Developing and Delivering Next Generation Therapies that Improve the Lives of People Living with Cancer
May 2024
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," "could," "believe," "goal," "projections," "indicate," "potential," "opportunity," 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 expectations for the commercial success of COSELA® (trilaciclib), our ability to further develop and expand the use of COSELA in the treatment of extensive-stage small cell lung cancer, the therapeutic potential of trilaciclib in the treatment triple-negative breast cancer ("TNBC") and with ADCs, that trilaciclib's greatest effect is on longer term endpoints including overall survival ("OS"), that trilaciclib may improve long-term immune surveillance for additional benefit after treatment, the expectation that achievement of the OS endpoint in the ongoing PRESERVE 2 Phase 3 clinical trial is expected to enable global regulatory submissions in 2024 and beyond, that G1's cash runway is expected to extend into the third quarter of 2025, global expansion, and that achieving the OS primary endpoint in the Phase 3 TNBC trial may serve as a catalyst for global expansion plans. In addition, COSELA may not achieve the degree of market acceptance for commercial success, the potential to demonstrate trilaciclib + gem/carbo as 1L TNBC standard of care, and the impact of pandemics such as COVID-19 (coronavirus), are based on our expectations and assumptions as of the date of this presentation. Each of these forward-looking statements involves risks and uncertainties that may cause our actual results to materially differ from those expressed or implied in such statements. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Applicable risks and uncertainties are discussed in our filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, our ability to successfully commercialize COSELA; the dependence on the commercial success of COSELA; our ability to complete clinical trials for, obtain approvals for, and commercialize additional indications of COSELA and any of our product candidates other than COSELA; our initial success in 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; chemotherapy shortages and market conditions. Except as required by law, we assume no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
G1Therapeutics® and G1Therapeutics logo and COSELA® and COSELA logo are trademarks of G1 Therapeutics, Inc. ©2024 G1 Therapeutics, Inc.
2
G1 Therapeutics: Opportunities for Significant Growth
Unique Marketed Product in | • Novel product that provides meaningful patient benefits via transient G1 arrest of HSPCs and T-Cells |
U.S. with Growing Revenue | • Established U.S. commercial infrastructure with growing revenue in initial ES-SCLC indication |
Potential to Transform | • Late 2Q24 (est.) Phase 3 final readout would provide important potential global commercial opportunity |
1L TNBC Treatment | • Robust OS observed in randomized Phase 2 with improvement continuing with subsequent therapies |
Opportunity to Improve Safety | • Phase 2 with sacituzumab govitecan serves as proof-of-concept for trilaciclib in TROP2 ADC combinations |
and Efficacy of Leading ADCs | • Following compelling initial results in January, mature efficacy results to be presented at ASCO 2024 |
Positioned for Global | • Evaluating additional late-stage studies and conducting research into next generation products |
• Planning to secure a partner for global expansion on a successful 1L TNBC readout | |
Expansion and Future Growth | |
• Anticipated cash runway into 3Q 2025 | |
Note: HSPCs: Hematopoietic stem and progenitor cells, ES-SCLC: Extensive Stage Small Cell Lung Cancer, 1L: First line, TNBC: Triple negative breast cancer; OS: overall survival, ADC: antibody-drug conjugate,
ASCO: American Association of Clinical Oncology
3
Agenda
Unique Marketed Product in U.S. with Growing Revenue
Potential to Transform 1L TNBC Treatment
Opportunity to Improve Safety and Efficacy of Leading ADCs
Positioned for Global Expansion and Future Growth
4
Trilaciclib Mechanism of Action
Temporarily Blocks Progression through Cell Cycle Via Transient CDK4/6 Inhibition
M
G2 HSPCs
Myeloid Lineages
Lymphoid Lineages G1
S | Transiently arrests HSPCs |
and T cells in G1 Phase |
Potential Benefits
Protects Bone Marrow and Immune System from | Improves Long-Term Immune Surveillance |
Cytotoxic Damage During Treatment | for Additional Benefit After Treatment |
5
Unique Product Attributes for Robust Transient G1 Arrest
Critical Characteristics of Trilaciclib Enabling Robust Transient G1 Arrest
IV administration
Precisely timed effect through
rapid IV onset
Potent and selective
CDK4 and CDK6 inhibition
Robust G1 arrest through
targeted activity
Short half-life
Optimizes ability for T-cells
to proliferate
These attributes are critical to maximize the benefits of transient CDK4/6 inhibition
6
Potential for Strong Growth within U.S. ES-SCLC Market
~20K ES-SCLC Patients in U.S. Receive Indicated Chemotherapy | Satisfaction with COSELA® (trilaciclib)4 | ||||||||||
100% | 4% | ||||||||||
5% | 14% | ||||||||||
75% | |||||||||||
High satisfaction among active | 50% | ||||||||||
~13% Market | prescribers driven by fewer | 91% | 86% | ||||||||
Penetration2 | hospitalizations and protection of | ||||||||||
multiple cell lineages3 | 25% | ||||||||||
$700M+ Market | 0% | ||||||||||
Opportunity1 | % of Oncologists | % of NP/PAs | |||||||||
Very Satisfied / | Neutral | Very Dissatisfied / | |||||||||
Satisfied | Dissatisfied |
Meaningful opportunity to continue growing share in $700M+ U.S. ES-SCLC market,
with high levels of satisfaction expressed by existing prescribers
- Based on ~20k patients and $36,600 current WAC pricing for 24 vials of trilaciclib (assumed 4 cycles per patient based on standard 1L ES-SCLC chemotherapy regimens)
- 1L market penetration as of 1Q 2024
- According to active prescriber data from internal ATU Tracking Studies, Q3 2023, which is further supported by Real World Evidence
4. Prescriber data from internal ATU Tracking Studies, Q3 2023 | 7 |
Strong COSELA Growth Expected in 2024
1Q24 Highlights
- $14.1M in net COSELA sales
- 4% quarterly vial volume growth; 33% growth over 1Q23
- Localized/regional variability masked strong execution and growth
- 30% growth in West region
- 20% growth in customers covered by Strategic accounts
- Enhanced and added new contracted customers
- Added three new top 100 accounts through April (78 total)
- 63 top 100 accounts ordered during quarter; highest since launch
April 2024 Highlights
- Highest volume & ex factory sales month since launch
- ~30% growth by large customers with slow start to 1Q24
- Double digit growth in contracted customers
Sales trends support confidence in COSELA net sales guidance of $60M to $70M
8
Potential for Future Development and Expansion in ES-SCLC
Expected Future Data in ES-SCLC
Lurbinectedin | Topotecan | Real World | |
Combination | Combination Post- | ||
Evidence | |||
(Phase 2) | Marketing Study | ||
Setting | 2L ES-SCLC | 2L ES-SCLC | 1L/2L ES-SCLC |
Combination | Lurbinectedin | Topotecan | Chemotherapy |
Target | ~30 Patients | ~300 Patients | NA |
Enrollment | |||
Evaluating | Evaluating overall | Evaluating OS | |
Details | myeloprotection | from U.S. | |
survival ("OS") | |||
and efficacy | Claims data | ||
Sponsor | UNC | G1 | G1 |
Lineberger | |||
Ongoing clinical studies and real-world-evidence will help guide
future development and expansion efforts in ES-SCLC
1. Huan et al., Assessment of Hospitalizations and Cytopenia Events Among Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Chemotherapy with Trilaciclib; ASCO Quality Care Symposium, October 2023, Abstract 531
9
Agenda
Unique Marketed Product in U.S. with Growing Revenue
Potential to Transform 1L TNBC Treatment
Opportunity to Improve Safety and Efficacy of Leading ADCs
Positioned for Global Expansion and Future Growth
10
Attachments
- Original Link
- Original Document
- Permalink
Disclaimer
G1 Therapeutics Inc. published this content on 08 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 08 May 2024 12:35:01 UTC.