(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
(Address of principal executive offices) | (zip code) |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Title of each class | Trading Symbol | Name of each exchange on which registered | ||||||||||||
Exhibit No. | Description | ||||
99.1 | |||||
99.2 | |||||
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
G1 THERAPEUTICS, INC. | ||||||||
By: | /s/ Jennifer Moses | |||||||
Jennifer Moses | ||||||||
Chief Financial Officer | ||||||||
Date: November 2, 2022 |
September 30, 2022 | December 31, 2021 | ||||||||||
Cash and cash equivalents and Marketable securities | $122,982 | $221,186 | |||||||||
Working Capital | $120,331 | $215,952 | |||||||||
Total Assets | $166,573 | $254,094 | |||||||||
Accumulated deficit | $(698,369) | $(584,459) | |||||||||
Total stockholders' equity | $45,965 | $143,541 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
Revenues | |||||||||||||||||||||||
Product sales, net | $ | 8,269 | $ | 3,576 | $ | 22,467 | $ | 6,717 | |||||||||||||||
License revenue | 15,307 | 1,282 | 18,584 | 18,963 | |||||||||||||||||||
Total revenues | 23,576 | 4,858 | 41,051 | 25,680 | |||||||||||||||||||
Operating expenses | |||||||||||||||||||||||
Cost of goods sold | 1,111 | 591 | 2,756 | 1,642 | |||||||||||||||||||
Research and development | 19,581 | 21,143 | 66,729 | 56,435 | |||||||||||||||||||
Selling, general and administrative | 24,432 | 24,268 | 76,857 | 72,474 | |||||||||||||||||||
Total operating expenses | 45,124 | 46,002 | 146,342 | 130,551 | |||||||||||||||||||
Loss from operations | (21,548) | (41,144) | (105,291) | (104,871) | |||||||||||||||||||
Other income (expense) | |||||||||||||||||||||||
Interest income | 211 | 7 | 270 | 35 | |||||||||||||||||||
Interest expense | (2,764) | (934) | (7,436) | (2,609) | |||||||||||||||||||
Other income (expense) | 48 | (76) | (234) | (208) | |||||||||||||||||||
Total other income (expense), net | (2,505) | (1,003) | (7,400) | (2,782) | |||||||||||||||||||
Loss before income taxes | (24,053) | (42,147) | (112,691) | (107,653) | |||||||||||||||||||
Income tax expense | 1,219 | 321 | 1,219 | 679 | |||||||||||||||||||
Net loss | $ | (25,272) | $ | (42,468) | $ | (113,910) | $ | (108,332) | |||||||||||||||
Net loss per share, basic and diluted | $ | (0.59) | $ | (1.00) | $ | (2.67) | $ | (2.60) | |||||||||||||||
Weighted average common shares outstanding, basic and diluted | 42,799,342 | 42,383,573 | 42,731,826 | 41,740,911 |
Summary of treatment-emergent adverse events (TEAEs) (≥ 15% of patients) in patients receiving trilaciclib in combination with sacituzumab govitecan-hziy | Summary of TEAEs in patients receiving sacituzumab govitecan-hziy1 (Only includes TEAEs also reported in patients receiving trilaciclib and sacituzumab govitecan-hziy) | |||||||||||||||||||||||||
Phase 2 trial of trilaciclib in combination with sacituzumab govitecan-hziy TEAEs (n=18) | ASCENT TEAEs (no trilaciclib) (n=258) | |||||||||||||||||||||||||
Adverse Event | Any Grade | Grade 3-4 | Adverse Event | Any Grade | Grade 3-4 | |||||||||||||||||||||
Fatigue | 44% | 0% | Fatigue | 52% | 4% | |||||||||||||||||||||
Nausea | 39% | 0% | Nausea | 62% | <4% | |||||||||||||||||||||
Constipation | 28% | 0% | Constipation | 37% | <1% | |||||||||||||||||||||
Diarrhea | 28% | 0% | Diarrhea | 65% | 11% | |||||||||||||||||||||
Headache | 28% | 0% | Headache | 18% | 1% | |||||||||||||||||||||
Neutropenia | 22% | 17% | Neutropenia | 64% | 52% | |||||||||||||||||||||
Decreased Appetite | 22% | 0% | Decreased Appetite | 28% | 2% | |||||||||||||||||||||
Leukopenia | 17% | 17% | Leukopenia | 17% | 10% | |||||||||||||||||||||
Abdominal Pain Upper | 17% | 0% | Abdominal Pain Upper | 21% | 3% | |||||||||||||||||||||
Alopecia | 17% | 0% | Alopecia | 47% | 0% |
Summary of other relevant TEAEs in patients receiving trilaciclib in combination with sacituzumab govitecan-hziy | Summary of other relevant treatment-related adverse events (TRAEs) in patients receiving sacituzumab govitecan-hziy2 | |||||||||||||||||||||||||
Phase 2 trial of trilaciclib in combination with sacituzumab govitecan-hziy TEAEs (n=18) | ASCENT TRAEs (no trilaciclib) (n=258) | |||||||||||||||||||||||||
Adverse Event | Any Grade | Grade 3-4 | Adverse Event | Any Grade | Grade 3-4 | |||||||||||||||||||||
Anemia | 6% | 0% | Anemia | 34% | 8% | |||||||||||||||||||||
Febrile Neutropenia | 0% | 0% | Febrile Neutropenia | 6% | 6% | |||||||||||||||||||||
Thrombocytopenia | 0% | 0% | Thrombocytopenia | 5% | 2% |
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