Financial Data and Key Metrics Changes - Net sales of COSELA for Q1 2024 were $14.1 million, a 34% increase from $10.5 million in Q1 2023 [16] - Total revenue for Q1 2024 was $14.5 million, compared to $12.9 million in Q1 2023 [16] - Operational cash burn for the quarter totaled approximately $8 million, with an expected year-end cash balance of $50 million to $60 million [17][18] Business Line Data and Key Metrics Changes - Overall vial volume growth was 4% compared to Q4 2023, attributed to fewer new patients added during the holiday period [8][58] - The company added over 50 new accounts, maintaining a patient share of around 13% in the first-line market [66][92] - Significant growth was observed in the strategic accounts function, which grew over 20% during the quarter [65] Market Data and Key Metrics Changes - The company added two new top 100 customers during Q1, bringing the total to 78 out of the top 100 that have ordered COSELA [11][92] - The West Region saw almost 13% growth, with three territories growing more than 15% [91] Company Strategy and Development Direction - The company aims to build category leadership in triple-negative breast cancer (TNBC) and is focused on upcoming data readouts from ongoing trials [59][99] - The strategy includes expanding the usage of COSELA in extensive-stage small cell lung cancer and enhancing existing contracts [4][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the 2024 net sales guidance of $60 million to $70 million despite short-term challenges [58][99] - The company anticipates a cash runway extending into Q3 2025, including costs related to TNBC filing and launch [18][71] Other Important Information - The company out-licensed global rights to lerociclib to Pepper Bio, expecting upfront payments and milestone payments totaling up to $135 million [98] - The final results from the Phase 3 PRESERVE 2 trial are expected late in Q2 2024, with plans for a supplemental NDA filing if results are positive [14][73] Q&A Session Summary Question: What were the challenges faced in Q1 regarding patient enrollment? - Management noted that the slow start in patient enrollment was due to the holiday period affecting new patient additions, but they are confident in improving execution moving forward [75] Question: How will the inclusion of Ukrainian patients affect the trial data? - Management confirmed that the FDA recommended including events from Ukrainian patients in the overall survival analysis, which may impact the timeline for results [25][68] Question: What is the expected chemotherapy treatment duration for TNBC patients compared to lung cancer? - The median number of chemotherapy cycles for TNBC is around eight, with a cumulative dose significantly higher when combined with trilaciclib [45] Question: How does the company plan to address accounts not currently using COSELA? - The company continues to add top accounts and leverage real-world evidence to drive adoption among those not currently using COSELA [27] Question: What is the market share for COSELA in second-line settings? - Approximately 90% of COSELA's use is in the first-line setting, with about 10% in second-line settings, indicating a consistent market share across both [121]

G1 Therapeutics (GTHX) came out with a quarterly loss of $0.20 per share versus the Zacks Consensus Estimate of a loss of $0.19. This compares to loss of $0.53 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -5.26%. A quarter ago, it was expected that this company would post a loss of $0.27 per share when it actually produced a loss of $0.21, delivering a surprise of 22.22%.Over the last four quarters, the company has surpasse ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 1, 2024 G1 THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 001-38096 26-3648180 (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.) 700 Park Offices Drive Suite 200 Research Triangle Park, NC 27709 (Add ...

- Achieved $14.1 Million in Net Revenue from Sales of COSELA® (trilaciclib) for First Quarter 2024 - - Reaffirmed 2024 Net COSELA Revenue Guidance of $60 to $70 Million - - Announced That Updated Efficacy Results from Phase 2 Trial of Trilaciclib in Combination with a TROP2 Antibody-Drug Conjugate (ADC) Will Be Presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting - - Announced That Final Analysis of Phase 3 PRESERVE 2 Trial Evaluating Overall Survival in 1L Metastatic Triple Neg ...

RESEARCH TRIANGLE PARK, N.C., April 17, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (NASDAQ:GTHX), a commercial-stage oncology company, will host a webcast and conference call to provide a financial and corporate update for the first quarter of 2024 on Wednesday May 1, 2024, at 8:30 a.m. ET. To register for the event and receive a dial in number and unique PIN to access the live conference call, please follow this link to register online. While not required, it is recommended that you join 10 minutes pri ...

RESEARCH TRIANGLE PARK, N.C., April 17, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, will host a webcast and conference call to provide a financial and corporate update for the first quarter of 2024 on Wednesday May 1, 2024, at 8:30 a.m. ET. To register for the event and receive a dial in number and unique PIN to access the live conference call, please follow this link to register online. While not required, it is recommended that you join 10 minutes pr ...

RESEARCH TRIANGLE PARK, N.C., April 04, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (NASDAQ:GTHX), a commercial-stage oncology company, today announced that G1's Chief Executive Officer Jack Bailey will provide a corporate presentation during the 23rd Annual Needham Virtual Healthcare Conference on Thursday, April 11, 2024, at 8:45 AM ET. The webcast of the event will be accessible on the Events & Presentations page of https://www.g1therapeutics.com/. About G1 TherapeuticsG1 Therapeutics, Inc. is a comme ...

[PART I](index=6&type=section&id=PART%20I) [Business](index=6&type=section&id=Item%201.%20Business) G1 Therapeutics is a commercial-stage biopharmaceutical company focused on developing and commercializing COSELA® (trilaciclib) for myeloprotection, with strategic expansion into TNBC and ADC combinations - G1 Therapeutics is a commercial-stage biopharmaceutical company focused on developing and commercializing novel small molecule therapeutics for cancer treatment, with **COSELA® (trilaciclib)** as its first FDA-approved product[18](index=18&type=chunk) - COSELA is the first and only therapy indicated to proactively protect bone marrow from chemotherapy damage, approved in the U.S. and China[18](index=18&type=chunk) - The core development strategy for trilaciclib focuses on **triple-negative breast cancer (TNBC)** and combinations with **antibody-drug conjugates (ADCs)**[19](index=19&type=chunk)[27](index=27&type=chunk) - The product portfolio includes trilaciclib, lerociclib, and a CDK2 inhibitor, with lerociclib and the CDK2 inhibitor having been out-licensed[25](index=25&type=chunk)[72](index=72&type=chunk)[73](index=73&type=chunk) [Development Pipeline and Clinical Trials](index=8&type=section&id=Development%20Pipeline%20and%20Clinical%20Trials) The development pipeline focuses on trilaciclib, with ongoing registrational Phase 3 trials in mTNBC (PRESERVE 2) and a post-marketing trial in 2L ES-SCLC, alongside completed trials including a discontinued Phase 3 in CRC Trilaciclib Development Pipeline Highlights | Indication | Phase / Status | Key Milestone | Primary Endpoint(s) | | :--- | :--- | :--- | :--- | | 1L metastatic TNBC (PRESERVE 2) | Registrational Phase 3 (enrollment complete) | Final OS analysis expected in 3Q 2024 | Overall Survival (OS) | | ADC combination in mTNBC | Phase 2 (enrollment complete) | Additional survival results expected mid-2024 | Progression-Free Survival (PFS) | | 1L Bladder cancer (mUC) | Phase 2 (trial complete) | Results to be presented at a future medical meeting | PFS | | 1L metastatic Colorectal cancer (CRC) | Phase 3 (trial discontinued) | Results announced in February 2023 | Co-primary: Severe neutropenia measures | - The pivotal Phase 3 PRESERVE 2 trial in mTNBC completed enrollment in October 2022, with final OS analysis expected in **Q3 2024** after an interim analysis did not meet early stopping criteria[57](index=57&type=chunk)[58](index=58&type=chunk) - The Phase 3 PRESERVE 1 trial in colorectal cancer was discontinued in February 2023 due to early anti-tumor efficacy data favoring the placebo arm, despite meeting myeloprotection endpoints[51](index=51&type=chunk)[52](index=52&type=chunk) - A post-marketing trial in 2L ES-SCLC with topotecan was initiated in October 2023 to evaluate survival outcomes as a condition of marketing approval[26](index=26&type=chunk)[65](index=65&type=chunk) [Commercialization and Market Opportunity](index=8&type=section&id=Commercialization%20and%20Market%20Opportunity) COSELA launched commercially in the U.S. in March 2021 for ES-SCLC, supported by NCCN/ASCO guidelines and a permanent J-code, with estimated addressable markets exceeding $700 million for ES-SCLC and $1 billion for mTNBC - COSELA became commercially available in the U.S. on **March 2, 2021**, following its FDA approval on February 12, 2021[23](index=23&type=chunk) - The estimated total addressable U.S. market for trilaciclib exceeds **$700 million** for ES-SCLC and **$1 billion** for metastatic TNBC[35](index=35&type=chunk) - COSELA is included in NCCN and ASCO clinical practice guidelines, and CMS has issued a permanent J-code for standardized insurance claims and payment[75](index=75&type=chunk) [Intellectual Property](index=18&type=section&id=Intellectual%20Property) The company's intellectual property portfolio includes over 385 global patent applications, with trilaciclib's composition-of-matter patents expiring in 2031 (potentially extended to 2034/2035) and method-of-use patents expiring between 2034 and 2042 - As of December 31, 2023, the patent estate includes over **385 granted or pending patent applications worldwide**, with more than **55 granted U.S. patents**[83](index=83&type=chunk) - Trilaciclib's composition-of-matter patents are expected to expire in **2031**, with a potential patent term extension to **December 2034 or February 2035** if granted[87](index=87&type=chunk)[88](index=88&type=chunk) - Patents covering methods of use for trilaciclib will expire between **2034 and 2039**, with pending applications potentially extending to **2042**[87](index=87&type=chunk)[89](index=89&type=chunk)[92](index=92&type=chunk) [License Agreements](index=21&type=section&id=License%20Agreements) G1 Therapeutics holds key out-licensing agreements, including an exclusive license with Simcere for trilaciclib in Greater China (amended for a $30 million payment), Genor Biopharma for lerociclib in Asia-Pacific, and Incyclix for a CDK2 inhibitor, while a previous EQRx agreement for lerociclib was terminated - An exclusive license agreement with Simcere for trilaciclib in Greater China was amended in April 2023, resulting in a one-time **$30.0 million payment** in exchange for waiving future royalty payments[105](index=105&type=chunk)[106](index=106&type=chunk) - An exclusive license with Genor Biopharma covers the development and commercialization of lerociclib in various Asia-Pacific territories[108](index=108&type=chunk) - The exclusive license agreement with EQRx for lerociclib in the U.S., Europe, and Japan was terminated by EQRx on **August 1, 2023**[115](index=115&type=chunk)[117](index=117&type=chunk) [Government Regulation](index=23&type=section&id=Government%20Regulation) The company operates under extensive FDA and global regulations, including the FDC Act, PREA, Hatch-Waxman, Anti-Kickback Statute, and pricing pressures from the Inflation Reduction Act, while also complying with data privacy laws like HIPAA, CCPA/CPRA, and GDPR - COSELA received a **5-year New Chemical Entity (NCE) exclusivity period** upon its approval in February 2021, expiring on **February 12, 2026**[188](index=188&type=chunk) - The company is subject to healthcare cost-containment measures, including the **Inflation Reduction Act of 2022 (IRA)**, which allows CMS to negotiate drug prices and imposes rebates for price increases exceeding inflation[147](index=147&type=chunk) - The company must comply with complex data privacy laws, including **HIPAA**, the **California Consumer Privacy Act (CCPA)**, and **Europe's General Data Protection Regulation (GDPR)**[172](index=172&type=chunk)[173](index=173&type=chunk)[176](index=176&type=chunk) [Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks, primarily its near-total dependence on COSELA's commercial success, including market acceptance, pricing, competition, a history of losses requiring additional funding, development delays, reliance on third parties, and intellectual property protection challenges - The company depends almost entirely on the commercial success of **COSELA** and may fail to achieve necessary market acceptance[207](index=207&type=chunk)[212](index=212&type=chunk) - The company has a history of significant operating losses, with a **$48.0 million loss in 2023** and an accumulated deficit of **$780.0 million** as of December 31, 2023, necessitating substantial additional funding[207](index=207&type=chunk)[238](index=238&type=chunk)[243](index=243&type=chunk) - Reliance on third parties for COSELA manufacturing and clinical trials increases risks related to supply chain disruptions, quality control, and trial execution[210](index=210&type=chunk)[343](index=343&type=chunk)[349](index=349&type=chunk) - Risks exist in protecting intellectual property, including potential patent challenges, litigation, and the development of similar competitor products[210](index=210&type=chunk)[366](index=366&type=chunk) [Unresolved Staff Comments](index=84&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - None[407](index=407&type=chunk) [Cybersecurity](index=84&type=section&id=Item%201C.%20Cybersecurity) The company maintains a cybersecurity program based on the NIST framework, with Board oversight and management-led risk mitigation, and has not experienced any material cybersecurity incidents in the last three fiscal years - Cybersecurity policies and practices are based on recognized frameworks from the **National Institute of Standards and Technology (NIST)**[408](index=408&type=chunk) - The Board of Directors, primarily through its audit committee, provides oversight of cybersecurity risk, with management leading daily risk management processes[416](index=416&type=chunk)[419](index=419&type=chunk) - No material cybersecurity incidents have been experienced in the last three fiscal years[415](index=415&type=chunk) [Properties](index=86&type=section&id=Item%202.%20Properties) The corporate headquarters is a leased 60,000 sq ft facility in Research Triangle Park, NC, with the lease expiring in September 2027, and a portion subleased effective January 2024 - The corporate headquarters is a leased facility of approximately **60,000 sq. ft.** in Research Triangle Park, NC, with the lease expiring in **September 2027**[420](index=420&type=chunk) - A sublease agreement for the third floor of the headquarters became effective **January 1, 2024**, through **August 31, 2027**[420](index=420&type=chunk) [Legal Proceedings](index=86&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently subject to any material pending legal proceedings - The company is not currently a party to any material legal proceedings[421](index=421&type=chunk) [Mine Safety Disclosures](index=86&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[422](index=422&type=chunk) [PART II](index=87&type=section&id=PART%20II) [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=87&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on the Nasdaq Global Select Market under "GTHX", with approximately 10 stockholders of record as of February 2024, and no equity repurchases in fiscal year 2023 - The company's common stock trades on the **Nasdaq Global Select Market** under the symbol **"GTHX"**[424](index=424&type=chunk) - As of **February 26, 2024**, there were approximately **10 stockholders of record**[425](index=425&type=chunk) - The company did not purchase any of its equity securities during fiscal year 2023[431](index=431&type=chunk) [[Reserved]](index=88&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=88&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In fiscal year 2023, G1 Therapeutics reported total revenues of **$82.5 million** (up 61%), driven by COSELA sales and a **$30 million** Simcere payment, while operating expenses decreased by **35%** to **$122.0 million**, narrowing the net loss to **$48.0 million**, with **$82.1 million** in cash sufficient for the next 12 months Financial Highlights (2023 vs. 2022) | Metric | 2023 (in millions) | 2022 (in millions) | Change (%) | | :--- | :--- | :--- | :--- | | Product sales, net | $46.3 | $31.3 | +48% | | License revenue | $36.2 | $20.0 | +81% | | **Total revenues** | **$82.5** | **$51.3** | **+61%** | | R&D Expenses | $43.7 | $83.3 | -48% | | SG&A Expenses | $71.1 | $100.4 | -29% | | **Total operating expenses** | **$122.0** | **$187.5** | **-35%** | | **Net loss** | **$(48.0)** | **$(147.6)** | **+67%** | - As of December 31, 2023, cash, cash equivalents, and marketable securities totaled **$82.1 million** ($32.2 million cash + $49.9 million marketable securities)[434](index=434&type=chunk)[568](index=568&type=chunk) - Management expects existing cash, cash equivalents, and marketable securities are sufficient to fund planned operations for at least the next **12 months**[494](index=494&type=chunk) [Results of Operations](index=95&type=section&id=Results%20of%20Operations) For 2023, net product sales of COSELA grew **48%** to **$46.3 million**, license revenue increased **81%** to **$36.2 million** (including a **$30 million** Simcere payment), R&D expenses decreased **48%** to **$43.7 million**, and SG&A expenses fell **29%** to **$71.1 million**, resulting in a net loss of **$48.0 million** - **2023 vs. 2022:** Net product sales increased by **$15.0 million (48%)** due to higher sales volume[478](index=478&type=chunk) - **2023 vs. 2022:** License revenue increased by **$16.2 million (81%)**, primarily due to a one-time **$30.0 million payment** from Simcere[479](index=479&type=chunk) - **2023 vs. 2022:** R&D expenses decreased by **$39.6 million (48%)**, mainly from a **$37.3 million reduction** in clinical program costs[481](index=481&type=chunk) - **2023 vs. 2022:** SG&A expenses decreased by **$29.3 million (29%)**, driven by reductions in commercialization activities (**$14.6 million**) and personnel costs (**$10.1 million**)[482](index=482&type=chunk) [Liquidity and Capital Resources](index=99&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2023, the company held **$82.1 million** in cash and equivalents, with an accumulated deficit of **$780.0 million**, and while current capital is sufficient for the next 12 months, additional long-term financing will be required, alongside a **$50.0 million** outstanding loan with Hercules Capital amended in June 2023 - The company had an accumulated deficit of **$780.0 million** as of December 31, 2023[494](index=494&type=chunk) - A loan agreement with Hercules Capital had **$50.0 million** outstanding as of December 31, 2023, and was amended in June 2023 to repay **$25.0 million** of debt and adjust covenants[505](index=505&type=chunk) - The company has an effective shelf registration statement (Form S-3) for up to **$300.0 million** in securities and an "at-the-market" (ATM) offering agreement for up to **$100.0 million**, with no shares sold to date[497](index=497&type=chunk)[498](index=498&type=chunk)[499](index=499&type=chunk) Contractual Obligations as of December 31, 2023 | Obligation Type | Total (in thousands) | Less than 1 Year | 1 to 3 Years | 3 to 5 Years | | :--- | :--- | :--- | :--- | :--- | | Operating lease obligations | $6,534 | $1,679 | $3,498 | $1,357 | | Long-term debt obligation (incl. interest) | $69,876 | $9,008 | $60,868 | $0 | | **Total** | **$76,410** | **$10,687** | **$64,366** | **$1,357** | [Quantitative and Qualitative Disclosures About Market Risk](index=104&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks stem from interest rate exposure on its cash, equivalents, marketable securities, and a variable-rate loan with Hercules Capital, while foreign currency and inflation risks are currently not considered significant - The company is exposed to interest rate risk on its cash, cash equivalents, and marketable securities, totaling **$82.1 million** as of December 31, 2023[525](index=525&type=chunk) - Market risk exposure exists from the variable interest rate loan with Hercules Capital, with **$50.0 million** of principal outstanding as of December 31, 2023[526](index=526&type=chunk) - Inflation and foreign currency exchange rate risks are not believed to have had a material effect on the business[527](index=527&type=chunk) [Financial Statements and Supplementary Data](index=105&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) Audited financial statements for 2023 show total assets of **$121.5 million** (down from **$188.0 million** in 2022), total liabilities of **$86.2 million** (down from **$119.2 million**), and total stockholders' equity of **$35.4 million**, with a net loss of **$48.0 million** (or **$0.93 per share**), a significant improvement from 2022 Key Balance Sheet Data (as of Dec 31) | (in thousands) | 2023 | 2022 | | :--- | :--- | :--- | | Cash, cash equivalents, and marketable securities | $82,156 | $145,070 | | Total Assets | $121,540 | $187,965 | | Loan Payable | $51,557 | $77,015 | | Total Liabilities | $86,154 | $119,218 | | Total Stockholders' Equity | $35,386 | $68,747 | Key Statement of Operations Data (Year Ended Dec 31) | (in thousands, except per share data) | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | | Total Revenues | $82,511 | $51,301 | $31,476 | | Total Operating Expenses | $122,038 | $187,479 | $173,933 | | Loss from Operations | $(39,527) | $(136,178) | $(142,457) | | Net Loss | $(47,967) | $(147,559) | $(148,352) | | Net Loss Per Share | $(0.93) | $(3.38) | $(3.54) | [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=105&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) This item is not applicable to the company - Not Applicable[529](index=529&type=chunk) [Controls and Procedures](index=105&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures and internal control over financial reporting were effective as of December 31, 2023, with no material changes during Q4 2023 - Management concluded that the company's disclosure controls and procedures were effective as of **December 31, 2023**[531](index=531&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of **December 31, 2023**[533](index=533&type=chunk) [Other Information](index=106&type=section&id=Item%209B.%20Other%20Information) No directors or officers adopted, terminated, or modified a Rule 10b5-1 trading arrangement during the fourth quarter of 2023 - No directors or officers adopted, terminated, or modified a Rule 10b5-1 trading arrangement during the **fourth quarter of 2023**[534](index=534&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=106&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - Not applicable[535](index=535&type=chunk) [PART III](index=107&type=section&id=PART%20III) [Directors, Executive Officers, Corporate Governance, Executive Compensation, Security Ownership, and Principal Accounting Fees](index=107&type=section&id=Items%2010%2C%2011%2C%2012%2C%2013%20and%2014) Information for Items 10 through 14, covering directors, executive officers, corporate governance, executive compensation, security ownership, and principal accounting fees, is incorporated by reference from the company's definitive Proxy Statement for the 2024 Annual Meeting of Stockholders - Information for Part III (Items 10-14) is incorporated by reference from the company's Proxy Statement for the 2024 Annual Meeting of Stockholders, to be filed within **120 days** of the fiscal year-end[537](index=537&type=chunk)[538](index=538&type=chunk)[539](index=539&type=chunk) [PART IV](index=108&type=section&id=PART%20IV) [Exhibits, Financial Statement Schedules](index=108&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section provides an index to the company's financial statements and a list of all exhibits filed with the Annual Report on Form 10-K, with no separate financial statement schedules provided - This section provides an index to the financial statements and lists all exhibits filed with the **10-K report**[540](index=540&type=chunk)[543](index=543&type=chunk) [Form 10-K Summary](index=112&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company has not provided a summary for its Form 10-K - None[547](index=547&type=chunk)

FORM 10-Q ______________________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________________ For the quarterly period ended September 30, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-38096 ________________________ ...

Drug Development and Clinical Trials - COSELA (trilaciclib) is the first FDA-approved therapy for myeloprotection during chemotherapy, conditionally approved in mainland China in July 2022[129][135]. - In a Phase 2 trial for metastatic triple-negative breast cancer (TNBC), trilaciclib demonstrated a median overall survival (OS) of 32.7 months compared to 10.5 months for chemotherapy alone, with a hazard ratio of 0.34[144]. - The ongoing pivotal Phase 3 trial (PRESERVE 2) for first-line mTNBC is expected to provide interim OS analysis results in Q1 2024[145]. - Trilaciclib has shown a >50% reduction in adverse events such as myelosuppression and diarrhea when combined with the ADC sacituzumab govitecan-hziy[146]. - The company is exploring trilaciclib's use in various cancers, focusing on metastatic TNBC and ADC combinations, with ongoing clinical trials to validate its benefits[137][143]. - In the Phase 2 trial for early-stage TNBC, high rates of pathologic complete response (pCR) were observed in patients with PD-L1(+) tumors, indicating trilaciclib's potential in enhancing immune responses[147]. - The median progression-free survival (PFS) was similar between patients receiving trilaciclib and those who did not in the ongoing Phase 2 study for metastatic urothelial carcinoma, with a median PFS of 6.0 months[148]. - Trilaciclib's mechanism of action includes enhancing long-term immune surveillance by increasing T cell function and memory T cell generation, which may improve clinical outcomes[142]. Financial Performance - COSELA generated net product sales of $21.6 million for the six months ended June 30, 2023, compared to $31.3 million for the year ended December 31, 2022[157]. - The company recorded $33.8 million in license revenue for the six months ended June 30, 2023, up from $20.0 million for the year ended December 31, 2022[157]. - Total revenues for the three months ended June 30, 2023, were $42.4 million, an increase of $31.8 million, or 301%, compared to $10.6 million for the same period in 2022[174]. - License revenue for the three months ended June 30, 2023, was $31.3 million, a significant increase of $29.4 million, or 1547%, compared to $1.9 million in 2022[176]. - Product sales, net increased to $11.1 million for the three months ended June 30, 2023, representing a growth of $2.4 million, or 28%, from $8.7 million in 2022[175]. - Total revenues for the six months ended June 30, 2023, were $55.3 million, an increase of $37.9 million, or 216%, compared to $17.5 million in 2022[184]. - License revenue for the six months ended June 30, 2023, was $33.8 million, an increase of $30.5 million, or 924%, compared to $3.3 million in 2022[186]. Expenses and Losses - The accumulated deficit as of June 30, 2023, was $750.9 million, primarily due to research and development costs[158]. - The company expects to continue incurring significant expenses and increasing operating losses as it develops trilaciclib and other product candidates[160]. - Research and development expenses decreased to $12.0 million for the three months ended June 30, 2023, down $8.8 million, or 42%, from $20.8 million in 2022[178]. - Selling, general and administrative expenses were $17.4 million for the three months ended June 30, 2023, a decrease of $8.3 million, or 32%, compared to $25.7 million in 2022[180]. - The company has experienced net losses since inception and anticipates continuing negative cash flows from operating activities[194]. Cash and Funding - As of June 30, 2023, the company had cash and cash equivalents of $55.9 million and marketable securities of $48.3 million[158]. - The company has funded its operations primarily through proceeds from its initial public offering, follow-on stock offerings, and a loan agreement with Hercules, with a total loan amount outstanding of $50.0 million as of June 6, 2023[195][206]. - The company believes existing cash and marketable securities will be sufficient to fund projected cash needs for at least the next 12 months[223]. - The loan agreement with Hercules has an outstanding principal of $50.0 million as of June 30, 2023, accruing interest at a variable rate[233]. Strategic Partnerships and Agreements - The company received a total of $66 million from Nanjing Simcere Dongyuan Pharmaceutical Co., Ltd for the development and commercialization of trilaciclib in Greater China, including a one-time payment of $30 million in April 2023[135][136]. - The company received a one-time, non-refundable payment of $30.0 million from Simcere for the relief of future royalty payments related to COSELA in Greater China[162]. - The company is eligible for up to $40.0 million in potential milestone payments from Genor Biopharma for the development of lerociclib[154]. - Under the Genor license agreement, the company received a non-refundable upfront cash payment of $6.0 million and has the potential to earn an additional $40.0 million upon reaching certain milestones[209]. - The EQRx license agreement included a non-refundable upfront cash payment of $20.0 million, with potential additional payments of up to $290.0 million based on milestones, but the agreement is expected to be terminated, reverting rights back to the company[211]. Workforce and Operational Changes - A workforce reduction of approximately 30% was approved, incurring costs of $1.4 million, fully paid off as of June 30, 2023[158]. - The company anticipates increased research and development, commercial activities, and selling, general and administrative expenses as it expands operations[160]. - The company expects expenses to increase as it continues the development of trilaciclib and seeks additional regulatory approvals for COSELA[222].