Tempest Therapeutics, Inc. · NASDAQ:TPST
Tempest Therapeutics — OvaScience — Investor Presentation (January 2018)
30 slides from Tempest Therapeutics's investor presentation, Jan 8, 2018
Slide 1: Forward-Looking Statements
Forward-Looking Statements This presentation includes forward-looking statements about the Company's plans for the OvaPrimeSM treatment, the OvaTureSM treatment and the AUGMENTSM treatment, including forward looking statements relating to: the potential market for the Company’s treatments; future mi
Slide 2: A company pioneering breakthrough, first-in-class science
A company pioneering breakthrough, first-in-class science Poised to revolutionize traditional in vitro fertilization (IVF) treatment by removing the need for hormone stimulation And developing fertility solutions for women for whom traditional IVF offers little hope for their own genetic child OvaSc
Slide 3: OvaScience: Transforming Female Infertility Therapy
OvaScience: Transforming Female Infertility Therapy 4 $75.7 million in cash and short-term investments as of September 30, 2017 Cash runway into 2020 Cost efficient operating structure Patent protection into 2035 65 issued patents in 44 countries 170+ pending applications in more than 130 countries
Slide 4: EggPC Cells: Pioneering Discovery That Upends Long-Held Dogma
EggPC Cells: Pioneering Discovery That Upends Long-Held Dogma 2011: OvaScience founded and licenses EggPC cell technology from MGH Discovery and development work by OvaScience: AUGMENT, OvaPrime, and OvaTure Drosophila ovary containing active EggPC cells (green) 2004: Discovery of EggPC cells in mou
Slide 5: The Breakthrough Science of EggPC Cells
The Breakthrough Science of EggPC Cells 6 Egg precursor (EggPC) cells are unipotent, immature egg cells found in the outer ovarian lining Patient ovary Ovarian Cortex EggPC Cells Hypothesized to be residual, undifferentiated germ cells from fetal development that have the capacity to mature into egg
Slide 6: EggPC Platform Yields Three Treatments Addressing Multiple Markets
EggPC Platform Yields Three Treatments Addressing Multiple Markets Addressable Market Status Phase 1b/2a Women undergoing IVF diagnosed with DOR, including POR and POI (0.6 million women per year)1 Preclinical development Women undergoing IVF (1.9 million women per year)2 Women undergoing IVF (1.9 m
Slide 7: Infertility Market is Large and Growing
Infertility Market is Large and Growing 8 1.3 billion women of reproductive age1 163 million women struggling with infertility2 111 million women seeking medical treatment3 73 million women undergoing fertility treatment4 1.9 million women undergoing IVF per year5 0.6 million women diagnosed with DO
Slide 8: Infertility Market is Large and Growing
Infertility Market is Large and Growing Worldwide Epidemiology Key growth drivers * Declining total fertility rates 1.3 billion women of reproductive age* + Women delaying childbirth + Increasing prevalence of obesity and chronic conditions 163 million women struggling with infertility? + Increasing
Slide 9: OvaPrime Potential Fertility Treatment that Restores Egg Production
OvaPrime Potential Fertility Treatment that Restores Egg Production 10
Slide 10: Traditional IVF is largely ineffective for women with POI and POR
11 Traditional IVF is largely ineffective for women with POI and POR, who have few or no eggs remaining in their ovaries. High failure rates with IVF Many patients resort to donor egg or adoption Often multiple failed IVF cycles The majority of patients resort to either a donor egg or adoption2 Some
Slide 11: OvaPrime: Potential Treatment for Primary Ovarian Insufficiency and Poor Ovarian Response
OvaPrime: Potential Treatment for Primary Ovarian Insufficiency and Poor Ovarian Response 12 Patient ovary Isolated EggPC cells from outer ovarian cortex (quiescent environment) Ovarian Cortex Autologous EggPC cells are injected into inner ovarian cortex (zone of active follicular development); pati
Slide 12: OvaPrime Preclinical Data: Animal Proof-of-Concept
OvaPrime Preclinical Data: Animal Proof-of-Concept Zou et al., 2009 Transplanted EggPC cells matured into oocytes which were fertilized after natural mating producing offspring expressing GFP Zhang et al., 2011 Transplanted EggPC cells matured into oocytes which were fertilized producing heterozygou
Slide 13: OvaPrime Preclinical Data: Proof-of-Concept Using Human EggPC Cells
OvaPrime Preclinical Data: Proof-of-Concept Using Human EggPC Cells 14 Human EggPC cells engineered to express GFP Micro-injected GFP-EggPC cells into human ovarian cortical strips Xenografted tissue into NOD/SCID* mice In Vivo (xenografts) Endogenous 14 days post transplant Source: 1White et al., N
Slide 14: OvaPrime Clinical Development Program
2017 2018 2019 2020 Phase 1 Study Single center, prospective, blinded, randomized, controlled study of 60 patients with POI and POR Initial readout of first 20 patients: No serious adverse events (SAEs) or adverse events (AEs) related to EggPC cells 7 mild AEs; 4 unrelated; 3 related to laparoscopic
Slide 15: Key OvaPrime Milestones
Key OvaPrime Milestones 16 Phase 1 study Readout: 6 months post-EggPCSM cell reintroduction safety for first 20 patients Completed Readout: 6 months post-EggPC cell reintroduction safety for all patients Q4 2018 Readout: Embryo transfers Q3 2019 Readout: Complete data set 2020 Phase 1b/2a study Begi
Slide 16: OvaTure Potential Fertility Treatment that Eliminates Hormone Stimulation
OvaTure Potential Fertility Treatment that Eliminates Hormone Stimulation 17
Slide 17: Traditional IVF is Associated with Risk of Serious Maternal Morbidity
Traditional IVF is Associated with Risk of Serious Maternal Morbidity 18 Hormone injections are a required component of traditional IVF. Sources: 1Kumar et al., Jrnl of Human Reproductive Sciences, 2011; Nastri CO et al., Ultrasound in Obstetrics & Gynecology, 2015; 2RESOLVE 3Luke et al. NEJM 2012 R
Slide 18: OvaTure: Potential Fertility Treatment that Eliminates Hormone Stimulation
OvaTure: Potential Fertility Treatment that Eliminates Hormone Stimulation 19 In vitro maturation Sperm Patient ovary Isolated EggPC cells from outer ovarian cortex (quiescent environment) Ovarian Cortex OvaTure Treatment In Preclinical Development *ICSI: intracytoplasmic sperm injection Fertilizati
Slide 19: Substantial Progress Toward in vitro Development of a Mature Egg from an EggPC Cell
Substantial Progress Toward in vitro Development of a Mature Egg from an EggPC Cell Optimized FACS sorting techniques Developed proprietary mAb with high specificity and selectivity Optimized Aggregate formation techniques Seeding density Media components Timing of dissection Optimized Addition of m
Slide 20: Human EggPC Cell Maturation Leads to Substantial Increase in Cytoplasmic Volume
Human EggPC Cell Maturation Leads to Substantial Increase in Cytoplasmic Volume 21 OvaTure eggs have grown from less than 10µm to greater than 100µm (fully matured endogenous eggs 100-120µm) Single EggPC cells 50µm 50µm 50µm Immature egg (frequently identified) Maturing egg (optimized maturation con
Slide 21: Structural Characteristics of Maturing Human EggPC Cells Consistent with Maturing Endogenous Eggs
Endogenous eggs (controls)1 50µm 50µm Germinal Vesicle (GV) Enlarged nucleus of an egg before meiotic division is completed Polar Body (PB) One of the small cells produced during the two meiotic divisions of developing eggs 50µm 50µm Zona Pellucida (ZP) Thickened outer membrane Structural Characteri
Slide 22: OvaTure Next Steps
23 OvaTure Next Steps Bovine Fertilization of bovine EggPCSM cell-derived egg Perform embryo transfer Bovine live birth from EggPC cell-derived egg Human Mature human EggPC cell-derived egg Where necessary, seek authorization to fertilize EggPC cell-derived egg (for research) Initiate regulatory pat
Slide 23: AUGMENT Designed to Improve Traditional IVF Success
AUGMENT Designed to Improve Traditional IVF Success 24
Slide 24: AUGMENT: Designed to Improve Traditional IVF Success
Patient ovary Ovarian Cortex AUGMENT: Designed to Improve Traditional IVF Success Isolated autologous mitochondria from EggPC cells Sperm AUGMENT Treatment Mitochondria are injected into egg during fertilization by ICSI* Isolated EggPC cells from outer ovarian cortex (quiescent environment) 25 *ICSI
Slide 25: AUGMENT Status
26 AUGMENT Status Offered at select clinics in Canada and Japan Signed exclusive licensing agreement with IVF Japan Group, a clinic network with extensive AUGMENT experience Opportunity to generate additional registry database and refine target patient population Minimal expense to OvaScience OvaSci
Slide 26: AUGMENT Status
(ox ener AUGMENT Status * Offered at select clinics in Canada and Japan + Signed exclusive licensing agreement with IVF Japan Group, a clinic network with extensive AUGMENT experience — Opportunity to generate additional registry database and refine target patient population - Minimal expense to Ova
Slide 27: Financial Summary
Financial Summary Cash, cash equivalents and short term investments: $75.7 million as of September 30, 2017 Shares outstanding: 35,705,722 as of September 30, 2017 Strong financial position with runway through key value inflection points 28
Slide 28: OvaScience: Transforming Female Infertility Therapy
OvaScience: Transforming Female Infertility Therapy 29 $75.7 million in cash and short-term investments as of September 30, 2017 Cash runway into 2020 Cost efficient operating structure Patent protection into 2035 65 issued patents in 44 countries 170+ pending applications in more than 130 countries
Slide 29: OvaScience: Transforming Female Infertility Therapy
OvaScience: Transforming Female Infertility Therapy oe: Breakthrough Technology in Reproductive Medicine + Discovery of egg precursor (EggPC™) cells unlocks innovative opportunities to improve female fertility through novel treatments ~ OvaPrime, in clinical development, potential fertility treatmen
Slide 30: OvaScience: Transforming women's fertility
OVA)SCLENC E* Transforming women’s fertility