UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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| Item 2.02 | Results of Operations and Financial Condition |
As of December 31, 2020, G1Therapeutics, Inc.’s (the “Company”) cash, cash equivalents and investments balance was approximately $207 million.
| Item 7.01 | Regulation FD Disclosure |
Attached to this Current Report on Form 8-K as Exhibit 99.1 is a presentation (the “Presentation”), which is incorporated herein by reference. The Company will use the Presentation in various meetings with securities analysts, investors, and others beginning January 11, 2021.
Pursuant to General Instruction B.2 of Current Report on Form 8-K, the information contained in, or incorporated into, Items 2.02 and 7.01, including the Presentation attached hereto as Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference to such filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Presentation dated January 2021 | |
| 104 | Cover Page Interactive Data File (embedded with the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| G1 THERAPEUTICS, INC. | ||
| By: | /s/ James Stillman Hanson | |
| James Stillman Hanson | ||
| General Counsel | ||
Date: January 11, 2021
Optimizing Chemotherapy, Advancing Survival 39th Annual J.P. Morgan Healthcare Conference January 2021 Exhibit 99.1
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this presentation include, but are not limited to, those relating to the therapeutic potential of trilaciclib, rintodestrant and lerociclib, the timing of marketing applications in the U.S. for trilaciclib in SCLC, trilaciclib’s possibility to improve patient outcomes across multiple indications, rintodestrant’s potential to be best-in-class oral SERD, our reliance on partners to develop and commercial licensed products, and the impact of pandemics such as COVID-19 (coronavirus), and are based on the company’s expectations and assumptions as of the date of this presentation. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the company’s actual results to differ from those expressed or implied in the forward-looking statements in this presentation are discussed in the company’s filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; and market conditions. Trilaciclib, rintodestrant and lerociclib are not approved by the FDA. The safety or effectiveness of trilaciclib, rintodestrant and lerociclib have not been established by the FDA. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Forward-Looking Statements
Transformed Company Heading into a Pivotal 2021 Trilaciclib CDK2 Discovery Platform Rintodestrant 2021 2020 Trilaciclib is a cornerstone therapy: Near-term U.S. launch in SCLC (Priority Review) Pipeline-in-a-molecule development opportunity Rintodestrant + palbociclib Phase 2 data expected 2Q Lerociclib OUT-LICENSED OUT-LICENSED $207M cash on hand (as of December 31, 2020) Streamlined company focused on maximizing the development and commercialization of trilaciclib Partner for Greater China
Chemo to Remain Mainstay Therapy Despite Shortcomings Over 1 million cancer patients receive chemo in the U.S. each year Cost-efficient and effective treatment option expected to remain backbone of SoC Established high water-mark that has proven difficult to exceed head-to-head Immunotherapy with chemo has demonstrated the best results in many tumors High unmet need for new therapies that can significantly reduce myelosuppression and meaningfully improve efficacy across patient populations Proactively reducing the damaging consequences of chemotherapy 1 Meaningfully improving overall survival in broad populations 2 Two Critical Areas of Unmet Need
Trilaciclib: Novel Approach to Address Shortcomings of Chemo Trilaciclib Transient IV CDK4/6 inhibitor Temporarily blocks progression through the cell cycle Leads to multiple potential downstream effects Protects HSPCs and myeloid and lymphoid cell lineages from damage caused by chemotherapy1-3 Ability to improve the immune response when administered with chemotherapy4-9 Neutrophils B-lymphocytes T-lymphocytes Erythrocytes Platelets Enhances T-cell activation Favorably alters tumor microenvironment Potential to benefit patients receiving chemotherapy across multiple tumor types 1. Weiss J, et al. Ann Oncol. 2019 Oct; 30(10): 1613–1621. 2. He S, et al. Sci Transl Med. 2017;9:eaal3986. 3. Bisi JE, et al. Mol Cancer Ther. 2016;15:783-93. 4. Tan A, et al. Lancet Oncol. 2019 Sep 28. 5. Zhang J, et al. Nature. 2018;553:91-95. 6. Jerby-Arnon L, et al. Cell. 2018;175:984-997. 7. Goel S, et al. Nature. 2017;548:471-475. 8. Deng J, et al. Cancer Discov. 2018;:216-233. 9. O’Shaugnessy et al., 2020 San Antonio Breast Cancer Symposium (SABCS), Poster #PD1-06.
Myelopreservation Impact1-5 Anti-Tumor Efficacy Impact6-11 Reduces rate of hematologic adverse events (less neutropenia, anemia, thrombocytopenia) Increases patients’ ability to receive longer duration of chemotherapy-based regimens Decreases rescue interventions and costs (less transfusions, G-CSF, hospitalizations) Protects the immune system from damage by chemotherapy Improves patients’ quality of life (well-being and less fatigue) Enhances T-cell activation and favorably alters the tumor microenvironment Trilaciclib Demonstrated Meaningful Benefits Across Studies Potential to provide myelopreservation and/or anti-tumor efficacy benefits in patients treated with chemotherapy Protects myeloid cell lineages Protects lymphoid cell lineages Improves immune response 1. Weiss J, et al. Ann Oncol. 2019 Oct; 30(10): 1613–1621. 2. He S, et al. Sci Transl Med. 2017;9:eaal3986. 3. Bisi JE, et al. Mol Cancer Ther. 2016;15:783-93. 4. Weiss et al. MASCC Oral Presentation, Abstract #MASCC9-0845. 5. Tan A, et al. Lancet Oncol. 2019 Sep 28. 6. Ferrarotto et al., 2020 North America Conference on Lung Cancer (NACLC), Abstract # OA03.08. 7. Zhang J, et al. Nature. 2018;553:91-95. 8. Jerby-Arnon L, et al. Cell. 2018;175:984-997. 9. Goel S, et al. Nature. 2017;548:471-475. 10. Deng J, et al. Cancer Discov. 2018;:216-233. 11. O’Shaugnessy et al., 2020 San Antonio Breast Cancer Symposium (SABCS), Poster #PD1-06.
Significant Expansion Opportunities for Trilaciclib Optimizing development plan across three core growth platforms will enable trilaciclib to benefit as many patients as possible Myelopreservation Improved Survival (single agent) Improved Survival (combinations) Protecting the bone marrow from the damaging consequences of myelotoxic chemo: Preserving / activating the immune system: Improving efficacy of immunotherapy and chemo combinations: Common SCLC regimens* 5-FU based regimens Other myelotoxic regimens Alternative to I/O treatment Following I/O treatment In tumors less responsive to I/O With PD-1/PD-L1 inhibitors With other immunotherapies * Expected 1Q 2021 U.S. launch in ES-SCLC Myelopreservation Focus Anti-Tumor Efficacy Focus + Chemo Backbone
Pipeline-in-a-Molecule Opportunity Beyond ES-SCLC Launch Aggressively pursuing development in areas of high strategic importance where trilaciclib is most likely to provide meaningful benefits to patients ES-SCLC 1L CRC 2L / 3L NSCLC 1L Bladder Cancer POTENTIAL APPROVAL / U.S. LAUNCH 1Q 2021 REGISTRATIONAL TRIALS PHASE 2 STUDIES Other Tumors TBD Trilaciclib Opportunity + Milestones and Royalties Neoadjuvant Breast Cancer Myelopreservation Improved Survival (single agent) Improved Survival (combinations) 1L / 2L TNBC Initiating in 1H 2021 Initiated in 2020 Initiated in 2020 Initiating in 1H 2021 Initiating in 1H 2021 Key Study Objective:
2021 Key Objectives Focused on successfully launching trilaciclib in ES-SCLC and accelerating development into other areas where chemotherapy is used Obtain U.S. approval for ES-SCLC and successfully launch trilaciclib in 1Q Establish trilaciclib as Standard of Care for ES-SCLC patients in the U.S. Maximize long-term value of trilaciclib by executing robust development plan Evaluate partnership options for rintodestrant following combination data readout in 2Q Continue managing investor capital efficiently
2021 Key Objectives Obtain U.S. approval for ES-SCLC and successfully launch trilaciclib in 1Q Establish trilaciclib as Standard of Care for ES-SCLC patients in the U.S. Maximize long-term value of trilaciclib by executing robust development plan Evaluate partnership options for rintodestrant following combination data readout in 2Q Continue managing investor capital efficiently
Prepared for Trilaciclib Approval and U.S. Launch in 1Q21 Following NDA approval, we are ready to make this important new treatment available to the majority of patients with ES-SCLC undergoing chemotherapy in the U.S. PDUFA action date for SCLC indication: February 15th, 2021 NDA under “Priority Review” Less complex CMC application given small molecule compound Identified HCP targets Profiled key accounts Engaged payors Educating leading patient advocacy organizations G1 infrastructure in place Marketing Market Access Commercial Operations Medical Affairs team Manufacturing and supply chain Boehringer Ingelheim field sales team trained and ready1 Experienced lung cancer team Incentivized structure (% net sales) NDA Discussions on Track Pre-Launch Activities Ongoing Ready for 1Q Launch 1. Three-year agreement where Boehringer Ingelheim leads sales force engagement initiatives for trilaciclib in the U.S. for the initial ES-SCLC indication. The agreement does not extend to additional indications.
Opportunity to Meaningfully Impact the Lives of Many Patients Based on incidence of 25k for all SCLC with 81% of patients being diagnosed at Extensive Stage; Decision Resources Group, Small Cell Lung Cancer Disease Landscape & Forecast, March 2020. Based on 22k 1L SCLC total patients (20K de novo ES-SCLC and 2K late relapse LS-SCLC) treated at an assumed 80% treatment rate (from 2020 internal primary market research). Based on 12.5k 2L SCLC total patients (11k progressed 1L SCLC and 1.5k early relapse LS-SCLC) treated at an assumed 72% treatment rate (from 2020 internal primary market research). Based on 5k 3L SCLC total patients treated at an assumed 50% treatment rate (from 2020 internal primary market research). Demonstrated in trilaciclib G1T28-02 and G1T28-05 study control arms. 2L Treated Patients1,3 9.5k 1L Treated Patients1,2 17.5k 3L Treated Patients1,4 2.5k Trilaciclib provides a meaningful improvement for SCLC patients and has potential to generate near-term revenue to further support ongoing development ~30k ES-SCLC Patients Treated Annually in the U.S.1 ES-SCLC patients predominately treated with highly myelosuppressive chemo regimens Limited successful innovation given aggressiveness of disease (1L median OS ~1 year5) Standard treatment includes 4 to 6 cycles of chemo Payor research and discussions indicate potential broad patient access to trilaciclib Anticipate pricing product above supportive care treatments and below therapeutics ~60% of ES-SCLC patients covered by Medicare (expect Medicare to cover label at launch)
Three Core Goals for a Successful U.S. ES-SCLC Launch Educate prescribers, payers, and patients on the benefits of trilaciclib’s proactive multi-lineage protection Gain inclusion into relevant guidelines / pathways; enable broad patient access; and ensure ease of use for prescribers / nurses / staff Increase awareness of the significant multi-lineage impact of myelosuppression on clinical outcomes, costs, and patients’ QoL Increase Awareness of Myelosuppression Communicate the Unique Benefits of Trilaciclib Optimize Early Experience 1 2 3 Focused on ensuring patients with ES-SCLC can benefit from trilaciclib first time and every time they are treated with chemotherapy
Prescribers are Enthusiastic to Use Trilaciclib Education will be key to establish trilaciclib as a Standard of Care for patients with ES-SCLC receiving chemotherapy Prescriber Enthusiasm to Use Trilaciclib for Patients with SCLC Following Education Source: internal market research conducted July 2020 (n=153 oncologists) 77% 77%
2021 Key Objectives Obtain U.S. approval for ES-SCLC and successfully launch trilaciclib in 1Q Establish trilaciclib as Standard of Care for ES-SCLC patients in the U.S. Maximize long-term value of trilaciclib by executing robust development plan Evaluate partnership options for rintodestrant following combination data readout in 2Q Continue managing investor capital efficiently
The Burden of Chemotherapy Myelosuppression has a significant negative impact on clinical outcomes, healthcare costs, and overall patient quality of life An unavoidable consequence of chemo that impacts patient safety, healthcare system costs and QoL MYELOSUPPRESSION Hospitalizations and unscheduled patient care Chemotherapy dose reductions and delays THROMBOCYTOPENIA Risk of bleeding Platelet transfusions ANEMIA Fatigue RBC transfusions and ESA rescue NEUTROPENIA Risk of infection G-CSF use (associated bone pain) Increased healthcare costs HEMATOLOGIC EVENT: CONSEQUENCE: RESPONSE:
Trilaciclib Meaningfully Reduces Myelosuppression in SCLC Reduced Incidence of Multi-lineage Myelosuppression in 1L‒3L SCLC1 (pooled data across our 3 randomized placebo-controlled double-blind trials) Clinical Results: Trilaciclib consistently demonstrated meaningful reductions in hematologic adverse events across multiple randomized SCLC studies P<0.0001 P=0.089 P=0.028 P=0.0067 1. Weiss et al., 2020 American Society of Clinical Oncology (ASCO), Abstract #384.
Trilaciclib Expected to Drive Significant Payor/Hospital Savings Average total annual cost per patient without a grade 3/4 hematologic event: Average Total Annual Cost Per Patient with a Grade 3/4 Hematologic Event (Jan 2016 – Dec 2019)1 Neutropenia $131,047 Anemia $95,954 Thrombocytopenia $90,053 Payor Impact: Trilaciclib’s ability to reduce the severe hematologic consequences of chemotherapy expected to result in a budget-neutral to savings-positive impact $67,802 Cost savings from less hematologic events largely driven by: Reduced interventions (e.g., G-CSF, ESA) Fewer required transfusions Fewer complications and hospitalizations 1. Epstein et al, Journal of Clinical Oncology May 25, 2020; 38, no. 15_suppl
Trilaciclib Improves Patients’ Quality of Life Patient Benefit: Trilaciclib’s proactive protection enables better quality of life for patients in this palliative treatment setting Epstein et al, Patient Burden and Real-World Management of Chemotherapy-Induced Myelosuppression: Results from an Online Survey of Patients with Solid Tumors; Advances in Therapy, July 2020 Weiss et al., MASCC Oral Presentation 2019, Abstract #MASCC 9-0845 “…the overall fatigue was the worst. It stole my energy and joy for both life and family. It made me want to quit chemo numerous times.” “I don’t feel like doing ANYTHING some days. It’s like depression but completely physical.” 89% of cancer patients with myelosuppression rate it as having a moderate to major impact on their life1: Measure Placebo (months) Trilaciclib (months) Improvement (months) Fatigue 2.3 7.0 4.7 Anemia –TOI (Trial Outcome Index) 3.8 7.2 3.4 Functional Well Being 3.8 7.6 3.8 Trilaciclib helps patient functioning in ES-SCLC patients: Median Time to Deterioration2 (pooled data from three randomized, placebo-controlled, double-blind trials) “Did not get out as much, not able to work, always feeling tired.”
Opportunity for Trilaciclib to Become Standard of Care in SCLC Heightened awareness of myelosuppression due to the COVID pandemic may further encourage adoption of trilaciclib as a Standard of Care Clinical Results: Meaningfully reduces the hematologic adverse events in SCLC Payer Impact: Provides cost savings for system (trilaciclib expected to be budget neutral or better) Patient Benefits: Improves the overall quality of life for patients
2021 Key Objectives Obtain U.S. approval for ES-SCLC and successfully launch trilaciclib in 1Q Establish trilaciclib as Standard of Care for ES-SCLC patients in the U.S. Maximize long-term value of trilaciclib by executing robust development plan Evaluate partnership options for rintodestrant following combination data readout in 2Q Continue managing investor capital efficiently
Aggressively Pursuing Development in Common Tumor Types Estimated new cases and deaths from National Cancer Institute for 2020. Estimated patients receiving chemotherapy from Kantar Health CancerMPact Patient Metrics, 2019 data based on IQVIA BrandImpact regimen shares and Kantar Health Treatment Architecture 2019 survey data for patients receiving chemo (rounded to nearest 5,000 patients). G1 has / will soon initiate sponsored studies in many of the most common and deadly tumor types Shading indicates areas of ongoing or soon to be initiated G1 sponsored studies Patients Receiving Chemo2: 110k 125k 30k 115k <5k 20k 45k <5k
Broad Portfolio of Impactful Studies Across Tumor Types Two registrational studies will be ongoing by mid 2021 in addition to multiple Phase 2 studies to evaluate trilaciclib in several treatment settings / tumor types Cancer Type Indication Study Size Phase 2 Pivotal Approval Lung SCLC NA 2L / 3L NSCLC (Post-checkpoint treatment) TBD Colorectal 1L CRC ~300 Breast 1L TNBC1 ~170 Breast 2L TNBC1 (Post-checkpoint treatment) ~80 Breast Neoadjuvant Adaptive Bladder 1L Bladder (Checkpoint combination) TBD Under Priority Review with FDA Ongoing Starting 1H 2021 Starting 1H 2021 Ongoing Starting 1H 2021 Starting 1H 2021 1. 1L TNBC and 2L TNBC cohorts being conducted under one study protocol.
Ongoing First-Line CRC Pivotal Trial Cycle X Day 2 Cycle X Day 1 Cycle X Day 2 Cycle X Day 1 Cycle X Day 14 Randomization 1:1 Placebo + CI FU Treatment Phase Placebo + FOLFOXIRI + bevacizumab Trilaciclib + FOLFOXIRI + bevacizumab Trilaciclib + CI FU Induction Phase 14-day cycles Maintenance Phase 14-day cycles Placebo + bev + CI FU Placebo + CI FU Trilaciclib + bev + CI FU Trilaciclib + CI FU Maximum of 12 cycles PRIMARY ENDPOINT: Myelopreservation SECONDARY ENDPOINTS: PFS/OS, PRO TARGET ENROLLMENT: ~300 participants PATIENTS TREATED UNTIL PROGRESSION MulTi-day Chemo Regimen FOLFOXIRI: most efficacious chemo regimen but highly myelosuppressive Ability to significantly expand FOLFOXIRI usage supported by market research Strong support from preclinical models for the benefits of trilaciclib in combination with 5-FU-based chemo regimens Until Progression
TNBC tumors categorized by lack of HR expression and HER2 gene amplification Tumors are aggressive and difficult to treat Targeted therapies only demonstrated benefit in subpopulations (e.g., PD-L1 agents, PARPs) Antibody Drug Conjugates (ADCs) demonstrated OS improvement in 3L to date, but have associated toxicity Metastatic TNBC is an Area of High Unmet Need Urgent need for new therapies that extend Overall Survival with decreased toxicity TNBC (15% - 20%) Breast Cancer Subtypes
Observed Robust OS Improvement in mTNBC Phase 2 Observed a robust statistically significant improvement in Overall Survival for both trilaciclib schedules Group 1 (gem/carbo)2 Group 3 (trila + gem/carbo)2 Group 2 (trila + gem/carbo)2 Treatment Group2 Median OS, months Hazard Ratio (95% CI) P Value Group 1: (gem/carbo) 12.6 - - Group 2: (gem/carbo + trilaciclib) Not Reached 0.31 (0.15-0.63) 0.0016 Group 3: (gem/carbo + trilaciclib) 17.8 0.40 (0.22-0.74) 0.0004 Overall Survival in Intent-to-Treat Population1 O'Shaughnessy et al., 2020 San Antonio Breast Cancer Symposium (SABCS), Poster #PD1-06. Note: primary endpoints relating to reduction in severe neutropenia not achieved in this study. Patients randomized to receive gem/carbo chemotherapy only (Group 1) or gem/carbo plus one of two dosing schedules of trilaciclib: trilaciclib administered on the day of chemotherapy (Group 2) or trilaciclib administered the day prior to and the day of chemotherapy (Group 3).
OS Improvement Regardless of PD-L1 Status Overall Survival improvement was observed regardless of tumor PD-L1 status (greater effect in PD-L1 positive tumors) Overall Survival for PD-L1 Positive Tumors1 Treatment Group2 Patients Median OS, months Hazard Ratio (95% CI) P Value Group 1: (gem/carbo) 17 10.5 (6.3 – 18.8) - - Group 2 and 3: (gem/carbo + trilaciclib) 32 32.7 (17.7 – NR) 0.34 (0.2 – 0.7) 0.004 Overall Survival for PD-L1 Negative Tumors1 Treatment Group2 Patients Median OS, months Hazard Ratio (95% CI) P Value Group 1: (gem/carbo) 10 13.9 (9.4 – NR) - - Group 2 and 3: (gem/carbo + trilaciclib) 26 17.8 (13.1 – NR) 0.48 (0.2 – 1.2) 0.093 O'Shaughnessy et al., 2020 San Antonio Breast Cancer Symposium (SABCS), Poster #PD1-06. Note: primary endpoints relating to reduction in severe neutropenia not achieved in this study. Patients randomized to receive gem/carbo chemotherapy only (Group 1) or gem/carbo plus one of two dosing schedules of trilaciclib: trilaciclib administered on the day of chemotherapy (Group 2) or trilaciclib administered the day prior to and the day of chemotherapy (Group 3).
Initiating TNBC Pivotal Trial (1L and 2L Cohorts) in 1H 2021 Pivotal study evaluating trilaciclib in mTNBC (PD-L1 positive and negative patients) complements ongoing I-SPY 2 Phase 2 Neoadjuvant BC study GC on Days 1 and 8 every 21 days until progression trilaciclib + GC on Days 1 and 8 every 21 days until progression Cohort 2: 2L TNBC (post-checkpoint) Cohort 1: 1L TNBC (checkpoint naive) Strong evidence of efficacy across subsets and line of treatment in Phase 2 trial Evaluating 1L checkpoint-naïve and 2L checkpoint-experienced patients Randomization 1:1 PRIMARY ENDPOINT: Overall survival SECONDARY ENDPOINTS: PRO, myelopreservation measures, PFS/ORR TARGET ENROLLMENT: ~170 1L and ~80 2L participants
Initiating Two Additional Trilaciclib Phase 2 Trials in 1H 2021 Important future expansion areas for trilaciclib with data available in next 2 – 3 years Strong rationale for trilaciclib + chemo + I/O in 1L bladder cancer Known immunogenic tumor responsive to chemo + I/O Data suggests synergistic effect of trilaciclib + checkpoint1-3 Similar chemo as TNBC study (gemcitabine/platinum) Benefits of treating patients until progression Interim data expected in late 2022 Primary aim to evaluate anti-tumor efficacy Randomized open-label study design 2L / 3L NSCLC Study (post-checkpoint) 1L Bladder Study (anti-PD-L1 combination) Important area to demonstrate benefits of trilaciclib in post-checkpoint setting Known immunogenic tumor Trilaciclib mechanism is distinct from checkpoints High unmet need as treatment options limited in 2L / 3L Complementary commercial fit with SCLC indication Interim data expected in early 2023 Primary aim to evaluate anti-tumor efficacy Randomized double-blind study Lai et al., Journal for ImmunoTherapy of Cancer 2020; 8:e000847. doi:10.1136/jitc-2020-000847. Deng et al., Cancer Discov. 2018;8(2):216- 33. Daniel et al., 2019 European Society for Medical Oncology (ESMO), Abstract # 1742PD
2021 Key Objectives Obtain U.S. approval for ES-SCLC and successfully launch trilaciclib in 1Q Establish trilaciclib as Standard of Care for ES-SCLC patients in the U.S. Maximize long-term value of trilaciclib by executing robust development plan Evaluate partnership options for rintodestrant following combination data readout in 2Q Continue managing investor capital efficiently
Rintodestrant Demonstrates a Favorable Oral SERD* Profile Next steps will be evaluated following data readout expected in 2Q21 * SERD = Selective Estrogen Receptor Degrader 40-patient Phase 2 combination trial with CDK4/6 inhibitor palbociclib ongoing; data in 2Q21 Phase 2 combination data will be important to help secure partner to fund Phase 3 investment Fulvestrant is currently only SERD available Proven approach but painful intramuscular injections limit use to 2L and preclude use in earlier lines of therapy An oral SERD has potential to move into earlier lines of ER-positive breast cancer therapy Rintodestrant monotherapy Phase 1b findings to date: Favorable tolerability - AEs mostly Grade 1 or Grade 2 Strong ER target engagement/occupancy with evidence of anti-tumor activity in heavily pre-treated patients
2021 Key Objectives Obtain U.S. approval for ES-SCLC and successfully launch trilaciclib in 1Q Establish trilaciclib as Standard of Care for ES-SCLC patients in the U.S. Maximize long-term value of trilaciclib by executing robust development plan Evaluate partnership options for rintodestrant following combination data readout in 2Q Continue managing investor capital efficiently
~$207M cash at year-end 2020 provides runway into second half of 2022 Efficiently executing plan with lean organization of ~125 FTEs Utilizing capital efficient promotion arrangement with Boehringer Ingelheim for trilaciclib U.S. launch in SCLC Expect to leverage co-development opportunities with partner Simcere for potential cost and timing efficiencies Access to debt facility up to $100M total ($20M drawn to date) Potential future milestones (up to $486M) and royalties from licensing agreements Continue to Efficiently Manage Capital Efficiently managing capital with a lean organization and benefiting from existing partnership arrangements
Maximizing Value of Trilaciclib Expect ES-SCLC launch in 1Q 2021 and multiple data readouts to drive expansion and long-term growth ES-SCLC 1L CRC 2L / 3L NSCLC 1L Bladder Cancer REGISTRATIONAL TRIALS PHASE 2 STUDIES Other Tumors TBD Trilaciclib Opportunity + Milestones and Royalties Neoadjuvant Breast Cancer Myelopreservation Improved Survival (single agent) Improved Survival (combinations) 1L / 2L TNBC Data Readout: 1H 2023 Data Readout: 2H 2023 Data Readout: 1H 2023 Data Readout: 2H 2023 Data Readout: 2H 2022 Key Study Objective: POTENTIAL U.S. APPROVAL Launch: 1Q 2021