COSELA Kickoff Analyst & Investor Summit Presentation
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COSELATM Kickoff Analyst & Investor Summit April 9, 2021 1 Forward-Looking Statements 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 COSELA™(trilaciclib), COSELA may fail to achieve the degree of market acceptance for commercial success, COSELA’s possibility to improve patient outcomes across multiple indications, 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 a successful commercial launch for COSELA (trilaciclib), the company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates other than COSELA; 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 commercial-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking G1TherapeuticsTM and G1Therapeutics logo, G1 to One™ and the G1 to One logo, and COSELATM and COSELA logo are trademarks of G1 Therapeutics, Inc. ©2021 G1 Therapeutics, Inc. 2 Agenda Welcome Educating Physicians on COSELA’s Will Roberts, Vice President, Investor Relations Clinical & Cost Benefits & Corporate Communications Marc Chioda, PharmD, Vice President, Medical Affairs Introduction to COSELA™ (trilaciclib) Moderated Expert Panel Jack Bailey, Chief Executive Officer Jared Weiss, MD Tajuana Bradley, MS, FNP-BC COSELA Commercial Strategy and Moderator: Marc Chioda, PharmD U.S. Launch Update Soma Gupta, Chief Commercial Officer Q&A Marc Chioda, PharmD, Vice President, Medical Affairs G1 Management Evan Hicks, Vice President, Marketing Closing COSELA Brand Strategy Jack Bailey, Chief Executive Officer Evan Hicks, Vice President, Marketing 3 Introduction to COSELA™ (trilaciclib) Jack Bailey Chief Executive Officer 4 COSELA is a Potential Cornerstone Therapy First and only proactive multilineage myeloprotection therapy to decrease the incidence of chemotherapy-induced myelosuppression Approved in U.S. for treatment of patients with extensive-stage small cell lung cancer receiving chemotherapy Pipeline-in-a-molecule development opportunity Tumor agnostic development program $207M cash on hand (as of December 31, 2020) Additional $86.4M in net proceeds from ATM during 1Q21 Focused on maximizing the development and commercialization of COSELA 5 Chemo to Remain Mainstay Therapy Despite Shortcomings Over 1 million cancer patients receive chemo in North America 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 improved results in many tumors Two Critical Areas of Unmet Need Proactively reducing the damaging Meaningfully improving overall consequences of chemotherapy survival in broad populations High unmet need for new therapies that can significantly reduce myelosuppression and meaningfully improve overall survival across patient populations 6 COSELA: Novel Approach Designed to Address Shortcomings of Chemo COSELA Transient IV CDK4/6 inhibitor Temporarily blocks progression through the cell cycle Leads to multiple potential downstream effects Helps protect HSPCs and myeloid and lymphoid cell Ability to improve the immune response when lineages from damage caused by chemotherapy1-3 administered with chemotherapy4-9 Neutrophils T-lymphocytes Enhances T-cell activation Erythrocytes B-lymphocytes Favorably alters tumor microenvironment Platelets 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. 7 COSELA A Pipeline-in-a-Molecule Myeloprotection Impact1-5 Anti-Tumor Efficacy6-11 ▪ Reduced rate of hematologic adverse Helps protect ▪ Increased patients’ ability to receive longer events (less neutropenia, anemia, myeloid cell duration of chemotherapy-based regimens thrombocytopenia) lineages Helps protect ▪ Decreased rescue interventions and costs ▪ Protected the immune system from lymphoid cell damage by chemotherapy (less transfusions, G-CSF, hospitalizations) lineages ▪ Improved aspects of patients’ quality Ability to improve ▪ Enhanced T-cell activation and favorably of life immune response alters the tumor microenvironment Approved as myeloprotective therapy in ES-SCLC with most common chemotherapy regimens; increased anti-tumor efficacy being evaluated in additional trials 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., 8 2020 San Antonio Breast Cancer Symposium (SABCS), Poster #PD1-06. Significant Expansion Opportunities for COSELA Myeloprotection Anti-Tumor Efficacy Improving efficacy of immunotherapy Preserving / activating and chemo combinations: Protecting the bone marrow from the the immune system: damaging consequences of − With PD-1/PD-L1 inhibitors − Alternative to I/O treatment myelotoxic chemo: − With other immunotherapies − Following I/O treatment − Common SCLC regimens* − In tumors less responsive to I/O 3 − 5-FU based regimens Improved Survival (combinations) − Other myelotoxic regimens Improved Survival (single agent) 2 Myeloprotection1 + Chemo Backbone * Approved; launched in U.S. in ES-SCLC in 1Q 2021 Optimizing development plan across three core growth platforms will enable COSELA to benefit as many patients as possible 1. Shown in pivotal trials in ES-SCLC; being explored in pivotal trial in 1L CRC. 2. To be/being explored in trials in 1L CRC (pivotal), 1L/2L TNBC (pivotal), neoadjuvant breast cancer (Ph2), and 2L/3L NSCLC (Ph2). 3. To be explored in trial in 1L bladder cancer (Ph2). 9 Pipeline-in-a-Molecule Opportunity Beyond ES-SCLC Launch Investigator Sponsored + Milestones and Studies (ISS) Royalties Key Study Objective: Phase 2 Trials Multiple Myeloprotection Cancers Other Initiating in Improved Survival (single agent) Tumors TBD 2021 Improved Survival (combinations) 1L Bladder Cancer 2L / 3L Initiating in NSCLC 1H 2021 COSELA Registrational Trials Neoadjuvant Initiating in Opportunity Breast Cancer 1H 2021 Initiated in 1L / 2L TNBC 2020 LAUNCHED IN Initiating in 1L CRC U.S. in 1Q 2021 1H 2021 Initiated in ES-SCLC 2020 Investigational trials Aggressively pursuing development in areas of high strategic importance where COSELA is most likely to provide meaningful benefits to patients 10 Approved by U.S. Food and Drug Administration to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC) 11 COSELA Commercial Strategy and U.S. Launch Update Soma Gupta Chief Commercial Officer Marc Chioda, PharmD Vice President, Medical Affairs Evan Hicks Vice President, Marketing 12 CONFIDENTIAL NASDAQ: GTHX Why the Market Needs COSELA 13 Small Cell Lung Cancer (SCLC) Overview A Devastating, Aggressive Type of Lung Cancer Demographics Outcomes Median Age at 5-year Survival 69 Diagnosis 3% for ES-SCLC SCLC Patients Male:Female Experience Grade 1.0 : 1.1 Ratio >48% 3/4 Neutropenia of SCLC Deaths Develop Grade Attributed to 3/4 Anemia in 1L >80% Smoking >22% “[Upon hearing the diagnosis,] I was absolutely crushed, devastated beyond belief. I didn’t speak to anyone for two months. I couldn't speak without crying. “It was sad to see her start treatment, but As far as my husband, he didn't hear anything after the also that this is what we're going to do as the 1st sentence.