The annual Russell US Indexes reconstitution captures the 4,000 largest US stocks as of Tuesday, April 30th, ranking them by total market capitalization. Membership in the US all-cap Russell 3000 Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000 Index or small-cap Russell 2000 Index as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings, and ...

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. According to the data as of the end of December 2023, about $10.5 trillion in assets are benchmarked against the Russell US indexes, which belong to FTSE Russell, a prominent global index provider. FTSE Russell is a leading global provider of benchmarking, analytics, and data solutions for investors, giving them a precise view of the market relevant to their ...

- PRESERVE 2 Did Not Achieve Statistical Significance in the Primary Endpoint of Overall Survival (OS) in the Intent-to-Treat (ITT) Population - - G1 is Sufficiently Funded to Achieve Anticipated Company Profitability in the Second Half of 2025 - RESEARCH TRIANGLE PARK, N.C., June 24, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced topline results from the final OS analysis of its Phase 3 PRESERVE 2 trial evaluating the efficacy and safety ...

- The Company Will Focus its Efforts on the Global Extensive-Stage Small Cell Lung Cancer (ES-SCLC) Market - - Management to Host Webcast and Conference Call Today at 8:30 AM ET - The study did not demonstrate a statistically significant treatment effect in the ITT population (n=187) with a hazard ratio (HR) of 0.91 (p=0.884). The median OS in the trilaciclib plus GCb arm was 17.4 months compared to 17.8 months in the control arm. Median OS numerically favored the trilaciclib arm in both PD-L1 subgroups (po ...

- New Positive Phase 2 Results in Metastatic Triple Negative Breast Cancer (mTNBC) Indicate That Use of Trilaciclib in Combination with a TROP2 ADC May Be Associated with Improved Median OS Compared to Historical Data for the ADC Alone - - Exploratory Analysis of a More Comparable Patient Population Showed an Approximately Six-Month Improvement in Median OS Among Patients Receiving Trilaciclib in Combination with the ADC Compared to Historical ADC Data - - Prolonged OS Observed in Patients Receiving Trilaci ...

RESEARCH TRIANGLE PARK, N.C., May 23, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that mature Phase 2 results describing the positive impact of trilaciclib administered in combination with the TROP2 antibody-drug conjugate (ADC) sacituzumab govitecan (SG) on overall survival (OS) and tolerability compared to SG alone based on historical data from the ASCENT trial will be presented in a poster session during the upcoming 2024 American So ...

RESEARCH TRIANGLE PARK, N.C., May 22, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (NASDAQ:GTHX), a commercial-stage oncology company, today announced that G1's Chief Medical Officer Dr. Raj Malik and Chief Commercial Officer Andrew Perry will participate in a fireside chat at TD Cowen's 5th Annual Oncology Innovation Summit: Insights for ASCO & EHA, on Wednesday, May 29, at 8:30AM EDT. The webcast of the event will be accessible on the Events & Presentations page of http://www.g1therapeutics.com. About G ...

RESEARCH TRIANGLE PARK, N.C. and SAN FRANCISCO, May 22, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (NASDAQ:GTHX), a commercial-stage oncology company, and Deimos Biosciences, a portfolio company of Jupiter Bioventures, announced a global licensing agreement (excluding the Asia-Pacific region) for lerociclib for radioprotective uses. Lerociclib is a potent and selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). Such inhibitors can increase the survival of animals exposed to radiation. Jupit ...

RESEARCH TRIANGLE PARK, N.C., May 01, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (NASDAQ:GTHX), a commercial-stage oncology company, today announced the grant of inducement stock options exercisable for 2,100 shares of G1's common stock and 1,050 restricted stock units (RSUs) to one hired employee under the Amended and Restated G1 Therapeutics, Inc. 2021 Inducement Equity Incentive Plan (the "Amended and Restated 2021 Plan"). These equity awards were granted as an inducement material to the new employee ...

PART I FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited Q1 2024 financial statements report a net loss of $10.2 million, with total assets at $102.0 million and sufficient liquidity for the next 12 months [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2024, total assets were $102.0 million, down from $121.5 million, primarily due to reduced cash and marketable securities Condensed Balance Sheet Data (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $19,887 | $32,218 | | Marketable securities | $45,299 | $49,938 | | Total current assets | $95,839 | $114,948 | | Total assets | $102,026 | $121,540 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $32,603 | $29,716 | | Loan payable, net of current portion | $37,147 | $51,557 | | Total liabilities | $74,287 | $86,154 | | Accumulated deficit | $(790,204) | $(779,985) | | Total stockholders' equity | $27,739 | $35,386 | | Total liabilities and stockholders' equity | $102,026 | $121,540 | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) Q1 2024 total revenues increased to $14.5 million, operating expenses decreased to $23.5 million, resulting in a net loss of $10.2 million Q1 2024 vs. Q1 2023 Statement of Operations (in thousands, except per share data) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Product sales, net | $14,079 | $10,492 | | License revenue | $397 | $2,454 | | **Total revenues** | **$14,476** | **$12,946** | | Cost of goods sold | $1,079 | $1,459 | | Research and development | $7,318 | $15,480 | | Selling, general and administrative | $15,127 | $21,753 | | **Total operating expenses** | **$23,524** | **$38,692** | | Loss from operations | $(9,048) | $(25,746) | | **Net loss** | **$(10,219)** | **$(27,595)** | | Net loss per share, basic and diluted | $(0.20) | $(0.53) | [Condensed Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity decreased to $27.7 million by March 31, 2024, primarily due to the $10.2 million net loss - The primary driver for the change in stockholders' equity during Q1 2024 was the net loss of **$10.2 million**[14](index=14&type=chunk) [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Q1 2024 saw net cash used in operations reduced to $8.9 million, with a net decrease in cash of $12.3 million Cash Flow Summary (in thousands) | Activity | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(8,898) | $(29,053) | | Net cash provided by investing activities | $5,289 | $2,910 | | Net cash used in financing activities | $(8,722) | $(214) | | **Net change in cash, cash equivalents and restricted cash** | **$(12,331)** | **$(26,357)** | | Cash, cash equivalents and restricted cash, end of period | $20,137 | $68,550 | [Notes to Unaudited Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) Notes detail business operations, accounting policies, financial instruments, loan covenants, and a new licensing agreement for lerociclib - The company's primary product is **COSELA® (trilaciclib)**, approved in the U.S. and China for myeloprotection in patients with extensive-stage small cell lung cancer (ES-SCLC)[19](index=19&type=chunk) - Management has evaluated its financial condition and concluded that its cash, cash equivalents, and marketable securities as of March 31, 2024, are **sufficient to fund planned operations for at least the next 12 months**, despite a history of net losses and an accumulated deficit of **$790.2 million**[22](index=22&type=chunk) - On April 30, 2024, the company entered into a licensing agreement with Pepper Bio, Inc. for lerociclib, which includes upfront payments and potential development and commercial milestones up to **$135.0 million**, plus double-digit royalties[117](index=117&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses COSELA® commercialization and pipeline advancement, with Q1 2024 showing increased product sales, reduced operating expenses, and sufficient liquidity [Overview](index=25&type=section&id=Overview) G1 Therapeutics focuses on commercializing COSELA® and expanding trilaciclib's applications, particularly in mTNBC and with ADCs - The company's primary commercial product is **COSELA® (trilaciclib)**, approved in the U.S. and China[120](index=120&type=chunk) - Core development paths for trilaciclib are focused on: (1) **triple negative breast cancer (TNBC)** and (2) combinations with **antibody-drug conjugates (ADCs)**[121](index=121&type=chunk) - Final overall survival (OS) results for the registrational Phase 3 trial of trilaciclib in mTNBC are expected in **late Q2 2024**[133](index=133&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20operations) Q1 2024 total revenues increased by 12% to $14.5 million, while operating expenses decreased by $15.2 million, significantly reducing the loss from operations Comparison of Operations (in thousands) | Line Item | Q1 2024 | Q1 2023 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Product sales, net | $14,079 | $10,492 | $3,587 | 34% | | License revenue | $397 | $2,454 | $(2,057) | -84% | | **Total revenues** | **$14,476** | **$12,946** | **$1,530** | **12%** | | Research and development | $7,318 | $15,480 | $(8,162) | -53% | | Selling, general and administrative | $15,127 | $21,753 | $(6,626) | -31% | | **Loss from operations** | **$(9,048)** | **$(25,746)** | **$16,698** | **-65%** | - The **$3.6 million (34%)** increase in net product sales was primarily due to increased sales volume from ongoing commercialization efforts[156](index=156&type=chunk) - R&D expenses decreased by **$8.2 million (53%)**, mainly due to a **$7.6 million** reduction in clinical program costs[159](index=159&type=chunk) - SG&A expenses decreased by **$6.7 million (31%)**, primarily due to reductions of **$3.7 million** in personnel costs and **$1.8 million** in commercialization activities[161](index=161&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2024, the company held $65.2 million in cash and marketable securities, deemed sufficient for 12 months, while complying with loan covenants - The company expects its cash, cash equivalents, and marketable securities of **$65.2 million** (as of March 31, 2024) to be **sufficient to fund planned operations for at least the next 12 months**[138](index=138&type=chunk)[164](index=164&type=chunk) - The company is required to comply with **financial covenants** under its Loan Agreement with Hercules, including a minimum cash requirement (**35% of outstanding debt**) and a conditional borrowing base tied to trailing three-month net product revenue[164](index=164&type=chunk)[170](index=170&type=chunk) - During Q1 2024, the company repaid **$8.2 million** in principal on its loan with Hercules The outstanding principal was **$41.8 million** as of March 31, 2024[171](index=171&type=chunk) Cash Flow Summary (in thousands) | Activity | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(8,898) | $(29,053) | | Net cash provided by investing activities | $5,289 | $2,910 | | Net cash used in financing activities | $(8,722) | $(214) | [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces interest rate risk on its cash, investments, and variable-rate loan, but does not anticipate a material impact from interest rate changes or inflation - The company has **interest rate risk** from its cash equivalents, marketable securities, and its variable-rate loan with Hercules[187](index=187&type=chunk)[188](index=188&type=chunk) - The interest rate on the Hercules loan is **variable**, equal to the greater of (prime + 5.65%) or **9.15%** As of March 31, 2024, **$41.8 million** of principal was outstanding[188](index=188&type=chunk) [Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2024, with no material changes to internal control over financial reporting - Management concluded that as of March 31, 2024, the company's disclosure controls and procedures were **effective at the reasonable assurance level**[191](index=191&type=chunk) - **No changes** occurred during Q1 2024 that have **materially affected**, or are reasonably likely to materially affect, the company's internal control over financial reporting[192](index=192&type=chunk) PART II OTHER INFORMATION [Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors were reported from those disclosed in the 2023 Annual Report on Form 10-K - There have been **no material changes** in the risk factors from those set forth in the 2023 Form 10-K[194](index=194&type=chunk) [Other Information](index=38&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, terminated, or modified Rule 10b5-1 trading arrangements during Q1 2024 - **No directors or officers** adopted, terminated, or modified a **Rule 10b5-1 trading arrangement** during Q1 2024[195](index=195&type=chunk) [Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including employment agreement amendments, certifications, and XBRL data