Verastem, Inc. · NASDAQ:VSTM
Verastem — Corporate Update (September 2020)
25 slides from Verastem's corporate update, Sep 16, 2020
Slide 1: Updated Results from the Phase 1/2 FRAME Study in Low-Grade Serous Ovarian Cancer
Updated Results from the Phase 1/2 FRAME Study in Low - Grade Serous Ovarian Cancer September 16, 2020 NASDAQ: VSTM
Slide 2: On Today's Call
2 On Today’s Call John Doyle, Vice President, Investor Relations and Finance Dan Paterson, Chief Operating Officer Rachel Grisham, MD, Medical Oncologist, Memorial Sloan Kettering Cancer Cente r ; Brian Stuglik, Chief Executive Officer Rob Gagnon, Chief Financial Officer Prepared Remarks Jonathan Pa
Slide 3: Safe Harbor Statement
3 This presentation includes forward - looking statements about, among other things, Verastem Oncology’s products and product candidates, including anticipated regulatory submissions, approvals, performance and potential benefits of Verastem Oncology products and product candidates, that are subject
Slide 4: Updated Phase 1/2 FRAME Study Data in Low-Grade Serous Ovarian Cancer
Updated Phase 1/2 FRAME Study Data in Low - Grade Serous Ovarian Cancer Dan Paterson President and Chief Operating Officer
Slide 5: RAF/MEK Inhibitor in Gynecological Malignancies
5 PHASE 1 / 1B PHASE 2 PHASE 3 MARKET RASm/RAFm gynecological cancers 1,2 VS - 6766 monotherapy FRAME study in LGSOC 1,3 VS - 6766 + defactinib FRAME study in KRASm endometrial cancer 1,3 VS - 6766 + defactinib Registration - directed study in LGSOC VS - 6766 + defactinib RAF/MEK Inhibitor VS - 6766
Slide 6: Favorable Tolerability Profile for Novel Intermittent Dosing Regimen
6 Favorable Tolerability Profile for Novel Intermittent Dosing Regimen of VS - 6766 plus Defactinib Daily at MTD N=6 28 - day cycle 4mg twice weekly N=26 28 - day cycle RP2D (VS - 6766 3.2mg twice weekly + defactinib 200mg twice daily) N=26 21 days of 28 - day cycle Adverse Event Grade ≥3 Grade ≥3 G
Slide 7: Robust ORR with Durability in Refractory LGSOC with Expanded Number of Patients
7 VS - 6766 in Combination with Defactinib Shows Robust ORR with Durability in Refractory LGSOC with Expanded Number of Patients (n=17) 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 -70 -60 -50 -40 -30 -20 -10 0 10 20 Response by RECIST Time (months) R e s p o n s e ( % c h a n g e f r o m b a s e l i
Slide 8: Robust ORR with Durability in Refractory LGSOC at Phase 2 Dose Level
8 VS - 6766 in Combination with Defactinib Shows Robust ORR with Durability in Refractory LGSOC at Phase 2 Dose Level • ORR in KRAS mt = 50% (3/6); data still maturing • Current overall ORR = 45% (5/11); data still maturing • 9/11 (82%) still on study at RP2D 1 • 2 pts on treatment for 2.5 yrs 0 2 4
Slide 9: Adaptive Design for Potential Accelerated Approval in Recurrent LGSOC
9 KRAS Mutated (mt) and Wild Type (wt), Phase 2, Recurrent LGSOC Adaptive Design for Potential Accelerated Approval * Selection Phase – KRAS mt only ** Expansion Phase – final sample size to be adjusted based on adaptive design FDA Was Supportive of Development Strategy and Adaptive Design This Regi
Slide 10: Low-Grade Serous Ovarian Cancer Treatment Landscape and Clinical Perspective
Low - Grade Serous Ovarian Cancer Treatment Landscape and Clinical Perspective Rachel Grisham, MD Memorial Sloan Kettering Cancer Center
Slide 11: What is Low-Grade Serous Ovarian Cancer (LGSOC)?
11 What is Low - Grade Serous Ovarian Cancer (LGSOC)? LGSOC is a type of ovarian cancer that disproportionately affects younger women Patients often experience significant pain and suffering from their disease over time A slow growing cancer, that has a median survival of almost 10 years, so patient
Slide 12: Treatment Landscape and Clinical Perspective: Rachel Grisham, MD
12 Treatment Landscape and Clinical Perspective Rachel Grisham, MD Memorial Sloan Kettering Cancer Center Bio: Dr. Grisham is a medical oncologist with clinical expertise in the diagnosis and treatment of women with gynecologic malignan ci es including ovarian, uterine, and cervical cancers as well
Slide 13: Low-Grade Serous Ovarian Cancer Market Opportunity
Low - Grade Serous Ovarian Cancer Market Opportunity Brian Stuglik Chief Executive Officer
Slide 14: 32% of LGSOC Patients Have KRAS Mutations
14 KRASm , 32% Wild - Type , 68% Incidence 10 Yr Prevalence Worldwide ~15,000 – 30,000 ~80,000 US ~1,000 – 2,000 ~6,000 32% of LGSOC Patient Have KRAS Mutations LGSOC: Key Drivers Are KRAS/NRAS/BRAF Mutations *Based on LGSOC representing 5 - 10% of epithelial ovarian cancer Wild - type KRAS includes
Slide 15: LGSOC: Limited Treatment Options With High Unmet Need
15 31 - 35% discontinuation rate with MEK inhibitors due to AEs No discontinuations in the FRAME study due to AEs Low - Grade Ovarian Cancer – Treatment Algorithm 1 Observe only Pt Chemo Combo: Carbo - Pt + Paclitaxel (preferred) + Beva for Stage II - IV (incl maintenance Beva) OR Hormonal Tx (2B) P
Slide 16: Key Takeaways and Next Steps
16 Commence Phase 2 registration - directed trial by the end of 2020 Report updated data from FRAME LGSOC cohort in mid - 2021 Validating Clinical Data in LGSOC VS - 6766 ± Defactinib Represents Best in Class Market Opportunity in LGSOC 1 AACR Project Genie, cBioportal KRAS mutations account for 32%
Slide 17: Other Program Updates
Other Program Updates Brian Stuglik Chief Executive Officer
Slide 18: NSCLC Clinical Strategy: KRAS Mutant, Enriched G12V, Phase 2
18 NSCLC Clinical Strategy: KRAS Mutant (mt), Enriched G12V, Phase 2, Recurrent NSCLC for Potential Accelerated Approval 1 Defactinib 200 mg PO BID (21/28 days) + VS - 6766 3.2 mg PO 2x/wk (21/28 days) 2 VS - 6766 4.0 mg PO 2x/wk (21/28 days) This Registration - directed Phase 2 Study is Expected to
Slide 19: Continuing to Move Forward Aggressively With Additional Opportunities
19 Continuing to Move VS - 6766 Forward Aggressively With Additional Opportunities Go - forward strategy is to focus primarily on KRAS G12V patients in NSCLC given clinical signals to - date KRAS G12V cohort added to ongoing FRAME study Completing Phase 1 investigating VS - 6766 in combination with
Slide 20: Other High Priority Lead Indications with Multiple Growth Opportunities
20 PRECLINICAL PHASE 1 / 1B PHASE 2 PHASE 3 MARKET Combinations FRAME study in NSCLC 1 with defactinib FRAME study in CRC 1 with defactinib FRAME study in KRAS - G12V NSCLC 1 with defactinib FRAME study in pancreatic 1 with defactinib Registration - directed study in recurrent KRASm NSCLC with defac
Slide 21: Corporate
Corporate Rob Gagnon Chief Financial Officer
Slide 22: Selling COPIKTRA Rights to Secura Bio
22 Selling COPIKTRA ® (duvelisib) Rights to Secura Bio Secura Bio to Assume All Operational and Financial Responsibilities, Including Existing Royalty Obligations Beginning in 2021 Annual OPEX Expected to be ~$50 Million New Verastem Headcount of ~50 Provides Cash Runway Through at Least 2024 Total
Slide 23: Key Financial Statistics
23 Key Financial Statistics * On April 23, 2019, we entered into a 4th Amendment to our existing Agreement with Hercules Capital, Inc. whereas we may borro w up to an aggregate amount of $75.0 million, of which $35.0 million was outstanding as of the date of amendment and 6/30/2020. ** The 2018 Note
Slide 24: Key Upcoming Milestones for Remainder of 2020
24 Monetize COPIKTRA; extend cash runway through at least 2024 Reduce OPEX for 2021 Close Secura Bio transaction in 3Q 2020 Regulatory path forward in LGSOC and KRAS mutant NSCLC during the 3Q 2020 Expand Phase 1/2 FRAME study to include new cohorts in pancreatic cancer, KRASm endometrial cancer and
Slide 25: Thank you
Thank you www.verastem.com Questions and Answers