Syros Pharmaceuticals, Inc. · OTC:SYRS
Syros Pharmaceuticals — Corporate Update (December 2020)
24 slides from Syros Pharmaceuticals's corporate update, Dec 7, 2020
Slide 1: An Expression Makes a World of Difference
An Expression Makes a World of Difference December 5, 2020 Exhibit 99.1
Slide 2: Forward-looking statements
Forward-looking statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation, inc
Slide 3: Accelerating our vision
Accelerating our vision Targeted hematology therapy franchise Gene control discovery engine Selective CDK inhibitor franchise Fully integrated biopharmaceutical company
Slide 4: Building a leading franchise that sets new standards of care in hematology
Building a leading franchise that sets new standards of care in hematology $3B+ in growing hematology markets 2 programs with planned registrational trials 3 targeted patient populations
Slide 5: Advancing SY-1425 and SY-2101 through late-stage development
Advancing SY-1425 and SY-2101 through late-stage development SY-1425 w/ aza SY-2101 w/ ATRA SY-1425 w/ ven+aza Initiate Phase 3 registration trial in ND HR-MDSQ1 2021 Potential NDA filing in ND HR-MDS2024 Initiate Phase 2 trial w/ safety lead-in in ND unfit AML2H 2021 Initial data from Phase 2 trial
Slide 6: Clear vision for SY-1425 in RARA-positive cancers
Clear vision for SY-1425 in RARA-positive cancers Now Registration strategy in MDS Triplet strategy in unfit AML Next Registration-enabling studies Commercialization Vision Foundation of care for all RARA+ patients
Slide 7: Compelling data and clear path forward for SY-1425
Compelling data and clear path forward for SY-1425 1 de Botton, ASH 2020; 2Fiore, ASH 2020 SY-1425/aza induces high CR rates, rapid onset of action and meaningful durability in RARA+ ND unfit AML1 SY-1425 safety profile supports multiple combination opportunities New translational data suggest RARA
Slide 8: Phase 2 trial of SY-1425 and azacitidine
Phase 2 trial of SY-1425 and azacitidine Primary Objective: ORR per IWG Other Analyses: Composite CR rate Duration of response Transfusion independence Overall survival Safety Regimen Azacitidine IV or SC days 1-7 and SY-1425 po days 8-28 each 28-day cycle Patient population: Relapsed/refractory AML
Slide 9: High CR rates, rapid onset of action, and durability in RARA-positive ND unfit AML
High CR rates, rapid onset of action, and clinically meaningful durability in RARA-positive ND unfit AML 89% of CRs were deep molecular or cytogenetic CRs Responses seen irrespective of mutation or cytogenetic risk 1.2 months Time to response 10.8 months Duration of response 18 months Overall surviv
Slide 10: New translational data highlight potential of SY-1425 in ven/aza-resistant patients
New translational data highlight potential of SY-1425 to benefit ND unfit AML patients who may be resistant to standard of care 30% of patients do not respond to upfront treatment with ven/aza Venetoclax resistance associated with monocytic phenotype,1-3 which includes low BCL2 and high MCL-1 expres
Slide 11: Generally well-tolerated combination in ND unfit AML patients
Generally well-tolerated combination in ND unfit AML patients No increase in neutropenia, anemia and thrombocytopenia compared to single-agent aza Majority of non-hematologic AEs are low grade and reversible a Includes all enrolled ND unfit patients, N=51. Data presented at ASH 2020 meeting
Slide 12: Clinical activity observed in heavily pretreated RARA-positive R/R AML
Clinical activity observed in heavily pretreated RARA-positive R/R AML ORR of 19% (4/21) with 2 responders on treatment at month 8 and 9 1 CRc 2 CRi 1 MLFS Higher ORR of 43% (3/7) in HMA and ven naïve patients Transfusion independence in 30% (6/20) Median OS of 5.9 months (95% CI: 3.1, 9.9) Data pre
Slide 13: ND HR-MDS represents ideal opportunity for SY-1425 with azacitidine
ND HR-MDS represents ideal opportunity for SY-1425 in combination with azacitidine HR-MDS and AML on a disease continuum; distinguished only by % blasts in marrow More than half of patients progress to AML1 Neutropenia may lead to infection-related complications including death2 HR-MDS is closely re
Slide 14: Initiating Phase 3 trial in ND RARA-positive HR-MDS patients
Initiating Phase 3 trial in ND RARA-positive HR-MDS patients FDA feedback supports: Focus on RARA+ population CR as primary endpoint for accelerated/ full approval Azacitidine as appropriate comparator Key Milestones Initiate registration trial 1Q 2021 Potential NDA 2024 Phase 3 trial 190 patients r
Slide 15: Initiating randomized Phase 2 trial of triplet regimen in ND unfit AML
Randomized portion of trial ~80 patients SY-1425 + venetoclax + azacitidine Venetoclax + azacitidine randomization (1:1) Safety lead-In ~15 patients Initiating randomized Phase 2 trial of triplet regimen in ND RARA-positive unfit AML patients Plan to evaluate triplet as salvage strategy for patients
Slide 16: ND HR-MDS and unfit AML represent significant market opportunities
ND HR-MDS and unfit AML represent significant market opportunities ~30% of all AML and MDS patients are RARA-positive Newly diagnosed HR-MDS ~15,000 new cases annually in US and EU Expected to grow into $1B+ market No new approved therapies in a decade Existing options offer limited efficacy Sources
Slide 17: SY-2101: Highly synergistic with our advancing targeted heme franchise
SY-2101: Highly synergistic with our advancing targeted heme franchise Strategic opportunity as we accelerate toward becoming a commercial-stage company Potential to become standard of care in APL Novel oral capsule of arsenic trioxide (ATO) Clinical-stage asset with opportunity for accelerated appr
Slide 18: Opportunity for SY-2101 to become standard of care in significant market
Opportunity for SY-2101 to become standard of care in significant market APL is ~10 % of AML Newly diagnosed APL Genetic fusion of RARA and PML genes ~2,000 patients diagnosed in US and Europe annually1,2 ~$250 million overall market opportunity3 Opportunity to become the standard of care and be ser
Slide 19: IV ATO is transformative therapy for APL but comes with heavy treatment burden
IV ATO is transformative therapy for APL patients but comes with heavy treatment burden >80% Cure rates IV ATO oral ATRA Significant opportunity to reduce treatment burden, increase access and reduce health care costs and utilization Current course of treatment involves up to 140 two- to four-hour i
Slide 20: Phase 1 PK study of SY-2101
Phase 1 PK study of SY-2101 Ravandi et al 2020 Haematologica Trisenox (arsenic trioxide) USPI Three dosing cohorts: 5, 10 and 15 mg orally Once daily 12 patients with advanced hematologic malignancies Median age: 76.5 Prior lines of therapy: Up to 5 Generally well-tolerated with low-grade AEs Lower
Slide 21: Advancing SY-2101 toward registration-enabling Phase 3 trial
Advancing SY-2101 toward registration-enabling Phase 3 trial FDA feedback supports: Molecular CR as primary endpoint for accelerated approval Event-free survival (EFS) as primary endpoint for full approval Dose confirmation study SY-2101 + ATRA Pivotal Phase 3 Trial ~150 newly diagnosed APL patients
Slide 22: Transaction overview
Transaction overview Asset acquisition Upfront cash payment of $12 million Additional regulatory milestone of $6 million in APL indication Aggregate sales milestones of up to $10 million Strategic financing Entered into a securities purchase agreement expected to yield $90.5M in gross proceeds Led b
Slide 23: Multiple expected value-driving clinical milestones and strong cash position
Multiple expected value-driving clinical milestones and strong cash position SY-5609 SY-2101 SY-1425 w/ aza SY-1425 w/ ven+aza Initiate Phase 3 registration trial in ND HR-MDS Q1 2021 Potential NDA filing in ND HR-MDS 2024 Initiate Phase 2 trial w/ safety lead-in in ND unfit AML2H 2021 Initial data
Slide 24: SYR2:S
SYR2:S
Syros Pharmaceuticals — Corporate Update (December 2020) on 6ix