Extensive stage Small Cell Lung Cancer

Expands on the previously granted patents covering the use of REQORSA in combination with immune checkpoint inhibitors applicable to Genprex's Acclaim-2 and Acclaim-3 clinical trials AUSTIN, Texas, March 12, 2024 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that the Korean Patent Office has issued a Notice of Patent Grant for a broad patent that covers the use of Genprex's lead drug candidate, Reqorsa® Immunogene Therapy, in combination with anti-PD-1 and PD-L1 antibodies through 2037. This patent will expand on the previously granted patents in the U.S., Japan, Mexico, Russia, Australia, Chile and China to cover the use of REQORSA in combination with immune checkpoint inhibitors, e.g., PD-1 and PD-L1 inhibitors. These patents are applicable to Genprex's Acclaim-2 and Acclaim-3 clinical trials. "We continue to secure exclusivity for our drug combinations of REQORSA with PD-1 antibodies, such as Keytruda® and PD-L1 antibodies, such as Tecentriq®, for the treatment of cancer in some of the largest markets," said Thomas Gallagher, Esq., Senior Vice President of Intellectual Property and Licensing at Genprex. "It is important that we continue to add to our global intellectual property estate and to build protection around our drug combinations as we advance REQORSA through the clinic." The Acclaim-2 study is a Phase 1/2 clinical trial that has three portions - a Phase 1 dose escalation portion, a Phase 2a expansion portion, and a Phase 2b randomized portion. The Acclaim-2 trial uses a combination of REQORSA and Merck & Co.'s Keytruda® in patients with late-stage non-small cell lung cancer (NSCLC) whose disease has progressed after treatment with Keytruda. Patients are treated at the 0.06 mg/kg dose level in the first cohort of patients and, subject to the Acclaim-2 SRC approval, will be treated at successive dose levels of 0.09 mg/kg and 0.12 mg/kg. Genprex expects to complete enrollment in the Phase 1 dose escalation portion of the Acclaim-2 study in the second half of 2024. Genprex was granted FDA Fast Track Designation for the Acclaim-2 patient population. The Acclaim-3 study has two portions - a Phase 1 dose escalation portion and a Phase 2 expansion portion. In November 2022 Genprex filed with the FDA the protocol for the Phase 1/2 Acclaim-3 clinical trial using a combination of REQORSA and Genentech's Tecentriq® as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC) who develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. The Phase 1 portion of the Acclaim-3 study is open for enrollment, and Genprex expects to complete the Phase 1 portion of the study by the second half of 2024. Genprex was granted FDA Fast Track Designation and Orphan Drug Designation for the Acclaim-3 patient population. About Genprex, Inc. Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex's technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex's oncology program utilizes its systemic, non-viral Oncoprex® Delivery System which encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company's lead product candidate, Reqorsa® Immunogene Therapy (quaratusugene ozeplasmid), is being evaluated in three clinical trials as a treatment for NSCLC and SCLC. Each of Genprex's three lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex's SCLC program has received an FDA Orphan Drug Designation. Genprex's diabetes gene therapy approach is comprised of a novel infusion process that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body's immune system. In a similar approach, GPX-003 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells. Interested investors and shareholders are encouraged to sign up for press releases and industry updates by visiting the Company Website, registering for Email Alerts and by following Genprex on Twitter, Facebook and LinkedIn. Cautionary Language Concerning Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex's reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under "Item 1A – Risk Factors" in Genprex's Annual Report on Form 10-K for the year ended December 31, 2022. Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Genprex's ability to advance the clinical development, manufacturing and commercialization of its product candidates in accordance with projected timelines and specifications; the timing and success of Genprex's clinical trials and regulatory approvals; the effect of Genprex's product candidates, alone and in combination with other therapies, on cancer and diabetes; Genprex's future growth and financial status, including Genprex's ability to maintain compliance with the continued listing requirements of The Nasdaq Capital Market and to continue as a going concern and to obtain capital to meet its long-term liquidity needs on acceptable terms, or at all; Genprex's commercial and strategic partnerships, including those with its third party vendors, suppliers and manufacturers and their ability to successfully perform and scale up the manufacture of its product candidates; and Genprex's intellectual property and licenses. These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law. Genprex, Inc. (877) 774-GNPX (4679) GNPX Investor Relations [email protected] GNPX Media Contact Kalyn Dabbs [email protected] SOURCE Genprex, Inc.

Reqorsa® Immunogene Therapy May be a Potential Therapy for ALK-Positive Lung Cancer REQORSA has Anti-Tumor Mechanisms that Target and Disrupt the Metabolism of Cancer Cells NPRL2 Gene Therapy Induces Effective Anti-Tumor Immunity in Non-Small Cell Lung Cancer Humanized Mouse Model AUSTIN, Texas, March 6, 2024 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that its research collaborators will present at the upcoming 2024 American Association for Cancer Research (AACR) Annual Meeting being held April 5-10, 2024 in San Diego, California. The collaborators will present positive preclinical data from studies of its lead product candidate, Reqorsa® Immunogene Therapy (quaratusugene ozeplasmid), as well as NPRL2 gene therapy, which both utilize the Company's non-viral Oncoprex® Delivery System for the treatment of lung cancer. "We are delighted to have our academic partners present this compelling body of preclinical evidence that support the therapeutic use of REQORSA to deliver the functioning TUSC2 gene to cancer cells. The data also highlights the potential use of our non-viral ONCOPREX Delivery System to deliver other tumor suppressor genes, such as the NPRL2 gene," said Rodney Varner, Chairman, President and Chief Executive Officer at Genprex. "We are pleased to have favorable results from three preclinical studies presented to an audience of global oncology specialists, providing further validation of the value of REQORSA and ONCOPREX in the fight against cancer." Featured Genprex-supported posters to be presented at AACR 2024 include: Title: "Quaratusugene ozeplasmid mediated TUSC2 upregulation in EML4-ALK bearing Non-Small Cell Lung Carcinoma can induce cellular apoptosis" Session Category: Molecular/Cellular Biology and Genetics Session Title: Apoptosis and Ferroptosis Session Date and Time: Sunday, April 7 from 1:30 pm – 5:00 p.m. PT Location: Poster Section 15 Poster Board Number: 7 Abstract Presentation Number: 351 Anaplastic Lymphoma Kinase (ALK) is a strong oncogenic driver in non-small cell lung carcinoma (NSCLC) and contributes to ~5% of NSCLC as a distinct clinicopathological subset. In this nonclinical study TUSC2 expression in three ALK+ cell lines were evaluated before and after exposure to REQORSA, referred to as TUSC2 gene therapy in the abstract, and to a TUSC2-containing plasmid. Researchers at the University of Michigan Rogel Cancer Center Judith Tam ALK NSCLC research initiative found that overexpressing TUSC2 via REQORSA treatment in ALK+ lung cancer cell lines had the ability to inhibit colony formation by 50%, which indicates that REQORSA inhibits growth of ALK+ lines. Additionally, researchers documented a strong pro-apoptotic response to TUSC2 expression in ALK+ NSCLC. The study found that the use of REQORSA or a TUSC2-containing plasmid to overexpress TUSC2 in ALK+ NSCLC cell lines was effective in decreasing cell growth and proliferation. Researchers believe the results support further clinical study of REQORSA as an anti-ALK NSCLC treatment strategy. Title: "Tumor Suppressor Gene TUSC2 suppresses energy metabolism in lung cancer cells with opposite effects in normal bronchial epithelial cells" Session Category: Experimental and Molecular Therapeutics Session Title: Cancer Biology and Metastasis Session Date and Time: Monday, April 8 from 1:30 p.m. – 5:00 p.m. PT Location: Poster Section 22 Poster Board Number: 6 Abstract Presentation Number: 3158 TUSC2 is a tumor suppressor gene often deleted in lung cancers and reduced TUSC2 expression is observed in approximately 80% of lung cancers. TUSC2 is also reduced in mesothelioma, breast, head-and neck, osteosarcoma, glioblastoma, and other cancers, which suggests the important anti-tumor role of TUSC2. Additionally, TUSC2 is known to play a critical role in mitochondrial respiration/energy metabolism as TUSC2 protein localizes to the mitochondria. Here, researchers investigated how human lung cancer cell lines A549 and H358, with decreased TUSC2 expression, alter their energy metabolism when TUSC2 protein is re-introduced. The study found that the TUSC2-deficient cancer cells consistently exhibited decreased glycolytic rates and mitochondrial ATP production. This is significant as it left these cells without enough energy to support their vital functions. By comparison, when Beas2B, a normal human bronchial epithelial cell line with normal levels of TUSC2, was transfected with a TUSC2 containing plasmid, the glycolytic rate and mitochondrial metabolism was increased, which suggests that this may be the mechanism by which REQORSA treatment affects immune and other non-cancerous cells that leads to increased immune response against tumors. The study further suggested that REQORSA may play an important role as a cancer treatment to target and disrupt the metabolism of cancer cells, leading to a decrease in the rate of glycolysis. Genprex currently has three clinical trials evaluating REQORSA in lung cancer. All three clinical trials have received U.S. Food and Drug Administration (FDA) Fast Track Designation. The Acclaim-1 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Tagrisso® (osimertinib) in patients with late-stage NSCLC with activating epidermal growth factor receptor (EGFR) mutations whose disease progressed after treatment with Tagrisso. Genprex completed the Phase 1 dose escalation portion of the trial and has already dosed the first patient in the Phase 2a expansion portion of the trial. The Acclaim-2 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Keytruda® (pembrolizumab) in patients with late-stage NSCLC whose disease progressed after treatment with Keytruda. The Acclaim-3 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Tecentriq® (atezolizumab) as maintenance therapy in patients with extensive-stage small-cell lung cancer (ES-SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as an initial treatment. The Acclaim-3 clinical trial also has FDA Orphan Drug Designation. Title: "Mechanism of NPRL2 gene therapy induced anti-tumor immunity in KRAS/STK11mt aPD1 resistant metastatic NSCLC" Session Category: Immunology Session Title: Inflammation, Host Factors, and Epigenetic Influences on Cancer Development and Treatment Session Date and Time: Monday, April 8 from 9:00 a.m.– 12:30 p.m. PT Location: Poster Section 5 Poster Board Number: 18 Abstract Presentation Number: 1420 Among other cancer types, NSCLC often has reduced NPRL2, a tumor suppressor gene, and the restoration of NPRL2 activates cell cycle arrest and apoptosis. In this humanized mouse model, researchers investigated the anti-tumor immune responses to NPRL2 gene therapy in pembrolizumab resistant KRAS/STK11mt NSCLC. In the study, induced lung metastases in humanized mice were treated through I.V. injection of NPRL2 nanoparticles, made with the ONCOPREX Delivery System, with or without pembrolizumab. The study found that the NPRL2 treatment decreased lung metastases but pembrolizumab had no effect. Additionally, a greater anti-tumor effect was seen in humanized compared to non-humanized mice, demonstrating that immune cells play a role in the effects of the NPRL2 nanoparticle therapy. Study findings suggest that NPRL2 gene therapy induces anti-tumor activity against KRAS/STK11mt tumors through dendritic cell-mediated antigen presentation and cytotoxic immune cell activation. Genprex Commentary: "Today's bolus of compelling data validates the potential of REQORSA and the ONCOPREX Delivery System as innovative cancer treatments. We were very encouraged to see the data document REQORSA's anti-tumor properties and demonstrate its ability to suppress cell growth and trigger cancer cell death," said Mark Berger, MD, Chief Medical Officer at Genprex. "These data are particularly significant as decreased TUSC2 expression is seen in approximately 80% of lung cancers, and REQORSA has the potential to address a large patient population. Additionally, data showing NPRL2 gene therapy induced anti-tumor activity further positions Genprex to expand its clinical pipeline with another drug candidate, and it reinforces the value of ONCOPREX's ability to deliver genes beyond TUSC2. We look forward to continuing to evaluate the ONCOPREX Delivery System using both REQORSA and NPRL2 as potential treatments for lung cancer." About Genprex, Inc. Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex's technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex's oncology program utilizes its systemic, non-viral Oncoprex® Delivery System which encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company's lead product candidate, Reqorsa® Immunogene Therapy (quaratusugene ozeplasmid), is being evaluated in three clinical trials as a treatment for NSCLC and SCLC. Each of Genprex's three lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex's SCLC program has received an FDA Orphan Drug Designation. Genprex's diabetes gene therapy approach is comprised of a novel infusion process that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body's immune system. In a similar approach, GPX-003 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells. For more information, please visit the Company's web site at or follow Genprex on Twitter, Facebook and LinkedIn. Cautionary Language Concerning Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex's reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under "Item 1A – Risk Factors" in Genprex's Annual Report on Form 10-K for the year ended December 31, 2022. Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Genprex's ability to advance the clinical development, manufacturing and commercialization of its product candidates in accordance with projected timelines and specifications; the timing and success of Genprex's clinical trials and regulatory approvals; the effect of Genprex's product candidates, alone and in combination with other therapies, on cancer and diabetes; Genprex's future growth and financial status, including Genprex's ability to maintain compliance with the continued listing requirements of The Nasdaq Capital Market and to continue as a going concern and to obtain capital to meet its long-term liquidity needs on acceptable terms, or at all; Genprex's commercial and strategic partnerships, including those with its third party vendors, suppliers and manufacturers and their ability to successfully perform and scale up the manufacture of its product candidates; and Genprex's intellectual property and licenses. These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law. Genprex, Inc. (877) 774-GNPX (4679) GNPX Investor Relations investors@genprex.com GNPX Media Contact Kalyn Dabbs media@genprex.com Company Codes: NASDAQ-NMS:GNPX

- Achieved $46.3 Million in Net Revenue from Sales of COSELA® (trilaciclib) for Full Year 2023, Representing 48% Growth Over 2022; Provided 2024 Net COSELA Revenue Guidance of $60 to $70 Million - - Net COSELA Revenue Grew 29% in the Fourth Quarter of 2023 to $13.9 Million - - Announced That Final Analysis of Phase 3 PRESERVE 2 Trial Evaluating Overall Survival in Metastatic Triple Negative Breast Cancer is Estimated to Occur in the Third Quarter of 2024 - - Presented New Analyses Indicating that Patients Who Previously Received Trilaciclib in a Clinical Trial Setting Experienced Improved Overall Survival with Subsequent Anticancer Therapies - - Provided Initial Results from Phase 2 Trial in Combination with a TROP2 Antibody-Drug Conjugate Indicating Improvements in Overall Survival for Patients Receiving Trilaciclib - - Management to Host Webcast and Conference Call today at 8:30 AM ET - RESEARCH TRIANGLE PARK, N.C., Feb. 28, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today provided a corporate and financial update for the fourth quarter and full year ended December 31, 2023. “The strong fourth quarter 2023 vial volume growth of COSELA, which has continued through the beginning of 2024, highlights not only the importance of this unique drug to oncologists treating people living with extensive-stage small cell lung cancer, but also the significant addressable market still available to us as we drive continued penetration and growth,” said Jack Bailey, Chief Executive Officer of G1 Therapeutics. “Looking ahead, our primary clinical focus is on completing our ongoing trials of trilaciclib in metastatic triple negative breast cancer, including our pivotal PRESERVE 2 trial. We remain confident in the potential of trilaciclib in this trial given the robust long term survival benefit observed in prior trials and the increased statistical power for the final analysis. If successful, we would work closely with the U.S. Food and Drug Administration to expeditiously file for label expansion and bring this therapy to patients as quickly as possible." Fourth Quarter 2023 and Recent Highlights Financial Recognized $13.9 Million and $46.3 Million in Net COSELA Revenue for the Fourth Quarter and Full Year 2023: Net COSELA revenue and vial volume grew 29% and 19%, respectively, during the fourth quarter over the third quarter of 2023 despite the impact of a platinum-based chemotherapy shortage. G1 recognized total revenues of $14.9 million and $82.5 million for the fourth quarter and full year of 2023, respectively. Cash Runway Extends into 2025: G1 ended 2023 with cash, cash equivalents, and marketable securities of $82.2 million. Clinical Final Analysis of the Phase 3 PRESERVE 2 Trial in Metastatic Triple Negative Breast Cancer (mTNBC) is Estimated to Occur in the Third Quarter of 2024: G1 announced that the Independent Data Monitoring Committee (DMC) recommended continuation of the Phase 3 PRESERVE 2 trial, evaluating trilaciclib in combination with gemcitabine and carboplatin for 1L treatment of mTNBC, to the final analysis. The DMC did not express any concerns or recommend any other changes to the study. The final analysis will be conducted on the intent-to-treat (ITT) population. G1 remains blinded to all data. (See February 12, 2024 press release here) Initial Efficacy Results from Ongoing Phase 2 Antibody-Drug Conjugate (ADC) Trial Suggest Improved Overall Survival (OS) Among Patients Receiving Trilaciclib in Combination with a TROP2 ADC: The preliminary data provided in January 2024 from the ongoing Phase 2 trial of trilaciclib in combination with the ADC sacituzumab govitecan (SG) in patients with mTNBC patients suggested clinically meaningful improvements in OS among patients receiving trilaciclib in combination with SG compared to SG alone (using historical data from the ASCENT study), including (1) median OS of 17.9 months with trilaciclib versus 12.1 months for SG alone and (2) estimated 12-month survival of 59% of patients receiving trilaciclib in combination with SG, representing a ~20% improvement over SG alone. The Company expects to provide updated OS results from this study mid-2024. (See January 8, 2024 J.P. Morgan update press release here) Medical Presented New Post Hoc Analyses Indicating that Patients Who Previously Received Trilaciclib Experienced Improved OS with Subsequent Anticancer Therapies (SACT): G1 presented new data at the 2023 San Antonio Breast Cancer Symposium (SABCS) from patients with mTNBC who participated in G1’s Phase 2 trial. These data indicate that patients who received trilaciclib with their cytotoxic chemotherapy during the trial and then received SACT after trilaciclib discontinuation exhibit statistically significant and clinically meaningful improvements in median OS (32.7 months versus 12.8 months; p=0.001). Additionally, median OS for patients who received prior trilaciclib was improved from the time they started their first SACT compared to patients who did not receive prior trilaciclib (14.0 months versus 5.8 months; p=0.001). (See December 5, 2023 SABCS press release here) Presented Four Posters During the 2023 ASCO Quality Care Symposium: These provide new real-world evidence indicating that trilaciclib administered prior to chemotherapy in patients with extensive-stage small cell lung cancer (ES-SCLC) lowers the rate of hospitalization and cytopenia events and may improve survival. (See October 27, 2023 ASCO Quality Care Symposium press release here) COSELA Recommended as a Myeloid Supportive Agent in the Updated ASCO SCLC Guidelines: The SCLC guidelines provide evidence-based recommendations to practicing clinicians on the management of patients with SCLC. (See October 18, 2023 ASCO Guidelines press release here) Fourth Quarter and Full Year 2023 Financial Results As of December 31, 2023, cash, cash equivalents and marketable securities totaled $82.2 million, compared to $145.1 million as of December 31, 2022. Total revenues for the fourth quarter of 2023 were $14.9 million, including $13.9 million in net product sales of COSELA and license revenue of $1.0 million, primarily related to supply and manufacturing services from Simcere and patent and clinical trial costs reimbursed primarily by EQRx and Simcere, compared to $10.3 million in total revenues in the fourth quarter of 2022. Total revenues for the full year 2023 were $82.5 million, including net product revenue of $46.3 million from sales of COSELA and license revenue of $36.2 million, compared to total revenues of $51.3 million in the prior year. Operating expenses for the fourth quarter of 2023 were $23.8 million, compared to $41.1 million for the fourth quarter of 2022. GAAP operating expenses include stock-based compensation expense of $3.2 million for the fourth quarter of 2023, compared to $4.4 million for the fourth quarter of 2022. Operating expenses for the full year 2023 were $122.0 million, compared to $187.5 million for the prior year. Stock-based compensation expense for the full year 2023 was $14.5 million, compared to $20.6 million for the prior year. Cost of goods sold expense for the fourth quarter of 2023 was $1.3 million, compared to $1.0 million for the fourth quarter of 2022, primarily due to an increase in product sales. Cost of goods sold expense for the full year 2023 was $7.2 million, compared to $3.7 million for the prior year. Research and development (R&D) expenses for the fourth quarter of 2023 were $7.4 million, compared to $16.6 million for the fourth quarter of 2022. The decrease in R&D expenses was primarily due to a decrease in the Company's clinical program costs. R&D expenses for the full year 2023 were $43.7 million, compared to $83.3 million for the prior year. Selling, general, and administrative (SG&A) expenses for the fourth quarter of 2023 were $15.2 million, compared to $23.6 million for the fourth quarter of 2022. The decrease in SG&A expenses was primarily due to decreases in commercialization activities, personnel costs, and medical affairs. SG&A expenses for the full year 2023 were $71.1 million, compared to $100.4 million for the prior year. The net loss for the fourth quarter of 2023 was $10.9 million, compared to $33.6 million for the fourth quarter of 2022. Net loss for the full year 2023 was $48.0 million, compared to a net loss of $147.6 million for the prior year. The basic and diluted net loss per share for the fourth quarter of 2023 was $(0.21), compared to $(0.73) for the fourth quarter of 2022. The basic and diluted net loss per share for the full year 2023 was $(0.93) compared to $(3.38) for the prior year. 2024 Financial Guidance G1 today provided full year 2024 financial guidance. The Company expects to generate between $60 million and $70 million in COSELA net revenue in 2024. G1's product revenue guidance is based on expectations for continued acceleration of sales performance of COSELA in the U.S. Additionally, the Company believes that its current cash runway is sufficient to fund its operations into 2025. Webcast and Conference Call G1 will host a webcast and conference call at 8:30 a.m. ET today to provide a corporate and financial update for the fourth quarter and full year ended December 31, 2023. Please note the following process to access the call via telephone: To register 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 to join 10 minutes prior to the start of the event. A live and archived webcast will be available on the Events & Presentations page of the Company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event. About COSELA® (trilaciclib) for Injection COSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021. Indication COSELA® (trilaciclib) is indicated 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. Important Safety Information COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib. Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity. The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia. This information is not comprehensive. Please click here for full Prescribing Information. https://www.g1therapeutics.com/cosela/pi/ To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch. About G1 Therapeutics G1 Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of next generation therapies that improve the lives of those affected by cancer, including the Company’s first commercial product, COSELA® (trilaciclib). G1 has a deep clinical pipeline and is executing a development plan evaluating trilaciclib in a variety of solid tumors, including breast, lung, and bladder cancers. G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on X (formerly known as Twitter) @G1Therapeutics and LinkedIn. G1 Therapeutics® and the G1 Therapeutics logo and COSELA® and the COSELA logo are trademarks of G1 Therapeutics, Inc. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," “could”, “believe,” “goal”, “projections,” "estimate," "intend," “indicate,” “potential,” “opportunity,” “suggest,” 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 press release include, but are not limited to, those related to the potential of trilaciclib in the Phase 3 PRESERVE 2 trial for reasons including the robust long term survival benefit observed in prior trials and the increased statistical power for the final analysis, are based on the company’s expectations and assumptions as of the date of this press release. 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 press release 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 dependence on the commercial success of COSELA (trilaciclib); the development and commercialization of new drug products is highly competitive; the Company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; 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; chemotherapy shortages and market conditions. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. G1 Therapeutics Contacts: John W. Umstead VChief Financial Officer919-747-8419jumstead@g1therapeutics.com Will RobertsCommunications OfficerVice President, Investor Relations & Corporate Communications919-907-1944 wroberts@g1therapeutics.com G1 Therapeutics, Inc.Balance Sheet Data(in thousands) December 31, 2023 December 31, 2022Cash and cash equivalents and Marketable securities$82,156 $145,070 Working Capital$85,232 $143,912 Total Assets$121,540 $187,965 Accumulated deficit$(779,985) $(732,018)Total stockholders' equity$35,386 $68,747 G1 Therapeutics, Inc.Condensed Statements of Operations(in thousands, except share and per share amounts) Three Months EndedDecember 31, Twelve Months EndedDecember 31, 2023 2022 2023 2022 Revenues(unaudited) Product sales, net$13,922 $8,870 $46,344 $31,337 License revenue 951 1,380 36,167 19,964 Total revenues 14,873 10,250 82,511 51,301 Operating expenses Cost of goods sold 1,256 992 7,195 3,748 Research and development 7,380 16,587 43,711 83,316 Selling, general and administrative 15,166 23,558 71,132 100,415 Total operating expenses 23,802 41,137 122,038 187,479 Loss from operations (8,929) (30,887) (39,527) (136,178)Other income (expense) Interest income 529 478 2,473 748 Interest expense (2,124) (2,996) (10,038) (10,432)Other income (expense) 548 237 2,240 3 Total other income (expense), net (1,047) (2,281) (5,325) (9,681)Loss before income taxes (9,976) (33,168) (44,852) (145,859)Income tax expense 902 481 3,115 1,700 Net loss$(10,878) $(33,649) $(47,967) $(147,559)Net loss per share, basic and diluted$(0.21) $(0.73) $(0.93) $(3.38)Weighted average common shares outstanding, basic and diluted 51,838,834 46,279,808 51,733,487 43,626,113