN ZEIDAN, PhD SVP Development ANDREW SPENCER, PhD SVP Preclinical R&D Millen
Slide 5: Compelling Orphan Endocrine Disease Pipeline
Product Candidate Indication Preclinical Phase 1 Phase 2 Phase 2b Phase 3 Livoletide (AZP-531) Prader-Willi Syndrome (PWS) Nevanimibe (ATR-101) Congenital Adrenal Hyperplasia (CAH) Endogenous Cushing’s Syndrome (CS) Compelling Orphan Endocrine Disease Pipeline Multiple late-stage programs in areas o
Slide 6: Livoletide (AZP-531) for Prader-Willi Syndrome
Livoletide (AZP-531) for Prader-Willi Syndrome
Slide 7: Prader-Willi Syndrome (PWS)
Prader-Willi Syndrome (PWS) Well-characterized genetic orphan endocrine disease Prader-Willi syndrome is characterized by: • Hyperphagia: Chronic feeling of insatiable hunger ‒ Starts at 5-8 years old and usually lasts until death ‒ Hallmark of PWS • Intellectual/emotional disabilities and psychiatr
Slide 8: PWS Patients and Families Have Significant Needs
8 PWS Patients and Families Have Significant Needs Almost all Prader-Willi syndrome patients suffer from hyperphagia Livoletide Nevanimibe “Assuming there is no complete cure for PWS, what specific things would you look for in an ideal treatment for PWS?” 0% 10% 20% 30% 40% 50% 60% 70% 80% Reduce hy
Slide 9: Critical Need for PWS Treatments
Livoletide Nevanimibe Critical Need for PWS Treatments Livoletide is a compelling late-stage drug candidate Well-defined development and regulatory path Livoletide pivotal study ZEPHYR initiated 1Q19 Beloranib Phase 3 program is useful precedent Phase 2b portion of Phase 2b/3 pivotal trial may suppo
Slide 10: Livoletide for Treatment of Hyperphagia in PWS
10 Livoletide for Treatment of Hyperphagia in PWS Pharmacology of UAG is distinct from that of AG Livoletide Nevanimibe LivoletideUnacylated Ghrelin (UAG)Acylated Ghrelin (AG) • Once-daily injectable cyclic peptide • Comparable in vitro and in vivo pharmacological profiles to UAG •More stable than l
Slide 11: Lower Relative UAG Levels Associated with PWS Hyperphagia
11 Lower Relative UAG Levels Associated with PWS Hyperphagia Livoletide Nevanimibe AG is elevated and relative amount of UAG is lower in hyperphagic phase of PWS Adapted from Kuppens, 2015 pg/mL Nutritional Phase Nutritional Phase Characteristics: • Phase 1a: Hypotonia with difficulty feeding • Phas
Slide 12: Robust Development Program
Phase 1 study • Single ascending dose (N=44) in healthy volunteers • Multiple ascending dose (N=32) in overweight / obese adults – Decreases in glucose and body weight • Multiple ascending dose (N=36) in Type 2 diabetes patients Double-blind, placebo-controlled Phase 2 clinical trial in PWS complete
Slide 13: 2-week Placebo-Controlled Phase 2 PWS Clinical Trial
13 2-week Placebo-Controlled Phase 2 PWS Clinical Trial Robust, meaningful decreases in Hyperphagia Questionnaire (HQ) -1.6 -4.3 -7 -6 -5 -4 -3 -2 -1 0 All Subjects p = 0.097 -1.6 -5.1-7 -6 -5 -4 -3 -2 -1 0 Home Residents1 -1.0 -6.2-7 -6 -5 -4 -3 -2 -1 0 Home Residents BL > 10 24 23 20 18 12 14 p =
Slide 14: Livoletide Demonstrated Similar Effect to Beloranib
-7 -6 -5 -4 -3 -2 -1 0 -7 -6 -5 -4 -3 -2 -1 0 14 Livoletide Demonstrated Similar Effect to Beloranib Similar HQ decreases observed with livoletide Livoletide Phase 2 Results (2 weeks) Beloranib Phase 3 Results (4 weeks) • McCandless et al., Diabetes Obes Metab (2017) 19:1751-61 •*1.8 mg for week 1-4
Slide 15: Livoletide PWS Pivotal Study
Livoletide PWS Pivotal Study 15 Single, pivotal Phase 2b/3 protocol Placebo (n~40) livoletide (n~40) Phase 2b Phase 3 Placebo crossover / 9-month extension Placebo crossover / 6-month extension 3 month endpoint 6 month endpoint Livoletide Nevanimibe Placebo (n=50) 60 mg/kg livoletide* (n=50) 120 mg/
Slide 16: Nevanimibe (ATR-101) for Orphan Adrenal Diseases
Nevanimibe (ATR-101) for Orphan Adrenal Diseases
Slide 17: Nevanimibe for Congenital Adrenal Hyperplasia
Clinical Proof of Concept • Clinical proof-of-concept from open-label Phase 2 clinical trial in CAH • Favorable safety profile in preclinical and clinical studies • Well-defined, adrenal-selective mechanism of action Clinical Trials Underway • Phase 2b clinical trial in CAH started in 3Q18 • Orphan
Slide 18: Nevanimibe Targets Starting Point of Adrenal Steroid Synthesis
18 Nevanimibe Targets Starting Point of Adrenal Steroid Synthesis Able to inhibit all steroidogenic pathways Livoletide Nevanimibe Congenital Adrenal Hyperplasia (CAH): Inactive 21-hydroxylase leading to elevated androgens and precursors XX
Slide 19: CAH Has Lifelong Impacts
19 CAH Has Lifelong Impacts Results from excess androgens or excess cortisol caused by under or overtreatment 1. Arlt, Endocrine Research, 2010 2. Jenkin-Jones, European Journal of Endocrinology, 2018 3. Hagenfeldt, Human Reproduction, 2008 4. Finkielstain, Endocrine Care, 2012 5. Falhammar, Europea
Slide 20: Nevanimibe Proof of Concept Established in CAH
20 Nevanimibe Proof of Concept Established in CAH Activity demonstrated through reductions in 17-OHP Livoletide Nevanimibe Mean change in 17-OHP by Study Visit (V) -3,000 -2,000 -1,000 0 1,000 2,000 3,000 V1 V2 V3 V4 V5 V6 V7 V8 V9 V10 V11 V12 V13 125 mg BID 250 mg BID 500 mg BID 750 mg BID 1000 mg
Slide 21: Nevanimibe CAH Phase 2b Study Overview
Phase 2b CAH study includes further dose ranging and 3 month continuous dosing • Study initiated in 3Q18 21 Nevanimibe CAH Phase 2b Study Overview Intrasubject dose escalation with 3 months continuous dosing Livoletide Nevanimibe 3 MONTHS OF CONTINUOUS NEVANIMIBE DOSING Primary Endpoint 17-OHP < 2x
Slide 22: Corporate
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Slide 23: Significant Potential Value Creation
3Q18 Nevanimibe Phase 2b CAH study initiation 4Q18 Merger with OvaScience and associated financing with total proceeds of $85M 1Q19 Livoletide pivotal Phase 2b/3 PWS study initiation 2Q19 Establish commercial organization in Boston area 2H19 Nevanimibe Phase 2b CAH study update 1H20 Nevanimibe Phase
Slide 24: Millendo is a Leading Company in Rare Endocrine Diseases
Pursue development of, obtain approval for, and commercialize nevanimibe for the treatment of CAH Continue to expand our pipeline by leveraging our expertise in in-licensing and acquiring product candidates Build a specialized sales and marketing organization in the United States targeting endocrino
Slide 25: Millendo Therapeutics
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