Tempest Therapeutics, Inc. · NASDAQ:TPST
Tempest Therapeutics — Millendo Therapeutics — Merger or Acquisition (March 2021)
23 slides from Tempest Therapeutics's merger presentation, Mar 29, 2021
Slide 1: Proposed Merger of Tempest and Millendo
Proposed Merger of Tempest and Millendo March 29, 2021
Slide 2: Forward-Looking Statements
2 Forward - Looking Statements This communication contains forward - looking statements (including within the meaning of Section 21 E of the Securities Exchange Act of 1934 , as amended, and Section 27 A of the Securities Act of 1933 , as amended (the “Securities Act”)) concerning Millendo Therapeut
Slide 3: Transaction Summary
3 Transaction Summary Ownership • Combined company to be renamed “Tempest Therapeutics” and trade under the ticker “TPST” • Issuance of Millendo stock to Tempest stockholders • Concurrent $30M PIPE financing • Ownership split at closing = 81.5% Tempest / 18.5 % Millendo Programs & Management • Exist
Slide 4: Overview of Tempest
4 Overview of Tempest * If approved by FDA Building an integrated company to deliver meaningful therapies to cancer patients Experienced management and Board with track record of delivering value First - in - class,* pharmaceutical - grade molecules showing early clinical activity Pharma interest an
Slide 5: First-in-Class Oncology Pipeline with Broad Potential
5 STAGE OF DEVELOPMENT Research IND - Enabling Phase 1 Phase 2 Status 1 First - in - Class* Oncology Pipeline with Broad Potential Indication(s) “HCC” hepatocellular carcinoma, “RCC” renal cell carcinoma, “CCA” cholangiocarcinoma, “ CRC” colorectal cancer TPST - 1120 PPAR α Antagonist Multiple Solid
Slide 6: Leadership Team Experienced in Drug Development
6 Leadership Team Experienced in Drug Development Sharon Sakai, Ph.D. SVP Regulatory Affairs Sam Whiting, M.D., Ph.D. Chief Medical Officer Tom Dubensky, Ph.D. CEO Steve Brady President and COO Peppi Prasit, Ph.D. Medicinal Chemistry Chan Whiting, Ph.D. SVP R&D Anne Moon, Ph.D. SVP Project Leadershi
Slide 7: Top-Tier Board and Investors
7 Top - Tier Board and Investors Stella Xu, Ph.D. Managing Director Paul Grayson Partner Tom Woiwode, Ph.D. Managing Director Robert Weisskoff , Ph.D. Managing Director Tom Dubensky, Ph.D. CEO Peppi Prasit, Ph.D. Founder Mike Raab Chairman Derek Yuan Healthcare Investor
Slide 8: TPST-1495 First-in-Class Dual EP2/4 Antagonist
8 TPST - 1495 First - in - Class Dual EP2/4 Antagonist
Slide 9: EP2/4 Antagonism Inhibits Pathways that Drive PGE2-Driven Cancers
9 • Prostaglandins (PGE2) drive tumor proliferation and immune suppression • NSAIDs block all four EP receptors, which is inappropriate for cancer • TPST - 1495 is highly specific for both EP2 and EP4 1 − Inhibits tumor cells and immune suppressive cells − Targeting EP4 is necessary but likely insuf
Slide 10: TPST-1495 More Potent than a Single EP4 Antagonist in Mouse CRC Model
10 TPST - 1495 Was Observed to be Significantly More Potent than a Single EP4 Antagonist in Mouse Model of CRC Treatment initiated in 6 - week old mice Work performed in the lab of Dr. Raymond Dubois (MUSC) 1 Eisai EP4 - only Antagonist Tumor burden at 8w of treatment No effect on animal weights obs
Slide 11: TPST-1495 Phase 1 Clinical Study Ongoing
11 TPST - 1495 Phase 1 Clinical Study Ongoing 1 NCT04344795 Dose and schedule finding with positive trend in PK/PD/tumor biomarkers/safety All - comers, with stated preference for CRC, NSCLC, SCCHN, urothelial, endometrial, gastroesophageal cancer Monotherapy Enrolling Combo with ⍺ PD - 1 • Phase 1
Slide 12: Early PK and PD Results Indicate Active Molecule
12 Early PK and PD Results Indicate Active Molecule TPST - 1495 inhibits prostaglandin immune suppression and modulates PGE2 production 24 hr P harmacokinetic (PK) profile (25 mg dose level) 0 5 10 15 20 12 10 100 1000 10000 Study Day 1: Time (h) T P S T - 1 4 9 5 C o n c e n t r a t i o n i n P l a
Slide 13: TPST-1495 Summary and Next Steps
13 TPST - 1495 Summary and Next Steps *Grade 3 AEs 26.3%, no Grade 4 or 5 AEs. Data as of March 23, 2021, n=19 Early clinical results indicate drug exposure, target engagement and tumor marker reduction Once daily dosing to optimize Cmax and Cmin Clinical Development Strategy • Indication specific m
Slide 14: TPST-1120 First-in-Class PPARα Antagonist
14 TPST - 1120 First - in - Class PPAR � Antagonist
Slide 15: TPST-1120: First PPARα Antagonist
15 Promotes anti - tumor immunity Inhibits angiogenesis Inhibits tumor cell proliferation • Druggable pathway: fenofibrates prescribed for dyslipidemia • Clinical activity in ongoing Ph1 trial: RECIST and prolonged SD benefits observed TPST - 1120: First PPAR α Antagonist Targets both tumor cells an
Slide 16: Significant Response in HCC Model Informs Clinical Development Strategy
16 Significant Response in HCC Model Informs Clinical Development Strategy * Hepa 1 - 6 tumor cells are β - catenin driven (Pandit et al. BMC Cancer (2018) 18:783) Source: Dipak Panigrahy collaboration; Rx initiated 12d post implantation; TPST - 1120 30 MGPK BID; α - PD - 1 200 ug Q3d Complete and d
Slide 17: TPST-1120 Accelerating to Frontline HCC
17 TPST - 1120 Accelerating to Frontline HCC Randomized Study Dose Finding Cohorts Additional Studies Under Consideration • TPST - 1120 + VEGF TKI in RCC • TPST - 1120 + IDH inhibitor in cholangiocarcinoma HCC: hepatocellular carcinoma; RCC: renal cell cancer; CCA: cholangiocarcinoma 1 NCT03829436 R
Slide 18: TPST-1120 + Nivolumab Partial Response
18 * These results may not be indicative of results to be achieved with other patients TPST - 1120 + Nivolumab Partial Response Heavily pre - treated patient with deep response:* 54yo F with metastatic RCC • Sites of metastatic disease: pulmonary; multiple soft tissue (chest, peri - renal, peri - va
Slide 19: TPST-1120 Clinical Profile and Next Steps
19 • Monotherapy − Dose escalation complete and maximum tolerated dose not reached − No DLTs and predominantly Grade 1 - 2 treatment - related AEs 1 − Monotherapy activity observed (prolonged disease control & tumor reductions) ▸ Two late - line treatment refractory patients with cholangiocarcinoma
Slide 20: TREX-1 Optimal Approach to Target STING
20 TREX - 1 Optimal Approach to Target STING
Slide 21: TREX1: The Right Approach to Target STING
21 • STING is a genetically - validated drug target in humans − Critical pivot point in immune decisions − Tumors modulate STING signaling to avoid immune recognition • TREX1 regulates STING activity − DNA exonuclease − Previously un - drugged target in pathway − Upregulated in tumors → enables syst
Slide 22: Multiple Potential Catalysts Through 2021-2022
22 Multiple Potential Catalysts Through 2021 - 2022 Diversified clinical and pre - clinical portfolio engenders a broad opportunity Catalysts and Events 1 “CRC” colorectal cancer; “ HCC” hepatocellular carcinoma; “FPI” first patient in; “RP2D” recommended Ph2 dose 1 Timing is an estimate is based on
Slide 23: Next Steps
23 • Registration Statement on Form S - 4 to be filed with SEC by Millendo • Proxy statement for Millendo (to be included in Form S - 4) • Stockholder approvals • Target closing in 1H 2021 Next Steps
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